Activity Average Burden 45 Revisions to State Reporting Requirements Report 90th percentile lead levels for large and medium PWSs 1,403 Modify milestones/ delete requirement to report compliance with LSLR schedule 15,724 Changes in violation and enforcement reporting  4,167 Reporting to State data base ( Record Keeping)  7,889 TOTAL 50,055 6( a)( ii)( a) Overhead Overhead includes supervisory staff and clerical staff to support the LCRMR, and annual nonrule specific training for all staff involved in the implementation/ oversight of the rule ( including supervisory and clerical staff). Overhead is determined by first estimating the number of technical FTEs nationally from all the State models ( oversight, reporting, record keeping) and applying the following percentages:

Supervision 10% Clerical 11% On going Training for State personnel 1.9% ( 5 days per FTE)

As an example, if 100 technical FTEs were needed in X year, then 10 supervisors, 11 clerical staff, and 1.9 FTEs worth of training or a total of 22.9 FTEs in overhead would be needed to support the LCRMR. For 1999 through 2001, the overhead is estimated to average 8,029 hours per year. The amount of overhead greatly fluctuates from year to year due to changes in the number of technical FTEs estimated over time. These fluctuations correspond primarily to start up activities and the lead and copper monitoring cycles.

6( a)( ii)( b) Notify Systems of Requirements The 1991 ICR assumed that $ 1.0 million would be required to notify systems of the original rule requirements and $ 0.7 million to notify systems of the requirements, thereafter. The Agency estimates States will also require $ 1.0 million to notify systems of the LCRMR requirements in 1999 and $ 0.7 million thereafter. The 1991 ICR assumed a work year of 1,920 hours per year per FTE and $ 50,000 per year ( fully burdened cost) or an average hourly rate of $ 26.04. Based on these assumptions, the $ 1.0 million equals approximately 674 hours per State ($ 1.0 million /$ 26.04/ 57 respondents) and $ 0.7 million June 1999 50 The State estimates presented in the 1991 LCR ICR and Drinking Water ICR were based on 57 State respondents. Since the 1991 ICR was prepared, the number of U. S. Territories has dropped to 6, resulting in a total of 56 State respondents.

51 SDWIS/ State is a data base that is currently being developed by EPA for use by the States to track compliance with the drinking water regulations. It is scheduled to be completed in 2000. Approximately 20 States are anticipated to use SDWIS/ State to manage their LCR tracking.

46 equals approximately 472 hours per State ($ 0.7 million /$ 26.04/ 57 respondents). 50 The net increase to States resulting from the LCRMR will be an increase in 1999 of 202 hours per State ( i. e., 674 hours  472 hours) or a total of 11,312 hours. Expressed as a three year average, States will incur an average increase in burden of 3,771 hours.

6( a)( ii)( c) Initial Activities During the 1999 through 2001 time frame, States will adopt the regulation, learn the new requirements, and modify the State data system to allow automated reporting of the new milestones to SDWIS. These activities are assumed to be " start up" activities and to occur in the three year ICR period only. Each of these activities is discussed in more detail below.

Regulatory Adoption. Each State is assumed to require 0.25 FTEs ( 520 hours) in 1999 for adoption of the LCRMR. This equals a total burden of 29,120 hours or an average of 9,707 hours over the three years.

Training. Each State is assumed to require a total of 375 hours of training on the LCRMR in 1999. EPA assumed that States would require 50 percent less time to become familiar with the requirements of the LCRMR than the 1991 LCR. The initial burden to review the LCR was derived from Table 10 of the ICR for the original LCR. The 1991 ICR assumed that $ 1.1 million would be required to train staff. Based on the 1991 State hourly rate of $ 26.04 and 57 respondents, the $ 1.1 million equals approximately 42,240 hours or 741 hours per system ($ 1.1 million /$ 26.04/ 57 respondents). Assuming 50 percent of this effort is needed to learn the LCRMR requirements, each State would require about 375 hours of training. Over 1999 through 2001, this will result in an average increase in burden of 7,000 hours.

Modify the State data system to accommodate new requirements. The Agency assumes that 36 of the 56 States will modify their existing data system to accommodate the new " Done" and " Deemed" milestone and will require 0.6 FTEs ( 1,248 hours) and contractor support to complete this effort. This equals an average annual burden of 14,976 hours. The remaining 20 States will use SDWIS/ State as their data system. 51 The burden and cost to modify SDWIS/ State will be incurred by EPA and is discussed in more detail in Section 6( c).

6( a)( ii)( d) Review of Lead and Copper Tap and WQP Monitoring Data and Related Information June 1999 52 Systems serving 100 or fewer people can only reduce the frequency of their lead and copper tap monitoring collection but not the number of samples. These systems must collect 5 samples whether they are on standard or reduced monitoring.

47 Overall States are estimated to incur an average annual increase in burden associated with the review of lead and copper tap and WQP monitoring data, and other related information of 2,913 hours. The reasons for this increase are discussed in more detail below.

Review of monitoring results for ( b)( 3) systems. Under the LCRMR, States are assumed to review lead and copper data for the 171 large ( b)( 3) systems. These systems will monitor once during the three year ICR period and submit an average of 57 sets of results and supporting documentation. States are assumed to require 1 hour to review this information. Over the ICR period, this will equal a burden increase of 57 hours per year.

Request use of non first draw samples. The Agency assumes that a total of 1,000 systems will provide documentation to the State that supports the need for the systems to collect non first draw samples. Fifty percent of the States are assumed to review and approve this monitoring prior to its start and would require 1 hour per system. The other 50 percent are assumed to review this information with the sample results and to require 0.5 hours to review the justification. Therefore, an average of 45 minutes per system was used in this calculation. This translates to a total burden of 750 hours or an average of 250 hours.

Specify reduced monitoring sites. The Agency assumes that States would designate reduced sampling sites for 9,847 systems in total ( i. e., 20% of the 49,239 systems serving > 100 people). 52 States are also assumed to require 0.5 hours per system to complete this activity. This equals an average annual burden increase of 1,642 hours.

Accelerated reduced monitoring. States are estimated to review fewer rounds of monitoring at an average burden of 1 hour per monitoring event. The average burden reduction for 1999 through 2001 is estimated to be 1,807 hours.

Monitoring waivers. State will experience an overall reduction in burden associated with this provision. States will incur a burden for reviewing and replying to each waiver request. States are assumed to require 0.5 hours to review these applications. The model estimates that 6,809 systems will apply for a waiver in 1999. States will spend an estimated 3,405 hours for this effort or an average of 1,135 hours over the three years, but will experience an annual reduction in burden associated with the review of less data of 2,270 hours. The net average annual burden reduction for 1999 through 2001 is estimated to be 1,135.

WQP tap monitoring at representative entry points by ground water systems. States are assumed to spend 0.5 hours reviewing a system's request to limit entry point monitoring to representative sites. A total of 397 systems is expected to make this request. This equals a total burden of 199 hours or an average of 66 hours over the three years. The procedure June 1999 48 for estimating State burden and cost associated with the review of WQP monitoring data is to assume that the State requires 3.42 hours per 6 month monitoring period to conduct this review. No reduction in burden or cost is assumed because the revision does not change the number of WQP entry point monitoring events.

State flexibility to calculate 90th percentile levels. Based on data verification reviews conducted in State drinking water offices, the Agency estimates that approximately 50 percent of the States will calculate the 90th percentile levels for the systems. As a simplifying assumption, the number of systems are assumed to be evenly distributed among the States and therefore, this calculation will be performed for half of the systems. The State burden associated with determining the 90th percentile lead and copper values is assumed to be 10 minutes to 2 hours. This equals an average annual burden increase of 2,077 hours over the three year ICR period. The actual additional burden to States may be negligible because many States already perform or validate this calculation.

Changes in treatment or addition of a new source for systems on reduced monitoring. States are assumed to require 0.5 hours to review documentation explaining changes in treatment or an addition of a new source and to determine whether additional action by the system is needed. EPA assumes in most cases that States will not require systems to take additional action. Two percent of systems per year that collect lead and copper tap samples on a reduced schedule are assumed to report a change in treatment or an addition of a new source. During the 1999  2001 time period, systems will submit an average of 527 reports per year. The burden associated with this review averages 264 hours over the three years.

Review of compliance with optimal WQPs. States are assumed to require an average of 6.83 hours per system per year to review compliance with OWQPs using the revised criteria for OWQP compliance. This translates to an extra 10 minutes per report. Over the three year ICR period, States will review an average of 10,493 reports per year and will incur an average of 1,740 additional hours to assess compliance. Although, the new criteria to assess compliance is projected to increase burden, the new compliance criteria is expected to reduce the number of treatment technique violations and associated enforcement actions, and could result in fewer systems being triggered back into standard lead and copper tap monitoring. These burden reductions are discussed below under the sections 6( a)( ii)( h) and 6( a)( ii)( i).

Review of reasons for changes in lead and copper tap monitoring location. States are also expected to experience burden reductions in areas that have not been directly revised by LCRMR. One of these is the review of reasons for changes in lead and copper tap monitoring location. Fewer letters are expected to be submitted by systems because there are fewer monitoring events due to monitoring waivers and accelerated reduced lead and copper monitoring. The model assumes that 50 percent of CWSs, conducting lead and copper tap monitoring, will submit letters explaining the need to change monitoring locations. NTNCWSs are assumed to control access to their monitoring locations and not to submit such explanations. During 1999 through 2001, States are estimated to review a June 1999 49 total of 4,331 fewer letters explaining reasons for changes in lead and copper tap monitoring location. States would have required 10 minutes to review these explanations. This translates to an average burden reduction of 241 hours.

Some of the lead and copper tap and WQP related revisions are not expected to have a quantifiable impact on State burden or are captured under other activities. These provisions are discussed in more detail below:

Meet copper action level for ( b)( 3) systems. This revision is not expected to have a quantifiable impact on State oversight, reporting, or record keeping burden because EPA assumes that few of the estimated 171 ( b)( 3) systems will exceed the copper action level and be triggered into increased monitoring or be required to install corrosion control treatment.

Designation of alternative monitoring schedule for systems on reduced monitoring. EPA assumes that States will make blanket decisions regarding which systems should conduct reduced monitoring in months other than June  September. EPA also assumes that States will have a data base that will allow them to easily identify seasonal NTNCWSs that do not operate during the summer months. States are assumed to incorporate their policy into their regulation or to provide a form letter to the systems. This burden is assumed to be captured under the burden to adopt the regulation or to notify the system of requirements.

Requests for reduced monitoring for PWSs meeting optimal WQPs. No burden reduction is assumed for States to no longer review requests from systems meeting their OWQPs to be placed on reduced monitoring. States are still required to determine whether such systems qualify for reduced monitoring and to notify the systems in writing of these determinations.

Sample Invalidation. EPA that less than 0.5 percent of systems each monitorng period ( about 380 systems) will seek to have samples invalidated. EPA assumes that States will need 0.5 hours to review these submissions. EPA also anticipates that some systems will be able to avoid the burden associated with increased monitoring or the installation of treatment, and that States will avoid the oversight, reporting, and record keeping burden associated with these activities. The Agency, therefore, estimates no net change in burden resulting from this provision.

Accelerated reduced WQP tap monitoring. States must review both tap and entry point WQP results to assess compliance. The accelerated reduced WQP tap monitoring provision does not impact the number of entry point monitoring events, which constitutes most of the WQP monitoring data. Therefore, no quantifiable impact on States is expected.

Sample certification and justifications. Under the LCRMR, States will no longer be required to review a system's justification explaining why its sampling pool contained insufficient Tier 1 sites or sites served by lead service lines or certifications that a sample June 1999 50 is first draw or was collected properly by the homeowner. The Agency assumes the burden to review these justifications to be negligible and assumes there to be no quantifiable State burden resulting from this revision.

6( a)( ii)( e) Source Water Monitoring States will review less source water monitoring data for the 5,384 systems that are now expected to be eligible for reduced source water monitoring. During the 1999 through 2001 time frame, an average of 926 of these systems would have submitted source water monitoring results during each of the three years. States are assumed to save 0.5 hours per monitoring event and incur an average reduction in burden of 463 hours over the 1999 through 2001 time period.

6( a)( ii)( f) Public Education

Change in reporting deadline. Due to the change in the deadline for reporting compliance with public education requirements, medium and large systems are expected to submit one additional report each year. Under the LCRMR, small systems are no longer required to deliver public service announcements and therefore, would continue to submit only one report ( public service announcements are required every six months). By 1999, only those systems continuing to exceed after treatment are expected to be delivering public education materials. A total of 397 medium and large systems are estimated to submit one additional reports each year. States are assumed to require 20 minutes to review each letter. This translates to an average increase in burden of 129 hours.

Deletion of reference to information on building permit record availability from mandatory language. States are assumed to incur a one time burden in 2000 to review requests from 10 percent of CWSs required to deliver public education ( 337 systems) to remove reference building permit record availability from their mandatory public education language. States are assumed to require 0.5 hours to review these requests. This equals an average annual burden of 56 hours per year.

Public education provisions for which no burden is quantified. The following revisions to the public education provisions are not expected to have a quantifiable impact on State burden because States are assumed to identify in their regulations when and to which systems such provisions apply, as follows:

S Use of alternative mandatory language for NTNCWSs and special CWSs;

S Removal of reference to lead service lines from the mandatory language; and,

S NTNCWSs use of e mail to distribute public education information.

In addition, the Agency could not quantify the burden to States to allow systems to no longer include a distribution list as part of their public education compliance letter, in those instances where systems have not made changes to this list. However, the Agency does June 1999 51 anticipate some change in record keeping burden for the State to track to which systems this provision applies.

6( a)( ii)( g) Lead Service Line Replacement

Review of Partial Lead Service Line Compliance Letters. Based on comments received on the April 1998 Notice of Data Availability, EPA assumes that 75 percent of the States will require those systems replacing lead service lines to submit information that demonstrates compliance with partial lead service line monitoring and notification requirements. As a simplifying assumption, the number of systems are assumed to be evenly distributed among States and therefore, this provision will impact 75 percent of systems. States are also assumed to review an average of 4,809 letters during the threeyear ICR period and to require 0.5 hours to review each letter. This equals an average annual burden of 2,405 hours.

Flexibility to Allow Shorter Notification Period. States have the discretion to allow less than a 45 day advance notice in those instances where the partial replacement is being performed in conjunction with emergency repairs. EPA assumes that States electing to exercise this flexibility will incorporate this provision into their regulations versus making case by case decisions. This burden is assumed to be covered in 0.25 FTEs needed for regulatory adoption.

6( a)( ii)( h) Enforcement A decrease in the number of violations is expected in some years due to a reduction in the amount of monitoring and changes in criteria for determining compliance with OWQPs. A notice of violation ( NOV) is assumed to be issued for each system in violation. States are assumed to use form letters and to require 1 hour of burden to prepare and send each NOV. This equals an average annual reduction in burden of 3,539 hours over the three years.

6( a)( ii)( i) State Reporting The major revisions to the State reporting requirements that impact burden during the ICR period are the addition of a " Done" and " Deemed" milestone, the elimination of the lead service line compliance letter, and the requirement for States to report all lead 90th percentile values for large and medium systems. In addition, as mentioned above, the number of violations are assumed to decline during some years, and will result in a corresponding decrease in the number of violations and enforcement actions reported by the State. Each of the burden impacts are discussed in more detail below

Report all 90th percentile lead levels for all large and medium systems. The LCRMR require the reporting of all 90th lead percentile values for large and medium systems. States are assumed to require 0.5 hours to report each 90th percentile lead value to SDWIS. Based on the number of systems projected to monitor for lead and copper, but be below the lead action level, EPA estimates that States will incur an average added burden of 1,403 hours during the 1999 through 2001 time period. June 1999 53 The LCRMR also eliminate the reporting of the milestones that indicate for which systems the States have required a corrosion control study, designated optimal corrosion control treatment, designated source water treatment, set MPLs, and those systems that have completed their corrosion control study, and have installed source water treatment. EPA assumes that this information would have already been reported to SDWIS by 1999 and therefore, no burden reduction is estimated for the elimination of these milestones.

52

Changes to milestone reporting and deletion of LSLR compliance letter. The LCRMR eliminate several of the interim milestones, including the milestone that denotes when the State has set OWQP ranges or limits ( i. e., WQPS milestone); require the reporting of a new " Done" and " Deemed" milestone; and eliminate the requirement for States to submit a separate report that documents each system that is in compliance with its lead service line replacement schedule. 53 Under the LCRMR, States will still be required to report the milestone that denotes those systems that must begin lead service line replacement ( i. e., LSLR milestone). During the 3 year ICR period, EPA estimates that States will no longer be required to report WQPS milestone for 5,218 systems at a burden of 0.5 hours per year. This translates to an annual reduction in burden of 870 hours. In addition, each State is assumed to no longer submit two lead service line replacement reports per year; one that summarizes compliance for systems on a January through December replacement schedule, and a second for those systems on a July through June replacement schedule. Systems are estimated to have required 2 hours to prepare and submit each report. The reduction in burden associated with the elimination of the lead service line replacement compliance report is an average of 224 hours per year.

EPA also estimates that States will report the " Deemed" milestone for all 75,945 systems sometime in the 2000 through 2001 time frame. The " Done" milestone is also assumed to be reported during these two years for all 75,813 systems that are not required to replace lead service lines. Those systems are not expected to be " done" until sometime outside the 2009 time frame. States will incur a burden of 0.5 hours per milestone, except when the " Done" and " Deemed milestones or " Deemed" and LSLR milestones can be reported during the same period for a given system. In those instances, the combined burden for the two milestones is 40 minutes. During this three year ICR period, States will incur a total burden of 50,454 hours to report these milestones or an annual average of 16,818 hours over the three years.

The overall impact of the revisions to the State milestone reporting requirements is an average annual increase of 15,724 hours. During the out years of 2002 through 2009, States are expected to incur a reduction in milestone reporting burden of 224 hours per year.

Changes in violation and enforcement reporting. States are projected to report fewer violations and enforcement actions due a reduction in the amount of monitoring required under the LCRMR and from revisions to the criteria for determining compliance with OWQPs. States would have required 0.5 hours to enter violation information into SDWIS and another 0.5 hours to enter related enforcement information. The Agency anticipates June 1999 54 The junior and chemist labor rates are Bureau of Labor Statistics March 1998 estimates. The labor rates for a trained operated are based on a discussion summary of the EPA Technology Design Workshop, held on November 6 and 7, 1997 in Denver, Colorado.

53 that States will realize an average annual reduction in burden of 4,167 hours during 1999 through 2001.

6( a)( ii)( j) Record Keeping States are assumed to maintain a subset of data in their data bases that includes: 90th percentile lead and copper values, reduced monitoring schedules, milestones, OWQP values or ranges, MPLs, violations, and enforcement actions. The Agency estimates a burden of 0.5 hours is needed to report each system specific record to the State data base. The estimated average burden reduction over the 3 years is 7,889 hours. This burden reduction is due to the overall decrease in the amount of monitoring and expected decrease in violation rate under the LCRMR. The States are also assumed to maintain paper copies of a larger set of data. ( Refer to Appendix A for this list.) The burden associated with maintaining paper files is captured under overhead ( i. e., clerical staff).

6( b) Estimating Respondent Costs This section discusses the Agency's procedure for estimating system and State costs. Sections 6( b)( i) and 6( b)( ii) pertain to system and State costs, respectively. For each respondent type, a distinction is made between labor and non labor costs.

6( b)( i) Costs To Public Water Systems EPA estimates that the annual cost to PWSs for these modifications will decrease by an average of $ 2,823,900 each year over 1999 through 2001. EPA estimates that non labor costs comprise $ 1,933,300 ( about 69 percent) of this cost reduction. These costs correspond to the purchase of reagents to analyze samples, buying preprinted public education materials, and mailing costs to submit reports to the State and to mail public education materials to people/ facilities served by the system.

6( b)( i)( a) Estimating Labor Costs for Water Systems The Agency applied an average labor rate that is dependent on system size and whether the respondent activity involved the collection and analysis of samples as follows:

Sample Collection and Analysis. For monitoring and analytical activities, the Agency assumed a labor mix of junior ( non specialized) labor, chemist labor, and a trained operator/ senior staff as follows: 33 percent of the labor was assumed to be chemist time at a rate of $ 22.69; 7 percent was assumed to be management time at a rate of $ 28 for systems serving 3,300 or fewer people) and $ 52 for systems serving more than 3,300 people; and 60 percent to be non specialized labor at a rate of $ 12.77. 54 This translates to an average hourly labor rate for monitoring activities of $ 17.11 for small systems and $ 18.79 for medium and large systems, as shown below: June 1999 54 Small (< 3,300) = ($ 12.77 * 0.60) + ($ 28.00 * 0.07) + ($ 22.69 * 0.33) = $ 17.11. Medium/ Large = ($ 12.77 * 0.60) + ($ 52.00 * 0.07) + ($ 22.69 * 0.33) = $ 18.79

Non Monitoring Activities. The hourly labor rate for activities that did not involve sample collection and analyses, were based on a 90 percent junior and 10 percent senior labor mix. The same labor rates as discussed above were applied. The average small system labor rate is $ 14.29 and $ 16.69 for medium and large systems, as shown below:

Small (< 3,300) = ($ 12.77 * 0.90) + ($ 28.00 * 0.10) = $ 14.29 Medium/ Large = ($ 12.77 * 0.90) + ($ 52.00 * 0.10) = $ 16.69 6( b)( i)( b) Estimating Non Labor Costs for Water Systems All of the non labor cost savings are attributed to the reduction in the number of samples to be analyzed each year. Estimates of analytical costs were based on current industry prices. The analysis for lead and copper were adjusted to eliminate the labor component to avoid double counting because all analyses are assumed to be performed in house. For example, an outside laboratory charges $ 30 for the analysis of lead and copper tap samples. This analysis is assumed to require one hour of a chemist's time to perform the analysis. The analytical cost of $ 7.31 is used ( i. e., $ 30  $ 22.69). The specific analytical costs are presented in Figure 6 3 below.

Figure 6 3: Analytical Costs ( Assumes analysis conducted by systems)

Column A Column B Column C Column D Type of Analysis Analytical Cost Labor Cost ( burden * chemist rate of $ 22.69/ hour) Net Cost Used in Calculation ( Column B  Column C)

Lead and/ or Copper ( analytical cost based on survey of laboratories)

Lead and Copper ( at the tap and source water) $ 30a $ 22.69 $ 7.31 Lead only ( LSL monitoring) $ 15b $ 11.35 $ 3.65 WQPs ( analytical cost based on 1991 LCR ICR)

Tap ( initial) $ 51c N/ A $ 51 Tap ( post initial) $ 40d N/ A $ 40 Entry point $ 25e N/ A $ 25 a Includes the analysis of both lead and copper. b Includes the analysis of lead only. c Includes the analysis of pH, alkalinity, orthophosphate ( if applicable), silica ( if applicable), calcium, conductivity, and temperature. June 1999 55 Systems do not need to purchase new laboratory equipment, in line meters, or computers in response to the LCRMR.

55 d Includes the analysis of pH, alkalinity, orthophosphate ( if applicable), silica ( if applicable), and calcium. e Includes the analysis of alkalinity. The pH and corrosion inhibitor are assumed to be read by an in line meter.

The remainder of the non labor costs are due to postage costs of $ 0.33 for systems to submit reports to the State and to send public education materials to consumers, and to purchase of pre printed public education materials. No capital/ start up costs are incurred as a result of the LCRMR. 55 Figure 6 4 below contains the change in system cost resulting from the LCRMR ( i. e., LCRMR cost minus the revised baseline costs), averaged over 1999 through 2001.

Figure 6 4: Change in Annual System Cost for 1999 through 2001 due to LCRMR ( in $ 1,000' s)

Activity Labor Cost Non Labor Cost Total Average Cost Initial Activities Read regulations and train staff 2,944.3 0.0 2,944.3 Tap and WQP Monitoring Requirements ( b)( 3) system monitoring 149.7 16.7 166.4 Alternative schedule for systems on reduced monitoring  24.5 0  24.5 Accelerated lead and copper monitoring  578.4  500.7  1079.1 Monitoring waivers  815.8  102.8  918.6 Accelerated WQP monitoring  93.0  99.0  192.0 Entry point monitoring at representative sites  761.7  1,129.8  1,891.5 Source Water Monitoring Requirements Reduced source water monitoring for PWSs w/ o MPLs  25.1  10.1  35.2 Public Education Delivery of public education materials  85.3  5.9  91.2 Lead Service Line Monitoring and Notification Requirements Partial lead service line monitoring  1,460.7  114.9  1575.6 Partial lead service line notification 158.0 12.8 170.8 June 1999 Figure 6 4: Change in Annual System Cost for 1999 through 2001 due to LCRMR ( in $ 1,000' s)

Activity Labor Cost Non Labor Cost Total Average Cost 56 This rate is the mean Technical labor rate based on a draft analysis of a recent ASDWA survey that was completed by 37 States.

56 Revisions to System Reporting Requirements Eliminate first draw/ customer collected certifications  80.8 0.0  80.8 Eliminate sample site justifications  29.6 0.0  29.6 Remove request for reduced monitoring  33.1 0.0  33.1 State flexibility to calculate 90th percentile values  136.9 0.0  136.9 Report changes in treatment or addition of new source 3.8 0.2 4.0 Evaluate/ report WQPs using new compliance criteria 51.0 0.1 51.1 Change public education reporting deadline 6.5 0.1 6.6 Report compliance with partial LSL replacement requirements 35.7 1.6 37.3 Impacts resulting from changes in other provisions Reporting of lead and copper results  87.0  1.3  88.3 Reporting of source water monitoring results  6.9  0.3  7.2 Specify lead and copper monitoring location changes  20.8 0.0  20.8 TOTAL  890.6  1933.3  2823.9 Note: Some of the information to be submitted to the State was assumed to be included with other information ( e. g., certifications with lead and copper monitoring results) and hence, no postage costs were estimated ( i. e., nonlabor costs).

6( b)( ii) Costs to States State costs were determined by multiplying the labor hours by $ 25.34 ($ 52,696/ 2,080 hours). 56 The average annual cost of labor to the State over the three years is estimated to be $ 1,268,400. States will also incur, during the first year of implementation, non labor costs for contractor services to modify State data systems to accommodate the reporting of the new " Done" and " Deemed" milestone. A total of $ 75,000 is estimated for each of the 36 State respondents. This equals an average annual total of $ 900,000 over the three year ICR period. The total average annual increase in costs to States is estimated to be $ 2,168,400. Figure 6 5 presents the State costs by revision. June 1999 57 Figure 6 5: Change in Annual State Costs for 1999 through 2001 due to LCRMR ( in $ 1,000' s)

Activity Average Costs Overhead 203.5 Notify systems of requirements 95.6 Initial Activities Regulation adoption 246.0 Train staff 177.4 Modify the data system 1,279.5 Review of Lead and Copper Tap and WQP Monitoring Data and Related Information Review of monitoring results for ( b)( 3) systems 1.4 Request use of non first draw samples 6.3 Specify reduced monitoring sites 41.6 Accelerated lead and copper monitoring  45.8 Monitoring waivers ( review of applications & less monitoring data)  28.7 Accelerated reduced WQP tap monitoring 0.0 WQP monitoring at representative entry points 1.7 State flexibility to calculate 90th percentile level 52.6 Changes in treatment or addition of a new source 6.7 Review of compliance with optimal WQP levels 44.1 Review of reasons for changes in lead and copper tap monitoring location  6.1 Source Water Monitoring Requirements Reduced source water monitoring for PWSs w/ o MPLs  11.7 Public Education Review of public education compliance letters 3.3 Request to remove reference to building permit record availability from mandatory language 1.4 Lead Service Line Replacement Review of compliance letter for partial LSLR requirements 60.9 Enforcement  89.7 June 1999 Activity Average Costs 58 Revisions to § 142.15 Requirements Report 90th percentile lead levels for large and medium PWSs 35.5 Modify milestones & delete requirement to report compliance with LSLR schedule 398.4 Changes in violation and enforcement reporting  105.6 Reporting to State data base ( Record Keeping)  199.9 TOTAL 2,168.4 Note: All costs are labor with the exception that $ 900,000 of the $ 1,279,500 to modify the data system are contractor costs.

6( c) Estimating Agency Burden And Cost EPA Headquarters and Regional offices will incur burdens and costs to develop guidance documents, address policy issues, oversee State Public Water System Supply Programs, modify SDWIS, and to process and analyze the LCRMR data. These functions will involve a mix of Headquarters, Regions, and contractor effort. Each is described in more detail below and summarized in Figure 6 6.

Figure 6 6: Average Annual Agency Burdens and Costs, 1999 2001 Burden Cost s ( in $ 1,000' s)

Headquarters 1,733 81.3 Region 5,616 221.5 Contractor N/ A 98.3 TOTAL 7,349 401.1 6( c)( i) Burden and Costs to Headquarters Headquarters is expected to undertake the following activities during the 1999 through 2001 resulting from the LCRMR.

Develop Guidance Documents/ Address Policy Issues. Headquarters will be responsible for developing guidance documents that will assist the States and systems in implementing the new requirements. Some of these guidance documents will include: determining compliance with OWQPs using the new criteria and changes to Federal reporting June 1999 57 This calculation is outlined on page A 36 of the ICR Handbook   EPA's Guide to Writing Information Collection Requests Under the Paperwork Reduction Act of 1995, 12/ 96.

59 requirements. The Agency assumes that it will also need to address policy issues that will arise as systems and States implement the new requirements. The Agency will also develop fact sheets. However, these documents are expected to be completed prior to the promulgation of the LCRMR, and are not included in the burdens and costs discussed below.

Modify SDWIS. SDWIS and the Data Transfer File format program that allows States to report to SDWIS will need to be modified to accommodate reporting of the new " Done" and " Deemed" milestones. No revisions will be needed to accept all lead 90th percentile values as SDWIS can already accept these data.

Analyze SDWIS data. On a national level, Headquarters will evaluate the status of systems using the new " Done" and " Deemed" milestones, and evaluate how levels of lead at the tap have changed over time using the 90th percentile levels reported for large and medium size systems.

The bulk of these activities is assumed to occur in 1999 through 2001. EPA estimates that these activities will require 1.0 FTE in 1999 and 2000 and 0.5 FTEs in 2001, for a total of 2.5 FTEs over the three year ICR period. This translates to a total burden of 5,200 hours over the three years ( i. e, 2.5 FTEs * 2,080 hours per FTE) or an average of 1,733 hours.

These FTEs are assumed to be a GS 13, Step 5. Based on the 1999 General Schedule, this equals a salary of $ 60,965. The hourly rate for a GS level is determined by dividing the annual pay rate for the GS level by 2,080, which represents the average number of hours worked during a calendar year ( including holidays and vacations). The answer is then multiplied by 1.6, the benefits multiplication factor. 57 Based on this procedure, the hourly rate equals $ 46.90 ( i. e., $ 60,965/ 2,080 * 1.6). Multiplied by the average annual burden of 1,733 hours, the average cost for Headquarters equals $ 81,278.

6( c)( ii) Burdens and Costs to Regional Staff During the first two years of LCRMR implementation, EPA Regional staff will assist States in understanding the requirements of the LCRMR. Regions will also evaluate progress on a Regional level using the new milestone and lead data. The Agency assumes that 0.33 FTEs per Region will be required during 1999 and 2000, and then decrease to 0.15 FTEs in 2001. This equals a total burden of 16,848 hours ( 2,080 hours per FTE * 0.81 * 10 FTEs) or an average burden of 5,616 hours over the three year ICR period.

The Regional FTEs are assumed to be a GS 12, Step 5. Based on the 1999 General Schedule, this equals a salary of $ 51,268. Using the procedure described in section 6( c)( i), the hourly rate would equal $ 39.44 ( i. e., $ 51,268/ 2,080 * 1.6). Multiplied by the average annual burden of 5,616 hours, the average annual cost to Regions would equal $ 221,495. June 1999 60 6( c)( iii) Contractor Costs The Agency estimates contractor support will be needed in three general areas:

Guidance Document Development Support The Agency estimates that it will require $ 100,000 in contractor support to develop guidance document during 1999.

Modify SDWIS/ State. Approximately 20 systems will use SDWIS/ State to maintain and report LCRMR data. EPA estimates that during 2000, the Agency will expend a total of $ 35,000 in contractor costs to modify SDWIS/ State to accept and report the new LCRMR milestones.

Modify SDWIS/ Fed. Contractor support will be required to modify SDWIS and DTF to accept the new milestone data. EPA estimates that $ 20,000 will be needed in 1999 to identify the needed changes. An additional $ 140,000 will be required to modify SDWIS in 2000.

No additional contractor support is anticipated in 2001 as a result of the LCRMR. The total contractor costs is estimated to be $ 295,000 or an annual average of $ 98,300 over the three year ICR period.

6( d) Estimating the Respondent Universe and Total Burden and Costs The universe of respondents for this ICR is comprised of the 75,945 CWSs and NTNCWSs, and the 56 State primacy agencies. Exhibit 6 7 presents a summary of total burdens and costs for the ICR period of 1999 2001.

The annual system burden is estimated to decrease an average of 36,773 hours over the 3 year ICR cycle. The annual system costs are projected to decrease an average of $ 2,823,900 and to be comprised of $ 890,600 in labor and $ 1,933,300 in non labor costs.

The average annual burden over the three years for States to carry out the LCRMR is estimated to increase by 50,055 hours. The average annual costs are estimated to increase by $ 2,168,400, with labor costs equaling $ 1,268,400 and non labor costs equaling $ 900,000.

The average Agency burden over the three year ICR period is estimated to increase by an average of 7,349 hours per year, and costs are estimated to increase an average of $ 401,100 ($ 302,800 in labor costs and $ 98,300 in contractor costs.

6( e) Bottom Line Burden Hours And Cost Table The national annual average burden and cost estimates for the LCRMR are presented in Figure 6 7 below. The average system and State burden per response is an increase of 0.3 hours and the cost per response is a reduction of $ 14. June 1999 61 Figure 6 7: Change in Respondent Average Annual Burdens and Costs for 1999 2001 Respondent Number of Respondents Total Responses Total Burden ( hrs) Total Cost ($)

Public Water System 75,945 2,654  36,773  2,823,900 State 56 42,996 50,055 2,168,400 TOTAL 76,001 45,650 13,282 ( 655,500)

Burden per Response 0.3 hours Cost per Response ( in $) $ 14 1. The number of system responses was determined by subtracting the total number of system reports to the State required under the LCRMR ( 59,824) from the number of reports required under the 1991 LCR ( 57,170), and then averaging the difference over three years. The number of reports was based on the LCRMR and revised baseline system reporting models and included the reporting of lead and copper monitoring data, WQP monitoring data, source water monitoring results, public education compliance letter, annual lead service line letter, monitoring waiver application ( LCRMR only); demonstration of representative entry points for WQPs ( LCRMR only), and partial lead service line replacement monitoring results/ demonstration of compliance with notification requirements ( LCRMR only). All other reporting requirements were assumed to be included with the reporting of lead and copper monitoring data and were not considered to be separate responses. All system reports were assumed to be submitted in hard copy format. 2. The number of State responses was similarly derived by subtracting the total number of State reports to EPA required under the LCRMR ( 100,105) from the number of reports required under the 1991 LCR ( 57,109), and then averaging the difference over three years. The number of reports was based on the LCRMR and revised baseline State reporting models. A report consisted of a single milestone, violation, or enforcement action, and each report that indicated which systems were in compliance with their lead service line replacement schedules. All State reports, except the 112 lead service line compliance letters, were assumed to be submitted electronically.

Figure 6 8 below shows the estimated respondent and Agency burden and cost for each of the 3 years in the ICR period. Systems and States are estimated to experience an increase in burden in 1999 due to initial implementation activities such as training, reading the regulations, and regulatory adoption. The initial activities are not expected to continue outside the ICR period. During 2002 through 2009, systems are expected to realize an annual average reduction in burden of 170,629 hours and a reduction in cost of $ 4,401,400. The increase in burden and costs to States is estimated to drop to an annual average increase of 2,333 hours and $ 58,900 during 2002 through 2009. June 1999 62 Figure 6 8: Annual Burden and Costs by Year for 1999  2001 Respondent/ Agency 1999 2000 2001 Burden ( hrs) Costs ( in $ K) Burden ( hrs) Costs ( in $ K) Burden ( hrs) Costs ( in $ K)

Systems 169,554  668  230,789  5,667  49,090  2,137 States 70,230 2,680 49,634 3,058 30,300 768 EPA 8,944 488 8,944 544 4,160 172 Total 248,728 2,500.0 ( 172,211) ( 2,065.0) ( 14,630) ( 1,197.0)

6( f) Reasons For Change In Burden This ICR reflects two sets of changes in burdens and costs. First, section 6( f)( i) provides an explanation of the differences between the currently approved baseline and the revised baseline burden estimates. Secondly, section 6( f)( ii) provides the changes in the burden resulting from LCRMR, as compared to the revised baseline for the LCR.

6( f)( i) Explanation of Differences between Currently Approved Baseline and the Revised Baseline Estimates This ICR amends the approved Drinking Water ICR ( EPA # 0270.39, OMB # 2040 0090). As discussed previously, the burden and cost estimates for the LCR contained in the current Drinking Water ICR are not used as the baseline for this revised May 1999 ICR. At the time of promulgation in 1991, the Agency estimated the record keeping and reporting burden associated with the LCR, assuming that approximately 50 percent of systems would exceed the lead or copper action levels, based on data from a select group of U. S. cities. Now that water systems have collected lead and copper samples from hundreds of thousands of household taps around the country to comply with the monitoring requirements of the rule, much more reliable predictions of burden can be made. Based on data reported to the SDWIS, EPA now estimates that approximately 29 percent of systems will exceed the lead or copper action level, resulting in significantly more systems able to reduce the number and frequency of monitoring sooner than originally predicted, and fewer systems triggered into public education and lead service line replacement requirements.

To more accurately assess the impact of the LCRMR, EPA has revised the models used to estimate the burden and cost of the 1991 LCR ( i. e., the revised baseline). These models incorporate the revised lead and copper exceedance estimates, use a standard EPA inventory data set, include public education activities, use more current costing factors, and more clearly distinguish the burden and cost associated with monitoring, reporting, and record keeping.

Exhibit 6 9 below contains a comparison of the burden and costs for the LCR portion of the currentlyapproved ICR, to those estimated for the revised baseline. The currently approved baseline is the total of the LCRrelated burden and costs in Exhibits 8 and 9 of the 1993 Program ICR and the public education burdens and costs from The Public Water System Supervision Program Public Notification and Education Requirements, ICR No. 270.34, September 27, 1995. A detailed description of assumptions used to recalculate the burdens and costs associated with the original LCR ( i. e., the baseline) and used to estimate those resulting from the LCRMR are contained in Appendix A. Sections 6( f)( i)( a) and 6( f)( ii)( b) provide an explanation for differences in the two baselines pertaining to system and State estimates, respectively. June 1999 63 Figure 6 9: Comparison of System Burden and Costs Estimates of the Drinking Water ICR and Revised Baselines Respondent Revised Baseline Currently Approved Baseline Difference Burden ( hrs) Costs ($) Burden ( hrs) Costs ($) Burden ( hrs) Costs ($)

Public Water System 1,990,330 49,921,200 1,557,238 33,482,083 433,092 16,439,117 States 428,116 10,848,500 1,420,000 43,200,000 ( 991,884) ( 32,351,500)

TOTAL 2,418,446 60,769,700 2,977,238 76,682,083 ( 558,792) ( 15,912,383)

1. The burden for the currently approved baseline is comprised of 1,235,694 hours for non public education activities and 321,544 hours for public education. The costs are divided between $ 21,424,333 for non public education activities and $ 12,057,750 for public education. 2. Only the public education burden and costs from the The Public Water System Supervision Program Public Notification and Education Requirements are included in Exhibit 6 9 above. Public notification burdens and costs are not included in this May 1999 ICR, but will be included in the ICR being developed for the revised Public Notification Regulation. 3. To estimate non labor costs for the currently approved baseline, ( as presented under line 14. d of the OMB form 83 I that accompanies this May 1999 ICR), EPA assumes that the hourly system labor rate is $ 10 and the State labor rate is $ 26.04.

6( f)( i)( a) Explanation of Differences in System Burdens and Costs The Drinking Water ICR does not provide detail on the specific activities that comprise the system burden and cost estimates. These estimates, however, are based on the 1991 LCR ICR. Appendix E of the 1991 LCR ICR provides year by year cost estimates for monitoring and non monitoring activities ( i. e., read regulations, plan and review, and training). Burden estimates are not specified for each year, but are provided as an annual average burden. The LCR costs presented in the Drinking Water ICR appear to include about $ 20 million in monitoring costs and $ 1.4 million in non monitoring costs. Monitoring from lead service lines does not appear to be included in the monitoring total. A possible explanation is that lead service line replacement and associated monitoring occur beyond the three year Drinking Water ICR period of 1994 through 1996. Public education costs and burdens from the Public Water System Supervision Program Public Notification and Education Requirements, add 321,544 hours and approximately $ 12 million in costs. The total system burden and costs for the currently approved baseline are approximately 1.6 million hours and $ 33.5 million. The revised baseline estimate for systems is approximately 2 million hours and $ 50 million. Exhibit 6 10 summarizes the differences in key assumptions used to estimate the two sets of baseline estimates. June 1999 58 The number of entry points was derived from a 1993 survey sponsored by the Association of State Drinking Water Administrators.

64 Figure 6 10: Assumptions that Differ between the Currently Approved Baseline and Revised Baseline Assumption Currently Approved Baseline Revised Baseline System Assumptions Number of PWS respondents 78,703 75,945 System labor rate $ 40 for senior, $ 10 for junior staff. Most activities were estimated at the junior rate. $ 14.29$ 18.79 depending on system size and collection activity.

Exceedance rate about 50% 30% for small PWSs, 25% for medium and large Collection/ analytical burden for lead and copper tap samples 3 hours. This burden also includes reporting results to the State. 3.5 hours and reporting burden is estimated separately.

Number of entry points used to determine number of source water samples and WQP entry point samples to be collected 1 to 54 entry points for ground water systems 1 entry point for surface water 1.2 to 36.3 entry points for ground water 1.3 to 4.7 entry points for surface water58 Lead Service Line Samples Not included in the Drinking Water ICR Includes two types of monitoring: 1) monitoring to determine if a line needs to be replaced and 2) monitoring and notification due to partial lead service line replacement.

Reporting Included as part of the collection/ analytical burden Estimated as a separate burden for the collection/ analytical burden. The estimated burden for most reports is 0.5 hours to 1 hour per report.

6( f)( i)( b) Explanation of Differences in State Burdens and Costs The 1991 LCR ICR did not specify the assumptions used to develop the State burden. The 1991 ICR presents State burden as two aggregate totals; one for initial, and a second for on going activities. States were estimated to require 793 FTEs per year for initial activities and 696 FTEs for on going activities. An FTE was assumed to equal 1,920 hours per FTE. The initial and on going burdens were averaged over 1992 through 2009, for an annual average of 1.42 million hours [( 793 * 1,920) + ( 696 * 1,920)]. No adjustments to this burden were made in the Drinking Water ICR. June 1999 65 Based on the level of detail provided in the 1991 ICR, the reasons for the difference in burden between the currently approved baseline and revised baseline cannot be specified, with the following exceptions: 1) In the revised baseline, an FTE equals 2,080 hours per year; 2) The number of State respondents is 57 in the revised baseline compared to 56 State respondents in the revised baseline.

The costs presented in the 1991 ICR are presented in more detail and were based on the survey entitled, State Costs of Implementing the 1986 Safe Drinking Water Act Amendments, Association of State Drinking Water Administrators, August 1989. Initial and on going cost estimates were provided for 13 collection activities. The initial costs were divided by 18 years and then added to the on going costs estimates for each of the 13 categories. No adjustments to State cost estimates were made in the Drinking Water ICR.

Unlike the currently approved ICR, the revised baseline contains costs that are specific to a given year, and only includes costs incurred during 1999 through 2001. Many of the State activities included in the currentlyapproved baseline are assumed to occur prior to 1999 and are not included in the revised baseline. More specifically, the revised baseline models assume that the following State activities have been completed prior to 1999: rule specific training, data system modification to accommodate LCR reporting, regulatory adoption activities, review of lead and copper sampling plan and initial tap/ WQP data, decision regarding systems required to conduct corrosion control study, decision regarding type of corrosion control treatment to be installed, review of tap and WQP follow up samples and setting of WQP levels for medium and large systems, and review of initial source water monitoring results, decision regarding source water treatment, review of follow up source water results, and assignment of MPLs. The currently approved baseline captures many of the initial activities that are no longer relevant and/ or are more labor intensive. For example, States would review more monitoring data in the early years of implementation because systems would not have qualified for reduced monitoring.

Figure 6 11 is a comparison of State costs under the currently approved baseline against the revised baseline.

Figure 6 11: Detailed State Cost Comparison between the Currently Approved Baseline and the Revised Baseline ( Costs are in $ millions)

Collection Activity Currently Approved Baseline Revised Baseline Cost Reason for Difference Adopt regulation $ 0.8 $ 0.0 Revised baseline assumes activity will only occur in the first year of implementation instead of each year.

DW Staff Training $ 0.7 $ 0.0 Revised baseline assumes rule specific training was completed prior to 1999, but overhead in revised baseline includes general training.

Expand lab capacity $ 7.0 $ 0.0 Revised baseline assumes this activity was completed prior to 1999.

Modify Data Management System $ 0.8 $ 0.0 Revised baseline assumes this activity was completed prior to 1999.

Lab Certification $ 0.7 0.7 N/ A June 1999 Collection Activity Currently Approved Baseline Revised Baseline Cost Reason for Difference 66 Notify systems of requirements $ 0.8 0.7 Similar assumptions were used in both baselines.

Assist High Risk Identification $ 6.0 0.0 Revised baseline assumes identification of sites would be essentially completed by 1999. Revised baseline includes State burden to identify reduced sampling sites.

Plan & Construction Review $ 3.7 0.0 Revised baseline assumes that treatment decisions were completed prior to 1999.

Treatment Plans for Small Systems $ 5.9 0.0 Corrosion Control Review $ 6.5 0.0 Revised baseline assumes this activity was completed by 1999.

Public Education/ Other $ 3.7 0.1 Revised baseline assumes States are reviewing compliance letters only. Unclear what activities are included in the currently approved baseline.

Formal Enforcement $ 5.0 0.6 Revised baseline includes NOVs only. Enforcement beyond this level is considered outside the scope of ICR. The currently approved baseline may have included other types of enforcement.

Review monitoring data 0.0 $ 4.8 The burden for this activity under currently approved baseline may be included under other activities.

Overhead adjustment N/ A $ 2.0 Benefits adjustment may have already been included in the salary for the currently approved baseline.

Data Entry and Reporting $ 2.8 $ 2.0 Reason for difference cannot be assessed beyond differences in number of respondents and State average hourly rate between the two baselines.

TOTAL 44.4 10.9 Note: Totals presented in the above table do not match those in Figure 6 9 due to independent rounding.

6( f)( ii) Differences between the LCRMR and LCR Burdens June 1999 67 This ICR subtracts 2,418,446 hours in system and State respondent burden that reflect the revised burden estimates for the LCR and adds 2,431,728 hours of respondent burden to implement the reporting and record keeping requirements of the LCRMR. The net impact of this program change is an overall increase of 13,282 hours in system and State burden per year. The change in respondent burden is summarized in Figure 6 12 below.

Figure 6 12: Change in Annual Respondent Burden ( in hours)

Respondent LCRMR LCR ( revised baseline) Difference Public Water System 1,953,557 1,990,330 ( 36,773)

States 478,171 428,116 50,055 TOTAL 2,431,728 2,418,446 13,282 This ICR subtracts $ 15,059,200 in system and State respondent non labor costs that reflect the revised burden estimates for the LCR and adds $ 14,025,900 in non labor respondent costs to implement the reporting and record keeping requirements of the LCRMR. The net impact of this program change is an overall decrease of $ 1,033,300 in system and State non labor costs per year. The change in these respondent costs is summarized in Figure 6 12 below.

Figure 6 13: Change in Annual Non Labor Respondent Costs ($)

Respondent LCRMR LCR ( revised baseline) Difference Public Water System 13,125,900 15,059,200 ( 1,933,300)

States 900,000 0 900,000 TOTAL 14,025,900 15,059,200 ( 1,033,300)

6( g) Burden Statement For the ICR period of 1999 through 2001, the average burden for systems to implement the requirements of the LCR ( i. e., the revised baseline) is estimated to be 26 hours per system per year. The average annual cost to systems is $ 657. System burden includes time required to collect and analyze samples, report results, maintain records, and deliver public education. The average burden for State agencies is estimated to be 7,645 hours per State per year. This burden includes the time to inform systems of the requirements, review and monitoring results and other system submissions, take appropriate follow June 1999 68 up action, maintain records, and report results to EPA. The estimated annual State cost is estimated to be $ 193,700 per State per year.

The average system burden associated with the LCRMR for the ICR period of 1999 through 2001 is estimated to decrease by 0.5 hours per system per year, with an associated average annual decrease in cost of $ 37 per system. System burden includes time required to read the regulations, attend training, collect and analyze samples, report results, maintain records, and deliver public education. The average burden for State agencies is estimated to be an increase of 894 hours per State per year. This burden includes the time to read the regulation, attend training, inform systems of the requirements, review and monitoring results and other system submissions, take appropriate follow up action, maintain records, and report results to EPA. The estimated annual State cost is estimated to increase by about $ 38,700 per State per year. Much of this increase can be attributed to one time start up costs. During 2002 to 2009 the average burden and cost increase drops significantly to an average increase of 42 hours and $ 1,052 per State per year.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, OPPE Regulatory Information Division, U. S. Environmental Protection Agency ( 2137), 401 M Street, SW, Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence.


[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Page 36548]
[FR Doc No: 2011-15539]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 20 and 21, 2011,
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD 20877.
    Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1609, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area), and follow the prompts to the desired center
or product area. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: On July 20, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the Edwards SAPIEN Transcatheter Heart Valve
sponsored by Edwards Lifesciences. The Edwards SAPIEN\TM\ Transcatheter
Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and
accessories implant system consists of the following:
     The Edwards SAPIEN Transcatheter Heart Valve consists of a
heterologous (bovine) pericardium leaflet valve sutured within a
stainless steel mesh frame, with a polyester skirt. It is offered in 2
sizes, a 23 mm and a 26 mm.
     The RetroFlex 3 Delivery System is used to advance the
bioprosthesis through the RetroFlex sheath over a guidewire and to
track the bioprosthesis over the aortic arch and for crossing and
positioning in the native valve. The delivery system also comes with a
sheath, introducer, loader, dilator, balloon (used to pre-dilate the
native annulus) and a crimper.
    On July 21, 2011, the committee will discuss, make recommendations,
and vote on information related to the humanitarian device exemption
for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD)
sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD
device is a pneumatically-driven extracorporeal ventricular assist
device. It is designed to provide bridge-to-transplant mechanical
support to the heart. The system consists of one or two extracorporeal
blood pumps (univentricular or biventricular support), cannulae for the
connection of the blood pumps to the atria and great arteries, and the
IKUS Stationary Driving Unit (electro-pneumatic driving system).
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
14, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on both days. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 6, 2011. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 8, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at<PHONE_NUMBER>, at least 7 days in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 15, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-15539 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P


                                  MEMORANDUM

Tetra Tech, Inc. 10306 Eaton Place, Suite 340 Fairfax, VA 22030 phone<PHONE_NUMBER> fax<PHONE_NUMBER>

TO:			Paul Shriner, EPA FROM:		Kelly Meadows and Christine Wong DATE: 		July 30, 2010

SUBJECT:		Estimating the number of potential facilities with increased costs due to noise or plume abatement and space constraints

EPA requested that Tetra Tech develop an analysis to estimate the universe of facilities that may need to be considered for increased costs of compliance with the 316(b) existing facility rule due to noise or plume abatement requirements, as well as space constraints, for installing cooling towers as a compliance response.  This memo documents the analysis and rationale for the estimated universe of affected facilities.  Tetra Tech has concluded that about one in four (25 percent) of the overall universe of facilities addressed by the proposed 316(b) existing facility rule may be affected by one or more of these technical factors; EPA has increased its estimate of compliance costs accordingly to account for additional technologies or other mitigation activities at these facilities.

Approach

To comply with a potential requirement for flow reduction, some facilities are likely to choose to install cooling towers to comply with this requirement.  Under certain conditions or at certain locations, the installation of cooling towers can lead to non-aquatic impacts such as plumes or noise.  Facilities located in densely populated areas or on small sites may also have difficulty identifying sufficient space to construct the towers.  In the majority of cases, these technical issues do not ultimately affect the feasibility of constructing the cooling tower, but they do affect the cost.  The analysis below reflects EPA's assumptions in estimating the number of facilities that may encounter these difficulties and establishes an approach for increasing the cost estimates accordingly.

Natural draft or mechanical draft cooling towers can produce a plume.  Plumes (comprised largely of water vapor) can create problems with fogging and icing, which have been recorded to create dangerous conditions for local roads and for air and water navigation, as well as cause aesthetic impacts.  To estimate the number of facilities that would likely be subject to plume abatement requirements, Tetra Tech used two indicators as a proxy for potential impacts: proximity to airports and proximity to major roads.  Tetra Tech selected a 2-mile radius from airports and a 0.5-mile radius from major roads as the distance thresholds for facilities likely to require plume abatement.  EPA had previously mapped the prevalence of cooling towers and their proximity to highways, navigable rivers and lakes, and railways, and defined those facilities that were within several hundred meters from those types of areas as being in "close proximity."  Tetra Tech selected a 2-mile radius from airports as a proximity threshold to include this earlier definition of "close proximity," plus a generous safety margin for aviation safety.  Tetra Tech selected the 0.5-mile radius from major roads as a proximity threshold to account for the distance required to disperse fog or ice-forming plumes, plus a generous safety margin.

Noise from mechanical draft cooling towers is generated by falling water inside the towers, plus fan or motor noise.  Noise from power plant sites generally do not result in off-site levels more than 10 decibels (dB) above background levels.  Facilities that make use of cooling towers, however, might expect the typical noise level to be approximately 70 dB within 50 feet of the tower.  Because sound levels diminish approximately 5 dB per doubling of distance, and 55 dB falls between the sound level of rainfall and normal conversation (and therefore would not be considered noise pollution), a buffer of 400 feet would suffice for noise abatement at most sites.  In addition, EPA's "Protective Noise Levels" guidance found that ambient noise levels of 55 dB was sufficient to protect public health and welfare and, in most cases, did not create an annoyance.  As for noise pollution at the site itself, the New York State Department of Environmental Conservation's "Assessing and Mitigating Noise Impacts" policy states that 60-70 dB is the beginning of the threshold for annoyance in non-industrial sites and that noise can exceed 65 dB (and up to 79 dB) in commercial or industrial sites.  A common goal is to keep new noise sources from increasing the overall noise levels by 5-10 dB.  Given that noise is measured on a logarithmic scale, adding a cooling tower that operates with a sound level of approximately 70 dB will be unlikely to add a significant level of noise to an already noisy industrial site.  Given that noise appears to dissipate relatively quickly (and the fact that many industrial sites are large and a 400 foot buffer would not be a significant limitation), effects from noise are not expected to be significant at most sites.  There will certainly be some sites that require noise mitigation, but the number of sites is likely to already be represented by the analyses for plume and population density.

Tetra Tech decided to use population density as a proxy indicator of facilities that might be subject to land or space constraints for installing cooling towers.  Tetra Tech conducted a geographic information systems (GIS) analysis of various U.S. Census (2007 figures) data to determine the point at which population blocks (blockgroups) indicate the transition from more densely developed urbanized areas to areas with ample space for development.  After comparing several urban areas as examples, a threshold of 1000 persons per square mile was selected as the approximate transition point.  The figures below show areas color-coded and labeled according to Census population density (2007 figures).  For this analysis, a facility was considered to be development restricted if the facility was located within a blockgroup where population density was greater than or equal to 1000 persons per square mile.

Washington DC and Buffalo, New York were examined to estimate the selected threshold and the graphics are presented below.  Topeka, Kansas and Salinas, California were also examined but are not presented below.

Population Density for Washington, DC

Population Density for Buffalo, NY

For the purpose of this analysis, facilities located within a blockgroup with a density greater than 1000 persons per square mile are considered to be potentially subject to space constraints for installing cooling towers.

Because proximity to airports, major roads, and densely populated areas may be correlated with the need for facilities to install technologies to mitigate those effects, the proximity analyses for all these of these factors are expected to complement one another.  In other words, each of these technical challenges relate to a proximity to other uses of surrounding areas (e.g., roads, residential, etc.); as a result, it is reasonable to expect that separate analyses for each challenge would identify some of the same facilities.

Analysis

Tetra Tech plotted the longitudinal and latitudinal coordinate locations of the model power plant facilities used to develop compliance costs.  Tetra Tech then plotted GIS layers to determine if facilities 1) fall within a 2-mile radius from all airports; 2) intersect the 0.5-mile radius from all major roadways (defined as a limited access road or highway); and 3) are located within a blockgroup with 2007 population density per sq mile >=1,000 (FacilPopDens1000).  The results are shown in the map below.

Results

Tetra Tech further refined the analysis with four additional steps.  First, the universe (initially comprised of 891 facilities, including all power plants and manufacturers that completed a technical questionnaire) was limited to facilities with a design intake flow (DIF) of greater than 125 million gallons per day (MGD).  Second, facilities that did not complete a detailed questionnaire were removed, as costs for these facilities will not be developed in the proposed rule.  Third, manufacturers were removed from the analysis, as these sites are already assigned "difficult" level costs in the EPRI cost methodology.  Fourth, statistical survey weights were added to properly adjust the representativeness of each facility.

Out of the 224	detailed questionnaire facilities (250 weighted) with a DIF greater than 125 MGD, the analyses showed that:

   1) 50 (56 weighted) of these 224 are within 0.5 miles of a major road.          o 1 of these was within 2 miles of airports.           o 12 of these are in high population density areas as defined by FacilPopDens1000.                # Of these 12, none are within 2 miles of airports.    2) 4 (4 weighted) of these 224 are within 2 miles of an airport.          o 1 of these was within 0.5 miles of a major road.          o None of these are within high population density areas.    3) 25 (28 weighted) of these 224 are within a high population density area.          o None of these are within 2 miles of an airport.          o 12 of these are within 0.5 miles of a major road.

As such, a total of 66 (29.4%) facilities (74 weighted or 29.6%) of the universe of facilities with a DIF >125 MGD facilities are subject to at least one constraint.  Given the conservative nature of this analysis, rounding the percentage of facilities that may require additional costs for abatement technologies or face challenges due to space constraints to 25% was deemed appropriate.

By comparison, Electric Power Research Institute (EPRI) conducted a survey of its members and found that approximately 23 percent of respondents answered that they would be concerned space constraints, should they be required to retrofit with cooling towers.[,]  While this seems to be consistent with Tetra Tech's analyses, over half of the facilities surveyed by EPRI had not yet studied the impacts of installing closed-cycled recirculating systems.  In addition, EPA personnel have observed, during the course of site visits, situations in which space constrained facilities were able to creatively resolve technical issues.  Additionally, based on EPA personnel best professional judgment, many facilities are conservative when estimating their required responses to potential regulations regarding cooling water intake structures.  Furthermore, facilities that have not yet studied their site-specific impacts from installing closed-cycle cooling may not take into account the innovative or creative solutions that can be developed, even for space-constrained areas.  As a result, the assumptions underlying EPA's analysis are likely to be conservative and may overstate compliance costs.

Given the results of the GIS analyses and the best professional judgment of EPA personnel, as well as the safety margins incorporated in the GIS analyses, Tetra Tech's analysis supports a threshold of 25 percent of facilities that may be constrained by cooling tower plume, noise, or space restrictions and should therefore be assigned an increased compliance cost.


[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63318-63319]
[FR Doc No: 2011-26322]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4032-DR; Docket ID FEMA-2011-0001]

Maine; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Maine (FEMA-4032-DR), dated September 13,
2011, and related determinations.

DATES: Effective Date: September 13, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated September 13, 2011, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Maine resulting from Tropical Storm Irene during the period of
August 27-29, 2011, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Maine.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.

    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Albert Lewis, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Maine have been designated as
adversely affected by this major disaster:

    Franklin, Oxford, and York Counties for Public Assistance.
    All counties within the State of Maine are eligible to apply for
assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

     Dated: October 5, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-26322 Filed 10-11-11; 8:45 am]
BILLING CODE 9111-23-P