9.92
                                      LSL
                                    Partial
                                     0.82
                                    No LSL
                                Representative
                                     1.18
                                     0.88
                                     1.61
                                     9.92
                                      LSL
                                    Partial
                                     0.82
                                      POU
                                     1.18
                                     0.88
                                     1.61
                                     4.72
                                    Partial
                                    Partial
                                     0.82
                                    No LSL
                                    Partial
                                     0.61
                                     0.46
                                     0.81
                                     4.72
                                    Partial
                                    Partial
                                     2.64
                                    Partial
                                Representative
                                     0.29
                                     0.20
                                     0.41
                                     4.72
                                    Partial
                                    Partial
                                     0.82
                                    No LSL
                                Representative
                                     0.61
                                     0.46
                                     0.81
                                     4.72
                                    Partial
                                    Partial
                                     0.82
                                      POU
                                     0.61
                                     0.46
                                     0.81
                                     0.82
                                    No LSL
                                    Partial
                                     0.82
                                    No LSL
                                Representative
                                     0.00
                                     0.00
                                     0.00
                                     0.82
                                    No LSL
                                    Partial
                                     0.82
                                      POU
                                     0.00
                                     0.00
                                     0.00
                                     5.48
                                      LSL
                               Represen - tative
                                     0.82
                                    No LSL
                                Representative
                                     0.70
                                     0.54
                                     0.95
                                     5.48
                                      LSL
                               Represen - tative
                                     0.82
                                      POU
                                     0.70
                                     0.54
                                     0.95
                                     2.64
                                    Partial
                               Represen - tative
                                     0.82
                                    No LSL
                                Representative
                                     0.32
                                     0.26
                                     0.40
                                     2.64
                                    Partial
                               Represen - tative
                                     0.82
                                      POU
                                     0.32
                                     0.26
                                     0.40
                                     0.82
                                    No LSL
                               Represen - tative
                                     0.82
                                      POU
                                     0.00
                                     0.00
                                     0.00
Note: This exhibit displays the avoided IQ loss per representative child associated with BLLs at the geometric mean, the 25[th] percentile, and the 75[th] percentile. It assumes the representative child spends their entire life in either the pre-rule or the post-rule drinking water concentration in the row. These calculations use the BLLs summarized in Exhibit 6-24.
Valuation of Avoided IQ Loss
The value of an IQ point is derived from EPA's reanalysis of Salkever (1995), which estimates that a one-point change in IQ results in a mean 1.9 percent change in lifetime earnings for males and a mean 3.4 percent change in lifetime earnings for females. Lifetime earnings are estimated using the average of 10 American Community Survey (ACS) single-year samples (2008 to 2017) and projected cohort life tables from the Social Security Administration. Projected increases in lifetime earnings are then adjusted for direct costs of additional years of education and forgone earnings while in school. The reanalysis of Salkever (1995) estimates a mean change of 0.08 years of schooling per change in IQ point resulting from a reduction in lead exposure for males and a mean change of 0.09 years of schooling for females.
To estimate the uncertainty underlying the model parameters of the Salkever (1995) reanalysis, EPA used a bootstrap approach to estimate a distribution of model parameters over 10,000 replicates (using random sampling with replacement). For each replicate, the net monetized value of a one-point change in IQ is subsequently estimated as the gross value of an IQ point, less the value of additional education costs and lost earnings while in school.
Based on the mean value of the 10,000 sampling iterations, EPA estimated that the change in one IQ point to be discounted to age 7 is $5,708 using a 7 percent discount rate and $22,503 using a 3 percent discount rate.   These are presented in 2016$ to be consistent with the cost estimates. As described in Section 6.4.5, benefits are further discounted back to year one of the analysis and annualized within the SafeWater LCR model. An additional discussion of the literature on the value of an IQ point, as well as details of the methods used in the EPA reanalysis of the value of the IQ point, are included in Appendix K. EPA will continue to review the economics literature and evaluate new data and methods that could result in improved estimates and a better understanding of the uncertainties surrounding the estimated effect of changes in IQ on lifetime earnings.
Implementation of Children's Benefit Calculations in the SafeWater LCR model
IQ benefits are estimated based on LSLRs, installation of POU devices, and installation and re-optimization of CCT that occur over the 35-year analysis period. As benefits are captured in the analysis when children turn 7 years of age, it is necessary to estimate the number of 7-year-olds who are served by each PWS receiving a benefit from a change in the lead concentration of their drinking water. In order to estimate the number of 7-year-olds receiving a benefit in a given year, the SafeWater LCR model takes the total population experiencing each water lead change, and multiplies that figure by the proportion of the United States population that is 7 years of age.
Because the SafeWater LCR model follows the population for a period of 35 years, all children who lived in areas experiencing the water lead concentration change who are younger than 7 years of age would also accrue benefits in future years of the 35-year period, as well as children born after the change in lead concentration as long as they reach the age of 7 during the course of the 35-year period. However, the proportion of the total PWS population experiencing a change in lead concentration that receives an IQ benefit in a given year remains the same: approximately 1.34 percent (the percentage of 7-year-olds in the total United States population according to the 2010 United States Census). This is because both the age distribution and the population served by each PWS are assumed to remain constant over the analysis period. Children who turn 7 a year after a LSL change is made will receive a comparatively smaller benefit than children who are born after the change was made, due to living a larger proportion of their life without the higher contribution of lead in their drinking water, and the resulting difference in BLLs between the with- and without-rule scenarios (without considering discounting). EPA refers to these comparatively smaller benefits as "partial benefits."
EPA does not assume that all homes with replaced LSLs have children living in the home. Rather, EPA assumes that the proportion of 7-year-olds living in homes that are undergoing a LSLR is equal to the proportion of the United States population that is 7 years old. This assumption takes care of the need to model the movement of children in and out of homes in the community, as the proportion of the population in these age groups is assumed to remain constant. In other words, if there are 1,000 households being served by a PWS that underwent a change in lead concentration, approximately 1.34 percent of the population in those households would accrue benefit annually, regardless of which specific home being served by the PWS they lived in. The accrued benefit for those children who are served by a PWS that has undergone a change is then a function of changes in the average lifetime BLL of the children due to the change in lead concentration, and the subsequent avoided IQ loss.
The modeling assumption that 1.34 percent of an affected water system's population is made up of 7-year-olds in each year of the analysis and that these children are evenly distributed across LSL and non-LSL households is necessary to estimate the national level impacts of the LCRR rule requirements. At the national level, total benefits calculated using these assumptions can be accurate, however, please note that the potential geographic variability in the impacted population of children will not be represented in this national scale model. For example, some geographic areas of the country may have higher percentages of young children, receiving greater benefits from implementing lead concentration reducing actions like CCT and LSLR. This national scale model does not capture the potential local variation in the estimated unit benefits for a given unit of cost at the local level.
Generally speaking, benefits in a given analysis year are calculated by the SafeWater LCR model using the inputs described earlier in this chapter in the following manner:
 LSLR, POU device installations, and CCT upgrades are recorded based on the rule option for the current analysis year.
 All people who are served by each PWS are assigned a water lead level based on the current state of their PWS.
 A without-rule lifetime average BLL is calculated for a representative 7-year-old child in each PWS water lead scenario modeled in a given analysis year. This without-rule lifetime average BLL assumes a BLL resulting from the water lead levels in the PWS if the rule had not been implemented. This lifetime average is calculated as the sum of the child's annual concurrent BLLs divided by the 7 years of life. Since this without-rule lifetime average BLL assumes this analysis year's rule implementation changes have not occurred, the without-rule blood lead average is equal to the BLL associated with the current state of water lead in the PWS.
 A with-rule lifetime average BLL is calculated for a representative 7-year-old child in each PWS water lead scenario that is modeled in the current analysis year. The with-rule lifetime average considers the water lead levels of the past 7 years of life with the rule. Again, this lifetime average is calculated as the sum of annual concurrent BLLs from Exhibit 6-24 divided by the 7 years of life, but is based on the new water lead levels that occurred due to the rule. Note that the years during the 7-year timeframe that were prior to any water lead changes resulting from the rule's implementation will have equivalent BLLs to the without-rule scenario. So, for this current analysis year, only the 7[th] year of the 7 years of BLLs incorporated into the lifetime blood lead average calculation will reflect the new water lead concentration.
 These estimated average BLLs from steps 3 and 4 are used with Equation 8 in Section 6.4.3 to estimate the avoided IQ loss due to the rule for a representative 7-year-old child in each particular implementation scenario.
 The number of current 7-year-olds who experience avoided IQ loss based on each of the changes made in the analysis year is then calculated by multiplying the total number of people from each PWS by both the proportion of the United States population that is 7 years of age and the proportion of people in each PWS experiencing each particular change.
 Each population of children 7 years of age for each PWS change is then multiplied by the avoided IQ loss calculated by Equation 8 to determine the total number of lost IQ points avoided in this current analysis year based on this year's changes.
 The total number of lost IQ points avoided in this current analysis year for all 7-year-olds based on this year's changes is then multiplied by the appropriately discounted value of an IQ point. This yields the total monetary benefit for the current analysis year for all changes that occurred in that analysis year. These estimated current year benefits are only considered partial benefits, as the current analysis year's 7-year-olds have only received a reduction in blood lead for this one year of their life. However, benefits are only realized in the year when a child is 7 years of age.
 EPA then calculates all future avoided IQ loss benefits through the end of the 35-year period that are associated with each PWS water lead change from this current analysis year using discounted values of an IQ point. The number of children 7 years of age affected by the current analysis year water lead changes in each PWS is assumed to remain constant for each future year of benefits. Partial benefits are calculated for children who were born before the year the water lead change occurred but were younger than age 7, and full benefits are calculated for all children age 0 in the current year of the analysis and all future children who are to be born and reach age 7 during the course of the period of analysis, as they will have lived their full lives with reduced BLLs due to the rule.
 All current and future avoided IQ loss benefits are summed to obtain the total benefits realized for the current analysis year's water lead changes due to the rule.
 This is repeated for each of the remaining analysis years.
Total benefits over the 35-year period are calculated by summing all the total benefits realized for all water lead changes that occur over the entire period of analysis.
The value of an IQ point presented in Section 6.4.4 is discounted to age 7 at both a 3 percent and 7 percent rate. Benefits are further discounted back to year one of the analysis and annualized within the SafeWater LCR model. This means that benefits that are accrued for 7-year-olds in year 25 of the analysis (e.g., the relevant discount rate is applied for each of the 24 years that have passed since year one of the analysis). EPA summed benefits for all years and all PWSs, and then annualized benefits for both the baseline and final rule scenarios.
Appendix G presents alternative blood lead estimates for children, alternative concentration-response functions for the relationship between lead and IQ, and an analysis with an alternative value of an IQ point.
Monetized National Annual Children's Benefits
The national annual children's benefits for a 3 percent and 7 percent discount rate are presented in Exhibit 6-27 and Exhibit 6-28, respectively. As described in Section 6.3, EPA estimated benefits under both the low- and high-cost scenarios used in the LCRR analysis to characterize uncertainty in the cost estimates.
Exhibit 6-27: National Annual Children's Benefits, All PWS, 3 Percent Discount Rate (2016$)

                               Low-Cost Estimate
                              High-Cost Estimate

                                  Previous LCR
                                   Final LCRR
                                  Incremental
                                  Previous LCR
                                   Final LCRR
                                  Incremental
 Number of Children Impacted (over 35 years)
29,000
928,000
900,000
704,000
3,210,000
2,506,000
 Annual IQ Point Decrement Avoided (CCT due to ALE)
190
3,225
3,035
5,228
18,000
12,000
 Annual Value of IQ Impacts Avoided (CCT due to ALE)
$3,344,000
$56,083,000
$52,739,000
$96,449,000
$318,322,000
$221,873,000
 Annual IQ Point Decrement Avoided (CCT due to TLE)
0
3,680
3,680
0
10,000
10,000
 Annual Value of IQ Impacts Avoided (CCT due to TLE)
$0
$64,736,000
$64,736,000
$0
$190,822,000
$190,822,000
 Annual IQ Point Decrement Avoided (LSLR  -  mandatory)
128
2,620
2,492
3,106
8,204
5,097
 Annual Value of IQ Impacts Avoided (LSLR  -  mandatory)
$2,375,000
$47,525,000
$45,150,000
$61,497,000
$156,772,000
$95,275,000
 Annual IQ Point Decrement Avoided (LSLR  -  goal-based)
0
1,807
1,807
0
3,337
3,337
 Annual Value of IQ Impacts Avoided (LSLR  -  goal-based)
$0
$32,855,000
$32,855,000
$0
$63,610,000
$63,610,000
 Annual IQ Point Decrement Avoided (LSLR  -  customer initiated)
0
1,572
1,572
0
1,677
1,677
 Annual Value of IQ Impacts Avoided (LSLR  -  customer initiated)
$0
$27,540,000
$27,540,000
$0
$29,198,000
$29,198,000
 Annual IQ Point Decrement Avoided (POU)
0
17
17
0
2,214
2,214
 Annual Value of IQ Impacts Avoided (POU)
$0
$324,000
$324,000
$0
$44,498,000
$44,498,000
Total Annual Benefits
$5,719,000
$229,062,000
$223,344,000
$157,946,000
$803,222,000
$645,276,000
Acronyms: ALE = action level exceedance, TLE = trigger level exceedance.
Note: This exhibit summarizes the national annual children's benefit for a 3 percent discount rate under the low- and high-cost scenarios. This table uses a 3 percent discount rate over the 35-year analysis period. Representative children are modeled throughout their lifetime, and their drinking water concentration and BLL can change in each year of the analysis as CCT, POU, or LSL changes happen in their modeled PWS. Detail may not add exactly to total due to independent rounding.
Exhibit 6-28: National Annual Children's Benefits, All PWS, 7 Percent Discount Rate (2016$)

                               Low-Cost Estimate
                              High-Cost Estimate

                                  Previous LCR
                                   Final LCRR
                                  Incremental
                                  Previous LCR
                                   Final LCRR
                                  Incremental
 Number of Children Impacted (over 35 years)
                                                                         29,000
                                                                        928,000
                                                                        900,000
                                                                        704,000
                                                                      3,210,000
                                                                      2,506,000
 Annual IQ Point Decrement Avoided (CCT Due to ALE)
                                                                            190
                                                                          3,225
                                                                          3,035
                                                                          5,228
                                                                         18,000
                                                                         12,000
 Annual Value of IQ Impacts Avoided (CCT Due to ALE)
                                                                       $581,000
                                                                     $9,551,000
                                                                     $8,971,000
                                                                    $17,790,000
                                                                    $57,148,000
                                                                    $39,358,000
 Annual IQ Point Decrement Avoided (CCT Due to TLE)
                                                                              0
                                                                          3,680
                                                                          3,680
                                                                              0
                                                                         10,000
                                                                         10,000
 Annual Value of IQ Impacts Avoided (CCT Due to TLE)
                                                                             $0
                                                                    $11,232,000
                                                                    $11,232,000
                                                                             $0
                                                                    $34,750,000
                                                                    $34,750,000
 Annual IQ Point Decrement Avoided (LSLR  -  Mandatory)
                                                                            128
                                                                          2,620
                                                                          2,492
                                                                          3,106
                                                                          8,204
                                                                          5,097
 Annual Value of IQ Impacts Avoided (LSLR-Mandatory)
                                                                       $451,000
                                                                     $8,703,000
                                                                     $8,252,000
                                                                    $12,707,000
                                                                    $30,776,000
                                                                    $18,069,000
 Annual IQ Point Decrement Avoided (LSLR  -  Goal Based)
                                                                              0
                                                                          1,807
                                                                          1,807
                                                                              0
                                                                          3,337
                                                                          3,337
 Annual Value of IQ Impacts Avoided (LSLR-Goal Based)
                                                                             $0
                                                                     $6,039,000
                                                                     $6,039,000
                                                                             $0
                                                                    $12,469,000
                                                                    $12,469,000
 Annual IQ Point Decrement Avoided (LSLR  -  customer initiated)
                                                                              0
                                                                          1,572
                                                                          1,572
                                                                              0
                                                                          1,677
                                                                          1,677
 Annual Value of IQ Impacts Avoided (LSLR-customer initiated)
                                                                             $0
                                                                     $4,797,000
                                                                     $4,797,000
                                                                             $0
                                                                     $5,038,000
                                                                     $5,038,000
 Annual IQ Point Decrement Avoided (POU)
                                                                              0
                                                                             17
                                                                             17
                                                                              0
                                                                          2,214
                                                                          2,214
 Annual Value of IQ Impacts Avoided (POU)
                                                                             $0
                                                                        $62,000
                                                                        $62,000
                                                                             $0
                                                                     $9,417,000
                                                                     $9,417,000
 Total Annual Benefits
                                                                     $1,032,000
                                                                    $40,385,000
                                                                    $39,353,000
                                                                    $30,497,000
                                                                   $149,599,000
                                                                   $119,102,000
Note: This exhibit summarizes the national annual children's benefit for a 7 percent discount rate under the low- and high-cost scenarios. It uses a 7 percent discount rate over the 35-year analysis period. Representative children are modeled throughout their lifetime, and their drinking water concentration and BLL can change in each year of the analysis as CCT, POU, or LSL changes happen in their modeled PWS. Detail may not add exactly to total due to independent rounding.
It should be noted that the results displayed here are national averages. EPA expects that there will be individuals that are exposed to higher (or lower) water concentrations than represented by the mean estimates in the exhibits. These individuals will have greater (or lower) reductions in risk of adverse health effects, and thus higher (or lower) benefits due to the rule for those endpoints quantified here and presented as population averages.
Appendix G contains a discussion of two alternative concentration-response functions and an alternative value of an IQ point used in conjunction with the BLLs and methods described in the main analysis. Appendix G also includes sensitivity analyses regarding alternative assumptions for drinking water inputs when no LSL is present. The first-liter alternative regulatory option benefits are also presented.
As can be seen in Appendix G, using the alternative concentration-response functions increases the benefits by 50 percent and 54 percent with and without the low-dose linearization assumptions, assuming a 3 percent discount rate, and 50 percent and 54 percent with and without the low-dose linearization assuming a 7 percent discount rate, compared to the Crump et al. (2013)-based estimates in this chapter. Additionally, use of the alternative IQ value based on Lin et al. (2018) decreases the valuation of the IQ benefits by 46 percent assuming a 3 percent discount rate, and 48 percent assuming a 7 percent discount rate. Alternative assumptions about the variation in water concentration due to changes in CCT when there is no LSL increases benefits by 133 percent and 130 percent when CCT with no LSL is assumed to have a water lead concentration of 1.15 ug/L at a 3 and 7 percent discount rate, respectively, and increases benefits by 220 percent and 215 percent when CCT with no LSL is assumed to have a water lead concentration of 1.86 ug/L at a 3 and 7 percent discount rate, respectively.
The alternative regulatory option requiring first-liter compliance sampling at LSLs and non-LSL locations reduced benefits by 48 percent in the low-cost option and 16 percent in the high-cost option assuming a 3 percent discount rate, and 49 percent in the low-cost option and 15 percent in the high-cost option assuming a 7 percent discount rate.
Additional concentration-response functions identified in the literature include Min et al. (2009), Jusko et al. (2008), and Budtz-Jørgensen et al. (2013), all of which confirm a stronger association between blood lead and IQ at lower BLLs. The use of any of these three concentration-response functions in place of the Crump et al. (2013) concentration-response function in this economic analysis would also lead to an increase in estimated benefits, as they each estimated a steeper relationship between blood lead and IQ than the Crump et al. (2013) study. Further discussion of these three studies can be found in Appendices D and J.
If EPA used a discount rate lower than 3 percent, it would generally result in an increase in benefits above those estimated using a 3 percent discount rate. This increase in benefits would result from both a higher baseline value of an IQ point due to the decreased discounting of future earnings and a higher value of an IQ point in future analysis years, as this base value would be subject to less discounting from year-to-year. Results using discount rates of 3 percent and 7 percent are presented in this economic analysis to remain consistent with the regulatory analysis guidance outlined in the Office of Management and Budget (OMB) Circular A-4.
Quantification of Adult Blood Lead Levels
In this section, EPA presents estimates of the changes in BLLs in adults associated with the LCRR. Adverse health endpoints in adults, which are also anticipated to be reduced by the rule, are discussed qualitatively in Appendix D. Likewise, the adverse health effects associated with copper are discussed in Appendix E. Methods used to estimate BLLs in adults are described in Section 6.5.1, and BLLs anticipated under the rule scenarios are presented in Section 6.5.2. Appendix H presents a sensitivity analysis of BLLs in adults when alternate background inputs are used as well as alternate blood lead models.
Methods for Estimating Blood Lead Levels in Adults
EPA estimated the BLLs associated with exposure from drinking water throughout adulthood. EPA estimated BLLs in adults for each year of life, beginning at age 20 and ending at age 80. EPA assessed men and women separately because NHANES data indicate that men have higher average BLLs than women.
Adult Lead Methodology
The Adult Lead Methodology (ALM) "uses a simplified representation of lead biokinetics to predict quasi-steady state blood lead concentrations among adults who have relatively steady patterns of site exposures" (USEPA, 2003, p. 1). The model assumes a linear slope between lead uptake and BLLs, which is termed the "biokinetic slope factor" and has units of ug/dL per ug/day. EPA developed the ALM primarily as a tool to estimate fetal blood lead concentrations in pregnant women exposed to lead-contaminated soils. Thus, the original version of the model estimates BLLs by adding site-specific exposures from soil lead to the geometric mean BLL for United States women aged 17 to 45. Equation 9 displays the original version of the ALM.

                 PbB= PbS x IRS xAFS x EFS xBKSFATS + PbB0
                                 (Equation 9)
Where:
      PbB	=	BLL
      PbS	=	Soil lead concentration (μg/g)
      IRS 	= 	Soil ingestion rate (g/day)
      AFS 	= 	GI tract absorption fraction for soil (unitless)
      EFS 	= 	Exposure frequency in soil (days/year)
      BKSF 	= 	Biokinetic slope factor (ug/dL per ug/day)
      ATS 	= 	Averaging time for soil exposure (days/year)
      PbB0 	= 	Background blood lead (μg/dL).
The ALM can be tailored for use in estimating blood lead concentrations in any adult exposed population and is able to consider additional sources of lead exposure, such as contaminated drinking water. Additionally, the biokinetic slope factor of 0.4 ug/dL per ug/day is in part derived from studies that measure both adult BLLs and concentrations of lead in drinking water (Sherlock et al., 1982; Pocock et al., 1983). Thus, EPA determined that the model is suitable for estimating steady-state changes in BLLs under the LCRR.
Modified Adult Lead Methodology
To estimate changes in BLLs in adults associated with the LCRR, EPA used a modified version of the ALM. As shown in Equation 10, EPA used the same basic form of the ALM equation, with the inputs for soil lead replaced by those for drinking water lead.

                 PbB= PbW x IRW xAFW x EFWxBKSF ATW + PbB0
                                 (Equation 10)
Where:
      PbB	=	BLL
      PbW	=	Water lead concentration (μg/L)
      IRW 	= 	Water intake rate (L/day)
      AFW 	= 	GI tract absorption fraction (unitless)
      EFW 	= 	Exposure frequency to water (days/year)
      BKSF 	= 	Biokinetic slope factor (ug/dL per ug/day)
      ATW 	= 	Averaging time for exposure to water (days/year)
      PbB0 	= 	Background blood lead (μg/dL).
For the background BLLs, EPA used geometric mean BLLs for males and females for each year of life between ages 20 and 80 from NHANES 2011 - 2016 (CDC, 2016). These results are summarized in 10-year age categories in Exhibit 6-29.
Exhibit 6-29: Geometric Mean Blood Lead Levels from NHANES 2011 - 2016 (CDC, 2016)
Age Group
Sex
Geometric Mean Blood Lead Level
(ug/dL)
20 - 29
                                     Male
                                     0.82

                                    Female
                                     0.52
30 - 39
                                     Male
                                     0.94

                                    Female
                                     0.61
40 - 49
                                     Male
                                     1.14

                                    Female
                                     0.81
50 - 59
                                     Male
                                     1.34

                                    Female
                                     1.14
60 - 69
                                     Male
                                     1.50

                                    Female
                                     1.22
70 - 80
                                     Male
                                     1.70

                                    Female
                                     1.33
             Note: This exhibit summarizes geometric mean BLLs for males and females for each year of life between ages 20 and 80 from NHANES 2011 - 2016. EPA used the background BLLs to estimate changes in BLLs in adults associated with the LCRR.
Exhibit 6-30 displays the constant variables used with Equation 10 above. Drinking water lead concentrations varied by LCR scenario and are presented in Exhibit 6-12.
Exhibit 6-30: Constant Variables Entered into the ALM
Water-Related Parameter
Proposed Value
Data Source
Water intake rate (mL/day)
                                724 mL (age 20)
                             997 mL (ages 21 - 65)
                              1,094 mL (ages 65+)
NHANES 2005 - 2012 data
GI tract absorption fraction
                                     0.15
Absorption fraction for adults suggested by Leggett (1993)
Exposure frequency (days/year)
                                      365
Consistent with assumption of daily exposure
Averaging time (days/year)
                                      365
Consistent with assumption of daily exposure
Biokinetic slope factor
                                      0.4
Default value in ALM
     Note: This exhibit summarizes the constant variables used in the Adult Lead Methodology (ALM).

A limitation to this approach is that there is "double-counting" of exposures to lead in drinking water, since NHANES is a nationally representative sample of individuals throughout the United States who may also be exposed to various concentrations of lead in their drinking water. By using the NHANES BLLs to set the background in the ALM, national average drinking water exposure would already be factored into the background levels. However, since the results of a quantitative benefits analysis typically depend on changes in BLLs rather than absolute values, the potential ramifications of this double-counting are minimal. Appendix H contains alternate approaches to the blood lead modeling using exposure estimates from SHEDS in place of NHANES for background inputs to the ALM, and also presents results using the beta version of EPA's All Ages Lead Model (AALM), which is currently under peer review. Neither of these approaches suffer from the potential issue of double-counting and include only modeled lead in drinking water estimates. EPA is not estimating benefits of avoided cardiovascular mortality that may result from the LCRR. EPA acknowledges that the scientific understanding of the relationship between lead exposure and cardiovascular mortality is evolving and scientific questions remain. In particular, there remains uncertainty about the best quantitative relationship to describe the impacts of changes in current adult blood lead levels on the risk of CVD mortality. The studies currently available to the Agency which quantitatively describe the risk relationship attempt to control for a variety of potential confounders that may affect CVD risk as well as exposure to lead. EPA needs additional scientific guidance on which studies sufficiently control for potential confounding factors that might introduce bias into the estimated lead CVD risk relationship. The Agency also needs to develop additional information on appropriate methods for modeling the lead cessation lag in the adult population (i.e. the time between the lead exposure reduction and the reduction in CVD risk).  EPA is considering ways to take these considerations into account as it explores approaches to quantifying such benefits.
Estimates of Pre- and Post-Rule Blood Lead Levels in Adults
Exhibit 6-31 displays BLL estimates for adults by each LSL, POU, or CCT combination summarized by age groups. Note that when "No LSL" is the beginning or post-rule state, 0.82 μg/L is the assumed concentration across all levels of CCT status (i.e., none, partial, representative). The extent to which changes in CCT status make meaningful differences in lead concentrations for those without LSL cannot be determined from the results presented in Exhibit 6-31.
Exhibit 6-31: Estimates of Blood Lead Levels in Adults Associated with Drinking Water Lead Exposures from LSL/CCT or POU Combinations
                                  LSL Status
                                  CCT Status
                                      Sex
Geometric Mean Blood Lead Level (ug/dL) for Specified Age Group in Years from the ALM

                                    20 - 29
                                    30 - 39
                                    40 - 49
                                    50 - 59
                                    60 - 69
                                    70 - 80
                                      LSL
                                     None
Male
                                     1.87
                                     2.02
                                     2.22
                                     2.42
                                     2.63
                                     2.89

Female
                                     1.57
                                     1.69
                                     1.89
                                     2.22
                                     2.35
                                     2.52
                                    Partial
                                     None
Male
                                     1.31
                                     1.44
                                     1.64
                                     1.84
                                     2.03
                                     2.25

Female
                                     1.01
                                     1.11
                                     1.31
                                     1.64
                                     1.75
                                     1.88
                                    No LSL
                                     None
Male
                                     0.87
                                     0.99
                                     1.19
                                     1.39
                                     1.55
                                     1.75

Female
                                     0.57
                                     0.66
                                     0.86
                                     1.19
                                     1.27
                                     1.38
                                      LSL
                                    Partial
Male
                                     1.40
                                     1.53
                                     1.73
                                     1.93
                                     2.12
                                     2.35

Female
                                     1.10
                                     1.20
                                     1.40
                                     1.73
                                     1.84
                                     1.98
                                    Partial
                                    Partial
Male
                                     1.09
                                     1.22
                                     1.42
                                     1.62
                                     1.80
                                     2.01

Female
                                     0.79
                                     0.89
                                     1.09
                                     1.42
                                     1.52
                                     1.64
                                    No LSL
                                    Partial
Male
                                     0.87
                                     0.99
                                     1.19
                                     1.39
                                     1.55
                                     1.75

Female
                                     0.57
                                     0.66
                                     0.86
                                     1.19
                                     1.27
                                     1.38
                                      LSL
                                Representative
Male
                                     1.14
                                     1.27
                                     1.47
                                     1.67
                                     1.84
                                     2.06

Female
                                     0.84
                                     0.94
                                     1.14
                                     1.47
                                     1.56
                                     1.69
                                    Partial
                                Representative
Male
                                     0.97
                                     1.10
                                     1.30
                                     1.50
                                     1.67
                                     1.87

Female
                                     0.67
                                     0.77
                                     0.97
                                     1.30
                                     1.39
                                     1.50
                                    No LSL
                                Representative
Male
                                     0.87
                                     0.99
                                     1.19
                                     1.39
                                     1.55
                                     1.75

Female
                                     0.57
                                     0.66
                                     0.86
                                     1.19
                                     1.27
                                     1.38
                                      POU
Male
                                     0.87
                                     0.99
                                     1.19
                                     1.39
                                     1.55
                                     1.75

Female
                                     0.57
                                     0.66
                                     0.86
                                     1.19
                                     1.27
                                     1.38
Note: This exhibit displays BLL estimates for adults by each LSL, POU, or CCT combination summarized by age groups. Note that BLLs by each year (not age group average) are used in the analysis.
Similar to the presented childhood BLLs (Section 6.4.2), the estimated BLLs in Exhibit 6-31 are average adult BLLs given the corresponding estimated lead tap water concentrations resulting from LSL, CCT, and POU status at steady-state, holding other exposures constant. In the LCRR cost-benefit simulation model, water systems are tracked as they move from one LSL, CCT, or POU status to another as a result of rule implementation. The number of males and females in each age group served by those water systems are proportional to the age/sex makeup of the United States population as a whole.
Exhibit 6-32 shows the estimated change in average lifetime BLLs for adults who experience a change in water lead concentration as a result of LSL removal and/or installation of CCT or POU, rather than the set of initial LSL, CCT, and POU status combinations.
Exhibit 6-32: Estimated Lifetime Average Blood Lead Level Change for Adults Experiencing Alternate LSL, CCT, and POU Status Combinations
                            Pre-Rule Drinking Water
                           Post-Rule Drinking Water
Estimated Change in the Geometric Mean of Blood Lead Change
Ages 20 - 80
(ug/dL)
                          Lead Concentration (ug/L)
                                  LSL Status
                                  CCT Status
                          Lead Concentration (ug/L)
                                  LSL Status
                                  CCT Status

                                     18.08
                                      LSL
                                     None
                                     0.82
                                    No LSL
                                     None
                                     1.03
                                     18.08
                                      LSL
                                     None
                                     5.48
                                      LSL
                                Representative
                                     0.75
                                     18.08
                                      LSL
                                     None
                                     0.82
                                    No LSL
                                Representative
                                     1.03
                                     18.08
                                      LSL
                                     None
                                     0.82
                                      POU
                                     1.03
                                     8.43
                                    Partial
                                     None
                                     0.82
                                    No LSL
                                     None
                                     0.46
                                     8.43
                                    Partial
                                     None
                                     2.64
                                    Partial
                                Representative
                                     0.35
                                     8.43
                                    Partial
                                     None
                                     0.82
                                    No LSL
                                Representative
                                     0.46
                                     8.43
                                    Partial
                                     None
                                     0.82
                                      POU
                                     0.46
                                     0.82
                                    No LSL
                                     None
                                     0.82
                                    No LSL
                                Representative
                                     0.00
                                     0.82
                                    No LSL
                                     None
                                     0.82
                                      POU
                                     0.00
                                     9.92
                                      LSL
                                    Partial
                                     0.82
                                    No LSL
                                    Partial
                                     0.54
                                     9.92
                                      LSL
                                    Partial
                                     5.48
                                      LSL
                                Representative
                                     0.27
                                     9.92
                                      LSL
                                    Partial
                                     0.82
                                    No LSL
                                Representative
                                     0.54
                                     9.92
                                      LSL
                                    Partial
                                     0.82
                                      POU
                                     0.54
                                     4.72
                                    Partial
                                    Partial
                                     0.82
                                    No LSL
                                    Partial
                                     0.23
                                     4.72
                                    Partial
                                    Partial
                                     2.64
                                    Partial
                                Representative
                                     0.12
                                     4.72
                                    Partial
                                    Partial
                                     0.82
                                    No LSL
                                Representative
                                     0.23
                                     4.72
                                    Partial
                                    Partial
                                     0.82
                                      POU
                                     0.23
                                     0.82
                                    No LSL
                                    Partial
                                     0.82
                                    No LSL
                                Representative
                                     0.00
                                     0.82
                                    No LSL
                                    Partial
                                     0.82
                                      POU
                                     0.00
                                     5.48
                                      LSL
                                Representative
                                     0.82
                                    No LSL
                                Representative
                                     0.28
                                     5.48
                                      LSL
                                Representative
                                     0.82
                                      POU
                                     0.28
                                     2.64
                                    Partial
                                Representative
                                     0.82
                                    No LSL
                                Representative
                                     0.11
                                     2.64
                                    Partial
                                Representative
                                     0.82
                                      POU
                                     0.11
                                     0.82
                                    No LSL
                                Representative
                                     0.82
                                      POU
                                     0.00
Note: This exhibit summarizes the estimated change in average lifetime BLLs for adults that experience the new status as a result of LSL removal and/or installation of CCT or POU, rather than the set of initial LSL, CCT, and POU status combinations.
Summary of Non-Quantified and Non-Monetized Benefits
In addition to the benefits monetized in the final rule analysis for reductions in lead exposure, several other benefits are not quantified. Multiple adverse health effects due to lead are expected to decrease as a result of the final LCRR. These adverse effects are summarized in Appendix D and are expected to affect both children and adults. EPA focused its non-quantified impacts assessment on the endpoints identified using two comprehensive United States Government documents summarizing the recent literature on lead exposure health impacts. These documents are EPA's Integrated Science Assessment for Lead (ISA) (USEPA, 2013), and the United States Department of Health and Human Services' NTP Monograph on Health Effects of Low-Level Lead (NTP, 2012). Both of these sources present comprehensive reviews of the literature on the risk of adverse health effects associated with lead exposure. EPA summarized those endpoints to which either the EPA ISA or the NTP Monograph assigned one of the top two tiers of confidence in the relationship between lead exposure and the risk of adverse health effects. These endpoints include cardiovascular effects, renal effects, reproductive and developmental effects, immunological effects, neurological effects, and cancer.
EPA was unable to quantify a number of final rule requirements that reduce lead exposure to both children and adults. The final rule will require additional lead public education requirements that target consumers, schools and child cares, health agencies, and specifically people living in homes with LSLs. Increased education will lead to additional averting behavior on the part of the exposed public, resulting in reductions in the negative impacts of lead. For example, residents at LSL locations may purchase and use POU devices to filter their drinking and cooking water, thereby reducing exposure. The final rule also will require the development of LSL inventories and making the location of LSLs publicly accessible. This will give exposed consumers more information and will provide potential homebuyers this information as well, possibly resulting in additional LSL removals initiated by homeowners before, during, or following home sale transactions. The benefits of these additional removals are not quantified in the analysis of the LCRR. Also, because of the lack of granularity in the lead tap water concentration data available to EPA for the regulatory analysis, the benefits of small improvements in CCT to individuals residing in homes with LSLs, like those modeled under the "find-and-fix," are not quantified.
EPA also did not quantify the benefits of reduced lead exposure to individuals who reside in homes that do not have LSLs. EPA has determined that the revised LCR requirements may result in reduced lead exposure to the occupants of these buildings as a result of improved monitoring and additional actions taken to optimize CCT. In the analysis of the LCRR, the number of non-LSL homes potentially affected by water systems increasing their corrosion control during the 35-year period of analysis is 8 million in the low-cost scenario and 17 million in the high-cost scenario. These households, while not having an LSL in place, may still contain leaded plumbing materials, including leaded brass fixtures and lead solder. These households could potentially see reductions in tap water lead concentrations. EPA has assessed the potential benefits to children of reducing lead water concentrations in these homes (see Appendix G), but has determined that the data are too limited and the uncertainties regarding the magnitude of decreases in lead levels are too significant to include in the quantified and monetized benefit estimates of this regulation. However, because of the significant number of homes without LSLs but with other leaded plumbing materials, these unquantified benefits could be significant.
Additionally, the risk of adverse health effects associated with copper that are expected to be reduced by the LCRR are summarized in Appendix E. These risks include acute GI symptoms, which are the most common adverse effect observed among adults and children. In sensitive groups, there may be reductions in chronic hepatic effects, particularly for those with rare conditions such as Wilson's disease and children predisposed to genetic cirrhosis syndromes. These diseases disrupt copper homeostasis, leading to excessive accumulation that can be worsened by excessive copper ingestion (NRC, 2000).
References
Bates, D.M. 2010. lme4: Mixed effects modeling with R. Springer.
Bates, D., M. Mächler, B. Bolker, and S. Walker. 2015. Fitting linear mixed effects models using lme4. Journal of Statistical Software 67(1):1 - 48. Available: https://doi.org/10.18637/jss.v067.i01.
Bolker, B.M., M.E. Brooks, C.J. Clark, S.W. Geange, J.R. Poulsen, M.H.H. Stevens, and J.S.S. White. 2009. Generalized linear mixed models: A practical guide for ecology and evolution. Trends in Ecology and Evolution 24(3):127 - 135.
Budtz-Jørgensen, E., D. Bellinger, B. Lanphear, and P. Grandjean. 2013. An international pooled analysis for obtaining a benchmark dose for environmental lead exposure in children. Risk Analysis 33(3):450 - 461. doi:10.1111/j.1539-6924.2012.01882.x.
Camara, E., K.R. Montreuil, A.K. Knowles, and G.A. Gagnon. 2013. Role of the water main in lead service line replacement: A utility case study. Journal AWWA 108(8):E423-E431. doi:10.5942/jawwa.2013.105.0102.
Campbell, A. 2016. Unpublished raw data.
Commons, C. 2011. Effect of Partial Lead Service Line Replacement on Total Lead at the Tap. Rhode Island Department of Health, Office of Drinking Water Quality.
Commons, C. 2014. A four-year follow-up on total lead at the tap following partial service line replacement in Cranston, RI. Addendum to a paper originally published in June 2012 entitled: Effect of partial lead service line replacement on total lead at the tap in Cranston, Rhode Island. Journal New England Water Works Association 187 - 188.
Craik, S. 2016. Unpublished raw data.
Crump, K.S., C. Van Landingham, T.S. Bowers, D. Cahoy, and J.K. Chandalia. 2013. A statistical reevaluation of the data used in the Lanphear et al. (2005) pooled-analysis that related low levels of blood lead to intellectual deficits in children. Critical Reviews in Toxicology 43(9):785 - 799. Doi:10.3109/10408444.2013.832726.
DC Water. 2016. Unpublished raw data.
DC Water. 2017. Personal communication with Maureen Schmelling. May 2017.
Del Toral, M.A., A. Porter, and M.R. Schock. 2013. Detection and evaluation of elevated lead release from service lines: A field study. Environmental Science and Technology 47:9300 - 9307.
Del Toral, M.A. 2016. Unpublished raw data. Flint sequential water sampling data for 2016.
Deshommes, E., A. Bannier, L. Laroche, S. Nour, and M. Prevost. 2016. Monitoring-based framework to detect and manage lead water service lines. Journal AWWA 108(11):E555 - E570.
Desmarais, M.C., B. Trueman, P. Wilson, D. Huggins, J. Swertfeger, E. Deshommes, and M. Prevost. 2015. Impact of Partial Lead Service Line Replacements on Water Quality: Lead Profiling Sampling Results in 6 North-American Utilities. Presented at the AWWA Water Quality Technology Conference & Expo, Salt Lake City, UT, November 15-19, 2015.
EPCOR Water Services. 2008. Lead at Customers Taps. Results of the 2007 Sampling Program. Draft Report.
Estes-Smargiassi, S., S.J.J. Steinkrauss, A. Sandvig, and T. Young,. 2006. Impacts of Lead Service Line Replacement on Lead Levels at the Tap. Presented at the AWWA Annual Conference, San Antonio, TX, June 11-15, 2006.
Glen, G., V. Zartarian, L. Smith, and J. Xue. 2012. The Stochastic Human Exposure and Dose Simulation Model for Multimedia, Multipathway Chemicals (SHEDS-Multimedia): Residential Module. SHEDS-Residential version 4 Technical Manual. Available: www.epa.gov/sites/production/files/2015-02/documents/shedsresidential_techmanual_2012.pdf.
Hayes, C.R., T.N. Croft, A. Campbell, I.P. Douglas, P. Gadoury, and M.R. Schock. 2014. Computational modelling techniques in the optimization of corrosion control for reducing lead in Canadian drinking water. Water Quality Research Journal of Canada 49(1):82.
Jusko, T.A., C.R. Henderson, B.P. Lanphear, D.A. Cory-Slechta, P.J. Parsons, and R.L. Canfield. 2008. Blood lead concentrations < 10 microg/dL and child intelligence at 6 years of age. Environmental Health Perspectives 116(2):243 - 248. doi:10.1289/ehp.10424.
Kirrane, E.F. and M.M. Patel. 2014. Memorandum from EPA NCEA to ISA for Lead Docket: Identification and Consideration of Errors in Lanphear et al. (2005) "Low-Level Environmental Lead Exposure and Children's Intellectual Function: An International Pooled Analysis."
Lanphear, B.P., R. Hornung, J.  Khoury, K. Yolton, P.A. Baghurst, D.C. Bellinger, and R. Roberts. 2005. Low-level environmental lead exposure and children's intellectual function: An international pooled analysis. Environmental Health Perspectives 113(7):894 - 899. doi:10.1289/ehp.7688.
Lanphear, B.P., R. Hornung, J. Khoury, K. Yolton, P.A. Baghurst, D.C. Bellinger, R. Roberts. 2019. Erratum: Low-level environmental lead exposure and children's intellectual function: An international pooled analysis. Environmental Health Perspectives 113(7):894 - 899.
Leggett, R.W. 1993. An age-specific kinetic model of lead metabolism in humans. Environmental Health Perspectives 101:598 - 616.
Lin, D., R. Lutter, and C.J. Ruhm. 2018. Cognitive performance and labour market outcomes. Labour Economics 51:121 - 135.
Min, M.O., L.T. Singer, H.L. Kirchner, S. Minnes, E. Short, Z. Hussain, and S. Nelson. 2009. Cognitive development and low-level lead exposure in poly-drug exposed children. Neurotoxicology and Teratology 31(4):225 - 231. doi:10.1016/j.ntt.2009.03.002.
Muylwyk, Q. 2016. Unpublished raw data.
National Research Council (NRC). 2000. Copper in Drinking Water. Washington, D.C.: The National Academies Press.
NSF International. 2019. Certified Product Listings for Lead Reduction. Available: http://info.nsf.org/Certified/DWTU/listings_leadreduction.asp?ProductFunction=053|Lead+Reduction&ProductFunction=058|Lead+Reduction&ProductType=&submit2=Search.
National Toxicology Program (NTP). 2012. NTP Monograph: Health Effects of Low-Level Lead. U.S. Department of Health and Human Services. Office of Health Assessment and Translation. Division of the National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.
O'Brien & Gere. 2015. Lead Service Line Monitoring to Assess Treatment pH Change. O'Brien & Gere Engineers, Inc.
Ozkaynak, H., J. Xue, V. Zartarian, G. Glen and L. Smith. 2011. Modeled estimates of soil and dust ingestion rates for children. Risk Analysis 31(4):592 - 608. doi:10.1111/j.1539-6924.2010.01524x.
Pinheiro, J., D. Bates, S. DebRoy, D. Sarkar, and R Core Team. 2017. nlme: Linear and Nonlinear Mixed Effects Models. R package version 3.1-128. Available: http://CRAN.R-project.org/package=nlme.
Pocock, S.J., A.G. Shaper, M. Walker, C.J. Wale, B. Clayton, T. Delves, R.F. Lacey, R.F. Packham, and P. Powell. 1983. Effects of tap water lead, water hardness, alcohol, and cigarettes on blood lead concentrations. Journal of Epidemiology and Community Health 37(1):1 - 7.
R Core Team. 2016. R: A language and environment for statistical computing R Foundation for Statistical Computing (Version 3.4.1. ed.). Vienna, Austria.
Salkever, D.S. 1995. Updated estimates of earnings benefits from reduced exposure of children to environmental lead. Environmental Research 70:1 - 6. doi:0013-9351/95.
Schock, M. 2016. Unpublished raw data.
Schwartz, J. and D. Otto. 1991. Lead and minor hearing impairment. Archives of Environmental and Occupational Health 46(5):300 - 305. doi:10.1080/00039896.1991.9934391.
Sherlock, J., G. Smart, G.I. Forbes, M.R. Moore, W.J. Patterson, W.N. Richards, and T.S. Wilson, T. S. 1982. Assessment of lead intakes and dose-response for a population in Ayr exposed to a plumbosolvent water supply. Human & Experimental Toxicology 1(2):115 - 122.
Stanek, L.W., J. Xue, C.R. Lay, E.C. Helm, M. Schock, D.A. Lytle, T.F. Speth, and V.G. Zartarian. 2020. Modeled impacts of drinking water Pb reduction scenarios on children's exposures and blood lead levels. Environmental Science and Technology 54(15):9474-9482. doi:10.1021/acs.est.0c00479.
Swertfeger, J., D.J. Harman, C. Shrive, D.H. Metz, and J. DeMarco. 2006. Water Quality Effects of Partial Lead Line Replacement. Presented at the AWWA Annual Conference, San Antonio, TX, June 11-15, 2006.
The Cadmus Group, Inc. 2007. Review of the Interim Optimal Corrosion Control Treatment for Washington, DC. The Cadmus Group, Inc. [OCCT Review 2007].
Triantafyllidou, S., M. Schock, M.K. DeSantis, and C. White. 2015. Low contribution of PbO2-coated lead service lines to water lead contamination at the tap. Environmental Science & Technology 49(6):3746 - 3754.
United States Census Bureau. 2013. 2010 Census of Population and Housing, Summary Population and Housing Characteristics. CPH-1-1, U.S. Government Printing Office. Washington, DC. https://www2.census.gov/library/publications/2012/dec/cph-1-1.pdf.
United States Centers for Disease Control and Prevention (CDC). 2014. National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Questionnaire. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available: https://www.cdc.gov/nchs/nhanes.
United States Centers for Disease Control and Prevention (CDC). 2016. National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Data. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Available: https://www.cdc.gov/nchs/nhanes.
United States Department of Housing and Urban Development (HUD). 2011. American Healthy Homes Survey: Lead and Arsenic Findings. Office of Healthy Homes and Lead Hazard Control. https://www.hud.gov/sites/documents/AHHS_REPORT.PDF.
United States Environmental Protection Agency (USEPA). 1994. Guidance Manual for the Integrated Exposure Uptake Biokinetic Model for Lead in Children. February 1994. Office of Solid Waste and Emergency Response. EPA/540/R-93/081. https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=2000WN4R.TXT.
USEPA. 2003. Recommendations of the Technical Review Workgroup for Lead for an Approach to Assessing Risks Associated with Adult Exposures to Lead in Soil. January 2003. Technical Review Workgroup for Lead. EPA-540-R03-001. Available: https://semspub.epa.gov/work/06/199244.pdf.
USEPA. 2007. Lead Human Exposure and Health Risk Assessments for Selected Case Studies (Draft Report): Volume I. Human Exposure and Health Risk Assessments  -  Full Scale. United States Environmental Protection Agency, Office of Air Quality Planning and Standards. EPA-452/D-07-001a. Research Triangle Park, NC. https://www3.epa.gov/ttn/naaqs/standards/pb/data/Pb-RA-Vol-1-073007.pdf.
USEPA. 2013. Integrated Science Assessment for Lead. United States Environmental Protection Agency, Office of Research and Development. Research Triangle Park, NC. EPA/600/R-10/075F.
USEPA. 2016. Stochastic Human Exposure and Dose Simulation (SHEDS) to Estimate Human Exposure to Chemicals. United States Environmental Protection Agency. Available: https://www.epa.gov/chemical-research/stochastic-human-exposure-and-dose-simulation-sheds-estimate-human-exposure.
United States Food and Drug Administration (FDA). 2017. Analytical Results of the Total Diet Study: Individual Year Analytical Results for elements 2007-2014 . Available: https://www.fda.gov/food/total-diet-study/analytical-results-total-diet-study.
White, P.D., P. Van Leeuwen, B.D. Davis, M. Maddaloni, K.A.Hogan, A.H.Marcus, and R.W. Elias. 1998. The conceptual structure of the integrated exposure uptake biokinetic model for lead in children. Environmental Health Perspectives 106(Suppl 6):1513 - 1530.
Xue, J., Zartarian, V., Liu, J., and Geller, A. M. 2012a. Methyl mercury exposure from fish consumption in vulnerable racial/ethnic populations: Probabilistic SHEDS-Dietary model analyses using 1999-2006 NHANES and 1990 - 2002 TDS data. Science of the Total Environment 414:373 - 379. doi:10.1016/j.scitotenv.2011.10.010.
Xue, J., V. Zartarian, S.W. Wang, S.V. Liu, and P. Georgopoulos. 2010. Probabilistic modeling of dietary arsenic exposure and dose and evaluation with 2003-2004 NHANES data. Environmental Health Perspectives 118(3):345 - 350. doi:10.1289/ehp.0901205.
Xue, J., V. Zartarian, and S. Nako. 2012b. The Stochastic Human Exposure and Dose Simulation Model for Multimedia, Multipathway Chemicals (SHEDS-Multimedia):Dietary Module. SHEDS-Dietary Version 1 Technical Manual. Available: https://www.epa.gov/sites/production/files/2015-02/documents/shedsdietary_techmanual_2012.pdf.
Xue, J., J. Liu, V. Zartarian, A.M. Geller, and B.D. Schultz. 2014a. Analysis of NHANES measured blood PCBs in the general US population and application of SHEDS model to identify key exposure factors. Journal of Exposure Science and Environmental Epidemiology 24:615 - 621. doi:1559-0631/14.
Xue, J., V. Zartarian, R. Tornero-Velez, and N. Tulve. 2014b. EPA's SHEDS-multimedia model: Children's cumulative pyrethroid exposure estimates and evaluation against NHANES biomarker data. Environmental International 73:304 - 311. doi:10.1016/j.envint.2014.08.008.
Zartarian, V., J. Xue, H. Ozkaynak, W. Dang, G. Glen, L. Smith, and C. Stallings. 2006. A probabilistic arsenic exposure assessment for children who contact Chromated Copper Arsenate (CCA)-treated playsets and decks, Part 1: Model methodology, variability results, and model evaluation. Risk Analysis 26(2):515 - 531. doi:10.1111/j.1539-6924.2006.00747.x.
Zartarian, V., G. Glen, S. Luther, and J. Xue. 2008. Stochastic Human Exposure and Dose Simulation Model for Multimedia, Multipathway Chemicals. SHEDS-Multimedia Model Version 3 Technical Manual.
Zartarian, V., J. Xue, G. Glen, L. Smith, N. Tulve, and R. Tornero-Velez. 2012. Quantifying children's aggregate (dietary and residential) exposure and dose to permethrin: Application and evaluation of EPA's probabilistic SHEDS-Multimedia model. Journal of Exposure Science and Environmental Epidemiology 22:267 - 273. doi:10.1038/jes.2012.12.
Zartarian, V., J. Xue, R. Tornero-Velez, J. Brown. 2017. Children's Lead Exposure: A multimedia Modeling Analysis to Guide Public Health Decision-Making. Environmental Health Perspectives. 125(9). CID 097009. Available: https://doi.org/10.1289/EHP1605
Comparison of Costs to Benefits
This chapter compares the incremental costs and benefits of the final Lead and Copper Rule revisions (LCRR). As a reminder, the incremental cost is the difference between costs that will be incurred under the final LCRR and the costs that would have been incurred if the previous Lead and Copper Rule (LCR) had remained in place with no changes. The same concept holds for the incremental benefits. The estimated benefits that would have accrued under the previous LCR are subtracted from those that will accrue under the final LCRR. That is, the previous LCR is the baseline for this analysis. Section 7.1 summarizes the incremental costs that were discussed in detail in Chapter 5. In Section 7.2, the United States Environmental Protection Agency (EPA) summarizes the incremental benefits that were presented in Chapter 6. Finally, Section 7.3 compares the incremental costs and benefits.
Summary of the Incremental Costs of the Final LCRR
Monetized Incremental Costs
Exhibit 7-1 provides the incremental costs of the final LCRR, for both the low and high cost scenarios, at a 3 percent discount rate in 2016 dollars. The same information is provided in Exhibit 7-2 at a 7 percent discount rate in 2016 dollars. Because many of the additional costs associated with the final LCRR are spread out fairly evenly over the 35-year period of analysis, the annual incremental cost is quite similar at the two discount rates.
Exhibit 7-1: National Annualized Incremental Costs of the Final LCRR at 3 Percent Discount Rate ($2016)
 PWS Annual Costs

                                                              Low Cost Scenario
                                                             High Cost Scenario
 Sampling

                                                                    $25,782,000
                                                                    $33,641,000
 PWS Lead Service Line Replacement

                                                                    $43,744,000
                                                                   $112,965,000
 Corrosion Control Technology

                                                                    $19,412,000
                                                                    $85,407,000
 Point-of Use Installation and Maintenance

                                                                     $3,418,000
                                                                    $20,238,000
 Public Education and Outreach

                                                                    $36,861,000
                                                                    $43,994,000
 Rule Implementation and Administration

                                                                     $2,576,000
                                                                     $2,576,000
 Total Annual PWS Costs

                                                                   $131,792,000
                                                                   $298,820,000
 State Rule Implementation and Administration

                                                                    $19,707,000
                                                                    $20,756,000
 Household Lead Service Line Replacement

                                                                     $7,918,000
                                                                    $14,076,000
 Wastewater Treatment Plant Costs

                                                                     $1,152,000
                                                                     $1,828,000
 Total Annual Rule Costs

                                                                   $160,571,000
                                                                   $335,481,000
 Notes:
      Sub-totals values may not add exactly to total values due to independent rounding.
Exhibit 7-2: National Annualized Incremental Costs of the Final LCRR at 7 Percent Discount Rate (2016$)
 PWS Annual Costs

                                                              Low Cost Scenario
                                                             High Cost Scenario
 Sampling

                                                                    $29,307,000
                                                                    $39,243,000
 PWS Lead Service Line Replacement

                                                                    $46,136,000
                                                                   $131,235,000
 Corrosion Control Technology

                                                                    $17,623,000
                                                                    $92,745,000
 Point-of Use Installation and Maintenance

                                                                     $3,308,000
                                                                    $19,928,000
 Public Education and Outreach

                                                                    $36,084,000
                                                                    $43,612,000
 Rule Implementation and Administration

                                                                     $4,147,000
                                                                     $4,147,000
 Total Annual PWS Costs

                                                                   $136,605,000
                                                                   $330,908,000
 State Rule Implementation and Administration

                                                                    $20,876,000
                                                                    $22,216,000
 Household Lead Service Line Replacement

                                                                     $8,393,000
                                                                    $16,728,000
 Wastewater Treatment Plant Costs

                                                                     $1,458,000
                                                                     $2,607,000
 Total Annual Rule Costs

                                                                   $167,333,000
                                                                   $372,460,000
       Notes:
 Sub-totals values may not add exactly to total values due to independent rounding.
Non-monetized Costs
As discussed in Section 5.5 of Chapter 5, the final LCRR is expected to result in additional phosphate being added to drinking water in order to reduce the amount of lead leaching into the water in the distribution system. The SafeWater LCR model estimated that, nationwide, the final LCRR will result in an increase of between 161,000 and 548,000 pounds of phosphorous being deposited into the nation's water bodies within 15 years of the rule's promulgation. This will grow to between 355,000 and 722,000 pounds per year within the 35-year period of analysis. At the national level, these additional quantities of phosphorous loadings are small, only 0.1 percent of the total phosphorous load deposited annually from all other sources. However, national average load impacts may obscure significant localized ecological impacts. These localized impacts, such as eutrophication, may occur in water bodies without restrictions on phosphate deposits, or in locations with existing elevated phosphate levels.
Also, note that the lead service line replacement (LSLR) unit cost estimates used in the SafeWater LCR model do not include certain indirect and non-market costs such as traffic congestion costs, inconvenience to homeowners and neighbors at LSLR sites, potential short term impact to the aesthetic appeal of the property, and additional impacts to landscaping and cost of replacement beyond lawn repair, which is covered in the cost estimates above. Because of these omissions the estimated cost of LSLR may be underestimated.
Summary of the Incremental Benefits of the final LCRR
Monetized Incremental Benefits
Exhibit 7-3 shows the incremental monetized benefits of the final LCRR at a 3 percent discount rate under the low and high cost scenarios. The information is provided in Exhibit 7-4 at a 7 percent discount rate. The benefit values are also broken out by the treatment technique action required by the final LCRR (e.g., corrosion control treatment [CCT], LSLR, point-of-use [POU] filtration). The benefits of annual intelligence quotient (IQ) point decrements avoided differ significantly by discount rate. This is because the value of an IQ point decrement is estimated as the present value of the lifetime lost earnings associated with lower IQ, and the longer a stream of income is discounted  -  in this case, up to 58 years  -  the more impact the discount rate has on the income stream's present value.
Exhibit 7-3: National Annualized Incremental Benefits of the Final LCRR at 3 Percent Discount Rate (2016$)

                                                              Low Cost Scenario
                                                             High Cost Scenario
 Number of Children Impacted (over 35 years)
                                                                        900,000
                                                                      2,506,000
 Annual IQ Point Decrement Avoided (CCT due to ALE)
                                                                          3,035
                                                                         12,000
 Annual Value of IQ Impacts Avoided (CCT due to ALE)
                                                                    $52,739,000
                                                                   $221,873,000
 Annual IQ Point Decrement Avoided (CCT due to TLE)
                                                                          3,680
                                                                         10,000
 Annual Value of IQ Impacts Avoided (CCT due to TLE)
                                                                    $64,736,000
                                                                   $190,822,000
 Annual IQ Point Decrement Avoided (LSLR  -  mandatory)
                                                                          2,492
                                                                          5,097
 Annual Value of IQ Impacts Avoided (LSLR  -  mandatory)
                                                                    $45,150,000
                                                                    $95,275,000
 Annual IQ Point Decrement Avoided (LSLR  -  goal based)
                                                                          1,807
                                                                          3,337
 Annual Value of IQ Impacts Avoided (LSLR  -  goal based)
                                                                    $32,855,000
                                                                    $63,610,000
 Annual IQ Point Decrement Avoided (LSLR  -  customer initiated)
                                                                          1,572
                                                                          1,677
 Annual Value of IQ Impacts Avoided (LSLR  -  customer initiated)
                                                                    $27,540,000
                                                                    $29,198,000
 Annual IQ Point Decrement Avoided (POU)
                                                                             17
                                                                          2,214
 Annual Value of IQ Impacts Avoided (POU)
                                                                       $324,000
                                                                    $44,498,000
 Total Annual Benefits
                                                                   $223,344,000
                                                                   $645,276,000
Acronyms: ALE = action level exceedance; CCT = corrosion control treatment; IQ = intelligence quotient; LSLR = lead service line replacement; POU = point-of-use; TLE = trigger level exceedance.
Note: Sub-totals values may not add exactly to total values due to independent rounding.

Exhibit 7-4: National Annualized Incremental Benefits of the Final LCRR at 7 Percent Discount Rate (2016$)

                                                              Low Cost Scenario
                                                             High Cost Scenario
 Number of Children Impacted (over 35 years)
                                                                        900,000
                                                                      2,506,000
 Annual IQ Point Decrement Avoided (CCT due to ALE)
                                                                          3,035
                                                                         12,000
 Annual Value of IQ Impacts Avoided (CCT due to ALE)
                                                                     $8,971,000
                                                                    $39,358,000
 Annual IQ Point Decrement Avoided (CCT due to TLE)
                                                                          3,680
                                                                         10,000
 Annual Value of IQ Impacts Avoided (CCT due to TLE)
                                                                    $11,232,000
                                                                    $34,750,000
 Annual IQ Point Decrement Avoided (LSLR  -  mandatory)
                                                                          2,492
                                                                          5,097
 Annual Value of IQ Impacts Avoided (LSLR  -  mandatory)
                                                                     $8,252,000
                                                                    $18,069,000
 Annual IQ Point Decrement Avoided (LSLR  -  goal based)
                                                                          1,807
                                                                          3,337
 Annual Value of IQ Impacts Avoided (LSLR  -  goal based)
                                                                     $6,039,000
                                                                    $12,469,000
 Annual IQ Point Decrement Avoided (LSLR  -  customer initiated)
                                                                          1,572
                                                                          1,677
 Annual Value of IQ Impacts Avoided (LSLR  -  customer initiated)
                                                                     $4,797,000
                                                                     $5,038,000
 Annual IQ Point Decrement Avoided (POU)
                                                                             17
                                                                          2,214
 Annual Value of IQ Impacts Avoided (POU)
                                                                        $62,000
                                                                     $9,417,000
 Total Annual Benefits
                                                                    $39,353,000
                                                                   $119,102,000

Acronyms: ALE = action level exceedance; CCT = corrosion control treatment; IQ = intelligence quotient; LSLR = lead service line replacement; POU = point-of-use; TLE = trigger level exceedance.
Note: Sub-totals values may not add exactly to total values due to independent rounding.
Non-monetized Benefits
In addition to the benefits monetized in the final rule analysis for reductions in lead exposure due to the final LCRR summarized above, there are several other benefits that were not quantified. EPA did not quantify or monetize benefits for lifestages beyond children ages 0-7. However, there are multiple adverse health effects due to lead exposure that are expected to decrease as a result of the final LCRR. These adverse health effects are summarized in Appendix D and are expected for both children and adults. Additionally, the adverse health effects associated with copper that are expected to be reduced by the final LCRR are summarized in Appendix E.
In Appendix D, six categories of adverse health effects associated with lead exposures are summarized. These include: cardiovascular effects (both morbidity and mortality effects; Section D.1), renal effects (Section D.2), reproductive and developmental effects (Section D.3), immunological effects (Section D.4), neurological effects (Section D.7), and cancer (Section D.8). While other adverse health effects are associated with exposure to lead, EPA focused on these endpoints in Appendix D because they were identified using two comprehensive U.S. Government documents summarizing the literature on lead exposure health impacts. These documents are EPA's Integrated Science Assessment for Lead (USEPA, 2013), hereafter referred to as the EPA ISA; and the U.S. Department of Health and Human Services' National Toxicology Program Monograph on Health Effects of Low-Level Lead (National Toxicology Program, 2012), and hereafter referred to as the NTP Monograph. Both of these sources present comprehensive reviews of the literature on adverse health effects associated with lead exposure. EPA summarized those endpoints to which either the EPA ISA or the NTP Monograph assigned one of the top two tiers of confidence in the relationship between lead exposure and the adverse health effects. Appendix I presents potential methods for quantifying 1) decreases in cases of attention-deficit/hyperactivity disorder (ADHD) based on reduced blood lead in children aged 8 to 15 years old and 2) avoided reductions in birth weight based on reduced maternal blood lead. These methods have not undergone extensive peer review and have therefore not been quantified or monetized as part of the primary benefits assessment of the final rule.
There are a number of final LCRR requirements that reduce lead exposure to both children and adults that EPA could not quantify. The final rule would require additional lead public education requirements that target consumers directly, schools and child cares, health agencies, and specifically people living in homes with lead service lines (LSLs). Increased education will likely induce members of the public to take additional averting behavior that incurs costs but also results in benefits from reductions in the negative impacts of lead. For example, residents may purchase and use POU devices to filter their drinking and cooking water, thereby reducing exposure. The final rule also would require the development of LSL inventories and making the location of LSLs publicly accessible. This information would give exposed consumers more information, and it would provide potential home buyers this information as well, potentially driving additional LSL removals initiated by homeowners. The benefits and costs of these additional removals are not quantified in the analysis of the final LCR. Because individuals are likely to only undertake voluntary actions in response to new information when the private benefits outweigh the costs, the net benefits of these voluntary actions are expected to be positive. Because of the lack of granularity in the lead concentration profile data, with regard to CCT status when samples were collected (see Section 6.2), the benefits of small improvements in CCT to individuals residing in homes with LSLs, like those modeled under the find-and-fix provisions, are not quantified.
EPA also did not quantify the benefits of reduced lead exposure to individuals who reside in homes that do not have LSLs. EPA has determined that the revised LCR requirements will result in reduced lead exposure to the occupants of these buildings as a result of improved monitoring and additional actions to optimize CCT. In the analysis of the final LCRR, the number of non-LSL homes potentially affected by water systems increasing their corrosion control during the 35-year period of analysis is 8 million in the low cost scenario and 17 million in the high cost scenario. These households, while not having an LSL in place, may still contain leaded plumbing materials, including leaded brass fixtures, and lead solder. These households could potentially see reductions in lead tap water concentrations. EPA has assessed some of the potential benefits to children of reducing lead water concentrations in these homes in Appendix G but has determined that the data are too limited and the uncertainties regarding the magnitude of decreases in lead levels are too significant to include in the quantified and monetized benefit estimates of this regulation. However, because of the significant number of homes without LSLs but with other leaded plumbing materials these unquantified benefits could be significant.
While the anticipated health benefits due to the final LCRR are expected to be primarily associated with reductions in lead exposures, some benefits due to copper reductions are also anticipated. These include decreased rates of acute gastrointestinal symptoms, which are the most common adverse effect observed among adults and children. In sensitive groups, there may be reductions in chronic hepatic effects, particularly for those with Wilson's disease and children pre-disposed to genetic cirrhosis syndromes. These diseases disrupt copper homeostasis, leading to excessive accumulation that can be worsened by excessive copper ingestion (National Research Council, 2000). These are discussed further in Appendix E.
Comparison of Incremental Costs to Incremental Benefits
Exhibit 7-5 compares the monetized annual incremental costs and the annual incremental benefits of the final LCRR at a 3 percent discount rate; the monetized net annual incremental benefits range from $63 to $310 million. Exhibit 7-6 provides the same information assuming a 7 percent discount rate; the monetized net annual incremental benefits range from negative $253 to negative $128 million. EPA considered both monetized and non-monetized costs and benefits for the final rule; see Sections VI.F.1 and VI.F.2 of the final rule Federal Register Notice.
Exhibit 7-5: Comparison of Estimated Monetized National Annualized Incremental Costs to Benefits of the Final LCRR at 3 Percent Discount Rate
 PWS Annual Costs

                                                              Low Cost Scenario
                                                             High Cost Scenario
 Annualized Incremental Costs

                                                                   $160,571,000
                                                                   $335,481,000
 Annualized Incremental Benefits

                                                                  $223,344,000
                                                                  $645,276,000
 Annual Net Benefits

                                                                   $62,773,000
                                                                  $309,795,000
Exhibit 7-6: Comparison of Estimated Monetized National Annualized Incremental Costs to Benefits of the Final LCRR at 7 Percent Discount Rate
 PWS Annual Costs

                                                              Low Cost Scenario
                                                             High Cost Scenario
 Annualized Incremental Costs

                                                                   $167,333,000
                                                                   $372,460,000
 Annualized Incremental Benefits

                                                                   $39,353,000
                                                                  $119,102,000
 Annual Net Benefits

                                                                  -$127,980,000
                                                                  -$253,358,000
References
National Research Council (NRC). 2000. Copper in Drinking Water. Washington, D.C.: National Academies Press.
National Toxicology Program (NTP). 2012. NTP Monograph: Health Effects of Low-Level Lead. U.S. Department of Health and Human Services. Office of Health Assessment and Translation. Division of the National Toxicology Program. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.
United States Census Bureau. 2010. Table AVG1. Average Number of People Per Household, By Race and Hispanic Origin, Marital Status, Age, And Education of Householder: 2010. http://www.census.gov/hhes/families/data/cps2010.html.
United States Environmental Protection Agency (USEPA). 2013. Integrated Science Assessment for Lead. July 2013. Office of Research and Development. EPA/600/R-10/075F.
Statutory and Administrative Requirements
Introduction
As part of the rulemaking process, the United States Environmental Protection Agency (EPA) is required to address the direct and indirect burden that the final Lead and Copper Rule revisions (LCRR) may place on certain types of governments, businesses, and populations. This chapter presents analyses performed by EPA in accordance with the following 13 federal mandates and statutory requirements:
Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review.
 Paperwork Reduction Act (PRA).
 The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.
 Unfunded Mandates Reform Act (UMRA) of 1995.
 Executive Order 13132: Federalism.
 Executive Order 13175: Consultation and Coordination with Indian Tribal Governments.
 Executive Order 13045: Protection of Children from Environmental Health and Safety Risks.
 Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use.
 National Technology Transfer and Advancement Act of 1995 (NTTAA).
 Executive Order 12898: Federal Action to Address Environmental Justice in Minority Populations and Low-Income Populations.
 Consultations with the Science Advisory Board (SAB), National Drinking Water Advisory Council (NDWAC), and the Secretary of Health and Human Services.
Many of the statutory requirements and executive orders listed above call for an explanation of why the final LCRR requirements are necessary, the statutory authority for the final requirements, and the primary objectives that the final requirements are intended to achieve (see Chapter 2 for additional information regarding the goals of the final LCRR). Others are designed to assess the financial and health effects of the final regulatory requirements on sensitive, low-income, and tribal populations as well as on small systems and governments.
Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), gives the Office of Management and Budget (OMB) the authority to review regulatory actions that are categorized as "significant" under Section 3(f) of Executive Order 12866. The Order defines "significant regulatory action" as one that is likely to result in a rule that may:
 Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities.
Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.
Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.
 Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
This action is an economically significant regulatory action that was submitted to the OMB for review. Any changes made in response to OMB recommendations have been documented in the docket. Exhibit 7-5 compares the annual estimated incremental costs and the annual incremental benefits of the final LCRR at a 3 percent discount rate, the net annual incremental benefits range from $63 to $310 million. Exhibit 7-6 provides the same information assuming a 7 percent discount rate, the net annual incremental benefits range from a negative $128 to a negative $253 million. The range in reported values represent cost-benefit estimation under the low and high cost scenarios developed by the Agency to characterize uncertainty in the computed cost estimates.
In addition to the monetized costs and benefits of the final regulation a number of non-monetized impacts exist. The localized eutrophication impacts to surface waters of increased phosphorous loading that might result from increased use of corrosion control treatment (CCT) under the final rule have not been assessed. Also, the positive impacts from reductions in drinking water lead exposure on cardiovascular effects (both morbidity and mortality effects), renal effects, reproductive and developmental effects, immunological effects, neurological effects, and cancer have not been quantified.
EPA did not quantify the impacts for reductions in lead exposure resulting from: the additional lead public education (PE) requirements that target consumers directly, schools and child cares, health agencies, and people living in homes with lead service lines (LSLs); nor the development of LSL inventories and making the inventories publicly accessible. These requirements to increase consumer information could drive averting behavior by private citizens and increase the number of LSLs replaced. Also, the benefits of small improvements in CCT to individuals residing in homes with LSLs, like those modeled under find-and-fix, are not quantified.
EPA did not quantify the benefits of reduced lead exposure to individuals who reside in homes that do not have LSLs. These households, while not having an LSL in place, may still contain leaded plumbing materials, including leaded brass fixtures, and lead solder. See Appendix F, Section F.4. These households could potentially see reductions in lead tap water concentrations under the final LCRR.
Additionally, the adverse health effects associated with copper that are expected to be reduced by the final LCRR are summarized in Appendix E. These include acute gastrointestinal symptoms, which are the most common adverse effect observed among adults and children. In sensitive groups, there may be reductions in chronic hepatic effects, particularly for those with Wilson's disease and children pre-disposed to genetic cirrhosis syndromes. These diseases disrupt copper homeostasis, leading to excessive accumulation that can be worsened by excessive copper ingestion (National Research Council, 2000). See Chapter 7 of this economic analysis (EA) document for greater detail on the non-monetized impacts of the final regulation.
Paperwork Reduction Act
The information collection requirements for the final LCRR has been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned the EPA ICR number 2040-0204 and is available in the docket at EPA-HQ-OW-2017-0300 at www.regulations.gov.
The PRA requires EPA to estimate the burden, as defined in 5 CFR 1320.3(b), on systems and Primacy Agencies of complying with the rule. The information collected as a result of the final LCRR should allow Primacy Agencies and EPA to determine appropriate requirements for specific systems and evaluate compliance with the final LCRR. Burden is defined at 5 CFR 1320.3(b) and means the total time, effort, and financial resources required to generate, maintain, retain, disclose, or provide information to or for a federal agency. The burden includes the time needed to conduct Primacy Agency and system activities during the first three years after promulgation, as described in Sections 8.3.1 and 8.3.2, respectively.
Primacy Agency Activities
EPA anticipates Primacy Agencies will be involved in the following activities for the first three years after publication of the final LCRR:
Implementation
 Read and understand the final rule.
 Adopt the rule and develops implementation program.
 Modify data management systems.
 Provide Primacy Agency staff training.
 Provide water system staff with training and technical assistance for implementation.
 Assist water system staff on the development of the water system's LSL inventory.
 Review water system lead service line replacement (LSLR) plan.
 Review water system LSL inventory.
 Review water system demonstrations of no LSLs.
System Activities
EPA anticipates systems will be involved in the following activities for the first three years after publication of the final LCRR:
Implementation
 Read and understand the final rule.
 Assign personnel and resources for rule implementation.
 Attends training and receive technical assistance from the Primacy Agency.
 Develop and submit to the Primacy Agency a LSLR plan.
 Develop and submit to the Primacy Agency a LSL inventory.
 Submit, if applicable, a demonstration to the Primacy Agency that they do not have LSLs.
For the first three years after publication of the rule in the Federal Register, the major information requirements apply to 67,712 respondents annually, including 67,656 public water systems (PWSs) and 56 Primacy Agencies. The net change in burden associated with moving from the information requirements of the previous rule to those in the final LCRR over the three years covered by the ICR is 3.17 to 3.39 million hours, for an average of 1.06 to 1.13 million hours per year. The range reflects the upper- and lower-bound estimates of the number of systems with LSLs. The total net change in costs over the three-year compliance period covered by the ICR are $115.2 to 123.3 million, for an average of $38.4 to $41.1 million per year (simple average over three years). The average burden per response (i.e., the amount of time needed for each activity that requires a collection of information) is 9.16 to 9.63 hours; the average cost per response is $333 to $351. The collection requirements are mandatory under the Safe Drinking Water Act (SDWA) (42 U.S.C. 300j-4 Subsections (a)(1)(A) and (a)(1)(B)). Details on the calculation of the final LCRR information collection burden and costs can be found in the ICR for final LCRR and Chapter 5 of this EA. A summary of the average annual burden and costs of the collection is presented in Exhibit 8-1. The burdens and costs reflect labor; there are no operation and maintenance (O&M) or capital costs associated with the activities in the first three years following rule promulgation.
Exhibit 8-1: Change in Average Annual Net Burden and Costs for the Final LCRR ICR
	Item
                                Burden (labor)
                                     Cost
                                   Responses
                                    Systems
                              838,014 to 896,641
                          $25,848,865 to $27,795,257
                               91,485 to 92,423
                               Primacy Agencies
                              219,011 to 232,699
                          $12,536,209 to $13,319,672
                               23,903 to 24,842
                                     Total
                            1,057,025 to 1,129,340
                          $38,385,074 to $41,114,928
                              115,388 to 117,265
                             Average per response
                                 9.16 to 9.63
                                 $333 to $351
                                not applicable
Source: ICR Supporting Statement, available in the docket at EPA-HQ-OW-2017-0300 at www.regulations.gov.
Note: Calculated in 2016 dollars. Detail may not add to totals because of independent rounding. Ranges shown for number of responses reflect upper- and lower-bound estimates of the number of systems with LSLs.
The low cost and high cost scenario total responses, burden, and cost for system and Primacy Agency startup activities, LSL inventory, and LSLR plan is provided in Exhibit 8-2.
Exhibit 8-2: Total Net Responses, Burden, and Costs for the Final LCRR ICR for Each Required Activity
Requirement
                               Low Cost Scenario
                              High Cost Scenario

                                   Responses
                                Burden (Hours)
                                     Cost
                                   Responses
                                Burden (Hours)
                                     Cost
System startup activities
                                    202,968
                                   1,353,120
                                  $40,028,655
                                    202,968
                                   1,353,120
                                 $40,028,655
Systems develop lead service line inventory
                                    10,269
                                    467,081
                                  $15,970,421
                                    12,624
                                    613,141
                                 $20,816,484
Systems submit a demonstration to the Primacy Agency that they do not have lead service lines
                                    49,435
                                    477,185
                                  $13,171,203
                                    47,104
                                    443,055
                                 $12,121,265
Systems conduct initial planning of LSLR Program
                                    11,782
                                    216,656
                                  $7,065,992
                                    14,574
                                    280,608
                                  $9,166,998
System Subtotal
                                    274,454
                                   2,514,042
                                  $77,546,595
                                    277,270
                                   2,689,924
                                 $83,385,770
Primacy Agency startup activities
                                      224
                                    399,168
                                  $22,848,376
                                      224
                                    399,168
                                 $22,848,376
Primacy Agency works with systems to develop lead service line inventory
                                    10,269
                                    50,668
                                  $2,900,236
                                    12,624
                                    64,416
                                  $3,687,172
Primacy Agency reviews demonstration of no lead service lines from systems
                                    49,435
                                    98,870
                                  $5,659,319
                                    47,104
                                    94,208
                                  $5,392,466
Primacy Agencies confer with PWS on initial planning for LSLR as part of initial LSLR Program activities
                                    11,782
                                    108,328
                                  $6,200,695
                                    14,574
                                    140,304
                                  $8,031,001
Primacy Agency Subtotal
                                    71,710
                                    657,034
                                  $37,608,626
                                    74,526
                                    698,096
                                 $39,959,015
Combined Systems and Primacy Agency
                                    346,164
                                   3,171,076
                                 $115,155,221
                                    351,796
                                   3,388,020
                                 $123,344,785
Source: ICR Supporting Statement, available in the docket at EPA-HQ-OW-2017-0300 at www.regulations.gov.ith lead service lines.
Note: Calculated in 2016 dollars. Detail may not add to totals because of independent rounding. Ranges shown for number of responses reflect upper- and lower-bound estimates of the number of systems with lead service lines.
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 in 40 CFR are listed in 40 CFR part 9.
The Final Regulatory Flexibility Analysis (FRFA)
The RFA of 1980, amended by the SBREFA of 1996, requires regulators to assess the effects of regulations on small entities including businesses, nonprofit organizations, and governments. RFA/SBREFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities (SISNOSE). Small entities include small businesses, small organizations, and small governmental jurisdictions.
The RFA provides default definitions for each type of small entity. Small entities are defined as: 1) a small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; 2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and 3) a small organization that is any "not-for-profit enterprise which is independently owned and operated and is not dominant in its field." However, the RFA also authorizes an agency to use alternative definitions for each category of small entity, "which are appropriate to the activities of the agency" after proposing the alternative definition(s) in the Federal Register and taking comment (5 USC 601(3)-(5)). In addition, to establish an alternative small business definition, agencies must consult with SBA's Chief Counsel for Advocacy.
For purposes of assessing the impacts of the final LCRR on small entities, EPA considered small entities to be systems serving 10,000 people or fewer. This is the cut-off level specified by Congress in the 1996 Amendments to the SDWA for small system flexibility provisions. As required by the RFA, EPA proposed using this alternative definition in the Federal Register (FR) (63 FR 7620, February 13, 1998; USEPA, 1998a), requested public comment, consulted with the SBA, and finalized the alternative definition in the Agency's Consumer Confidence Reports regulation (63 FR 44524, August 19, 1998; USEPA, 1998b). As stated in that Final Rule, the alternative definition would be applied for all future drinking water regulations.
Need for and Objectives of the Rule
The need for the rule, the objectives of the rulemaking, the stakeholder outreach conducted, and the statutory authority EPA is utilizing to finalize the rule are described in detail in Chapter 2. See Section 2.1 for detailed information on the need for the rule and the Lead and Copper Rule's (LCR) regulatory history, Section 2.2 for information on stakeholder outreach during the rulemaking process, and Section 2.3 for additional detail on the statutory authority for the promulgation of the final LCRR.
Summary of SBAR Comments and Recommendations
Because the Agency has determined that the LCRR has a SISNOSE, EPA sought input from small entity stakeholders. On August 14, 2012, the EPA's Small Business Advocacy Chairperson convened an SBAR Panel under Section 609(b) of the RFA, as amended by the SBREFA. In addition to its chairperson, the SBAR Panel consisted of the Director of the Standards and Risk Management Division within the EPA's Office of Ground Water and Drinking Water, the Administrator of the Office of Information and Regulatory Affairs within the OMB, and the Chief Counsel for Advocacy of the SBA. Detailed information on the overall panel process can be found in the panel report titled, The Small Business Advocacy Review Panel on EPA's Planned Proposed Rule to Public Water System Requirements (SBREFA Panel Report) and can be found in the LCRR docket (EPA-HQ-OW-2017-0300). Prior to convening the SBAR Panel, EPA conducted outreach with small entities that will potentially be affected by the proposed LCRR. In July 2012, the EPA invited SBA, OMB, and nine potentially affected Small Entity Representatives (SERs) to a conference call and solicited comments on the previous materials sent to them. EPA shared the small entities' written comments with the SBAR Panel as part of the convening document.
Summary of the Proposed Rule and Public Comments on the Impacts to Small Entities
EPA proposed revisions that provide small community water systems (CWSs), serving 10,000 or fewer persons, and all non-transient, non-community water systems (NTNCWSs) greater flexibility to comply with the requirements of the LCRR. In 1998, EPA designated CCT as an affordable compliance technology for all categories of small systems in accordance with SDWA Section 1412(b)(4)(E)(iii) (USEPA, 1998). EPA has determined that CCT is still an affordable technology for small systems, however, EPA recognized that small systems tend to have more limited technical, financial, and managerial capacity to implement complex treatment techniques.
EPA proposed three compliance alternatives for a lead action level exceedance (ALE) to allow increased flexibility for small CWSs that serve 10,000 or fewer people and four compliance alternatives for NTNCWSs of any size. The proposed rule would allow water systems to select the most financially and technologically viable strategy that is effective in reducing lead in drinking water. EPA proposed the following compliance alternatives for small CWSs: 1) full LSLR, 2) installation and maintenance of OCCT, or 3) installation and maintenance of POU treatment devices. EPA proposed the above three compliance alternatives for NTNCWSs and an additional compliance alternative of replacement of all lead-bearing plumbing materials. As proposed, the NTNCWS must have control of all plumbing materials and must have no LSLs to select this last option.
All other regulatory requirements of the proposed rule were consistent between small (serving 10,000 or fewer people) and medium (PWSs serving 10,001 to 50,000 people) sized PWSs. For an outline of other proposed rule requirements, see Exhibit 8-3 below, the final rule FRN (USEPA, 2020), and the proposed rule documents including the proposed rule FRN (USEPA, 2019a) and Chapter 3 of the proposed rule EA (USEPA, 2019b).