$10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.07
                                     $4.62
                                     $0.06
                                     $4.12
                                       5
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06
                                     $4.49
                                     $0.06
                                     $3.85
                                       6
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06
                                     $4.35
                                     $0.05
                                     $3.60
                                       7
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06
                                     $4.23
                                     $0.05
                                     $3.36
                                       8
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06
                                     $4.10
                                     $0.05
                                     $3.14
                                       9
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06
                                     $3.99
                                     $0.04
                                     $2.94
                                      10
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06
                                     $3.87
                                     $0.04
                                     $2.75
Total
-
                                     0.75
                                     51.32

                                      124
                                     8,468

                                                                Annualized Cost
                                    $0.14
                                    $8.90
                                    $0.15
                                    $9.77

Table 6-16: Annual Processor Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                     Number of Processors per Nanomaterial
                             Number of Processors
                               Reports per Firm
                Rule Familiar-ization  Cost (per Firm) (2015$)
Form Completion, CBI Substantiation and Recordkeeping Burden Cost (per Report) (2015$)
             Electronic Reporting Requirements (per Firm) (2015$)
                           Total Cost Per Processor
                       Total Processor Number of Reports
                    Total Processor Cost
(Millions 2015$)

                                      Low
                                     High

                                      Low
                                     High
                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                      149
                                     9,826
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      149
                                     9,826
                                    $1.63
                                   $107.15
                                     $1.63
                                    $107.15
                                       2
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.16
                                    $11.55
                                     $0.16
                                    $11.12
                                       3
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.16
                                    $11.21
                                     $0.15
                                    $10.39
                                       4
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.15
                                    $10.89
                                     $0.14
                                     $9.71
                                       5
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.15
                                    $10.57
                                     $0.13
                                     $9.08
                                       6
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.14
                                    $10.26
                                     $0.12
                                     $8.48
                                       7
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.14
                                    $9.96
                                     $0.11
                                     $7.93
                                       8
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.14
                                    $9.67
                                     $0.10
                                     $7.41
                                       9
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.13
                                    $9.39
                                     $0.10
                                     $6.92
                                      10
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.13
                                    $9.12
                                     $0.09
                                     $6.47
                                     Total
                                       -
                                      287
                                    19,645

                                      287
                                    19,645

Annualized Cost
                                    $0.31
                                    $20.96
                                    $0.34
                                    $23.01

Table 6-17: Agency Cost Estimate for the Rule (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                               Hours per Report
                            Agency Cost per Report
                           Total Number of Reportsa
                                 Total Burden
                       Discounted Cost (Millions 2015$)

                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     6.38
                                     $525
                                      214
                                    14,062
                                     1,363
                                    89,716
                                    $0.112
                                    $7.38
                                    $0.112
                                    $7.38
                                       2
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.011
                                    $0.80
                                    $0.011
                                    $0.77
                                       3
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.011
                                    $0.77
                                    $0.010
                                    $0.72
                                       4
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.011
                                    $0.75
                                    $0.009
                                    $0.67
                                       5
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.010
                                    $0.73
                                    $0.009
                                    $0.63
                                       6
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.010
                                    $0.71
                                    $0.008
                                    $0.58
                                       7
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.010
                                    $0.69
                                    $0.008
                                    $0.55
                                       8
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.009
                                    $0.67
                                    $0.007
                                    $0.51
                                       9
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.009
                                    $0.65
                                    $0.007
                                    $0.48
                                      10
                                     6.38
                                     $525
                                      22
                                     1,561
                                      140
                                    9,961
                                    $0.009
                                    $0.63
                                    $0.006
                                    $0.45
                                     Total
                                     63.80
                                       -
                                      411
                                    28,113
                                     2,621
                                    179,362
                                       -

                                       -
                                                                Annualized Cost
                                    $0.02
                                    $1.44
                                    $0.02
                                    $1.59

Table 6-18: Total Social Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                                Burden (Hours)
                       Discounted Costs (Millions 2015$)

                               3% Discount Rate
                               7% Discount Rate

                                   Industry
                                    Agency
                                    Total
                                   Industry
                                    Agency
                                    Total
                                   Industry
                                    Agency
                                    Total

                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                       1
                                    30,422
                                   1,978,409
                                     1,363
                                    89,716
                                    31,785
                                   2,068,125
                                    $2.35
                                    $152.6
                                    $0.11
                                    $7.38
                                     $2.46
                                    $160.0
                                    $2.35
                                    $152.6
                                    $0.11
                                    $7.38
                                     $2.46
                                    $160.01
                                       2
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.23
                                    $16.45
                                    $0.01
                                    $0.80
                                     $0.24
                                    $17.25
                                    $0.22
                                    $15.84
                                    $0.01
                                    $0.77
                                     $0.24
                                    $16.60
                                       3
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.23
                                    $15.97
                                    $0.01
                                    $0.77
                                     $0.24
                                    $16.74
                                    $0.21
                                    $14.80
                                    $0.01
                                    $0.72
                                     $0.22
                                    $15.52
                                       4
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.22
                                    $15.51
                                    $0.01
                                    $0.75
                                     $0.23
                                    $16.26
                                    $0.20
                                    $13.83
                                    $0.01
                                    $0.67
                                     $0.21
                                    $14.50
                                       5
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.21
                                    $15.06
                                    $0.01
                                    $0.73
                                     $0.22
                                    $15.78
                                    $0.18
                                    $12.93
                                    $0.01
                                    $0.63
                                     $0.19
                                    $13.55
                                       6
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.21
                                    $14.62
                                    $0.01
                                    $0.71
                                     $0.22
                                    $15.32
                                    $0.17
                                    $12.08
                                    $0.01
                                    $0.58
                                     $0.18
                                    $12.67
                                       7
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.20
                                    $14.19
                                    $0.01
                                    $0.69
                                     $0.21
                                    $14.88
                                    $0.16
                                    $11.29
                                    $0.01
                                    $0.55
                                     $0.17
                                    $11.84
                                       8
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.20
                                    $13.78
                                    $0.01
                                    $0.67
                                     $0.20
                                    $14.44
                                    $0.15
                                    $10.55
                                    $0.01
                                    $0.51
                                     $0.16
                                    $11.06
                                       9
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.19
                                    $13.38
                                    $0.01
                                    $0.65
                                     $0.20
                                    $14.02
                                    $0.14
                                    $9.86
                                    $0.01
                                    $0.48
                                     $0.15
                                    $10.34
                                      10
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.18
                                    $12.99
                                    $0.01
                                    $0.63
                                     $0.19
                                    $13.61
                                    $0.13
                                    $9.22
                                    $0.01
                                    $0.45
                                     $0.14
                                     $9.66
                                     Total
                                    58,423
                                   3,955,167
                                     2,621
                                    179,362
                                    61,045
                                   4,134,529
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                                               Annualized Costs
                                    $0.44
                                    $29.86
                                    $0.02
                                    $1.44
                                    $0.46
                                    $31.30
                                    $0.49
                                    $32.78
                                    $0.02
                                    $1.59
                                    $0.51
                                    $34.37

Annual Nanomaterials Growth Rate
Low and High-End Estimates in the Growth Rate of the Number Nanomaterials per Manufacturer
The main analysis presented in this report assumes that the number of nanomaterials reported per manufacturer will double over the next 10 years (or an annual growth rate of approximately 8 percent). EPA calculated two alternative cost scenarios: (1) assuming the number of nanomaterials per firm will grow by 50 percent over the next 10 years, and (2) assuming the number of nanomaterials per firm quadruples over the next 10 years. For both analyses, EPA assumes that each firm will still manufacture 12 nanomaterials in year 1 and report on the 4.67 commercially relevant nanomaterials subject to the rule.
   Low-end estimates. A 50 percent increase in the number of nanomaterials manufactured by each firm over the next 10 years will result in approximately 0.26 additional reports per manufacturer each year, for a total of 7.01 reports over the 10 year period.
   High-end estimates. Assuming the number of nanomaterials per firm quadruples over the next 10 years, approximately 1.56 manufacturer reports will be submitted every year after year 1, for a total of 18.68 reports over the 10-year period.
Consistent with the main analysis, we continue to assume that there are 2.32 processors per nanomaterial, and that processors submit one report each.
Industry, Agency and Total Costs
Low-end estimates. As indicated in Table 6-19 and Table 6-21, manufacturers will incur a labor burden of 107,554 hours in the first year and 5,983 hours in each subsequent year and the annualized cost will be $1.25 million with 3 percent discount rate ($1.41 million with a 7 percent discount rate). As shown in Table 6-20 and Table 6-22, processors will incur a labor burden of 252,670 hours in the first year and 14,037 hours in each subsequent year and the annualized cost will be $2.93 million with 3 percent discount rate ($3.31 million with a 7 percent discount rate).

Table 6-23 contains the total Agency burden and cost under this scenario; 16,321 hours in the first year and 907 hours in each subsequent year and an annualized cost of $0.20 million with a 3 percent discount rate and $0.23 million with a 7 percent discount rate.
The combined industry and Agency burden of this scenario is 564,887 hours over the 10-year period with an annualized social cost of $4.38 million with a 3 percent discount rate and $4.95 with a 7 percent discount rate. The total social costs are presented in Table 6-24.
High-end estimates. As shown in Table 6-19 and Table 6-21, manufacturers are estimated to incur a labor burden of 107,554 hours in the first year 35,757 hours in each subsequent year. The annualized costs of this scenario are approximately $3.12 million with a 3 percent discount rate and $3.27 million with a 7 percent discount rate. As indicated in Table 6-20 and Table 6-22, processors will incur a labor burden of 252,670 hours in the first year and 84,223 hours in each subsequent year and the annualized cost will be $7.35 million with 3 percent discount rate ($7.71 million with a 7 percent discount rate).
Table 6-23 presents the Agency burden and costs estimates of this scenario. The Agency burden is estimate to be 16,321 hours in the first year and 5,440 hours in each subsequent year. The annualized cost is $0.51 million with a 3 percent discount rate and $0.53 million with a 7 percent discount rate.
The total social burden of this scenario is presented in Table 6-24 and is 1.51 million hours over the 10-year period with an annualized social cost of $10.98 million with a 3 percent discount rate and $11.51 million with a 7 percent discount rate.

Table 6-19: Annual Manufacturer Burden Hours (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                                Number of Firms
                               Reports per Firm
                    Rule Familiarization Burden (per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                 Electronic Reporting Requirements (per Firm)
                             Total Burden Per Firm
                       Total Industry Number of Reports
                             Total Industry Burden

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      165
                                     4.67
                                     4.67
                                     0.82
                                      139
                                     1.42
                                    651.84
                                      652
                                      771
                                      771
                                    107,554
                                    107,554
                                       2
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       3
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       4
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       5
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       6
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       7
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       8
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       9
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                      10
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                     Total
                                       -
                                     7.01
                                     18.68
                                       -
                                       -
                                       -
                                       -

                                     1,156
                                     3,082
                                    161,400
                                    429,368

Table 6-20: Annual Processor Burden Hours (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                     Number of Processors per Nanomaterial
                             Number of Processors
                          Number of Reports per Firm
                    Rule Familiarizationc Burden (per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                    Electronic Reporting Burden (per Firm)
                          Total Burden Per Processor
                       Total Number of Processor Reports
                            Total Processor Burden

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                     1,788
                                     1,788
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                     1,788
                                     1,788
                                    252,670
                                    252,670
                                       2
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       3
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       4
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       5
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       6
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       7
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       8
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       9
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                      10
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                     Total
                                       -
                                     2,682
                                     7,151

                                       -
                                       -
                                       -
                                       -
                                     2,682
                                     7,151
                                    379,005
                                   1,010,681

Table 6-21: Annual Manufacturer Labor Costs (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                              Number of Firms[a]
                              Reports per Firm[b]
                Rule Familiarization Cost (per Firm)[b] (2015$)
Form Completion, CBI Substantiation and Recordkeeping Cost (per Report)[b] (2015$)
            Electronic Reporting Requirements (per Firm)[b] (2015$)
                             Total Burden Per Firm
                      Total Industry Number of Reports[b]
                     Total Industry Cost (Millions 2015$)

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      165
                                     4.67
                                     4.67
                                    $63.66
                                    $10,730
                                    $110.31
                                    $50,285
                                    $50,285
                                      771
                                      771
                                    $8.30
                                     $8.30
                                     $8.30
                                     $8.30
                                       2
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.45
                                     $2.68
                                     $0.43
                                     $2.58
                                       3
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.44
                                     $2.60
                                     $0.40
                                     $2.41
                                       4
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.42
                                     $2.52
                                     $0.38
                                     $2.25
                                       5
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.41
                                     $2.45
                                     $0.35
                                     $2.10
                                       6
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.40
                                     $2.38
                                     $0.33
                                     $1.97
                                       7
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.39
                                     $2.31
                                     $0.31
                                     $1.84
                                       8
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.38
                                     $2.24
                                     $0.29
                                     $1.72
                                       9
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.36
                                     $2.18
                                     $0.27
                                     $1.61
                                      10
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.35
                                     $2.11
                                     $0.25
                                     $1.50
                                     Total
                                       -
                                     7.01
                                     18.68

                                     1,156
                                     3,082

                                                              Annualized Costs
                                    $1.25
                                    $3.12
                                    $1.41
                                    $3.27

Table 6-22: Annual Processor Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                    Number of Processors per Nano-material
                             Number of Processors
                               Reports per Firm
                 Rule Familiar-ization Cost (per Firm) (2015$)
Form Completion, CBI Substantiation and Record-keeping Burden Cost (per Report)b (2015$)
                 Electronic Reporting Costs (per Firm) (2015$)
                           Total Cost Per Processor
                          Discounted Cost (per firm)
                      Total Processor Number of Reportsb
                     Total Processor Cost (Millions 2015$)

                                      Low
                                     High

                               3% Discount Rate
                               7% Discount Rate
                                      Low
                                     High
                              3% Discount
 Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                     1,788
                                     1,788
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                   $10,904
                                   $10,904
                                     1,788
                                     1,788
                                    $19.49
                                    $19.49
                                    $19.49
                                    $19.49
                                       2
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                   $10,587
                                   $10,191
                                      99
                                      596
                                    $1.05
                                    $6.31
                                     $1.01
                                     $6.07
                                       3
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                   $10,278
                                    $9,524
                                      99
                                      596
                                    $1.02
                                    $6.12
                                     $0.95
                                     $5.68
                                       4
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,979
                                    $8,901
                                      99
                                      596
                                    $0.99
                                    $5.95
                                     $0.88
                                     $5.30
                                       5
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,688
                                    $8,319
                                      99
                                      596
                                    $0.96
                                    $5.77
                                     $0.83
                                     $4.96
                                       6
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,406
                                    $7,775
                                      99
                                      596
                                    $0.93
                                    $5.61
                                     $0.77
                                     $4.63
                                       7
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,132
                                    $7,266
                                      99
                                      596
                                    $0.91
                                    $5.44
                                     $0.72
                                     $4.33
                                       8
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $8,866
                                    $6,791
                                      99
                                      596
                                    $0.88
                                    $5.28
                                     $0.67
                                     $4.05
                                       9
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $8,608
                                    $6,346
                                      99
                                      596
                                    $0.85
                                    $5.13
                                     $0.63
                                     $3.78
                                      10
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $8,357
                                    $5,931
                                      99
                                      596
                                    $0.83
                                    $4.98
                                     $0.59
                                     $3.53
                                     Total
                                       -
                                     2,682
                                     7,151

                                     2,682
                                     7,151

                                                                Annualized Cost
                                   $10,053
                                    $8,599

                                    $2.93
                                    $7.35
                                    $3.31
                                    $7.71

Table 6-23: Agency Cost Estimate for the Rule  (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                               Hours per Report
                            Agency Cost per Report
                           Total Number of Reportsa
                                 Total Burden
                       Discounted Cost (Millions 2015$)

                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                    $6.38
                                     $525
                                     2,558
                                     2,558
                                    16,321
                                    16,321
                                    $1.34
                                    $1.34
                                    $1.34
                                    $1.34
                                       2
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07
                                    $0.43
                                    $0.07
                                    $0.42
                                       3
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07
                                    $0.42
                                    $0.07
                                    $0.39
                                       4
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07
                                    $0.41
                                    $0.06
                                    $0.37
                                       5
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07
                                    $0.40
                                    $0.06
                                    $0.34
                                       6
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06
                                    $0.39
                                    $0.05
                                    $0.32
                                       7
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06
                                    $0.37
                                    $0.05
                                    $0.30
                                       8
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06
                                    $0.36
                                    $0.05
                                    $0.28
                                       9
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06
                                    $0.35
                                    $0.04
                                    $0.26
                                      10
                                    $6.38
                                     $525
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06
                                    $0.34
                                    $0.04
                                    $0.24
                                     Total
                                     63.80
                                       -
                                     3,837
                                    10,233
                                    24,482
                                    65,286
                                       -

                                       -
                                                                Annualized Cost
                                    $0.20
                                    $0.51
                                    $0.23
                                    $0.53

Table 6-24: Total Social Costs (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                                Burden (Hours)
                       Discounted Costs (Millions 2015$)

                               3% Discount Rate
                               7% Discount Rate

                                   Industry
                                    Agency
                                    Total
                                   Industry
                                    Agency
                                    Total
                                   Industry
                                    Agency
                                    Total

                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                     Low
                                     High
                                       1
                                    360,224
                                    360,224
                                    16,321
                                    16,321
                                    376,545
                                    376,545
                                    $27.8
                                    $27.8
                                    $1.34
                                    $1.34
                                    $29.13
                                    $29.13
                                    $27.8
                                    $27.8
                                    $1.34
                                    $1.34
                                    $29.13
                                    $29.13
                                       2
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.50
                                    $8.99
                                    $0.07
                                    $0.43
                                     $1.57
                                     $9.42
                                    $1.44
                                    $8.65
                                    $0.07
                                    $0.42
                                     $1.51
                                     $9.07
                                       3
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.46
                                    $8.72
                                    $0.07
                                    $0.42
                                     $1.53
                                     $9.15
                                    $1.35
                                    $8.08
                                    $0.07
                                    $0.39
                                     $1.41
                                     $8.48
                                       4
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.41
                                    $8.47
                                    $0.07
                                    $0.41
                                     $1.48
                                     $8.88
                                    $1.26
                                    $7.56
                                    $0.06
                                    $0.37
                                     $1.32
                                     $7.92
                                       5
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.37
                                    $8.22
                                    $0.07
                                    $0.40
                                     $1.44
                                     $8.62
                                    $1.18
                                    $7.06
                                    $0.06
                                    $0.34
                                     $1.24
                                     $7.40
                                       6
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.33
                                    $7.98
                                    $0.06
                                    $0.39
                                     $1.40
                                     $8.37
                                    $1.10
                                    $6.60
                                    $0.05
                                    $0.32
                                     $1.15
                                     $6.92
                                       7
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.29
                                    $7.75
                                    $0.06
                                    $0.37
                                     $1.36
                                     $8.13
                                    $1.03
                                    $6.17
                                    $0.05
                                    $0.30
                                     $1.08
                                     $6.47
                                       8
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.26
                                    $7.53
                                    $0.06
                                    $0.36
                                     $1.32
                                     $7.89
                                    $0.96
                                    $5.76
                                    $0.05
                                    $0.28
                                     $1.01
                                     $6.04
                                       9
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.22
                                    $7.31
                                    $0.06
                                    $0.35
                                     $1.28
                                     $7.66
                                    $0.90
                                    $5.39
                                    $0.04
                                    $0.26
                                     $0.94
                                     $5.65
                                      10
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.18
                                    $7.09
                                    $0.06
                                    $0.34
                                     $1.24
                                     $7.44
                                    $0.84
                                    $5.03
                                    $0.04
                                    $0.24
                                     $0.88
                                     $5.28
                                     Total
                                    540,405
                                    1.44 M
                                    24,482
                                    65,286
                                    564,887
                                    1.51 M

                                                               Annualized Costs
                                    $4.18
                                     $10.5
                                    $0.20
                                    $0.51
                                    $4.38
                                    $10.98
                                    $4.72
                                    $11.0
                                    $0.23
                                    $0.53
                                    $4.95
                                    $11.51

Summary of all Analyses
Table 6-25 presents a summary of the costs and assumptions of the sensitivity analyses. As shown in the table, the total annualized industry costs range from $0.44 million per year (with a three percent discount rate) with the assumption that a manufacturer submits an average of 0.39 reports in the first year, to $29.86 million per year (with a three percent discount rate) under the assumption a firm submits an average of 25.67 reports in the first year. This would suggest that the cost estimates are more sensitive to the number of reports submitted in the first year, than to increased costs in subsequent years (either through the growth in the number of nanomaterials or the number firms subject to the rule).
Table 6-25: Comparison of Annualized Costs of Sensitivity Analyses (Millions 2015$)
                                   Scenario
                     Annualized Costs at 3% discount rate
                     Annualized Costs at 7% discount rate

                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
Main Analysis
                                    $5.44
                                    $0.26
                                    $5.71
                                    $5.98
                                    $0.29
                                    $6.26
Change in Number of Firms (Section 6.1) -- Low End
                                    $2.75
                                    $0.13
                                    $2.88
                                    $3.02
                                    $0.15
                                    $3.17
Change in Number of Firms (Section 6.1) -- High End
                                    $10.39
                                    $0.22
                                    $10.89
                                    $11.40
                                    $0.16
                                    $11.96
 Annual Industry Growth Rate of 11.6 percent (Section 6.2)
                                    $11.07
                                    $0.54
                                    $11.61
                                    $4.28
                                    $0.55
                                    $11.90
Change in Number of Nanomaterials per Firm in Year 1 (Section 6.3) -- Low End
                                    $0.44
                                    $0.02
                                    $0.46
                                    $0.49
                                    $0.02
                                    $0.51
Change in Number of Nanomaterials per Firm in Year 1 (Section 6.3) --High End
                                    $29.86
                                    $1.44
                                    $31.30
                                    $32.78
                                    $1.59
                                    $34.37
Change in nanomaterial growth rate (Section 6.4) -- 50% in 10 years
                                    $4.18
                                    $0.20
                                    $4.38
                                    $4.72
                                    $0.23
                                    $4.95
Change in nanomaterial growth rate (Section 6.4) -- 400% in 10 years
                                    $10.48
                                    $0.51
                                    $10.98
                                    $10.98
                                    $0.23
                                    $11.51

  -  Benefits
As noted in the NMSP Interim Report (EPA, 2009b), EPA requires additional information to fulfill its mandate under TSCA to fully assess the risks posed by the production, sale, and use of chemical substances manufactured as nanoscale materials in the United States. With this information, EPA will be able to screen these chemicals more effectively to identify whether additional risk assessment and management steps are needed.
By enhancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and expeditiously evaluate any potential risks posed by nanoscale materials. The more EPA can base its decisions on actual data rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk whether higher or lower than it would be if based on assumptions alone. Ultimately, enhancing the risk screening process will have positive consequences for human and ecosystem health and will enable a more efficient allocation of EPA's and society's resources. EPA would have an increased ability to anticipate industry trends, particularly for chemicals for which EPA has concerns.
The benefits resulting from the rule are discussed qualitatively in this section. Quantification of the benefits of the rule would require more specific information about each user's use patterns and preferences as well as the changes in these patterns and preferences that would result from the additional information made available under the rule. These data are not readily available and collecting such data would be cost-prohibitive. For example, one approach would be to conduct a national willingness-to-pay (WTP) survey of the general public to determine the value that the public places on the availability of the information resulting from the rule. However, such a survey, or a survey to collect similar information, has not been conducted.
Market Failure
When buyers or sellers do not have perfect information, rational decision making cannot occur and a market failure exists. Information regarding the hazards associated with a chemical substance may not be widely known for several reasons. In one case, known as asymmetric information, consumers and producers do not have the same level of information regarding the aggregate production, uses, and hazards of a chemical substance.  Because information is a public good, producers are reluctant to provide information (that is, businesses may perceive the high costs of collecting and disclosing information to be greater than the benefits from increased access to chemical information). Individual consumers are simultaneously unlikely to be willing to pay the cost of collecting and reporting information if they can use information developed and paid for by others.
In addition to concerns about these direct costs, industry may have a disincentive to disclose data due to the possibility of liability or regulation (Applegate, 1991). For example, some firms releasing Toxic Release Inventory (TRI) data saw a negative response in financial markets, indicating further reasons why businesses may be reluctant to disclose information (Konar and Cohen, 1997). As a result, data on the chemicals subject to the rule may be produced below what is optimal for society.
Benefits of Information-Based Policies
The rule will supply information on nanomaterial production to which the Agency (or the public) does not currently have access. Increasing and improving the amount of available data serves to reduce inefficiencies, described above, arising from asymmetric information.
Increased and improved data on the production, sale, and use of nanomaterials in the U.S. would allow EPA and others to use the data more effectively as part of screening and prioritization programs. Screening chemicals for potential risks is an essential first step in developing and prioritizing risk management activities. Effective risk-screening by EPA depends on the ability to characterize chemical uses accurately and to predict potential exposures. Current screening activities are greatly hampered by the incomplete and inconsistent nature of available data. In addition, EPA's current screening activities are further hampered by the fact that EPA must rely on relatively limited public sources of information. This rule will benefit society by filling these information gaps and contributing to better assessments of potential risks and risk management decisions.
The rule will increase publicly available data about a chemical's potential risks and consequently is likely to result in (a) a reduction in the cost of risk-based decision making about the chemical, and (b) an improvement in the expected outcome of the decisions.
 Reduced cost of risk-based decision making. By making new information about potentially toxic substances available to the public (including EPA and other government agencies), this rule can replace other information-gathering, management, and dissemination activities related to nanomaterials. Once the data are publicly available, information users and decision makers will avoid the time and resource costs required to individually perform these activities. In effect, the rule increases the efficiency (and strength) of the decision-making process.
 Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting resources toward their most highly valued uses. With incomplete information regarding toxic chemicals, public and private decision makers are not able to assess adequately the benefits and costs of actions that involve these substances. For example, EPA decisions regarding whether, when, and how to target chemicals for further risk assessment can be misdirected if basic risk-screening information is unavailable or inadequate. With more information to supplement the data provided in the NMSP and fill gaps in the current understanding of the benefits and risks of nanoscale substances, EPA can better direct its limited resources toward high-priority risks. Improved information can therefore help lead to more socially optimal reductions in risks to humans and the environment.
The rule will generate both types of benefits. First, it will provide data that are otherwise unavailable or reduce EPA's and other decision-makers' reliance on databases and information sources that are inadequate for accurately characterizing the risks associated with the nanomaterials in commerce that need to be evaluated and potentially regulated. As discussed in Chapter 4, EPA will bear the cost of collecting and managing the data; however, by providing more reliable and complete data on nanomaterial uses and exposures, the rule will also allow EPA to save time and resources in screening chemicals and in developing risk management priorities.
Second, the rule will allow EPA to better prioritize its risk management activities -- to move more quickly in addressing nanomaterials that pose relatively high risks (and/or relatively low risk-management costs).
For example, potential problems from incomplete information include the designation of an inappropriately high priority level to a chemical substance, resulting in unnecessary effort and resource expenditures for both regulated parties and EPA in cases where adequate data would have led the Agency to act differently. Similarly, if a business cannot provide adequate data for its product, that product may be subject to regulations which are unsuitable for its true hazard level (Applegate, 1991). In these cases, it is in the best interest of the business to disclose information about its chemical production. Reporting through TSCA ensures the public that the chemical information provided by firms is credible, and thus is more likely to be utilized efficiently (Cohen and Santhakumar, 2007). As described by Konar and Cohen (1997), information provision can also serve as informal regulation, providing financial incentives for reducing behaviors which may lead to negative externalities.

Specific benefits that accrue from the use of the information generated by this rule are discussed in the following sections.

Potential Users of Information Generated by the Rule
EPA is expected to be the primary user of the information generated by the rule, although other public and private organizations, in particular those interested in managing the health and environmental risks posed by nanomaterials, will also use the non-confidential data. The information is expected to be applied and disseminated by these users in a number of ways; however, it will primarily serve to reduce the costs of screening and managing chemical risks and to improve risk management decisions. The American public will be the ultimate beneficiaries of the rule. By lowering the cost of decision-making in the public sector, the rule will free up resources for other public or private uses. Similar gains will also result from cost savings in private-sector decision-making. By improving risk management decisions, the rule will also help to better target risk management activities to the areas where the net benefits (i.e., risk reductions net of control costs) are expected to be the largest.
The users and beneficiaries of the reporting program and the benefits they derive from improved data on nanomaterials are discussed in more detail in the sections below.
EPA Risk-Screening and Management Programs
EPA's Office of Pollution Prevention and Toxics (OPPT) has a multifaceted approach to managing chemical risks. Chemicals enter OPPT's system primarily through a request by the Interagency Testing Committee or a request by the public or are otherwise identified by the Agency. The chemicals then enter one of several more detailed screening processes. Depending on the outcome of these screening processes, the next step may include entering one of EPA's risk management programs. EPA's current programs and tools to evaluate and manage chemical risks include:
    Risk Screening. OPPT screens chemicals on the TSCA Inventory to identify potential risks and determine whether more detailed assessments should be undertaken. With the data currently available, EPA does not have the information needed to effectively and systematically screen most nanomaterials, some of which may not even be included in the inventory. The rule would supply exposure-related information that the Agency does not currently have, recognizing that industry has a greater knowledge than EPA about its own operations and the uses of chemicals it manufactures and/or sells. Without this information, EPA would likely: (1) not screen these chemicals, (2) screen them using outdated or anecdotal exposure information, or (3) screen them but rely on exposure estimates using modeling data. Therefore, data collected as a result of the rule will improve the Agency's ability to screen nanomaterials in commerce, allowing the Agency to better focus its chemical screening programs and to identify potentially risky situations earlier than otherwise possible.
 Master Testing List. The data collected under the rule for nanomaterials would also help to determine which chemicals substances belong on the Master Testing List (MTL). The MTL is a list of chemicals identified by the Agency as having inadequate data for health and/or environmental risk assessments. OPPT uses the MTL to establish priorities for chemical testing, keep the public informed, solicit input from industry on specific chemical exposure and risk assessment needs, and to encourage industry to perform testing. Exposure-related manufacturing, processing, and use data would enable EPA to better target testing needs to situations in which potential exposures are known to occur, thereby increasing the efficiency of efforts in these programs and facilitating earlier completion of critical testing needs.

 Design for the Environment (DfE) program. EPA's DfE program incorporates principles and strategies from both the Existing Chemicals review program, by focusing on specific chemical uses and establishing partnerships with industry to develop voluntary long-range plans for risk management. The data collected under the rule would help to identify use cluster candidates for this program. The data could be used to assist in ranking activities, identifying high-risk areas, and developing realistic approaches for reducing risk.
Other Federal Risk Management Programs
Other governmental agencies, such as the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC), share regulatory authority over chemical substances or products containing them. In the case of NIOSH, the agency compiles summaries of available information and recommends exposure limits. Therefore, EPA serves as a conduit for chemical hazard information between the chemical producers and these other agencies.
OSHA currently manages occupational exposure to chemicals by setting a variety of chemical and personal protection standards, by requiring preparation of emergency response and process safety management plans and by requiring provision of health and safety data to workers for chemicals used in the workplace. OSHA will be able to use the data collected under the rule to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential. The information provided by the rule could increase OSHA's ability to manage chemical hazards, exposures, and risks in occupational settings.
NIOSH will also benefit from the exposure-related information collected under the rule. The exposure information that NIOSH uses to determine occupational safety and health in businesses nationwide may be based on outdated information collected under the National Occupational Exposure Survey (NOES). Completed in 1983, NOES collected information such as plant site location, plant site SIC, information on the plant site's occupational safety and health programs, occupational titles of workers potentially exposed, the number of employees per occupational title, information on process steps, and trade names of products. Recognizing that some of the nanomaterials reported under the rule may have been developed in the last decade, NIOSH could use the data in place of the NOES data to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential.
CPSC also could use the new data directly in conducting its exposure and risk assessment activities (e.g., screening consumer products for chemical hazards). CPSC obtains risk information to screen chemical hazards from a network of hospital emergency rooms. This information is limited to injuries and illnesses resulting from acute exposures only.
Additional data required by the rule would provide a better source of reliable information on the chemicals used in consumer products. CPSC would improve its ability to identify the nanomaterials used in consumer products and, with consideration of hazard data, to identify chemical - consumer use situations presenting greater potential risk. The information could improve CPSC's ability to meet its program objective of protecting the public from chemical hazards in consumer products.
State and Local Programs
The data collected under the rule will also help state and local authorities with rulemaking, information collection, and voluntary program activities. Because state and local governments must address chemicals, use patterns, and exposure scenarios that may be unique or isolated, state and local agency access to improved data on nanomaterials will assist in identifying situations that pose potentially high risks for individual states or locations within those states.
Nongovernmental Organization (NGO) Initiatives and Private-Sector Stewardship
Many private-sector organizations have a strong interest in reducing risks and providing leadership in preventing pollution while still maintaining productive economic enterprises. These organizations can better meet these objectives by developing a better understanding of how chemicals are used in general. This will allow them to more effectively manage risks and participate in community, regional, and national priority setting for chemicals.
The publicly available (non-CBI) information collected under the rule can support activities typically undertaken by NGOs, such as tracking industry trends, organizing grassroots involvement in risk-based decision-making, and conducting outreach and educational programs. These organizations could use the new data to identify and establish priorities for risks; to evaluate chemicals and chemical use patterns to determine areas of concern; to identify and promote pollution prevention opportunities; and to focus pollution prevention, public outreach, and education initiatives and activities.
Industry can use the collected data to improve corporate product stewardship programs through access to use information reported by multiple companies. The American Chemistry Council's Responsible Care program is one example of a corporate product stewardship program that could use this information. Use information supplied under the rule could be used to further strengthen this program. The Responsible Care program requires companies to take responsibility for their products from cradle to grave, which requires an understanding of how their product is being used not only by their customers, but also further down the value chain. Despite this private effort, some companies have told EPA that they do not know how their chemicals are used. Non-CBI information provided by multiple companies could give an individual company a better understanding of the downstream uses of its products, therefore enabling more effective implementation of the Responsible Care concepts.

  -  Small Entity Impact Analysis
This chapter estimates the impact that the rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies.
The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on small entities, including businesses, nonprofit organizations, and governments. In some instances, agencies also are required to examine regulatory alternatives that may reduce adverse economic effects on significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA, however, does not specifically define "a significant economic impact on a substantial number" of small entities. Sections 603 and 604 of the RFA require that regulatory flexibility analyses identify the types, and estimate the numbers, of small entities to which the rule will apply; and describe the rule requirements to which small entities will be subject and any regulatory alternatives, including exemptions and deferral, that would lessen the rule's burden on small entities.
The major steps followed in the analysis are described below.
Select a Relevant Small Business Definition
The RFA relies on the definition of "small business" found in the Small Business Act, which authorizes the Small Business Administration (SBA) to develop definitions for "small business" for industries in each North American Industry Classification System (NAICS) code. These definitions can be based either on a company's number of employees or its sales, depending on SBA's criteria for that industry. As nascent fields, nanotechnology manufacturing and processing have not been assigned distinct NAICS codes under the most recent classification system, NAICS 2012. This analysis therefore applies the SBA small business definitions to the subset of 19 identified nanomaterials companies described in Section 2.2 to the NAICS listed for the global parent company of each company as listed in the Dun & Bradstreet database.
Note that there are two definitions of small business used in this Economic Analysis. The first definition, which has been used in the previous chapters of this Economic Analysis, is used to determine if a nanomaterials firm is exempt from the rule requirements. According to this definition, which was adapted from the standard TSCA definition provided in 40 CFR 704.3, a manufacturer or processor of a TSCA section 8(a) chemical substance is defined as small if  total annual sales of the company, combined with those of any parent company, are below $11 million. The second definition, which is used only in this chapter, is based on the small business definitions established by the SBA for the various industries (SBA, 2016). As described in Chapter 2, 19 companies in the subset were considered under the rule's definition of small to be "large" (i.e. not small) companies (with greater than $11 million in revenue), and therefore, subject to the rule.
To determine the percent of the manufacturers subject to the rule that would be considered small under SBA size standards, the small business thresholds for the 19 companies in the subset were identified. For companies for which Dun and Bradstreet did not provide a current parent company NAICS code, EPA researched the company website or determined, based on best professional judgement, the appropriate NAICS category. The ultimate parent NAICS codes and corresponding small business size standards are shown in Table 8-1.
Table 8-1: Ultimate Parent NAICS Codes for the 19 "Large" Businesses in Subset
                          Ultimate Parent NAICS Code
                                  Description
                                Number of Firms
                        Small Business Threshold (2016)
                                    331313
Alumina Refining and Primary Aluminum Production
                                       1
                           Less than 1,000 employees
                                    325120
Industrial Gas Manufacturing
                                       1
                           Less than 1,000 employees
                                    325199
All Other Basic Organic Chemical Manufacturing
                                       1
                           Less than 1,250 employees
                                    325510
Paint and Coating Manufacturing
                                       1
                           Less than 1,000 employees
                                    325998
All Other Miscellaneous Chemical Product and Preparation Manufacturing
                                       2
                            Less than 500 employees
                                    332812
Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers
                                       1
                            Less than 500 employees
                                    333249
Other Industrial Machinery Manufacturing
                                       1
                            Less than 500 employees
                                    333515
Cutting Tool and Machine Tool Accessory Manufacturing
                                       1
                            Less than 500 employees
                                    334516
Analytical Laboratory Instrument Manufacturing
                                       1
                           Less than 1,000 employees
                                    335991
Carbon and Graphite Product Manufacturing
                                       1
                            Less than 750 employees
                                    336390
Other Motor Vehicle Parts Manufacturing
                                       1
                           Less than 1,000 employees
                                    423450
Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
                                       1
                            Less than 200 employees
                                    541330
Engineering Services
                                       2
                       Less than $15,000,000 in revenue
                                    541712
Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) 11
                                       1
                           Less than 1,000 employees
                                    551112
Offices of Other Holding Companies
                                       1
                       Less than $20,500,000 in revenue
                                    331313
Alumina Refining and Primary Aluminum Production
                                       1
                           Less than 1,000 employees
                                    325120
Industrial Gas Manufacturing
                                       1
                           Less than 1,000 employees
Note: NAICS codes, descriptions are based on the 2012 NAICS
Source: D&B, 2016; SBA, 2016

Estimate the Number of Small Businesses
To estimate the total number firms that are subject to the rule and considered small under SBA size standards, EPA considered the subset of companies described above to determine the percentage that meet the SBA size definition, based on employment and sales data from Dun and Bradstreet. EPA then applied these percentages to the total estimate of regulated firms.
Of the 19 nanomaterials manufacturers and parent companies in the subset that are subject to the rule, 4 companies (21 percent) meet the SBA small business definitions for their respective NAICS classifications, and 15 companies (79 percent) do not meet the SBA small business definitions. These results are provided in Table 8-2. Note that all of these companies are considered "large" businesses under the rule definition of small business (greater than $11 million in annual revenue).
Table 8-2: Small Business and Large Business Characteristics of Subset
                              Population Category
                           Number of Firms in Subset
                               Percent of Subset
Small Businesses
                                       4
                                      21%
Large Businesses
                                      15
                                      79%
Total
                                      19
                                     100%
Source: D&B, 2016; Lux Research, 2007; Nanowerk, 2009.

For purposes of this economic analysis, we assume that the proportion of small businesses is the same for processors as it is for manufacturers. Multiplying the percent of U.S.-based nanomaterials firms in the subset that meet the SBA small business definitions (21 percent) by the previously estimated number of U.S.-based nanomaterials firms subject to the rule (see Table 2-5) yields an estimate of around 411 nanomaterials firms in the first year and 77 firms in subsequent years that meet SBA criteria for being considered "small" businesses. All of these companies would be considered large businesses under the rule definition of small business.
Table 8-3: Estimated Number of Regulated Firms
                              Population Category
                     Percent of Population that are Small
                   Estimated. Number of Nanomaterial Firms

                                  First Year
                               Subsequent Years
Manufacturers
                                      21%
                                      35
                                      35
Processors
                                      21%
                                      376
                                      42
Total Firms
                                       -
                                      411
                                      77
Source: BCC Research, 2006; D&B, 2016.

Estimate the Cost-to-Sales Ratio for Small Companies
As indicated in Table 3-13, the total cost of the rule over the 10-year analysis period is $5.44 million with a 3 percent discount rate and $5.98 million with a 7 percent discount rate. On a per-firm basis, annualized costs for manufacturers are approximately $9,846 with a 3 percent discount rate and $10,809 with a 7 percent discount rate, and for processors annualized costs are approximately $10,053 with a 3 percent discount rate and $10,214 with a 7 percent discount rate.
Past small business analyses developed by EPA have used a lower impact threshold of compliance costs of less than 1 percent of sales and a higher impact threshold as compliance costs of greater than 3 percent of sales to evaluate the economic impacts faced by the small entities. Therefore, to determine the magnitude of any potential adverse impact of the rule on small entities, annualized per-company compliance costs were compared to annual sales.
Given the expected annualized per-company costs for manufacturers, a 1 percent-of-sales threshold for economic impact equates to annualized sales thresholds of approximately $984,607 to $1,080,876; in other words, in order for the compliance cost to exceed one percent of sales, sales must be less than these values. Similarly, 3 percent-of-sales thresholds for economic impact range from approximately $328,202 to $360,292. These equivalences, and those for processors, are show in Table 8-4.

Table 8-4: Characterization of Economic Impacts
                             Economic Impact Type
                           Cost-to-Sales Percentage
                       Equivalent Sales Dollar Threshold

                                    (2015$)

                                Annualized (3%)
                                Annualized (7%)
Manufacturers
                                 Higher Impact
                                    > 3%
                                 < $328,202
                                 < $360,292
                                 Lower Impact
                                   1% to 3%
                           $328,202 to > $984,607
                            $360,292 to $1,080,876
                              Less than 1% Impact
                                    < 1%
                                 > $984,607
                                > $1,080,876
Processors
                                 Higher Impact
                                    > 3%
                                 < $335,100
                                 < $340,450
                                 Lower Impact
                                   1% to 3%
                            $335,100 to $1,005,299
                            $340,450 to $1,021,351
                              Less than 1% Impact
                                    < 1%
                                > $1,005,299
                                > $1,021,351

D&B data for the 4 small businesses (by SBA definitions) identified among the 19 companies in the 95-company subset of U.S.-based nanomaterials firms (with D&B sales data) subject to the rule were used to develop cost-to-sales ratios for these companies, which are believed to be representative of cost-to-sales ratios for the estimated 411 small businesses. Table 8-5 summarizes the estimated cost impacts for the subset of small business, and applies these percentages to estimate impacts to the estimated 411 impacted small businesses. As indicated, all 4 small businesses (100 percent) from the subset, and thus all small businesses in the estimated 411 subject to the rule, are expected to experience an impact of less than one percent of sales.
EPA notes that at based on estimated rule costs and sales thresholds as summarized in Table 8-5, no firms subject to the rule (manufacturers or processors) would be impacted at greater than 1 percent, because companies with sales revenue less than $11 million per year are exempt from the rule.
Table 8-5: Estimate of Impacts on Small Business Subset
                             Economic Impact Type
                           Cost-to-Sales Percentage
                                    Subset
                     Estimated Total Number of Small Firms

                               3% Discount Rate
                               7% Discount Rate

                                    Number
                                    Percent
                                    Number
                                    Percent
                                    Number
                                    Percent
Higher Impact
                                    > 3%
                                       0
                                      0%
                                       0
                                      0%
                                       0
                                      0%
Lower Impact
                                   1% to 3%
                                       0
                                      0%
                                       0
                                      0%
                                       0
                                      0%
Less than 1% Impact
                                    < 1%
                                       4
                                     100%
                                       4
                                     100%
                                      411
                                     100%
Total
                                      --
                                       4
                                     100%
                                       4
                                     100%
                                      411
                                     100%
Source: D&B, 2009; EPA, 2009a.
There are several reasons why the rule may impact certain small businesses more than others. Recently chartered companies may have lower sales at the time of reporting and therefore experience a relatively higher impact under the rule as a percentage of current annual sales. Some firms may sell only a single nanomaterial that comprises (and limits) its entire revenue stream, raising the impact of the rule as a percent of sales; other firms may offer a broad portfolio of products other than nanomaterials. However, in EPA's judgment, no companies are expected to experience a prohibitive cost or burden under the rule.
Appendix B presents a sensitivity analysis for the cost-to-sales ratio based on the number of nanomaterials produced.

  -  Other Impact Analyses
Several statutes and executive orders (EOs) pertain to the rule. This chapter presents statements discussing paperwork reduction, unfunded mandates, regulatory planning and review, tribal governments, children's health, and environmental justice, among others.
Employment Impact Analysis
While a standalone analysis of employment impacts is not included in a standard cost-benefit analysis, EPA typically examines employment impacts for regulations promulgated under TSCA. Executive Order 13563 states, "Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation" (emphasis added). For this rule, EPA presents a qualitative assessment of the potential for employment impacts in the short and long term for firms that might be directly or indirectly affected by the rule.
Regulatory employment impacts are difficult to disentangle from other economic changes affecting employment decisions that occur over the timeframe of analysis and across affected regions and industries. Labor market responses to regulation are complex. They depend on labor demand and supply elasticities and possible labor market imperfections (e.g. wage stickiness, structural unemployment, etc.). The observability of an employment response may depend on the unit of measurement. Possible measured units include the number of jobs, job years, types of job, hours worked, and earnings. Net employment impacts are composed of a mix of potential declines and gains in different areas of the economy including the directly regulated sector, the environmental protection sector, upstream and downstream sectors, and ultimately all affected sectors. In light of these complexities, economic theory provides a constructive framework for analysis. The theory is explained below, followed by a quick summary of empirical findings in the rapidly expanding literature relevant to employment effects of environmental regulation. The final subsections present qualitative assessments of the employment impacts of the current rulemaking.
Theory
Microeconomic theory describes how firms adjust their use of inputs in response to changes in economic conditions. Labor is one of many inputs to production, along with capital, energy, and materials. In competitive markets, firms choose inputs and outputs to maximize profit as a function of market prices and technological constraints.[,] Berman and Bui (2001) adapt this model to analyze how environmental regulations affect the quantity of labor demanded by regulated firms. They model environmental regulation as effectively requiring certain factors of production, such as pollution abatement capital, at levels that firms would not otherwise choose. Berman and Bui (2001) model two components that drive changes in firm-level labor demand: output effects and substitution effects. Regulation affects the profit-maximizing quantity of output by changing the marginal cost of production. If a regulation causes marginal cost to increase, it will place upward pressure on output prices, leading to a decrease in demand for output, and resulting in a decrease in production. The output effect describes how, holding labor intensity constant, a decrease in production causes a decrease in labor demand. As noted by Berman and Bui, although many assume that regulations must increase marginal cost, it need not be the case. A regulation could induce a firm to upgrade to less polluting and more efficient equipment or production processes that lower the marginal cost of production.
The substitution effect describes how, holding output constant, regulation affects the labor-intensity of production. Although increased environmental regulation may increase the use of pollution control equipment and energy to operate that equipment, or otherwise change production processes, the impact on labor demand is ambiguous. For example, pollution abatement technologies or materials that alter the production process, requirements for inspection and certification, and required paperwork and recordkeeping may affect the amount of labor necessary to produce a unit of output. Berman and Bui model the substitution effect as the effect of regulation on pollution control equipment and expenditures and the corresponding change in the labor-intensity of production. In summary, as output and substitution effects may be positive or negative, economic theory alone cannot predict the direction of the net effect of environmental regulation on labor demand at the level of the regulated firm. This rule will require manufacturers and processors of certain nanoscale materials to electronically report to EPA certain information. This requirement may impact labor demand at regulated firms through increased labor needs.
In addition to changes to labor demand in the regulated industry, net employment impacts encompass changes in other related sectors throughout the U.S. economy. For example, this rule will increase the amount of data on nanomaterials available for Federal agency risk management programs, state and local government programs, private sector, and non-governmental organization researchers. As a result, this increased amount of data may increase labor demand at organizations that analyze the data. Therefore, it is important to consider the net effect of compliance actions on employment across multiple sectors or industries. If the U.S. economy is at full employment, even a large-scale environmental regulation is unlikely to have a noticeable impact on aggregate net employment. Instead, labor in affected sectors would primarily be reallocated from one productive use to another, and net national employment effects from environmental regulation would be small and transitory (e.g., as workers move from one job to another). Some workers may retrain or relocate in anticipation of new requirements or require time to search for new jobs, while shortages in some sectors or regions could bid up wages to attract workers. These adjustment costs can lead to local labor disruptions. Although the net change in the national workforce is expected to be very small, localized reductions in employment may adversely impact individuals and communities just as localized increases may have positive impacts. If, on the other hand, the economy is operating at less than full employment, economic theory does not clearly indicate the direction or magnitude of the net impact of environmental regulation on employment (Schmalensee and Stavins 2011). For example, the Congressional Budget Office considered EPA's Mercury Air Toxics Standards and regulations for industrial boilers and process heaters as potentially leading to short-run net increases in economic growth and employment, driven by capital investments for compliance with the regulations (Congressional Budget Office 2011).