0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    46,185
                                       8
                                      413
                                      24
                                      437
                                      352
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    48,660
                                       9
                                      437
                                      25
                                      462
                                      372
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    51,212
                                      10
                                      462
                                      27
                                      489
                                      396
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    54,540
                                     Total
                                       -
                                       -
                                       -
                                     4,354
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                    600,828
Notes:
a The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years.
b Derived in Table 3-2
c Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding.

Table 6-3: Annual Industry Labor Costs (Increased Annual Growth Rate Scenario)
                                     Year
                                Number of Firms
                          Total Number of Reports[a]
                 Rule Familiarization Cost (per Firm)b (2013$)
         Form Completion and Recordkeeping Cost (per Report)c (2013$)
             Electronic Reporting Requirements (per Firm)d (2013$)
                          Total Cost per Firm (2013$)
                     Total Industry Cost (Millions 2013$)
                       Discounted Cost (Millions 2013$)

                                   Existing
                                      New
                                     Total

                                   Existing
                                      New
                                   Existing
                                      New
                                   Existing
                                      New
                                   Existing
                                      New

                                   Existing
                                      New
                                       1
                                       0
                                      295
                                      295
                                     1,493
                                    $0.00
                                    $56.51
                                       0
                                    $9,281
                                       0
                                    $98.04
                                       0
                                   $47,119
                                    $13.90
                                    $13.90
                                    $13.90
                                       2
                                      295
                                      17
                                      312
                                      251
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $2.34
                                    $2.27
                                    $2.18
                                       3
                                      312
                                      18
                                      330
                                      266
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $2.47
                                    $2.33
                                    $2.16
                                       4
                                      330
                                      19
                                      349
                                      281
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $2.61
                                    $2.39
                                    $2.13
                                       5
                                      349
                                      20
                                      369
                                      296
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $2.76
                                    $2.45
                                    $2.11
                                       6
                                      369
                                      21
                                      390
                                      313
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $2.91
                                    $2.51
                                    $2.08
                                       7
                                      390
                                      23
                                      413
                                      334
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $3.12
                                    $2.61
                                    $2.08
                                       8
                                      413
                                      24
                                      437
                                      352
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $3.28
                                    $2.67
                                    $2.04
                                       9
                                      437
                                      25
                                      462
                                      372
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $3.45
                                    $2.73
                                    $2.01
                                      10
                                      462
                                      27
                                      489
                                      396
                                    $0.00
                                    $56.51
                                    $9,281
                                    $9,281
                                    $11.87
                                    $98.04
                                    $5,209
                                   $47,119
                                     $3.68
                                    $2.82
                                    $2.00
                                     Total
                                       -
                                       -
                                       -
                                     4,354
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -

                                                                Annualized Cost
                                    $3.85
                                    $4.07
Notes:
a The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years.
b Derived in Table 3-2
c Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding.

Table 6-4: Agency Cost Estimate for the Proposed Rule (Increased Annual Growth Rate Scenario)
                                     Year
                                  Wage Rate
                               Hours per Report
                            Agency Cost per Report
                                    (2013$)
                           Total Number of Reportsa
                                     Total
                       Discounted Cost (Millions 2013$)

                                    Burden
                             Cost (Millions 2013$)
                               3% Discount Rate
                               7% Discount Rate
                                       1
                                    $77.36
                                     4.38
                                     $339
                                     1,493
                                     6,539
                                    $0.51
                                    $0.51
                                    $0.51
                                       2
                                    $77.36
                                     4.38
                                     $339
                                      251
                                     1,099
                                    $0.09
                                    $0.08
                                    $0.08
                                       3
                                    $77.36
                                     4.38
                                     $339
                                      266
                                     1,165
                                    $0.09
                                    $0.08
                                    $0.08
                                       4
                                    $77.36
                                     4.38
                                     $339
                                      281
                                     1,231
                                    $0.10
                                    $0.09
                                    $0.08
                                       5
                                    $77.36
                                     4.38
                                     $339
                                      296
                                     1,296
                                    $0.10
                                    $0.09
                                    $0.08
                                       6
                                    $77.36
                                     4.38
                                     $339
                                      313
                                     1,371
                                    $0.11
                                    $0.09
                                    $0.08
                                       7
                                    $77.36
                                     4.38
                                     $339
                                      334
                                     1,463
                                    $0.11
                                    $0.09
                                    $0.08
                                       8
                                    $77.36
                                     4.38
                                     $339
                                      352
                                     1,542
                                    $0.12
                                    $0.10
                                    $0.07
                                       9
                                    $77.36
                                     4.38
                                     $339
                                      372
                                     1,629
                                    $0.13
                                    $0.10
                                    $0.07
                                      10
                                    $77.36
                                     4.38
                                     $339
                                      396
                                     1,734
                                    $0.13
                                    $0.10
                                    $0.07
                                     Total
                                       -
                                     43.80
                                       -
                                     4,354
                                    19,071
                                       -
                                       -
                                       -

                                                                Annualized Cost
                                    $0.14
                                    $0.15
Notes:
aThe total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

Table 6-5: Total Social Costs for the Proposed Rule (Increased Annual Growth Rate Scenario)
                                     Year
                                Burden (Hours)
                           Discounted Costs (2013$)

                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                    Total
                                   Industry
                                    Agency
                                    Total
                                   Industry
                                    Agency
                                    Total
                                       1
                                    206,058
                                     6,539
                                    212,597
                                    $13.90
                                    $0.51
                                    $14.41
                                    $13.90
                                    $0.51
                                    $14.41
                                       2
                                    34,657
                                     1,099
                                    35,757
                                    $2.27
                                    $0.08
                                    $2.35
                                    $2.18
                                    $0.08
                                    $2.26
                                       3
                                    36,669
                                     1,165
                                    37,834
                                    $2.33
                                    $0.08
                                    $2.42
                                    $2.16
                                    $0.08
                                    $2.24
                                       4
                                    38,757
                                     1,231
                                    39,988
                                    $2.39
                                    $0.09
                                    $2.48
                                    $2.13
                                    $0.08
                                    $2.21
                                       5
                                    40,923
                                     1,296
                                    42,220
                                    $2.45
                                    $0.09
                                    $2.54
                                    $2.11
                                    $0.08
                                    $2.18
                                       6
                                    43,166
                                     1,371
                                    44,537
                                    $2.51
                                    $0.09
                                    $2.60
                                    $2.08
                                    $0.08
                                    $2.15
                                       7
                                    46,185
                                     1,463
                                    47,648
                                    $2.61
                                    $0.09
                                    $2.70
                                    $2.08
                                    $0.08
                                    $2.15
                                       8
                                    48,660
                                     1,542
                                    50,202
                                    $2.67
                                    $0.10
                                    $2.77
                                    $2.04
                                    $0.07
                                    $2.12
                                       9
                                    51,212
                                     1,629
                                    52,841
                                    $2.73
                                    $0.10
                                    $2.83
                                    $2.01
                                    $0.07
                                    $2.08
                                      10
                                    54,540
                                     1,734
                                    56,274
                                    $2.82
                                    $0.10
                                    $2.92
                                    $2.00
                                    $0.07
                                    $2.07
                                     Total
                                    600,822
                                    19,071
                                    619,898
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -

                                                               Annualized Costs
                                    $3.85
                                    $0.14
                                    $3.99
                                    $4.28
                                    $0.15
                                    $4.22
Source: EPA, 2003a; OPM, 2013

 Number of Nanomaterials per Firm
Low and High-End Estimates for the Number of Nanomaterials per Firm
As described in Section 2.4, the median number of TSCA-related nanomaterials manufactured per firm is 13 (based on a subgroup of 34 firms), and after excluding those produced for R&D purposes (approximately 61 percent of all nanomaterials), EPA estimated 5.06 to be "commercially relevant" and therefore subject to the proposed rule. The number of nanomaterials produced by the 34 businesses in the subgroup ranged from 1 to 66. As a sensitivity analysis, EPA has estimated industry and Agency burden associated with the proposed rule using the high and low values from this range. Assuming a low-end estimate of 1 nanomaterial, on average each firm will report on 0.39 nanomaterials in the first year and 0.04 in the subsequent years. Using the high-end estimate of 66 nanomaterials, a firm will submit 25.67 reports in the first year and 2.85 reports in all future years.
Table 6-6: Estimated High- and Low-End Estimated Number of Commercially Relevant Nanomaterials per Firm
                              Population Category
                            Nanomaterials per Firm
                             R&D Exclusion (%)
                             R&D Exclusion (#)
                   "Commercial" Nano-materials per Firma

                                  First Year
                               Subsequent Years
                             Reporting Businesses
                                       1
                                    61.11%
                                     0.61
                                     0.39
                                     0.04

                                      66
                                    61.11%
                                     40.33
                                     25.67
                                     2.85
Notes:
a The total number of nanomaterials subject to proposed rule is assumed to double over the analysis period of 10 years. (see section 2.4 for more details)

Industry, Agency and Total Costs
Low-end estimates. Based on the number of firms and the burden estimates derived in Section 2.3 and Section 3.3, and using the low-end estimate of 0.39 reports in the first year and 0.04 in the subsequent years, the total industry burden is 16,491 hours in the first year and 1,673 hours future years, with an annualized cost of $0.21 million with a 3 percent discount rate ($0.23 with a 7 percent discount rate) Table 6-7 and Table 6-8 present the industry cost and burden estimates.

Table 6-9 contains the Agency burden estimate of 504 hours in the first year and 52 hours each subsequent year, and the annualized cost of estimates of $0.01 million with a 3 percent discount rate ($0.01 million with a 7 percent discount rate).

Table 6-10 presents the total social costs of $0.22 million with a 3 percent discount rate and $0.24 million with a 7 percent discount rate.

High-end estimates. Using the high end estimate of 25.67 reports in the first year, and 2.85 reports in each subsequent year, the industry burden is 1,042,657 hours in the first year and 115,737 hours in each subsequent year, with an annualized cost of $13.76 million with a 3 percent discount rate ($15.10 with a 7 percent discount rate). The industry burden and cost estimates are presented in Table 6-7 and Table 6-8 respectively.
Table 6-9 presents the total Agency burden estimate of 33,168 hours in the first year and 3,682 in each subsequent year, and the annualized Agency cost estimate of $0.50 million with a 3 percent discount rate ($0.55 with a 7 percent discount rate).
Table 6-10 contains the total social costs and burden of using the high end-estimate. The total social burden is 2.12 million hours over the ten year period, and the annualized cost is $14.26 million with a 3 percent discount rate and $15.66 with a 7 percent discount rate.

Table 6-7: Total Annual Industry Burden Hours (Low-and High-End Nanomaterials Estimates Scenario)
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                    Rule Familiarizationc Burden (per Firm)
             Form Completion and Recordkeeping Burden (per Report)
                 Electronic Reporting Requirements (per Firm)d
                             Total Burden Per Firm
                       Total Industry Number of Reportsb
                             Total Industry Burden

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     295.0
                                     0.39
                                     25.67
                                     0.82
                                     137.6
                                     1.42
                                     55.90
                                     3,534
                                      115
                                     7,573
                                    16,491
                                   1,042,657
                                       2
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       3
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       4
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       5
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       6
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       7
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       8
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       9
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                      10
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                     Total
                                       -
                                     0.75
                                     51.32
                                       -
                                       -
                                       -
                                       -

                                      221
                                    15,139
                                    31,544
                                   2,084,293
Notes:
a EPA assumes that the number of firms remains constant over the analysis period.
b The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 6-8 : Annual Industry Labor Costs (Low-and High-End Nanomaterials Estimates Scenario)
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                   Rule Familiarization  Cost (per Firm)[b]
                                    (2013$)
    Form Completion and Recordkeeping Burden  Cost (per Report)[b] (2013$)
             Electronic Reporting Requirements (per Firm)b (2013$)
                             Total Burden Per Firm
                       Total Industry Number of Reportsb
                              Total Industry Cost
                                (Millions $2013)

                                      Low
                                     High

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

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      295
                                     0.39
                                     25.67
                                    $56.51
                                    $9,281
                                    $98.04
                                    $3,774
                                   $238,409
                                      115
                                     7,573
                                    $1.11
                                    $70.33
                                     $1.11
                                    $70.33
                                       2
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.11
                                     $7.58
                                     $0.11
                                     $7.30
                                       3
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.11
                                     $7.36
                                     $0.10
                                     $6.82
                                       4
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.10
                                     $7.14
                                     $0.09
                                     $6.37
                                       5
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.10
                                     $6.94
                                     $0.09
                                     $5.96
                                       6
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.10
                                     $6.73
                                     $0.08
                                     $5.57
                                       7
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09
                                     $6.54
                                     $0.08
                                     $5.20
                                       8
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09
                                     $6.35
                                     $0.07
                                     $4.86
                                       9
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09
                                     $6.16
                                     $0.07
                                     $4.54
                                      10
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09
                                     $5.98
                                     $0.06
                                     $4.25
                                     Total
                                       -
                                     0.75
                                     51.32
                                       -
                                       -
                                       -
                                       -

                                      221
                                    15,139

                                                                Annualized Cost
                                    $0.21
                                    $13.76
                                    $0.23
                                    $15.10
Notes:
a EPA assumes that the number of firms remains constant over the analysis period.
b The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 6-9: Agency Cost Estimate for the Proposed Rule (Low-and High-End Nanomaterials Estimates Scenario)
                                     Year
                                  Wage Rate
                               Hours per Report
                            Agency Cost per Report
                           Total Number of Reportsa
                                 Total Burden
                       Discounted Cost (Millions 2013$)

                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                    $77.36
                                     4.38
                                     $339
                                      115
                                     7,573
                                      504
                                    33,168
                                    $0.039
                                    $2.57
                                    $0.039
                                    $2.57
                                       2
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.004
                                    $0.28
                                    $0.004
                                    $0.27
                                       3
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.004
                                    $0.27
                                    $0.003
                                    $0.25
                                       4
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.004
                                    $0.26
                                    $0.003
                                    $0.23
                                       5
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.004
                                    $0.25
                                    $0.003
                                    $0.22
                                       6
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.003
                                    $0.25
                                    $0.003
                                    $0.20
                                       7
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.003
                                    $0.24
                                    $0.003
                                    $0.19
                                       8
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.003
                                    $0.23
                                    $0.002
                                    $0.18
                                       9
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.003
                                    $0.22
                                    $0.002
                                    $0.17
                                      10
                                    $77.36
                                     4.38
                                     $339
                                      12
                                      841
                                      52
                                    3,682
                                    $0.003
                                    $0.22
                                    $0.002
                                    $0.15
                                     Total
                                       -
                                     43.80
                                       -
                                      221
                                    15,139
                                      969
                                    66,311
                                       -

                                       -

                                                                Annualized Cost
                                    $0.01
                                    $0.50
                                    $0.01
                                    $0.55
Notes:
aThe total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

Table 6-10: Total Social Costs for the Proposed Rule
                                     Year
                                Burden (Hours)
                      Discounted Costs ( Millions 2013$)

                               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
                                    16,491
                                   1,042,657
                                      504
                                    33,168
                                    16,994
                                   1,059,651
                                    $1.11
                                    $70.33
                                    $0.04
                                    $2.57
                                     $1.15
                                    $72.90
                                    $1.11
                                    $70.33
                                    $0.04
                                    $2.57
                                     $1.15
                                    $72.90
                                       2
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.11
                                    $7.58
                                    $0.00
                                    $0.28
                                     $0.11
                                     $7.86
                                    $0.11
                                    $7.30
                                    $0.00
                                    $0.27
                                     $0.11
                                     $7.56
                                       3
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.11
                                    $7.36
                                    $0.00
                                    $0.27
                                     $0.11
                                     $7.63
                                    $0.10
                                    $6.82
                                    $0.00
                                    $0.25
                                     $0.10
                                     $7.07
                                       4
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.10
                                    $7.14
                                    $0.00
                                    $0.26
                                     $0.11
                                     $7.41
                                    $0.09
                                    $6.37
                                    $0.00
                                    $0.23
                                     $0.10
                                     $6.61
                                       5
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.10
                                    $6.94
                                    $0.00
                                    $0.25
                                     $0.10
                                     $7.19
                                    $0.09
                                    $5.96
                                    $0.00
                                    $0.22
                                     $0.09
                                     $6.17
                                       6
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.10
                                    $6.73
                                    $0.00
                                    $0.25
                                     $0.10
                                     $6.98
                                    $0.08
                                    $5.57
                                    $0.00
                                    $0.20
                                     $0.08
                                     $5.77
                                       7
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09
                                    $6.54
                                    $0.00
                                    $0.24
                                     $0.10
                                     $6.78
                                    $0.08
                                    $5.20
                                    $0.00
                                    $0.19
                                     $0.08
                                     $5.39
                                       8
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09
                                    $6.35
                                    $0.00
                                    $0.23
                                     $0.10
                                     $6.58
                                    $0.07
                                    $4.86
                                    $0.00
                                    $0.18
                                     $0.07
                                     $5.04
                                       9
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09
                                    $6.16
                                    $0.00
                                    $0.22
                                     $0.09
                                     $6.39
                                    $0.07
                                    $4.54
                                    $0.00
                                    $0.17
                                     $0.07
                                     $4.71
                                      10
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09
                                    $5.98
                                    $0.00
                                    $0.22
                                     $0.09
                                     $6.20
                                    $0.06
                                    $4.25
                                    $0.00
                                    $0.15
                                     $0.06
                                     $4.40
                                     Total
                                    31,544
                                   2,084,293
                                      969
                                    66,311
                                    32,513
                                   2,116,806
                                       -

                                       -

                                       -
                                       -

                                       -

                                       -

                                                               Annualized Costs
                                    $0.21
                                    $13.76
                                    $0.01
                                    $0.50
                                    $0.22
                                    $14.26
                                    $0.23
                                    $15.10
                                    $0.01
                                    $0.55
                                    $0.24
                                    $15.66
Source: EPA, 2003a; OPM, 2013

 Annual Nanomaterials Growth Rate
Low and High-End Estimates in the Growth Rate of the Number Nanomaterials per Firm
The main analysis presented in this report assumes that the number of nanomaterials reported per firm 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 13 nanomaterials in year 1 and report on the 5.06 commercially relevant nanomaterials subject to the proposed rule.
Industry, Agency and Total Costs
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 0.28 additional reports each year, for a total of 2,239 reports over the 10 year period. As indicated in Table 6-11 and Table 6-12, industry will incur a labor burden of 206,058 hours in the first year and 11,461 hours in each subsequent year and the annualized cost will be $2.09 million with 3 percent discount rate ($2.36 million with a 7 percent discount rate).
Table 6-13 contains the total Agency burden and cost under this scenario; 9,807 hours in the first year and 363 in each subsequent year and an annualized cost of $0.08 million with a 3 percent discount rate and $0.09 million with a 7 percent discount rate.
The combined industry and Agency burden of this scenario is 319,011 hours over the 10-year period with an annualized social cost of $2.17 million with a 3 percent discount rate and $2.45 with a 7 percent discount rate. The total social costs are presented in Table 6-15.
High-end estimates. Assuming the number of nanomaterials per firm quadruples over the next 10 years, approximately 1.69 reports will be submitted every year after year 1, for a total of 5,971 reports over the 10-year period. As shown in Table 6-11 and Table 6-12, industry is estimated to incur a labor burden of 206,098 hours in the first year and 68,517 hours in each subsequent year. The annualized costs of this scenario are approximately $5.23 million with a 3 percent discount rate and $5.49 million with a 7 percent discount rate.
Table 6-13 present the Agency burden and costs estimates of this scenario. The Agency burden is estimate to be 6,538 hours in the first year and 2,179 in each subsequent year. The annualized cost is $0.19 million with a 3 percent discount rate and $0.20 million with a 7 percent discount rate.
The total social burden of this scenario is presented in See Table 6-14 and is 1,141,719 hours over the 10-year period with an annualized social cost of $5.43 million with a 3 percent discount rate and $5.69 million with a 7 percent discount rate.

Table 6-11: Total Industry Burden Hours (Increased Nanomaterials Growth Scenario)
                                     Year
                              Number of Firms[a]
                              Reports per Firm[b]
                   Rule Familiarization[c] Burden (per Firm)
             Form Completion and Recordkeeping Burden (per Report)
                Electronic Reporting Requirements (per Firm)[d]
                             Total Burden Per Firm
                      Total Industry Number of Reports[b]
                             Total Industry Burden

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     295.0
                                     5.06
                                     5.06
                                     0.82
                                     137.6
                                     1.42
                                    698.50
                                      699
                                     1,493
                                     1,493
                                    206,058
                                    206,058
                                       2
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       3
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       4
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       5
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       6
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       7
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       8
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       9
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                      10
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                     Total
                                       -
                                     7.59
                                     20.24
                                       -
                                       -
                                       -
                                       -

                                     2,239
                                     5,971
                                    309,204
                                    822,708
Notes:
[a] EPA assumes that the number of firms remains constant over the analysis period.
[b] The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
[c] Derived in Table 3-2
[d] Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 6-12: Annual Industry Labor Costs (Increased Nanomaterials Growth Scenario)
                                     Year
                              Number of Firms[a]
                              Reports per Firm[b]
                Rule Familiarization Cost (per Firm)[b] (2013$)
    Form Completion and Recordkeeping Burden  Cost (per Report)[b] (2013$)
            Electronic Reporting Requirements (per Firm)[b] (2013$)
                             Total Burden Per Firm
                      Total Industry Number of Reports[b]
                     Total Industry Cost (Millions $2013)

                                      Low
                                     High

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

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      295
                                     5.06
                                     5.06
                                    $56.51
                                    $9,281
                                    $98.04
                                    $47,119
                                    $47,119
                                     1,493
                                     1,493
                                    $13.90
                                    $13.90
                                    $13.90
                                    $13.90
                                       2
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.75
                                     $4.49
                                     $0.72
                                     $4.32
                                       3
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.73
                                     $4.36
                                     $0.68
                                     $4.04
                                       4
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.71
                                     $4.23
                                     $0.63
                                     $3.77
                                       5
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.69
                                     $4.11
                                     $0.59
                                     $3.53
                                       6
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.67
                                     $3.99
                                     $0.55
                                     $3.30
                                       7
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.65
                                     $3.87
                                     $0.52
                                     $3.08
                                       8
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.63
                                     $3.76
                                     $0.48
                                     $2.88
                                       9
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.61
                                     $3.65
                                     $0.45
                                     $2.69
                                      10
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.59
                                     $3.54
                                     $0.42
                                     $2.51
                                     Total
                                       -
                                     7.59
                                     20.24
                                       -
                                       -
                                       -
                                       -

                                     2,239
                                     5,971

                                                              Annualized Costs
                                    $2.09
                                    $5.23
                                    $2.36
                                    $5.49
Notes:
[a] EPA assumes that the number of firms remains constant over the analysis period.
[b] The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
[c] Derived in Table 3-2
[d] Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 6-13: Agency Cost Estimate for the Proposed Rule (Increased Nanomaterials Growth Scenario)
                                     Year
                                  Wage Rate
                               Hours per Report
                            Agency Cost per Report
                          Total Number of Reports[a]
                                 Total Burden
                       Discounted Cost (Millions 2013$)

                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                    $77.36
                                     4.38
                                     $339
                                     1,493
                                     1,493
                                   6,538.03
                                   6,538.03
                                    $0.51
                                    $0.51
                                    $0.51
                                    $0.51
                                       2
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.03
                                    $0.16
                                    $0.03
                                    $0.16
                                       3
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.03
                                    $0.16
                                    $0.02
                                    $0.15
                                       4
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.03
                                    $0.15
                                    $0.02
                                    $0.14
                                       5
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02
                                    $0.15
                                    $0.02
                                    $0.13
                                       6
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02
                                    $0.15
                                    $0.02
                                    $0.12
                                       7
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02
                                    $0.14
                                    $0.02
                                    $0.11
                                       8
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02
                                    $0.14
                                    $0.02
                                    $0.10
                                       9
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02
                                    $0.13
                                    $0.02
                                    $0.10
                                      10
                                    $77.36
                                     4.38
                                     $339
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02
                                    $0.13
                                    $0.02
                                    $0.09
                                     Total
                                       -
                                     43.80
                                       -
                                   2,239.05
                                   5,970.80
                                   9,807.04
                                   26,152.10
                                       -

                                       -

                                                               Annualized Costs
                                    $0.08
                                    $0.19
                                    $0.09
                                    $0.20
Notes:
[a]The total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

Table 6-14: Total Social Costs for the Proposed Rule
                                     Year
                                Burden (Hours)
                      Discounted Costs ( Millions 2013$)

                               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
                                    206,058
                                    206,058
                                     6,538
                                     6,538
                                    212,596
                                    212,596
                                    $13.90
                                    $13.90
                                    $0.51
                                    $0.51
                                    $14.41
                                    $14.41
                                    $13.90
                                    $13.90
                                    $0.51
                                    $0.51
                                    $14.41
                                    $14.41
                                       2
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.75
                                    $4.49
                                    $0.03
                                    $0.16
                                     $0.78
                                     $4.65
                                    $0.72
                                    $4.32
                                    $0.03
                                    $0.16
                                     $0.75
                                     $4.48
                                       3
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.73
                                    $4.36
                                    $0.03
                                    $0.16
                                     $0.76
                                     $4.52
                                    $0.68
                                    $4.04
                                    $0.02
                                    $0.15
                                     $0.70
                                     $4.18
                                       4
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.71
                                    $4.23
                                    $0.03
                                    $0.15
                                     $0.73
                                     $4.38
                                    $0.63
                                    $3.77
                                    $0.02
                                    $0.14
                                     $0.65
                                     $3.91
                                       5
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.69
                                    $4.11
                                    $0.02
                                    $0.15
                                     $0.71
                                     $4.26
                                    $0.59
                                    $3.53
                                    $0.02
                                    $0.13
                                     $0.61
                                     $3.65
                                       6
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.67
                                    $3.99
                                    $0.02
                                    $0.15
                                     $0.69
                                     $4.13
                                    $0.55
                                    $3.30
                                    $0.02
                                    $0.12
                                     $0.57
                                     $3.42
                                       7
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.65
                                    $3.87
                                    $0.02
                                    $0.14
                                     $0.67
                                     $4.01
                                    $0.52
                                    $3.08
                                    $0.02
                                    $0.11
                                     $0.53
                                     $3.19
                                       8
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.63
                                    $3.76
                                    $0.02
                                    $0.14
                                     $0.65
                                     $3.89
                                    $0.48
                                    $2.88
                                    $0.02
                                    $0.10
                                     $0.50
                                     $2.98
                                       9
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.61
                                    $3.65
                                    $0.02
                                    $0.13
                                     $0.63
                                     $3.78
                                    $0.45
                                    $2.69
                                    $0.02
                                    $0.10
                                     $0.47
                                     $2.79
                                      10
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.59
                                    $3.54
                                    $0.02
                                    $0.13
                                     $0.61
                                     $3.67
                                    $0.42
                                    $2.51
                                    $0.02
                                    $0.09
                                     $0.44
                                     $2.61
                                     Total
                                    309,204
                                    822,708
                                     9,807
                                    26,152
                                    319,011
                                    848,860
                                       -

                                       -

                                       -
                                       -

                                       -

                                       -

                                                               Annualized Costs
                                    $2.09
                                    $5.23
                                    $0.08
                                    $0.19
                                    $2.17
                                    $5.43
                                    $2.36
                                    $5.49
                                    $0.09
                                    $0.20
                                    $2.45
                                    $5.69
Source: EPA, 2003a; OPM, 2013

 Summary of all Analyses
Table 6-15 presents a summary of the costs and assumptions of the sensitivity analyses. As shown in the table, the total annualized industry costs range from $0.21 million per year (with a three percent discount rate) with the assumption that a firm submits 0.39 reports in the first year to $13.76 million per year (with a three percent discount rate) under the assumption a firm submits 25.67 reports in the first year. This would suggest that the cost estimates are more sensitive to the number of reports submitted in the first year, than increased costs in subsequent years (either through the growth in the number of nanomaterials or the number firms subject to the proposed rule).
Table 6-15: Comparison of Annualized Costs of Sensitivity Analysis (Millions 2013$)
                                   Scenario
                     Annualized Costs at 3% discount rate
                     Annualized Costs at 7% discount rate

                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
                                 Main Analysis
                                    $2.71
                                    $0.10
                                    $2.80
                                    $2.97
                                    $0.11
                                    $3.08
                  Annual Industry Growth Rate of 5.8 percent
                                 (Section 6.1)
                                    $3.85
                                    $0.14
                                    $3.99
                                    $4.28
                                    $0.15
                                    $4.22
              0.39 Nanomaterials per Firm in Year 1 (Section 6.2)
                                    $0.21
                                    $0.01
                                    $0.22
                                    $0.23
                                    $0.01
                                    $0.24
             25.67 Nanomaterials per Firm in Year 1 (Section 6.2)
                                    $13.76
                                    $0.50
                                    $14.26
                                    $15.10
                                    $0.55
                                    $15.66
    The number of nanomaterials will grow by 50% over 10 years(Section 6.3)
                                    $2.09
                                    $0.08
                                    $2.17
                                    $2.36
                                    $0.09
                                    $2.45
    The number of nanomaterials will quadruple over 10 years (Section 6.3)
                                    $5.23
                                    $0.19
                                    $5.43
                                    $5.49
                                    $0.09
                                    $5.69
Note: Totals may not sum due to rounding

  -  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 reduce the 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 proposed rule are discussed qualitatively in this section. Quantification of the benefits of the proposed 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 proposed 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 proposed 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 proposed rule may be produced below what is optimal for society.
 Benefits of Information-Based Policies
The proposed 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 proposed rule will benefit society by filling these information gaps and contributing to better assessments of potential risks and risk management decisions.
The proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed rule are discussed in the following sections.

 Potential Users of Information Generated by the Proposed Rule
EPA is expected to be the primary user of the information generated by the proposed 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 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed rule to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential. The information provided by the proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 proposed 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, processing, and distribution have not been assigned NAICS codes under the most recent classification system, NAICS 2012. This analysis therefore applies the SBA small business definitions to a subset of nanomaterials companies matched in the D&B database (further described in Section 8.2) according to the NAICS listed for the global parent company of each company in that 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 proposed rule requirements. According to this definition, which was adapted from the standard TSCA definition provided in 40 CFR 704.3, a manufacturer 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 $4 million. The second definition, which is used only in this chapter, is based on the small business definitions found in the SBA for the various industries. The small business thresholds for the industries identified in the D&B database range from 100 to 1,000 employees. Twenty companies in the subset meet the SBA small business definition. Thus, although considered small businesses for the purposes of this small entity impact analysis, they are expected to incur the full compliance costs of the rule. All twenty of these nanomaterials firms are expected to experience an impact of less than one percent of sales.
Table 8-1: Ultimate Parent NAICs Codes for the 20 Small Businesses in Subset
                          Ultimate Parent NAICS Code
                                  Description
                                Number of Firms
                           Small Business Threshold
                                    325130
                    Synthetic Dye and Pigment Manufacturing
                                       3
                           Less than 1,000 employees
                                    325180
                 Other Basic Inorganic Chemical Manufacturing
                                       4
                           Less than 1,000 employees
                                    325998
    All Other Miscellaneous Chemical Product and Preparation Manufacturing
                                       2
                            Less than 500 employees
                                    331221
                       Rolled Steel Shape Manufacturing
                                       1
                           Less than 1,000 employees
                                    334413
                Semiconductor and Related Device Manufacturing
                                       1
                            Less than 500 employees
                                    335991
                   Carbon and Graphite Product Manufacturing
                                       1
                            Less than 750 employees
                                    423220
                     Home Furnishing Merchant Wholesalers
                                       1
                            Less than 100 employees
                                    423330
         Roofing, Siding, and Insulation Material Merchant Wholesalers
                                       1
                            Less than 100 employees
                                    423510
          Metal Service Centers and Other Metal Merchant Wholesalers
                                       2
                            Less than 100 employees
                                    541712
Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
                                       4
                            Less than 500 employees
Note: NAICS codes, descriptions, and small business definitions are all from the 2012 NAICS
Source: D&B, 2009; SBA, 2014

 Estimate the Number of Small Businesses
To estimate the number of small and large businesses in the population of U.S. nanomaterials firms, EPA matched the selection described in Chapter 2 to the Dun & Bradstreet (D&B) corporate database to identify company and parent company sales and employment, measured the percentage of companies defined as small and large within the selection (based on the SBA definitions), and applied these percentages to the total estimate of firms.