Table C-1. Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)]
                                 Cost Element
                              Unit Cost
 (2013$)
                               Inflation Factor
                              Unit Cost
 (2015$)
                                     Hours
                                  Total Cost
0.5 hours technical time
                                                                             --
                                                                             --
                                                                        $75.89
                                                                       per hour
                                                                            0.5
                                                                        $37.95
480 labels
                                                                $0.22 per label
                                                                          1.017
                                                                         $0.22
                                                                      per label
                                                                             --
                                                                       $107.44
                                                                          TOTAL
                                                                            0.5
                                                                           $145
Notes:
Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
Label cost, Grainger, 2014; cost elements, quantities, RIB 1989; inflators, labor, Table B-1 and Table B-3.

Chemicals Used in the Workplace. Costs for workplace labeling requirements are estimated by assuming that the facility purchases six large signs, priced at $54.30 each in 2014 dollars (Grainger, 2014). These signs will be mounted in areas where the chemicals are used or formulated. For example, a placard might be posted at each of six vessels: a mixing tank, a reactor, two separators, and two storage vessels (EPA, 1989). The labeling process is also assumed to require 0.5 hours of technical time to compile label information and ten minutes of production worker time to post each placard. Technical labor costs include wages, fringe benefits, and overhead, as described in Appendix B.
The resulting per chemical, per site costs of labeling for chemicals in the workplace are shown in Table C-2.
Table C-2. Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)]
                                 Cost Element
                                   Unit Cost
                                    (2014$)
                               Inflation Factor
                                   Unit Cost
                                    (2015$)
                                     Hours
                                  Total Cost
0.5 hours technical time
                                      --
                                      --
                                    $75.89
                                   per hour
                                      0.5
                                    $37.95
6 labels or placards
                                $54.30 per item
                                     1.001
                                    $54.36
                                   per item
                                      --
                                     $326
10 minutes per label/placard production worker time
                                      --
                                      --
                                    $30.91
                                   per hour
                                      1.0
                                    $30.91
                                     TOTAL
                                      1.5
                                     $395
Notes:
Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
Placard cost, Grainger 2014; cost elements and quantities, EPA, 1989; inflators and labor unit costs, Table B-1 and Table B-3.
Preparing Material Safety Data Sheet (MSDS) Information
If the SNUR cites 40 CFR §721.72(c), then to avoid engaging in a Significant New Use, each facility is required to create, post, and distribute material safety data sheets (MSDSs). Based on estimates in OSHA 1983, the 1989 EPA report (EPA, 1989) has estimated that creation of an MSDS for a chemical substance requires 2.0 hours of technical labor time and 0.25 hours of clerical time. Further, EPA assumes that the manufacturer provides 20 copies of the MSDS to customers and retains 20 copies for use onsite, for a total of 40 copies (EPA, 1989). The loaded hourly wage rates and the inflator used in estimating unit photocopy costs are derived in Appendix B. The resulting cost of MSDS preparation is shown in Table C-3.
Table C-3. Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]
Cost Element
                               Unit Cost (1988$)
                               Inflation Factor
                                   Unit Cost
                                    (2015$)
                                     Hours
                                  Total Cost
2.0 hours technical time
                                      --
                                      --
                                    $75.89
                                   per hour
                                       2
                                     $152
0.25 hours clerical time
                                      --
                                      --
                                    $33.66
                                   per hour
                                     0.25
                                    $8.42
40 copies
                                     $0.05
                                     2.004
                                    $0.10
                                   per copy
                                      --
                                    $4.01
                                     TOTAL
                                     2.25
                                     $164
Note:
Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
Cost elements, quantities, and 1988 copy cost, RIB 1989; inflators and labor unit costs, Table B-1 and Table B-3.

Employee Training
The final required component of the haz-comm program is employee training, based on 40 CFR §721.72(d). The 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow-up (EPA, 1989), assumes that a training program currently is in place, but the existing program must be modified to add new information pertaining to the PMN substance. Subsequently, the training program must be expanded to include such material each time the training course is presented. Costs of modifying the program and presenting the modified program are mainly labor costs for the trainer and the trainees.
Inserting the new information about the PMN substance into the training program and conducting the revised training is assumed to require 0.5 hours of the trainer's time. An additional 0.25 hours per trainee is estimated to be required, and an average of 25 affected workers is assumed per facility (EPA, 1989). If additional production workers needed to be trained, for example because they might come into contact with the chemical due to spills or leaks, training costs could be higher than estimated here (EPA, 1989).
Labor rates for training are based on the loaded rates derived in Appendix B for chemical technicians and chemical industry production workers. The total cost of the employee training requirement is shown in Table C-4.
Table C-4. Annual Costs for Employee Training, Per Chemical [40 CFR §721.72(d)]
                                 Cost Element
                                   Unit Cost
                                    (2015$)
                                     Hours
                                  Total Cost
0.5 hours technical time (trainer)
                                $75.89 per hour
                                      0.5
                                    $37.95
0.25 hours per production employee X average of 25 workers per plant = 6.25 hours
                                $30.91 per hour
                                     6.25
                                     $193
                                                                          TOTAL
                                     6.75
                                     $231
Notes:
Total costs were calculated using unrounded values from (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
Cost elements and quantities, EPA, 1989; labor unit costs, Table B-1
Protection in the Workplace
The following section estimates costs of assessing needs for dermal protection and evaluating protective gear for impermeability, as well as the costs of gloves, goggles, protective clothing, and respirators.
Dermal Protection Selection
If the SNUR cites 40 CFR §721.63(a)(1), then to avoid engaging in a Significant New Use, the employer must ensure that each person who is likely to experience dermal exposure to a PMN chemical, must be provided with and is required to wear personal protective equipment (e.g., gloves) that will prevent dermal exposure to the substance. The equipment must be selected and used in accordance with 29 CFR § § 1910.132 and 1910.133 (promulgated by the Occupational Safety and Health Administration, OSHA). The selection and administration of this dermal protection is estimated to require 10 hours labor by an industrial hygienist, annually (EPA, 1999). The wage rate of the hygienist was calculated as described in Appendix B. The cost calculations for the dermal protection selection requirement are given in Table C-5. This covers only costs of selecting the dermal protection needed, not costs of the items themselves. For costs of purchasing dermal protective items, see the sections below on costs of gloves, eyewear, and clothing.
Table C-5. Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)]
Cost Element
                               Unit Cost
(2015$)
                                     Hours
                                 Total Cost[1]
                    10 hours industrial hygienist (IH) time
                                $56.83 per hour
                                      10
                                     $568
Notes:
Total costs were calculated using unrounded values (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
Labor rates, Table B-1; cost elements and quantities, EPA, 1999.
Impermeability Testing
As part of the workplace protection requirements specified under 40 CFR §721.63(a)(3), to avoid engaging in a Significant New Use, the SNUR may require that employers demonstrate that each item of protective equipment provided (e.g., gloves) provides an impervious barrier, to protect employees from dermal exposure. Requirements outlined in §721.63(a)(3) are provided in two parts, §721 .63(a)(3)(i) and (ii). The employer may use a combination of (i) testing and/or (ii) evaluating manufacturer specifications. The following discussion is based on the Economic Analysis of Expedited Significant New Use Rules for 168 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules (EPA, 1998) and assumes that the manufacturer uses both testing and evaluation of manufacturer specifications. The analysis assumes that costs are incurred annually.
The first step, described at 40 CFR §721.63(a)(3)(i), is to perform actual impermeability testing. To determine the costs of impermeability testing compliance, Best Manufacturing Company, a leading manufacturer and tester of chemical resistant articles, was consulted (Best, 1997).
As described in EPA, 1998, Best used one of two methodologies for impermeability testing. In the first method, chemical samples were submitted to Best with a specific article to be tested for impermeability. This method was cheaper, costing $200 (1997 dollars) per chemical, but the burden of finding an appropriate article of protection lay with the chemical manufacturer. In the second method, the chemical manufacturer simply submitted chemical samples to Best, who in turn determined the most appropriate product, even if a competitor manufactured the product. This method was more costly at $800 (1997 dollars) per chemical.
The second method of impermeability testing is favored in this analysis for several reasons. First, the burden of finding and submitting an article of protection is shifted from the chemical manufacturer to the testing company, who would have greater experience in Personal Protective Equipment (PPE) selection. Second, should the article submitted fail the impermeability test, other articles may have to be submitted until satisfactory test results are obtained. Furthermore, substances subject to SNURs may include new and/or rare chemicals, which may have undiscovered or unknown properties. This uncertainty may impede chemical manufacturers' ability to effectively submit appropriate PPE articles for testing. Finally, the first method is essentially a pass-fail test. If an article passes the impermeability test, then it is acceptable. In the second method, several articles may be tested and compared, and, while one or more acceptable articles may result, the most impermeable article is always determined for the chemical. To obtain the best article rather than merely a satisfactory article of protection, the second method of testing is more appropriate. For these reasons, unit costs of $800 per chemical (1997 dollars) are assumed for impermeability testing. The cost of the impermeability testing is assumed to be driven by labor costs of the company performing the testing, thus test costs were inflated with an Employment Cost Index as described in Appendix B. The administration of this test would also require two hours of industrial hygienist labor (EPA, 1999).
The second step to compliance with the workplace protection requirements at §721.63 (a)(3)(ii) is the evaluation of specifications from the manufacturer or supplier of the protective equipment. This requirement helps ensure that the protective equipment will be impervious to the PMN chemical(s). The evaluation of manufacturer specifications requires an estimated four hours of industrial hygienist labor.
Annual costs of the impermeability testing requirements are presented in Table C-6.
Table C-6. Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)]
                                 Cost Element
                              Unit Cost
 (1997$)
                               Inflation Factor
                                   Unit Cost
                                    (2015$)
                                     Hours
                                 Total Cost[1]
  Impermeability Testing [§721.63(a)(3)(i)]
                              Impermeability Test
                                     $800
                                 per chemical
                                     1.664
                                    $1,331
                                 per chemical

                                    $1,331
                           Industrial Hygienist time

                                    $56.83
                                   per hour
                                       2
                                     $114

                                   Subtotal
                                       2
                                    $1,444
  Evaluation of Manufacturer's Specifications  [§721.63(a)(3)(ii)]
                           Industrial Hygienist time

                                    $56.83
                                   per hour
                                       4
                                     $227

                                   Subtotal
                                       4
                                     $227
                                                                          TOTAL
                                       6
                                    $1,672
Note:
1 Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
1997 costs, Best, 1997; cost elements and quantities, EPA, 1998 and EPA, 1999; inflators and labor rates, Table B-1 through Table B-3.
Gloves
If the SNUR cites 40 CFR §721.63(a)(2)(i), then gloves must be worn to avoid engaging in a Significant New Use. Gloves may also be acquired as a result of the dermal protection selection at §721.63 (a)( 1). If standard, disposable medical-grade gloves are used, they are assumed to be worn and discarded by the worker following each day of exposure. Each site is assumed to have 25 workers, each of them exposed 250 days per year. This reflects the high-side assumptions in EPA, 1989 (page 25) for the number of workers and exposure days. Each pair was estimated to cost $0.44 in 2014 (Grainger, 2014). Total annual costs of providing disposable gloves are developed by applying the assumptions above regarding the number of workers exposed (25 per site) and frequency of replacement (one pair per worker per day of exposure H 250 days of exposure per year). For some chemicals, heavy-duty gloves may be used. They are generally not disposed of daily, but are more expensive. The estimated costs of gloves purchased in compliance with SNUR Personal Protective Equipment requirements are presented below in Table C-7. The cost estimates for each chemical assume that the more expensive heavy-duty gloves are used in cases where the SNUR explicitly requires gloves.
Table C-7. Annual Cost of Gloves [40 CFR §721.63(a)(2)(i)]
                                 Cost Element
                          Unit Cost  (2014$ per pair)
                               Inflation Factor
                      Unit Cost
 (2015$ per pair)
                          Number of Pairs Required[1]
                             Total Cost (2015$)[2]
Disposable nitrile gloves (replaced daily)
                                     $0.44
                                     1.001
                                     $0.44
                                     6,250
                                    $2,764
Heavy duty butyl gloves (replaced every 25 work days)
                                    $70.73
                                     1.001
                                    $70.81
                                      250
                                    $17,704
Notes:
[1] The analysis assumes that 25 workers who are exposed 250 days/year replace disposable gloves daily and replace heavy duty gloves every 25 work days.
[2] Total costs were calculated using unrounded unit cost values and inflation factors (Table B-3), so results may differ from calculations using the rounded values shown in this table.
Sources:
Item costs, Grainger, 2014; item type and quantity, EPA, 1998; inflator, Table B-3.
Eyewear
If the SNUR cites 40 CFR §721.63(a)(2)(iii), then to avoid engaging in a Significant New Use, employer must provide eye protection. Eye protection may also be acquired as a result of the dermal protection selection at §721.63 (a)( 1). Protective goggles are expected to be used at a rate of one set per worker and replaced every four months. Each site is assumed to have 25 workers, each of them exposed 250 days per year. The SNUR may not specify the exact type of eyewear required. OSHA guidelines in 29 CFR § 1910.133 (b)( 1), however, state that protective eye and face devices purchased after July 5, 1994 shall comply with ANSI Z87.1-1989. To determine the cost of goggles that meet this standard, EPA consulted with eyewear specialists at equipment supplier LSS. A standard pair of goggles that meets the ANSI Z87.1-1989 specification was priced at $8.73 per pair in 2014 (Grainger, 2014; RIB, 1998). A price estimate for a heavy-duty pair of goggles compliant with the ANSI standard is also included in Table C-8.
The cost estimates for each chemical assume that the more expensive heavy-duty goggles are used in cases where the SNUR explicitly requires goggles. Costs of protective eyewear were inflated as described in Appendix B and are presented in Table C-8 below.
Table C-8. Annual Cost of Protective Eyewear [40 CFR §721.63(a)(2)(iii)]
                                 Cost Element
                                   Unit Cost
                               (2014$ per pair)
                               Inflation Factor
                                   Unit Cost
                               (2015$ per pair)
                          Number of Pairs Required[1]
                             Total Cost (2015$)[2]
Standard Goggles
                                    $8.73
                                     1.001
                                    $8.74
                                      75
                                     $656
Heavy duty chemical-splash/impact goggles
                                    $11.95
                                     1.001
                                    $11.96
                                      75
                                     $897
Notes:
1 The analysis assumes 25 workers replacing goggles three times per year.
2 Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Sources:
Item costs, Grainger, 2014; item type and quantity, EPA, 1998; inflator, Table B-3.
Clothing
Costs for a standard coverall clothing set, estimated at $36.25 in 1997 (LSS, 1997), were inflated as described in Appendix B and are shown in Table C-9 below. Costs for full-body protective clothing are based on the coverall clothing set with a hood (LSS, 1997) as shown in Table C-9.
If the SNUR cites 40 CFR §721.63(a)(2)(ii) or (iv), then to avoid engaging in a Significant New Use, employers must provide protective clothing. Protective clothing may also be acquired as a result of the dermal protection selection at §721.63(a)(1). Protective clothing, (a)(2)(iv), and full-body chemical resistant clothing, (a)(2)(ii), are assumed to last four months. Each site is assumed to have 25 workers, each of them exposed 250 days per year.
Table C-9 shows estimated costs, after inflating as described in Appendix B, for a standard coverall clothing set that cost $41.00 in 2014 (Grainger, 2014) and for full-body protective clothing  -  the coverall clothing set with a hood  -  costing $117.94 in 2014 (Grainger, 2014).
Table C-9. Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)]
                                 Cost Element
                                   Unit Cost
                                (2014$ per set)
                               Inflation Factor
                                   Unit Cost
                                (2015$ per set)
                              Number Required[1]
                             Total Cost (2015$)[2]
Coverall with hood [full-body clothing] §721.63(a)(2)(ii)
                                   $117.94
                                     1.001
                                   $118.08
                                      75
                                    $8,856
Coverall §721.63(a)(2)(iv)
                                    $41.00
                                     1.001
                                    $41.05
                                      75
                                    $3,079
Notes: 1 The analysis assumes 25 workers replacing coverall three times per year.
[2] Totals were calculated using unrounded unit cost values and inflation factors (see Table B-3), so results may differ from calculations using the rounded values shown in this table.
Sources:
Item costs, Grainger, 2014; item type and quantity, EPA, 1998; inflation factor, Table B-3.

Respirators
For some PMN chemicals, to avoid engaging in a Significant New Use, the SNUR requires either the use of respirators or compliance with a New Chemical Exposure Limit (NCEL). Both requirements differ by chemical.[18]For costing purposes, this analysis assumes that respirators are used. Earlier, PMN SNURs referenced specific paragraphs at 40 CFR §721.63 (a)(5) that identified fifteen types of NIOSH-approved respirator units. However, with rulemaking docket OPPT-2003-0063 (EPA, 2007b), PMN SNURs began to describe respirator choices directly. Costs of the SNUR respirator choices were estimated based on the costs of the respirator in §721.63 (a)(5) that appeared to best match the SNUR descriptions.
Table C-10. Crosswalk Between SNUR Text and Respirator Types at 40 CFR §721.63(a)(5)
                Respirator types at 40 CFR §721.63 (a)(5) [1]
                          Requirement Stated in SNUR
                        (exact SNUR wording may differ)
(ii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped
with a tight-fitting facepiece.
Some SNURs may specify "full" facepiece
Some SNURs may specify "or other positive pressure mode"
Supplied-air respirator operated in pressure demand
or continuous flow mode and equipped with a tight-
fitting full facepiece.

Supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a tight-fitting full facepiece
(iii) Category 19C Type C supplied-air respirator operated
in pressure demand or continuous flow mode and equipped
with a hood or helmet or tight-fitting facepiece.
Some SNURs may specify "half" or "full" facepiece.
Supplied-air respirator operated in pressure demand
or continuous flow mode and equipped with a hood
or helmet or tight-fitting facepiece (either half- or
full-face).
(iv) Category 21C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters.
Some SNURs may specify a "half" or "full" facepiece.

Some SNURs may specify "if oil aerosols absent" or other restrictions related to oil aerosols.
Air-purifying respirator equipped with a tight-fitting
full facepiece and High Efficiency Particulate Air
(HEPA) filters.

Air-purifying, tight-fitting respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters (either half- or full-face).
Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if oil aerosols absent), R100 (restricted use when oil aerosols present), or P100 (appropriate when oil aerosols present) filters.

Air purifying, tight-fitting full-face respirator equipped with the appropriate combination cartridges tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridge), with a particulate filter (N100 if oil aerosols are absent, R100, or P100).
(v) Category 21C powered air-purifying respirator equipped
with a tight-fitting facepiece and high efficiency particulate filters.
Some SNURs may specify a "half" or "full" facepiece.
Powered air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters.
Powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters.
(vi) Category 21C powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate filters.
Powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters.
Note:
1 The table specifies respirator types at 40 CFR §721.63 (a)(5) that are most similar to the equipment described in the SNUR text for the current and recent SNUR rulemakings. Any significant differences between the specified respirator type at 40 CFR §721.63 (a)(5) and the SNUR text respirator type are noted in italics.

Table C-11 gives average costs of various respirator types, both as originally estimated in 2014. It also estimates costs per plant site for a chemical requiring respirators.
The respirators specified in the SNURs are typically comprised of a respirator unit and any number of the following: special cartridges (such as high efficiency particulate filters, organic vapor cartridges, and paint, lacquer, and enamel filters), hoods or helmets, and filter caps. The costs for each site of providing respirators to chemically-exposed workers, shown in Table 4 of Chapter 2 of the report, are calculated based on the assumptions stated there, that (1) there are 25 chemically-exposed workers requiring protective equipment, (2) respirators are replaced once a year, and (3) cartridges (and cartridge filters and caps) are replaced at a rate of one pair (two cartridges) every five of the 250 days that workers are exposed, or 50 times per year. For example, for the respirator type described at 40 CFR §721.63(a)(5)(xv), the annual cost per worker in 2015 dollars would be as follows:
$29.54 per respirator + ($6.39 per cartridge x 50 cartridges/year) = $348.91 per worker.
 Typically a SNUR describes more than one type of respirator, but only one type of respirator is needed to comply with the workplace protection requirements.
Table C-11. Annual Per-Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)]
721.63 (a)(5) par.
NIOSH approval type at 40 CFR §721.63 (a)(5)
(See Table C-10  for cross-walk to respirators in SNUR)
Annual Average Costs
(2014$)
Annual Average Costs
(2015$)[1]

Respirator Unit
Cartridge Set
Per Worker[2]
Inflation Factor
Annual Per Worker
Annual Per Site (25 workers)[3]
(i)
19C Type C Supplied-air with full facepiece
                                    $1,857
                                    $0.00
                                    $1,857
                                     1.001
                                    $1,859
                                   $46,480
(ii)
19C Type C Supplied-air with tight-fitting facepiece
                                    $1,857
                                    $0.00
                                    $1,857
                                     1.001
                                    $1,859
                                   $46,480
(iii)
19C Type C Supplied-air with hood or helmet or tight-fitting facepiece
                                    $2,343
                                    $0.00
                                    $2,343
                                     1.001
                                    $2,346
                                   $58,645
(iv)
21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)
                                     $258
                                    $8.57
                                     $686
                                     1.001
                                     $687
                                   $17,179
(v)
21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs
                                    $1,086
                                    $28.00
                                    $2,486
                                     1.001
                                    $2,489
                                   $62,224
(vi)
21C PAPR with loose hood or helmet and HEPAs
                                    $2,497
                                    $55.35
                                    $5,264
                                     1.001
                                    $5,271
                                   $131,763
(vii)
21C Air-purifying with HEPA and disposable respirators
                                    $29.50
                                    $6.38
                                     $349
                                     1.001
                                     $349
                                    $8,723
(viii)
23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE)
                                     $252
                                    $18.34
                                    $1,169
                                     1.001
                                    $1,170
                                   $29,260
(ix)
23C PAPR with tight-fitting facepiece and combination cartridges approved PLE
                                    $1,086
                                     $116
                                    $6,886
                                     1.001
                                    $6,894
                                   $172,354
(x)
23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE
                                    $2,362
                                     $112
                                    $7,981
                                     1.001
                                    $7,990
                                   $199,760
(xi)
23C Air-purifying with combination cartridges for PLE, including disposable respirators
                                    $29.50
                                    $8.16
                                     $438
                                     1.001
                                     $438
                                   $10,950
(xii)
23C Air-purifying with full-facepiece and organic gas/vapor cartridges
                                     $258
                                    $8.97
                                     $707
                                     1.001
                                     $707
                                   $17,683
(xiii)
23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges
                                    $1,086
                                    $95.00
                                    $5,836
                                     1.001
                                    $5,843
                                   $146,073
(xiv)
23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges
                                    $2,362
                                    $87.23
                                    $6,723
                                     1.001
                                    $6,731
                                   $168,286
(xv)
23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges
                                    $29.50
                                    $6.38
                                     $349
                                     1.001
                                     $349
                                    $8,723
Notes:
1 Annual average costs were inflated as described in Table B-3.
2 "Respirator unit" costs include both the respirator and any required add-ons such as hoods and helmets. A "cartridge set" includes two cartridges and any filters or caps required. Assumes cartridge sets are replaced every five days (50 times during 250 exposure days) so that each worker requires one respirator unit and 50 cartridge sets per year.
3 Totals were estimated from unrounded unit costs and inflation factors, so results may differ from calculations using the rounded values shown in this table

Table C-12 shows how the average costs per NIOSH-type respirator were calculated, based on prices of respirators listed in on an industrial supply website. To calculate the cost of respirators that meet the NIOSH criteria, the prices of units listed on the website that meet each NIOSH criteria were averaged. Costs of additional items such as hoods, helmets, cartridges, and filter caps were also obtained. These are added to the cost of the basic respirator unit if they are required under the SNUR regulation and if the unit does not already include the item. For example, §721.63(a)(5)(x) requires a hood or helmet. One model in the catalog that satisfies the requirement already includes a hood, while another unit requires that a separate hood be purchased. The cost of the hood was added to the unit cost and the combined cost was then averaged with the model with integrated hood.
Many respirator specifications also require cartridges. The costs of the cartridges were averaged for the corresponding requirements. In some instances, certain cartridges or filters require a secondary cartridge to function properly (e.g., some paint, lacquer and enamel filters required the organic vapors cartridges and filter retainer caps). These additional items were priced and added to the cost for the basic cartridge before averages were taken.
Some cartridge prices were unavailable, for instance, §721.63(a)(5)(ix) and (x) require a powered air-purifying respirator (PAPR) with a paint, lacquer and enamel cartridge. The only cartridges available for these models of respirators are HEPA cartridges. In these cases the costs of a paint, lacquer, and enamel cartridge are assumed to be the same as for a HEPA cartridge.
The 2014 purchase costs of the varying types of respiratory protective equipment are shown in Table C-12.

Table C-12. Respirator Prices and Average Costs in 2014, by NIOSH Type
                                     40CFR
                                  NIOSH Type

                             2014 Average Cost[2]
                                §721.63 (a)(5)

                                  Item Number
                           Respirator Description[1]
                                   2014 Cost
                                  Item Number
                        Filter/Cartridge Description[1]
                                   2014 Cost
                                Respirator Unit
                                 Cartridge Set
                                      (i)
                  19C Type C Supplied-air with full facepiece
                                    $1,857
                                      --

11W028
3M: Supplied Air Kit, Belt-Mounted
                                    $1,323

22RP31
SPERIAN: Supplied Air Respirators
                                    $2,390

                                     (ii)
             19C Type C Supplied-air with tight-fitting facepiece
                                    $1,857
                                      --

11W028
3M: Supplied Air Kit, Belt-Mounted
                                    $1,323

22RP31
SPERIAN: Supplied Air Respirators
                                    $2,390

                                     (iii)
    19C Type C Supplied-air with hood or helmet or tight-fitting facepiece
                                    $2,343
                                      --

2V152
SPEEDGLAS: Supplied Air System, PPA Hood
                                    $2,093

23UA35
ALLEGRO: Supplied Air System
                                    $2,593

                                     (iv)
21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)
                                     $258
                                    $8.57

4JG19
3M: Low Maintenance Full Face Respirator, Silicone/Thermoplastic Elastomer Facepiece
                                                                           $232
3PB42
3M P100 Filters for Half and Full Face Respirator
                                                                          $6.90

5WZA2
3M Ultimate FX Respirator
                                                                           $340

3A183
North by Honeywell: Full Face Respirator, Silicone Facepiece
                                                                           $384
T451
North by Honeywell: Filter, Magenta
                                                                          $9.05

5VD41
North by Honeywell: Low Maintenance Full Face Respirator, Thermoplastic Elastomer Facepiece
                                                                           $194

5HB59
Honeywell: Full Face Respirator, Silicone Facepiece. 5 point, Bayonet
                                                                           $165
3NVJ9
Honeywell: Bayonet Filter, P100
                                                                          $9.95

3NVJ2
Honeywell: Full Face Respirator, Silicone Facepiece, 5 point Bayonet with Mesh
                                                                           $276

3NVT7
Honeywell: Full Face Respirator, Silicone Facepiece, 5 point, Threaded
                                                                           $180
3NVL3
Honeywell: Threaded Filter, P100
                                                                          $8.11

3NVT4
Honeywell: Full Face Respirator, Silicone Facepiece, 5 point Threaded with Mesh
                                                                           $269

3PPP3
MSA: Full Face Respirator, Silicone Facepiece 4 point, Bayonet
                                                                           $226
LN08
MSA: Bayonet Magenta Filter
                                                                          $5.95

3PB94
MSA: Full Face Respirator, Silicone Facepiece European Style 4 point, Bayonet
                                                                           $200

4LR28
MSA: Full Face Respirator, Silicone Facepiece European Style  5 point threaded
                                                                           $372
4LR74
MSA: Threaded Magenta Filter
                                                                         $11.44

                                      (v)
    21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs
                                    $1,086
                                    $28.00

8EM74
3M: PAPR System, L, Rechargeable NiMH
                                                                         $1,010
9W546
3M: PAPR HEPA Cartridge for 3M PAPR Systems
                                                                         $32.29

9CRJ8
3M: PAPR System, M, Rechargeable NiMH
                                                                           $954

5JGF6
MSA: PAPR System, 4 Point Suspension
                                                                         $1,446
2YRD2
MSA:PAPR HEPA Cartridge for MSA TL PAPR
                                                                         $23.93

5KB69
MSA: PAPR System, 5 Point Suspension
                                                                           $933

                                     (vi)
                 21C PAPR with loose hood or helmet and HEPAs
                                    $2,497
                                    $55.35

11W052
3M: PAPR System, Belt-Mounted, PETG, with hood
                                                                         $2,144
9W546
3M:PAPR HEPA Cartridge for 3M PAPR Systems
$32.29

11W053
3M: PAPR System, Li-Ion, Polycarbonate, with helmet
                                                                         $2,838

32HD65
ALLEGRO: Pureflo PAPR White Helmet/Hood HE Filter
                                                                        $3,036
32HD72
 ALLEGRO: Pureflo HE (HEPA) Filter
$104

16M251,16M257,16M249
North by Honeywell: PAPR System Backpack +
Hood+
Breathing Tube
                                                                         $2,248
1AAN4
North by Honeywell: Magenta
$29.75

16M250,16M257,16M249
North by Honeywell: PAPR System Belted +
Hood+
Breathing Tube
                                                                         $2,218

                                     (vii)
            21C Air-purifying with HEPA and disposable respirators
                                    $29.50
                                    $6.38

8CCM3
3M 6000 Series Low-Maintenance Respirator
                                                                        $29.50
5WYZ4
3M: Disk Filter P100
                                                                         $6.38

                                    (viii)
23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE)
                                     $252
                                    $18.34

4JG19
3M: Low Maintenance Full Face Respirator, Silicone/Thermoplastic Elastomer Facepiece
                                                                           $232
3PB42
3M: Black/Magenta Cartridge for Half and Full Face Respirator
                                                                       $19.88

5WZA2
3M Ultimate FX Respirator
                                                                           $340

3A183
North by Honeywell: Full Face Respirator, Silicone Facepiece
                                                                           $384
4JG10
North by Honeywell: Black/Magenta Cartridge
                                                                         $18.25

5VD41
North by Honeywell: Low Maintenance Full Face Respirator, Thermoplastic Elastomer Facepiece
                                                                           $194

4EU80
Honeywell: Combination Cartridge, Bayonet
                                                                       $19.20

5HB59
Honeywell: Full Face Respirator, Silicone Facepiece. 5 point, Bayonet
                                                                           $165

3NVJ2
Honeywell: Full Face Respirator, Silicone Facepiece. 5 point mesh
                                                                           $276

3NVT7
Honeywell: Full Face Respirator, Silicone Facepiece. 5 point threaded
                                                                           $180
3NVN9
Honeywell: Combination Cartridge, Threaded
                                                                       $18.29

3NVT4
Honeywell: Full Face Respirator, Silicone Facepiece. 5 point mesh, threaded
                                                                           $269

3PPP3
MSA: Full Face Respirator, Silicone Facepiece 4 point, Bayonet
                                                                           $226
4LN01
MSA: Combination Cartridge Bayonet
                                                                         $15.13

3PB94
MSA: Full Face Respirator, Silicone Facepiece European Style 4 point, Bayonet
                                                                           $200

4LR28
MSA: Full Face Respirator, Silicone Facepiece European Style  5 point threaded
                                                                           $372
4MG01
MSA: Combination Cartridge, Threaded
                                                                         $19.31

                                     (ix)
 23C PAPR with tight-fitting facepiece and combination cartridges approved PLE
                                    $1,086
                                     $116

8EM74
3M: PAPR System, L, Rechargeable NiMH
                                                                         $1,010
5F793
3M: PAPR OV, HEPA Filter
$171

9CRJ8
3M: PAPR System, M, Rechargeable NiMH
                                                                           $954

5JGF6
MSA: PAPR System, 4 Point Suspension
                                                                         $1,446
3NNF7
MSA: PAPR Black/Magenta Filter
$60.17

5KB69
MSA: PAPR System, 5 Point Suspension
                                                                           $933

                                      (x)
 23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE
                                    $2,362
                                     $112

11W052
3M: PAPR System, Belt-Mounted, PETG, with hood
                                                                         $2,144
5F793
3M: PAPR OV, HEPA Filter
$171

11W053
3M: PAPR System, Li-Ion, Polycarbonate, with helmet
                                                                         $2,838

16M251,16M257,16M249
North by Honeywell PAPR System Backpack +
Hood+
 Breathing Tube
                                                                         $2,248
1AAN4
North by Honeywell: Black and Magenta
$53.75

16M250,16M257,16M249
North by Honeywell PAPR System Belted +
Hood+
Breathing Tube
                                                                         $2,218

                                     (xi)
23C Air-purifying with combination cartridges for PLE, including disposable respirators
                                    $29.50
                                    $8.16

8CCM3
3M 6000 Series Low-Maintenance Respirator
                                                                        $29.50
                                     5WYZ4
                             3M: Disk Filter P100
                                    $8.16

                                    (xii)
    23C Air-purifying with full-facepiece and organic gas/vapor cartridges
                                     $258
                                    $8.97

4JG19
3M: Low Maintenance Full Face Respirator, Silicone/Thermoplastic Elastomer Facepiece
$232
6AM37
3M OV Filters for Half and Full Face Respirator
                                                                          $8.05

5WZA2
3M Ultimate FX Respirator
$340

3A183
North by Honeywell: Full Face Respirator, Silicone Facepiece
$384
16M237
North by Honeywell: Respirator Cartridge, Black
                                                                          $9.51

5VD41
North by Honeywell: Low Maintenance Full Face Respirator, Thermoplastic Elastomer Facepiece
$194

5HB59
Honeywell: Full Face Respirator, Silicone Facepiece. 5 point, Bayonet
$165
4EU73
Honeywell: OV Chemical Cartridge, Bayonet
                                                                          $9.52

3NVJ2
Honeywell: Full Face Respirator, Silicone Facepiece, 5 point Bayonet with Mesh
$276

3NVT7
Honeywell: Full Face Respirator, Silicone Facepiece, 5 point, Threaded
$180
4EU73
Honeywell: OV Chemical Cartridge, Threaded , Bayonet
                                                                          $9.25

3NVT4
Honeywell: Full Face Respirator, Silicone Facepiece, 5 point Threaded with Mesh
$269

3PPP3
MSA: Full Face Respirator, Silicone Facepiece 4 point, Bayonet
$226
4LM93
MSA: Black Chemical Cartridge
                                                                          $7.81

3PB94
MSA: Full Face Respirator, Silicone Facepiece European Style 4 point, Bayonet
$200

4LR28
MSA: Full Face Respirator, Silicone Facepiece European Styl 5 point threaded
$372
4LR57
MSA: Black Chemical Cartridge, Threaded
                                                                          $9.71

                                    (xiii)
    23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges
                                    $1,086
                                     $95

8EM74
3M: PAPR System, L, Rechargeable NiMH
                                    $1,010
5F789
3M: PAPR Black  Cartridge for 3M PAPR Systems
                                                                           $130

9CRJ8
3M: PAPR System, M, Rechargeable NiMH
                                     $954

5JGF6
MSA: PAPR System, 4 Point Suspension
                                    $1,446
3NNF7
MSA: PAPR Black/Magenta Filter
                                                                         $60.17

5KB69
MSA: PAPR System, 5 Point Suspension
                                     $933

                                    (xiv)
 23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges
                                    $2,362
                                    $87.23

11W052
3M: PAPR System, Belt-Mounted, PETG, with hood
                                    $2,144
5F789
3M: PAPR Black Cartridge for 3M PAPR Systems
                                     $130

11W053
3M: PAPR System, Li-Ion, Polycarbonate, with helmet
                                    $2,838

16M251,16M257,16M249
North by Honeywell PAPR System Backpack +
Hood+
 Breathing Tube
                                    $2,248
                                     1AAN4
North by Honeywell: Black Cartidge
                                    $44.45

16M250,16M257,16M249
North by Honeywell PAPR System Belted +
Hood+
Breathing Tube
                                    $2,218

                                     (xv)
23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges
                                    $29.50
                                     $6.38

8CCM3
3M 6000 Series Low-Maintenance Respirator
                                    $29.50
                                     5WYZ4
3M: OV Filter[4]
                                    $6.38

Notes:
1 See Table C-10 for the cross-walk between respirator types in the SNUR and in this table.
2 Average costs presented in this table are rounded to the nearest dollar figure, so results may differ from calculations using the rounded values shown in this table.
3 Paint, lacquer and enamel (PLE) cartridges for PAPRs were not listed in the catalog. The costs for PLE cartridges are assumed to be the same as combination HEPA and OV cartridges, as both particulate and vapor filters are recommended for paints (US Safety, 2011).
[4] Organic Vapor cartridges were not listed in the catalog for disposable respirators. The costs for OV cartridges are assumed to be the same as HEPA cartridges.
Sources:
Grainger, 2014; EPAB 1999

Recordkeeping
There are two main types of recordkeeping requirements for the substances listed in the current SNURs: those for companies submitting a SNUN, and those for all companies that manufacture, import or process SNUR-regulated substances, regardless of whether they have made a submission to EPA.
SNUN Submitters
Companies submitting a SNUN must keep records under 40 CFR §721.40. Some EPA reports have assumed that SNUN recordkeeping hours would be 5 percent of SNUN submission hours, or about five to six hours. Other EPA reports have estimated that electronic submission of SNUNs is expected to reduce the recordkeeping burden to approximately one hour (EPA, 2009a, p. 16) For this report, the SNUN recordkeeping hours were included in the SNUN submission hours (see Table 8) and the SNUN recordkeeping cost was not separately estimated.
All Manufacturers and Processors
Whether or not they submit a SNUN, firms that manufacture, import, or process the SNUR substance must keep records based on 40 CFR §721.125(a) through (k), to document compliance with SNUR conditions for avoiding a Significant New Use. (For firms producing under the R&D exemption, R&D recordkeeping would be needed. R&D recordkeeping costs were not estimated for this report.)
Recordkeeping requirements vary between PMN chemicals, reflecting differences in SNUR restrictions. For all chemicals in the current SNURs, manufacturers, importers, and processors must keep records on quantities supplied or purchased under 40 CFR §721.125(a), (b), and (c). For chemicals with water discharge restrictions, companies must keep records concerning water discharge compliance, under §721.125(k). For chemicals with other use restrictions, or for those few chemicals with workplace protection or hazard communication restrictions, companies must keep records under other 40CFR §721.125 paragraphs, to document compliance.
The 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. Therefore, EPA expects that records supporting TSCA section 5 submissions, including SNUNs, will be created and stored electronically, including records related to: manufacturing, importing, or processing volumes; shipment amounts and customer information; clothing impermeability determinations; the hazard communication program including labels and MSDS copies; compliance with other use restrictions; and/or compliance with disposal and release to water limitations. Records must be maintained for five years from the date of their creation.

Costs for compliance with the recordkeeping requirements for substances subject to a SNUR are based on the approach in Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Followup (EPA, 1989) which in turn was based on Recordkeeping Costs for a Generic SNUR, prepared for EPA in 1988 by Kearney/Centaur (Kearney, 1988a). These reports drew on recordkeeping costs estimated for the Comprehensive Assessment Information Rule, CAIR. Industry recordkeeping costs for CAIR compliance were estimated in reports Kearney prepared for EPA, including Estimated Cost of the Final Comprehensive Assessment Information Rule, June 1, 1988 (Kearney, 1988b, pages 63 to 65). To account for the burden reductions resulting from for electronic reporting, these recordkeeping costs were updated using the approach outlined in The Economic Analysis of the Premanufacture Notification Electronic Reporting Rule (EPA, 2009a).
This report uses the basic Kearney (1988a and 1988b) estimates and assumptions to estimate recordkeeping costs for SNUR requirements and adjusts for efficiencies and costs savings generated by electronic submissions. Unlike Kearney (1988a), this report presents costs for each §721.125 recordkeeping requirement separately. This report also avoids minor rounding errors by calculating from unrounded data. However, the underlying methodology is identical to the Kearney 1988a/RIB 1989 reports, resulting in identical costs per chemical except for differences due to inflation and rounding. The paragraphs that follow describe estimates and assumptions used from Kearney (1988a and 1988b).
Cost per page. Kearney (1988a) based recordkeeping costs on a cost per page basis and assumes that the ratios of labor hours to page count for each labor category, file drawer space to page count, and cost of miscellaneous supplies such as folders and labels to page count, are the same as the per-page ratios estimated for EPA's Comprehensive Assessment and Reporting Rule. The CAIR estimates are given in the 1988 report, Estimated Cost of the Final Comprehensive Assessment Information Rule, June 1, 1988, page 65 (Kearney, 1988b). EPA (2009a) assumes that the recordkeeping burden for SNURs will be reduced by half because of the efficiencies in creating and storing section 5 notices and supporting documents electronically. Therefore the per-page labor burden estimates from the CAIR report (Kearney, 1988b) have been reduced by half. In addition, all material costs associated with paper records, such as paper, and, filing cabinets have been removed, as files will now be stored electronically.

Table C-13 summarizes estimates from Kearney 1988a and the CAIR report (Kearney, 1988b) and adjusts for electronic reporting.. It also shows the derivation of costs from these estimates, after inflation. The method is as follows:
 Technical labor was estimated at 1 hour for 750 pages in the CAIR report (Kearney, 1988b, page 65), or .00133 hours per page. Adjusting for electronic submissions this burden is now .00067 hours per page. The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B-1.
 Clerical labor was estimated at 10 hours for 750 pages in the CAIR report (Kearney, 1988b, page 65), or .01333 hours per page. Adjusting for electronic submissions this burden is now .00667 hours per page. The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B-1.
 The photocopying cost of $0.05 per page (Kearney 1988a), file storage costs of $0.065 per page, and miscellaneous materials costs of $0.0133 (Kearney, 1988b, page 65) were removed to account for the cost savings from keeping electronic files. . It should be noted that none of the costs listed above account for inflation
Table C-13. Recordkeeping Estimates from Kearney 1988a and 1988b
                                  Labor Costs
                  Kearney Estimates for CAIR Rule (1988a, b)
                            Adjusted for Inflation
                             Per Page Cost - 2015$

                                   Estimate
                               ePMN Cost Savings
                                  CAIR Pages
                                 Cost Per Page
                                Cost Per Hour
                                 Cost Per Page

                                      (a)
                                      (b)
                                      (c)
                           (d) = [(a) *(1-(b))]/(c)

Labor Costs
                                   Technical
                                    1 hour
                                      50%
                                      750
                                    0.00067
                                    $75.89
                                    $0.0506
                                   Clerical
                                   10 hours
                                      50%
                                      750
                                    0.00667
                                    $33.66
                                    $0.2244
                                                                    Total Labor

                                 0.00733 hours

                                    $0.2750
Material Costs
                                 Photocopying
                             $0.05 [1988 dollars]
                                     100%
                                       1
                                     $0.00

                                     $0.00
                                 File Cabinet
                 1/4 of cabinet priced at $195 [1997 dollars]
                                     100%
                                      750
                                     $0.00

                                     $0.00
                                Misc. Materials
                           $10 total [1988 dollars]
                                     100%
                                      750
                                     $0.00

                                     $0.00
                                Total Materials

                                     $0.00
                                    Total Cost per Page (Labor & Materials)
                                    $0.2750
Notes:
[1]Per-page labor hours and materials costs were originally estimated in Kearney 1988b for the CAIR rule. The CAIR per-page costs were then used to estimate SNUR recordkeeping per-page costs in Kearney 1988a, and adjusted for the burden reductions from electronic reporting using the approach outlined in EPA, 2009a. This clarifies the method by which the original CAIR per-page costs and hours were calculated. It also adjusts costs for inflation using labor rates from Table B-1 and inflation factors from Table B-3.
[2]Cost per page is $0 because paper copies are no longer kept.

Pages per chemical at one site. In order to estimate recordkeeping costs, the analysis multiplies the costs per page for each recordkeeping element estimated in Table C-13 by the number of pages required for each SNUR recordkeeping requirement at 40 CFR §721.125 as estimated by Kearney (1998a). The Kearney data was used by EPA in its original expedited-SNUR economic analysis (EPA, 1989). For example, maintaining MSDS copies as required at §721.125(h) would require 5 pages. The following estimates from Kearney (1988a) are also used:
 Manufacture and import volume, and sales and transfer data require 485 pages of records per year. This reflects 40 invoices per month (see haz-comm Section C.1 above), 480 for sales/transfer and 5 for manufacturer/import (Kearney, 1988a, p.11).
 Disposal compliance records, if required, cover items such as waste production, shipping manifests, permits, and transfer receipts. The 600 disposal compliance pages assume 50 pages per month (Kearney, 1988a, p.11).
(This report uses slightly different terminology from EPA, 1989: "Protective clothing" instead of "protective gloves," "haz-comm" instead of "employee information and training." Recordkeeping for "impermeability determination" was not separately costed out in EPA, 1989. This report assumes it is included under "protective clothing" recordkeeping.)
Cost per chemical. Table C-14 shows annual recordkeeping activities at one site for one SNUR chemical, by CFR requirement. If all recordkeeping requirements at 40 CFR §721.125 applied to a single chemical, there would be costs for 1.1 hours of technical time and 11.4 hours of clerical time. However, in reality, few if any chemicals will have all of the recordkeeping requirements listed in Table C-14. Recordkeeping costs would be lower for chemicals with relatively few SNUR restrictions because fewer pages would be needed to document SNUR compliance.
Table C-14 does not include costs of recordkeeping resulting from a SNUN submission; those costs were included in the SNUN submission cost.
Table C-14. Annual Per-Chemical Costs of Recordkeeping Requirement [40 CFR 721.125]
                              40CFR §721.125[2]
                                  Requirement
                                     Pages
                                      (a)
                          Labor and Materials Cost[1]
                                    (2015$)
                                     Hours

                                   Per Page
                                      (b)
                           Per Chemical (c)=(a)*(b)
                                 Per Page
 (d)
                           Per Chemical (e)=(a)*(d)
                                   (a)(b)(c)
                       Volumes & sales/transfer data
                                      485
                                    $0.2750
                                     $133
                                    0.00733
                                     3.56
                                    (d)(e)
      Protective clothing [§721.63] and impermeability [§721.63(a)(3)]
                                      20
                                    $0.2750
                                    $5.50
                                    0.00733
                                     0.15
                                      (f)
                          Haz-comm program [§721.72]
                                      250
                                    $0.2750
                                     $69
                                    0.00733
                                     1.83
                                      (g)
                          Label copies [§721.72(b)]
                                       5
                                    $0.2750
                                    $1.38
                                    0.00733
                                     0.04
                                      (h)
                           MSDS copies [§721.72(c)]
                                       5
                                    $0.2750
                                    $1.38
                                    0.00733
                                     0.04
                                      (i)
                     Use limitations compliance [§721.80]
                                      250
                                    $0.2750
                                     $69
                                    0.00733
                                     1.83
                                      (j)
                        Disposal compliance [§721.80]
                                      600
                                    $0.2750
                                     $165
                                    0.00733
                                     4.40
                                      (k)
                          Release to water compliance
                                  [§721.90]
                                      100
                                    $0.2750
                                    $27.50
                                    0.00733
                                     0.73
                                     TOTAL
                                     1,715
                                    $0.2750
                                     $472
                                    0.00733
                                     12.58
Notes:
1 This table multiplies cost per page estimates from Table C-13 by the number of pages estimated for each recordkeeping cost element. (This table does not include recordkeeping for SNUN submissions required by 40 CFR §721.40.)  Total costs are calculated from unrounded values and may not equal the sum and/or product of rounded values.
2 40 CFR 721.125(a) through (k) list recordkeeping that may be specified in the SNUR. The recordkeeping specified depends on which 40 CFR §721 provisions [in brackets] were used by the SNUR to define reportable New Uses (§721.63, §721.72, §721.80, and/or §721.90). Few if any SNUR chemicals would require all of the recordkeeping costs listed above since few if any chemicals are subject to all of the requirements (a) through (k).
3 Pages count estimates for each SNUR requirement are from Kearney, 1988a.

Costs of Testing
EPA recognizes that TSCA Section 5 does not require developing any particular test data before submission of a Significant New Use Notice. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them. (Upon review of a SNUN, the Agency has the authority to require appropriate testing, but that is a cost of regulatory follow-up, not of the SNUN submission itself.) For informational purposes, the SNURs describe tests recommended by EPA to provide sufficient information to evaluate the chemical substance. However, as was explained in the discussion of SNUNs earlier in this report, it appears that firms rarely elect to do these recommended tests to support a SNUN, and especially not the higher-cost tests. For informational purposes, this appendix presents estimated costs for testing often recommended for chemicals that have been the subject of PMNs and are subject to Significant New Use Rules (SNURs).
Testing Guidelines
In the SNURs, EPA identifies a set of tests for each PMN chemical that can be used by firms making Significant New Use Notice or other submissions to EPA to characterize risks of the chemical. The tests are recommended in the SNUR, not mandatory. They are identified by guideline numbers which can be used to look up published test protocols. Table D-1 lists test guidelines cited in the current and recent SNUR rulemakings, and their associated costs, Table D-2 presents certain assumptions used in the analysis, and Table D-3 presents Persistent Bioaccumulative Toxic (PBT) tiered testing requirements. The types of guidelines are described below.
OPPTS Harmonized Test Guidelines
Most SNUR tests are identified by their OPPTS number from the series of OPPTS Harmonized Test Guidelines and OPPTS harmonized public drafts not yet promulgated as OPPTS guidelines. These guidelines blended testing guidance from OPPT (published in the Code of Federal Regulations), EPA's Office of Pesticide Programs, the Organization for Economic Cooperation and Development (OECD), and other sources. The harmonized guidelines fall into several categories, including the following:
 Series 835--Fate, Transport and Transformation Test Guidelines
 Series 850--Ecological Effects Test Guidelines
 Series 870--Health Effects Test Guidelines
They are available electronically on EPA's website (EPA, 2006). Cross-references for health effects guidelines are listed at 63 FR 41847, August 5, 1998.
Code of Federal Regulations
SNUR tests may also come from the Code of Federal Regulations (CFR), identified for example as "40 CFR 799.9370" or just "799.9370." In addition, in costing out test guidelines, this report sometimes uses costs for a CFR guideline when costs have not been developed for the equivalent OPPTS harmonized guideline. 40 CFR parts 795 through 798 include pre-harmonization test guidelines, typically updated before 1990. 40 CFR part 799 includes more recent TSCA test guidelines, based on harmonized test guidelines. (63 FR 41845, August 5, 1998).
OECD
A few SNUR tests are identified by their OECD number. The OECD guidelines may have OPPTS equivalents. For example, OECD 407 28-Day Oral Toxicity in Rats is essentially equivalent to OPPTS 870.3050.
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
For some nanomaterials SNUR tests may refer to OECD's Guidance Manual for the Testing of Manufactured Nanomaterials. Because of the newness of nanomaterial testing tests may not have protocol numbers, but rather refer to the guidelines described in the manual.
PBT Category
For some chemicals, the SNUR cites tiered testing according to a testing strategy published in the Federal Register (FR), Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999 (64 FR 60194), which in turn refers to a number of tests by OPPTS or OECD guideline number.
ASTM, NTIS, and Other Sources
Test guidelines may also come from the American Society for Testing and Materials (for example, ASTM D2035-80 Modified Coagulation-flocculation Jar Test of Water) (www.astm.org) or other sources. The guideline for a neurotoxicity functional observational battery, NTIS PB 91-154617, is available from the National Technical Information Service (www.ntis.gov).

Table D-1. Cost Estimates for Test Guidelines Cited in SNURs
                                   Guideline
                                     Test
                                    Species
                                 Route/Method
                                     Cost
                                    2015$
Product Properties

830.6315
Flammability
                                      NA
                                      NA
                                    $2,490
830.7050
Absorption in Aqueous Solution: ultraviolet/visible spectra
                                      NA
                                      NA
                                    $2,517
830.7200
Melting Point / Melting Range
                                      NA
                                8-test average
                                    $1,494
830.7550
Partition Coefficient (n-Octanol/Water)
                                      NA
                              Shake Flask Method
                                    $7,807
830.7560
Partition Coefficient (n-Oct/Water)
                                      NA
                               Generator Column
                                    $8,298
830.7570
Partition Coefficient (n-Oct/Water)
                                      NA
                             Liquid Chromatography
                                    $5,461
830.7840
Water Solubility
                                      NA
                                 Flask Method
                                    $11,283
830.7860 (796.1860)[x]
Water Solubility: Column Generator Method
                                      NA
                               Generator Column
                                    $23,815
Described EPA Consent Order
Atmospheric Half Life Test
                                      NA
                                      NA
                                       *
Karel Vershueren Handbook, odor and taste test
Odor and taste test (in Handbook of Environmental Data on Organic Chemicals, by Karel Vershueren, 4th Ed, Vol. 1, Page 22)
                                      NA
                                      NA
                                    $2,490
Fate, Transport, Transformation

835.1110
Activated Sludge Sorption Isotherm
                                      NA
                                      NA
                                    $21,817
835.1220
Sediment and Soil Adsorption/Desorption Isotherm
                                      NA
                                      NA
                                    $33,462
835.1230
Sediment and Soil Adsorption/Desorption (batch equilibrium)
                                      NA
                                      NA
                                    $47,254
835.1240
Leaching and adsorption/desorption
                                      NA
                                      NA
                                    $62,141
835.2110
Hydrolysis as a Function of pH
                                      NA
                                      NA
                                    $65,744
835.2120
Hydrolysis test
                                      NA
                                      NA
                                    $46,366
835.2130
Hydrolysis as a Function of pH and Temperature
                                      NA
                                      NA
                                       *
835.2210 (796.3700)
Photolysis in Aqueous Solution in Sunlight
                                      NA
                                      NA
                                   $131,513
835.3100 (796.3100)
Aerobic Aquatic Biodegradation
                                      NA
                                      NA
                                    $18,054
835.3110
Ready Biodegradation
                                      NA
                            Average of six methods
                                    $14,106
835.3120
Sealed-Vessel CO2 Production Test
                                      NA
                                      NA
                                    $8,748
835.3140
CO2 in Sealed Vessels Test
                                      NA
                                      NA
                                       *
835.3170
Shake Flask Die-Away Test
                                      NA
                                      NA
                                    $57,522
835.3180
Sediment/Water Microcosm Biodegradation
                                      NA
                                 Flow-through
                                   $145,288
835.3190
Aerobic Mineralization in Surface Water  -  Simulation Biodegradation Test
                                      NA
                                      NA
                                       *
835.3200
(OECD 302B)
Inherent Biodegradation: Modified Zahn-Wellens
                                      NA
                                      NA
                                    $11,431
835.3210
Modified SCAS Test
                                      NA
                                      NA
                                    $33,685
835.3220
Porous Pot Test
                                      NA
                                      NA
                                    $36,484
835.3400
Anaerobic Biodegradability of Organic Chemicals
                                      NA
                                      NA
                                    $13,886
835.5045 (OECD 302A)
Inherent Biodegradability: Modified SCAS Test
                                      NA
                                      NA
                                    $16,045
835.5270 (795.7000)
Sunlight Photolysis in Waters Containing Dissolved Humic Substances (Indirect Photolysis Screening Test)
                                      NA
                                      NA
                                    $27,739
D2035-80 (ASTM D 2035-80)
Standard Practice for Coagulation-Flocculation Jar Test of Water
                                      NA
                                      NA
                                    $4,791
OECD 303A
Simulation Test - Aerobic Sewage Treatment, with measurement of loss of the parent
                                      NA
                                      NA
                                    $48,248
OECD 307
Aerobic and Anaerobic Transformation in Soil
                                      NA
                                 Flow-through
                                   $316,402
OECD 307
Aerobic and Anaerobic Transformation in Soil
                                      NA
                             Bio-meter type flasks
                                   $299,093
OECD 308
Anaerobic transformation in aquatic sediment systems
                                      NA
                                      NA
                                       *
OECD 309
Aerobic mineralisation in surface water
                                      NA
                                      NA
                                       *
OECD 310
Ready biodegradability-CO2 in Sealed Vessels (headspace test)
                                      NA
                                      NA
                                       *
OECD 311 (835.3400)
Anaerobic biodegradability of organic compounds in digested sludge
                                      NA
                                      NA
                                       *
OECD TG 310
CO2 in Sealed Vessels  -  Headspace Test
                                      NA
                                      NA
                                       *
Draft OECD Jan 2002
Phototransformation of chemicals on soil surfaces-2 soils
                                      NA
                                      NA
                                    $48,248
Ecological Effects

850.1000
Special Considerations for Conducting Aquatic Laboratory Studies
                                      NA
                                      NA
                                       *
850.1010 (797.1300)
Daphnid Acute Toxicity
                                    Daphnid
                                 Flow-through
                                    $16,908
850.1010 (797.1300)
Daphnid Acute Toxicity
                                    Daphnid
                                    Static
                                    $16,684
850.1075 (797.1400)
Fish Acute Toxicity
                                Fathead Minnow
                                 Flow-through
                                    $23,301
850.1075 (797.1400)
Fish Acute Toxicity
                                      NA
                                    Static
                                    $18,872
850.1085
Fish Acute Toxicity Test mitigated by humic acid
                                Fathead Minnow
                                 Flow-through
                                       *
850.1085
Fish Acute Toxicity Test mitigated by humic acid
                                Fathead Minnow
                                    Static
                                    $19,672
850.1300
Daphnid Chronic Toxicity Test
                                    Daphnid
                                 Flow-through
                                   $151,441
850.1350
Mysid Chronic Toxicity Test
                                     Mysid
                                 Flow-through
                                    $49,708
850.1400
Fish Early Life Stage Toxicity
                                 Rainbow Trout
                                 Flow-through
                                    $77,229
850.1400
Fish Early Life Stage Toxicity
                                Fathead Minnow
                                 Flow-through
                                    $52,209
850.1730
Fish BCF
                                Fathead Minnow
                                 Flow-through
                                   $168,958
850.1925
Site-Specific Aquatic Microcosm Test
                                      NA
                                      NA
                                       *
850.1950
Field testing for Aquatic Organisms[3]
                                      NA
                                      NA
                                   $751,335
850.5400
Algal Toxicity, Tiers I and II
                                      NA
                                      NA
                                   $20,431
850.5400
Shake-Flask Test for Estimation of Biodegradability of Toxic Organic Substances in the Aquatic Environment. Ecotoxicology and Environmental Safety 14:239-251 on P-08-513 utilizing a 96-Hour Bioassay in Algae
                                      NA
                                      NA
                                       *
OECD 218
Chironomid Sediment Toxicity
                                      NA
                                      NA
                                    $32,223
OECD 225
Effects on Sediment Species (Lumbriculus)
                                      NA
                                Spiked Sediment
                                    $32,317
Cripe, C.R., Walker, W.W., Pritchard, P.H., Borquin, A.W. (1987)
Modified Shake-Flask Biodegradation Test
                                      NA
                                      NA
                                       *
Health Effects

870.1100
Acute Oral Toxicity
                                     Rats
                                    Gavage
                                    $8,806
870.1300
Acute Inhalation Toxicity
                                    Rats[4]
                                  Inhalation
                                    $19,419
870.2500
Acute Dermal Irritation Test
                                    Rabbits
                                    Dermal
                                    $6,972
870.2600
Dermal Sensitization Test
                                  Guinea Pigs
                                      NA
                                    $13,369
870.3050
Repeated Dose 28-day Oral Toxicity Test
                                    Rodents
                                      NA
                                       *
870.3100
90-Day Oral Toxicity
                                     Rats
                                    Gavage
                                   $176,390
870.3250
Subchronic Dermal Toxicity - 90 days
                                     Rats
                                    Dermal
                                   $150,564
870.3465[1]
Subchronic Inhalation Toxicity
                                     Rats
                                  Inhalation
                                   $578,156
870.3465 (mod)
Subchronic Inhalation Toxicity (w/ 60 day recovery group)
                                     Rats
                                  Inhalation
                                   $275,790
870.3465 (OECD 413)[1]
Subchronic Inhalation Toxicity (90-day exposure/180-day retention)
                                     Rats
                                  Inhalation
                                   $481,850
870.3550
Reproductive/Developmental Toxicity Screening Test
                                      NA
                                     Oral
                                       *
870.3650
Combined repeated dose toxicity test with the reproductive/developmental screening test
                                     Rats
                                      NA
                                       *
870.3700
Prenatal Developmental Toxicity {2 species}
                                     Rats
                                    Gavage
                                   $133,895
870.3800
Reproduction/Fertility Effects (2-Generation Reproduction)
                                     Rats
                                    Gavage
                                   $445,721
870.4200
Carcinogenicity {2 species} (24 months)
                                     Rats
                                    Gavage
                                  $1,777,232
870.4200
Carcinogenicity {2 species}
                                     Rats
                                  Inhalation
                                  $1,410,397
870.4300
Combined Chronic Toxicity/Carcinogenicity Test
                                     Rats
                                    Gavage
                                  $1,357,430
870.5100
Bacterial reverse mutation test
                                      NA
                                 Direct plate
                                    $10,137
870.5265
Salmonella typhimurium Reverse Mutation Assay (Ames Test)
                                      NA
                   Average of direct plate and Azo reduction
                                    $14,630
870.5385
Mammalian Bone Marrow Chromosomal Aberration Test
                                     Rats
                                    Gavage
                                    $41,830
870.5395
In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings)
                                     Mice
                        Gavage (Average of 1 and 3 day)
                                    $24,811
870.5395
In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings)
                                     Mice
                        Intravenous (Two test average)
                                    $24,811
870.5550
Unscheduled DNA Synthesis in Mammalian Cells in Culture
                                Rat Hepatocytes
                                      NA
                                    $25,621
870.6100
Delayed Neurotoxicity of Organophosphorus Substances (Acute)
                                     Hens
                                Gavage (Acute)
                                    $43,804
870.6100
Delayed Neurotoxicity of Organophosphorus Substances (Subchronic 28-day)
                                     Hens
                              Gavage (Subchronic)
                                    $86,890
870.6200
Neurotoxicity Screening Battery (Acute)
                                     Rats
                                    Gavage
                                   $176,512
870.7485
Metabolism and Pharmacokinetics (Tier I)
                                     Rats
                                    Gavage
                                   $218,467
870.7800
Immunotoxicity
                                     Rats
                                    Gavage
                                    $74,995
ASTM F739 -91 (ASTM F739)[2]
Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact
                                      NA
                          Average (Gases and Liquids)
                                    $16,394
OECD 105
Water Solubility Test
                                      NA
                                 Flask Method
                                    $7,926
OECD 112
Dissociation Constant in Water Test
                                      NA
                             Conductometric Method
                                    $6,945
OECD 206
Avian Reproduction Test
                                Bobwhite Quail
                                      NA
                                   $114,805
OECD 206
Avian Reproduction Test
                                 Mallard Ducks
                                      NA
                                   $124,146
OECD 303A
Simulation Test - Aerobic Sewage Treatment: Activated Sludge Units
                                      NA
                                      NA
                                    $48,248
OECD 307
Aerobic and Anaerobic Transformation in Soil Test
                                      NA
                                 Flow Through
                                   $316,402
OECD 307
Aerobic and Anaerobic Transformation in Soil Test
                                      NA
                             Bio-meter Type Flasks
                                   $316,402
OECD 308
Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Test
                                      NA
                                      NA
                                       *
OECD 311
Anaerobic Biodegradability of Organic Compounds in Digested Sludge Test
                                      NA
                                      NA
                                       *
OECD 314
Simulation Test to Assess the Biodegradability of Chemicals Discharged  in Wastewater
                                      NA
                                      NA
                                       *
OECD 404 (870.2500)
Acute Dermal Irritation
                                    Rabbits
                                    Dermal
                                    $6,972
OECD 405 (870.2400)
Acute Eye Irritation
                                    Rabbits
                                      Eye
                                    $6,972
OECD 407 (870.3050)
Repeated dose 28-day oral toxicity study in rodents
                                     Rats
                               Gavage (28 Days)
                                    $65,035
OECD 412
Repeated Dose Inhalation Toxicity (28-Day Study)
                                     Rats
                             Inhalation (28 Days)
                                   $145,610
OECD 416
Two-Generation Reproduction Toxicity Test
                                     Rats
                                    Dietary
                                   $479,879
OECD 421 (870.3550)
Reproduction/developmental toxicity screening tests
                                     Rats
                                    Gavage
                                    $76,281
OECD 422 (870.3650)
Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen
                                     Rats
                                    Gavage
                                   $152,052
OECD 422 (mod)
Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen (90 days w/ histopathology)
                                     Rats
                                    Gavage
                                   $285,872
OECD 425
Acute Oral toxicity: Up-and-down Procedure
                                     Rats
                                    Gavage
                                    $6,735
OECD 428
Skin Absorption: In Vitro Method
                                      NA
                                      NA
                                       *
OECD 453
Combined Chronic Toxicity/Carcinogenicity Test
                                     Rats
                                  Inhalation
                                  $3,987,297
ASTM D6007-02
Small Scale Chamber Test to Determining Formaldehyde Concentration in Air from Wood Products
                                      NA
                                      NA
                                       *
EPA draft
Inhalation Monitoring Data Collection Guidelines
                                      NA
                                      NA
                                       *
Described in EPA Consent Order
Information to Address Cardiac Sensitization
                                      NA
                                      NA
                                       *
Endocrine Disruptor Screening Program Tests
890.1200
Aromatase (human recombinant) test
                                      NA
                                      NA
                                       *
OCSPP 890.1550 (OECD 456)
Steriodogenesis (human cell line-H295R) test
                                      NA
                                      NA
                                       *
Nanomaterial Specific Tests[5, 6]
ASTM D2565-99(2008)
Release of MWCNTs after exposure of liquid polymer forms to sunlight:
                                      NA
Consult Standard Practice for Xenon-Arc Exposure of Plastics Intended for Outdoor Applications
                                       *
ASTM E1354-09
Release of MWCNTs during the burning of liquid polymer forms:
                                      NA
Consult Standard Test Method for Heat and Visible Smoke Release Rates for Materials and Products Using an Oxygen Consumption Calorimeter
                                       *
ASTM E2865-12
Standard Guide for Measurement of Electrophoretic Mobility and Zeta Potential of Nanosized Biological Materials
NA
Surface Charge by Electrophoresis
                                       *
EPA method 1320
Release of MWCNTs after landfill disposal:
                                      NA
Multiple Extraction Procedure to determine the fraction of MWCNTs released during the leaching that the liquid polymer forms will undergo from repetitive precipitation of acid rain
                                       *
NCL Method PCC-2
Measuring the Zeta Potential of Nanoparticles
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured  Nanomaterials
Dustiness Test
                                      NA
                                EN 15051 Method
                                    $2,841
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Dry particle size distribution by count for each PMN substance in a form which has the highest content of particles smaller than 10 microns as manufactured, processed or used in the workplace at sites controlled by the Company
                                      NA
            STEM (scanning transmission electron microscopy) method
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Surface chemistry
                                      NA
                           Average of Three Methods
                                     $669
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Configuration of Carbon Nanotube ends
                                      NA
                                      NA
                                     $829
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Release of MWCNTs during solid polymer form shipping and use
                                      NA
A simple short-term test consisting of placing the solid polymer forms in a standard rock tumbler and determining the amount of free MWCNTs after a period of l, 5, 15, and 30 days to screen for significant release of MWCNTs from the solid polymer forms.
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM C100 (>90% MWCNTs. < 7% aluminia and <5% of iron oxide)
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM U100 (>97% MWCNTs. <3% of iron oxide, 1% alumnia)
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CSI-015, a viscous resin (honey-like) comprised of 98.5% epoxy resin, 1,5% GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM PEB-201, a very highly viscous resin (tar-like paste) comprised of 64.3% polyester, 31.6% styrene, remainder GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CM1-20, a pellet comprised of 79% polyamide, 12.5% white mineral oil, remainder GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CM2-20 a pellet comprised of 78% polyamid resin, 22% GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CM3-20 a pellet comprised of 79% polyamid 11, 21% GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CM5-20 a pellet comprised of 60% polycarbonate, 20% flame retardant, 20% GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CM12-30, a pellet comprised of cyclic butylenes trephthalate (CBT), 30% GRAPHISTRENGTH C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM CM13-30, a pellet comprised of 65% polyacrylic-polyolefin, 15% acrlonitrile-butadiene copolymer, 20% GRAPHISTRENGTHTM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
GRAPHISTRENGTH TM C M6-20 a granule comprised of 80%polyamid6, 20% GRAPHISTRENGTH TM C100
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Workplace exposure monitoring and characterization testing (including byproducts)
                                      NA
                                      NA
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Certain material characterization data
                                      NA
                                      NA
                                       *
Notes:
* Indicates this cost has not been calculated for this report.
[+] Indicates that EPA, EPAB staff estimated this test cost in fall of 2009 and it is more recent that the other EPA, OPPTS EPAB test cost estimates presented in the table, the majority of which were estimated prior to 1990. [1] For some PMNs, recommended testing under guideline 870.3465 would involve an additional 3 month recovery group, as well as other evaluation beyond the standard requirements in the test guideline. These activities would raise testing cost substantially.
1 The recommended testing for some PMN chemicals may include a glove permeation test following ASTM F739 and F1194-99 guidelines. ASTM F1194-99 is a standard guide for documenting the results of chemical permeation tests (see www.astm.org). The additional costs of following ASTM F1194-99 (average of gases and liquids) were not estimated for this report.
2 Costs for field testing will be site-specific, with a wide range of actual costs. A report from EPA's Office of Pesticide Programs estimated an average test cost of $600,000 ($2008) for guideline 850.1950, for simulated or actual field testing for aquatic organisms (EPA, 2008a, Appendix C).
[3] Performing the test on species other than rats may change the test costs. For example, testing on rabbits is likely to increase costs.
[4] Fate, transport and transformation, ecological effects, and health effects testing may be required for nanomaterials, however nano-specific costs for these tests were not estimated for this report.
[5] While the Agency expects that analytical methodology validation costs may be more expensive for nanomaterials than for traditional chemicals, EPA was unable to gather any information on nanomaterial-specific analytical methodology validation and therefore uses the traditional chemical costs as a proxy.

Test Costs by Guideline
Table D-1 gives dollar cost for each test, based on assumptions and adjustments discussed below. This section describes the development of individual test costs.
EPA's Office of Pollution Prevention and Toxics, Economic and Analysis Branch, regularly develops cost estimates of test guidelines to support TSCA rule development. Estimates are based on assumptions about species, route of administration, study duration, and other aspects of methodology. Costs are calculated based on costs of labor, materials, and equipment needed to perform testing, with overhead and fee. Many of the test costs were developed in the 1990s. Test costs have been inflated using Employment Cost Index inflators from the Bureau of Labor Statistics (see Appendix B). However, generally they have not been updated to reflect subsequent changes in laboratory technologies.
Testing laboratories perform analytical method validation to ensure that proper dose concentrations are used in toxicity studies (EPA, 2005a, p. 3-9). This analysis assumes that for health effects tests (e.g. 870 series guidelines), tests of up to 90 days in duration have method validation costs of $3,500, and longer-term tests have validation costs of $8,500 in 2004 dollars. Using the inflation rates found in Appendix B, validation costs are $4,482 and $10,885 in 2015 dollars. For simplicity, the method validation cost for ecological effects tests (e.g. 850 series guidelines) was assumed to be $4,482 for each test. In addition, this analysis assumes that analytical method validation costs are the same for both nanomaterials and traditional chemicals.
In cases where costs have not been estimated for the specified guideline, EPA uses the cost from an approximately equivalent guideline (listed in Table D-1 and Table D-3 in parentheses). Many of these equivalents are listed in the Federal Register at 63 FR 41847, August 5, 1998. In some cases the test protocol itself states that it is essentially equivalent to another test upon which it was based. Sometimes judgment was needed to select the closest equivalent(s).
In some cases, EPA has not costed out the test for the species, route, duration, and/or other method listed in the SNUR, or the SNUR specifies a guideline but does not specify these details. In such cases, EPA has made the adjustments described below. The adjustments were selected based on discussions with EPA scientists and on SNUR language, published test guidelines, assumptions underlying the cost estimates in EPAB's test cost database, EPA review and Consent Order history for specific PMNs, or other sources.
Default Parameters
Costs for many of the guidelines have been estimated for different combinations of species, route, length of study and other aspects of methodology, but in some cases the SNUR may not specify all of these variables. Where this occurs, EPA has used certain default parameters, listed in Table D-2.

Table D-2.  Default Parameters for Species, Route, and Study Type
                                   Variable

                                    Default
Species
Mammals
Fish
Invertebrates
Algae
Rats
Fathead minnow[1]
Daphnids
[Four species -- see text]
Route/Method
Mammalian
Fish
Invertebrates
Gavage
Flow-through
Flow-through
Notes:
[1] For guideline 850.1400 tests also in PBT tier tests, rainbow trout is the default species. (See PBT discussion below.)
SNUR Testing Tiers
A SNUR may recommend tiered testing. In such cases, costs are lower if only the first-tier tests are performed, and higher if all tests listed for the chemical are performed. Testing is "tiered" if later tests are contingent on the results of earlier tests, and/or if some tests are contingent on the firm reaching a certain chemical volume or time limit. Some tiers are explicit in the SNUR text; others result because the SNUR references the tiered PBT Category testing described at 64 FR 60194.
Test Cost Assumptions and Comments
This section explains treatment of certain tests listed in this or past SNUR rulemakings.
 A SNUR may recommend algal acute toxicity testing according to OPPTS Guideline 850.5400. This guideline has been previously costed by EPA for four separate algal species (Navicula pelliculosa, Skeletonema costatum, Anabaena flos-aquae, and Selenastrum capricornutum). If a SNUR does not specify the algal species to be used, the average costs of the four algal species tests are used.
 For OPPTS test guideline 835.3100 (Aerobic Aquatic Biodegradation), a SNUR may call for an additional analytical methodology to identify the isononyl phenol degradation product, which may be a substantial add-on to the basic cost. Table D-1 gives costs for 835.3100 but not for the extended test.
 A SNUR may recommend a "modified" version of ASTM test guideline D2035-80 (Coagulation-Flocculation Jar Test of Water). Table D-1 gives costs for D2035-80 but not for the additional analytical methodology.
 For test guideline OECD 422 (Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening), a SNUR may recommend extended histopathology. Although the OECD 422 protocol does include histopathology, it is possible that extending the histopathology would increase the cost beyond that shown in Table D-1.
 A SNUR may recommend two variations of test guideline OECD 218 (Chironomid Sediment Toxicity), one using the acute portion of the sediment and the other using the chronic portion. Costs were not determined for these two variants. The cost of the test performed on midge under flow through conditions was used for both.
 A SNUR may recommend "a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline)". "Freshwater and marine" refers to the name of the test, not the number of species required by EPA. The cost estimates assume only one species is used.
Persistent Bioaccumulative Toxic (PBT) tiered testing
A SNUR may cite tiered testing for Persistent Bioaccumulative Toxic chemical substances (PBTs) according to the testing strategy in EPA's New Chemicals Program PBT Category document, published in the Federal Register notice, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at 64 FR 60194.
In 64 FR 60194, there are three tiers of testing. The results of Tier 1 determine whether Tier 2 testing is needed and the results of Tier 2 testing determine whether Tier 3 testing is needed. Table D-3 lists the tests in the PBT category document. These tests are also listed in Table D-1.
To obtain a cost estimate for SNURs that cite PBT Category testing (64 FR 60194), costs of individual tests from 64 FR 60194 would have to be added up as appropriate, depending on the specific SNUR language. The test list would also need to be adjusted to avoid double counting tests listed in the SNUR both explicitly by guideline number, and implicitly due to their inclusion in PBT Category tiers.
Other assumptions related to PBT testing are described below:
 The PBT category tests at 64 FR 60194 specify rainbow trout as the species for the chronic fish toxicity test, 850.1400. For SNURs that recommend PBT Category testing, 850.1400 costs would be based on using rainbow trout. If 850.1400 is recommended without PBT testing, costs would be based on using fathead minnows.
 For PBT Tier 1 ready biodegradability tests, firms may either choose among six methods in test guideline 835.3110 or follow test guideline 835.3120. The cost of 835.3110 is calculated as the average cost of its six possible methods. The cost estimates assume an equal chance of using either 835.3110 or 835.3120.
Table D-3. Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements
                                   PBT Tier
                                   Guideline
                                     Test
                                     Cost
                                     2015$
                                       1
                                OPPTS 830.7560*
                                     -or-
                                OPPTS 830.7570*

Partition Coefficient (n-Oct/Water), Generator Column method
-or-
Partition Coefficient (n-Oct/Water), Liquid Chromatography  method
Average
                                    $8,298

                                    $5,461
                                    $6,880
                                       1
                                OPPTS 835.2110
Hydrolysis as a Function of pH
                                    $64,744
                                       1
                                OPPTS 835.3110
                                     -or-
                                OPPTS 835.3120
Ready Biodegradability  (choose one of  6 methods; cost is average of the 6)
-or-
[Ready biodegradability] Sealed-vessel CO2 Production Test
Average
                                    $14,106

                                $8,748 $11,427
                                       2
                                OPPTS 835.3170
Shake-flask Die-away Test [measures biodegradability]
                                   $57,522
                                       2
                                OPPTS 850.1730
Fish Bioconcentration
                                   $168,958
                                       3
                                OPPTS 835.3180
Sediment/Water Microcosm Biodegradation
                                   $145,288
                                       3
                         40CFR 797.1330 or 850.1300**
Daphnid Chronic Toxicity Test
                                   $151,441
                                       3
                         40CFR 797.1600 or 850.1400**
Fish Early Life Stage Toxicity (in rainbow trout)
                                    $77,229
                                       3
                                   OECD 422
Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening (in rats)
                                   $152,052
Total cost, All tiers***
                                   $836,541
Sources:
64 FR 60194, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at http://www.epa.gov/EPA-TOX/1999/November/Day-04/t28888.htm. Tests costs are from Table D-1.
* The PBT FR notice cites 830.7560 and 830.7570. This table used costs for similar tests 796.1720 and 796.1570, respectively. Tests 830.7550 (Partition Coefficient  using Shake Flask method) and "the new `slow-stir' method currently under development by the OECD" are also mentioned as options for determining the Oct/Water partition coefficient, in the PBT FR notice Response to Comments but not in the main Testing Strategy discussion.
** PBT FR notice cites both tests as equivalents. This table uses costs for 850.1300 and 850.1400 since they were costed out more recently by EPA.
*** Assuming all tests are conducted.

Testing Costs by Chemical