While material safety data sheets may provide much of the information needed to update the written haz-comm program, many employers may perform a more detailed assessment of exposure risks associated with the chemical and develop more site-specific procedures for workers potentially exposed to such chemicals.  For purposes of the economic analysis, EPA assumes that each employer will engage the services of a professional industrial hygienist (IH), either in-house or on a consulting basis, for four hours to perform such an assessment.  Loaded hourly rates for IH services were calculated based on Bureau of Labor Statistics data, as described in tables B-1 and B-2.  Costs for the written haz-comm program, in 2010 dollars, are as follows
          4 hours Industrial Hygienist time x $51.24 per hour = $205
      The estimates of IH hours to update the program come from a 1998 EPA report (EPA, 1998).
Labeling

      If the SNUR cites 40 CFR §721.72(b), then to avoid engaging in a Significant New Use, manufacturers must ensure that containers used to distribute the PMN substance in commerce are labeled with the necessary hazardous substance warnings and procedures.  In addition, containers used in the workplace must bear similar labels or, alternatively, the employer must provide equivalent signage, operating procedures, or other written material to communicate hazard information to workers.  The cost of providing such labeling was estimated in a 1989 EPA report (EPA, 1989) and has been updated here using more recent cost information.
Standard formats are assumed to be used for creating labels or other signage, and the information required for the labels is assumed to be already available from the MSDS for the chemical (see below).

                       	Chemicals Distributed in Commerce
For chemicals distributed in commerce, the labeling process is assumed to require 0.5 hours of technical labor time per chemical to compile label information.  It is assumed to require 480 labels per chemical.  The assumption of 480 labels per chemical is from a 1989 EPA report (EPA, 1989), and is based on the assumption that, on average, each chemical is shipped twice monthly to 20 customers.  This is consistent with roughly 10,000 kilograms of chemical per year shipped in 40 five-gallon containers per month (EPA, 1989).
Technical labor is fully loaded with fringe benefits and overhead, as described in Appendix B.  Labeling materials costs were obtained from a national safety equipment supply house catalog (LSS, 1997) and were inflated as described in Appendix B.  The resulting costs of labeling for chemicals distributed in commerce, per chemical substance at one site, are shown in Table C-1.

Table C-1 Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)]
                                 Cost Element
                           Unit Cost
 (1997 Dollars)
                               Inflation Factor
                           Unit Cost
 (2010 Dollars)
                                     Hours
                                  Total Cost
0.5 hours technical time
                                      --
                                      --
                                    $61.71
                                   per hour
                                      0.5
                                     $31
480 labels
                                $0.16 per label
                                     1.359
                                    $0.22
                                   per label
                                      --
                                     $104
                                     TOTAL
                                      0.5
                                     $135
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.
Source: 1997 label cost, EPAB 1998, LSS 1997; cost elements, quantities, RIB 1989; inflators, labor, Table B-1 and Table B-3.

                       	Chemicals Used in the Workplace
      Workplace labeling requirements are costed by assuming the facility purchases six large (14" x 10") signs, priced at $38.30 each in 1997 dollars (LSS, 1997; EPA, 1998).  Costs of these signs were inflated as described in Appendix B.  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 10 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             (1997 Dollars)
                               Inflation Factor
                   Unit Cost                  (2010 Dollars)
                                     Hours
                                  Total Cost
0.5 hours technical time
                                      --
                                      --
                                    $61.71
                                   per hour
                                      0.5
                                    $30.85

6 labels or placards (14" x 10")
                                $38.30 per item
                                     1.359
                                    $52.03
                                   per item
                                      --
                                     $312

10 minutes per label/placard production worker time
                                      --
                                      --
                                    $28.61
                                   per hour
                                      1.0
                                    $28.61
                                     TOTAL
                                      1.5
                                     $372
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.
Source: 1997 placard cost, EPA, 1998, LSS, 1997; 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 Dollars)
                               Inflation Factor
                                  Unit Cost
                                 (2010 Dollars)
                                     Hours
                                  Total Cost
2.0 hours technical time
                                      --
                                      --
                                    $61.71
                                   per hour
                                       2
                                     $123
0.25 hours clerical time
                                      --
                                      --
                                    $28.98
                                   per hour
                                     0.25
                                     $7.25
40 copies
                                     $0.05
                                     1.843
                                     $0.09
                                   per copy
                                      --
                                     $3.69
                                     TOTAL
                                     2.25
                                     $134
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.
Source: 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
                                (2010 Dollars)
                                     Hours
                                  Total Cost
0.5 hours technical time (trainer)
                                $61.71 per hour
                                      0.5
                                    $30.85
0.25 hours per production employee X average of 25 workers per plant = 6.25 hours
                                $28.61 per hour
                                     6.25
                                     $179
                                     TOTAL
                                     6.75
                                     $210
Note:
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.
Source: 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
(2010 Dollars)
                                     Hours
                                 Total Cost[1]
10 hours industrial hygienist (IH) time
                                $51.24 per hour
                                      10
                                     $512
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.
Source: 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 Dollars)
                               Inflation Factor
                                Unit Cost

                                (2010 Dollars)
                                     Hours
                                 Total Cost[1]
Impermeability Testing [§721.63(a)(3)(i)]

      Impermeability Test
                                     $800
                                 per chemical
                                     1.505
                                    $1,204
                                 per chemical

                                    $1,204
      Industrial Hygienist time

                                    $51.24
                                   per hour
                                       2
                                    $102.49

                                   Subtotal
                                       2
                                    $1,306
Evaluation of Manufacturer's Specifications  [§721.63(a)(3)(ii)]

      Industrial Hygienist time

                                    $51.24
                                   per hour
                                       4
                                     $205

                                   Subtotal
                                       4
                                     $205
                                                                        TOTAL

                                       6
                                    $1,511
Notes:
[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.
Source: 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 $0.43 in 1997 (LSS, 1997); the cost has been inflated as described in Appendix B.  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     ($1997 per pair)
                               Inflation Factor
                      Unit Cost
 ($2010 per pair)
                          Number of Pairs Required[1]
                             Total Cost ($2010)[2]
Disposable nitrile gloves (replaced daily)
                                     $0.43
                                     1.359
                                     $0.58
                                     6,250
                                    $3,651
Heavy duty butyl gloves (replaced every 25 work days)
                                    $34.00
                                     1.359
                                    $46.19
                                      250
                                    $11,548
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.
Source: 1997 item costs, LSS, 1997; 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 $4.05 per pair in 1997 (LSS, 1997; 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
                               ($1997 per pair)
                               Inflation Factor
                                   Unit Cost
                                (2010$ per pair)
                          Number of Pairs Required[1]
                             Total Cost ($2010)[2]
Standard Goggles
                                     $4.05
                                     1.359
                                     $5.50
                                      75
                                     $413
Heavy duty chemical-splash/impact goggles
                                     $6.05
                                     1.359
                                     $8.22
                                      75
                                     $616
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.
Source: 1997 item costs, LSS, 1997; 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 $36.25 in 1997 (LSS, 1997) and for full-body protective clothing  -  the coverall clothing set with a hood  -  costing $61.20 in 1997 (LSS, 1997).

Table C-9 Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)]
                                 Cost Element
                                  Unit Cost
                                ($1997 per set)
                               Inflation Factor
                                   Unit Cost
                                (2010$ per set)
                              Number Required[1]
                             Total Cost ($2010)[2]
Coverall with hood [full-body clothing] §721.63(a)(2)(ii)
                                    $61.20
                                     1.359
                                    $83.15
                                      75
                                    $6,236
Coverall  §721.63(a)(2)(iv)
                                    $36.25
                                     1.359
                                    $49.25
                                      75
                                    $3,694
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.
Source: 1997 item costs, LSS, 1997; 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.
Notes:
[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 1997 and after applying inflation factors from Table B-3.  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 Section 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 1997 dollars would be as follows:
  $10.83 per respirator + ($8.94 per cartridge x 50 cartridges/year) = $457.83 per worker.
The 1997 cost was adjusted for inflation as shown in Table C-11.
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
(1997 Dollars)
                    Annual Average Costs
(2010 Dollars)[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
                                     $804
                                     $0.00
                                     $804
                                     1.359
                                    $1,092
                                    $27,309
                                     (ii)
19C Type C Supplied-air with tight-fitting facepiece
                                     $804
                                     $0.00
                                     $804
                                     1.359
                                    $1,092
                                    $27,309
                                     (iii)
19C Type C Supplied-air with hood or helmet or tight-fitting facepiece
                                     $932
                                     $0.00
                                     $932
                                     1.359
                                    $1,266
                                    $31,661
                                     (iv)
21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)
                                     $181
                                     $9.76
                                     $669
                                     1.359
                                     $908
                                    $22,711
                                      (v)
21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs
                                     $627
                                    $35.50
                                    $2,402
                                     1.359
                                    $3,264
                                    $81,599
                                     (vi)
21C PAPR with loose hood or helmet and HEPAs
                                     $525
                                    $26.89
                                    $1,870
                                     1.359
                                    $2,540
                                    $63,512
                                     (vii)
21C Air-purifying with HEPA and disposable respirators
                                    $12.53
                                     $7.00
                                     $363
                                     1.359
                                     $493
                                    $12,313
                                    (viii)
23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE)
                                     $192
                                    $15.71
                                     $978
                                     1.359
                                    $1,328
                                    $33,202
                                     (ix)
23C PAPR with tight-fitting facepiece and combination cartridges approved PLE
                                     $627
                                    $35.50
                                    $2,402
                                     1.359
                                    $3,264
                                    $81,599
                                      (x)
23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE
                                     $525
                                    $26.88
                                    $1,869
                                     1.359
                                    $2,540
                                    $63,495
                                     (xi)
23C Air-purifying with combination cartridges for PLE, including disposable respirators
                                    $14.30
                                     $8.90
                                     $459
                                     1.359
                                     $624
                                    $15,600
                                     (xii)
23C Air-purifying with full-facepiece and organic gas/vapor cartridges
                                     $192
                                    $10.47
                                     $716
                                     1.359
                                     $972
                                    $24,303
                                    (xiii)
23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges
                                     $826
                                    $41.15
                                    $2,884
                                     1.359
                                    $3,918
                                    $97,952
                                     (xiv)
23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges
                                     $640
                                    $41.15
                                    $2,697
                                     1.359
                                    $3,665
                                    $91,614
                                     (xv)
23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges
                                    $10.83
                                     $8.94
                                     $458
                                     1.359
                                     $622
                                    $15,550
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 a 1997 catalog.  To calculate the cost of respirators that meet the NIOSH criteria, the prices of all units in the supplier catalog (LSS, 1997) 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 listed in LSS (1997) 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 from LSS (1997).  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 in LSS (1997) 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 1997 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 1997, by NIOSH Type
                                     40CFR
                                  NIOSH Type
                              Catalog Item Number
                                Description[1]
                                   1997 Cost
                             1997 Average Cost[2]
                                §721.63 (a)(5)

                                Respirator Unit
                                 Cartridge Set
                                      (i)
19C Type C Supplied-air with full facepiece
                                     $804
                                      --

7A-24506
Allegro Economical Full-Face Airline Kits, p144
                                   $758.95

7A-32366
311Survivair Supplied Air Respirator Kits, p144
                                   $849.10

                                     (ii)
19C Type C Supplied-air with tight-fitting facepiece
                                      $80
                                      --

7A-24506
Allegro Economical Full-Face Airline Kits, p144
                                    $758.95

7A-32366
Survivair Supplied Air Respirator Kits, p144
                                    $849.10

                                     (iii)
19C Type C Supplied-air with hood or helmet or tight-fitting facepiece
                                     $932
                                      --

7A-29363
Allegro Hood Systems, p144
                                    $932.15

                                     (iv)
21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)
                                     $181
                                      $10

7A-9838
North Full-Face Respirator, p114
                                    $210.10

7A-7122
North HEPA Cartridge, p115
                                    $11.15

7A-12338
Willson Full-Face Silicone Respirator, p116
                                    $215.10

7A-7526
Willson HEPA Cartridge, p117
                                    $11.75

7A-10516
3M 7800 Full-Facepiece Respirator, p118
                                    $202.10

7A-11839
3M HEPA Cartridge, p118
                                     $7.00

7A-33446
Pro-Tech Full-Face Respirator, p122
                                    $106.45

7A-3070-1
Pro-Tech HEPA Cartridge, p123
                                     $9.87

7A-3195
Willson 1600/1700 Series Full-Face Respirators, p124
                                    $215.10

7A-3202
Willson HEPA Cartridge, p125
                                    $12.50

7A-23959
AO7Star Full-Face Respirator (Silicone), p126
                                    $203.25

7A-9940
AO7Star HEPA Cartridge, p127
                                     $9.44

7A-24158
MSA Advantage 1000 Full-Face Respirator, p134
                                    $112.60

7A-29946
MSA HEPA Cartridge, p134
                                     $6.60

                                      (v)
21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs
                                     $627
                                      $36

7A-13599
3M Face-Mounted PAPR System, p142
                                    $720.00

7A-13601
3M HEPA Replacement Cartridge, p142
                                    $36.50

7A-32505
RACAL Powerflow PAPR, p142
                                    $534.90

7A-11936
RACAL Replacement Cartridge, p142
                                    $34.50

                                     (vi)
21C PAPR with loose hood or helmet and HEPAs
                                     $525
                                      $27

7A-32506
RACAL Air-Mate PAPR 12, p143
                                    $411.05

7A-24505
RACAL HEPA Replacement Cartridge, p143
                                    $24.65

7A-32477
RACAL Breathe-Easy HEPA Cartridges and Turbo Unit, p141
                                    $548.50

7A-12838
RACAL HEPA Replacement Cartridge
                                    $29.12

7A-12840
RACAL Breathe-Easy 10 Tyvek Hood, p140
                                    $91.30

                                     (vii)
21C Air-purifying with HEPA and disposable respirators
                                      $13
                                      $7

7A-15255
3M 6000 Series Low-Maintenance Respirator, p135
                                    $10.90

7A-12518P
3M Adaptor, p135
                                     $1.63

7A-11839
3M HEPA Cartridge, p135

                                     $7.00

                                    (viii)
23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE)
                                     $192
                                      $16

7A-9838
North Full-Face Respirator, p114
                                    $210.10

7A-7117
North Organic Vapors Cartridge, p115
                                    $10.50

7A-7125
North Paint Spray/Mists Prefilter, p115
                                     $2.38

7A-7125-2
North Filter Covers, p115
                                     $4.35

7A-12338
Willson Full-Face Silicone Respirator, p116
                                    $215.10

7A-7527
Willson Organic Vapors Cartridge, p117
                                    $10.25

7A-7531
Willson Dusts/Mists/Pesticides/Paint Spray Prefilter, p117
                                     $2.52

7A-7532
Willson Retainer Caps, p117
                                     $4.00

7A-10516
3M 7800 Full-Facepiece Respirator, p118
                                    $202.10

7A-9279
3M Organic Vapors Cartridge, p119
                                     $8.91

7A-9284
3M Paint Spray Prefilter, p119
                                     $2.37

7A-9292
3M Retainer Caps, p119
                                     $3.90

7A-33446
Pro-Tech Full-Face Respirator, p122
                                    $106.45

7A-955-4
Pro-Tech Organic Vapors Cartridge, p123
                                     $9.27

7A-9605
Pro-Tech Paint Spray Prefilter, p123
                                     $1.95

7A-3195
Willson 1600/1700 Series Full-Face Respirators, p124
                                    $215.10

7A-3197
Willson Organic Vapors Cartridge, p125
                                    $11.22

7A-3203
Willson Pesticides/Paint Spray Prefilter, p125
                                     $3.36

7A-3858
Willson Retainer Caps, p125
                                     $4.27

7A-23959
AO7Star Full-Face Respirator (Silicone), p126
                                    $203.25

7A-9935
AO7Star Organic Vapors Cartridge, p127
                                     $8.76

7A-10043
AO7Star Dusts/Mists/Paint Spray Prefilter, p127
                                     $3.07

7A-10044
AO7Star Retainer Clips, p 127
                                     $3.20

                                     (ix)
23C PAPR with tight-fitting facepiece and combination cartridges approved PLE
                                     $627
                                      $36

7A-13599
3M Face-Mounted PAPR System, p142
                                    $720.00

---
Paint, Lacquer, Enamel Cartridge[3]
                                    $36.50

7A-32505
RACAL Powerflow PAPR, p142
                                    $534.90

---
Paint, Lacquer, Enamel Cartridge[3]
                                    $34.50

                                     (x)
23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE
                                     $525
                                      $27

7A-32506
RACAL Air-Mate PAPR 12, p143
                                    $411.05

---
Paint, Lacquer, Enamel Cartridge[3]
                                    $24.65

7A-32477
RACAL Breathe-Easy HEPA Cartridges and Turbo Unit, p141
                                    $548.50

7A-12840
RACAL Breathe-Easy 10 Tyvek Hood, p140
                                    $91.30

---
Paint, Lacquer, Enamel Cartridge[3]
                                    $29.10

                                     (xi)
23C Air-purifying with combination cartridges for PLE, including disposable respirators
                                      $14
                                      $9

7A-12711
Willson Freedom 2000 Series Organic Vapors Respirator, p136
                                    $17.85

7A-7531
Willson Dusts/Mists/Paint Spray/Pesticides Prefilter, p136
                                     $2.52

7A-13509
Willson Retainer Caps, p136
                                     $2.03

7A-33826
Moldex 8000 Series Half-Mask Respirator, p139
                                    $10.75

7A-22751
Moldex Organic Vapors Cartridge, p139
                                     $8.03

7A-22753
Moldex Paint Spray/Pesticides Prefilter, p139
                                     $2.56

7A-22754
Moldex Retainer Caps, p139
                                     $2.65

                                    (xii)
23C Air-purifying with full-facepiece and organic gas/vapor cartridges
                                     $192
                                      $10

7A-9838
North Full-Face Respirator, p114
                                    $210.10

7A-7117
North Organic Vapors Cartridge, p115
                                    $10.50

7A-12338
Willson Full-Face Silicone Respirator, p116
                                    $215.10

7A-7527
Willson Organic Vapors Cartridge, p117
                                    $10.25

7A-10516
3M 7800 Full-Facepiece Respirator, p118
                                    $202.10

7A-9279
3M Organic Vapors Cartridge, p119
                                     $8.91

7A-9292
3M Retainer Caps, p119
                                     $3.90

7A-33446
Pro-Tech Full-Face Respirator, p122
                                    $106.45

7A-955-4
Pro-Tech Organic Vapors Cartridge, p123
                                     $9.27

7A-3195
Willson 1600/1700 Series Full-Face Respirators, p124
                                    $215.10

7A-3197
Willson Organic Vapors Cartridge, p125
                                    $11.22

7A-23959
AO7Star Full-Face Respirator (Silicone), p126
                                    $203.25

7A-9935
AO7Star Organic Vapors Cartridge, p127
                                     $8.76

                                    (xiii)
23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges
                                     $826
                                      $41

7A-32473
RACAL Breathe-Easy Organic Vapors and Turbo Unit, p141
                                    $548.50

7A-12844
RACAL Breathe-Easy 7 Full Face, p140
                                    $277.90

7A-12830
RACAL Organic Vapors Replacement Cartridges, p141
                                    $41.15

                                    (xiv)
23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges
                                     $640
                                      $41

7A-32473
RACAL Breathe-Easy Organic Vapors and Turbo Unit, p141
                                    $548.50

7A-12840
RACAL Breathe-Easy 10 Tyvek Hood, p140
                                    $91.30

7A-12830
RACAL Organic Vapors Replacement Cartridges, p141
                                    $41.15

                                     (xv)
23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges
                                      $11
                                      $9

7A-15255
3M 6000 Series Low-Maintenance Respirator, p135
                                    $10.90

7A-15256
3M Organic Vapors Cartridge, p135
                                     $9.85

7A-33826
Moldex 8000 Series Half-Mask Respirator, p139
                                    $10.75

7A-22751
Moldex Organic Vapors Cartridge, p139
                                     $8.03

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 HEPA cartridges.
Source: LSS 1997; 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 5 to 6 hours.  Other EPA reports have estimated that electronic submission of SNUNs is expected to reduce the recordkeeping burden to approximately 1 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, importers, 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.

      All recordkeeping requirements essentially involve copying and filing relevant records, including those 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).

      This report uses the basic Kearney (1988a and 1988b) estimates and assumptions to estimate recordkeeping costs for SNUR requirements.  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

	Recordkeeping costs are based on cost per page.  Kearney (1988a) 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).  Table C-13 summarizes estimates from Kearney 1988a and the CAIR report (Kearney, 1988b).  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.  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.  The analysis estimates a cost per hour and per page using fully loaded labor rates from Table B-1.

   * The photocopying cost from Kearney 1988a ($0.05 per page) was inflated using an inflation factor from Table B-3.

   * File space for CAIR was estimated at (1/4) of a four-drawer file cabinet for 750 pages (Kearney, 1988b, page 65) or 0.000333 of a cabinet per page.  A standard, four-drawer, full-suspension file cabinet was priced from a national office products supplier at $195 in 1997 (BT Office Products, 1997; Item #LGM-202401; EPA, 1998).  This results in $0.065 per page cost for file space, before inflation ($195 x 0.25 file cabinet/750 pages).  The cost per page was inflated using an inflation factor from Table B-3.

   * Miscellaneous materials costs were estimated at $10.00 for 750 pages in the CAIR report (Kearney, 1988b, page 65), or $0.0133/page before inflation.  This cost per page was inflated using an inflation factor from Table B-3.

Table C-13 Recordkeeping Estimates from Kearney 1988a and 1988b
                                  Labor Costs
                    Kearney Estimates for CAIR Rule (1988b)
                            Adjusted for inflation
                             Per page cost - 2010$

                                     Hours
                                  CAIR Pages
                                Hours Per Page
                                Cost Per Hour
                                Cost Per Page
                                   Technical
                                       1
                                      750
                                    0.00133
                                    $61.71
                                    $0.0823
                                   Clerical
                                      10
                                      750
                                    0.01333
                                    $28.98
                                    $0.3864
                                  Total Labor

                                    0.01467

                                    $0.4687

                                Materials Costs
                    Kearney Estimates for CAIR Rule (1988a)
                            Adjusted for inflation
                             Per page cost - 2010$

                                   Estimate
                                  CAIR Pages
                                Cost Per Page
                               Inflation Factor
                                Cost Per Page
                                 Photocopying
                             $0.05 [1988 dollars]
                                       1
                                    $0.050
                                     1.843
                                    $0.0922
                                 File Cabinet
                 1/4 of cabinet priced at $195 [1997 dollars]
                                      750
                                    $0.065
                                     1.359
                                    $0.0883
                                Misc. Materials
                           $10 total [1988 dollars]
                                      750
                                    $0.013
                                     1.843
                                    $0.0246
                                Total Materials

                                    0.1283

                                    $0.2050
   Total Cost per Page (Labor & Materials)
                                    $0.6737
Notes:
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.  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.

	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 2.3 hours of technical time, 23 hours of clerical time, 1,715 photocopies, approximately one-half of a four-drawer file cabinet, and other miscellaneous materials such as folders.  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[3]
                         Labor and materials cost[1]
                                    (2010$)
                                    Hours

                                      (a)
                                   Per Page
                                      (b)
                           Per Chemical (c)=(a)*(b)
                                 Per Page
 (d)
                           Per Chemical (e)=(a)*(d)
                                                                      (a)(b)(c)
Volumes & sales/transfer data
                                      485
                                    $0.6737
                                     $327
                                    0.01467
                                     7.11
                                    (d)(e)
Protective clothing [§721.63] and impermeability [§721.63(a)(3)]
                                      20
                                    $0.6737
                                    $13.47
                                    0.01467
                                     0.29
                                      (f)
Haz-comm program [§721.72]
                                      250
                                    $0.6737
                                     $168
                                    0.01467
                                     3.67
                                      (g)
Label copies [§721.72(b)]
                                       5
                                    $0.6737
                                     $3.37
                                    0.01467
                                     0.07
                                      (h)
MSDS copies [§721.72(c)]
                                       5
                                    $0.6737
                                     $3.37
                                    0.01467
                                     0.07
                                      (i)
Use limitations compliance [§721.80]
                                      250
                                    $0.6737
                                     $168
                                    0.01467
                                     3.67
                                      (j)
Disposal compliance [§721.80]
                                      600
                                    $0.6737
                                     $404
                                    0.01467
                                     8.80
                                      (k)
Release to water compliance [§721.90]
                                      100
                                    $0.6737
                                    $67.37
                                    0.01467
                                     1.47
                                     TOTAL
                                     1,715
                                    $0.6737
                                    $1,155
                                    0.01467
                                     25.15
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.

                                  APPENDIX D

                               COSTS OF TESTING

                                  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.  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.

      * CFR.  SNUR tests may also come from the Code of Federal Regulations, 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
                                    2010$
Product Properties

830.6315
Flammability
NA
NA
                                    $2,252
830.7050
Absorption in Aqueous Solution: ultraviolet/visible spectra
NA
NA
                                    $2,277
830.7200
Melting Point / Melting Range
NA
8-test average
                                    $1,351
830.7550
Partition Coefficient (n-Octanol/Water)
NA
Shake Flask Method
                                    $7,061
830.7560
Partition Coefficient (n-Oct/Water)
NA
Generator Column
                                    $7,506
830.7570
Partition Coefficient (n-Oct/Water)
NA
Liquid Chromatography
                                    $4,940
830.7840
Water Solubility
NA
Flask Method
                                   $10,205
830.7860 (796.1860)[x]
Water Solubility: Column Generator Method
NA
Generator Column
                                    $22,033
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
                                       *
Fate, Transport, Transformation

835.1110
Activated Sludge Sorption Isotherm
NA
NA
                                    $19,733
835.1220
Sediment and Soil Adsorption/Desorption Isotherm
NA
NA
                                    $30,266
835.2110
Hydrolysis as a Function of pH
NA
NA
                                    $59,465
835.2130
Hydrolysis as a Function of pH and Temperature
NA
NA
                                       *
835.2210 (796.3700)
Photolysis in Aqueous Solution in Sunlight
NA
NA
                                   $118,953
835.3100 (796.3100)
Aerobic Aquatic Biodegradation
NA
NA
                                    $16,330
835.3110
Ready Biodegradation
NA
Average of six methods
                                    $12,759
835.3120
Sealed-Vessel CO2 Production Test
NA
NA
                                    $7,912
835.314
CO2 in Sealed Vessels Test
NA
NA
                                       *
835.3170
Shake Flask Die-Away Test
NA
NA
                                    $52,029
835.3180
Sediment/Water Microcosm Biodegradation
NA
Flow-through
                                   $136,045
835.3200 (OECD 302B)
Inherent Biodegradation: Modified Zahn-Wellens
NA
NA
                                    $10,339
835.3220
Porous Pot Test
NA
NA
                                    $33,000
835.3400
Anaerobic Biodegradability of Organic Chemicals
NA
NA
                                    $12,560
835.5045 (OECD 302A)
Inherent Biodegradability: Modified SCAS Test
NA
NA
                                    $14,513
835.5270 (795.7000)
Sunlight Photolysis in Waters Containing Dissolved Humic Substances (Indirect Photolysis Screening Test)
NA
NA
                                    $25,089
D2035-80 (ASTM D 2035-80)
Standard Practice for Coagulation-Flocculation Jar Test of Water
NA
NA
                                    $4,333
OECD 303A
Simulation Test - Aerobic Sewage Treatment, with measurement of loss of the parent
NA
NA
                                    $43,640
OECD 307
Aerobic and Anaerobic Transformation in Soil
NA
Flow-through
                                   $286,184
OECD 307
Aerobic and Anaerobic Transformation in Soil
NA
Bio-meter type flasks
                                   $270,528
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
                                       *
Ecological Effects

850.1000
Special Considerations for Conducting Aquatic Laboratory Studies
NA
NA
                                       *
850.1010 (797.1300)
Daphnid Acute Toxicity
Daphnid
Flow-through
                                    $15,293
850.1010 (797.1300)
Daphnid Acute Toxicity
Daphnid
Static
                                    $15,091
850.1075 (797.1400)
Fish Acute Toxicity
Fathead Minnow
Flow-through
                                    $21,076
850.1075 (797.1400)
Fish Acute Toxicity
NA
Static
                                    $17,069
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
                                    $17,793
850.1300
Daphnid Chronic Toxicity Test
Daphnid
Flow-through
                                   $136,977
850.1400
Fish Early Life Stage Toxicity
Rainbow Trout
Flow-through
                                    $69,853
850.1400
Fish Early Life Stage Toxicity
Fathead Minnow
Flow-through
                                    $47,223
850.1730
Fish BCF
Fathead Minnow
Flow-through
                                   $152,822
850.1925
Site-Specific Aquatic Microcosm Test
NA
NA
                                       *
850.1950
Field testing for Aquatic Organisms[3]
NA
NA
                                   $679,578
OECD 218
Chironomid Sediment Toxicity
NA
NA
                                    $29,146
850.5400
Algal Toxicity, Tiers I and II
NA
NA
                                    $18,480
Health Effects

870.1100
Acute Oral Toxicity
Rats
Gavage
                                    $7,965
870.1300
Acute Inhalation Toxicity
Rats[4]
Inhalation
                                    $17,564
870.3100
90-Day Oral Toxicity
Rats
Gavage
                                   $159,544
870.3250
Subchronic Dermal Toxicity - 90 days
Rats
Dermal
                                   $169,384
870.3465[1]
Subchronic Inhalation Toxicity
Rats
Inhalation
                                   $522,939
870.3465 (mod)
Subchronic Inhalation Toxicity (w/ 60 day recovery group)
Rats
Inhalation
                                   $249,450
870.3465 (OECD 413)[1]
Subchronic Inhalation Toxicity (90-day exposure/180-day retention)
Rats
Inhalation
                                   $435,830
870.3700
Prenatal Developmental Toxicity {2 species}
Rats
Gavage
                                   $121,107
870.3800
Reproduction/Fertility Effects (2-Generation Reproduction)
Rats
Gavage
                                   $403,152
870.4200
Carcinogenicity {2 species} (24 months)
Rats
Gavage
                                  $1,607,496
870.4200
Carcinogenicity {2 species}
Rats
Inhalation
                                  $1,275,697
870.43
Combined Chronic Toxicity/Carcinogenicity Test
Rats
Gavage
                                  $1,227,788
870.5100
Bacterial reverse mutation test
NA
Direct plate
                                    $9,169
870.5265
Salmonella typhimurium Reverse Mutation Assay (Ames Test)
NA
Average of direct plate and Azo reduction
                                    $13,233
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)
                                    $22,441
870.5395
In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings)
Mice
Intravenous (Two test average)
                                    $22,441
870.5550
Unscheduled DNA Synthesis in Mammalian Cells in Culture
Rat Hepatocytes
NA
                                    $23,174
870.6100
Delayed Neurotoxicity of Organophosphorus Substances (Acute)
Hens
Gavage (Acute)
                                    $39,621
870.6100
Delayed Neurotoxicity of Organophosphorus Substances (Subchronic 28-day)
Hens
Gavage (Subchronic)
                                    $95,818
870.6200
Neurotoxicity Screening Battery (Acute)
Rats
Gavage
                                   $159,654
870.7800
Immunotoxicity
Rats
Gavage
                                    $67,832
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)
                                    $14,829
OECD 404 (870.2500)
Acute Dermal Irritation
Rabbits
Dermal
                                    $6,306
OECD 405 (870.2400)
Acute Eye Irritation
Rabbits
Eye
                                    $6,306
OECD 407 (870.3050)
Repeated dose 28-day oral toxicity study in rodents
Rats
Gavage (28 Days)
                                    $58,824
OECD 412
Repeated Dose Inhalation Toxicity (28-Day Study)
Rats
Inhalation (28 Days)
                                   $131,703
OECD 416
Two-Generation Reproduction Toxicity Test
Rats
Dietary
                                   $434,048
OECD 421 (870.3550)
Reproduction/developmental toxicity screening tests
Rats
Gavage
                                    $68,996
OECD 422 (870.3650)
Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen
Rats
Gavage
                                   $137,531
OECD 422 (mod)
Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen (90 days w/ histopathology)
Rats
Gavage
                                   $258,569
OECD 425
Acute Oral toxicity: Up-and-down Procedure
Rats
Gavage
                                    $6,092
ASTM D6007-02
Small Scale Chamber Test to Determining Formaldehyde Concentration in Air from Wood Products
NA
NA
                                       *
Nanomaterial Specific Tests[5][, 6]
OECD's Guidance Manual for the Testing of Manufactured  Nanomaterials
Dustiness Test
NA
EN 15051 Method
                                    $2,570
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
                                    $561[7]
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
                                       *
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
                                       *
OECD's Guidance Manual for the Testing of Manufactured Nanomaterials
Configuration of Carbon Nanotube ends
NA
 NA
                                     $750
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 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.
[6] The test cost is an average of the test costs for three methods: EELS, XPS (ESCA), and Auger electron spectroscopy.
Source: EPA OPPTS Economic and Policy Analysis Branch cost estimates.  Many costs were estimated in the 1990s or earlier.  All have been inflated (see Table B-1 and Table B-3 for inflation index).  Dollar costs include $4,054or $9,854 for analytical method validation; where applicable (see text).  Species and route or method may be specified in SNURs or may be unspecified but assumed in this table for costing purposes.
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 $4,054 and $9,854in 2010 dollars.  For simplicity, the method validation cost for ecological effects tests (e.g. 850 series guidelines) was assumed to be $4,054 for each test. In addition, this analyses assumes that analytical method validation costs are the same for both nanomaterials and traditional chemcials.

       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
                                     2010$
                                       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
                                    $7,506

                                 $4,940 $6,223
                                       1
                                OPPTS 835.2110
Hydrolysis as a Function of pH
                                    $59,465
                                       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
                                    $12,759

                                $7,912 $10,336
                                       2
                                OPPTS 835.3170
Shake-flask Die-away Test [measures biodegradability]
                                   $52,029
                                       2
                                OPPTS 850.1730
Fish Bioconcentration
                                   $152,822
                                       3
                                OPPTS 835.3180
Sediment/Water Microcosm Biodegradation
                                   $136,045
                                       3
                         40CFR 797.1330 or 850.1300**
Daphnid Chronic Toxicity Test
                                   $136,977
                                       3
                         40CFR 797.1600 or 850.1400**
Fish Early Life Stage Toxicity (in rainbow trout)
                                   $69,853
                                       3
                                   OECD 422
Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening (in rats)
$137,531
Total cost, all tiers (assuming all tests are conducted)
                                   $761,280
Source: 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.

Testing Costs by Chemical
	Test costs attributable to a SNUN are likely to be much lower than the costs that would be implied by adding up costs of all of the testing recommended in the SNUR for that chemical, and usually are zero.   See the main text of this report for a discussion of testing.
                                  APPENDIX E

                                  REFERENCES

                                  REFERENCES
29 CFR 1910. Occupational Safety and Health Standards. Code of Federal Regulations, Part 1910, Title 29, November 25, 1983.
63 FR 41847. Test Guidelines; Notice of Availability, Federal Register, Volume 63, August 5, 1998.
      64 FR 60914. Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, Federal Register, Volume 64, November 8, 1999.
      71 FR 6733. Export Notification; Proposed Change to Reporting Requirements, Federal Register, Volume 71, February 9, 2006. Available from the Federal Docket Management System as docket EPA-HQ-OPPT-2005-005 8 at http://www.regulations.gov.
75 FR 773. TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations, Federal Register, Volume 75, January 6, 2010.
ASTM. American Society for Standards and Materials. http://www.astm.org.
Best, 1997. Personal communication between Tom DeCoff of Eastern Research Group, Lexington, MA and Best Manufacturing Co. technical support services, Austin, TX, December 1997.
      BLS, 2006a. U.S. Bureau of Labor Statistics, Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC Occupational Comparability between SOC and OCS. Downloaded February 2006 from
      http://www.bls.gov/ncs/ect/sp/ecsm0003.htm.
     BLS, 2006b. U.S. Bureau of Labor Statistics, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (April 28, 2006), at http://www.bls.gov.
BLS, 2006c. U.S. Bureau of Labor Statistics. Change has Come to the ECI (June 14, 2006) at http://www.bls.gov/ncs/ect/sp/ecsm0001.htm

      BLS, 2006d. Bureau of Labor Statistics.  Employment Cost Index, Historical Listing Current-Dollar 1975-2005 (May 10, 2006) at http://www.bls.gov/web/ecconst.pdf.
BLS, 2008. U.S. Bureau of Labor Statistics, 2008 Congressional Budget Submission (2008) at http://www.dol.gov/dol/budget/2008/PDF/CBJ-2008-V3-01.pdf
BLS, 2011. U.S. Bureau of Labor Statistics, Occupational Employment Statistics [OES]. May 2010	National Industry-Specific Occupational Employment and Wage Estimates Sectors	31, 32, and 33  - Manufacturing. (May 17, 2011) at http://www.bls.gov/oes/current/naics2_31-33.htm

BLS, 2011a. U.S. Bureau of Labor Statistics. "Employer Costs for Employee Compensation Supplementary Tables December 2010.
." ( Marc 9, 2011. thttp://www.bls.gov/ncs/ect/sp/ecsuptc17.pdf . (Note: The BLS report title and content is updated
      periodically to include more recent data, on the same website.)
     BLS, 2011b. U.S. Bureau of Labor Statistics. Consumer Price Index- All Urban Consumers, U.S. City Average (Series ID: CUUR0000SA0), extracted June 16, 2011. Available through http:/data.bls.gov/cgi-bin/srgate
     BLS, 2011c. U.S. Bureau of Labor Statistics. Employment Cost Index  -  Total Compensation: All Workers, Private Industry, Seasonally Adjusted. (Series ID: CIS2010000000000I), extracted June 16, 2010.  Available through http:/data.bls.gov/cgi-bin/srgate.

BLS, 2011d. Bureau of Labor Statistics. Employment Cost Index  -  Total Compensation: Professional and  Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted June 16, 2010. http:/data.bls.gov/cgi-bin/srgate.
Branch, 2006. Raphael E. Branch and Lowell Mason. U.S. Bureau of Labor Statistics, "Seasonal adjustment in the ECI and the conversion to NAICS and SOC."  Monthly Labor Review. Vol. 129, No. 4, April 2006.  Available at www.bls.gov.
BT Office Products, 1997. BT Office Products International. Office Products Catalog, 1997.
Caroll, 2006.  Richard E. Caroll. U.S. Bureau of Labor Statistics, "Changes affecting the Employment Cost Index: an overview."  Monthly Labor Review. Vol. 129, No. 4, April 2006.  Available at www.bls.gov
CMA, 1991. Chemical Manufacturers Association. Responses to Questions on Burden Associated with	PMN Submissions. Distributed by the Chemical Manufacturers	Association, Washington, DC.
EPA, 1989. U.S. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow- Up. Washington, DC, July 19, 1989. (OTS/RIB later became OPPT/EPAB.)
      EPA, 1992. U.S. EPA, Office of Policy, Planning, and Evaluation. Instructions for Preparing Information Collection Requests (ICRs). Washington, DC, June 1, 1992.
      EPA, 1994. U. S. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. Washington, DC, September 9, 1994. (OTS/RIB later became OPPT/EPAB.)
     EPA, 1997. Office of Pollution Prevention and Toxics. Chemistry Assistance Manual for Premanufacture Notification Submitters, EPA 744-R-97-003, March 1997. http://www.epa.gov/oppt/newchems/pubs/chem-pmn/
      EPA, 1998. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 168 Chemical Substances and Background Support Document for Economic Analysis of	Significant New Use Rules. Washington, DC, January 1998.
EPA, 1999. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 41 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC, July 20, 1999.  (Docket OPPTS-50635.)
      EPA, 2000. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1139.06. [Information Collection Request for] TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions: Supporting Statement for Request for OMB Review under the Paperwork Reduction Act. Attachment 5, Wage Rates Estimation, August 29, 2000.
     EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC. August 2002.
EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch, Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC: June 10, 2002.
     EPA, 2003a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances. Washington, DC, 2003. Available from the Federal Docket Management System as EPA-HQ-OPPTS-2002-0078 at http://www.regulations.gov.
     EPA, 2003b. U.S. EPA, Office of Pollution Prevention and Toxics. Significant New Uses of Certain Chemical Substances, 68 FR 15061, March 28, 2003. EPA Docket No. OPPT-2002-0060.
     EPA, 2005a. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, November 2005, available from the Federal Docket Management System as EPA-HQ-OPPT-2005-005 8-0017 at http://www.regulations.gov.
      EPA, 2005b. U.S. EPA, Office of Pollution Prevention and Toxics ICR No. 118.08. [Information Collection Request for] TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act, October 11, 2005.
      EPA, 2006. U.S. EPA, Office of Pollution Prevention and Toxics, Harmonized Test Guidelines, available at http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/index.html
      EPA, 2007a. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 0574.14. [Information Collection Request for] Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances: Supporting Statement for a Request for OMB Review under The Paperwork Reduction Act, December 6, 2007.
     EPA, 2007b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances (EPA Docket OPPT-2003-0063), December 4, 2006 (Revised March 12, 2007).
     EPA, 2007c. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of Expedited Significant New Use Rules for 38 Chemical Substances (EPA Docket OPPT-2006-0898), August 17, 2007

EPA, 2008a. U.S. EPA, Office of Pesticides Programs, Economic Analysis of the Proposed Change in	Data Requirements for Antimicrobial Pesticides, June 2008, available from the Federal Docket	Management System as EPA-HQ-OPP-2008-0110-0046 at http://www.regulations.gov.
      EPA, 2008b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Final Significant New Use Rule for 183 Perfluoroalkyl Sulfonates, August 20, 2007.
     EPA, 2008c. U.S. EPA, Office of Pollution Prevention and Toxics, "New Chemicals Program: Is a Filing Necessary for my Chemical," (Updated June 23, 2008) web page at www.epa.gov/opptintr/newchems/pubs/whofiles.htm

EPA, 2008d. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Significant New Use Rule for Chloranil, January 8, 2008.

EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule. (EPA-HQ-OPPT-2008-0296). July 13, 2009

EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics. ICR No.: 0795.13 [Information Collection Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction Act. March 6, 2009 at http://www.regulations.gov.

Kearney, 1988a. Memorandum to Bill Massouda, Reporting and recordkeeping costs for a generic SNUR, February 3, 1988. [Memo submitted to U.S. EPA/Office of Toxic Substances (now OPPT) under contract 68-02-3980 with A.T.Kearney, Inc.].
      Kearney, 1988b. Estimated Cost of the Final Comprehensive Assessment Information Rule, June 1, 1988. Prepared by Kearney/Centaur for US EPA.
LSS, 1997. Lab Safety Supply. 1997 Product Catalog.
NTIS. National Technical Information Service. http://www.ntis.gov.
OECD. Organization for Economic Cooperation and Development. http://www.oecd.org.

OECD, 2010. Organization for Economic Cooperation and Development. Guidance Manual for the Testing of Manufactured Nanomaterials. June 2010.  Accessed from http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&doclanguage=en

OPM, 2010. Office of Personnel Management, Salary Table 2010-DCB, Washington BaltimoreNorthern Virginia, DC-MD-PA-VA-WV. Accessed from http://www.opm.gov/oca/10tables/pdf/DCB.pdf.
      OSHA, 1983. US Dept of Labor, OSHA, Office of Regulatory Analysis, Final Regulatory Impact and Regulatory Flexibility Analyses of the Hazard Communication Standard. Washington DC, August 9, 1983.
Sleemi, 2006. Fehimida Sleemi. U.S. Bureau of Labor Statistics, "Employment Cost Index Publication Plans". Monthly Labor Review. Vol. 129, No. 4, April 2006. available at www.bls.gov/opub/mlr/2006/04/art2full.pdf