Economic Analysis of Expedited New Use Rule for 23 Chemical Substances
(EPA Docket EPA-HQ-OPPT-2012-0182)






March 28, 2012





-- Does not contain TSCA CBI  - 





		Economic and Policy Analysis Branch
	Economics, Exposure and Technology Division
Office of Pollution, Prevention, and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460








                                                                               
                                                                               

		



                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
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Contributors
The EPA analyst responsible for this report was Stephanie Suazo of the Economic and Policy Analysis Branch; Economics, Exposure and Technology Division; Office of Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt Associates Inc. under EPA Contract No. EP-W08-010.
 
	


Executive Summary
This Economic Analysis estimates the potential costs of Significant New Use Rules (SNURs) covering 23 chemicals that have been the subject of TSCA premanufacture notices (PMNs). Appendix A lists each regulated chemical's generic or specific chemical name and Chemical Abstract Service Registry Number (CASRN) (if non-confidential). The SNURs are being published under the rulemaking docket number EPA-HQ- OPPT-2012-0182 as direct final rules. The SNURs define "Significant New Uses" that trigger EPA notification requirements. To submit a Significant New Use Notice or request a SNUR modification, a firm incurs a modest submission cost, plus costs of any additional data generated to support the submission. By avoiding a Significant New Use, a firm can avoid submission costs, but may incur other compliance costs. For example, it may incur costs associated with restricting chemical releases to water or preventing worker exposure. The options available to a firm considering the manufacture, import, and/or processing of a chemical covered under a SNUR, and the types of associated costs to the firm, are summarized in Table ES-1. 
It should be noted that the costs listed in Table ES-1 may be incurred for reasons other than the SNUR. The costs of avoiding a Significant New Use are attributable to the SNUR only if, in the absence of the SNUR, the firm would have adopted a different approach. For example, a SNUR may define any use other than that described in the PMN as a Significant New Use. If the PMN submitter would have conformed to the uses described in the PMN even without the SNUR, then any associated costs of adhering to the PMN uses would not be due to the SNUR. Costs to a PMN submitter of practices required by a TSCA Section 5(e) Consent Order would be attributable to the Consent Order, not the SNUR. If a processor would have workers wear gloves even without SNUR requirements, then the gloves costs would not be attributable to the SNUR. The costs in Table ES-1 are attributable to the SNUR only if the firm adopts a different approach due to the Significant New Use Rule. 

Table ES-1. Compliance Options and Associated Costs Incurred by a Firm due to SNUR
Option[1]
Costs
Quantified Costs per Chemical (2011$)[2]
1
Manufacture, import, or process in a way that avoids a Significant New Use, such as limiting water releases, engaging in PMN uses only, importing only, limiting volumes, providing workplace protection, or providing hazard communications.
All SNUR chemicals require ongoing recordkeeping. In addition, many SNUR chemicals may involve costs of complying with water release restrictions and foregoing non-PMN uses; these costs were not quantified for this report. Costs for worker protection and hazard communication apply to relatively few chemicals, but are quantified.
Typically, annual costs for recordkeeping are under $1,188. For the few SNUR chemicals where these apply, annual costs for worker protection may be $37,395 or more and for haz-comm is $1,084.
2
Submit a request for modification or revocation of the SNUR (§721.185).
Costs of submitting a request for modification or revocation, including costs of developing supporting data (e.g., testing, if needed).
$6,037 submission cost plus any testing costs.[3] EPA receives very few such requests, typically 0-3 per year.
3
Electronic submission of a Significant New Use Notice (SNUN), indicating to EPA that the firm would like to manufacture, import, or process the chemical for a Significant New Use as defined in the SNUR.
Costs of electronically submitting a SNUN (including SNUN recordkeeping and user fee[4]) plus ongoing recordkeeping. Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not required by law.
$8,537 submission cost (including SNUN recordkeeping and $2,500 fee)[4,5] plus ongoing recordkeeping costs of under $1,188. EPA usually receives well under ten SNUNs in a year. Based on review of recent SNUNs, it appears that firms rarely conduct toxicity or fate testing to support a SNUN (such testing would be voluntary).
4
Petition EPA for an equivalency determination to consider alternative controls to prevent release or exposure that are equivalent to those identified in the SNUR (§721.30).
Costs of submitting an electronic request for equivalency determination.
$6,037 one-time submission cost.
5
Do not manufacture, import, or process the substance except for R&D (the R&D exemption is covered in 40 CFR §721.47).
Cost of profits foregone due to delaying or avoiding commercial activity that would otherwise be pursued. R&D recordkeeping costs if manufacture for R&D.
Costs not quantified.
Notes: 
Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations). Costs come from Table 3 through Table 8. 
1 Firms may follow multiple Options simultaneously.
[2] Quantified costs are attributable to the SNUR Significant New Use definition only if a firm would not otherwise follow the specified practices. $37,395 is the annual cost for dermal protection selection; impermeability testing, heavy-duty gloves, and a lower-cost respirator (see Table 5). Some firms may have export notification costs (see Chapter 3 of this report).
3 See Appendix D for costs of individual tests recommended in current and recent SNURs.
[4] EPA charges a nominal flat fee of $2,500 for a PMN or SNUN submission. 
[5] SNUR chemicals not on the TSCA Inventory are "new" chemicals requiring a PMN, so some firms may need to make a submission before commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report).
	Table of Contents
1	Introduction	1-1
1.1	Statutory Authority and Significant New Uses under the Proposed SNURs	1-1
1.2	Summary of Methodology	1-2
1.3	Organization of this Report	1-2
2	Costs of a Significant New Use Rule (SNUR), by Option	2-3
2.1	Comply with SNUR Limits (Option 1)	2-5
2.1.1	Hazard Communication	2-6
2.1.2	Protection in the Workplace	2-7
2.1.3	Recordkeeping	2-12
2.1.4	Hidden Costs: production volume limits, limiting releases to water, PMN uses, import-only, and disposal	2-13
2.2	Request Modification or Revocation of a SNUR (Option 2)	2-14
2.2.1	Costs of Developing and Submitting Testing Data	2-14
2.2.2	Costs for Submitting a Request for Modification or Revocation of a SNUR	2-15
2.2.3	Other Costs	2-16
2.2.4	Total Costs for Option 2	2-16
2.3	Submit SNUN (Option 3)	2-16
2.3.1	SNUR "New" Chemicals	2-17
2.3.2	Advance Compliance Exemption	2-18
2.3.3	Costs for Submitting a SNUN	2-18
2.3.4	Potential for Subsequent Regulatory Actions	2-18
2.4	Request Equivalency Determination (Option 4)	2-19
2.5	Decide Not to Produce Chemical (Option 5)	2-19
2.6	Summary of Costs for Each Option	2-19
3	Export Notification Costs	3-1
3.1	Estimated Number of Annual Export Notifications per Exporter	3-1
3.2	Exporter Costs	3-2
3.2.1	Estimated Submission (Mailing) Costs	3-2
3.2.2	Compile and Maintain the List of Products	3-2
3.2.3	Write or Revise Export Notification	3-3
3.2.4	Check Orders and Send Notifications	3-3
4	Agency Costs	4-1
4.1	SNUN Processing Costs	4-1
4.2	Export Notification Processing Burden	4-4
5	Additional Analyses	5-1
5.1	Regulatory Flexibility Act (RFA)	5-1
5.2	Unfunded Mandates Reform Act (UMRA)	5-1
5.3	Paperwork Reduction Act (PRA)	5-2
5.4	Executive Order 12866, Regulatory Planning and Review	5-2
5.5	Executive Order 13132, Federalism	5-2
5.6	Executive Order 12898, Environmental Justice	5-2
5.7	Executive Order 13045, Protection of Children	5-2
5.8	Executive Order 13175, Tribal Governments	5-2
5.9	Executive Order 13211, Energy Supply, Distribution, or Use	5-3
APPENDIX A:	List of PMNs and their Chemical Names	A-1
APPENDIX B:	Inflators and Wage Rates	B-1
APPENDIX C:	Costs of Hazard Communication, Protection in the Workplace, and Recordkeeping Requirements	C-1
APPENDIX D:	Costs of Testing	D-1
APPENDIX E:	References	E-1
List of Tables
Table ES-1. Compliance Options and Associated Costs Incurred by a Firm due to SNUR	iii
Table 1. Summary of Compliance Options and Associated Costs Potentially due to a SNUR	2-2
Table 2. Production and Use Restrictions/Requirements	2-4
Table 3. Annual Costs of Hazard Communication Requirements	2-5
Table 4. Annual Costs of Workplace Protection Requirement	2-6
Table 5. Sample Costs of Workplace Protection	2-9
Table 6. Annual Costs of Recordkeeping Requirements (40 CFR §721.125)	2-11
Table 7. Sample Costs of Recommended Testing	2-12
Table 8. Costs of Requirement to Modify/Revoke SNUR or Submit SNUN	2-14
Table 9. Derivation of Total Mailing Cost for 12 Notices	3-2
Table 10. TSCA 12(b) Export Notification Cost per Notification	3-3
Table 11. Agency Costs for SNUN and Other Submission Review and Processing	4-3
Table 12. TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2011$)	4-4
Table A-1. PMNs and Chemical Names Referenced in this Economic Analysis	A-1
Table B-1. Derivation of Loaded Wage Rates	B-4
Table B-2. Derivation of Industrial Hygienist Wage Rate (NAICS 31, 32, 33)	B-5
Table B-3. Derivation of Inflation Factors	B-7
Table C-1. Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)]	C-10
Table C-2. Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)]	C-11
Table C-3. Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]	C-11
Table C-4. Annual Costs for Employee Training, Per Chemical [40 CFR §721.72(d)]	C-12
Table C-5. Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)]	C-13
Table C-6. Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)]	C-14
Table C-7. Annual Cost of Gloves [40 CFR §721.63(a)(2)(i)]	C-15
Table C-8. Annual Cost of Protective Eyewear [40 CFR §721.63(a)(2)(iii)]	C-16
Table C-9. Annual Cost of Protective Clothing [40 CFR §721.63(a)(2)]	C-16
Table C-10. Crosswalk Between SNUR Text and Respirator Types at 40 CFR §721.63(a)(5)	C-18
Table C-11. Annual Per-Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)]	C-20
Table C-13. Recordkeeping Estimates from Kearney 1988a and 1988b	C-30
Table C-14. Annual Per-Chemical Costs of Recordkeeping Requirement [40 CFR 721.125]	C-31
Table D-1. Cost Estimates for Test Guidelines Cited in SNURs	D-3
Table D-2.  Default Parameters for Species, Route, and Study Type	D-15
Table D-3. Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements	D-17
                                       

Introduction
This report presents the U.S. Environmental Protection Agency (EPA), Office of Chemical Safety and Pollution Prevention's (OCSPP)'s analysis of the potential costs incurred as a result of direct final Significant New Use Rules (SNURs) being promulgated for 23 chemical substances which have gone through premanufacture notice (PMN) review. The SNURs are being published under the rulemaking docket number OPPT-2012-0182. Appendix A lists the generic or specific chemical name and Chemical Abstract Service Registry Number (CASRN) (if non-confidential) for each PMN.
Statutory Authority and Significant New Uses under the Proposed SNURs
EPA may promulgate a SNUR for a substance when (1) the substance is the subject of a section 5(e) Consent Order (40 CFR §721.160), or (2) the Agency determines that activities other than those described in the PMN may result in significant changes in human exposure or environmental release levels and/or that concern exists about the substance's health or environmental effects (40 CFR §721.170). In contrast to PMN requirements, which apply mainly to manufacturers and importers (TSCA § 5(a)(1)(A), 40 CFR §720.22), the SNUR applies to processors as well as to manufacturers and importers (TSCA § 5(a)(1)(B), 40 CFR §721.5).
Each substance analyzed here was the subject of at least one premanufacture notice submitted under the Toxic Substances Control Act (TSCA), and is now being regulated as a result of PMN review. For the current rulemaking, three of the 23 chemicals have commenced commercial manufacture or import and so are listed on the TSCA Inventory; they are no longer "new" chemicals. For chemicals in this type of rulemaking, SNUR requirements are sometimes based on past Consent Orders entered into with a PMN or SNUN submitter under TSCA Section 5(e). For the current rulemaking, SNUR requirements for 9 of the 23 substances are based on prior Consent Orders.
EPA promulgates a SNUR to designate specific activities involving the chemical substance that EPA has determined constitute a "significant new use." No person may manufacture or process a chemical substance for a significant new use, unless they submit a significant new use notice (SNUN) to EPA at least 90 days in advance. Examples of typical "significant new uses" that can trigger the requirement to submit a SNUN (if EPA has promulgated a SNUR applying these requirements to a specific chemical) include:
   * Domestic manufacture in the United States
   * Manufacture of a particular aggregate or annual volume
   * Use other than that specified in the PMN
   * Releases to water resulting in a surface water concentration exceeding a specified amount
   * Handling the chemical without employing specified personal protective equipment (e.g., gloves, goggles, respirators) or hazard communication (haz-comm) measures (e.g., label, MSDS, worker training) 
If EPA does not promulgate a SNUR for a given chemical, then these requirements would not apply (unless they apply to a PMN submitter via a §5(e) Consent Order). If EPA has promulgated a SNUR containing these types of significant new use designations, as long as the person does not engage (nor intend to engage) in any activities defined by the SNUR as a significant new use, then that person may proceed to handle the chemical without submitting a SNUN. 
Summary of Methodology
This analysis quantifies, to the extent possible, the costs to society of the proposed rule by identifying the costs to industry associated with complying with the rule, and the costs to EPA of administering the rule. Types of industry costs analyzed include those for worker protection, hazard communication, testing, submission of required information, export notification, and recordkeeping. Agency costs include reviewing and processing the data received as a result of the rule. Data sources for this analysis include burden estimates derived from previous information collection requests and economic analyses for related rules, compensation data acquired from government publications, and supplementary market research to produce an estimate of the universe of affected entities and measure the impact of the proposed rule on small entities.
In previous economic analyses of SNURs, EPA identified those requirements under Subparts A, B, C, and D of 40 CFR §721 that may indirectly impose costs on manufacturers, importers, and processors of PMN substances (e.g., EPA, 1989). Some of these costs, such as providing personal protective equipment under §721.63, were estimated in earlier SNUR economic analyses and are presented as part of this analysis. Resources were not available to quantify other costs, such as for limiting releases to water, avoiding uses not listed in the PMN, or keeping production below a specified level; they are described only qualitatively.
It was not feasible within available resources to aggregate costs, or to estimate how often costs are actually incurred as a result of SNURs, except for costs of SNUN submissions.
Organization of this Report
The remainder of this report estimates the quantified portion of costs potentially associated with SNURs such as those included in this rulemaking. Chapter 2 presents estimates of the costs that could be incurred by manufacturers, importers, and/or processors under the various SNUR options. Chapter 3 addresses export notification costs. Chapter 4 addresses costs to EPA of administering the SNURs, while Chapter 5 presents an analysis of other impacts, as required by various statutes and executive orders. Appendix A lists the chemicals that are subject to the proposed SNURs. Appendix B provides the wage rates and inflators used in this analysis. Other appendices give cost estimation details and references.


Costs of a Significant New Use Rule (SNUR), by Option
A SNUR specifies requirements that a firm must meet if it chooses to manufacture, import, or process a PMN chemical without engaging in a Significant New Use that would trigger notification to EPA. A SNUR also requires recordkeeping for anyone manufacturing, importing, or processing the SNUR chemical. A SNUR recommends testing, but does not require testing. EPA rarely receives results of tests performed specifically to support a SNUN. Table 1 sets forth possible responses to a SNUR. A firm may select more than one course of action. For example, it may produce a chemical in a way that avoids a Significant New Use, while simultaneously submitting a Significant New Use Notice for a proposed new use. These options are described below along with their costs.
Table 1. Summary of Compliance Options and Associated Costs Potentially due to a SNUR 
Option[1]
Costs
Quantified Costs per Chemical (2011$)[2]
1
Manufacture, import, or process in a way that avoids a Significant New Use, such as limiting water releases, engaging in PMN uses only, importing only, limiting volumes, providing workplace protection, or providing hazard communications.
All SNUR chemicals require ongoing recordkeeping. In addition, many SNUR chemicals may involve costs of complying with water release restrictions and foregoing non-PMN uses; these costs were not quantified for this report. Costs for worker protection and hazard communication apply to relatively few chemicals, but are quantified.
Typically, annual costs for recordkeeping are under $1,188. For the few SNUR chemicals where these apply, annual costs for worker protection may be $37,395 or more and for haz-comm is $1,084.
2
Submit a request for modification or revocation of the SNUR (§721.185).
Costs of submitting a request for modification or revocation, including costs of developing supporting data (e.g., testing, if needed).
$6,037  submission cost plus any testing costs.[3] EPA receives very few such requests, typically 0-3 per year
3
Electronic submission of a Significant New Use Notice (SNUN), indicating to EPA that the firm would like to manufacture, import, or process the chemical for a Significant New Use as defined in the SNUR.
Costs of electronically submitting a SNUN (including SNUN recordkeeping and user fee[4]) plus ongoing recordkeeping. Rarely, a firm may choose to conduct toxicity or fate testing to support the SNUN, but such testing is not required by law.
$8,537 submission cost (including SNUN recordkeeping and $2,500 fee)[4,5] plus ongoing recordkeeping costs of under $1,188. EPA usually receives well under ten SNUNs in a year. Based on review of recent SNUNs, it appears that firms rarely conduct toxicity or fate testing to support a SNUN (such testing would be voluntary).
4
Petition EPA for an equivalency determination to consider alternative controls to prevent release or exposure that are equivalent to those identified in the SNUR (§721.30).
Costs of submitting an electronic request for equivalency determination.
$6,037  one-time submission cost.
5
Do not manufacture, import, or process the substance except for R&D (the R&D exemption is covered in 40 CFR §721.47).
Cost of profits foregone due to delaying or avoiding commercial activity that would otherwise be pursued. R&D recordkeeping costs if manufacture for R&D.
Costs not quantified.
Notes: Section numbers refer to 40 CFR §721 (in the Code of Federal Regulations). Costs come from Table 3 through Table 8. 
[1] Firms may follow multiple Options simultaneously.
[2] Quantified costs are attributable to the SNUR Significant New Use definition only if a firm would not otherwise follow the specified practices. $37,395 is the annual cost for dermal protection selection; impermeability testing, heavy-duty gloves, and a lower-cost respirator (see Table 5). Some firms may have export notification costs (see Chapter 3 of this report).
[3] See Appendix D for costs of individual tests recommended in current and recent SNURs.
[4] EPA charges a nominal flat fee of $2,500 for a PMN or SNUN submission. 
[5] SNUR chemicals not on the TSCA Inventory are "new" chemicals requiring a PMN, so some firms may need to make a submission before commercial production or import, even in the absence of a SNUR (see Section 2.3 of this report).

Comply with SNUR Limits (Option 1)
A firm can avoid engaging in a Significant New Use and submitting a SNUN by meeting all applicable SNUR requirements. The firm may also pursue this option temporarily by complying with SNUR restrictions while also pursuing other options such as making a submission to EPA. If it does avoid engaging in a Significant New Use (and if the chemical is on the TSCA Inventory or if the firm has already submitted a PMN), no notice to EPA is required. Table 2 shows the types of requirements a firm must meet to avoid engaging in a Significant New Use. 
The Significant New Use designation in a SNUR for a specific chemical reflects either the use scenario described in the PMN for that chemical (what the submitter was already planning to do) or the requirements in the 5(e) Consent Order resulting from the PMN submission. Thus, it is likely that the typical PMN submitter will incur no added costs of complying with the SNUR requirements so as to avoid a Significant New Use. However, if there is any export of these chemicals, there will be export notification costs that result from the TSCA Section 12 (b) requirements that are automatically triggered for chemicals regulated under TSCA Section 5 (see Chapter 3 for details).
Table 2. Production and Use Restrictions/Requirements
40 CFR Reference (Code of Federal Regulations)
Restriction/Requirement
Number of Chemicals Affected[1]
Sample Costs Per Chemical
(2011$)
§721.63
Workplace protection
                                       3
                              $12,428 to $37,395
§721.72
Hazard communication
                                       3
                                    $1,084
           Industrial Commercial, and Consumer Activities (§721.80)
§721.80(a, b, c) 
Enclosed use only
                                       0
                                Not quantified
§721.80(d, e) 
Use at site only
                                       0
                                Not quantified
§721.80(f)
Import only (do not manufacture)
                                       0
                                Not quantified
§721.80(g, h, i)
Use only as intermediate
                                       2
                                Not quantified
§721.80(j, k)
Engage only in uses listed in PMN or Consent Order
                                      13
                                Not quantified
§721.80(l, m, n, o)
Limits non-industrial uses
                                       0
                                Not quantified
§721.80(p, q, s, t)
Limit production volume
                                       3
                                Not quantified
§721.80(r, u)
Volume-triggered testing
                                       3
                                Not quantified
§721.80(v, w, x, y)
Restricts physical form of chemical
                                       1
                                Not quantified
                    Disposal, water release, recordkeeping
§721.85
Disposal
                                       0
                                Not quantified
§721.90
Limit releases to water
                                       4
                                Not quantified
§721.125[3]
Recordkeeping for all manufacturers,  importers, and processors
                                      23
                                 Up to $1,188
Notes:
[1] Some chemicals have more than one type of restriction.
2 $12,428 is the annual cost for dermal protection selection and heavy duty gloves. $37,395 is the annual cost for dermal protection selection; heavy duty gloves, impermeability testing/evaluation of manufacturer specifications, and a lower-cost respirator (see Table 5).
[3] This excludes SNUN recordkeeping under §721.40. See the recordkeeping discussion in Appendix C.
Source: Costs are summarized in Table 3, Table 4, and Table 6, and derived in Appendix C.
The costs of meeting the haz-comm, protective equipment, and recordkeeping requirements are quantified for this report. Appendix C presents a more detailed derivation of these costs. The export notification costs are summarized in Chapter 3. Complying with requirements to avoid a Significant New Use also may result in additional costs that affect a significant number of the chemicals, such as costs associated with limiting releases to water, that were not quantified for this report; these costs are also summarized below.
Hazard Communication
Requirements. Each SNUR may require firms that manufacture, import, or process one of the PMN substances to implement a haz-comm program for the applicable chemical, or else submit a SNUN. For purposes of the economic analysis, it is assumed that each facility has in place a haz-comm program consistent with that required by OSHA's Hazard Communication standard (29 CFR 1910; November 25, 1983). Much of the haz-comm cost methodology used in this analysis came from a 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Followup (EPA, 1989). The cost estimates provided here are for one chemical produced at one site, assumed to have 25 exposed workers and roughly a 10,000 kilogram annual shipment volume. Higher volumes would increase costs, although not necessarily proportionately. The major elements of a haz-comm program that could apply to a SNUR chemical, based on the requirements in §721.72, are:
   * Revision of the existing written haz-comm program to incorporate information about the chemical [§721.72(a)];
   * Creation of labels and application of labels to containers used for distributing the chemical in commerce [§721.72(b)];
   * Creation of labels or signage and posting of hazard data in areas of the facility where the chemical is used or stored [§721.72(b)];
   * Creation and distribution of material safety data sheets (MSDSs) [§721.72(c)]; and
   * Employee awareness training on where and how the chemical is used, the hazards associated and availability of hazard information about the chemical, and protective equipment and other measures in place to reduce and minimize exposure to the chemical [§721.72(d)].
Costs. The annual costs of compliance with the haz-comm requirements for PMN substances subject to haz-comm requirements appear in Table 3. Further, the costs are for substances with full haz-comm requirements, and may overstate haz-comm costs for substances with partial requirements. Appendix C gives the detailed cost derivation.
Table 3. Annual Costs of Hazard Communication Requirements
Requirement
Cost
(2011$)[1,2]
Hours
Update written program
                                     $206
                                       4
Labeling
Distribution in commerce
                                     $140 
                                      0.5

Use in the workplace
                                     $383 
                                      1.5
MSDS preparation
                                     $141 
                                     2.25
Employee training
                                     $214 
                                     6.75
TOTAL
                                    $1,084 
                                      15
Notes: 1 Figures are rounded to whole dollars. Substances not subject to all of these requirements may have lower costs. See Table C-1 through Table C-4, and Section C.1.1 for derivations.
[2] Hourly labor costs are derived in Table B-1.
Protection in the Workplace
Requirements. Under 40 CFR §721.63, manufacturers, importers, or processors must comply with worker protection requirements as specified in the SNUR on the regulated chemical, or else submit a SNUN. The core components of the worker protection requirements include provision of personal protective equipment (PPE) such as gloves, goggles, protective clothing, and respirators.
In some cases, EPA specifies the type of PPE required. In other cases, EPA requires adequate dermal protection but does not specify particular PPE. Instead, it requires the employer to evaluate worker exposure conditions and hazards, and select appropriate PPE. Generally the employer is also required to determine that dermal PPE is impervious to the PMN substance by one or both of the following methods: (1) perform impermeability testing on the PPE under the expected conditions of exposure, and/or (2) rely on equipment manufacturers' specifications. Employers not already providing adequate dermal protection would need to do so.
Costs. Annual costs for worker protection items are shown in Table 4 below. The derivation of the sample minimum and maximum annual costs for worker protection is found in Table 5. The costs of worker protection were originally estimated in a 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow-Up (EPA, 1989), as a range of costs, depending on the assumed number of worker-days of exposure. This report uses the high end of the assumptions about worker-day exposure, updated to adjust for inflation. The estimates are for one chemical at one site with 25 exposed workers; actual costs would vary with the number of workers. Appendix C gives the detailed cost derivation.
Table 4. Annual Costs of Workplace Protection Requirement
Personal Protective Equipment and Requirement Citation at 40 CFR
Unit Cost (2011$)[1]
Quantity Required[1]
Total Annual Cost[2] 
(2011$)
Dermal Protection Selection §721.63(a)(1)
     10 hours industrial hygienist (IH) time
                                   $51.53 	
                                      10
                                     $515
Impermeability Testing §721.63(a)(3) 
     Impermeability Test
                                    $1,332 
                                       1
                                    $1,332 
     Evaluation of Manufacturer's Specifications    
                                     $206 
                                       1
                                     $206 
Gloves §721.63(a)(2)(i) 
     Standard (disposable)
                                    $0.60 
                                     6,250
                                    $3,767 
     Heavy-duty butyl
                                    $47.65 
                                      250
                                   $11,913 
Protective clothing §721.63(a)(2) 
     [ii] - Full-body (coverall with hood)
                                    $85.77 
                                      75
                                    $6,433 
     [iv] - Coverall (no hood)
                                    $50.80 
                                      75
                                    $3,810 
Eyewear §721.63(a)(2)(iii) 
     Standard goggles
                                    $5.68 
                                      75
                                     $426 
     Heavy-duty goggles
                                    $8.48 
                                      75
                                     $636 
Respirator Types3  
Supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting full facepiece. [similar to §721.63(a)(5)(ii)]
                                    $1,127 
                                      25
                                   $28,171 
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). [similar to §721.63(a)(5)(iii)]
                                    $1,306 
                                      25
                                   $32,660 
Air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters.[similar to §721.63(a)(5)(iv)]
                                     $937 
                                      25
                                   $23,428 
Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters. [similar to §721.63(a)(5)(iv)]
                                     $937 
                                      25
                                   $23,428 
Powered air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. [similar to §721.63(a)(5)(v)]
                                    $3,367 
                                      25
                                   $84,175 
Powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters. [similar to §721.63(a)(5)(v)]
                                    $3,367 
                                      25
                                   $84,175 
Powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters. [similar to §721.63(a)(5)(vi)] 
                                    $2,621 
                                      25
                                   $65,517 
Notes:
1 Quantities assume: 1) 25 workers exposed 250 days per year; 2) standard gloves replaced daily and heavy-duty gloves replaced every 25 days; 3) respirator units replaced annually and cartridge sets replaced every five days (50 cartridges sets per year); 4) goggles and protective clothing replaced three times yearly. 
2 Total annual costs were calculated using unrounded unit cost estimates, and may not equal the product of the rounded estimates shown in this table.
3 This table lists respirator choices that typically would satisfy SNUR requirements for a particular chemical, for current and recent SNURs. Future SNURs may list different choices. The citations in brackets refer to respirator types listed at 40 CFR. While the SNURs no longer reference the §721.63(a)(5) categories, costs in this analysis are based on costs estimated in 1997 for the §721.63(a)(5) categories. See Table C-10 for the crosswalk between respirator types in SNURs and in this table. The respirator "unit cost" is per worker. Total respirator costs include costs of the respirator plus the costs of any add-on items such as hoods, helmets, cartridges, filters, and caps, if these items are required for a particular respirator. 
Source: Appendix C, Tables Table C-5 through Table C-11. 

The costs of purchasing protective equipment are derived in Appendix C, and have been annualized based on the assumptions listed above regarding their use and lifetime in the workplace. Costs for evaluating hazards when PPE is not specified in the SNUR are based on estimates of the reasonable time required for a safety professional to perform such evaluations. Costs for conducting impermeability testing are based on consultation with PPE vendors, as described in Appendix C. Table 4 summarizes the annual costs associated with protection in the workplace, including the PPE itself, as well as selecting required dermal protection, and performing impermeability testing and/or evaluating manufacturer's information.
Table 5 shows a sample of the minimum and maximum annual cost of workplace protection, assuming 25 workers who are exposed for 250 hours per year. The minimum cost includes the cost of heavy-duty butyl gloves, and 10 hours of an industrial hygienist's time for dermal protection selection. The maximum cost includes the cost of gloves, dermal protection, impermeability testing, and the annual cost of the least expensive respirator and filters for 25 workers. 
Table 5. Sample Costs of Workplace Protection
Cost Element 
Annual Cost (2011$)
Example #1: Gloves and Dermal Protection Selection
                                       
      Heavy-duty butyl Gloves 
                                    $11,913
      Dermal Protection Selection
                                     $515 
                                                 Total per site with 25 workers
                                   $12,428 
Example #2: Gloves , Testing, and Respirator
      Heavy-duty butyl Gloves
                                   $11,913 
      Dermal Protection Selection
                                     $515 
      Impermeability Test
                                    $1,332 
      Evaluation of Manufacturer's Specifications    
                                     $206 
      Least Cost Respirator 
                                   $23,428 
                                                 Total per site with 25 workers
                                   $37,395 
Source: Table 4.
In cases where the SNUR specifies the type of protective gear, the estimates assume workers would not otherwise wear adequate protective equipment. To the extent that workers would otherwise be adequately protected (as a result of the company's own safety program related to other chemical hazards, or to comply with OSHA's PPE standards), these costs may be an overestimate of the actual costs.
In some cases, the SNUR requires dermal protection but does not specify any particular gear, allowing regulated companies to make that determination. Table 4 shows costs of assessing needs and demonstrating impermeability. These cost estimates would reflect a situation where the dermal protection is already in place but the manufacturer must demonstrate that it is adequate. If companies also have to purchase additional protective gear, incremental costs attributable to the SNUR would include the added items. For example, if a firm already providing gloves and goggles determined that it would have to add protective clothing to avoid engaging in a Significant New Use, this would increase costs even if particular protective clothing is not specified in the SNUR.
Recordkeeping
Requirements. Under 40 CFR §721.40, recordkeeping is required for SNUN submitters. This recordkeeping cost was included in the SNUN submission cost and is not separately estimated here.
In addition, the SNURs specify recordkeeping requirements for manufacturers, importers, and processors, by identifying paragraphs selected from 40 CFR §721.125(a) through (k). These recordkeeping requirements apply even if the firm does not engage in a reportable New Use or make a submission to EPA, so long as it manufactures, imports, or processes the chemical. The recordkeeping requirements vary by chemical. For example, only chemicals that must establish a Hazard Communications program to avoid a Significant New Use would be required to keep records documenting their haz-comm program. (For firms producing under the R&D exemption, R&D recordkeeping would be needed. R&D recordkeeping costs were not estimated for this report.)
SNUR 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 disposal and water discharge limitations; and/or compliance with restrictions on volumes, nature of manufacture or use, or on the chemical's physical form (powder, liquid etc.).
Costs. Annual costs for compliance with 40 CFR §721.125 recordkeeping requirements are low, but do potentially apply to all SNUR chemicals, and the recordkeeping could continue for years. Costs are presented in Table 6 and derived in Appendix C. They are estimated for one chemical at one site, and include technical and clerical labor time, photocopying charges, and costs for records storage.
Table 6 summarizes recordkeeping costs by requirement at 40 CFR §721.125. The totals in Table 6 provide the cost if all recordkeeping requirements in paragraphs §721.125 (a) through (k) were required; this would seldom, if ever, be the case for a single chemical.
Table 6. Annual Costs of Recordkeeping Requirements (40 CFR §721.125)
                               40CFR §721.1252
                                 Cost Element
                                Cost (2011$)[1]
                                     Hours
                                   (a)(b)(c)
Volumes & sales/transfer data
                                     $336 
                                     7.11
                                    (d)(e)
Protective clothing [§721.63] and impermeability [§721.63(a)(3)]
                                    $13.86 
                                     0.29
                                      (f)
Haz com program [§721.72]
                                     $173 
                                     3.67
                                      (g)
Label copies [§721.72(b)]
                                    $3.46 
                                     0.07
                                      (h)
MSDS copies [§721.72(c)]
                                    $3.46 
                                     0.07
                                      (i)
Use limitations compliance [§721.80]
                                     $173 
                                     3.67
                                      (j)
Disposal compliance [§721.80]
                                     $416 
                                     8.80
                                      (k)
Water discharge compliance [§721.90]
                                    $69.28 
                                     1.47
                                                                          TOTAL
                                    $1,188
                                     25.15
Notes:
1 Recordkeeping applies to all SNUR chemicals. This table does not cover recordkeeping for SNUN submissions. See Appendix C Table C-14 for derivations.
Hidden Costs: production volume limits, limiting releases to water, PMN uses, import-only, and disposal
Several types of costs that may be incurred by complying with the significant new use designations are not quantified in this report, including production volume limits, releases to water, disposal, and other use restrictions. For example:
   * Keeping production volume below specified limits to avoid a Significant New Use could result in a decrease in profits; a potential "hidden" cost. A firm producing for sale may have to restrict its sales of the chemical. If the chemical is for internal use, it may have to substitute to a less cost-effective chemical.
   * A producer could incur costs of determining whether discharges to water would constitute a Significant New Use and of limiting releases in order to avoid the Significant New Use.
   * Similarly, avoiding uses not listed in the original PMN could result in "hidden" costs of foregone profits if the firm cannot market the chemical for certain applications. If the firm wants to use the chemical for internal use, it may have to substitute to other chemicals or technologies that cost more or have lesser performance resulting in higher production costs.
   * Importing could be costlier than manufacturing a PMN substance in the United States.

 Request Modification or Revocation of a SNUR (Option 2)
Under 40 CFR §721.185, EPA may modify or revoke a SNUR upon review of a submittal from a manufacturer, importer, or processor. Consequently, the second option for a firm is to request modification or revocation of the SNUR. According to New Chemical Program records EPA receives few modify/revoke requests (typically up to three per year) due to SNURs. 
This option may have some or all of the following associated costs:
   * One-time costs of testing to develop health and environmental effects data for a chemical subject to the SNUR; 
   * One-time costs of submitting a request for modification or revocation;
   * Ongoing costs of complying with SNUR restrictions (Option 1 in this report) or of avoiding production while the modification request is being processed (Option 5). The firm may also incur costs of complying with any SNUR restrictions that are not ultimately revoked or may incur hidden costs of avoiding production altogether.
These costs are discussed below.
Costs of Developing and Submitting Testing Data
40 CFR §721.185(b)(1) requires that a modification request include "information sufficient to support the request." For each PMN substance, the SNUR identifies health, ecological, and/or fate/transport/transformation testing that would help characterize the risks associated with the substance. However, there is no requirement for a requester to perform the recommended tests or even to perform testing at all. It is possible that some of the recommended tests, or other tests, would be performed by the submitter to support a request for modification and revocation of a SNUR. For informational purposes, costs for various tests recommended in SNURs over the years are listed in Appendix D. If no additional testing is performed to support a modification request, costs may be similar to costs of a SNUN  -  discussed later in this section  -  minus the user fee.
Table 7 below provides an example of potential costs if a firm were to perform a standard set of basic ecotoxicity tests to support a request to modify or revoke a SNUR. 
Table 7. Sample Costs of Recommended Testing 
Test Guideline
Test Description
Estimated Cost
(2011$)
Ecotoxicity Base Set
  OPPTS 850.5400
Algal Toxicity, Tiers I and II
                                   $18,873 
  OPPTS 850.1010
Daphnid Acute Toxicity
                                   $15,619 
  OPPTS 850.1075
Fish Acute Toxicity
                                   $21,524 
                                                     Sample TOTAL Testing Cost:
                                    $56,016
Source: Costs are from Table D-1.
Costs for Submitting a Request for Modification or Revocation of a SNUR
The costs associated with submitting a request for modification and revocation of a SNUR (or of submitting a SNUN) are estimated to be similar to the costs for preparing a PMN submission, except that there is no user fee for the modify/revoke request. The PMN submission costs came from EPA's 1994 Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications, which relied on industry estimates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, submit the form and data to EPA, and maintain a file of the submission (EPA, 1994, Table III-2 and pages III-11, -12, and -13). The 1994 estimates were based on a survey conducted by the Chemical Manufacturers Association (CMA, 1991), which became the American Chemistry Council. The burden associated with PMN submission and preparation has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices.  Electronic submission of SNUN forms is expected to remove all clerical burden associated with preparing a SNUN (EPA, 2009a, p.7). In addition, electronic submission is expected reduce all recordkeeping burden associated with SNUN submissions by fifty percent. Because, the recordkeeping burden for PMNs was not estimated separately, for the purposes of this report we assume this burden reduction is captured in the removal of all clerical burden.
In the 1994 EPA report, the average effort required to prepare and submit a PMN was 95 to 114 hours. This burden is reduced to 83 to 100 hours after accounting for the ePMN savings (EPA, 2009a). This included recordkeeping for the submission, but the recordkeeping cost was not broken out. For this analysis, the costs of a preparing a SNUN were derived using the averages of the hours for each type of labor from the 1994 report, after adjusting for the ePMN savings. The method of calculating hourly loaded labor costs is described in Appendix B.

Other Costs
EPA's review of the submitter's request may cause delays in the start of manufacturing or processing activities. Such delays could cause the company to forego opportunities to earn profits for the duration of the review period. Alternatively, the submitter may elect to produce under the constraints of the SNUR during the review period, so as to avoid a Significant New Use. EPA may not revoke all SNUR provisions as a result of the request. If the company is allowed to continue production and chooses to do so, it would bear costs of complying with any SNUR restrictions that are not revoked. Costs of complying with SNUR restrictions pending EPA modification or revocation were discussed under Option 1.
Table 8. Costs of Requirement to Modify/Revoke SNUR or Submit SNUN 
Labor Category
Average Hours
Loaded Wage Rate[1] (2011$)
Total Labor Cost  (Loaded Wage x Average Hours)



Request to Modify SNUR 
(Option 2)
SNUN (Option 3)
Equivalency Determination (Option 4)
Clerical[2]

                                       0
                                    $29.63 
                                      $0
                                      $0
                                      $0
Technical[3]

                                     74.2
                                    $64.66 
                                    $4,798
                                    $4,798
                                    $4,798
Managerial[3]

                                      18
                                    $70.72 
                                    $1,273
                                    $1,273
                                    $1,273
Subtotal

                                     92.2
                                      --
                                    $6,071
                                    $6,071
                                    $6,071
                             User Fees (SNUN only)
                                      $0
                                    $2,500
                                      $0
                                     TOTAL
                                    $6,071
                                    $8,571
                                    $6,071
                                  Test Costs
                                   Sometimes
                                    Rarely
Notes:
1 Loaded wages include fringe benefits and overhead. See Appendix B of this report for derivation. Wage rates presented in this table are rounded values; however, unrounded values are used to calculate total labor costs. For this reason, total labor costs may not equal the product of rounded values.
[2] The estimate of no clerical burden is taken from the Economic Analysis of the Premanufacture Notice Electronic Reporting Final Rule (EPA, 2009a, page 7).
3 Hours range for each technical and managerial labor is from the PMN Amendments RIA (EPA, 1994, Table III-2).
Total Costs for Option 2
The total costs associated with requesting a modification or revocation of a SNUR include the costs of generating new supporting data plus the administrative cost of preparing the submission.
Submit SNUN (Option 3)
Under 40 CFR §721.5, manufacturers, importers, or processors who would like to undertake a Significant New Use of a substance listed in a SNUR are required to submit a Significant New Use Notice (SNUN) at least 90 days before the firm plans to commence the manufacture, import, or processing of the substance. For example, they could submit a SNUN if they wish to produce above the volume limit listed in the SNUR for a given chemical, since any production beyond that volume would be defined as a Significant New Use.
The SNUN provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The notice form used to submit a SNUN is the same as that for a PMN, and the costs of submitting a SNUN are estimated based on the costs incurred to submit a PMN.
This option could have the following costs:
   * One-time costs of the SNUN and $2,500 user fee. (However, in some cases, a notification may be needed for reasons other than the SNUR; see Section 2.3.1 below.)
   * Ongoing costs of complying with SNUR restrictions to avoid engaging in a Significant New Use (Option 1 in this report) or of avoiding production while the SNUN is being processed (Option 5); costs of recordkeeping, and of complying with any restrictions resulting from the SNUN review.
   * Rarely, the SNUN submitter may elect to perform some of the testing recommended in the SNUR as a way to characterize effects of a chemical. These tests are not mandatory, and firms do not usually conduct testing to support a SNUN, so any such costs are likely to be zero or low. 
The assumption regarding testing is based on an analysis of the 18 SNUNs submitted over a three-year period, from 2005 through 2007. A list of human health tests submitted to EPA with PMNs and SNUNs was also available from a confidential database maintained by EPA's Office of Pollution Prevention and Toxics Risk Assessment Division. Only one SNUN described toxicity or environmental fate testing that seemed reasonably likely to have been performed to support a SNUN. In that case, two relatively low-cost tests (fish acute toxicity and daphnid acute toxicity) may have been conducted to support a SNUN, although it is also possible that the testing was done for some other reason not apparent in the SNUN itself. A substantial portion of the SNUNs did provide or reference test results. However, in almost all cases, the testing appeared to have been conducted for reasons other than a SNUR. For example, the SNUN might include laboratory reports that had already been submitted for a PMN for the same chemical.
SNUR "New" Chemicals
If a SNUR chemical is not on the TSCA Inventory and a potential manufacturer or importer has not yet filed a PMN, submission costs may be incurred but are not attributable to the SNUR.
All SNUR chemicals in this rulemaking were the subject of at least one PMN. For PMN chemicals to be added to the TSCA Inventory, manufacturing (or import) must have commenced, with notification to EPA through a Notice of Commencement, or NOC. Thus, SNUR chemicals not yet in commercial manufacture (or import) are not on the TSCA Inventory. They legally remain "new" chemicals subject to PMN requirements.
For "new" chemicals, firms who have not yet submitted a PMN must notify EPA 90 days before manufacturing/importing the chemical for commercial purposes. This submission is still designated a PMN but may contain information demonstrating the submitter intends to engage in a significant new use. Either way, the firm uses the same submission form and provides the data listed at 40 CFR §720.45. Consequently, for this special situation, the submission cost is incurred due to PMN requirements, not due to the SNUR. (See EPA's 1997 Chemistry Assistance Manual for Premanufacture Notification Submitters for an overview of New Chemicals requirements [EPA, 1997]).
Advance Compliance Exemption
Another option available to firms before the SNUR is promulgated is to seek an advance compliance exemption under 40 CFR §721.45(h). The submission cost for this option is the same as that for a SNUN, but by negotiating an advance compliance agreement with EPA a firm might diminish any loss of profits due to delay. This option is not available after the SNUR is promulgated.
Costs for Submitting a SNUN
As with Option 2 above (Request Modification or Revocation of a SNUR), the costs for submitting a SNUN are estimated to be equivalent to the costs of completing a PMN submission. If the SNUN is submitted at the same time as a request to modify a SNUR (Option 2), the added cost would be less than shown here due to overlap in information in the two submissions. Table 8 shows the costs of preparing a SNUN.
Potential for Subsequent Regulatory Actions
The Agency recognizes that if submission of a SNUN does result from a SNUR, the Agency may take additional regulatory actions under TSCA. These additional regulatory actions might be necessary to further evaluate an intended new use and associated activities, or to prohibit or limit that activity before it occurs to prevent unreasonable risk of injury to human health or the environment. It is not known what specific subsequent regulatory actions, if any, the Agency may determine are necessary after reviewing a SNUN. Any such actions are highly dependent on the circumstances surrounding the individual SNUN (e.g., available information and scientific understanding about the chemical and its risks at the time the SNUN is being reviewed). 
Should the Agency's review of the SNUN result in further regulatory actions, the Agency will initiate and follow the appropriate procedures for taking those actions. Included in those procedures would be an assessment of the costs and benefits of those actions. 
Subsequent regulatory action may be a Consent Order under TSCA Section 5(e). Assessments of costs and benefits for a Consent Order would be limited, similar to those supporting PMN reviews leading to Consent Orders, in contrast to the in-depth benefit-cost analyses prepared under some other TSCA Sections. 
The description above was adapted from text in Economic Analysis of the Significant New Use Rule for Chloranil, January 8, 2008, Section 2.4; and Economic Analysis of the Final Significant New Use Rule for 183 Perfluoroalkyl Sulfonates, August 20, 2007, Section 3.4. Both reports are from the U.S. EPA Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. The nature of the follow-up regulatory action and benefit/cost analysis may differ between SNUNs for newer chemicals submitted as a result of a direct final rulemaking such as this one, and SNUNs for older chemicals such as chloranil and most perfluoroalkyl sulfonates.
Request Equivalency Determination (Option 4)
Under 40 CFR §721.30, EPA may review applications from facilities who propose alternative methods of controlling or preventing exposures or releases to those specified in the SNUR. In these cases, EPA evaluates the alternatives using an abbreviated review process. As shown in Table 8, the costs of submitting an equivalency determination request are expected to be the same as those for submitting a SNUN except that no user fee is required.
For this option the EPA review period is 45 days compared to 90 days for a SNUN, therefore any potential loss of profits due to delays may be less than for a SNUN under Option 3.
In addition to the costs of submitting the equivalency determination request, each submitter will also incur costs to develop data to support the request. However, total costs of the equivalency option should be no more than the costs of complying with controls in the SNUR to avoid a significant new use -- for example, controls related to workplace protection or environmental release. Otherwise, presumably there would be no incentive for the submitter to choose this alternative. Finally, to produce the chemical following EPA review, the submitter would incur costs from recordkeeping and from any restrictions not waived (see Option 1).
Decide Not to Produce Chemical (Option 5)
Some firms may find that the costs of meeting the SNUR requirements and/or restrictions (Option 1) or preparing a SNUN or other submission (Options 2, 3, or 4) are financially unattractive. In these cases, the firm could choose not to manufacture, import, or process the PMN substance.
While this option avoids the costs of meeting the specifications in the SNUR or submitting a request for some alternative, it entails the "hidden" cost of the profit that will be foregone as a result of not engaging in the commercial activity originally planned. For example, if the firm does not produce the SNUR substance, then it will forego the profit it would have achieved by producing it. That foregone profit is a potential "hidden" cost of Option 5. Similarly, if the firm would have used the SNUR substance in the production of another product and must substitute to a more costly substance, it will incur those additional costs of production. If the firm elects to produce for R&D purposes only, it may have costs associated with R&D recordkeeping attributable to the SNUR.
Firms that exercise Option 5 may still incur export notification costs, if they export any existing stockpiles of the product. This cost is quantified in Chapter 3 below.
Summary of Costs for Each Option
Table 1, above, gave an overview of compliance options. Table 3 through Table 6 summarized the quantified portion of potential costs of either following restrictions to avoid engaging in a Significant New Use, or of making a submission to EPA. Table 7 presented sample testing costs. Costs are for one chemical at one site, and  -  where volume is relevant  -  are based on standard assumptions that include 25 exposed workers per site and, for haz-comm costs, annual shipments of about 10,000 kilograms per site. Costs are not otherwise adjusted for the nature of the chemical or process, volume, location, or other firm-specific or chemical-specific factors.
As mentioned above, costs are estimated for one chemical at one site, not for aggregate production. Resources were not available to estimate aggregate costs. Among other things, it is not known how many firms are affected by the SNURs. EPA receives a handful of Significant New Use Notices per year due to SNURs. However, if a SNUR chemical is on the TSCA Inventory, a firm may use the chemical in a way that avoids a Significant New Use (Option 1), and never make a submission. It is not known how many firms are affected but do not make a submission. Also, it is not known whether firms avoid the chemical altogether specifically due to the SNUR. However, at least for the years immediately following SNUR promulgation, these numbers are likely to be small. This is because the chemicals in this type of SNUR rulemaking are still relatively new  -  as Appendix A indicates, most were submitted to EPA as PMNs in the past four Federal fiscal years  -  and, in addition, often have confidential chemical identities. 
   * For firms manufacturing, importing, or processing within SNUR restrictions to avoid a Significant New Use (Option 1), quantifiable costs can range from about one thousand dollars (if the only added cost is for recordkeeping) to over $35,000 per chemical if the firm must add worker protection measures such as gloves, protective clothing, and respirators that it would not otherwise use. Most chemicals are also subject to costs that could be significant but are not quantified in this report, such as restrictions on releases to water or on other aspects of use.
   * For submissions to EPA (Options 2, 3, and 4), the basic one-time submission cost is estimated at $5,834, including recordkeeping for the submission. For the SNUN (Option 3), EPA also collects a $2,500 fee. 
   * One objective of the rule is that EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. Consequently, after submitting a SNUN, the firm may need to comply with restrictions as a result of the SNUN review process, possibly leading to further costs similar to those in Option 1.
   * Rarely, firms may choose to perform toxicity and/or environmental fate testing to support a SNUN (Option 3). Such testing is not mandatory. Costs for such testing are expected to be zero for most SNUNs and expected to be low for the few SNUNs for which a submitter might voluntarily perform such testing.
   * Companies that might have manufactured, imported, or processed a chemical in the absence of the SNUR may incur "hidden" costs, such as loss of profits from delayed or foregone sales, if they avoid the chemical altogether (Option 5). These costs were not quantified.
   * Companies may incur costs from more than one Option, for example if they temporarily produce in conformance with SNUR restrictions while submitting a SNUN and waiting the required 90 days plus any extensions.
For some firms, costs may be attributable to EPA's New Chemicals review process, but not to the SNUR itself. For example, a firm may already be bound by a TSCA Section 5(e) Consent Order following review of its PMN, so that the SNUR based on the 5(e) order imposes no added costs for that firm. As another example, in rulemakings where a SNUR chemical is not on the TSCA Inventory, firms that have not yet submitted a PMN must submit one to EPA before commercial production/import, with or without the SNUR (see Section 2.3, SNUR "New" Chemicals). 
If the SNUR reflects the PMN use scenario, and the PMN submitter would stick to the PMN uses even in the absence of a SNUR, then there would be no added costs for the PMN submitter attributable to the SNUR. Also, firms may also incur worker protection, haz-comm and other costs for reasons other than the SNUR, so that SNUR requirements may impose no added costs. 
Export Notification Costs
Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical subject to various TSCA sections (40 CFR §707.60 through 75). For TSCA 5(a)(2) (the section under which EPA promulgates significant new use rules) and certain other TSCA sections, this is a one-time notification requirement per destination country for each exporter of a chemical substance. After receiving a notification from a firm, EPA notifies the importing country and the United States State Department (40 CFR §707.70). To calculate the burden associated with making export notifications, EPA first estimated the average annual number of export notifications made by an exporter, in Section 3.1. EPA then derived the annual and per notification burden associated with preparing and submitting an export notification, in Section 3.2. 
EPA estimated the average burden associated with making a single notification, but did not estimate either the total number of exporters of a SNUR chemical or the number of notifications per SNUR chemical. This is because the SNURs apply to a variety of different chemicals with a variety of unrelated uses, manufactures, and processors, making it impractical within the resources available for this report to assess the potential number of exporters and importing countries per chemical. 
Most underlying data in this section come from the 2009 TSCA Section 12(b) ICR, 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 (EPA, 2009b), with updating for inflation. 
Estimated Number of Annual Export Notifications per Exporter
EPA's 2009 TSCA Section 12(b) ICR estimated that the average exporter making notifications will make 12 notifications per year.  This includes notifications resulting from SNURs and notifications resulting from other TSCA activities. A notification is typically no more than one page per chemical/country combination, and one notification mailing often includes multiple chemicals and/or destination countries. 
The percent of notifications due to PMN SNURs is unknown, and it is also unknown how many notifications may result from this rulemaking, as not all manufacturers may choose to export a chemical, or they may make several notifications for a single chemical. 
Exporter Costs
The 2009 TSCA Section 12(b) ICR (EPA, 2009b, page 11, Table 3), estimated the annual export notification cost for an exporter under the one-time export notification requirement. These costs include the cost to the exporter of compiling a list of their products that are subject to TSCA Section 12(b) requirements, writing or revising an export notification letter to EPA, checking the outgoing shipments, and sending the notification letters with the associated shipping costs.
The per-notification cost was calculated based on the average burden per firm making notifications. Exporters making more notifications per year may benefit from economies of scale and have lower costs per notification; those making fewer notifications may have higher costs per notification.
Estimated Submission (Mailing) Costs
Regulated companies will incur mailing costs for export notifications delivered to EPA. Notifications are assumed shipped via the U.S. Postal Service (USPS) as first-class registered mail with a return receipt (USPS, 2012). The estimated per-shipment and annual mailing costs incurred by individual submitters are detailed in Table 9.
           Table 9. Derivation of Total Mailing Cost for 12 Notices
Postal Service
Cost
Registered mail, regular, with $0 declared value
                                    $10.95
Return receipt, requested at time of mailing (receive by mail)
                                     $2.35
Postage, regular First Class, up to 1 ounce
                                     $0.45
Cost per export notice - Subtotal
                                    $13.75

                                     x 12
Total Mailing Cost for 12 Notices
                                    $165.00
Source:  Mailing rates are from the US Postal Service web site as of March 2012 (https://www.usps.com/ship/service-chart.htm). The mailing method comes from the Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, November 2005 (EPA, 2005a), as clarified in a later SNUR economic analysis (EPA, 2007c, Table 8). 
Compile and Maintain the List of Products
Since TSCA §12(b) information collection activity has been in place for over twenty years, most respondents will have already developed a list of their products subject to TSCA §12(b) export notification. Respondents need only check for new regulations promulgated and any new products exported by the company. Updating the list is estimated to take an average of one hour of technical time, which may also include some proportion of legal time (EPA, 2009b). The total burden can vary from two hours per year up to two hours per month, depending on the number of products exported by the company and the number of their products subject to TSCA §12(b) (EPA, 2009b).
The number of submitters per year who report under TSCA §12(b) has varied over time, rising from around 160 in 1991 to over 460 in 2000, and declining since. In the most recent TSCA §12(b) ICR, EPA estimated there would be approximately 300 submitters per year in near-future years (EPA, 2009b). Of these 300 submitters, EPA estimated that 200 companies were near the lower burden estimate of 2 hours per year, and 100 companies were near the upper estimate of 24 hours per year. Compiling the list for all respondents was therefore estimated to take 2,800 hours (2 hours x 200 firms plus 24 hours x 100 firms), or an average of about 9.3 hours of technical time per firm per year for 12 notifications per year (EPA, 2009b).
Write or Revise Export Notification
Companies that export chemicals subject to TSCA §12(b) reporting must prepare an export notification to send to EPA when export shipments are made. Time for initial preparation of the export notice may vary depending on whether the company has prior experience with this requirement. This step is estimated to take an average of one hour of technical time (which may also include some proportion of legal time) per firm per year for 12 notifications per year (EPA, 2009b).
Check Orders and Send Notifications
Companies that export chemicals subject to TSCA §12(b) reporting must check outgoing shipments against the list of their products described above. A form letter notifying EPA and providing the required data must be printed and mailed within the required time period. This process is estimated to take an average one half hour of clerical time per export notification or 6 hours for 12 notifications (EPA, 2009b). 
The burdens and associated costs for each notification activity are provided in Table 10 below. 
Table 10. TSCA 12(b) Export Notification Cost per Notification 
                                       
                                   Technical
                                   Clerical
                                     Total
                                       
                                     $/Hr
                                     Hours
                                     2011$
                                     $/Hr
                                     Hours
                                     2011$
                                     2011$
                                     Hours
Compile list
                                    $64.66 
                                      9.3
                                     $601 
                                      --
                                      --
                                      --
                                     $601 
                                      9.3
Write letter
                                    $64.66 
                                       1
                                    $64.66 
                                      --
                                      --
                                      --
                                     $65 
                                       1
Check order and send notice
                                      --
                                      --
                                      --
                                    $29.63
                                       6
                                     $178
                                     $178 
                                       6
Mailing cost[1]
                                      --
                                      --
                                      --
                                      --
                                      --
                                      --
                                     $165 
                                       -
Total per facility[2`]
                                       
                                     10.3
                                     $666 
                                       
                                       6
                                     $178 
                                    $1,009 
                                     16.3
Total per Notification
                                       
                                     0.86
                                    $55.50
                                       
                                     0.50
                                    $14.81
                                    $84.06
                                     1.36
Notes: 
[1] Mailing costs reflect March 2012 USPS rates and can be found in Table 9.
[2]An average facility submitting notifications is assumed to submit 12 export notifications per year.
Source: Appendix B of this report derives technical and clerical hourly labor costs. Other costs are from 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 (EPA, 2009b, p.10), and are updated to 2011 dollars. 


Agency Costs
This SNUR is expected to generate Agency costs for both SNUN review and processing, and export notification processing. Because it is unknown how many SNUNs and export notifications will be submitted as a result of this rulemaking, all Agency costs are estimated at the per-case level and are not aggregated to estimate the total Agency burden. Section 4.1 describes the burden to the Agency of reviewing and processing a single SNUN submission. Section 4.2 derives the Agency burden of processing and reviewing export notifications.
SNUN Processing Costs
EPA's costs to review and process industry submissions (SNUNs, requests to modify or revoke the SNUR, and requests for equivalency determinations) are assumed to be the same as EPA costs to review PMNs and are presented in Table 11. Costs to review and process industry submissions  -  SNUNs, requests to modify a SNUR, and requests for equivalency determination  -  are assumed to be similar to EPA costs to review PMNs.
The list of review steps, estimates of staff-year full-time equivalents (FTEs), estimates of extramural costs, and the percent of chemicals requiring a particular review step are derived from the costs for processing PMN submissions in Table VII-1 of a 1994 EPA report, Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency burden associated with processing a SNUN has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. The ePMN rule affects SNUN submissions and requests for equivalency determination, but not requests to modify or revoke a SNUR. However, for simplicity, this analysis continues to assume that Agency per-submission costs are the same for all three types of submissions. Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28).
The GS levels used for Agency staff reflect the judgment of Agency staff familiar with the PMN/SNUN review process. The salary of a Full Time Equivalent EPA staff was calculated using GS-13 Step 5 salary data (OPM, 2010). The original PMN cost estimates were for GS 12 and were presented as low and high estimates, based on the most junior (Step 1) and the most senior (Step 10) GS-12 pay rates, respectively. However, this analysis uses the higher GS-13 staff level and, for simplicity, a single intermediate pay rate (Step 5) within that GS level. A loading factor of 1.6 was applied to the salary to reflect fringe benefits and overhead (EPA, 1992). The loaded salary calculations are described in Appendix B. 
For each review step, the "EPA staff" cost is calculated by multiplying the number of FTEs (in the first column) by the fully loaded average salary. This shows EPA staff cost for chemicals requiring the selected review step. 
The Extramural Cost column shows costs for contractor support and other outside purchases for chemicals requiring the selected review step, inflated from 1993 prices, as explained in Appendix B. 
The Percent of Cases is a weighting factor applied to reflect the fact that not all chemicals require each review step. For example, in the PMN process, all chemicals require Administrative Prescreening, but not all chemicals require the intensive scrutiny of "Standard Review." The three types of submissions resulting from a SNUR may have weighting factors that differ from each other and from the weighting factors for PMNs. Changes in weighting factors could cause actual review costs to be higher or lower than calculated here. For example, some SNUNs require little review because they are determined to be "invalid"  -  i.e. not required in the first place. However, often a SNUN may take more Agency time than a typical PMN because of factors such as the need to retrieve old PMN records from archives, and the likelihood that more data requiring EPA review is submitted with a SNUN than would be submitted on average with a PMN. Resources were not available to update the review hours to reflect the current review process or to tailor the cost estimates to SNUNs. Therefore, for this analysis, the review steps and weighting factors are assumed to be the same as those derived in 1994 for PMNs.
The Weighted Cost column is calculated by multiplying the Unweighted Costs (EPA staff cost plus extramural costs) by the percentage of cases requiring this review step. Weighted costs are then multiplied by the burden reduction of 16.5 percent to account for burden savings generated electronic submission. This calculation yields total Agency costs for submission review and processing shown in Table 11.

Table 11. Agency Costs for SNUN and Other Submission Review and Processing
                                  view Steps
                             EPA staff (FTE) Cost
                              Extramural Cost [2]
                                Unweighted Cost
                                 Pct. of Cases
                               Weighted Cost[3]
                           ePMN Burden Reduction[4]
                   Weighted Cost with ePMN Burden Reduction
                                       
                                 FTE fraction
                               Cost per FTE [1]
                               FTE Total (2011$)
                                    1993$ 
                                    2011$ 
                                       
                                       
                                       
                                       
                                       
                                       
                                      (a)
                                      (b)
                                  (c)=(a)*(b)
                                      (d)
                                      (e)
                                  (f)=(c)+(e)
                                      (g)
                                  (h)=(f)*(g)
                                      (i)
                                (j)=(h)*(1-(i))
Pre-notice Consultation
                                    0.0024
                                   $161,446
                                     $387
                                     $4.00
                                     $6.91
                                     $394
                                      41%
                                     $162
                                     0.165
                                     $135
Administrative Prescreen/Notice Receipt/User Fee
                                    0.0024
                                   $161,446
                                     $387
                                    $92.00
                                    $158.87
                                     $546
                                     100%
                                     $546
                                     0.165
                                     $456
CRSS (Chemical Review and Search Strategy)
                                    0.0025
                                   $161,446
                                     $404
                                     $268
                                    $462.80
                                     $866
                                     100%
                                     $866
                                     0.165
                                     $723
SAT (Structure Activity Team)
                                    0.0006
                                   $161,446
                                    $96.87
                                    $14.00
                                    $24.18
                                     $121
                                     100%
                                     $121
                                     0.165
                                    $101.07
Engineering/Exposure
                                    0.0015
                                   $161,446
                                     $242
                                    $56.00
                                    $96.70
                                     $339
                                     100%
                                     $339
                                     0.165
                                     $283
Exposure/Fate
                                    0.0008
                                   $161,446
                                     $129
                                     $0.00
                                     $0.00
                                     $129
                                     100%
                                     $129
                                     0.165
                                     $108
Focus
                                    0.0009
                                   $161,446
                                     $145
                                    $23.00
                                    $39.72
                                     $185
                                     100%
                                     $185
                                     0.165
                                     $154
Standard Review Functions
                                    0.0219
                                   $161,446
                                    $3,536
                                     $511
                                    $882.43
                                    $4,418
                                      29%
                                    $1,281
                                     0.165
                                    $1,070
Division Directors Meeting
                                    0.0129
                                   $161,446
                                    $2,083
                                     $113
                                    $195.14
                                    $2,278
                                      15%
                                     $342
                                     0.165
                                     $285
Order Development/Negotiation Review
                                    0.0171
                                   $161,446
                                    $2,761
                                    $22.00
                                    $37.99
                                    $2,799
                                      3%
                                    $83.96
                                     0.165
                                    $70.11
Post Order Data Review
                                    0.0886
                                   $161,446
                                    $14,304
                                     $0.00
                                     $0.00
                                    $14,304
                                      3%
                                     $429
                                     0.165
                                     $358
Order Modification
                                    0.2167
                                   $161,446
                                    $34,985
                                     $0.00
                                     $0.00
                                    $34,985
                                      3%
                                    $1,050
                                     0.165
                                     $876
New Chemical SNUR Development
                                    0.0277
                                   $161,446
                                    $4,472
                                    $85.00
                                    $146.78
                                    $4,619
                                      7%
                                     $323
                                     0.165
                                     $270
Notices of Commencement
                                    0.0012
                                   $161,446
                                     $194
                                    $40.00
                                    $69.07
                                     $263
                                      31%
                                    $81.47
                                     0.165
                                    $68.03
FOIA (Freedom of Information Act) Requests
                                    0.0333
                                   $161,446
                                    $5,376
                                     $287
                                    $495.61
                                    $5,872
                                      1%
                                    $58.72
                                     0.165
                                    $49.03
CBI (Confidential Business Information) Substantiation
                                    0.0004
                                   $161,446
                                    $64.58
                                     $3.00
                                     $5.18
                                    $69.76
                                     100%
                                    $69.76
                                     0.165
                                    $58.25
                                                                          TOTAL
                                    $6,067
                                     0.165
                                    $5,066
Notes:
[1] GS-13 Step 5 salaries loaded with benefits and overhead. See Table B-1 derivation.
[2] Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices as described in Appendix B. 
3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table. 
[4] Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28).
Sources: FTEs per review step, 1993 extramural costs, and percent of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM, 2011.

Export Notification Processing Burden
Under TSCA Section 12(b), exporters must notify EPA if they intend to export chemicals subject to SNURs, as described in Chapter 3 above. The Agency burden and cost due to TSCA §12(b) export notification result from three tasks. In the first task, EPA receives export notifications from companies that intend to export one of the chemicals subject to TSCA §12(b) (EPA, 2009b). In the second task, EPA staff prepares separate notification letters that are subsequently reviewed and delivered to importing countries, their embassies, or representatives, and to the importing country's US embassies (EPA, 2009b). (See Table 9 for the cost of mailing one notification). The third task is comprised of EPA staff responses to public inquiries and other TSCA 12(b) activities. The work of responding to non-routine requests for information and clarification from industry and importing countries, and of handling other tasks associated with the TSCA §12(b) program, was estimated to require roughly 400 hours per year (EPA, 2009b). Since the current rulemaking covers only a very small percent of the chemicals subject to TSCA 12(b) reporting, a very small percent of such activity will be attributable to the current rulemaking. 
Because it is unknown how many, if any, notifications EPA will receive or send as a result of the current rulemaking, the costs to the Agency are presented per activity. The burden for the first two Agency activities is provided in Table 12 below. To estimate the Agency cost, hourly burdens are multiplied by the loaded wage rate of a GS-13, Step 5, which is derived in Appendix B. 
Table 12. TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2011$)
                                Agency Activity
                              Hours per Activity
                               FTE per Activity1
                      Loaded GS-13, Step 5 FTE Wage Rate
                                 Mailing Cost
                        Total Agency Cost per Activity
                                       
                                      (a)
                                (b) = (a)/2,080
                                      (c)
                                      (d)
                              (e) = ((b)*(c))+(d)
          Process an incoming notification from an exporting company
                                      0.1
                                   0.000048
                                   $161,446
                                       
                                     $7.76
            Prepare and mail a notification to an importing country
                                      0.5
                                   0.000240
                                   $161,446
                                    $13.75
                                    $52.56
Notes:
1 The burden associated with an Agency activity is the burden for the Agency to process one incoming notification, or to prepare and mail an outgoing notification 
Source: Appendix B of this report derives Agency labor costs. Mailing costs are from Table 9 of this report. Other burdens are from 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 (EPA 2009b), updated for inflation.

Additional Analyses
This chapter presents additional analysis of other potential impacts of this rulemaking, as required under various statutes and executive orders.
Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et. seq.), as amended by the Small Business Regulatory Enforcement Fairness Act, requires regulators to consider the impact of regulations on small entities, in particular small businesses. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a significant new use. Where a use is new, by definition no small or large entities presently engage in such activities. Although some small entities may decide to manufacture or process a substance for the new use after the SNUR is promulgated, EPA receives very few SNUNs, and few of those are submitted by small entities. In response to the promulgation of SNURs covering over 1000 chemical substances, the Agency receives only a handful of SNUNs per year.  For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY2006, six in FY2007, eight in FY2008, seven in FY2009, two in 2010, and ten in 2011 (EPA, 2012), for an average of 6 per year from all SNURs.  EPA has no reason to believe that this SNUR would alter the pattern of SNUN submissions that EPA has historically seen. In addition, the estimated reporting cost for submission of a SNUN is minimal regardless of the size of the firm, averaging about $8,300 including SNUN recordkeeping and reporting costs. The Agency currently offers some relief to certain small businesses with sales (including those of subsidiary/parent companies) of less than $40 million per year by reducing the SNUN submission fee from $2,500 to $100. This lower fee reduces the cost of submitting a SNUN to about $5,800 for smaller firms. During the six year period from 2005-2010, only three submitters self-identified as small in their SNUN submission (EPA, 2012). EPA believes the cost of submitting a SNUN is relatively small compared the cost of developing and marketing a chemical new to firm and that the requirement to submit a SNUN generally does not have a significant economic impact. 
In response to a SNUR, firms could also decide to request an equivalency determination or a request for SNUR modification or revocation. The submission cost for these requests is about $5200. EPA believes this cost to be low compared to the cost of developing and marketing a chemical new to the firm. The expected number of requests is also expected to be small. In general, EPA receives from zero to three modification/revocation requests per year due to SNURs, therefore it is unlikely that a substantial number of small entities would be affected. 
Unfunded Mandates Reform Act (UMRA)
EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Paperwork Reduction Act (PRA)
According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond, to a collection of information that requires Office of Management and Budget (OMB) approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0012 (EPA, 2007a). This action does not impose any additional burden requiring OMB approval. 
Executive Order 12866, Regulatory Planning and Review
Executive Order 12866, Regulatory Planning and Review, requires OMB review for rules with an impact on the economy of $100 million or more, or with any other potential significant impact. OMB has previously determined that these types of SNURs are not a "significant regulatory action" that would require OMB review under this Executive Order.
Executive Order 13132, Federalism
Executive Order 13132, Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure "meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications." This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).
Executive Order 12898, Environmental Justice
This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Executive Order 13045, Protection of Children
Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 27, 1997), requires EPA to identify and assess environmental health and safety risks that may disproportionately affect children. This type of analysis is required for rules that will have an impact of $100 million or more only. The impact of these SNURs will be less than $100 million and therefore no analysis of such impacts on children is required.
Executive Order 13175, Tribal Governments
Executive Order 13175 is Consultation and Coordination with Indian Tribal Governments (59 FR 22951, November 6, 2000). This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes.
Executive Order 13211, Energy Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

List of PMNs and their Chemical Names
Table A-1. PMNs and Chemical Names Referenced in this Economic Analysis 
No.
PMN[1]
CAS RN[2]
Name[2]
1
P-05-0714
N/A
Polyether ester acid compound with a polyamine amide (generic)
2
P-07-0537
 N/A
Alkanenitrile, bis(cyanoalkyl)amino (generic)
3
P-07-0706
 N/A
Phosphonic Acid Ester (generic)
4
P-10-0135
N/A
Fluoroketone (generic)
5
P-10-358
 N/A
Polycyclic polyamine diester organometallic compound (generic)
6
P-11-0128
440102-72-7
3-Indoliu m, 2-[2-[3-[2-(1 ,3-dihydro-1 ,3,3-trimethyl-2H-indol-2-ylidene)ethylidene]-2-[1 -(phenyl-1 Htetrazol-5-y)thio],-T-cyclohexen-1 -yl]ethenyl]-1 ,3, 3-trimethyl-. chloride
7
P-11-0264
 N/A
Brominated aromatic oligomer (generic)
8
P-11-0338
 N/A
biphenyl alkyl morpholino ketone (generic)
9
P-11-0481
1200806-67-2
1,2-Cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester
10
P-11-0561
 N/A
Tetrafluoroethylene Chlorotrifluoroethylene copolymer (generic)
11
P-11-0567
 N/A
Fluoropolymer (generic)
12
P-11-0568
 N/A
Fluoropolymer (generic)
13
P-11-0569
 N/A
Fluoropolymer (generic)
14
P-11-0594
 N/A
mercaptoalkoxysilane (generic)
15
P-11-0654
1332716-20-7
Phenol, 2-[[[3-(1H-imidazol-1-yl)propyl]imino]phenylmethyl]-5-(octyloxy)-
16
P-12-0022
 N/A
Complex strontium aluminate, rare earth doped (generic)
17
P-12-0023
 N/A
Complex strontium aluminate, rare earth doped (generic)
18
P-12-0024
 N/A
Complex strontium aluminate, rare earth doped (generic)
19
P-12-0025
 N/A
Complex strontium aluminate, rare earth doped (generic)
20
P-12-0026
 N/A
Complex strontium aluminate, rare earth doped (generic)
21
P-12-0033
26537-19-9
Benzoic acid, 4-(1, 1-dimethylethyl)-, methyl
22
P-12-0051
 N/A
Substituted alkylamide (generic)
23
P-12-0052
 N/A
Substituted alkylamide (generic)








Key: PMN = Premanufacture Notice. CAS RN = Chemical Abstract Service Registry Number.
Notes:
[1]The PMN number reflects the Federal Fiscal Year and sequence of submission. For example, those starting "P-07" were submitted in the twelve months ending September 31, 2007. 
[2] If a CAS RN is identified as "N/A" meaning "Not available" and/or the chemical name is indicated to be "generic" then the chemical identity is indicated to be confidential.
 
Inflators and Wage Rates
This appendix describes the derivation of the fully loaded labor rates and inflation factors used in calculating costs of labor, materials, and other inputs. Costs for this report are for year-end 2010.
Derivation of Loaded Wage Rates
Unit labor costs are calculated by adding fringe benefits and overhead to the wage or salary to derive a fully loaded labor cost. The basic method is described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). The resulting loaded labor rates are given in Table B-1. Costs are calculated for several labor categories: Managerial, Professional/ Technical, Clerical, Production Workers, Industrial Hygienists, and EPA staff.
In March 2004, BLS began using the North American Industry Classification System (NAICS) codes instead of the Standard Industrial Classification (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS). The following table shows the crosswalk between old and new occupational titles.
EPAB Reports Labor Category
BLS Old Title (OCS)
BLS New Title (SOC)
 Managerial
 Executive, administrative, and managerial
 Management, business, and financial
 Professional/Technical
 Professional specialty and technical
 Professional and  related
 Clerical
 Administrative support, including clerical
 Office and administrative support
Source: Employer Costs for Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC Occupational Comparability between SOC and OCS (BLS, 2006a); and Weinstein, 2004.
Derivation of Labor Rates for Managerial, Professional/Technical, Clerical, and Production Labor
Wages and fringe benefits for managerial, professional/technical, clerical and production labor were taken from the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, for December, for manufacturing industries.
The cost of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same ECEC series. Fringe benefits as a percent of wages are calculated separately for each labor category. For example, for December 2011, the average wage rate for professional/technical labor was $38.48; the average fringe benefit was $19.64. Fringe benefits as a percent of wages were $19.64/$38.48, or approximately 51.04%.
An additional loading factor of 17 percent is applied to wages to account for overhead. This approach is used for consistency with Office of Pollution Prevention and Toxics economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For example, the December 2011 fully loaded wage for professional/technical labor is $38.48 x (1 + 0.5104 + 0.17) = $64.66.
Fully loaded costs for managerial, clerical, and production labor are calculated in a similar manner, as shown in Table B-1.
Derivation of Labor Rates for Industrial Hygienists
For industrial hygienists, wages were based on another BLS data series, Occupational Employment Statistics [OES], National Industry-Specific Occupational Employment and Wage Estimates. OES data were used because ECEC data were not available for very specific occupations. However, the OES data covers only wages, not fringe benefits. Therefore, the Industrial Hygienist fringe benefits continue to be based on ECEC data.
The wage rate for Industrial Hygienists is a weighted average of the hourly mean wage for Occupational Health and Safety Specialists, Standard Occupational Classification (SOC) 29-9011, and Occupational Health and Safety Technicians, SOC 29-9012, in Manufacturing. The wage rate for each occupation was weighted by employment for the occupation. The North American Industry Classification System (NAICS) codes for Manufacturing are 31, 32, and 33 (BLS, 2005). The calculations are shown in Table B-2.
As with other labor categories, the fringe benefits factor came from the BLS Employer Costs for Employee Compensation Supplementary Tables December 2011 (BLS, 2012a). Benefits for "professional specialty and technical" occupations were used, and loaded wages were calculated as for other types of labor. An additional loading factor of 17 percent of wages was applied for overhead. Calculations are shown in Table B-1.
Derivation of Labor Rates for EPA Staff
Agency labor costs are calculated based on annual Federal salaries for the Washington-Baltimore area published by the Office of Personnel Management effective January 2010 (OPM, 2010). The average salary for one Full Time Equivalent (FTE) staff is estimated as the salary for a GS-13 Step 5 employee.
Multiplying the annual pay by an assumed loading factor of 1.6 to reflect Federal fringe benefits and overhead, the loaded annual salary of EPA staff was calculated to be $161,446.
The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled "the benefits multiplication factor" in the EPA Guide, but has been used in many EPA Office of Pollution Prevention and Toxics ICRs to reflect both fringe benefits and overhead for Federal staff. For example, it was used in an August 2000 document supporting ICR No. 1139.06 (EPA, 2000), with the following explanation:
      "The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor). The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead." (EPA, 2000)
Table B-1. Derivation of Loaded Wage Rates
                              EPAB Labor Category
                                 Data Sources
                                     Date
                                     Wage
                                Fringe Benefit
                               Fringes as % wage
                              Over-head % wage[2]
                           Fringe + Overhead Factor
                                Loaded Wages[1]
                                       
                                       
                                       
                                      (a)
                                      (b)
                                 (c) =(b)/(a)
                                      (d)
                                 (e)=(c)+(d)+1
                                 (f)=(a) x (e)
Managerial
BLS ECEC, Private Manufacturing industries, "Mgt, Business, and Financial"[3]
Dec-11
                                    $43.01
                                    $20.40
                                    47.43%
                                      17%
                                     1.64
                                    $70.72
Professional/
Technical
BLS ECEC, Private Manufacturing industries, "Professional and related"[3]
Dec-11
                                    $38.48
                                    $19.64
                                    51.04%
                                      17%
                                     1.68
                                    $64.66
Clerical
BLS ECEC, Private Manufacturing industries, "Office and Administrative Support" 3
Dec-11
                                    $17.69
                                     $8.93
                                    50.48%
                                      17%
                                     1.67
                                    $29.63



                                       
                                       
                                       
                                       
                                       
                                       
Production Worker
BLS ECEC, Private Manufacturing industries, "Production, transport, and material moving." 3
Dec-11
                                    $16.86
                                     $9.32
                                    55.28%
                                      17%
                                     1.72
                                    $29.05
Industrial Hygienist
Wage: BLS OES Occupat. Employ. and Wages, for Manufacturing (NAICS 31, 32, 33), average of wages for Occup. Health/ Safety Specialists (SOC 29-9011) and Occup. Health/Safety Technicians (SOC 29-9012), weighted by employment. 4 

Fringes: BLS ECEC, Private Manufacturing industries, "Professional and related" 3
Wage: May-10

Fringe: Dec-11
                                    $30.67
                                      --
                                    51.04%
                                      17%
                                     1.68
                                    $51.53
EPA staff FTE
Annual Federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step 5 pay rates, with 60% overhead. [5]
Dec-11
                               $100,904 (annual)
                                       
                                      --
                                       
                          [Included in 60% overhead]
                                       
                                      60%
                                       
                                      1.6
                                       
                                   $161,446
                                   (annual)
Notes:
1 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, unrounded values were used.
2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
[3] Employer Costs for Employee Compensation Supplementary Tables December 2011, US Bureau of Labor Statistics, March 14, 2012 (BLS, 2012a).
4 Employment and unweighted wages are from BLS Occupational Employment Statistics (National Industry-Specific Employment and Wage Estimates), May 2010.
5 The salary is unloaded Federal GS-13 Step 5 salary for calendar 2011, from the Office of Personnel Management salary table for Washington-Baltimore-Northern Virginia (OPM, 2011). The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9).

Table B-2. Derivation of Industrial Hygienist Wage Rate (NAICS 31, 32, 33)

                          Occupation Title (SOC Code)
                                  Employment
                               Mean Hourly Wage
                                    Weight
                               Weighted Wage[1]
                                       
                                      (a)
                                      (b)
                                      (c)
                               (d) = (c) x (b)
Occupational Health & Safety Specialists (29-9011)
                                     8,520
                                    $31.91
                                     0.861
                                    $27.49
Occupational Health & Safety Technicians (29-9012)
                                     1,370
                                    $22.94
                                     0.139
                                     $3.18
Industrial Hygienist (weighted average)
                                     9,890
                                      --
                                       1
                                    $30.67
 Notes:
[1] Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, unrounded values were used.
Source: Employment and unweighted wages are for manufacturing (NAICS 31, 32, 33) from BLS Occupational Employment Statistics (Occupational Employment and Wages), for May 2010 (BLS, 2011). 
Derivation of Inflation Factors
Costs of equipment and supplies were inflated using the Consumer Price Index  -  All Urban Consumers; wages were inflated using the appropriate Employment Cost Index (ECI). Where both labor and equipment/supplies were involved, we used the inflation factor corresponding to the dominant cost category. For example, test costs include a mix of labor, equipment, and supplies. Assuming that the largest component of test costs comes from labor, we used the ECI for private industry, all workers. Complete information on the derivation of the inflation factors used is given in Table B-3 below.
In 2006, the Bureau of Labor Statistics (BLS) made several changes to the Employment Cost Index. The changes are described on a BLS web page, "Change has come to the ECI," (BLS, 2006c) and in several April 2006 Monthly Labor Review articles posted on the BLS web site: "Changes affecting the Employment Cost Index: an overview" (Caroll 2006); "Employment Cost Index Publication Plans" (Sleemi, 2006); and "Seasonal adjustment in the ECI and the conversion to NAICS and SOC" (Branch, 2006).
Under a mandate from OMB, BLS changed its classification of industries and occupations from the Standard Industrial Classification (SIC) and Occupational Classification System (OCS) to the North American Industry Classification System (NAICS) and Standard Occupational Classification (SOC) system. In 2006, BLS adjusted all ECI series to reflect this change. 
In addition to changing the industry and occupational classification systems, in 2006, BLS rebased the ECI from June 1989 = 100 to December 2005 = 100 for all current and historical non-seasonally adjusted series, including the NAICS and SIC based series. (Seasonally adjusted indices, including those in Table B-3 of this report, may not exactly equal 100 for December 2005 as a result of the seasonal adjustment. Seasonal adjustments are explained in Branch, 2006.)  
According to BLS, the official ECI for the years 1975-2005 is the SIC-OCS based series, and for subsequent years, the official ECI is the NAICS-SOC based series (Sleemi, 2006, p.8).  
"Starting year" indices in Table B-3 continue to be SIC-SOC based. Current year indices are NAICS-SOC based. We use indices from both the NAICS-SOC and the SIC-OCS based ECI series because neither series spans the entire period over which testing and other costs need to be inflated. 
      
Table B-3. Derivation of Inflation Factors
                                     Item
                           Inflation Index Source[1]
                                 Starting Year
                            Index for Starting Year
                                      (a)
                              Index for 2011
(b)
                          Inflation Factor 
(b)/(a) 2
Chemical testing (toxicity, ecological effects etc.)
BLS ECI, SA, Total comp, Private industry, All Workers, 4[th] Q [BLS 2006d and 2012c] 
                                    varies
                                    varies
                                     115.1
                                    varies
White collar/other labor mix; equipment; supplies. 
Example for test costed in 1993
                                     1993
                                     66.5
                                     115.1
                                     1.731
Tests were first costed out in various years, depending on the test; inflation factors vary depending original cost date. 
Example for test costed in 2000
                                     2000
                                     83.8
                                     115.1
                                     1.374
Impermeability testing of gloves and other gear[3]
BLS ECI, SA, Total comp, Private industry, All Workers, 4[th] Q [BLS 2006d and 2012c]
                                     1997
                                     74.9
                                     115.1
                                     1.537
Export notification
BLS ECI, ,Total comp, Private industry, Professional and related, 4[th] Q [BLS 2012d] 4
                                     1992
                                     64.9
                                     115.7
                                     1.783
Agency Extramural costs White collar labor; equipment; supplies
BLS ECI, Total comp, Private industry, Professional and related, 4[th] Q [BLS 2012d] 4
                                     1993
                                     67.0
                                     115.7
                                     1.727
Labels, placards, gloves,  eyewear, clothing, respirators, file cabinet
BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 2012b]
                                     1997
                                     160.5
                                    224.939
                                     1.401


                                       
                                       
                                       
                                       
Photocopies
Record keeping materials
BLS CPI, All urban consumers, not SA. CUUR0000SA0, Annual [BLS 2012b]
                                     1988
                                     118.3
                                    224.939
                                     1.901
Notes: 
1 In 2006, Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series "were rebased to December 2005 = 100 from June 1989 = 100."  The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (BLS, 2006b). The Consumer Price Index (CPI) was not rebased. 
"Starting year" ECI indices are SIC-OCS based:  Seasonally Adjusted (SA) ECS10002I for private industry All Workers, and not SA ECU11122I for private industry Professional and Related Workers. 
After 2006, ECI indices are NAICS-SOC based: Seasonally Adjusted (SA) CIS2010000000000I for private industry All Workers, and not SA CIU2010000120000I (B) for private industry Professional, and Related workers. 
2 Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values. BLS CPI values were published with one decimal place through 2006 and with three decimal places after that.
3 We began using the ECI for Private Industry All Workers in EPA, 2007b, to better reflect the labor mix for impermeability testing. Earlier PMN SNUR economic analyses used the ECI for Private Industry White Collar Workers.
[4] Beginning with the report, Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA Docket OPPT-2009-0922, we began to use the not-seasonally adjusted CIU2010000120000I for private industry Professional, and Related workers, instead of SA CIS2010000W00000I for private industry white collar workers because BLS retired the "white-collar" series. 

Costs of Hazard Communication, Protection in the Workplace, and Recordkeeping Requirements
Section 2.1 of the main text of this report discusses costs of worker protection, hazard communication (haz-comm), and recordkeeping for SNURs. This appendix presents dollar costs and labor hours of these requirements, for one chemical at one site. Some requirements listed here may not be cited in the current rulemaking, but have been cited in past SNUR rulemakings.
The haz-comm costs reflect the annual costs of updating the written program, labeling for chemical distribution and storage, creating and distributing material safety data sheets (MSDS), and employee training. The personal protective equipment (PPE) costs reflect the annualized costs of providing required equipment (i.e., gloves, goggles, clothing, or respirators), assessing dermal protection needs associated with the chemical, and performing required impermeability testing, and/or evaluating manufacturer's information. Finally, the annual recordkeeping costs include labor, photocopying, and record storage costs.
To estimate the costs of haz-comm, worker protection, and recordkeeping requirements, a number of assumptions were made, based on the original EPA analysis for generic SNUR provisions, Economic Analysis of Final Significant New Use Rule: General Provisions for New Chemical Followup (EPA, 1989). In that report, EPA estimated that the number of workers exposed to any one substance would range from 10 to 25, and that a worker potentially would be exposed to a substance for a minimum of 50 days per year to a maximum of 250 days per year. The current analysis uses the high ends of those two ranges. Thus, each site is assumed to have 25 chemically-exposed workers requiring training and/or protective equipment, with each of them assumed to be exposed for 250 days per year.
Labor costs are derived from the United States Bureau of Labor Statistics sources as described in Appendix B. Material costs were primarily obtained from a national safety equipment supply house catalog (LSS, 1997) and are inflated as described in Appendix B.
Costs of haz-comm, workplace protection, and recordkeeping are discussed in Sections C.1, C.2, and C.3, respectively. Table 4 and Table 6 in the main text summarize these costs by SNUR requirement.
Modifying the Hazard Communication Program
As mentioned in Section 2.1, it is assumed that each facility has in place a haz-comm program consistent with that required by OSHA's Hazard Communication standard (29 CFR 1910; November 25, 1983), so that costs attributable to the SNUR are costs of adding one chemical to the program. Much of the haz-comm methodology and assumptions came from the EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Followup (EPA, 1989), which in turn relied partly on the 1983 OSHA study, Final Regulatory Impact and Regulatory Flexibility Analyses of the Hazard Communication Standard OSHA, 1983).
It was assumed that the haz-comm costs would be incurred each year. For example, there would be worker turnover and need for refresher training, the MSDS would need revision due to changing information, placards would wear out (EPA, 1989). To the extent that some steps would not need repeating each year, costs could be lower than estimated here. The hazard communication costs summarized in Table 3 above are detailed here.
Updating the Written Program
If the SNUR cites 40 CFR §721.72(a), then to avoid engaging in a Significant New Use, which would trigger other SNUR requirements, manufacturers must update their written haz-comm program to incorporate information about the chemical. The written part of the program includes data and information about hazardous chemicals present in the workplace, the hazards associated with such chemicals, procedures for employees who routinely work with or around such chemicals, procedures for non-routine tasks that may involve exposure (e.g., tank cleaning), and personal protective equipment requirements when working with or around such chemicals.
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 Table B-1and Table 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$)
                               Inflation Factor
                              Unit Cost
 (2011$)
                                     Hours
                                  Total Cost
0.5 hours technical time
                                      --
                                      --
                                    $64.66
                                   per hour
                                      0.5
                                      $32
480 labels
                                $0.16 per label
                                     1.401
                                     $0.22
                                   per label
                                      --
                                     $108
                                                                          TOTAL
                                      0.5
                                     $140
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$)
                               Inflation Factor
                                   Unit Cost
                                    (2011$)
                                     Hours
                                  Total Cost
                           0.5 hours technical time
                                      --
                                      --
                                    $64.66
                                   per hour
                                      0.5
                                    $32.33
                       6 labels or placards (14" x 10")
                                $38.30 per item
                                     1.401
                                    $53.68
                                   per item
                                      --
                                     $322
              10 minutes per label/placard production worker time
                                      --
                                      --
                                    $29.05
                                   per hour
                                      1.0
                                    $29.05
                                     TOTAL
                                      1.5
                                     $383
Note: 
Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Source: 1997 placard cost, EPA, 1998, LSS, 1997; cost elements and quantities, EPA, 1989; inflators and labor unit costs, Table B-1 and Table B-3. 
Preparing Material Safety Data Sheet (MSDS) Information
If the SNUR cites 40 CFR §721.72(c), then to avoid engaging in a Significant New Use, each facility is required to create, post, and distribute material safety data sheets (MSDSs). Based on estimates in OSHA 1983, the 1989 EPA report (EPA, 1989) has estimated that creation of an MSDS for a chemical substance requires 2.0 hours of technical labor time and 0.25 hours of clerical time. Further, EPA assumes that the manufacturer provides 20 copies of the MSDS to customers and retains 20 copies for use onsite, for a total of 40 copies (EPA, 1989). The loaded hourly wage rates and the inflator used in estimating unit photocopy costs are derived in Appendix B. The resulting cost of MSDS preparation is shown in Table C-3.
Table C-3. Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]
Cost Element
                               Unit Cost (1988$)
                               Inflation Factor
                                   Unit Cost
                                    (2011$)
                                     Hours
                                  Total Cost
2.0 hours technical time
                                      --
                                      --
                                    $64.66
                                   per hour
                                       2
                                     $129
0.25 hours clerical time
                                      --
                                      --
                                    $29.63
                                   per hour
                                     0.25
                                     $7.41
40 copies
                                     $0.05
                                     1.901
                                     $0.10
                                   per copy
                                      --
                                     $3.80
                                                                          TOTAL
                                     2.25
                                     $141
Note:
Total costs were calculated using unrounded unit cost values and inflation factors (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Source: Cost elements, quantities, and 1988 copy cost, RIB 1989; inflators and labor unit costs, Table B-1 and Table B-3.
Employee Training
The final required component of the haz-comm program is employee training, based on 40 CFR §721.72(d). The 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow-up (EPA, 1989), assumes that a training program currently is in place, but the existing program must be modified to add new information pertaining to the PMN substance. Subsequently, the training program must be expanded to include such material each time the training course is presented. Costs of modifying the program and presenting the modified program are mainly labor costs for the trainer and the trainees.
Inserting the new information about the PMN substance into the training program and conducting the revised training is assumed to require 0.5 hours of the trainer's time. An additional 0.25 hours per trainee is estimated to be required, and an average of 25 affected workers is assumed per facility (EPA, 1989). If additional production workers needed to be trained, for example because they might come into contact with the chemical due to spills or leaks, training costs could be higher than estimated here (EPA, 1989).
Labor rates for training are based on the loaded rates derived in Appendix B for chemical technicians and chemical industry production workers. The total cost of the employee training requirement is shown in Table C-4.
Table C-4. Annual Costs for Employee Training, Per Chemical [40 CFR §721.72(d)]
                                 Cost Element
                                   Unit Cost
                                    (2011$)
                                     Hours
                                  Total Cost
0.5 hours technical time (trainer)
                                $64.66 per hour
                                      0.5
                                    $32.33
0.25 hours per production employee X average of 25 workers per plant = 6.25 hours
                                $29.05 per hour
                                     6.25
                                     $182
                                                                          TOTAL
                                     6.75
                                     $214
Note: 
Total costs were calculated using unrounded values from (see Appendix B), so results may differ from calculations using the rounded values shown in this table.
Source: Cost elements and quantities, EPA, 1989; labor unit costs, Table B-1.
Protection in the Workplace
The following section estimates costs of assessing needs for dermal protection and evaluating protective gear for impermeability, as well as the costs of gloves, goggles, protective clothing, and respirators.
Dermal Protection Selection
If the SNUR cites 40 CFR §721.63(a)(1), then to avoid engaging in a Significant New Use, the employer must ensure that each person who is likely to experience dermal exposure to a PMN chemical, must be provided with and is required to wear personal protective equipment (e.g., gloves) that will prevent dermal exposure to the substance. The equipment must be selected and used in accordance with 29 CFR § § 1910.132 and 1910.133 (promulgated by the Occupational Safety and Health Administration, OSHA). The selection and administration of this dermal protection is estimated to require 10 hours labor by an industrial hygienist, annually (EPA, 1999). The wage rate of the hygienist was calculated as described in Appendix B. The cost calculations for the dermal protection selection requirement are given in Table C-5. This covers only costs of selecting the dermal protection needed, not costs of the items themselves. For costs of purchasing dermal protective items, see the sections below on costs of gloves, eyewear, and clothing.
Table C-5. Annual Costs for Dermal Protection Selection [40 CFR §721.63(a)(1)]
Cost Element
                               Unit Cost
(2011$)
                                     Hours
                                 Total Cost[1]
10 hours industrial hygienist (IH) time
                               $51.53  per hour
                                      10
                                     $515
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 $800 per chemical (1997 dollars) are assumed for impermeability testing. The cost of the impermeability testing is assumed to be driven by labor costs of the company performing the testing, thus test costs were inflated with an Employment Cost Index as described in Appendix B. The administration of this test would also require two hours of industrial hygienist labor (EPA, 1999).
The second step to compliance with the workplace protection requirements at §721.63 (a)(3)(ii) is the evaluation of specifications from the manufacturer or supplier of the protective equipment. This requirement helps ensure that the protective equipment will be impervious to the PMN chemical(s). The evaluation of manufacturer specifications requires an estimated four hours of industrial hygienist labor.
Annual costs of the impermeability testing requirements are presented in Table C-6.
Table C-6. Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)]
                                 Cost Element
                              Unit Cost 
 (1997$)
                               Inflation Factor
                                   Unit Cost
                                    (2011$)
                                     Hours
                                 Total Cost[1]
  Impermeability Testing [§721.63(a)(3)(i)] 
                              Impermeability Test
                                     $800
                                 per chemical
                                     1.537
                                    $1,229
                                 per chemical
                                       
                                    $1,229
                           Industrial Hygienist time
                                       
                                       
                                       
                                    $51.53
                                   per hour
                                       2
                                    $103.07
                                       
                                   Subtotal
                                       2
                                    $1,332
  Evaluation of Manufacturer's Specifications  [§721.63(a)(3)(ii)]
                           Industrial Hygienist time
                                       
                                       
                                    $51.53
                                   per hour
                                       4
                                     $206
                                       
                                   Subtotal
                                       4
                                     $206
                                                                          TOTAL
                                       6
                                    $1,539
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       
 (2011$ per pair)
                          Number of Pairs Required[1]
                             Total Cost (2011$)[2]
                  Disposable nitrile gloves (replaced daily)
                                     $0.43
                                     1.401
                                     $0.60
                                     6,250
                                    $3,767
             Heavy duty butyl gloves (replaced every 25 work days)
                                    $34.00
                                     1.401
                                    $47.65
                                      250
                                    $11,913
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
                               (2011$ per pair)
                          Number of Pairs Required[1]
                             Total Cost (2011$)[2]
                               Standard Goggles
                                     $4.05
                                     1.401
                                     $5.68
                                      75
                                     $426
                   Heavy duty chemical-splash/impact goggles
                                     $6.05
                                     1.401
                                     $8.48
                                      75
                                     $636
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
                                (2011$ per set)
                              Number Required[1]
                             Total Cost (2011$)[2]
          Coverall with hood [full-body clothing] §721.63(a)(2)(ii)
                                    $61.20
                                     1.401
                                    $85.77
                                      75
                                    $6,433
                         Coverall  §721.63(a)(2)(iv)
                                    $36.25
                                     1.401
                                    $50.80
                                      75
                                    $3,810
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 Chapter 2 of the report, are calculated based on the assumptions stated there, that (1) there are 25 chemically-exposed workers requiring protective equipment, (2) respirators are replaced once a year, and (3) cartridges (and cartridge filters and caps) are replaced at a rate of one pair (two cartridges) every five of the 250 days that workers are exposed, or 50 times per year. For example, for the respirator type described at 40 CFR §721.63(a)(5)(xv), the annual cost per worker in 1997 dollars would be as follows:
$10.83 per respirator + ($8.94 per cartridge x 50 cartridges/year) = $457.83 per worker.
The 1997 cost was adjusted for inflation as shown in Table C-11. Typically a SNUR describes more than one type of respirator, but only one type of respirator is needed to comply with the workplace protection requirements.
Table C-11. Annual Per-Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)]
721.63 (a)(5) par.
NIOSH approval type at 40 CFR §721.63 (a)(5)
(See Table C-10  for cross-walk to respirators in SNUR)
Annual Average Costs 
(1997$)
Annual Average Costs 
(2011$)[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
                                     1.401
                                    $1,127
                                    $28,171
(ii)
19C Type C Supplied-air with tight-fitting facepiece
                                     $804
                                     $0.00
                                     $804
                                     1.401
                                    $1,127
                                    $28,171
(iii)
19C Type C Supplied-air with hood or helmet or tight-fitting facepiece
                                     $932
                                     $0.00
                                     $932
                                     1.401
                                    $1,306
                                    $32,660
(iv)
21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)
                                     $181
                                     $9.76
                                     $669
                                     1.401
                                     $937
                                    $23,428
(v)
21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs
                                     $627
                                    $35.50
                                    $2,402
                                     1.401
                                    $3,367
                                    $84,175
(vi)
21C PAPR with loose hood or helmet and HEPAs
                                     $525
                                    $26.89
                                    $1,870
                                     1.401
                                    $2,621
                                    $65,517
(vii)
21C Air-purifying with HEPA and disposable respirators
                                    $12.53
                                     $7.00
                                     $363
                                     1.401
                                     $508
                                    $12,702
(viii)
23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE)
                                     $192
                                    $15.71
                                     $978
                                     1.401
                                    $1,370
                                    $34,250
(ix)
23C PAPR with tight-fitting facepiece and combination cartridges approved PLE
                                     $627
                                    $35.50
                                    $2,402
                                     1.401
                                    $3,367
                                    $84,175
(x)
23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE
                                     $525
                                    $26.88
                                    $1,869
                                     1.401
                                    $2,620
                                    $65,500
(xi)
23C Air-purifying with combination cartridges for PLE, including disposable respirators
                                    $14.30
                                     $8.90
                                     $459
                                     1.401
                                     $644
                                    $16,093
(xii)
23C Air-purifying with full-facepiece and organic gas/vapor cartridges
                                     $192
                                    $10.47
                                     $716
                                     1.401
                                    $1,003
                                    $25,070
(xiii)
23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges
                                     $826
                                    $41.15
                                    $2,884
                                     1.401
                                    $4,042
                                   $101,044
(xiv)
23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges
                                     $640
                                    $41.15
                                    $2,697
                                     1.401
                                    $3,780
                                    $94,506
(xv)
23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges
                                    $10.83
                                     $8.94
                                     $458
                                     1.401
                                     $642
                                    $16,041
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
7A-33826
Willson Retainer Caps, p136
Moldex 8000 Series Half-Mask Respirator, p139
                                     $2.03
                                    $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 five to six hours. Other EPA reports have estimated that electronic submission of SNUNs is expected to reduce the recordkeeping burden to approximately one hour (EPA, 2009a, p. 16) For this report, the SNUN recordkeeping hours were included in the SNUN submission hours (see Table 8) and the SNUN recordkeeping cost was not separately estimated.  
All Manufacturers, 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
                                       
                  Kearney Estimates for CAIR Rule (1988a, b)
                            Adjusted for Inflation
                             Per Page Cost - 2011$

                                   Estimate
                                  CAIR Pages
                                 Cost Per Page
                       Cost Per Hour or Inflation Factor
                                 Cost Per Page
Labor Costs
                                   Technical
                                    1 hour
                                      750
                                 0.00133 hours
                                    $64.66
                                    $0.0862
                                   Clerical
                                   10 hours
                                      750
                                 0.01333 hours
                                    $29.63
                                    $0.3950
                                  Total Labor
                                                                  0.01467 hours
                                       
                                    $0.4812
Material Costs
                                 Photocopying
                             $0.05 [1988 dollars]
                                       1
                                    $0.050
                                     1.901
                                    $0.0951
                                 File Cabinet
                 1/4 of cabinet priced at $195 [1997 dollars]
                                      750
                                    $0.065
                                     1.401
                                    $0.0911
                                Misc. Materials
                           $10 total [1988 dollars]
                                      750
                                    $0.013
                                     1.901
                                    $0.0254
                                Total Materials
                                                                         $0.128
                                       
                                    $0.2115
                                    Total Cost per Page (Labor & Materials)
                                    $0.6928
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] 
                                    (2011$)
                                    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
                                    $0.6928
                                     $336
                                    0.01467
                                     7.11
                                    (d)(e)
 Protective clothing [§721.63] and impermeability [§721.63(a)(3)]
                                      20
                                    $0.6928
                                    $13.86
                                    0.01467
                                     0.29
                                      (f)
 Haz-comm program [§721.72]
                                      250
                                    $0.6928
                                     $173 
                                    0.01467
                                     3.67
                                      (g)
 Label copies [§721.72(b)]
                                       5
                                    $0.6928
                                    $3.46 
                                    0.01467
                                     0.07
                                      (h)
 MSDS copies [§721.72(c)]
                                       5
                                    $0.6928
                                    $3.46 
                                    0.01467
                                     0.07
                                      (i)
 Use limitations compliance     [§721.80]
                                      250
                                    $0.6928
                                     $173 
                                    0.01467
                                     3.67
                                      (j)
 Disposal compliance [§721.80]
                                      600
                                    $0.6928
                                     $416 
                                    0.01467
                                     8.80
                                      (k)
 Release to water compliance [ §721.90]
                                      100
                                    $0.6928
                                    $69.28 
                                    0.01467
                                     1.47
                                     TOTAL
                                     1,715
                                    $0.6928
                                    $1,188
                                    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.

Costs of Testing
EPA recognizes that TSCA Section 5 does not require developing any particular test data before submission of a Significant New Use Notice. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them. (Upon review of a SNUN, the Agency has the authority to require appropriate testing, but that is a cost of regulatory follow-up, not of the SNUN submission itself.)  For informational purposes, the SNURs describe tests recommended by EPA to provide sufficient information to evaluate the chemical substance. However, as was explained in the discussion of SNUNs earlier in this report, it appears that firms rarely elect to do these recommended tests to support a SNUN, and especially not the higher-cost tests. For informational purposes, this appendix presents estimated costs for testing often recommended for chemicals that have been the subject of PMNs and are subject to Significant New Use Rules (SNURs). 

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


Table D-1. Cost Estimates for Test Guidelines Cited in SNURs  
                                   Guideline
                                     Test
                                    Species
                                 Route/Method
                                     Cost
                                    2011$ 
Product Properties
 
 
 
                                       
830.6315
Flammability
NA
NA
                                    $2,300
830.7050
Absorption in Aqueous Solution: ultraviolet/visible spectra
NA
NA
                                    $2,325
830.7200
Melting Point / Melting Range
NA
8-test average
                                    $1,380
830.7550
Partition Coefficient (n-Octanol/Water)
NA
Shake Flask Method
                                    $7,212
830.7560
Partition Coefficient (n-Oct/Water)
NA
Generator Column
                                  $7,665.48 
830.7570
Partition Coefficient (n-Oct/Water)
NA
Liquid Chromatography
                                    $5,045
830.7840
Water Solubility
NA
Flask Method
                                  $10,422.28 
830.7860 (796.1860)[x]
Water Solubility: Column Generator Method
NA
Generator Column
                                  $22,502.05 
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
                                    $20,153
835.1220
Sediment and Soil Adsorption/Desorption Isotherm
NA
NA
                                    $30,910
835.2110 
Hydrolysis as a Function of pH
NA
NA
                                    $60,731
835.2120
Hydrolysis test
NA
NA
                                    $41,938
835.2130
Hydrolysis as a Function of pH and Temperature
NA
NA
                                       *
835.2210 (796.3700)
Photolysis in Aqueous Solution in Sunlight
NA
NA
                                   $121,486
835.3100 (796.3100)
Aerobic Aquatic Biodegradation
NA
NA
                                    $16,678
835.3110
Ready Biodegradation
NA
Average of six methods
                                    $13,031
835.3120
Sealed-Vessel CO2 Production Test
NA
NA
                                    $8,081
835.3140
CO2 in Sealed Vessels Test
NA
NA
                                       *
835.3170
Shake Flask Die-Away Test
NA
NA
                                    $53,137
835.3180 
Sediment/Water Microcosm Biodegradation
NA
Flow-through
                                   $138,942
835.3190
Aerobic Mineralization in Surface Water  -  Simulation Biodegradation Test
NA
NA
                                       *
835.3200 (OECD 302B)
Inherent Biodegradation: Modified Zahn-Wellens
NA
NA
                                    $10,559
835.3210
Modified SCAS Test
NA
NA
                                   $30,468 
835.3220
Porous Pot Test
NA
NA
                                    $33,703
835.3400 
Anaerobic Biodegradability of Organic Chemicals
NA
NA
                                    $12,828
835.5045 (OECD 302A)
Inherent Biodegradability: Modified SCAS Test
NA
NA
                                    $14,822
835.5270 (795.7000)
Sunlight Photolysis in Waters Containing Dissolved Humic Substances (Indirect Photolysis Screening Test)
NA
NA
                                    $25,624
D2035-80 (ASTM D 2035-80)
Standard Practice for Coagulation-Flocculation Jar Test of Water
NA
NA
                                    $4,426
OECD 303A
Simulation Test - Aerobic Sewage Treatment, with measurement of loss of the parent
NA
NA
                                    $44,569
OECD 307
Aerobic and Anaerobic Transformation in Soil
NA
Flow-through
                                   $292,278
OECD 307
Aerobic and Anaerobic Transformation in Soil
NA
Bio-meter type flasks
                                   $276,289
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
                                    $15,619
850.1010 (797.1300)
Daphnid Acute Toxicity
Daphnid
Static
                                    $15,412
850.1075 (797.1400)
Fish Acute Toxicity
Fathead Minnow
Flow-through
                                    $21,524
850.1075 (797.1400)
Fish Acute Toxicity
NA
Static
                                    $17,433
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
                                    $18,172
850.1300
Daphnid Chronic Toxicity Test
Daphnid
Flow-through
                                   $139,894
850.1350
Mysid Chronic Toxicity Test
Mysid
Flow-through
                                   $44,961 
850.1400
Fish Early Life Stage Toxicity
Rainbow Trout
Flow-through
                                    $71,341
850.1400
Fish Early Life Stage Toxicity
Fathead Minnow
Flow-through
                                    $48,229
850.1730
Fish BCF
Fathead Minnow
Flow-through
                                   $156,076
850.1925
Site-Specific Aquatic Microcosm Test
NA
NA
                                       *
850.1950
Field testing for Aquatic Organisms[3]
NA
NA
                                   $694,050
OECD 218 
Chironomid Sediment Toxicity
NA
NA
                                    $29,767
850.5400
Algal Toxicity, Tiers I and II
NA 
NA 
                                    $18,873
Health Effects
 
 
 
                                       
870.1100
Acute Oral Toxicity
Rats
Gavage
                                    $8,134
870.1300
Acute Inhalation Toxicity
Rats[4]
Inhalation
                                    $17,938
870.2500
Acute Dermal Irritation Test
Rabbits
Dermal
                                    $6,306 
870.2600
Dermal Sensitization Test
Guinea Pigs
NA
                                   $12,092 
870.3050
Repeated Dose 28-day Oral Toxicity Test
Rodents
NA
                                       *
870.3100
90-Day Oral Toxicity 
Rats
Gavage
                                   $162,941
870.3250
Subchronic Dermal Toxicity - 90 days
Rats
Dermal
                                   $172,991
870.3465[1]
Subchronic Inhalation Toxicity
Rats
Inhalation
                                   $534,075
870.3465 (mod)
Subchronic Inhalation Toxicity (w/ 60 day recovery group) 
Rats
Inhalation
                                   $254,763
870.3465 (OECD 413)[1]
Subchronic Inhalation Toxicity (90-day exposure/180-day retention)
Rats
Inhalation
                                   $445,112
870.3550
Reproductive/Developmental Toxicity Screening Test
NA
Oral
                                       *
870.3650
Combined repeated dose toxicity test with the reproductive/developmental screening test
Rats
NA
                                       *
870.3700
Prenatal Developmental Toxicity {2 species}
Rats
Gavage
                                   $123,686
870.3800
Reproduction/Fertility Effects (2-Generation Reproduction)
Rats
Gavage
                                   $411,738
870.4200
Carcinogenicity {2 species} (24 months)
Rats
Gavage
                                  $1,641,728
870.4200
Carcinogenicity {2 species}
Rats
Inhalation
                                  $1,302,863
870.4300
Combined Chronic Toxicity/Carcinogenicity Test
Rats 
Gavage
                                  $1,253,934
870.5100
Bacterial reverse mutation test
NA
Direct plate
                                    $9,364
870.5265
Salmonella typhimurium Reverse Mutation Assay (Ames Test)
NA
Average of direct plate and Azo reduction
                                    $13,515
870.5385
Mammalian Bone Marrow Chromosomal Aberration Test
Rats
Gavage
                                   $37,836 
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)
                                    $22,919
870.5395
In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte Micronucleus Assay (Average of 1 and 3 day dosings)
Mice
Intravenous (Two test average) 
                                    $22,919
870.5550
Unscheduled DNA Synthesis in Mammalian Cells in Culture
Rat Hepatocytes
NA
                                    $23,668
870.6100
Delayed Neurotoxicity of Organophosphorus Substances (Acute)
Hens
Gavage (Acute)
                                    $40,464
870.6100
Delayed Neurotoxicity of Organophosphorus Substances (Subchronic 28-day)
Hens
Gavage (Subchronic)
                                    $97,858
870.6200
Neurotoxicity Screening Battery (Acute)
Rats
Gavage
                                   $163,054
870.7800
Immunotoxicity
Rats 
Gavage
                                    $69,277
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)
                                    $15,144
OECD 105
Water Solubility Test
NA
Flask Method
                                    $7,169 
OECD 112
Dissociation Constant in Water Test
NA
Conductometric Method
                                    $6,416 
OECD 206
Avian Reproduction Test
Bobwhite Quail 
NA
                                   $106,052 
OECD 206
Avian Reproduction Test
Mallard Ducks
NA
                                   $114,681
OECD 303A
Simulation Test - Aerobic Sewage Treatment: Activated Sludge Units
NA
NA
                                    $44,569
OECD 307
Aerobic and Anaerobic Transformation in Soil Test
NA
Flow Through 
                                   $292,278
OECD 307
Aerobic and Anaerobic Transformation in Soil Test
NA
Bio-meter Type Flasks
                                   $276,289
OECD 308
Aerobic and Anaerobic Transformation in Aquatic Sediment Systems Test
NA
NA
                                       *
OECD 311
Anaerobic Biodegradability of Organic Compounds in Digested Sludge Test
NA
NA
                                       *
OECD 314
Simulation Test to Assess the Biodegradability of Chemicals Discharged  in Wastewater
NA
NA
                                       *
OECD 404 (870.2500)
Acute Dermal Irritation
Rabbits
Dermal
                                    $6,440
OECD 405 (870.2400)
Acute Eye Irritation
Rabbits
Eye
                                    $6,440
OECD 407 (870.3050) 
Repeated dose 28-day oral toxicity study in rodents
Rats 
Gavage (28 Days)
                                    $60,077
OECD 412
Repeated Dose Inhalation Toxicity (28-Day Study)
Rats
Inhalation (28 Days)
                                   $134,508
OECD 416
Two-Generation Reproduction Toxicity Test
Rats
Dietary
                                   $443,291
OECD 421 (870.3550)
Reproduction/developmental toxicity screening tests
Rats 
Gavage
                                    $70,465
OECD 422 (870.3650)
Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen
Rats
Gavage
                                   $140,459
OECD 422 (mod)
Combined Repeated Dose Study with Reproductive/Developmental Toxicity Screen (90 days w/ histopathology)
Rats
Gavage
                                   $264,076
OECD 425
Acute Oral toxicity: Up-and-down Procedure
Rats
Gavage
                                    $6,221
OECD 453
Combined Chronic Toxicity/Carcinogenicity Test
Rats
Inhalation
                                  $3,606,487 
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
                                    $2,625
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
                                    $573[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
                                     $766
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 $4,140 or $10,055 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 $4,140 and $10,055 in 2011 dollars. For simplicity, the method validation cost for ecological effects tests (e.g. 850 series guidelines) was assumed to be $4,140 for each test. In addition, this analysis assumes that analytical method validation costs are the same for both nanomaterials and traditional chemicals.
In cases where costs have not been estimated for the specified guideline, EPA uses the cost from an approximately equivalent guideline (listed in Table D-1 and Table D-3 in parentheses). Many of these equivalents are listed in the Federal Register at 63 FR 41847, August 5, 1998. In some cases the test protocol itself states that it is essentially equivalent to another test upon which it was based. Sometimes judgment was needed to select the closest equivalent(s). 
In some cases, EPA has not costed out the test for the species, route, duration, and/or other method listed in the SNUR, or the SNUR specifies a guideline but does not specify these details. In such cases, EPA has made the adjustments described below. The adjustments were selected based on discussions with EPA scientists and on SNUR language, published test guidelines, assumptions underlying the cost estimates in EPAB's test cost database, EPA review and Consent Order history for specific PMNs, or other sources. 
Default Parameters
Costs for many of the guidelines have been estimated for different combinations of species, route, length of study and other aspects of methodology, but in some cases the SNUR may not specify all of these variables. Where this occurs, EPA has used certain default parameters, listed in Table D-2. 

Table D-2.  Default Parameters for Species, Route, and Study Type
                                   Variable
                                       
                                    Default
Species
Mammals
Fish
Invertebrates
Algae
Rats
Fathead minnow[1]
Daphnids
[Four species -- see text]
Route/Method
Mammalian
Fish
Invertebrates
Gavage
Flow-through
Flow-through
Notes:  
[1] For guideline 850.1400 tests also in PBT tier tests, rainbow trout is the default species. (See PBT discussion below.)
SNUR Testing Tiers
A SNUR may recommend tiered testing. In such cases, costs are lower if only the first-tier tests are performed, and higher if all tests listed for the chemical are performed. Testing is "tiered" if later tests are contingent on the results of earlier tests, and/or if some tests are contingent on the firm reaching a certain chemical volume or time limit. Some tiers are explicit in the SNUR text; others result because the SNUR references the tiered PBT Category testing described at 64 FR 60194. 
Test Cost Assumptions and Comments
This section explains treatment of certain tests listed in this or past SNUR rulemakings.
   * A SNUR may recommend algal acute toxicity testing according to OPPTS Guideline 850.5400. This guideline has been previously costed by EPA for four separate algal species (Navicula pelliculosa, Skeletonema costatum, Anabaena flos-aquae, and Selenastrum capricornutum). If a SNUR does not specify the algal species to be used, the average costs of the four algal species tests are used.
   * For OPPTS test guideline 835.3100 (Aerobic Aquatic Biodegradation), a SNUR may call for an additional analytical methodology to identify the isononyl phenol degradation product, which may be a substantial add-on to the basic cost. Table D-1 gives costs for 835.3100 but not for the extended test. 
   * A SNUR may recommend a "modified" version of ASTM test guideline D2035-80 (Coagulation-Flocculation Jar Test of Water). Table D-1 gives costs for D2035-80 but not for the additional analytical methodology. 
   * For test guideline OECD 422 (Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening), a SNUR may recommend extended histopathology. Although the OECD 422 protocol does include histopathology, it is possible that extending the histopathology would increase the cost beyond that shown in Table D-1.
   * A SNUR may recommend two variations of test guideline OECD 218 (Chironomid Sediment Toxicity), one using the acute portion of the sediment and the other using the chronic portion. Costs were not determined for these two variants. The cost of the test performed on midge under flow through conditions was used for both.
   * A SNUR may recommend "a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test guideline)". "Freshwater and marine" refers to the name of the test, not the number of species required by EPA. The cost estimates assume only one species is used.
Persistent Bioaccumulative Toxic (PBT) tiered testing
A SNUR may cite tiered testing for Persistent Bioaccumulative Toxic chemical substances (PBTs) according to the testing strategy in EPA's New Chemicals Program PBT Category document, published in the Federal Register notice, Category for Persistent, Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at 64 FR 60194.  
In 64 FR 60194, there are three tiers of testing. The results of Tier 1 determine whether Tier 2 testing is needed and the results of Tier 2 testing determine whether Tier 3 testing is needed. Table D-3 lists the tests in the PBT category document. These tests are also listed in Table D-1.
To obtain a cost estimate for SNURs that cite PBT Category testing (64 FR 60194), costs of individual tests from 64 FR 60194 would have to be added up as appropriate, depending on the specific SNUR language. The test list would also need to be adjusted to avoid double counting tests listed in the SNUR both explicitly by guideline number, and implicitly due to their inclusion in PBT Category tiers. 
Other assumptions related to PBT testing are described below:
   * The PBT category tests at 64 FR 60194 specify rainbow trout as the species for the chronic fish toxicity test, 850.1400. For SNURs that recommend PBT Category testing, 850.1400 costs would be based on using rainbow trout. If 850.1400 is recommended without PBT testing, costs would be based on using fathead minnows.
   * For PBT Tier 1 ready biodegradability tests, firms may either choose among six methods in test guideline 835.3110 or follow test guideline 835.3120. The cost of 835.3110 is calculated as the average cost of its six possible methods. The cost estimates assume an equal chance of using either 835.3110 or 835.3120. 
Table D-3. Persistent Bioaccumulative Toxic (PBT) Tiered Testing Requirements
                                   PBT Tier
                                   Guideline
                                     Test
                                     Cost
                                     2011$
                                       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
                                    $7,665
                                       
                                $5,045  $6,355
                                       1
                                OPPTS 835.2110
Hydrolysis as a Function of pH
                                    $60,731
                                       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
                                    $13,031
                                       
                                $8,081  $10,556
                                       2
                                OPPTS 835.3170
Shake-flask Die-away Test [measures biodegradability]
                                    $53,137
                                       2
                                OPPTS 850.1730
Fish Bioconcentration
                                   $156,076
                                       3
                                OPPTS 835.3180
Sediment/Water Microcosm Biodegradation
                                   $138,942
                                       3
                         40CFR 797.1330 or 850.1300**
Daphnid Chronic Toxicity Test
                                   $139,894
                                       3
                         40CFR 797.1600 or 850.1400**
Fish Early Life Stage Toxicity (in rainbow trout)
                                    $71,341
                                       3
                                   OECD 422
Combined Repeated Dose Oral Toxicity with Reproductive/ Developmental Toxicity Screening (in rats)
$140,459 
                                       
Total cost, all tiers (assuming all tests are conducted)
                                   $777,491
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. 
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