ECONOMIC ANALYSIS OF EXPEDITED SIGNIFICANT NEW USE RULES

FOR 65 CHEMICAL SUBSTANCES

 (EPA DOCKET OPPT-2003-0063)

— DOES NOT CONTAIN TSCA CBI —

Prepared by:

Economic and Policy Analysis Branch

Economics, Exposure and Technology Division

Office of Pollution Prevention and Toxics

U.S. ENVIRONMENTAL PROTECTION AGENCY

1200 PENNSYLVANIA AVENUE, N.W.

WASHINGTON, DC 20460

December 4, 2006

(Revised March 12, 2007)

CONTRIBUTORS

The EPA analyst responsible for this report was Carol Rawie.  Analytical and draft preparation support was provided by Abt Associates Inc. under EPA Contract No. 68-W-02-077.

ABSTRACT

	This report estimates costs of Significant New Use Rules (SNURs) covering 65 chemicals that have been the subject of TSCA premanufacture notices (PMNs).  The SNURs define “Significant New Uses” that trigger EPA notice requirements. To submit a Significant New Use Notice or request SNUR modification, a firm incurs a modest submission cost, plus a potentially much higher cost if it performs full health and environmental effects testing to support the submission. Potential testing costs attributable to the SNURs range from none to more than $1.6 million per chemical.  Actual test costs will depend on case-by-case discussions between EPA and industry.

	By avoiding a Significant New Use, a firm can avoid submission and testing costs, but may incur other compliance costs.  For example, it may incur costs of limiting water releases, not quantified here but potentially affecting many chemicals.  It may incur costs of providing worker protection and/or hazard communications, affecting several chemicals.  Estimates assume 25 exposed workers per site and/or annual shipments of roughly 10,000 kilograms. The firm may also incur “hidden” costs, not quantified here, for example if it foregoes profitable opportunities to use the chemical in an application that would be a Significant New Use or limits production volume to avoid a Significant New Use.

	Costs are estimated for one chemical at one site, and reflect SNUR restrictions and testing specific to each chemical, but are not otherwise chemical-specific.  EPA receives only a handful of notices per year due to SNURs.  The number of firms affected but not making submissions to EPA is not known, and costs are not aggregated.

	This report was prepared in 2006.  It was revised in March, 2007, to remove one PMN SNUR, but was not otherwise updated in 2007.

TABLE OF CONTENTS

  TOC \o "1-3" \h \z    HYPERLINK \l "_Toc152671740"  CONTRIBUTORS	  PAGEREF _Toc152671740 \h  i

  HYPERLINK \l "_Toc152671741"  ABSTRACT	  PAGEREF _Toc152671741 \h  ii

  HYPERLINK \l "_Toc152671742"  LIST OF TABLES	  PAGEREF _Toc152671742 \h  v

  HYPERLINK \l "_Toc152671743"  1.0	INTRODUCTION	  PAGEREF _Toc152671743 \h  1

  HYPERLINK \l "_Toc152671744"  2.0	COSTS OF A SIGNIFICANT NEW USE RULE (SNUR), BY OPTION	  PAGEREF _Toc152671744 \h  4

  HYPERLINK \l "_Toc152671745"  2.1	Comply with SNUR Limits (Option 1)	  PAGEREF _Toc152671745 \h  4

  HYPERLINK \l "_Toc152671746"  2.2	Request Modification or Revocation of a SNUR (Option 2)	  PAGEREF _Toc152671746 \h  12

  HYPERLINK \l "_Toc152671747"  2.3	Submit SNUN (Option 3)	  PAGEREF _Toc152671747 \h  14

  HYPERLINK \l "_Toc152671748"  2.4	Request Equivalency Determination (Option 4)	  PAGEREF _Toc152671748 \h  16

  HYPERLINK \l "_Toc152671749"  2.5	Decide Not to Produce Chemical (Option 5)	  PAGEREF _Toc152671749 \h  16

  HYPERLINK \l "_Toc152671750"  2.6	Summary of Costs for Each Option	  PAGEREF _Toc152671750 \h  16

  HYPERLINK \l "_Toc152671751"  3.0	EXPORT NOTIFICATION COSTS	  PAGEREF _Toc152671751 \h  24

  HYPERLINK \l "_Toc152671752"  4.0	AGENCY COSTS	  PAGEREF _Toc152671752 \h  26

  HYPERLINK \l "_Toc152671753"  5.0	ADDITIONAL ANALYSES	  PAGEREF _Toc152671753 \h  27

  HYPERLINK \l "_Toc152671754"  5.1	Regulatory Flexibility Act (RFA)	  PAGEREF _Toc152671754 \h  27

  HYPERLINK \l "_Toc152671755"  5.2	Unfunded Mandates Reform Act (UMRA)	  PAGEREF _Toc152671755 \h  28

  HYPERLINK \l "_Toc152671756"  5.3	Paperwork Reduction Act (PRA)	  PAGEREF _Toc152671756 \h  28

  HYPERLINK \l "_Toc152671757"  5.4	Executive Order 12866, Regulatory Planning and Review	  PAGEREF _Toc152671757 \h  28

  HYPERLINK \l "_Toc152671758"  5.5	Executive Order 13132, Federalism	  PAGEREF _Toc152671758 \h  28

  HYPERLINK \l "_Toc152671759"  5.6	Executive Order 12898, Environmental Justice	  PAGEREF _Toc152671759 \h  28

  HYPERLINK \l "_Toc152671760"  5.7	Executive Order 13045, Protection of Children	  PAGEREF _Toc152671760 \h  29

  HYPERLINK \l "_Toc152671761"  5.8	Executive Order 13175, Tribal Governments	  PAGEREF _Toc152671761 \h  29

  HYPERLINK \l "_Toc152671762"  5.9	Executive Order 13211, Energy Supply, Distribution, or Use	  PAGEREF _Toc152671762 \h  29

  HYPERLINK \l "_Toc152671763"  APPENDIX A	LIST OF PMNs AND THEIR CHEMICAL NAMES	A-  PAGEREF _Toc152671763 \h  1

  HYPERLINK \l "_Toc152671764"  APPENDIX B	INFLATORS AND WAGE RATES	B-  PAGEREF _Toc152671764 \h  1

  HYPERLINK \l "_Toc152671765"  B.1	Derivation of Loaded Wage Rates	B-  PAGEREF _Toc152671765 \h  1

  HYPERLINK \l "_Toc152671766"  B.2.	Derivation of Inflation Factors	B-  PAGEREF _Toc152671766 \h  5

  HYPERLINK \l "_Toc152671767"  APPENDIX C	COSTS OF HAZARD COMMUNICATION, PROTECTION IN THE WORKPLACE, AND RECORDKEEPING REQUIREMENTS	C-  PAGEREF _Toc152671767 \h  1

  HYPERLINK \l "_Toc152671768"  C.1	Modifying the Hazard Communication Program	C-  PAGEREF _Toc152671768 \h  1

  HYPERLINK \l "_Toc152671769"  C.2	Protection in the Workplace	C-  PAGEREF _Toc152671769 \h  5

  HYPERLINK \l "_Toc152671770"  C.3	Recordkeeping	C-  PAGEREF _Toc152671770 \h  20

  HYPERLINK \l "_Toc152671771"  APPENDIX D	COSTS OF TESTING	D-  PAGEREF _Toc152671771 \h  1

  HYPERLINK \l "_Toc152671772"  D.1	Testing Guidelines	D-  PAGEREF _Toc152671772 \h  1

  HYPERLINK \l "_Toc152671773"      D.2      Test Costs by Guideline	D-  PAGEREF _Toc152671773 \h  5

  HYPERLINK \l "_Toc152671774"  D.3	Testing Costs by Chemical	D-  PAGEREF _Toc152671774 \h  7

  HYPERLINK \l "_Toc152671775"  APPENDIX E 	COSTS FOR SNUN, MODIFICATION/REVOCATION, OR EQUIVALENCY DETERMINATION	E-  PAGEREF _Toc152671775 \h  1

  HYPERLINK \l "_Toc152671776"  APPENDIX F	AGENCY COSTS	F-  PAGEREF _Toc152671776 \h  1

  HYPERLINK \l "_Toc152671777"  APPENDIX G	REFERENCES	G-  PAGEREF _Toc152671777 \h  1

LIST OF TABLES

Table 1 Compliance Options and Associated Costs Incurred by a Firm due to SNUR

Table 2 Production and Use Restrictions/Requirements

Table 3 Annual Costs of Hazard Communication Requirements

Table 4 Annual Costs of Workplace Protection Requirements

Table 5 Annual Costs of Workplace Protection Requirements - Summary

Table 6 Annual Costs of Recordkeeping Requirements

Table 7 Costs of Testing Requirements

Table 8 Costs of Requirement to Modify/Revoke SNUR or Submit SNUN

Table 9 Quantified Costs by PMN Chemical and Option

Table 10 Annual Per-Site Haz-Comm, Worker Protection, and Recordkeeping Costs

Table 11 Derivation of Total Mailing Cost for 25 Notices

Table 12 TSCA 12(b) Export Notification Costs: Annual Average Burden per Respondent

               Facility Averaging 25 Notices

Table A-1 PMNs and Chemical Names Referenced in this Economic Analysis

Table B-1 Derivation of Loaded Wage Rates

Table B-2 Weighted Average Wages for Industrial Hygienists - Manufacturing (NAICS 31, 32, 33)

Table B-3 Derivation of Inflation Factors

Table C-1 Annual Costs of Labeling for Distribution in Commerce

Table C-2 Annual Costs of Labeling for Use in Workplace

Table C-3 Annual Costs for Material Safety Data Sheets (MSDSs)

Table C-4 Annual Costs for Employee Training

Table C-5 Annual Costs for Dermal Protection Selection

Table C-6 Annual Costs of Impermeability Testing

Table C-7 Annual Cost of Gloves

Table C-8 Annual Cost of Protective Eyewear

Table C-9 Annual Cost of Protective Clothing

Table C-10 Crosswalk Between SNUR Text and Respirator Types at 40 CFR

Table C-11 Annual Per-Chemical Costs for Respiratory Protection

Table C-12 Respirator Prices and Average Costs in 1997, by NIOSH Type

Table C-13 Annual Per-Chemical Costs of Personal Protective Equipment

Table C-14 Annual Per-Chemical Costs of Recordkeeping Requirements

Table C-15 Annual Per-Chemical Costs of Recordkeeping Requirements

Table D-1 Cost Estimates for Test Guidelines Cited in SNUR

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

Table D-3 Testing Requirements and Costs for all SNUR Chemicals

Table E-1 Industry Costs for SNUN, Request to Modify/Revoke, or Equivalency Determination

Table F-1 Agency Costs for SNUN and Other Submission Review and Processing

1.0	INTRODUCTION

	This report presents the U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics’ (OPPT’s) analysis of the potential costs incurred as a result of direct final Significant New Use Rules (SNURs) being promulgated for 65 chemical substances which have gone through premanufacture notice (PMN) review.  Appendix A lists the generic or specific chemical name and CAS number (if non-confidential) for each PMN.

	EPA promulgates a SNUR for a substance when potential uses could result in increased exposure to or releases of the substance, and in turn present an unreasonable risk to health or the environment.  In contrast to PMN requirements, which apply mainly to manufacturers and importers (40 CFR §720.22), the SNUR applies to processors as well as to manufacturers and importers (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 the PMN review process.  Some are still “new” chemicals, not yet listed on the TSCA Inventory.  For some chemicals, SNUR requirements are based on prior Consent Orders entered into with the original PMN submitter under TSCA Section 5(e).

	A SNUR specifies the conditions under which the manufacture, import, and/or processing of the PMN substance is allowed without prior notice to EPA, thus defining its permissible uses that do not constitute a “Significant New Use.”  For example:

If the SNUR specifies that the chemical may only be imported but not manufactured in the U.S., then manufacture in the U.S. is considered a Significant New Use;

If the SNUR specifies a limit to the quantity of the chemical that a firm may produce in the U.S., then manufacture of any quantity exceeding that limit is considered a Significant New Use;

If the SNUR limits the use of the chemical to uses (products, applications, and/or functions) listed in the PMN, then any other use is considered a Significant New Use;

If the SNUR limits the amount of the chemical that may be released to water, then any amount exceeding that limit is considered a Significant New Use; or

If the SNUR requires workplace protection or hazard communication (haz-comm) for the chemical, then not providing the required workplace protection or haz-comm is considered a Significant New Use.

	If a firm produces, imports, or processes the chemical in commercial quantities, then to avoid engaging in a Significant New Use that would trigger submission requirements, the firm must meet the specifications in the SNUR.  Anything that exceeds what is specified as allowable in the SNUR is considered a Significant New Use and triggers a submission to EPA. 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 1.

Table 1 Compliance Options and Associated Costs Incurred by a Firm due to SNUR

Option1	Costs	Quantified Costs per Chemical ($2005)2

1.	Satisfy the limits and/or requirements specified in the SNUR, such as limiting water releases, engaging in PMN uses only, importing only, limiting volumes, providing workplace protection, or providing hazard communications. 	Costs of meeting haz-comm, personal protective equipment, and recordkeeping requirements are quantified in this analysis.  Other costs, such as of complying with water release restrictions, limiting volume, avoiding domestic manufacture, and foregoing non-PMN uses, may exist but are not quantified.	$1,039 to $40,587 annual costs for recordkeeping, haz-comm, and worker protection.

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).	$5,385 submission cost plus any testing costs. 4

3.	Submit 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-- i.e., in some way other than what is specified as allowable in the SNUR.	Costs of submitting a SNUN, including associated recordkeeping and user fee.3 Testing costs are also possible, but only for a small minority of chemicals, and so are not assigned to this option in Table 9. 	$7,885 submission cost (including $2,500 fee) plus any testing costs.3

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 a request for equivalency determination. 	$5,385 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 the profit foregone as a result of not engaging in the commercial activity originally planned. 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 9, below.

1 Firms may follow multiple Options simultaneously.

2 Quantified costs are attributable to the SNUR only if a firm would not otherwise follow the specified practices.

3 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, SNUR “New” Chemicals).

4 Testing costs attributable to the SNUR range from none to over $1.6 million. They are somewhat more likely to be undertaken for a request to modify/revoke than for a SNUN.

In previous economic analyses of SNURs, EPA identified those requirements under Subparts A, B, C, and D of 40 CFR §721 that may impose costs on manufacturers, importers, and processors of PMN substances (e.g., RIB, 1989).  Some of these costs, such as providing personal protective equipment under §721.63, are estimated and presented as part of this analysis.  Other costs, such as for limiting releases to water, avoiding uses not listed in the PMN, or keeping production below a specified level, are described only qualitatively.

	The remainder of this report estimates the quantified portion of costs associated with the SNURs being promulgated for the chemicals listed in Appendix A.  Section 2 presents estimates of the costs incurred by manufacturers, importers, and/or processors under the SNUR options in Table 1.  Section 3 addresses one-time export notification costs.  Section 4 addresses costs to EPA of administering the SNURs, while Section 5 presents an analysis of other impacts, as required by various statutes and executive orders.  The appendices give cost estimation details.

2.0	COSTS OF A SIGNIFICANT NEW USE RULE (SNUR), BY OPTION

	A SNUR specifies requirements a firm must meet if it chooses to manufacture, import, or process a PMN chemical.  A firm may select one or more courses of action.  These options are described below along with their costs.  Appendix B provides the wage rates and inflators used in this analysis.

2.1	Comply with SNUR Limits (Option 1)

	A firm can avoid engaging in a Significant New Use by meeting SNUR requirements related to production and use.  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 further notice to EPA is required.  Table 2 below shows the types of requirements a firm must meet to avoid engaging in a Significant New Use.

Table 2 Production and Use Restrictions/Requirements

40 CFR Reference (Code of Federal Regulations)	Restriction/Requirement No. of Chemicals Affected1	Costs Per Chemical2

§721.63	Workplace protection	8	$0 to $38,606

§721.72	Hazard communication	10	$0 or $942

     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	1	Not quantified

§721.80(f)	Import only (do not manufacture)	9	Not quantified

§721.80(g,h,i)	Use only as intermediate	2	Not quantified

§721.80(j, k)	Stick to uses listed in PMN or Consent Order	23	Not quantified

§721.80(l,m,n,o)	Limits non-industrial uses	0	Not quantified

§721.80  (p, q, s, t)	Limit production volume	18	Not quantified

§721.80  (r, u)	Volume-triggered testing	0	Not quantified

§721.80 ( v, w, x, y)	Restricts physical form of chemical	6	Not quantified

     Disposal, water release, recordkeeping

§721.85	Disposal	1	Not quantified

§721.90	Limit releases to water	32	Not quantified

§721.1253	Recordkeeping for all manufacturers,  importers, and processors	All chemicals (65)	Up to $1,039

Notes:

	1 Some chemicals have more than one type of restriction.

2 See Table 10 below for haz-comm, worker protection, and recordkeeping costs.

	3 For SNUN recordkeeping under §721.40, see the recordkeeping discussion in Appendix C.

The requirements and costs of meeting the hazard communication (haz-comm), protective equipment, and recordkeeping requirements are quantified for this report.   These costs are summarized below and presented, for each chemical, at the end of Section 2 in Table 10.  Appendix C provides a more detailed presentation of the derivation of these costs.  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 water release, 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 hazard communication (haz-comm) program for the applicable chemical.   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 User Rules: General Provisions for New Chemical Followup (RIB, 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 to be low.  Costs are for substances with full haz-comm requirements, and may overstate haz-comm costs for substances with partial requirements. Costs are summarized in Table 3.  Appendix C gives the detailed cost derivation.

Table 3  Annual Costs of Hazard Communication Requirements

Requirement	Cost

($2005)1	Hours

Update written program	$178 	4

Labeling: 	Distribution in commerce	$120 	0.5

 	Use in the workplace	$333 	1.5

MSDS preparation	$116 	2.25

Employee training	$194 	6.75

TOTAL	$942	15

Notes:

1Figures are rounded to whole dollars. Substances not subject to all of these requirements may have lower costs. See Appendix C for derivations.

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 for a chemical.  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 do one or both of the following:  (1) perform impermeability testing on the PPE to ensure the equipment will be impervious to the PMN substance under the expected conditions of exposure, and/or (2) rely on equipment manufacturers' specifications to determine whether the equipment will provide adequate protection. 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.  Table 5 shows the number of chemicals requiring the specified type of protection.  The costs of worker protection were originally estimated in an 1989 EPA report, Economic Analysis of Final Significant New Use Rules: General Provisions for New Chemical Follow-Up (RIB, 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, and updates costs to reflect 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 Requirements

Requirement	Cost ($2005)1

Dermal protection plan (industrial hygienist)	$446

Impermeability testing (excluding evaluation of manufacture specifications)	$1,161

Evaluation of manufacturer's specifications	$178

Subtotal  	$1,785

Personal protective equipment

Gloves (disposable)	$3,270

Gloves (heavy duty)	$10,343

Clothing (coverall with hood)	$5,585

Clothing (coverall, no hood)	$3,308

Eyewear (standard goggles)	$370

Eyewear (heavy duty goggles)	$552

Respirator Types2

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)]	$24,459

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)]	$28,357

Air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters.[similar to §721.63(a)(5)(iv)]	$20,341

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)]	$20,341

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)]	$73,084

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)]	$73,084

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)]	$56,884

Notes:

1 Figures may not sum due to rounding.

2This table lists respirator choices as contained within the current SNURs, Docket No. OPPTS-2003-0063.  Future SNURs may list different choices.  The numbers in parentheses refer to paragraphs under 40 CFR §721.63(a)(5) listing respirator types.  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.  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 (see Appendix C for derivations).

	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 below provides a summary of the quantified costs of the worker protection requirements for substances in these SNURs.  Costs are per chemical produced at a single site.  The costs are tabulated for each PMN substance in Table 10.

	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 cases where the SNUR requires dermal protection but does not specify any particular gear, it was not feasible to determine which particular gear might be needed, and so only the costs of assessing needs and demonstrating impermeability were included. The 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, costs would be higher than those shown here.   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, annual costs would be somewhat higher than costs in the table.

Table 5  Annual Costs of Workplace Protection Requirements - Summary

Protection in the workplace costs*	No. of Chemicals	Costs equal to:

Chemicals with no costs	57	N/A

Chemicals covering costs of:	8

	(a) dermal protection selection and impermeability testing/evaluation of manufacturer's specifications.	2	$1,785

(b) dermal protection selection, impermeability testing/evaluation of manfacturer's specifications, and heavy duty gloves.	2	$12,128

(c)  supplying respirators only.	2	$20,341

(d) supplying respirators, dermal protection selection, and impermeability testing/evaluation of manufacturer's specifications.	1 $22,126

(e) dermal protection selection, impermeability testing/evaluation of manufacturer's specifications, heavy duty gloves, heavy duty goggles, full body chemical protective clothing, and repirators.	1	$38,606

TOTAL	65

*This table summarizes Table 10.

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 shows the cost if recordkeeping is required under all paragraphs in §721.125(a) through (k), which would seldom, if ever, be the case for a single chemical.  Appendix C breaks out cost by recordkeeping topic.

Table 6  Annual Costs of Recordkeeping Requirements (40 CFR §721.125)

Requirement	Cost ($2005)1	Hours

Technical labor	$121 	2.29

Clerical labor	$603 	22.87

Photocopies	$142 	-

File cabinet	$136 	-

Miscellaneous materials	$38 	-

TOTAL	$1,039 	25.15

Notes:

1Figures are rounded to whole dollars. Applies to all SNUR chemicals. Assumes all recordkeeping paragraphs §721.125(a) through (k) are specified, and so may overstate costs. Does not cover recordkeeping for SNUN submissions.  See Appendix C for derivations and cost by §721.125 paragraph.

PMN uses, production volume limits, import-only, water releases, disposal

	Several types of costs that may be incurred by complying with the SNUR limits are not quantified in this report.

Water release, disposal, and other use restrictions may result in costs not quantified for this report.  For example:

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.

Keeping production volume below specified limits to avoid a Significant New Use could result in a decrease in profits if the firm is producing for sale, a potential “hidden” cost.  If the firm is producing the chemical for internal use, it may have to substitute to a less cost-effective chemical, another potential “hidden” cost.

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 US.

2.2	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. The second option is thus for the firm to request modification or revocation of the SNUR, with some or all of the following 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 Required Testing Data

	For each PMN substance, the SNUR identifies any health, ecological, and/or fate/transport/transformation testing that would help characterize the risks associated with the substance.  Such testing is recommended but not required in the SNUR, and may be provided by the submitter to support a request for modification and revocation of a SNUR.  40 CFR §721.185(b)(1) requires that a modification request include “information sufficient to support the request.”  (For SNUNs, while TSCA does not mandate development of new test data for a SNUN, a firm may also elect to conduct tests to support the SNUN.)

	This analysis assumes the firm performs all of the tests.  This may overstate costs, since in reality, testing required depends on case-by-case discussions between EPA and the chemical supplier, and test costs may be substantially less than those estimated here.   If no additional testing is needed to support a modification request (for example, if testing already performed for other purposes were acceptable to EPA), costs would be similar to costs of a SNUN -- discussed later in this section -- less the user fee.

	The SNUR lists recommended tests by test guideline numbers which can be used to look up published test protocols.  Testing costs for each PMN substance are calculated by adding up costs for individual test protocols listed in the SNUR for that substance.  The costs for individual test protocols have been determined by EPA over the years (mostly since 1990) to support TSCA rule development and adjusted for inflation, but have not generally been updated to reflect laboratory technology changes.  Detailed information on the procedure used to estimate testing costs for each PMN substance is found in Appendix D.

	Table 7 below summarizes the potential costs of the testing requirements specified for the chemicals covered by the SNURs, and Table 9 shows total costs by option for each of the PMN Substances (most of the Option 2 costs are for testing.)   If all listed tests are performed, testing would cost from a few thousand dollars to well over one million dollars per chemical.  Usually potential costs are in the tens or hundreds of thousands of dollars.  The SNURs identify certain chemicals for tiered testing.  Later tests are contingent on the results of earlier tests and/or volume or time limit triggers.  In such cases, “low estimate” costs assume only the first-tier tests are performed, while “high estimate” costs assume tests in all tiers are performed. See Appendix D for details.

 	Test costs are per company, and are one-time costs (not annualized).  For many chemicals, if full testing is needed, the test costs could dominate the costs quantified in this report.  However, essential hazard data may become available from other sources, so tests are not always needed.   Test costs in Tables 7 and 9 most likely represent a high-end estimate of testing costs attributable to the SNURs.

Table 7  Costs of Testing Requirements

Testing Costs*	No. of Chemicals	No. of Chemicals

	Low Estimate	High Estimate

Less than $30,000	3	1

Between $30,001 and $50,000	10	 9

Between $50,001 and $100,000	16	13

Between $100,001 and $500,000	32	25

Between $500,001 and $1,000,000	3	6

Over $1,000,000	1	11

TOTAL	65	65

Notes:

1 See Appendix D for details.

	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 are estimated to be similar to the costs for preparing a PMN submission.  In its Regulatory Impact Analysis for the amendments to the PMN regulations, EPA relied on industry estimates of the effort needed to collect and compile all data required for a PMN submission, prepare the form, and submit the form and data to EPA (RIB, 1994).  These estimates, based on a 1991 survey conducted by the Chemical Manufacturers Association, indicate that the average effort required to prepare and submit a PMN is between 95 and 114 hours.  This analysis uses the average of the estimated hours for each step, resulting in the cost shown in Table 8.  The costs associated with these labor time estimates are derived in Appendix E.

	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 ($2005)1

	Request to Modify/Revoke SNUR

(Option 2)	Submit a SNUN (Option 3)	Request Equivalency Determination (Option 4)

Costs of preparing submission (105 labor hours)	$5,385	$5,385	$5,385

User fees

NONE	$2,500	NONE

TOTAL

$5,385	$7,885	$5,385

Test Costs

More likely	Less likely

	Notes:

1Figures are rounded to whole dollars (see Appendix E for derivation).

	Total Costs for Option 2

	The total costs associated with requesting a modification or revocation of a SNUR include the costs of performing any needed testing plus the administrative cost of preparing the submission.  Costs of preparing the submission itself are relatively small, but testing costs can be very significant.  These costs are combined in Table 9, which shows total costs by option for each of the PMN substances.  If full testing is not needed, costs could be much lower than shown in Table 9.

2.3	Submit SNUN (Option 3)

	Under 40 CFR §721.5, manufacturers, importers, or processors who would like to undertake a Significant New Use of a PMN 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:

Costs of preparing the SNUN and of the $2,500 user fee.  (However, in some cases, a notification may be needed even without a SNUR; see SNUR “New” Chemicals, below.)

Costs of complying with SNUR restrictions (or of avoiding production) while the SNUN is being processed; costs of recordkeeping and of complying with any restrictions resulting from the SNUN review (see the discussion of Option 1 for compliance costs).

The SNUN submitter may need to perform some of the tests listed in the SNUR. However, the likelihood of testing is judged to be less for a SNUN than for the request to modify the SNUR (Option 2). This analysis assumes the firm would not perform testing for the SNUN.  (If testing were needed, then Option 3 costs may be closer to those estimated for Option 2, a request for modification/revocation of the SNUR.)

	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 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 premanufacture notification 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 manual 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 can diminish the 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.  In addition, as was mentioned above, there could be testing costs, delay costs, or other costs not included in Table 9 for this option.  Table 8 shows the costs of preparing a SNUN; details are in Appendix E.

2.4	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).

2.5	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 PMN 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 PMN 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.

2.6	Summary of Costs for Each Option

	Table 1, above, gave an overview of compliance options.  Table 9, below, summarizes, for each SNUR chemical, the quantified portion of costs of either following restrictions to avoid engaging in a Significant New Use, or of making a submission to EPA.  Costs reflect restrictions and testing specific to each chemical, but are not otherwise adjusted for the nature of the chemical or process, volume, location, or other firm-specific or chemical-specific factors.  Costs 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.

	Table 9 costs are estimated for one chemical at one site, not for aggregate production.  EPA receives a handful of Significant New Use Notices per year due to SNURs.  For SNUR chemicals on the TSCA Inventory, it is not known how many firms are affected but do not make a submission because they use the chemical in a way that avoids a Significant New Use (Option 1).  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 SNUR chemicals are still relatively new and, in addition, often have confidential chemical identities.  Some are not yet in commercial production at all.

For firms producing, importing, or processing within SNUR restrictions to avoid a Significant New Use (Option 1), all chemicals have annual recordkeeping costs of up to $1,039 per chemical.  Some chemicals have annual hazard communication costs of $942 per chemical and/or annual worker protection costs ranging from $1,785 to $38,606 (Table 10).  Most chemicals are also subject to costs that could be significant but are not quantified in this report, such as restrictions on water release or on other aspects of use.

For submissions to EPA (Options 2, 3, and 4), the basic one-time submission cost is estimated at $5,385.  For the SNUN (Option 3), EPA also collects a $2,500 fee

After submitting a SNUN, the firm may need to comply with restrictions as a result of the SNUN review process, possibly imposing further costs similar to those in Option 1.

Firms may perform health and environmental effects testing to support a submission, especially for a request to modify/revoke the SNUR (Option 2).  Table 9 shows modify/revoke costs with and without testing. Testing costs are quite variable.  If all tests in the SNUR are performed due to the SNUR, one-time costs increase dramatically for some chemicals, to over $1 million.  However, even if the SNUR leads to testing, actual costs may be much lower than shown in the Option 2 depending on case-by-case discussions with EPA.  Appendix D gives test cost details.

Companies that might have produced, 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.

	For some firms, costs may be attributable to the 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 imposes no added costs for that firm.  As another example, if the 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).

	Firms may also incur testing, worker protection, haz-comm and other costs for reasons other than the SNUR, so that SNUR requirements may impose no added costs.

	Table 9  Quantified Costs by PMN Chemical and Option ($2005)1

	SNUR Sequence Number	PMN Number	Option 1	Option 2	Option 3	Option 4

 Produce within SNUR criteria to avoid significant new use2	Modification or Revocation of a SNUR3	Submission of SNUN4	Request for Equivalency Determination5

	Testing Cost	Submission Cost

Cost	Low	High

Cost	Cost

1	P97-0415	$24,107	$300,576	$300,576	$5,385	$7,885	$5,385

2	P00-0614	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

3	P00-0617	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

4	P98-0625	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

5	P98-0626	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

6	P98-0627	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

7	P98-0628	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

8	P98-0629	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

9	P98-1181	$13,167	$311,255	$311,255	$5,385	$7,885	$5,385

10	P98-1182	$13,167	$311,255	$311,255	$5,385	$7,885	$5,385

11	P99-0511	$1,039	$32,178	$932,338	$5,385	$7,885	$5,385

12	P00-0011	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

13	P00-1121	$1,981	$222,180	$1,358,194	$5,385	$7,885	$5,385

14	P00-1122	$1,981	$291,103	$1,427,117	$5,385	$7,885	$5,385

15	P00-1123	$1,981	$222,180	$1,358,194	$5,385	$7,885	$5,385

16	P00-1124	$1,981	$222,180	$1,358,194	$5,385	$7,885	$5,385

17	P00-1125	$1,981	$222,180	$1,358,194	$5,385	$7,885	$5,385

18	P00-1126	$1,981	$291,103	$1,427,117	$5,385	$7,885	$5,385

19	P01-0109	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

20	P01-0110	$1,039	$8,796	$588,028	$5,385	$7,885	$5,385

21	P01-0111	$1,039	$3,862	$132,640	$5,385	$7,885	$5,385

22	P01-0257	$1,039	$63,680	$63,680	$5,385	$7,885	$5,385

23	P01-0258	$1,039	$63,680	$63,680	$5,385	$7,885	$5,385

24	P01-0259	$1,039	$63,680	$63,680	$5,385	$7,885	$5,385

25	P01-0261	$1,039	$63,680	$63,680	$5,385	$7,885	$5,385

26	P01-0442	$1,039	$382,952	$382,952	$5,385	$7,885	$5,385

27	P01-0563	$1,039	$62,504	$62,504	$5,385	$7,885	$5,385

28	P01-0564	$1,039	$62,504	$62,504	$5,385	$7,885	$5,385

29	P01-0764	$22,322	$222,180	$1,122,339	$5,385	$7,885	$5,385

30	P01-0769	$1,039	$115,325	$463,081	$5,385	$7,885	$5,385

31	P01-0770	$1,039	$115,325	$463,081	$5,385	$7,885	$5,385

32	P01-0771	$1,039	$115,325	$463,081	$5,385	$7,885	$5,385

33	P01-0772	$1,039	$115,325	$463,081	$5,385	$7,885	$5,385

34	P01-0856	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

35	P01-0862	$1,039	$92,213	$119,386	$5,385	$7,885	$5,385

36	P01-0901	$2,824	$270,126	$270,126	$5,385	$7,885	$5,385

37	P01-0902	$2,824	$270,126	$270,126	$5,385	$7,885	$5,385

38	P01-0918	$40,587	$532,489	$532,489	$5,385	$7,885	$5,385

39	P01-0919	$1,039	$206,296	$206,296	$5,385	$7,885	$5,385

40	P02-0214	$22,322	$222,180	$1,122,339	$5,385	$7,885	$5,385

41	P02-0269	$1,039	$1,283,112	$1,283,112	$5,385	$7,885	$5,385

42	P02-0322	$1,039	$96,573	$96,573	$5,385	$7,885	$5,385

43	P02-0359	$1,039	$96,573	$96,573	$5,385	$7,885	$5,385

44	P02-0382	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

45	P02-0406	$1,039	$67,540	$530,621	$5,385	$7,885	$5,385

46	P02-0423	$1,039	$791,588	$1,691,748	$5,385	$7,885	$5,385

47	P02-0434	$1,039	$14,560	$14,560	$5,385	$7,885	$5,385

48	P02-0514	$1,039	$504,954	$504,954	$5,385	$7,885	$5,385

49	P02-0522	$1,039	$96,573	$96,573	$5,385	$7,885	$5,385

50	P02-0530	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

51	P02-0585	$1,039	$113,357	$113,357	$5,385	$7,885	$5,385

52	P02-0697	$1,039	$67,540	$530,621	$5,385	$7,885	$5,385

53	P02-0698	$1,039	$222,180	$222,180	$5,385	$7,885	$5,385

54	P02-0737	$1,039	$171,317	$1,071,477	$5,385	$7,885	$5,385

55	P02-0747	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

56	P02-0766	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

57	P02-0869	$1,039	$96,573	$96,573	$5,385	$7,885	$5,385

58	P02-0912	$1,039	$80,834	$80,834	$5,385	$7,885	$5,385

59	P02-0929	$1,039	$138,464	$138,464	$5,385	$7,885	$5,385

60	P02-0961	$1,039	$80,834	$80,834	$5,385	$7,885	$5,385

61	P02-1088	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

62	P03-0041	$1,039	$47,943	$47,943	$5,385	$7,885	$5,385

63	P03-0043	$1,039	$63,680	$63,680	$5,385	$7,885	$5,385

64	P03-0046	$1,039	$165,642	$165,642	$5,385	$7,885	$5,385

65	P03-0047	$1,039	$165,642	$165,642	$5,385	$7,885	$5,385

Notes:

	1All costs are rounded to the nearest dollar figure.  Option 5 (no production or import except for R&D), has no quantified costs and so is not listed in this table.  However, most PMN chemicals have other restrictions which could lead to unquantified costs, such as restrictions on releases to water, uses not listed in PMN, or production volumes.

2Option 1 includes annual costs for recordkeeping ($1,039),  haz-comm ($942), and worker protection. Costs of other restrictions were not quantified (limiting water discharges, avoiding uses not listed in PMN, import only, limiting production volume, etc.).  See Table 10 and Appendix C.

3Option 2 includes one-time costs of request to modify/revoke SNUR ($5,385) and for testing.  For chemicals with PBT testing or other tiered testing, the “low” cost assumes added testing is not triggered by Tier 1 test results, or by other test triggers that may be in the SNUR.  “High" costs assume added testing is triggered by Tier 1 test results or by other triggers (see Appendix D).  Costs of following SNUR restrictions pending Agency revocation of SNUR were not quantified.  If full testing is not needed, costs would be lower.  For test costs by PMN chemical, see Table D-3.

4Option 3 includes one-time costs of SNUN ($5,385) plus a $2,500 user fee.  Costs of the following restrictions during or resulting from Agency review were not quantified. Analysis assumes no testing costs for this option.  If testing is also needed, costs would be higher.

5Option 4 includes one-time costs of request for equivalency determination ($5,385).  Costs of following SNUR restrictions during review and of alternative controls were not quantified.

Table 10  Annual Per-Site Haz-Comm, Worker Protection, and Recordkeeping Costs*

No.	PMN	Haz-Comm ($2005) 40 CFR 721.72	Workplace Protection ($2005)  40 CFR 721.63	Recordkeeping ($2005) 40 CFR 721.125	Total Quantified Cost ($2005)

1	P97-0415	$942	$22,126  (a)	$1,039	$24,107

2	P00-0614	$0	$0	$1,039	$1,039

3	P00-0617	$0	$0	$1,039	$1,039

4	P98-0625	$0	$0	$1,039	$1,039

5	P98-0626	$0	$0	$1,039	$1,039

6	P98-0627	$0	$0	$1,039	$1,039

7	P98-0628	$0	$0	$1,039	$1,039

8	P98-0629	$0	$0	$1,039	$1,039

9	P98-1181	$0	$12,128 (b)	$1,039	$13,167

10	P98-1182	$0	$12,128 (b)	$1,039	$13,167

11	P99-0511	$0	$0	$1,039	$1,039

12	P00-0011	$0	$0	$1,039	$1,039

13	P00-1121	$942	$0	$1,039	$1,981

14	P00-1122	$942	$0	$1,039	$1,981

15	P00-1123	$942	$0	$1,039	$1,981

16	P00-1124	$942	$0	$1,039	$1,981

17	P00-1125	$942	$0	$1,039	$1,981

18	P00-1126	$942	$0	$1,039	$1,981

19	P01-0109	$0	$0	$1,039	$1,039

20	P01-0110	$0	$0	$1,039	$1,039

21	P01-0111	$0	$0	$1,039	$1,039

22	P01-0257	$0	$0	$1,039	$1,039

23	P01-0258	$0	$0	$1,039	$1,039

24	P01-0259	$0	$0	$1,039	$1,039

25	P01-0261	$0	$0	$1,039	$1,039

26	P01-0442	$0	$0	$1,039	$1,039

27	P01-0563	$0	$0	$1,039	$1,039

28	P01-0564	$0	$0	$1,039	$1,039

29	P01-0764	$942	$20,341 (c)	$1,039	$22,322

30	P01-0769	$0	$0	$1,039	$1,039

31	P01-0770	$0	$0	$1,039	$1,039

32	P01-0771	$0	$0	$1,039	$1,039

33	P01-0772	$0	$0	$1,039	$1,039

34	P01-0856	$0	$0	$1,039	$1,039

35	P01-0862	$0	$0	$1,039	$1,039

36	P01-0901	$0	$1,785 (d)	$1,039	$2,824

37	P01-0902	$0	$1,785 (d)	$1,039	$2,824

38	P01-0918	$942	$38,606 (e)	$1,039	$40,587

39	P01-0919	$0	$0	$1,039	$1,039

40	P02-0214	$942	$20,341 (c)	$1,039	$22,322

41	P02-0269	$0	$0	$1,039	$1,039

42	P02-0322	$0	$0	$1,039	$1,039

43	P02-0359	$0	$0	$1,039	$1,039

44	P02-0382	$0	$0	$1,039	$1,039

45	P02-0406	$0	$0	$1,039	$1,039

46	P02-0423	$0	$0	$1,039	$1,039

47	P02-0434	$0	$0	$1,039	$1,039

48	P02-0514	$0	$0	$1,039	$1,039

49	P02-0522	$0	$0	$1,039	$1,039

50	P02-0530	$0	$0	$1,039	$1,039

51	P02-0585	$0	$0	$1,039	$1,039

52	P02-0697	$0	$0	$1,039	$1,039

53	P02-0698	$0	$0	$1,039	$1,039

54	P02-0737	$0	$0	$1,039	$1,039

55	P02-0747	$0	$0	$1,039	$1,039

56	P02-0766	$0	$0	$1,039	$1,039

57	P02-0869	$0	$0	$1,039	$1,039

58	P02-0912	$0	$0	$1,039	$1,039

59	P02-0929	$0	$0	$1,039	$1,039

60	P02-0961	$0	$0	$1,039	$1,039

61	P02-1088	$0	$0	$1,039	$1,039

62	P03-0041	$0	$0	$1,039	$1,039

63	P03-0043	$0	$0	$1,039	$1,039

64	P03-0046	$0	$0	$1,039	$1,039

65	P03-0047	$0	$0	$1,039	$1,039

Notes:

* Costs were rounded.  See Appendix C for derivations.

1 The cost for P97-0415 consists of the annual cost of supplying respirators, dermal protection selection ($446), and impermeability testing/evaluation of manufacturer's specifications ($1,339).  For this chemical, the SNUR listed respirator choices.  The least expensive choice appeared to be an "air-purifying, tight-fitting  respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters."  The annual cost of the least expensive choice is used here ($20,341).

2 This cost consists of dermal protection selection ($446), impermeability testing/evaluation of manufacturer's specifications ($1,339), and the cost of supplying heavy duty gloves ($10,343).  For these chemicals, the SNUR did not specify what type of gloves to use.  Heavy duty gloves were chosen to provide an upper-bound estimate.

3 The cost for P01-0764 and P02-0214 consists of the annual cost of supplying respirators.  For these chemicals, the SNUR listed respirator choices.  The least expensive choice appeared to be an "air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters.”  The annual cost of the least expensive choice is used here ($20,341).

4 This cost consists of dermal protection selection ($446) and impermeability testing/evaluation of manufacturer's specifications ($1,339).

5 The cost for P01-0918 consists of dermal protection selection ($446), impermeability testing/evaluation of manufacturer's specifications ($1,339); the cost of supplying heavy duty gloves ($10,343), heavy duty goggles ($552), and protective clothing ($5,585); and respirator ($20,341).  For this chemical, the SNUR did not specify what type of gloves, or eyewear to use.  Heavy duty gloves and goggles were chosen to provide an upper-bound estimate. For this chemical, the SNUR listed respirator choices.  The least expensive choice appeared to be an "air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters."  The annual cost of the least expensive choice is used here ($20,341).

3.0	EXPORT NOTIFICATION COSTS

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical identified in a SNUR (40 CFR §707.60 through 75).

The exporter must submit a notice the first time in the calendar year that it exports the particular chemical to a particular country.  Notifications must include the exporter's name and address, the chemical name, the date(s) of export or intended export, the importing country (or countries), and the section of TSCA under which EPA has taken action.

An EPA report, Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (EPAB, 2005b), estimated the annual export notification cost for an exporter making 25 submissions in a year, as shown in Tables 11 and 12.  The cost per chemical at one firm could be more than the cost per submission, since firms may need to make more than one submission per chemical.

After receiving a notification from a firm, EPA notifies the importing country and the US State Department (40 CFR §707.70).  Not all incoming notices require that a notification be sent out.  For an estimated 8,600 incoming notifications and 1,600 outgoing notifications, total Agency costs were estimated at $178,025 per year (EPAB, 2005b).  There could be multiple notifications by EPA for some SNUR chemicals.

Table 11  Derivation of Total Mailing Cost for 25 Notices1

Dates that the rates were verified on United States Postal Service web site:	Nov '05	June '06

Postal services - Cost for 25 notices

Registered mail, regular, with $0 declared value	$7.50 	$7.90

Return receipt, requested at time of mailing (receive by mail)	$1.75  $1.85

Postage, regular First Class , up to 1 ounce	$0.37 	0.39

Subtotal	$9.62 	$10.14

Cost per export notice	× 25	× 25

Total Mailing Cost for 25 Notices	$240.50	$253.50

Notes:

1Information in italics shows the exact postal services assumed for cost purposes in the November 2005 report, Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (EPAB, 2005b).  To better show the cost change between November 2005 and June 2006, figures are not rounded in this table.

Source:  Mailing rates are from the US Postal Service web site as of November 2005 and June 2006 (http://www.usps.com/common/category/postage.htm).

Table 12  TSCA 12(b) Export Notification Costs: Annual Average Burden per Respondent Facility Averaging 25 Notices

	Technical	Clerical	Total

	$/Hr	Hours	$2005	$/Hr	Hours	$2005	$2005	Hours

Compile list	$53.02	8.3	$440	--	--	--	$440	8.3

Write letter	$53.02	1	$53	--	--	--	$53	1

Check order and send notice	--	--	--	$26.37	12.5	$330	$330	12.5

Mailing cost	--	--	--	--	--	--	$254	-

Total per facility	$106	9.3	$493	$26	12.5	$330	$1,076	21.8

Source: Appendix B of this report derives technical and clerical hourly labor costs. Other costs are from Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements (EPAB, 2005b).

4.0	AGENCY 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.  These costs are estimated at $5,291 per case.  The required Agency steps, full-time equivalent (FTE) staff needs, and extramural costs such as for contractor support are derived in Appendix F from EPA's analysis of the Agency costs of processing PMN submissions (RIB, 1994), with adjustments to reflect inflation and changes in Agency staff levels.  The original EPA analysis used a range of salaries, but this analysis uses one typical salary.

The PMN costs reflect estimates made in 1994, in Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (RIB, 1994).  The average cost to review a SNUN may be different from that estimated for PMNs, both because of differences between PMNs and SNUNs, and because the PMN review hours may have changed since 1994.  Resources were not available to re-estimate costs for SNUNs.  See Appendix F for details.

5.0	ADDITIONAL ANALYSES

	This section presents additional analysis of other potential impacts of this rulemaking, as required under various statutes and executive orders.

	5.1	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.   EPA's experience to date is that, in response to the promulgation of SNURS covering over 1000 chemicals, the Agency receives only a handful of notices per year.  Of those SNUNs submitted, none appear to be from small entities in response to any SNUR.  In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR.

	This leaves open the question of how many small businesses are affected but do not submit SNUNs.  For example, businesses may change their behavior in order to use a chemical in a manner that avoids triggering Significant New Use notification requirements, and make no submission to EPA.

Data and resources were not available to estimate the number of small businesses affected by the current rule.  However, a 1989 analysis suggested that few small businesses would be affected by SNURs for chemicals that have undergone PMN review. The 1989 report estimated that 9% of firms subject to SNURs would be small businesses, based on the portion of PMN submitters who were small businesses (RIB, 1989).  The threshold to be considered a “small business” was $40 million in sales, which is consistent with the definition used at 40 CFR §700.43 to set PMN fees.

	Past bona fide submissions also suggest that few firms other than possibly some PMN submitters will be affected.  EPA has received few bona fides indicating interest in manufacturing or importing chemicals subject to past SNURs.  EPA also has received few public comments during rulemaking on SNURs covering PMN chemicals.  For example, a SNUR published in the spring of 2003 covering 62 chemicals resulted in industry comments on only three PMNs, none from small businesses (EPA Docket No. OPPT-2002-0060; EPA, 2003).

	It remains possible that some small businesses are affected by SNURs without EPA being aware, for example if the firms have made no submissions or comments to EPA.   However, even if a small business were interested in supplying a SNUR chemical, the SNUR's impact on profits is generally expected to be minor.  For example, the firm may have a small expense of  keeping records and/or of changing workplace practices to comply with restrictions.  If modifying production practices would be overly costly, or if the firm wishes to engage in a Significant New Use but believes that expensive testing is needed to support a submission to EPA, it may instead forego production, thus sacrificing profits.  The amounts of lost profits, if any, were not quantified for this report, but usually should be low.  This is because SNUR chemicals are relatively new and few compared to the many thousands of chemicals on the TSCA Inventory, and so are unlikely to be central to a firm’s business.

	Based on these considerations and on the limited data available, EPA expects that any compliance with a SNUR will not have a significant economic impact on a substantial number of small entities.

5.2	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).

5.3	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 ICR No. 574).  This action does not impose any additional burden requiring OMB approval.

5.4	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.

5.5	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).

5.6	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).

5.7	Executive Order 13045, Protection of Children

	Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 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.

5.8	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.

5.9	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.

APPENDIX A

LIST OF PMNs AND THEIR CHEMICAL NAMES

APPENDIX A	LIST OF PMNs AND THEIR CHEMICAL NAMES

Table A-1  PMNs and Chemical Names Referenced in this Economic Analysis1

	No	PMN	CAS	Name

1	P97-0415	2682-49-7	2-Thiazolidinone

2	P00-0614	n/a	(Generic) Manganese heterocyclic tetraamine complex

3	P00-0617	n/a	(Generic) Manganese heterocyclic tetraamine complex

4	P98-0625	n/a	(Generic) Manganese heterocyclic tetraamine complex

5	P98-0626	n/a	(Generic) Manganese heterocyclic tetraamine complex

6	P98-0627	n/a	(Generic) Manganese heterocyclic tetraamine complex

7	P98-0628	n/a	(Generic) Manganese heterocyclic tetraamine complex

8	P98-0629	n/a	(Generic) Manganese heterocyclic tetraamine complex

9	P98-1181	247041-56-1	2-Butenoic acid, 4,4'-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-C8-10-isoalkyl esters, C9-rich

10	P98-1182	n/a	2-Butenoic acid, 4,4'-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-C9-11-isoalkyl esters, C10-rich

11	P99-0511	n/a	(Generic) Mixed metal Oxide

12	P00-0011	103331-86-8	Alcohols, C12-14 secondary, ethoxylated propoxylated

13	P00-1121	12163-45-0	Manganese strontium oxide (MnSr03)

14	P00-1122	12032-75-6	Manganese yttrium oxide (MnY03)

15	P00-1123	12230-80-7	Barium manganese oxide (BaMn03)

16	P00-1124	359427-90-0	Barium calcium manganese strontium oxide

17	P00-1125	12049-47-7	Manganate (Mn021-), calcium (2:1)

18	P00-1126	12438-71-0	Manganese yttrium oxide (Mn2Y05)

19	P01-0109	n/a	(Generic) Halogenated naphthalic anhydride

20	P01-0110	n/a	(Generic) Halogenated benzimidazole

21	P01-0111	n/a	(Generic) Dibenzimidazothianaphthalene

22	P01-0257	n/a	(Generic) Amine terminated bisphenol A diglycidyl ether polymer

23	P01-0258	n/a	(Generic) Amine terminated bisphenol A diglycidyl ether polymer

24	P01-0259	n/a	(Generic) Amine terminated bisphenol A diglycidyl ether polymer

25	P01-0261	n/a	(Generic) Amine terminated bisphenol A diglycidyl ether polymer

26	P01-0442	13169-90-9	Calcium hydroxide oxide silicate

27	P01-0563	174489-76-0	Benzoic acid, 2-chloro-5-nitro-, l,l-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester

28	P01-0564	174489-43-1	Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester

29	P01-0764	39290-90-9	Magnesium potassium titanium oxide

30	P01-0769	333955-69-4	Benzeneamine, N-phenyl-, ar-(C9-rich C8-10-branched alkyl) derivs

31	P01-0770	333955-70-7	Benzeneamine, N-phenyl-, ar, ar'-(C9-rich C8-10-branched alkyl) derivs

32	P01-0771	333955-79-6	10H-Phenothiazine, ar-(C9-rich C8-10-branched alkyl) derivs

33	P01-0772	333955-80-9	10H-Phenothiazine, ar, ar'-(C9-rich C8-10-branched alkyl) derivs

34	P01-0856	350820-95-0	Cashew, nutshell liq., ethoxylated

35	P01-0862	n/a	(Generic) Ethoxylated alkylsulfate, substituted alkylamine salt

36	P01-0901	n/a	(Generic) Disubstituted benzene metal salt

37	P01-0902	n/a	(Generic) Disubstituted benzene metal salt

38	P01-0918	n/a	Isocyanate compound, modified with methoxysilane

39	P01-0919	346709-25-9	Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-hydrolyzed

40	P02-0214	39318-30-4	Lithium potassium titanium oxide

41	P02-0269	n/a	Acrylic acid, polymer with substituted acrylamides

42	P02-0322	547-68-2	Zinc, [ethandioato(2-)-. kapp. 01, . kappa. 02]-

43	P02-0359	n/a	(Generic) Substituted pyridine coupled with diazotized substituted nitrobenzonitrile, diazotized substituted benzenamine and substituted pyridinecarbonitrile

44	P02-0382	n/a	(Generic) Alkylbenzene sulfonate

45	P02-0406	n/a	(Generic) Acetaldehyde based polymer

46	P02-0423	n/a	(Generic) Complex halogenated salt of tris(ethylated aminocarbocyclic)methane

47	P02-0434	n/a	(Generic) Trimellitic anhydride, polymer with substituted glycol, alkyl phenols and ethoxylated nonylphenol

48	P02-0514	n/a	(Generic) Diethoxybenzenamine derivative, diazotized, coupled with aminonaphthalenesulfonic acid derivative, ammonium salt

49	P02-0522	n/a	(Generic) Substituted acridin naphtha substituted benzamide

50	P02-0530	119344-86-4	1-Butanone, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl] -

51	P02-0585	6712-98-7	2-Propanol, 1-[bis(2-hydroxyethyl)amino]-

52	P02-0697	n/a	(Generic) Dineopentyl-4-substituted phthalate

53	P02-0698	n/a	(Generic) Metal oxide, modified with alkyl and vinyl terminated polysiloxanes

54	P02-0737	n/a	(Generic) Diazotized substituted heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel complex, alkaline salt

55	P02-0747	n/a	(Generic) Polyaromatic amine phosphate

56	P02-0766	383905-85-9	Polyphosphoric acids, compds. with piperazine

57	P02-0869	n/a	(Generic) Substituted anthraquinone

58	P02-0912	2362-14-3	Phenol, 4,4'-cyclohexylidenebis[2-methyl-

59	P02-0929	n/a	(Generic) Disubstituted-N'- hydroxy-benzenecarboximidamide

60	P02-0961	n/a	(Generic) Spiro naphthoxazine

61	P02-1088	n/a	(Generic) Aminoalkyl substituted alkylphenol

62	P03-0041	n/a	(Generic) Alkyl silane methacrylate

63	P03-0043	452082-53-0	Phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2-hydroxypropyl ethers

64	P03-0046	136504-87-5	1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-soya acyl derivs., inner salts

65	P03-0047	90194-13-1	Benzenemethanaminium, N-(3-aminopropyl)-N,N-dimethyl-, N-soya acyl derivs., chlorides

Key: PMN = Premanufacture Notice. CAS = Chemical Abstract Service.

Notes:

1The order of chemicals in this table reflects the order in the draft Federal Register notice and may differ from the order of chemicals in the published Federal Register notice.APPENDIX B

INFLATORS AND WAGE RATES

APPENDIX B	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 2005.

B.1	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 (Rice, 2002).  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.

B.1.1	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 2005, the average wage rate for professional/technical labor was $31.02; the average fringe benefit was $16.73.  Fringe benefits as a percent of wages were $16.73/$31.02, or approximately 53.9 percent.

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 (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPAB, 2002).  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 2005 fully loaded wage for professional/technical labor is $31.02 × (1+0.539329 + 0.17) = $53.02.

Fully loaded costs for managerial, clerical, and production labor are calculated in a similar manner, as shown in Table B-1.

B.1.2	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: Private Manufacturing Industry by Occupation (BLS, 2006c).  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.

B.1.3	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 2006 (OPM, 2006).  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 $140,262.

The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (OPPE, 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, 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.”  (ICR No.1139.06)

Table B-1  Derivation of Loaded Wage Rates1

EPAB Labor Category	Data Sources	Date	Wage	Fringe Benefit	Fringes as % wage*	Over-head % wage2	Fringe + overhead factor*	Loaded Wages* Inflation Factor3	Loaded Wages

	(a)	(b)	(c)=(b)/(a)	(d)	(e)=(c)+(d)+1	(f)=(a)  (e)	(g)	(h)=(f)  (g)

Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial”4	Dec-05	$38.22	$18.89	49.42%	17%	1.66	$63.61	1	$63.61

Professional/

Technical	BLS ECEC, Private Manufacturing industries, “Professional and related“4	Dec-05	$31.02	$16.73	53.93%	17%	1.71	$53.02	1	$53.02

Clerical	BLS ECEC, Private Manufacturing industries, “Office and Administrative Support”4	Dec-05	$15.73	$7.97	50.67%	17%	1.68	$26.37	1 $26.37

Production Worker	BLS ECEC, Private Manufacturing industries, “Production.”4	Dec-05	$15.34	$8.93	58.21%	17%	1.75	$26.88	1	$26.88

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.5	May-05	$26.10

Fringes: BLS ECEC, Private Manufacturing industries, “Professional and related”4	Dec-05	--	--	53.93%	17%	1.71	$44.61	1	$44.61

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.6	Jan-06	$87,664 (annual)	--	[Included in 60% overhead]	60%	1.60	$140,262 (annual)	1	$140,262       (annual)

Notes:

1Wage data are rounded to the closest dollar figure in this table; however, in calculations using these numbers for this report, unrounded values were used.

2An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program  (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report  (EPAB, 2002).

3An inflation factor of “1” means wage data was not escalated to reflect inflation.

4Unpublished Employer Costs for Employee Compensation: Private Manufacturing Industry by Occupation, December 2005.  Data received by Carol Rawie, US EPA, from Raphael Branch, US Bureau of Labor Statistics, May 10, 2006 (BLS, 2006c).  The data is not seasonally adjusted (email from Raphael Branch to Carol Rawie, November 17, 2005).

5Employment and unweighted wages are from BLS Occupational Employment Statistics (National Industry-Specific Employment and Wage Estimates), May 2005.

6The Federal salary is the unloaded Federal GS-13 Step 5 salary ($87,664) for 2006, from the Office of Personnel Management salary table for Washington-Baltimore-Northern Virginia (OPM, 2006).  The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (OPPE, 1992, page 30, footnote 9).

Table B-2  Weighted Average Wages for Industrial Hygienists – Manufacturing (NAICS 31, 32, 33)1

Occupation Title (SOC code)	Employment

(a)	Mean hourly wage

(b)	Weight

(c)	Weighted Wage

(d)=(c) x (b)

Occupational Health & Safety Specialists (29-9011)	5,630	$27.27	0.811 $22.12

Occupational Health & Safety Technicians (29-9012)	1,310	$21.08	0.189 $3.98

Industrial Hygienist (weighted average)	6,940	--	1	$26.10

Notes:

1Wage data are rounded to the closest dollar figure in this table; however, in calculations using these numbers for this report, unrounded values were used.

Source: Employment and unweighted wages are from BLS Occupational Employment Statistics (Occupational Employment and Wages), for May 2005 (BLS, 2005).

  SEQ CHAPTER \h \r 1 B.2.	Derivation of Inflation Factors

	Costs of equipment and supplies were inflated to year 2005 dollars 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.

Table B-3 Derivation of Inflation Factors

Item	Inflation index source	Starting year	Index for starting year (a) Index for 2005

(b)2	Inflation factor (b)/(a)3

Chemical testing (toxicity, ecological effects etc.)	BLS ECI, SA, total comp, private industry, All Workers.  ECS10002I, 4th Q [BLS, 2006d] varies	varies	100.3	varies

White collar/other labor mix; equipment; supplies.  	Example for test costed in 1993	1993	66.5	100.3	1.508

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	100.3	1.197

Impermeability testing of gloves and other gear1	BLS ECI, SA, total comp, private industry, All Workers. ECS10002I, 4th Q [BLS, 2006d] 	1997 74.9	100.3	1.339

Export notification	BLS ECI, SA, Total comp, Private industry, White Collar. ECS11102I, 4th Q [BLS, 2006d]	1992	63.2	100.3	1.587

Agency Extramural costs White collar labor; equipment; supplies	BLS ECI, SA, Total comp, Private industry, White Collar.   ECS11102I, 4th Q [BLS, 2006d] 	1993	65.5	100.3	1.531

Labels, placards, gloves, eyewear, clothing, respirators 	BLS CPI, all urban consumers, not SA. CUUR0000SAO, Annual [BLS, 2006e]	1997	160.5 195.3	1.217

File cabinet

	Photocopies	BLS CPI, all urban consumers, not SA. CUUR0000SAO, Annual [BLS, 2006e]	1988	118.3	195.3

1.651

Record keeping materials

	Key: BLS = Bureau of Labor Statistics.  CPI = Consumer Price Index.  ECI = Employment Cost Index.  SA = Seasonally Adjusted.  Total Comp = Total Compensation (wages/salaries and benefits).  4th Q = Fourth Quarter.  “ECS10002I” etc. refer to BLS series Ids.

Notes:

1 The index selected represents a change from a prior PMN SNUR economic analysis (EPAB, 2003).  The prior report used a series (ECS11102I) for private industry White Collar workers; this report uses the series (ECS10002I) for all private industry workers.  The change better reflects the mix of labor likely to be involved in impermeability testing.

2 In 2006, the 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 index factors in this table and explained on the BLS website, Employment Cost Index News Release Text: Employment Cost Index, March 2006  (BLS, 2006b).  The SIC-based series (as opposed to NAICS-based) are used here because they contain historical data.  The CPI was not rebased.

3 While indexes for the starting year and 2005 are rounded to one decimal place in this table, unrounded indexes were used to calculate the inflation factor.

APPENDIX C

COSTS OF HAZARD COMMUNICATION, PROTECTION IN THE WORKPLACE, AND RECORDKEEPING REQUIREMENTSAPPENDIX C	COSTS OF HAZARD COMMUNICATION, PROTECTION IN THE WORKPLACE, AND RECORDKEEPING REQUIREMENTS

Section 2.1 of this economic analysis presents a discussion of the methodology for assessing the costs of the worker protection, hazard communication, and recordkeeping requirements of the batch SNUR.  This appendix presents the dollar costs and labor hours of these requirements, for one chemical at one site.  The hazard communication (haz-comm) costs reflect the annual costs of updating the written program, creating and applying labels for chemical distribution and storage, creating and distributing material safety data sheets (MSDS), and employee training.  The personal protective equipment (PPE) costs shown 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 technical and clerical labor time, reproduction charges, and costs for the storage of records.

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 (RIB, 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 Employer Costs for Employee Compensation (BLS, 2006c) and other BLS 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.

Haz-comm costs, costs of providing protection in the workplace, and recordkeeping costs   are discussed in Sections C.1, C.2, and C.3, respectively.  These costs, as well as total costs calculated by summing the haz-comm, protection in the workplace, and recordkeeping costs, are summarized for each PMN substance in Table 10 above.

C.1	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 (RIB, 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 (RIB, 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.

	C.1.1	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.  Costs for IH services were obtained from the BLS Occupational Employment and Wages series, using the hourly mean wage for occupational health and safety specialists and technicians in the healthcare practitioner and technical occupations group, loaded with fringe benefits and overhead as described in Appendix B.  Costs for the written haz-comm program are as follows:

4 hours Industrial Hygienist time   ×   $44.61 per hour  =   $178

The estimates of IH hours to update the program come from a 1998 EPA report (EPAB, 1988).

C.1.2	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 (RIB, 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).

C.1.2.1		 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 (RIB, 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 (RIB, 1989).

Technical labor is fully loaded with fringe benefits and overhead, as described in Appendix B.  Labeling materials costs were obtained from a national safety equipment supply house catalog (LSS, 1997) and were inflated as described in Appendix B.  The resulting costs of labeling for chemicals distributed in commerce, per chemical substance at one site, are shown in Table C-1.

Table C-1  Annual Costs of Labeling for Distribution in Commerce [40 CFR §721.72(b)(2)]

Cost Element	Unit Cost          (1997 Dollars)	Inflation

Factor	Unit Cost

(2005 Dollars)	Hours	Total Cost1

	0.5 hours technical time	$0.16 per label	1.217	$53.02	per hour	0.5	$27

	480 labels

	$0.19	per label

$93

	TOTAL	0.5	$120

	Notes:

	1Total 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, Appendix B.

C.1.2.2 	Chemicals Used in the Workplace

Workplace labeling requirements are costed by assuming the facility purchases six large (14" × 10") signs, priced at $38.30 each in 1997 dollars (LSS, 1997; EPAB, 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 (RIB, 1989).  The labeling process is also assumed to require 0.5 hours of technical time to compile label information and 10 minutes of production worker time to post each placard.  Technical labor costs include wages, fringe benefits, and overhead, as described in Appendix B.

The resulting per chemical, per site costs of labeling for chemicals in the workplace are shown in Table C-2.

Table C-2  Annual Costs of Labeling for Use in Workplace [40 CFR §721.72(b)(1)]

Cost Element	Unit Cost             (1997 Dollars)	Inflation Factor	Unit Cost                  (2005 Dollars)	Hours	Total Cost1

0.5 hours technical time

$38.30 per item

1.217

	$53.02	per hour	0.5	$27

6 labels or placards (14" x 10")

$47

per item

$280

10 minutes per label/placard production worker time

$26.88

per hour

1.0

$27

TOTAL	1.5	$333

Notes:

1Total 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, EPAB, 1998, LSS, 1997; cost elements and quantities, RIB, 1989; inflators and labor unit costs, Appendix B.

C.1.3	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 (RIB, 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 (RIB, 1989). The loaded hourly wage rates and the inflator used in estimating unit photocopy costs are derived in Appendix B.  The resulting cost of MSDS preparation is shown in Table C-3.

Table C-3  Annual Costs for Material Safety Data Sheets (MSDSs) [40 CFR §721.72(c)]

Cost Element	Unit Cost

(1988 Dollars)	Inflation Factor	Unit Cost

(2005 Dollars)	Hours	Total Cost1

2.0 hours technical time

	$53.02	per hour	2	$106

0.25 hours clerical time

	$26.37	per hour	0.25	$7

40 copies	$0.05	1.651	$0.08	per copy

$3

TOTAL	2.25	$116

Notes:

1Total 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, Appendix B.

C.1.4	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 Followup (RIB, 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 (RIB, 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 (RIB, 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               (2005 Dollars)	Hours	Total Cost1

0.5 hours technical time (trainer)  	$53.02	per hour	0.5	$27

0.25 hours per production employee × average of 25 workers per plant = 6.25 hours	$26.88	per hour	6.25	$168

TOTAL	6.75	$194

Notes:

	1Total 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, RIB, 1989; labor unit costs, Appendix B.

C.2	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.

C.2.1	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 (EPAB, 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

(2005 Dollars)	Hours	Total Cost1

10 hours industrial hygienist (IH) time	$44.61 per hour	10	$446

Notes:

1Total 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, BLS 2006c and Appendix B; cost elements and quantities, EPAB, 1999.

C.2.2	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 prevent 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 (EPAB, 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 EPAB, 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 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 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 (EPAB, 1999).

The second step to compliance with the workplace protection requirements at §721.63(a)(3)(ii) is the evaluation of specifications from the manufacturer or supplier of the protective equipment.  This requirement helps ensure that the protective equipment will be impervious to the PMN chemical(s).  The evaluation of manufacturer specifications requires an estimated four hours of industrial hygienist labor.

Annual costs of the impermeability testing requirements are presented in Table C-6.

Table C-6  Annual Costs of Impermeability Testing [40 CFR §721.63(a)(3)]

Cost Element	Unit Cost         (1997 Dollars)	Inflation Factor	Unit Cost                      (2005 Dollars)	Hours	Total Cost*

Impermeability Testing [§721.63(a)(3)(i)]

     Impermeability Test	$800	1.339	$1,071	per chemical

$1,071

     Industrial Hygienist time

	$44.61	per hour	2	$89

Subtotal	2	$1,161

Evaluation of Manufacturer's Specifications  [§721.63(a)(3)(ii)]

     Industrial Hygienist time

	$44.61	per hour	4	$178

Subtotal	4	$178

TOTAL	6	$1,339

Notes:

1Total 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, EPAB, 1998 and EPAB, 1999; inflators and labor rates, Appendix B.

C.2.3	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 RIB, 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 x 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        ($2005 per pair)	Number of Pairs Required1	Total Cost ($2005)2

Disposable nitrile gloves (replaced daily) 	$0.43	1.217	$0.52	6,250 $3,270

Heavy duty butyl gloves (replaced every 25 work days)	$34.00	1.217	$41 250	$10,343

Notes:

1The analysis assumes that 25 workers who are exposed 250 days/year replace disposable gloves daily and replace heavy duty gloves every 25 work days.

2Total 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, EPAB, 1998; inflator, Appendix B.

C.2.4	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         ($2005 per pair)	Number of Pairs Required1	Total Cost2

Standard Goggles 	$4.05	1.217	$5	75	$370

Heavy duty chemical-splash/impact goggles	$6.05	1.217	$7	75	$552

Notes:

1The analysis assumes 25 workers replacing goggles three times per year.

2Total 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, EPAB, 1998; Inflator, Appendix B.

C.2.5	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   ($2005 per set)	Number Required1	Total Cost2

Coverall with hood [full-body clothing] §721.63(a)(2)(ii)	$61.20	1.217 $74	75	$5,585

Coverall  §721.63(a)(2)(iv)	$36.25	1.217	$44	75	$3,308

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 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, EPAB, 1998; inflation factor, Appendix B.

C.2.6	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), which differ by chemical.  For costing purposes, this analysis assumes that respirators are used.  In the past, PMN SNURs referenced specific paragraphs at 40 CFR §721.63 (a)(5) that identified fifteen types of NIOSH-approved respirator units. However, the current SNURs 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)

SNUR Text	Respirator types at 40 CFR §721.63 (a)(5)1

Supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting full facepiece.	(ii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting facepiece.

	SNUR specifies “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).	(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.

	SNUR specifies “half” or “full” facepiece.

Air-purifying respirator equipped with a tight-fitting full facepiece and High Efficiency Particulate Air (HEPA) filters. 	(iv) Category 21C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters.

Air-purifying, tight-fitting respirator (either half- or full-face) equipped with N100 (if aerosols absent), R100, or P100 filters.	(iv) Category 21C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters.

	SNUR specifies “half” or “full” facepiece option

Powered air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. 	(v) Category 21C powered air-purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters.

Powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters.	(v) Category 21C powered air-purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters.

	SNUR specifies “half” or “full” facepiece option

Powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters.	(vi) Category 21C powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate filters.

Notes:

1The table specifies respirator types at 40 CFR §721.63(a)(5) that are most similar to the equipment described in the SNUR text. 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, as originally estimated in 1997 and after inflating to 2005 dollars.  It also estimates costs per plant site for a chemical requiring respirators.

 The respirators specified in the SNURs are typically comprised of a respirator unit and any number of the following: special cartridges (such as high efficiency particulate filters, organic vapor cartridges, and paint, lacquer, and enamel filters), hoods or helmets, and filter caps. The costs for each site of providing respirators to chemically-exposed workers, shown in Table 4 of Section 2 of the report, are calculated based on the assumptions stated there, that (1) there are 25 chemically-exposed workers requiring protective equipment, (2) respirators are replaced once a year, and (3) cartridges (and cartridge filters and caps) are replaced at a rate of one pair (two cartridges) every five of the 250 days that workers are exposed, or 50 times per year.  For example, for the respirator type described at 40 CFR §721.63(a)(5)(xv), the total annual cost in 1997 dollars would be as follows:

($10.83 per respirator + $8.94 per cartridge × 50 cartridges/year) × 25 workers = $11,446

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.  In such cases, among the acceptable respirators, the type with the lowest average cost was assumed in order to estimate workplace protection costs in Table 10 in the main text.

Table C-11  Annual Per-Chemical Costs for Respiratory Protection [40 CFR §721.63(a)(4)]

§721.63 (a)(5) par.	NIOSH approval type at 40 CFR §721.63 (a)(5)

(See Table C-10 for cross-walk to respirators in SNUR)	Annual Average Costs

(1997 Dollars)	Annual Average Costs

(2005 Dollars)1

Respirator Unit	Cartridge Set	Per Worker2	Inflation Factor	Annual Per Worker	Annual Per Site (25 workers)3

(i)	19C Type C Supplied-air with full facepiece	$804	$0	$804	1.217	$978 $24,459

(ii)	19C Type C Supplied-air with tight-fitting facepiece	$804	$0	$804 1.217	$978	$24,459

(iii)	19C Type C Supplied-air with hood or helmet or tight-fitting facepiece	$932	$0	$932	1.217	$1,134	$28,357

(iv)	21C Air-purifying with full facepiece and high efficiency particulate filters (HEPAs)	$181	$10	$669	1.217	$814	$20,341

(v)	21C Powered air-purifying (PAPR) with tight fitting facepiece and HEPAs	$627	$36	$2,402	1.217	$2,923	$73,084

(vi)	21C PAPR with loose hood or helmet and HEPAs	$525	$27	$1,870	1.217 $2,275	$56,884

(vii)	21C Air-purifying with HEPA and disposable respirators	$13	$7	$363 1.217	$441	$11,028

(viii)	23C air-purifying with full facepiece and combination cartridges approved for paints, lacquers and enamels (PLE)	$192	$16	$978	1.217 $1,189	$29,737

(ix)	23C PAPR with tight-fitting facepiece and combination cartridges approved PLE	$627	$36	$2,402	1.217	$2,923	$73,084

(x)	23C PAPR with loose-fitting hood or helmet and combination cartridges for PLE	$525	$27	$1,869	1.217	$2,275	$56,869

(xi)	23C Air-purifying with combination cartridges for PLE, including disposable respirators	$14	$9	$459	1.217	$559	$13,972

(xii)	23C Air-purifying with full-facepiece and organic gas/vapor cartridges	$192	$10	$716	1.217	$871	$21,767

(xiii)	23C PAPR with tight-fitting facepiece and organic gas/vapor cartridges	$826	$41	$2,884	1.217	$3,509	$87,730

(xiv)	23C PAPR with a loose-fitting hood or helmet and organic gas/vapor cartridges	$640	$41	$2,697	1.217	$3,282	$82,053

(xv)	23C Air-purifying with organic gas/vapor cartridges, including disposable cartridges	$11	$9	$458	1.217	$557	$13,927

Notes:

1 Annual average costs were inflated to 2005 dollars as described in Table B-3.

	2“Respirator unit” costs include both the respirator itself and any required add-on items such as hoods and helmets. A “cartridge set” includes two cartridges and any filters or caps required. The analysis assumes that 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.

3Total costs were estimated from unrounded unit cost values from this and other tables and unrounded inflation factors from (see Appendix B), 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 Type1

40CFR	NIOSH Type	Catalog Item Number	Description	1997 Cost	1997 Average Cost2

§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