Document ID: EPA-HQ-OPPT-2003-0063-0159
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-04-02T04:00Z

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

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

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

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

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

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

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

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

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

7A-3858	Willson Retainer Caps, p125	$4.27

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

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

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

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

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

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

---	Paint, Lacquer, Enamel Cartridge3	$36.50

7A-32505	RACAL Powerflow PAPR, p142	$534.90

	 	---	Paint, Lacquer, Enamel Cartridge3	$34.50

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

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

---	Paint, Lacquer, Enamel Cartridge3	$24.65

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

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

	 	---	Paint, Lacquer, Enamel Cartridge3	$29.10	

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

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

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

7A-13509	Willson Retainer Caps, p136	$2.03

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

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

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

	 	7A-22754	Moldex Retainer Caps, p139	$2.65

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Notes:

1See Table C-10 for the cross-walk between respirator types in the SNUR
and in this table.

2Average costs presented in this table are rounded to the nearest dollar
figure, so results may differ from calculations using the rounded values
shown in this table.

3Paint, lacquer and enamel (PLE) cartridges for PAPRs were not listed in
the catalog.  The costs for PLE cartridges are assumed to be the same as
HEPA cartridges.

Source: LSS, 1997; EPAB, 1999C.2.7	Annual Costs of Protection in the
Workplace Requirements

Based on the equipment purchase costs shown above in Tables C-7, C-8,
C-9, and C-11, and the assumptions made regarding replacement intervals
for the equipment, Table C-13 below shows the annual costs of providing
the various types of personal protective equipment in the workplace, per
chemical, at one manufacturing site, with 25 exposed workers. 

                      

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

Personal Protective Equipment and Requirement Citation at 40 CFR	Unit
Cost ($2005)	Quantity Required	Total Annual Cost ($2005)1

Dermal Protection Selection §721.63(a)(1)

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

Impermeability Testing §721.63(a)(3)

	     Impermeability Test	$1,161	1	$1,161

     Evaluation of Manufacturer's Specifications	$178	1	$178

Gloves §721.63(a)(2)(i)

	     Standard (disposable)	$0.52	6,250	$3,270

     Heavy-duty butyl	$41	250	$10,343

Protective clothing §721.63(a)(2)

	     [ii] - Full-body (coverall with hood)	$74	75	$5,585

     [iv] - Coverall (no hood)	$44	75	$3,308

Eyewear §721.63(a)(2)(iii)

	     Standard goggles	$5	75	$370

     Heavy-duty goggles	$7	75	$552

Respirators used in the SNUR [§721.63(a)(4)]     

Unit cost is per worker, and includes one respirator unit and 50
Cartridge sets per year.

Supplied-air respirator operated in pressure demand or continuous flow
mode and equipped with a tight-fitting full facepiece. [ii in Table
C-11] 	$978	25	$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). [iii in Table C-11]	$1,134	25	$28,357

Air-purifying respirator equipped with a tight-fitting full facepiece
and High Efficiency Particulate Air (HEPA) filters. [iv] 

Air-purifying, tight-fitting respirator (either half- or full-face)
equipped with N100 (if aerosols absent), R100, or P100 filters. [iv in
Table C-11]	$814	25	$20,341

Powered air-purifying, tight-fitting full-face respirator equipped with
N100 (if oil aerosols absent), R100, or P100 filters. [v] 

Powered air-purifying respirator equipped with a tight-fitting facepiece
(either half- or full-face) and HEPA filters. [v in Table C-11]	$2,923
25	$73,084

Powered air-purifying respirator equipped with a loose-fitting hood or
helmet and High Efficiency Particulate Air (HEPA) filters. [vi in Table
C-11]	$2,275	25	$56,884

Notes: 

1Total annual costs assume: 1) 25 workers exposed 250 days per year; 2)
standard gloves replaced daily and heavy-duty gloves replaced every 25
days; 3) respirators replaced annually and cartridge sets replaced every
five days (50 cartridges sets per year); 4) goggles and protective
clothing replaced three times yearly.  See Table C-10 for the crosswalk
between respirator types in the SNUR and in this table.  Total annual
costs were calculated using unrounded unit cost estimates, and may not
equal the product of the rounded estimates shown in this table.   

Source: Tables C-5, C-6, C-7, C-8, C-9, and C-11.

C.3	Recordkeeping

	There are two main types of recordkeeping requirements for the
substances listed in the current SNUR: those for companies submitting a
SNUN, and those for all companies that that manufacture, import or
process SNUR-regulated substances.  

	Companies submitting a SNUN must keep records under 40 CFR §721.40. 
Some EPAB reports have assumed that SNUN recordkeeping hours would be 5
percent of SNUN submission hours, or about 5 to 6 hours.  For this
report, the SNUN recordkeeping hours were included in the SNUN
submission hours (see Appendix E) and the SNUN recordkeeping cost was
not separately estimated.  

	Whether or not they submit a SNUN, firms that manufacture, import, or
process the SNUR substance must keep records based on 40 CFR
§721.125(a) through (k), to document compliance with SNUR conditions
for avoiding a Significant New Use. (For firms producing under the R&D
exemption, R&D recordkeeping would be needed.  R&D recordkeeping costs
were not estimated for this report.)

	Recordkeeping requirements vary between PMN chemicals, reflecting
differences in SNUR restrictions.  For all chemicals in the current
SNURs, manufacturers, importers, and processors must keep records on
quantities supplied or purchased under 40 CFR §721.125(a), (b), and
(c).  For chemicals with water discharge restrictions, companies must
keep records concerning water discharge compliance, under §721.125(k). 
For chemicals with other use restrictions, or for those few chemicals
with workplace protection or hazard communication restrictions,
companies must keep records to document compliance.

All recordkeeping requirements essentially involve copying and filing
relevant records, including those related to: manufacturing, importing,
or processing volumes; shipment amounts and customer information;
clothing impermeability determinations; the hazard communication program
including labels and MSDS copies; compliance with other use
restrictions; and/or compliance with disposal and water discharge
limitations.  Records must be maintained for five years from the date of
their creation.

 

	Costs for compliance with the recordkeeping requirements for substances
subject to a SNUR are based on the approach in Economic Analysis of
Final Significant New Use Rules: General Provisions for New Chemical
Followup (RIB, 1989) which in turn was based on Recordkeeping Costs for
a Generic SNUR, prepared for EPA in 1988 by Kearney/Centaur (Kearney,
1988a).  These reports drew on recordkeeping costs estimated for the
Comprehensive Assessment Information Rule, CAIR.  Industry recordkeeping
costs for CAIR compliance were estimated in reports Kearney prepared for
EPA, including Estimated Cost of the Final Comprehensive Assessment
Information Rule, June 1, 1988 (Kearney, 1988b, pages 63 to 65).  

This report uses the basic Kearney (1988a and 1988b) estimates and
assumptions to estimate recordkeeping costs for SNUR requirements. 
Unlike Kearney (1988a) and previous PMN SNUR economic reports, this
report presents costs for each  §721.125 recordkeeping requirement
separately.  This report also avoids minor rounding errors by
calculating from unrounded data.  However, the underlying methodology is
identical to the Kearney 1988a/RIB 1989 reports, resulting in identical
costs per chemical except for differences due to inflation and rounding.
 The paragraphs that follow describe estimates and assumptions used from
Kearney (1988a and 1988b).

	Kearney (1988a) assumes that the ratios of labor hours to page count
for each labor category, file drawer space to page count, and cost of
miscellaneous supplies such as folders and labels to page count, are the
same as those estimated for EPA’s Comprehensive Assessment and
Reporting Rule.  The CAIR estimates are given in the 1988 report,
Estimated Cost of the Final Comprehensive Assessment Information Rule,
June 1, 1988, page 65 (Kearney, 1988b).  Table C-14 summarizes estimates
from Kearney 1988a and the CAIR report (Kearney, 1988b), and the
derivation of $2005 costs from these estimates, as follows:

Technical labor was estimated at 1 hour for 750 pages in the CAIR report
(Kearney, 1988b, page 65), or .00133 hours per page.  The analysis
estimates a cost per hour and per page using fully loaded labor rates as
estimated in Table B-1.

Clerical labor was estimated at 10 hours for 750 pages in the CAIR
report (Kearney, 1988b, page 65), or .01333 hours per page.  The
analysis estimates a cost per hour and per page using fully loaded labor
rates as estimated in Table B-1.

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

File space for CAIR was estimated at ¼ of a four-drawer file cabinet
for 750 pages (Kearney, 1988b, page 65) or 0.000333 of a cabinet per
page.  A standard, four-drawer, full-suspension file cabinet was priced
from a national office products supplier at $195 in 1997 (BT Office
Products, 1997; Item #LGM-202401; EPAB, 1998).  This results in $0.065
per page cost for file space, before inflation ($195 × 0.25 file
cabinet/750 pages). The cost per page was inflated using an inflation
factor estimated in Table B-3.

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

Table C-14  Recordkeeping Estimates from Kearney 1988a and 1988b

Labor Costs	Kearney Estimates (1988b)	Estimates in $2005

	Hours	Pages	Hours Per Page	Cost Per Hour ($2005)	Cost Per Page ($2005)

Technical	1	750	0.0013	$53.02	$0.07

Clerical	10	750	0.0133	$26.37	$0.35

Materials Costs	Kearney Estimates (1988a)	Estimates in $2005

	Estimate	Pages	Cost Per Page ($1998)	Inflation Factor2	Cost Per Page
($2005)

Photocopying	$0.05	1	$0.050	1.651	$0.083

File Cabinet	1/4 of cabinet priced at $195	750	$0.065	1.217	$0.079

Misc. Materials	$10 total	750	$0.013	1.651	$0.022

Source: Labor costs, Table B-1; inflation factors, Table B-3.

In order to estimate recordkeeping costs, the analysis multiplies the
costs per page for each recordkeeping element estimated in Table C-14 by
the number of pages required for each SNUR recordkeeping requirement at
40 CFR §721.125 as estimated by Kearney (1998a).  The Kearney data was
used by EPA in RIB, 1989. For example, maintaining MSDS copies as
required at §721.125(h) would require 5 pages.  The following estimates
from Kearney (1988a) are also used: 

Manufacture and import volume, and sales and transfer data require 485
pages of records per year.  This reflects 40 invoices per month (see
haz-comm Section C.1 above), 480 for sales/transfer and 5 for
manufacturer/import  (Kearney, 1988a, p.11).

Disposal compliance records, if required, cover items such as waste
production, shipping manifests, permits, and transfer receipts.  The 600
disposal compliance pages assume 50 pages per month (Kearney, 1988a,
p.11).

This report uses slightly different terminology from RIB, 1989:
“Protective clothing” instead of “protective gloves,”
“haz-comm” instead of “employee information and training.” Also,
recordkeeping for “impermeability determination” was not separately
costed out in RIB, 1989. This report assumes it is included under
“protective clothing” recordkeeping.

	Total estimated annual costs for recordkeeping are summarized in Table
C-15 for a chemical that has numerous SNUR restrictions.  Recordkeeping
costs would be lower for chemicals with relatively few SNUR restrictions
because fewer pages would be needed to document SNUR compliance. Table
C-15 does not include costs of recordkeeping resulting from a SNUN
submission; those costs were included in the SNUN submission cost. 

	As shown in Table C-15, annual recordkeeping activities at one site for
one SNUR chemical is estimated to require a maximum of 2.3 hours
technical time, 23 hours clerical time, 1,715 photocopies, approximately
one-half of a 4-drawer file cabinet, and other miscellaneous materials
such as folders.   Table C-15  Annual Per-Chemical Costs of
Recordkeeping Requirements [40 CFR 721.125]1 

40CFR §721.1252	Cost Element	Estimated Number of Pages3	Estimated Labor
Cost	Estimated Materials Cost	Total Estimated Cost Per Chemical ($2005)

	Technical Labor	Clerical Labor	Photocopying Cost

($2005)	File Cabinet Cost ($2005)4	Misc. Materials Cost ($2005)

Number of Hours	Cost ($2005)	Number of Hours	Cost ($2005)

(a)(b)(c)	Volumes & sales/transfer data	485	0.65	$34 	6.47	$171	$40 	$38
$11	$294

(d)(e)	Protective clothing [§721.63] and impermeability
[§721.63(a)(3)]	20	0.03	$1	0.27	$7	$2	$2	$0.44	$12

(f)	Haz com program [§721.72]	250	0.33	$18 	3.33	$88	$21 	$20	$6	$152

(g)	Label copies [§721.72(b)]	5	0.01	$0.35 	0.07	$2	$0.41 	$0.40	$0.11
$3

(h)	MSDS copies [§721.72(c)]	5	0.01	$0.35 	0.07	$2	$0.41 	$0.40	$0.11
$3

(i)	Use limitations compliance [§721.80]	250	0.33	$18 	3.33	$88	$21 
$20	$6	$152

(j)	Disposal compliance [§721.80]	600	0.80	$42 	8.00	$211	$50 	$47	$13
$364

(k)	Water discharge compliance [§721.90]	100	0.13	$7 	1.33	$35	$8 	$8
$2	$61

TOTAL

1,715	2.29	$121	22.87	$603	$142 	$136	$38	$1,039

Notes: 

1This table multiplies per page estimates from Table C-14 by the
estimated number of pages presented here for each recordkeeping cost
element.  The table does not include recordkeeping for SNUN submissions
required by 40 CFR §721.  Total costs are calculated from unrounded
values and may not equal the sum and/or product of rounded values.  

240 CFR 721.125(a) through (k) list recordkeeping that may be specified
in the SNUR. The recordkeeping specified depends on which 40 CFR §721
provisions [in brackets] were used by the SNUR to define reportable New
Uses (§721.63, §721.72, §721.80).

3Pages estimates are from Kearney, 1988a and are specific to SNURs.

4The file space per chemical was rounded in Kearney 1988 to ½ of a file
cabinet, but Table C-15 calculations use unrounded values, so that the
file cabinet cost here is slightly higher than it would have been using
the Kearney rounding.  The per-SNUN file space is 0.57cabinet (0.25
cabinet for CAIR / 750 CAIR pages) × 1,715 SNUN pages). 

APPENDIX D

COSTS OF TESTING

APPENDIX D	COSTS OF TESTING

	This appendix presents a detailed description of the methodology used
to estimate costs for health and environmental effects testing
recommended for chemicals subject to the current Significant New Use
Rules.

D.1	Testing Guidelines 

	In the SNURs, EPA identifies a set of tests for each PMN chemical that
can be used by firms making Significant New Use Notice or other
submissions to EPA to characterize risks of the chemical.  The tests are
recommended in the SNUR, not mandatory. They are identified by guideline
numbers which can be used to look up published test protocols.  Table
D-1 lists all test guidelines cited in the SNUR and their associated
costs, Table D-2 presents certain assumptions used in the analysis, and
Table D-3 aggregates costs for testing guidelines associated with each
PMN chemical.  The types of guidelines are described below.

OPPTS Harmonized.  Most SNUR tests are identified by their OPPTS number
from the series of OPPTS Harmonized Test Guidelines and OPPTS harmonized
public drafts not yet promulgated as OPPTS guidelines.  These guidelines
blended testing guidance from OPPT (published in the Code of Federal
Regulations), EPA's Office of Pesticide Programs, the Organization for
Economic Cooperation and Development (OECD), and other sources.  The
harmonized guidelines fall into several categories, including the
following:

	Series 835--Fate, Transport and Transformation Test Guidelines

	Series 850--Ecological Effects Test Guidelines

	Series 860--Residue Chemistry Test Guidelines

	Series 870--Health Effects Test Guidelines

They are available electronically on EPA’s website (OPPT, 2006).
Cross-references for health effects guidelines are listed at 63 FR
41847, August 5, 1998.

CFR.  SNUR tests may also come from the Code of Federal Regulations,
identified for example as “40 CFR 799.9370” or just “799.9370.”
In addition, in costing out test guidelines, this report sometimes uses
costs for a CFR guideline when costs have not been developed for the
equivalent OPPTS harmonized guideline.  40 CFR parts 795 through 798
include pre-harmonization test guidelines, typically updated before
1990. 40 CFR part 799 includes more recent TSCA test guidelines, based
on harmonized test guidelines. (63 FR 41845, August 5, 1998).

OECD.  A few SNUR tests are identified by their OECD number.  The OECD
guidelines may have OPPTS equivalents.  For example, OECD 407 28-Day
Oral Toxicity in Rats is essentially equivalent to OPPTS 870.3050. 

PBT Category.  For some chemicals, the SNUR cites tiered testing
according to a testing strategy published in the Federal Register (FR),
Category for Persistent, Bioaccumulative, and Toxic New Chemical
Substances, November 4, 1999 (64 FR 60194), which in turn refers to a
number of tests by OPPTS or OECD guideline number.

ASTM, NTIS, and other sources.  Test guidelines may also come from the
American Society of Testing and Materials (for example, ASTM D2035-80
Modified Coagulation-flocculation Jar Test of Water) (www.astm.org) or
other sources The guideline for a neurotoxicity functional observational
battery, NTIS PB 91-154617, is available from the National Technical
Information Service (www.ntis.gov).

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

Guideline 4	Test	Species	Route/Method	Cost	Hours

799.9370	Prenatal Developmental Neurotoxicity Study	Rats	gavage	$109,700
1079

830.7200 / (OECD 102)	Melting Point / Melting Range	NA	Average of eight
tests	$1,498	13

830.7550 / (OECD 107)	Partition Coefficient (n-Octanol/Water)	NA	Shake
Flask Method	$7,297	50

830.7560 / (796.1720)	Log Kow (generator column) 	NA	Generator column
$3,698	39

830.7570 / (796.1570)	Log Kow (liquid chromatography)	NA	Liquid
Chromatography	$2,690	28

830.7560 / (796.1720) and 830.7570 / (796.1570) (avg) 1	Log Kow (liquid
chromatography or generator column)	NA	Average of 2 tests	$3,194	34

835.1110	Activated Sludge Sorption Isotherm	NA	NA	$11,036	82

835.2110 1	Hydrolysis as a Function of pH	NA	NA	$52,966	130

835.3100 / (796.3100)	Aerobic Aquatic Biodegradation	NA	NA	$14,560	174

835.3110 1	Ready Biodegradation	NA	Average of six methods	$11,379	112

835.3170 2	Shake Flask Die-Away Test	NA	NA	$46,402	88

835.3180 3	Sediment/Water Microcosm Biodegradation	NA	flow-through
$121,303	1496

835.3210	Modified SCAS Test	NA	NA	$27,173	316

835.3220	Porous Pot Test	NA	NA	$45,507	539

850.1010 / (797.1300)	Daphnid Acute Toxicity	Daphnid	flow-through
$13,524	54

850.1075 / (797.1400)	Fish Acute Toxicity	Fathead Minnow	flow-through
$18,681	65

850.1085	Fish Acute Toxicity Test mitigated by humic acid	Fathead Minnow
static	$15,737	74

850.1300 3	Daphnid Chronic Toxicity Test	Daphnid	flow-through	$38,882
173

850.1400	Fish Early Life Stage Toxicity	Fathead Minnow	flow-through
$41,951	291

850.1400 3	Fish Early Life Stage Toxicity	Rainbow Trout	Flow-through
$62,109	432

850.1730 2	Fish BCF	Fathead Minnow	flow-through	$68,923	775

850.5400	Algal Toxicity, Tiers I and II	Average of four species	NA
$15,739	60

850.5400	Algal Toxicity, Tiers I and II	Selenastrum capricornutum	NA
$15,742	58

870.2600	Skin Sensitization	Guinea Pigs	Average of two methods	$11,072
56

870.3050 / (OECD 407) 	Repeated Dose Oral Toxicity in Rodents (28-Day)
Rats	gavage (28 day)	$52,285	328

870.3100	90-Day Oral Toxicity	Rats	gavage	$138,464	834

870.3465	Subchronic Inhalation Toxicity	Rats	inhalation	$382,952	2458

870.3465 (mod)	Subchronic Inhalation Toxicity (w/ 60 day recovery group)
Rats	inhalation	$222,180	2882

870.3700	Prenatal Developmental Toxicity {2 species}	Mice	aerosol
$124,400	1385

870.3700	Prenatal Developmental Toxicity {2 species}	Rats	gavage
$113,357	1157

870.3800	Reproduction/Fertility Effects (2-Generation Reproduction)	Rats
gavage	$598,724	5024

870.4200	Carcinogenicity {2 species}	Rats	gavage	$900,159	8275

870.4200	Carcinogenicity {2 species}	Rats	inhalation	$1,136,014	11683

870.5100	Bacteria Reverse Mutation Assay	NA	Direct plate	$12,301	48

870.5265	Salmonella typhimurium Reverse Mutation Assay (Ames Test)	NA
Average of Direct plate and Azo reduction	$11,687	48

870.5395	In Vivo Mammalian Bone Marrow Cytogenetics Tests: Erythrocyte
Micronucleus Assay (Average of 1 and 3 day dosings)	Mice	gavage (average
of 1 and 3 day)	$19,878	114

870.5550	Unscheduled DNA Synthesis in Mammalian Cells in Culture	Rat
hepatocytes	NA	$20,552	124

870.6200	Neurotoxicity Screening Battery (Subchronic)	Rats	dietary
(subchronic)	$172,791	1387

D2034-80 (ASTM D 2035-80)	Standard Practice for Coagulation-Flocculation
Jar Test of Water	NA	NA	$3,862	25

NTIS:PB 91-154617 / (798.6050)	Functional Observation Battery
(Subchronic)	Rats	gavage (subchronic)	$81,664	537

OECD 218 / (795.1350)	Chironomid Sediment Toxicity	Midge	flow-through
$94,863	949

OECD 422 3	Combined Repeated Dose Study with Reproductive/Developmental
Toxicity Screen	Rats	gavage	$125,462	1146

Notes:

1Guideline in tiered testing as described in the New Chemicals
Program’s PBT Category Tier 1 (64 FR 60194).

2Guideline in tiered testing as described in the New Chemicals
Program’s PBT Category Tier 2 (64 FR 60194).

3Guideline in tiered testing as described in the New Chemicals
Program’s PBT Category Tier 3 (64 FR 60194).

4Some guidelines list two numbers. In this instance, cost for the second
guideline is used as an approximate cost when the first does not have a
test cost.

  SEQ CHAPTER \h \r 1 D.2	Test Costs by Guideline

	Table D-1 gives dollar cost and hours for each test, based on
assumptions and adjustments discussed below.  This section describes the
development of individual test costs.

	EPA's Office of Pollution Prevention and Toxics, Economic and Analysis
Branch, regularly develops cost estimates of test guidelines to support
TSCA rule development. Estimates are based on assumptions about species,
route of administration, study duration, and other aspects of
methodology.   Costs are calculated based on costs of labor, materials,
and equipment needed to perform testing, with overhead and fee.  Many of
the test costs were developed in the 1990s.  Test costs have been
inflated using Employment Cost Index inflators from the Bureau of Labor
Statistics (see Appendix B). However, generally they have not been
updated  to reflect subsequent changes in laboratory technologies. 

	Testing laboratories perform analytical method validation to ensure
that proper dose concentrations are used in toxicity studies (EPAB 2005,
p. 3-9).  This analysis assumes that for health effects tests (e.g. 870
series guidelines), tests of up to 90 days in duration have method
validation costs of $3,500, and longer term tests have validation costs
of $8,500.  For simplicity, the method validation cost  for ecological
effects tests (e.g. 850 series guidelines) was assumed to be $3,500 for
each test. 9

  SEQ CHAPTER \h \r 1 In cases where costs have not been estimated for
the specified guideline, EPA uses the cost from an approximately
equivalent guideline (listed in Tables D-1 and D-3 in parentheses). 
Many of these equivalents are listed in the Federal Register at 63 FR
41847, August 5, 1998, but sometimes judgment was needed to select the
closest equivalent(s).  

	

	In some cases, EPA has not costed out the test for the species, route,
duration, and/or other method  listed in the SNUR, or the SNUR specifies
a guideline but does not specify these details.  In such cases, EPA has
made the adjustments described below. The adjustments were selected
based on discussions with EPA scientists and on SNUR language, published
test guidelines, assumptions underlying the cost estimates in EPAB's
test cost database, EPA review and Consent Order history for specific
PMNs, or other sources (Rawie 2004). 

	Default Parameters

	

	Costs for many of the guidelines have been estimated for different
combinations of species, route, length of study and other aspects of
methodology, but in some cases the SNUR may not specify all of these
variables.  Where this occurs, EPA has used certain default parameters,
listed in Table D-2. 

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

	Variable	Default

Species	Mammals

Fish

Invertebrates

Algae	Rats

Fathead minnow1

Daphnids

[Four species -- see text]

Route/Method	Mammalian

Fish

Invertebrates	Gavage

Flow-through

Flow-through

Notes:

1For guideline 850.1400 tests duplicated in PBT tier tests, rainbow
trout is the default. (See PBT test discussion below.)

  SEQ CHAPTER \h \r 1 Persistent Bioaccumulative Toxic (PBT) tiered
testing

	For some chemicals, the SNUR cites tiered testing for Persistent
Bioaccumulative Toxic chemical substances (PBTs) according to the
testing strategy in EPA’s New Chemicals Program PBT Category document,
published in the Federal Register notice, Category for Persistent,
Bioaccumulative, and Toxic New Chemical Substances, November 4, 1999, at
64 FR 60194.   

	In 64 FR 60194, there are three tiers of testing.  The results of Tier
1 determine whether Tier 2 testing is needed and the results of Tier 2
testing determine whether Tier 3 testing is needed.  To obtain a cost
estimate for SNURs that cite PBT Category testing (64 FR 60194),
individual tests from 64 FR 60194 were listed in Table D-3 as
appropriate, depending on the specific SNUR language.  The test list was
adjusted to avoid double counting tests listed in both the PBT Category
tiers and in the SNUR. 

  SEQ CHAPTER \h \r 1 Other assumptions related to PBT testing are
described below:

The PBT category tests at 64 FR 60194 specify rainbow trout as the
species for the chronic fish toxicity test, 850.1400.  For SNURs that
recommend PBT Category testing, 850.1400 costs are based on using
rainbow trout.  If 850.1400 is recommended without PBT testing, costs
are based on using fathead minnows.

For PBT Tier 1 ready biodegradability tests, firms may either choose
among six methods in test guideline 835.3110 or follow test guideline
835.3120. The costs estimates assume 835.3110 was used, and calculate
the average cost of its six methods.

Tiers and other Adjustments 

	The SNURs identify certain chemicals for tiered testing.  In Table D-3,
the “low” costs assume only the first-tier tests are performed,
while “high” costs assume all tests listed for the chemical are
performed.  For this cost analysis, testing is treated as “tiered”
if later tests are contingent on the results of earlier tests, and/or if
some tests are contingent on the firm reaching a certain chemical volume
or time limit.  Some tiers result because the SNUR references the tiered
PBT Category testing described at 64 FR 60194.  

	Other adjustments are as follows:

A SNUR may recommend algal acute toxicity testing following OPPTS
Guideline 850.5400.  This guideline has been previously costed by EPA
for four separate algal species (Navicula pelliculosa, Skeletonema
costatum, Anabaena flos-aquae, and Selenastrum capricornutum).  If a
SNUR does not specify the algal species to be used, the average costs of
the four algal species tests are used.

For OPPTS test guideline 835.3100, a SNUR may call for an additional
analytical methodology to identify the isononyl phenol degradation
product, which may be a substantial add-on to the basic cost.  No cost
information was available for the extended test.  As a result, the
stated cost for this testing requirement may understate the true cost.

A SNUR may recommend a “modified” version of ASTM test guideline
D2035-80.  No cost information was available for the additional
analytical methodology.  As a result, the cost information used for this
test may understate the actual cost.

For OECD test guideline 422, a SNUR may recommend extended
histopathology.  Although the OECD 422 protocol does include
histopathology, it is possible that extending the histopathology would
increase the cost.  In such a case, the cost information used may
underestimate the actual cost of performing this test.

A SNUR may recommend two variations of OECD test guideline 218
(Chironomid Sediment Toxicity), one using the acute portion of the
sediment and the other using the chronic portion.  Cost information was
not available for these two variants.  The cost of the test performed on
midge under flow through conditions was used for both.

A SNUR may recommend “a fish acute toxicity test, freshwater and
marine (OPPTS 850.1075 test guideline)”.  “Freshwater and marine”
refers to the name of the test, not the number of species required by
EPA.  The cost estimates assume only one species is used.

D.3	Testing Costs by Chemical 

	Testing costs for each PMN chemical are calculated by adding up costs
of individual tests listed in the SNUR for that substance.

	Table D-3 presents recommended test guidelines, the costs associated
with each guideline, and the total testing cost estimates for each
chemical.  An asterisk denotes that the SNUR did not specify which
species or route/method to use and where suitable test costs were
available, the default assumptions mentioned above were used.

Table D-3 Testing Requirements and Costs for all SNUR Chemicals1

SNUR Sequence Number	PMN Number	PBT Tier	SNUR Guideline	 	Species	 
Route/ Method	Cost ($2005)	Hours	Low Cost	High Cost

 

 

$2005	Hours	$2005	Hours

1	P97-0415	 	 	 	 	 	 	 	 	$300,576	2,401	$300,576	2,401

 

	850.1010   (797.1300)

Daphnid

flow-through	$13,524	54

 

 

	850.1075   (797.1400)

Fathead Minnow

flow-through	$18,681	65

 

 

	850.54

Average of four species

NA	$15,739	60

 

 

	NTIS:PB 91-154617   (798.6050)

Rats

gavage (subchronic)	$81,664	537

 

 

	OECD 422   

Rats

gavage	$125,462	1,146

 

 	 	 	835.322	 	NA	 	NA	$45,507	539	 	 	 	 

2	P00-0614	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

3	P00-0617	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

4	P98-0625	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

5	P98-0626	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

6	P98-0627	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

7	P98-0628	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

8	P98-0629	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

9	P98-1181	 	 	 	 	 	 	 	 	$311,255	2,221	$311,255	2,221

 

	870.6200	*	Rats	*	dietary (subchronic)	$172,791	1,387

 

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

10	P98-1182	 	 	 	 	 	 	 	 	$311,255	2,221	$311,255	2,221

 

	870.6200	*	Rats	*	dietary (subchronic)	$172,791	1,387

 

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

11	P99-0511	 	 	 	 	 	 	 	 	$32,178	162	$932,338	8437

 

Tier 1	870.5395

Mice	*	gavage (average of 1 and 3 day) (a)	$19,878	114

 

Tier 1	870.5100

NA	*	Direct plate	$12,301	48

 

 	 	Tier 2	870.4200	*	Rats	*	gavage	$900,159	8,275	 	 	 	 

12	P00-0011	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.5400	*	Average of four species

NA	$15,739	60

 

 	 	 	850.1010   (797.1300)	 	Daphnid	*	flow-through	$13,524	54	 
 	 	 

13	P00-1121	 	 	 	 	 	 	 	 	$222,180	2,882	$1,358,194	14,565

 	 	Tier 1	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 
 	 	 

 	 	Tier 2	870.4200	*	Rats	 	inhalation	$1,136,014	11,683	 	 	 	 

14	P00-1122	 	 	 	 	 	 	 	 	$291,103	3,657	$1,427,117	15,340

 	 	Tier 1	850.1730	 	Fathead Minnow	 	flow-through	$68,923	775	 
 	 	 

 	 	Tier 1	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 
 	 	 

 	 	Tier 2	870.4200	*	Rats	 	inhalation	$1,136,014	11,683	 	 	 	 

15	P00-1123	 	 	 	 	 	 	 	 	$222,180	2,882	$1,358,194	14,565

 	 	Tier 1	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 
 	 	 

 	 	Tier 2	870.4200	*	Rats	 	inhalation	$1,136,014	11,683	 	 	 	 

16	P00-1124	 	 	 	 	 	 	 	 	$222,180	2,882	$1,358,194	14,565

 	 	Tier 1	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 
 	 	 

 	 	Tier 2	870.4200	*	Rats	 	inhalation	$1,136,014	11,683	 	 	 	 

17	P00-1125	 	 	 	 	 	 	 	 	$222,180	2,882	$1,358,194	14,565

 	 	Tier 1	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 
 	 	 

 	 	Tier 2	870.4200	*	Rats	 	inhalation	$1,136,014	11,683	 	 	 	 

18	P00-1126	 	 	 	 	 	 	 	 	$291,103	3,657	$1,427,117	15,340

 	 	Tier 1	850.1730	 	Fathead Minnow	 	flow-through	$68,923	775	 
 	 	 

 	 	Tier 1	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 
 	 	 

 	 	Tier 2	870.4200	*	Rats	 	inhalation	$1,136,014	11,683	 	 	 	 

	19	P01-0109	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

20	P01-0110	 	 	 	 	 	 	 	 	$8,796	63	$588,028	4,619

 

Tier 1	830.7200   (OECD 102)

NA	*	Average of eight tests	$1,498	13

 

 

Tier 1	830.7550   (OECD 107)

NA	*	Shake Flask Method	$7,297	50

 

 

Tier 2	D2034-80   (ASTM D 2035-80)

NA

NA	$3,862	25

 

 

Tier 3	850.5400

Average of four species

NA	$15,739	60

 

 

Tier 3	850.1010   (797.1300)

Daphnid

flow-through	$13,524	54

 

 

Tier 3	850.1075   (797.1400)	*	Fathead Minnow

flow-through	$18,681	65

 

 

Tier 4	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 4	850.1400

Rainbow Trout

flow-through	$62,109	432

 

 

Tier 4	850.1300

Daphnid

flow-through	$38,882	173

 

 

Tier 4	835.3180

NA

Flow-through	$121,303	1,496

 

 

Tier 4	835.3170

NA

NA	$46,402	88

 

 

Tier 4	835.2110

NA

NA	$52,966	130

 

 

Tier 4	OECD 422   

Rats

gavage	$125,462	1,146

 

 	 	Tier 4	835.3110	 	NA	 	Average of six methods	$11,379	112	 	 
 	 

21	P01-0111	 	 	 	 	 	 	 	 	$3,862	25	$132,640	668

 

Tier 1	D2034-80  (ASTM D 2035-80)

NA

NA	$3,862	25

 

 

Tier 2	850.1075   (797.1400)	*	Fathead minnow	*	flow-through	$18,681	65

 

 

Tier 2	850.5400

Average of four species

NA	$15,739	60

 

 

Tier 2	850.1010   (797.1300)

Daphnid

flow-through	$13,524	54

 

 

Tier 3	850.1300

Daphnid	*	flow-through	$38,882	173

 

 	 	Tier 3	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291	 	 
 	 

	22	P01-0257

	$63,680	253	$63,680	253

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.1085	*	Fathead Minnow	*	static	$15,737	74

 

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

23	P01-0258	 	 	 	 	 	 	 	 	$63,680	253	$63,680	253

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.1085	*	Fathead Minnow	*	static	$15,737	74

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

24	P01-0259	 	 	 	 	 	 	 	 	$63,680	253	$63,680	253

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.1085	*	Fathead Minnow	*	static	$15,737	74

 

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

25	P01-0261	 	 	 	 	 	 	 	 	$63,680	253	$63,680	253

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.1085	*	Fathead Minnow	*	static	$15,737	74

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

26	P01-0442	 	 	 	 	 	 	 	 	$382,952	2,458	$382,952	2,458

 	 	 	870.3465	 	Rats	 	inhalation	$382,952	2,458	 	 	 	 

27	P01-0563	 	 	 	 	 	 	 	 	$62,504	353	$62,504	353

 

	835.3100   (796.3100)

NA

NA	$14,560	174

 

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60

28	P01-0564	 	 	 	 	 	 	 	 	$62,504	353	$62,504	353

 

	835.3100   (796.3100)

NA

NA	$14,560	174

 

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

	29	P01-0764	 	 	 	 	 	 	 	 	$222,180	2,882	$1,122,339	11,157

 

Tier 1	870.3465 (mod)   

Rats

inhalation	$222,180	2,882

 

 	 	Tier 2	870.4200	*	Rats	*	gavage	$900,159	8,275	 	 	 	 

30	P01-0769	 	 	 	 	 	 	 	 	$115,325	863	$463,081	4,110

 

Tier 1	835.3170

NA

NA	$46,402	88

 

 

Tier 1	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 2	835.3180

NA

Flow-through	$121,303	1,496

 

 

Tier 2	850.1300

Daphnid

flow-through	$38,882	173

 

 

Tier 2	850.1400

Rainbow Trout

flow-through	$62,109	432

 

 	 	Tier 2	OECD 422   	 	Rats	 	gavage	$125,462	1,146	 	 	 	 

31	P01-0770	 	 	 	 	 	 	 	 	$115,325	863	$463,081	4,110

 

Tier 1	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 1	835.3170

NA

NA	$46,402	88

 

 

Tier 2	835.3180

NA

Flow-through	$121,303	1,496

 

 

Tier 2	850.1400

Rainbow Trout

flow-through	$62,109	432

 

 

Tier 2	OECD 422   

Rats

gavage	$125,462	1,146

 

 	 	Tier 2	850.1300	 	Daphnid	 	flow-through	$38,882	173	 	 	 	 

	32	P01-0771	 	 	 	 	 	 	 	 	$115,325	863	$463,081	4,110

 

Tier 1	835.3170

NA

NA	$46,402	88

 

 

Tier 1	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 2	850.1300

Daphnid

flow-through	$38,882	173

 

 

Tier 2	850.1400

Rainbow Trout

flow-through	$62,109	432

 

 

Tier 2	835.3180

NA

Flow-through	$121,303	1,496

 

 	 	Tier 2	OECD 422   	 	Rats	 	gavage	$125,462	1,146	 	 	 	 

33	P01-0772	 	 	 	 	 	 	 	 	$115,325	863	$463,081	4,110

 

Tier 1	835.3170

NA

NA	$46,402	88

 

 

Tier 1	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 2	OECD 422   

Rats

gavage	$125,462	1,146

 

 

Tier 2	835.3180

NA

Flow-through	$121,303	1,496

 

 

Tier 2	850.1300

Daphnid

flow-through	$38,882	173

 

 	 	Tier 2	850.1400	 	Rainbow Trout	 	flow-through	$62,109	432	 	 
 	 

34	P01-0856	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.5400	*	Average of four species

NA	$15,739	60

 

 

	850.1010   (797.1300)	*	Daphnid	*	flow-through	$13,524	54

 

 	 	 	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681
65	 	 	 	 

35	P01-0862	 	 	 	 	 	 	 	 	$92,213	576	$119,386	892

 

Tier 1	835.3110

NA	*	Average of six methods	$11,379	112

 

 

Tier 1	850.1300

Daphnid	*	flow-through	$38,882	173

 

 

Tier 1	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291

 

 	 	Tier 2	835.3210	 	NA	 	NA	$27,173	316	 	 	 	 

36	P01-0901	 	 	 	 	 	 	 	 	$270,126	3,059	$270,126	3,059

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.5400

Selenastrum capricornutum

NA	$15,742	58

 

 	 	 	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 	 	 
 

37	P01-0902	 	 	 	 	 	 	 	 	$270,126	3,059	$270,126	3,059

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.5400

Selenastrum capricornutum

NA	$15,742	58

 

 	 	 	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 	 	 
 

38	P01-0918	 	 	 	 	 	 	 	 	$532,489	3,348	$532,489	3,348

 

	870.2600

Guinea Pigs	*	Average of two methods	$11,072	56

 

 

	870.3465

Rats

inhalation	$382,952	2,458

 

 	 	 	870.3100	*	Rats	*	gavage	$138,464	834	 	 	 	 

39	P01-0919	 	 	 	 	 	 	 	 	$206,296	1,610	$206,296	1,610

 

	850.1300

Daphnid	*	flow-through	$38,882	173

 

 

	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291

 

 	 	 	OECD 422   	 	Rats	 	gavage	$125,462	1,146	 	 	 	 

40	P02-0214	 	 	 	 	 	 	 	 	$222,180	2,882	$1,122,339	11,157

 

Tier 1	870.3465 (mod)   	*	Rats

inhalation	$222,180	2,882

 

 	 	Tier 2	870.4200	*	Rats	*	gavage	$900,159	8,275	 	 	 	 

41	P02-0269	 	 	 	 	 	 	 	 	$1,283,112	10,733	$1,283,112	10,733

 

	870.3465

Rats

inhalation	$382,952	2,458

 

 	 	 	870.4200	*	Rats	*	gavage	$900,159	8,275	 	 	 	 

42	P02-0322	 	 	 	 	 	 	 	 	$96,573	524	$96,573	524

 

	850.1300

Daphnid	*	flow-through	$38,882	173

 

 

	850.1400

Fathead Minnow	*	flow-through	$41,951	291

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

43	P02-0359	 	 	 	 	 	 	 	 	$96,573	524	$96,573	524

 

	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291

 

 

	850.5400	*	Average of four species

NA	$15,739	60

 

 	 	 	850.1300	 	Daphnid	*	flow-through	$38,882	173	 	 	 	 

44	P02-0382	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

45	P02-0406	 	 	 	 	 	 	 	 	$67,540	276	$530,621	4,386

 

Tier 1	830.7560 and 830.7570 (avg) / 796.1720 and 796.1570 (avg)

NA

Average of 2 tests	$3,194	34

 

 

Tier 1	835.2110

NA

NA	$52,966	130

 

 

Tier 1	835.3110

NA

Average of six methods	$11,379	112

 

 

Tier 2	835.3170

NA

NA	$46,402	88

 

 

Tier 2	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 3	850.1300

Daphnid

Flow-through	$38,882	173

 

 

Tier 3	850.1400

Rainbow Trout

Flow-through	$62,109	432

 

 

Tier 3	OECD 422   

Rats

gavage	$125,462	1,146

 

 	 	Tier 3	835.3180	 	NA	 	Flow-through	$121,303	1,496	 	 	 	 

46	P02-0423	 	 	 	 	 	 	 	 	$791,588	6,522	$1,691,748	14,797

 

Tier 1	870.3800	*	Rats	*	gavage	$598,724	5,024

 

 

Tier 1	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

Tier 1	870.5265

NA	*	Average of Direct plate and Azo reduction	$11,687	48

 

 

Tier 1	870.5395

Mice	*	gavage (average of 1 and 3 day) (a)	$19,878	114

 

 

Tier 1	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

Tier 1	850.5400	*	Average of four species

NA	$15,739	60

 

 

Tier 1	870.3700	*	Rats

gavage	$113,357	1,157

 

 	 	Tier 2	870.4200	*	Rats	*	gavage	$900,159	8,275	 	 	 	 

47	P02-0434	 	 	 	 	 	 	 	 	$14,560	174	$14,560	174

 	 	 	835.3100   (796.3100)	 	NA	 	NA	$14,560	174	 	 	 	 

	48	P02-0514	 	 	 	 	 	 	 	 	$504,954	3,585	$504,954	3,585

 

	799.9370	*	Rats (a)

gavage	$109,700	1,079

 

 

	870.3465

Rats

inhalation	$382,952	2,458

 

 	 	 	870.5100	 	NA	 	Direct plate	$12,301	48	 	 	 	 

49	P02-0522	 	 	 	 	 	 	 	 	$96,573	524	$96,573	524

 

 	850.1300

Daphnid	*	flow-through	$38,882	173

 

 

 	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291

 

 

 	850.5400	*	Average of four species

NA	$15,739	60

 

50	P02-0530	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.5400	*	Average of four species

NA	$15,739	60

 

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 	 	 	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681
65	 	 	 	 

51	P02-0585	 	 	 	 	 	 	 	 	$113,357	1,157	$113,357	1,157

 	 	 	870.3700	 	Rats	 	gavage	$113,357	1,157	 	 	 	 

52	P02-0697	 	 	 	 	 	 	 	 	$67,540	276	$530,621	4,386

 

Tier 1	835.2110

NA

NA	$52,966	130

 

 

Tier 1	835.3110

NA

Average of six methods	$11,379	112

 

 

Tier 1	830.7560 and 830.7570 (avg) / 796.1720 and 796.1570 (avg)

NA

Average of 2 tests	$3,194	34

 

 

Tier 2	835.3170

NA

NA	$46,402	88

 

 

Tier 2	850.1730

Fathead Minnow

flow-through	$68,923	775

 

 

Tier 3	850.1400

Rainbow Trout

Flow-through	$62,109	432

 

 

Tier 3	OECD 422   

Rats

gavage	$125,462	1,146

 

 

Tier 3	835.3180

NA

Flow-through	$121,303	1,496

 

 	 	Tier 3	850.1300	 	Daphnid	 	Flow-through	$38,882	173	 	 	 	 

53	P02-0698	 	 	 	 	 	 	 	 	$222,180	2,882	$222,180	2,882

 	 	 	870.3465 (mod)   	 	Rats	 	inhalation	$222,180	2,882	 	 	 
 

54	P02-0737	 	 	 	 	 	 	 	 	$171,317	1,006	$1,071,477	9,281

 	 	Tier 1	870.5550	 	Rat hepatocytes	 	NA	$20,552	124	 	 	 	 

 	 	Tier 1	870.3100	 	Rats	 	gavage	$138,464	834	 	 	 	 

 	 	Tier 1	870.5100	*	NA	 	Direct plate	$12,301	48	 	 	 	 

 	 	Tier 2	870.4200	*	Rats	*	gavage	$900,159	8,275	 	 	 	 

55	P02-0747	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1010   (797.1300)	*	Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

56	P02-0766	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

57	P02-0869	 	 	 	 	 	 	 	 	$96,573	524	$96,573	524

 

	850.1300

Daphnid	*	flow-through	$38,882	173

 

 

	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

58	P02-0912	 	 	 	 	 	 	 	 	$80,834	464	$80,834	464

 

	850.1300

Daphnid	*	flow-through	$38,882	173

 

 	 	 	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291	 	 	 
 

59	P02-0929	 	 	 	 	 	 	 	 	$138,464	834	$138,464	834

 	 	 	870.3100	*	Rats	 	gavage	$138,464	834	 	 	 	 

60	P02-0961	 	 	 	 	 	 	 	 	$80,834	464	$80,834	464

 

	850.1300

Daphnid	*	flow-through	$38,882	173

 

 	 	 	850.1400	*	Fathead Minnow	*	flow-through	$41,951	291	 	 	 
 

61	P02-1088	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

62	P03-0041	 	 	 	 	 	 	 	 	$47,943	179	$47,943	179

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

63	P03-0043	 	 	 	 	 	 	 	 	$63,680	253	$63,680	253

 

	850.1010   (797.1300)

Daphnid	*	flow-through	$13,524	54

 

 

	850.1075   (797.1400)	*	Fathead Minnow	*	flow-through	$18,681	65

 

 

	850.1085	*	Fathead Minnow	*	static	$15,737	74

 

 	 	 	850.5400	*	Average of four species	 	NA	$15,739	60	 	 	 	 

64	P03-0046	 	 	 	 	 	 	 	 	$165,642	1,485	$165,642	1,485

 	 	 	870.3050   (OECD 407)	 	Rats	 	gavage (28 day)	$52,285	328	 
 	 	 

 	 	 	870.3700	 	Rats	*	gavage	$113,357	1,157	 	 	 	 

65	P03-0047	 	 	 	 	 	 	 	 	$165,642	1,485	$165,642	1,485

 	 	 	870.3050   (OECD 407)	 	Rats	 	gavage (28 day)	$52,285	328	 
 	 	 

 	 	 	870.3700	 	Rats	*	gavage	$113,357	1,157	 	 	 	 

	Notes:

	1This table estimates low and high costs associated with testing
guidelines for each PMN included in this SNUR.

	* Default assumptions used in cases where species and/or route/method
are not specified in SNUR.

** Indicates these tests comprise the low cost estimate.

(a) The SNUR specifies “intraperitoneal” route, but assumed
“gavage” for cost purposes.

(b) The SNUR specifies “two species,” but assumed rats-only for cost
purposes.



APPENDIX E

COSTS FOR SNUN, MODIFICATION/REVOCATION,

OR EQUIVALENCY DETERMINATION

APPENDIX E 	COSTS FOR SNUN, MODIFICATION/REVOCATION, OR EQUIVALENCY
DETERMINATION

Estimates of the costs of completing a Significant New Use Notice (SNUN)
form are based on the costs of completing a PMN submission, since the
data requirements are the same and the same form is used for both. 
EPA's 1994 Regulatory Impact Analysis (RIA) for amendments to the PMN
regulations 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 were
based on a survey conducted by the Chemical Manufacturers Association
(CMA, 1991), which became the American Chemistry Council.

In the 1994 EPA report, the average effort required to prepare and
submit a PMN was 95 to 114 hours.  This included recordkeeping for the
submission, but the recordkeeping cost was not broken out.  For this
analysis, the costs of a preparing a SNUN were derived using the
averages of the hours for each type of labor from the 1994 report. The
method of calculating hourly loaded labor costs is described in Appendix
B.  

As shown in Table E-1, the cost of submitting a request to modify or
revoke a SNUR is the same as the cost for an equivalency determination. 
The cost of submitting a SNUN is $2,500 higher due to EPA's notification
user fee.  

In addition to submission costs, there may be testing costs if the
submitter believes performing the tests will help its submission, and/or
costs of any testing or restrictions that might result from EPA review
of the submission.  These other types of costs are discussed in Appendix
C (worker protection, hazard communication) and Appendix D (testing).

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

Labor Category	Hours Range1	Average Hours	Loaded Wage Rate2 ($2005)
Total Labor Cost  (loaded wage x hours)

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

Clerical	12 - 14	13	$26.37	$343	$343	$343

Technical	67 - 80	73.5	$53.02	$3,897	$3,897	$3,897

Managerial	16 - 20	18	$63.61	$1,145	$1,145	$1,145

Subtotal	95 - 114	104.5

$5,385	$5,385	$5,385

User fees (SNUN only)	$0	$2,500	$0

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

Notes: 

1 Hours range for each labor category are from the PMN Amendments RIA
(RIB. 1994) 

2 Loaded wages include fringe benefits and overhead. See Appendix B for
derivation. Wage rates presented in this table are rounded values;
however, unrounded values are used to calculate total labor costs. For
this reason, total labor costs may not equal the product of rounded
values.



APPENDIX F

AGENCY COSTS

APPENDIX F	AGENCY COSTS

EPA submission review costs are presented in Table F-1.   Costs to
review and process industry submissions -- SNUNs, requests to modify
SNUR, and requests for equivalency determination -- are assumed to be
similar to EPA costs to review PMNs.  	

The list of review steps, estimates of staff-year full-time equivalents
(FTEs), and estimates of extramural costs are derived from the costs for
processing PMN submissions in a 1994 EPA report, Regulatory Impact
Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture
Notifications (RIB, 1994).  The percent of chemicals requiring a
particular review step are from RIB, 1994.

The GS levels used for Agency staff reflect the judgment of Agency staff
familiar with the PMN/SNUN review process.  The salary of a Full Time
Equivalent EPA staff was calculated using GS-13 Step 5 salary data (OPM,
2006). The original PMN cost estimates were for GS 12 and were presented
as low and high estimates, based on the most junior (Step 1) and the
most senior (Step 10) GS-12 pay rates, respectively.  However, this
analysis uses the higher GS-13 staff level and, for simplicity, a single
intermediate pay rate (Step 5) within that GS level.  A loading factor
of 1.6 was applied to the salary to reflect fringe benefits and overhead
(OPPE, 1992).  The loaded salary calculations are described in Appendix
B. 

For each review step, the “EPA staff” cost is calculated by
multiplying the number of FTEs (in the first column) by the fully loaded
average salary.  This shows EPA staff cost for chemicals requiring the
selected review step. 

The Extramural Cost column shows costs for contractor support and other
outside purchases for chemicals requiring the selected review step,
inflated from 1993 prices, as explained in Appendix B.  

The Percent of Cases is a weighting factor applied to reflect the fact
that not all chemicals require each review step.  For example, in the
PMN process, all chemicals require Administrative Prescreening, but not
all chemicals require the intensive scrutiny of “Standard Review.” 
The three types of submissions resulting from a SNUR may have weighting
factors that differ from each other and from the weighting factors for
PMNs.  Changes in weighting factors could cause actual review costs to
be higher or lower than calculated here.  For example, some SNUNs
require little review because they are determined to be “invalid” --
i.e. not required in the first place.  However, often a SNUN may take
more Agency time than a typical PMN because of factors such as the need
to retrieve old PMN records from archives, and the likelihood that more
data requiring EPA review is submitted with a SNUN than would be
submitted on average with a PMN.   Resources were not available to
update the review hours to reflect the current review process or to
tailor the cost estimates to SNUNs.  Therefore, for this analysis, the
review steps and weighting factors are assumed to be the same as those
derived in 1994 for PMNs.

The Weighted Cost column is calculated by multiplying the Unweighted
Costs (EPA staff cost plus extramural costs) by the percentage of cases
requiring this review step.  This calculation yields total Agency costs
for submission review and processing shown in Table F-1.

		

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

        Review Steps	 EPA staff (FTE) Cost	Extramural Cost 2	Unweighted
Cost	Pct. of Cases	Weighted Cost

	FTE fraction	Cost per FTE 1	FTE Total ($2005)	1993 dollars	2005 dollars
 

(1)	(2)	(3)=(1)*(2)	(4)	(5)	(6)=(3)+(5)	(7)	(8)=(6)*(7)

Prenotice consultation	0.0024	$140,262 	$337	$4	$6	$343	41%	$141

Administrative prescreen/ notice receipt/user fee	0.0024	$140,262	$337
$92	$141	$478	100%	$478

CRSS (Chemical Review and Search Strategy)	0.0025	$140,262	$351	$268
$410	$761	100%	$761

SAT (Structure Activity Team)	0.0006	$140,262	$84	$14	$21	$106	100%	$106

Engineering/Exposure	0.0015	$140,262	$210	$56	$86	$296	100%	$296

Exposure/Fate	0.0008	$140,262	$112	$0	$0	$112	100%	$112

Focus	0.0009	$140,262	$126	$23	$35	$161	100%	$161

Standard Review Functions	0.0219	$140,262	$3,072	$511	$782	$3,854	29%
$1,118

Division Directors Meeting	0.0129	$140,262	$1,809	$113	$173	$1,982	15%
$297

Order Development/ Negotiation Review	0.0171	$140,262	$2,398	$22	$34
$2,432	3%	$73

Post Order Data Review	0.0886	$140,262	$12,427	$0	$0	$12,427	3%	$373

Order Modification	0.2167	$140,262	$30,395	$0	$0	$30,395	3%	$912

New Chemical SNUR Development	0.0277	$140,262	$3,885	$85	$130	$4,015	7%
$281

Notices of Commencement	0.0012	$140,262	$168	$40	$61	$230	31%	$71

FOIA (Freedom of Information Act) Requests	0.0333	$140,262	$4,671	$287
$439	$5,110	1%	$51

CBI (Confidential Business Information) Substantiation	0.0004	$140,262
$56	$3	$5	$61	100%	$61

TOTAL	$5,291

Notes:

1 GS-13 Step 5 salaries loaded with benefits and overhead.  See Appendix
B derivation.

2 Extramural costs consist of contracting support and other purchases
directly attributable to the PMN review process inflated from 1993
prices as described in Appendix B. 

3Weighted costs were calculated using unrounded unit cost estimates, so
results may differ from calculations using the rounded values shown in
this table.

Sources: FTEs per review step and 1993 extramural costs are from RIB,
1994.  Percents of cases are from RIB, 1994.  GS-13 salaries are from
OPM, 2006. 

							

APPENDIX G

REFERENCES

APPENDIX G	REFERENCES

29 CFR 1910.  Occupational Safety and Health Standards.  Code of Federal
Regulations, Part 1910, Title 29, November 25, 1983.

63 FR 41847. Test Guidelines; Notice of Availability, Federal Register,
Volume 63, August 5, 1998. 

64 FR 60914.  Category for Persistent, Bioaccumulative, and Toxic New
Chemical Substances, Federal Register, Volume 64, November 8, 1999. 
Available from the Federal Docket Management System as docket
EPA-HQ-OPPTS-53171A at http://www.regulations.gov.

71 FR 6733.  Export Notification; Proposed Change to Reporting
Requirements, Federal Register, Volume 71, February 9, 2006.  Available
from the Federal Docket Management System as docket
EPA-HQ-OPPT-2005-0058 at http://www.regulations.gov.

ASTM.  American Society for Standards and Materials. 
http://www.astm.org. 	

Best, 1997.  Personal communication between Tom DeCoff of Eastern
Research Group, Lexington, MA and Best Manufacturing Co. technical
support services, Austin, TX, December 1997. 

BLS, 2005.  U.S. Bureau of Labor Statistics, Occupational Employment
Statistics [OES].  May 2005 National Industry-Specific Occupational
Employment and Wage Estimates Sectors 31, 32, and 33 – Manufacturing. 
 HYPERLINK "http://www.bls.gov/OES/current/naics2_31-33.htm" 
http://www.bls.gov/OES/current/naics2_31-33.htm .  

BLS, 2006a.  U.S. Bureau of Labor Statistics, Employer Costs for
Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC
Occupational Comparability between SOC and OCS.  Downloaded February
2006 from   HYPERLINK "http://www.bls.gov/ncs/ect/sp/ecsm0003.htm" 
http://www.bls.gov/ncs/ect/sp/ecsm0003.htm .

BLS, 2006b.  U.S. Bureau of Labor Statistics, Employment Cost Index News
Release Text: Employment Cost Index, March 2006 (April 28, 2006), at
http://  HYPERLINK "http://www.bls.gov"  www.bls.gov .

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

BLS, 2006d. Bureau of Labor Statistics.  Employment Cost Index,
Historical Listing Current-Dollar 1975-2005 (May 10, 2006) at
http://www.bls.gov/web/ecconst.pdf.

BLS, 2006e.  Bureau of Labor Statistics.  Consumer Price Index- All
Urban Consumers, U.S. City Average (Series ID: CUUR0000SA0), extracted
May 29, 2006.

BT Office Products, 1997.  BT Office Products International. Office
Products Catalog, 1997.

CMA, 1991.  Chemical Manufacturers Association.  Responses to Questions
on Burden Associated with PMN Submissions.  Distributed by the Chemical
Manufacturers Association, Washington, DC.

EPA, 1997. Office of Pollution Prevention and Toxics.  Chemistry
Assistance Manual for Premanufacture Notification Submitters, EPA
744-R-97-003, March 1997.    HYPERLINK
"http://www.epa.gov/oppt/newchems/pubs/chem-pmn/" 
http://www.epa.gov/oppt/newchems/pubs/chem-pmn/   

EPA, 2003.   U.S. EPA, Office of Pollution Prevention and Toxics.
Significant New Uses of Certain Chemical Substances, 68 FR 15061, March
28, 2003.  EPA Docket No. OPPT-2002-0060. 

EPAB, 1998. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Economic Analysis of Expedited
Significant New Use Rules for 168 Chemical Substances and Background
Support Document for Economic Analysis of Significant New Use Rules.  
Washington, DC, January 1998.

EPAB, 1999. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Economic Analysis of Expedited
Significant New Use Rules for 41 Chemical Substances and  Background
Support Document for Economic Analysis of Significant New Use Rules. 
Washington, DC, July 20, 1999. Available from the Federal Docket
Management System under EPA-HQ-OPPTS-50635 at
http://www.regulations.gov.

EPAB, 2002.  U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report.  Washington, DC.  August
2002.

EPAB, 2003.  U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Economic Analysis of Expedited
Significant New Use Rules for 65 Chemical Substances.  Washington, DC,
2003.  Available from the Federal Docket Management System as
EPA-HQ-OPPTS-2002-0078 at http://www.regulations.gov.

  SEQ CHAPTER \h \r 1 EPAB, 2005a.  Economic Analysis for the Final
Section 4 Test Rule for High Production Volume Chemicals: Final Report,
October 28, 2005, U.S. EPA.

  SEQ CHAPTER \h \r 1 EPAB, 2005b.  Economic Analysis of the Proposed
Change to TSCA Section 12(b) Export Notification Requirements, November
2005, available from the Federal Docket Management System as
EPA-HQ-OPPT-2005-0058-0017 at http://www.regulations.gov.

Kearney, 1988a.  Memorandum to Bill Massouda, Reporting and
recordkeeping costs for a generic SNUR, February 3, 1988. [Memo
submitted to U.S. EPA/Office of Toxic Substances (now OPPT) under
contract 68-02-3980 with A.T.Kearney, Inc.]. 

Kearney, 1988b.  Estimated Cost of the Final Comprehensive Assessment
Information Rule, June 1, 1988.  Prepared by Kearney/Centaur for US EPA.

ICR No. 118.08.  [Information Collection Request for] TSCA Section
5(a)(2) Significant New Use Rules for Existing Chemicals (Renewal). 
Supporting Statement for a Request for OMB Review under the Paperwork
Reduction Act, October 11, 2005.

ICR No. 0574.12. [Information Collection Request for]Pre-Manufacture
Review Reporting and Exemption Requirements for New Chemical Substances
and Significant New Use Reporting Requirements for Chemical Substances:
Supporting Statement for a Request for OMB Review under The Paperwork
Reduction Act, Dec 22, 2004.

ICR No. 1139.06. [Information Collection Request for]  TSCA Existing
Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary
Test Data Submissions: Supporting Statement for Request for OMB Review
under the Paperwork Reduction Act. Attachment 5, Wage Rates Estimation,
August 29, 2000.

LSS, 1997.  Lab Safety Supply.  1997 Product Catalog.

NTIS.  National Technical Information Service. http://www.ntis.gov. 

OECD. Organization for Economic Cooperation and Development.
http://www.oecd.org. 

OPPE, 1992.  U.S. EPA, Office of Policy, Planning, and Evaluation. 
Instructions for Preparing Information Collection Requests (ICRs).
Washington, DC, June 1, 1992.

OPM, 2006.  Office of Personnel Management, Salary Table 2006-DCB,
Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. accessed from  
HYPERLINK "http://www.opm.gov/oca/06tables/indexGS.asp" \t "_blank" 
http://www.opm.gov/oca/06tables/indexGS.asp .

OPPT, 2006.  U.S. EPA, Office of Pollution Prevention and Toxics,
Harmonized Test Guidelines, available at     HYPERLINK
"http://www.epa.gov/opptsfrs/home/guidelin.htm" 
http://www.epa.gov/opptsfrs/home/guidelin.htm .

OSHA, 1983. US Dept of Labor, OSHA, Office of Regulatory Analysis, Final
Regulatory Impact and Regulatory Flexibility Analyses of the Hazard
Communication Standard. Washington DC, 8/9/83.

RIB, 1989.  U.S. EPA, Office of Toxic Substances, Regulatory Impacts
Branch.  Economic Analysis of Final Significant New Rules: General
Provisions for New Chemical Follow-Up.  Washington, DC, July 19, 1989. 
(OTS/RIB later became OPPTS/EPAB.)

RIB, 1994.  Regulatory Impacts Branch.  Regulatory Impact Analysis of
Amendments to Regulations for TSCA Section 5 Premanufacture
Notifications.  Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9,
1994. (OTS/RIB later became OPPTS/EPAB.)

 

Rice, 2002.  Cody Rice. Wage Rates for Economic Analysis of the Toxics
Release Inventory Program.  Washington, DC: U.S.EPA,Office of Pollution
Prevention and Toxics, Economic and Policy Analysis Branch, June 10,
2002.

Silagi, 1992.  William Silagi.  Economic Analysis in Support of the
Final Rule Promulgated under TSCA Section 12(b).  Washington, DC:  U.S.
EPA, Office of Pollution Prevention and Toxics, Economic and Policy
Analysis Branch, June 1992.

Weinstein, 2004.  Harriet G. Weinstein and Mark A. Loewenstein, U.S.
Bureau of Labor Statistics. Comparing Current and Former Industry and
Occupation ECEC Series. Originally posted August 25, 2004 at   HYPERLINK
"http://www.bls.gov/opub/cwc/print/cm20040823ar01p1.htm" 
http://www.bls.gov/opub/cwc/print/cm20040823ar01p1.htm .

 This report covers chemicals that went through PMN review and are part
of an expedited rulemaking process.  The relevant Office of Management
and Budget Information Collection Request number is ICR No. 0574.12. 
EPA also promulgates SNURs through conventional rulemaking that are
covered by ICR No. 188.08.  

 For example, OPPT’s Information Collection Request (ICR) for TSCA
Section 5(a)(2) Significant New Use Rules for Existing Chemicals
(Renewal), October 11, 2005, estimates SNUN recordkeeping costs at 5.67
hours (ICR 118.08, page 12). 

 In February of 2006, EPA proposed changes to the TSCA 12(b) export
notification requirements (71 FR 6733).  The anticipated changes are
expected to reduce per-chemical notification costs. However, the rule
had not been finalized as of August, 2006, so costs here are for the
requirements as they were before the regulatory changes.

 This supercedes an earlier EPA estimate that the one-time cost of
preparing and submitting an export notification was $62.60 in 1992
(Silagi, 1992).

 Bona fides are submitted to EPA by manufacturers and importers to
determine a chemical's TSCA Chemical Inventory and regulatory status.

 This is a change from the method used in a 2003 report, Economic
Analysis of Expedited Significant New Use Rules For 65 Chemical
Substances (EPAB, 2003; EPA docket number OPPT-2002-0078).  Previously,
wage rates for production workers came from the BLS National Employment,
Hours, and Earnings, Average Hourly Earnings of Production Workers,
while fringe benefits were taken from the ECEC data.  Here, both wages
and fringes for production workers come from ECEC data, for better
consistency with the method of estimating labor costs for other labor
categories.

 Employer Costs for Employee Compensation, Private Manufacturing
Industry by Occupation, unpublished BLS data (BLS, 2006a).  Past SNUR
economic analyses, such as EPAB, 2003, used ECEC data for “All Goods
Producing” sectors (manufacturing, mining, and construction). 
However, the manufacturing sector data seems more relevant since the
SNUR mainly affects the chemicals industry.

	 Past SNUR economic analyses have used the term “technical” labor.
Here the category is called “professional/technical” labor, to make
clear how it relates to BLS categories.  In 2004, BLS changed from the
Occupational Classification System, OCS, to the Standard Occupational
Classification system, SOC.  In the process, the “Professional
specialty and technical” category became the “Professional and
related” category.  However, the coverage of the old and new
occupational groups is approximately the same. See the BLS article,
Comparing Current and Former Industry and Occupation ECEC Series
(Weinstein, 2004).

 This represents a change in data sources for Industrial Hygienist wages
as compared to the prior PMN SNUR economic analysis, which used data
from a 1997 professional journal salary survey (EPAB, 2003). 

 The GS-13 Step 5 is consistent with ICR No. 0574.12 (12/22/2004) which
covers PMN SNURs.  This grade level represents a change from the earlier
PMN SNUR economic analysis (EPAB, 2003), which used an average of GS-12
Step 1 and GS-12 Step 10 salaries.  The change is based on the judgment
of EPA staff familiar with the SNUN process that a GS-13 (or higher)
grade level is more typical for PMN and SNUN reviewers (Carol Rawie
conversation with Karen Chu, EPA OPPT/Chemical Control Division,
5/1/06). 

Figures presented here are rounded.

 Data on PMN notices suggest that some PMN submitters expected to
produce less than 10,000 kilograms per year of the SNUR chemicals, but
many expected to produce much more, often over 100,000 kg.   It is not
known whether expected volumes were realized in practice.  Production
volumes of secondary suppliers affected by the SNUR are also unknown. 
Annual volumes significantly greater than 10,000 kg could lead to higher
haz-comm costs than those estimated here.

 ADVANCE \d4 EPA’s website at
http://www.epa.gov/oppt/newchems/pubs/ncelmain.htm explains that in
Consent Orders and subsequent SNURs, EPA can require respirators unless
workplace air measurements show that air-borne concentrations of the
chemical are below a New Chemical Exposure Limit established by EPA to
protect health.  NCEL provisions are modeled after Occupational Safety
and Health Administration Permissible Exposure Limits (PELs), and also
cover sampling and analytical methods, monitoring, respiratory
protection, and recordkeeping.

 The cost was inflated as shown in Table C-11.

 The total cost is estimated using unrounded unit cost estimates and may
not equal the product of the unrounded figures shown in this example.

 For example, OPPT’s Information Collection Request (ICR) for TSCA
Section 5(a)(2) Significant New Use Rules for Existing Chemicals
(Renewal), October 11, 2005, estimates SNUN recordkeeping costs at 5.67
hours (ICR 118.08, page 12).

 

 SNUN submission costs estimated in Appendix E of this report were based
on PMN submission costs from a 1994 report, Regulatory Impact Analysis
of Amendments to Regulations for TSC Section 5 Premanufacture
Notifications (RIB, 1994).  Page III-14 of the 1994 report refers to
“the normal records kept with a PMN submission which are included in
the estimates for submission costs.”  Page III-12 identifies
“maintaining a file of the submission” as part of the labor hours
for the PMN reporting form. These statements imply that the 95 to 114
total hours for a PMN submission (page III-10 of RIB 1994) included
recordkeeping hours.  

 Table 6 in the main text estimates total recordkeeping costs for a
chemical with multiple SNUR restrictions, including workplace
protection, hazard communication, water discharge, disposal, and other
limitations. Because few if any chemicals will have all of these
restrictions, the total cost presented will be an overestimate of
recordkeeping costs for most chemicals subject to the SNUR. 

 For an overview of the PMN review process, see the Chemistry Assistance
Manual for Premanufacture Notification Submitters, EPA, 1997.

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