Economic Analysis of the Significant New Use Rule

for the Trichoderma reesei (T. reesei) organism 

Subject to MCAN J-10-2

(EPA DOCKET EPA–HQ–OPPT–2010–0994)

November 1, 2011

—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
Economic Analysis for SNUR, Docket OPPT-2010-0994 i November 2011

Contributors

The EPA analyst responsible for this report was Stephanie Suazo. Analytical and draft 

preparation support was provided by Abt Associates Inc. under EPA Contract No. EP-W-08-010.
Economic Analysis for SNUR, Docket OPPT-2010-0994 ii November 2011

Abstract

This Economic Analysis estimates the potential costs of a Significant New Use Rule (SNUR) 

covering the microorganism identified generically as Trichoderma reesei (T. reesei) that has been 

the subject of Microbial Commercial Activities Notification (MCAN) J–10–2. The proposed 

SNUR requires manufacturers, importers, or processors of T. reesei organism to notify EPA at 

least 90 days prior to the occurrence of any significant new use. A significant new use is defined 

as any manufacturing, processing, or use of the microorganism without containment and 

inactivation controls described in the MCAN notice. A firm intending to engage in these 

activities would be required to submit a Significant New Use Notice (SNUN), incurring an 

estimated submission cost of $8,302 per chemical, and potentially other minor costs. The 

required notification will provide EPA with the opportunity to evaluate the intended use and, if 

necessary, to prevent or limit potentially adverse effects from that activity before it occurs.

To submit a Significant New Use Notice or request a SNUR modification, a firm incurs a modest

submission cost, plus costs of any additional data generated to support the submission. By 

avoiding a Significant New Use, a firm can avoid submission costs, but may incur other 

compliance costs. For example, it may incur costs of restricting microbe releases or preventing 

worker exposure.
Economic Analysis for SNUR, Docket OPPT-2010-0994 iii November 2011

Table of Contents

Contributors...................................................................................................................................... i

Abstract ........................................................................................................................................... ii

1 Introduction............................................................................................................................. 1

1.1 Statutory Authority ............................................................................................. 1

1.2 Summary of Methodology .................................................................................. 1

1.3 Organization of this Report................................................................................. 1

2 Affected Entities..................................................................................................................... 3

2.1 Chemicals Subject to the Proposed Rule ............................................................ 3

2.2 Significant New Uses under the Proposed SNUR.............................................. 3

2.3 Potentially Affected Companies......................................................................... 4

3 Industry Compliance Costs..................................................................................................... 5

3.1 Wage Rates ......................................................................................................... 5

3.2 Unit Industry Compliance Costs......................................................................... 6

3.2.1 Rule Familiarization.................................................................................... 6

3.2.2 CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup

..................................................................................................................... 7

3.2.3 Form Completion and Submission Fee....................................................... 8

3.2.4 Recordkeeping for Companies Choosing to Submit a SNUN.................... 9

3.2.5 Recordkeeping for Companies that do not Submit a SNUN .................... 10

3.2.6 Customer Notification............................................................................... 10

3.2.7 Import Certification .................................................................................. 11

3.2.8 Export Notification ................................................................................... 11

3.3 Summary of Per Submission Costs, by Option................................................. 13

3.4 Likelihood of SNUN Submission ..................................................................... 14

3.5 Potential for Subsequent Regulatory Actions................................................... 14

4 Agency Costs........................................................................................................................ 16

4.1 Labor Rates for EPA Staff................................................................................ 16

4.2 SNUN Processing Costs ................................................................................... 17

4.3 Export Notification Cost................................................................................... 20

5 Benefits................................................................................................................................. 21

6 Additional Analyses.............................................................................................................. 22

6.1 Regulatory Flexibility Act ................................................................................ 22

6.2 Unfunded Mandates Reform Act (UMRA) ...................................................... 22

6.3 Paperwork Reduction Act (PRA)...................................................................... 22

6.4 Executive Order 13132, Federalism ................................................................. 23

6.5 Executive Order 12898, Environmental Justice................................................ 23

6.6 Executive Order 13045, Protection of Children ............................................... 23

6.7 Executive Order 13175, Tribal Governments................................................... 23

6.8 Executive Order 13211, Energy Supply, Distribution, or Use ......................... 24

7 References............................................................................................................................. 25

Appendix A: Inflators and Wage Rates......................................................................................... 28
Economic Analysis for SNUR, Docket OPPT-2010-0994 iv November 2011

List of Tables

Table 1: Loaded Industry Wage Rates, December 2010 .................................................. 6

Table 2: Rule Familiarization Burden and Cost for SNUR Submitters ........................... 7

Table 3: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup 

Burden and Cost for First-Time Submitters....................................................... 8

Table 4: Industry Cost Estimate to Complete the SNUN Form ....................................... 9

Table 5: Industry Cost Estimate to Complete and Submit the SNUN Form.................... 9

Table 6: Annual Per-Chemical Costs of Recordkeeping Requirement for Companies 

that Choose not to Submit a SNUN.................................................................. 10

Table 7: Derivation of Total Mailing Cost for 12 Notices............................................. 12

Table 8: TSCA 12(b) Export Notification Cost per Notification ................................... 13

Table 9: Compliance Options and Associated Costs Incurred by a Firm Due to the 

Proposed SNUR ............................................................................................... 14

Table 10: Derivation of Loaded Agency Wage Rates...................................................... 17

Table 11: Derivation of Inflation Factors for Agency Extramural Costs......................... 18

Table 12: Agency Costs for SNUN and Other Submission Review and Processing ....... 19

Table 13: TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2010$) 20

Table 14: Derivation of Loaded Wage Rates ................................................................... 30

Table 15: Derivation of Inflation Factors......................................................................... 32
Economic Analysis for SNUR, Docket OPPT-2010-0994 1 November 2011

1 Introduction

This report presents the U.S. Environmental Protection Agency (EPA), Office of Chemical Safety and 

Pollution Prevention (OCSPP’s) analysis of the potential costs incurred as a proposed Significant New 

Use Rule (SNUR) being promulgated for the microorganism identified generically as Trichoderma reesei

(T. reesei) which has been the subject of Microbial Commercial Activities Notification (MCAN) J–10–2. 

The SNUR is being published under the rulemaking docket number EPA–HQ–OPPT–2010–0994.

1.1 Statutory Authority 

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical 

substance is a “significant new use.” EPA must make this determination by rule after considering all 

relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a 

chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a SNUN 

to EPA at least 90 days before manufacturing, importing, or processing the chemical substance for that 

use (15 U.S.C. 2604(a)(1)(B)). The general SNUR provisions are found at 40 CFR Part 721, Subpart A.

EPA has interpreted the TSCA section 3(2) definition of ‘‘chemical substance’’ as authorizing EPA to 

regulate microorganisms under TSCA. See the Federal Register of April 11, 1997 (62 FR 17910) (FRL–

5577–2). Microorganisms that are not intergeneric are implicitly included on the TSCA Inventory, which 

would include naturally-occurring microorganisms such as T. reesei (see § 725.8(b)). Thus, such 

microorganisms are only subject to TSCA section 5 notification requirements upon promulgation of a 

SNUR, pursuant to TSCA section 5(a)(2).

1.2 Summary of Methodology

This analysis quantifies, to the extent possible, the costs to society of the proposed rule by identifying the 

costs to industry associated with performing the required reporting and recordkeeping, and the costs to 

EPA of administering the rule. Industry costs consist of rule familiarization; registration with the Central 

Data Exchange (CDX) electronic reporting tool; collection, compilation, and submission of required 

information for significant new uses of the microorganism; export notification; and recordkeeping. 

Agency costs include reviewing and processing the data received as a result of the rule. Data sources for 

this analysis include burden estimates derived from previous information collection requests and 

economic analyses for related rules, and compensation data acquired from government publications.

In addition to costs, this report qualitatively discusses the benefits of the proposed rule based on the value 

of the information it will provide. The benefits analysis was undertaken to address the implicit call for 

cost-benefit balancing contained in TSCA, as well as the requirements of Executive Order 12866.

1.3 Organization of this Report

The remainder of this report provides EPA’s economic analysis in support of the proposed rule. The 

chemical substances and entities affected are characterized in Chapter 2. Chapter 3 contains estimates of 

the industry costs to comply with the proposed rule, and Chapter 4 shows estimates of the government 

costs associated with the administration of the proposed rule. Chapter 5 addresses the benefits of the 

proposed rule. Several additional impact analyses are presented in Chapter 6, including: small entity 

impact analysis, as mandated by the Regulatory Flexibility Act (RFA); a burden hour analysis that

responds to the requirements of the Paperwork Reduction Act (PRA); an analysis of unfunded mandates 

that pertains to the Unfunded Mandates Reform Act (UMRA); an analysis of environmental justice 
Economic Analysis for SNUR, Docket OPPT-2010-0994 2 November 2011

implications that addresses the requirements of Executive Order 12898; and an analysis of children’s 

health pertinent to Executive Order 13045.

Note that all dollar amounts in this analysis are reported in 2010 dollars.
Economic Analysis for SNUR, Docket OPPT-2010-0994 3 November 2011

2 Affected Entities

2.1 Chemicals Subject to the Proposed Rule 

This SNUR will use notice and comment procedures. This proposed rule would require persons to notify 

EPA at least 90 days before commencing the manufacture, import, or processing the microorganism 

identified generically as Trichoderma reesei (T. reesei) that was the subject of the was the subject of the 

Microbial Commercial Activities Notification (MCAN) J–10–2 prior to the occurrence of any significant 

new use. A significant new use is defined as any manufacturing, processing, or use of the microorganism 

without containment and inactivation controls as described in the MCAN notice. Based on information 

on analogous Trichoderma reesei species, EPA identified concerns for opportunistic infections to immune 

compromised persons from exposures to large quantities of the MCAN substance. For the uses described 

in the MCAN J-10-2, human and environmental exposures are minimal based on adequate containment 

and inactivation controls listed in the notice. Therefore, EPA has not determined that the proposed 

manufacturing, processing, or use of the substance with the specific containment and inactivation controls 

described in the MCAN may present an unreasonable risk. However, based upon consideration of 

alternative uses for the substance, EPA has determined that use of the substance without adequate 

containment and inactivation controls, resulting in releases of active cells may cause serious health 

effects. Additional information relating to the assessment of this chemical substance, including sanitized 

reports and a list of references used, is available under docket ID number EPA–HQ–OPPT–2010–0994.

The MCAN states that the generic (non-confidential) use of the microorganism will be to produce 

enzymes for ethanol production.

2.2 Significant New Uses under the Proposed SNUR 

EPA may promulgate a SNUR for a substance when potential use could result in significant changes in 

human exposure or environmental release levels and/or that concern exists about the substance’s health or 

environmental effects (40 CFR §721.170). According to TSCA Section 5(a)(2), the determination that a 

chemical use qualifies as a significant new use must consider all relevant factors, including:

• The projected volume of manufacturing, importation, and processing of the chemical 

substance;

• The extent to which a use changes the type or form of exposure of human beings or the 

environment to a chemical substance;

• The extent to which a use increases the magnitude and duration of exposure of human 

beings or the environment to a chemical substance; and

• The reasonably anticipated manner and methods of manufacturing, processing, 

distribution in commerce, and disposal of a chemical substance.

Additionally, EPA has determined that the results of the following tests would help characterize the human 

health effects of the MCAN substance: (1) a survival competition study to determine the ability of the 

MCAN microorganism to survive in the environment. Testing should evaluate the microorganism relative to 

the survival of the unmodified parent, or recipient strain, and conduct counts of the MCAN microorganism 

versus total fungi. This test may require some supplementation with carbon source(s) and could involve 

more than one soil type. (2) A study to determine adequate inactivation in an anaerobic fermentation 

environment under production conditions of ethanol content and ethanol distillation temperatures. (3) 

Investigate whether paracelsin will be produced, and at what levels if T.reesi is grown on various plant 

biomass materials for different durations under various fermentation conditions in cellulosic biomass 
Economic Analysis for SNUR, Docket OPPT-2010-0994 4 November 2011

facilities. (4) If produced, whether paracelsin would be denatured/inactivated during biofuel production and 

processing. (5) If released from the facility, whether paracelsin would be degraded/inactivated during 

wastewater treatment. (6) If released to the environment, the persistence, stability, dissemination, 

accumulation, and the potential resulting biological activity of paracelsin with exposure to organisms in the 

environment.

It should be noted that testing is not required under TSCA Section 5(a) and all testing of the MCAN 

substance as a result of the proposed SNUR is voluntary and therefore the costs of any testing are not 

attributable to the proposed rule.

2.3 Potentially Affected Companies 

The proposed SNUR applies to processors as well as to manufacturers and importers (40 CFR §721.5) of 

the T. reesei species. It would require manufacturers, importers, and processors to notify EPA at least 90 

days before commencing the manufacture, import, or processing of T. reesei organism without the 

containment and inactivation controls as described in the MCAN notice.
Economic Analysis for SNUR, Docket OPPT-2010-0994 5 November 2011

3 Industry Compliance Costs 

The proposed SNUR discussed in this report specifies that any manufacture, import, or processing of the 

microbe without the containment and inactivation controls as described in the MCAN notice will require 

reporting under section 5(a)(1)(A) of TSCA. Therefore, a firm intending to manufacture, import, and/or 

process the microorganism for these applications must submit a SNUN. Alternatively, a firm can decide 

not to manufacture, import, and/or process the microbe or to manufacture, import, and/or process the 

microbe in such a way that it is not considered a significant new use. The firm, therefore, has two

options:

• Option 1: Submit a SNUN. 

3.2.8

A SNUN indicates to EPA that the firm would like to manufacture, 

import, and/or process the microbe for a significant new use. The firm must submit the SNUN to 

EPA at least 90 days before it plans to commence the manufacture, import, and/or processing of 

the new use of the substance; the SNUN provides EPA with the opportunity to evaluate the 

intended use and, if necessary, to prohibit or limit that activity before it occurs. If EPA allows the 

manufacture, import, and/or processing of the microbe for a significant new use, then the costs 

associated with this option are the costs of submitting the SNUN (including a user fee) plus, if 

there is any export of the microbe, the export notification costs that result from TSCA Section 12 

(b) requirements that are automatically triggered for the microorganism regulated under TSCA 

Section 5 (see Section for details).

• Option 2: Comply with SNUR limits (not manufacture, import, and/or process a new use of the 

chemical)

The remainder of this chapter estimates the quantified portion of costs associated with the proposed 

SNUR for the uses of the microorganism. Section 

. A firm can avoid engaging in a Significant New Use and submitting a SNUN by not 

manufacturing, importing, and/or processing the microbe in a manner such that they would be 

considered new uses. While this option avoids the costs of submitting a SNUN, it may entail the 

“hidden” cost of the foregone profit as a result of not engaging in the commercial activity 

originally planned, and may involve substituting the microorganism for another, more costly 

microbe. If the firm elects to produce the microbe for research and development (R&D) purposes 

only (an exemption for R&D purposes is provided in 40 CFR §721.47), it may have costs 

associated with R&D recordkeeping. In addition, if the firm exports the microbe, it will incur the 

export notification costs. The firm may also pursue this option temporarily by complying with 

SNUR restrictions while also pursuing Option 1. Due to the uncertainty related to this option and 

EPA’s expectation that affected entities will select Option 1: the costs of Option 2 are not fully 

quantified in this report.

3.1 summarizes the wage rates used in this chapter. 

Section 3.2 provides the unit industry compliance costs, including the costs of rule familiarization, 

registration with the Central Data Exchange (CDX) electronic reporting tool, completing the SNUN form,

submission fee, import certification, and export notification. Total costs under each option are presented 

in Section 3.3.

3.1 Wage Rates

The proposed rule involves activities that may require efforts by employees in three labor classifications: 

managerial, technical, and clerical. Costs for each activity are calculated by estimating the labor hours 

required in each labor category and multiplying those burdens by the wage rate for each labor category. 

This section presents the estimated wage rate in each labor category.

Loaded wage rates for managerial, technical, and clerical personnel are derived by combining data on 

wages and fringe benefits with estimates of overhead rates, following the methodology described in Wage 
Economic Analysis for SNUR, Docket OPPT-2010-0994 6 November 2011

Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). Wage data for each 

labor category in December 2010 are provided by the Employer Costs for Employee Compensation 

(ECEC) Supplemental Tables available on the BLS website (BLS, 2011a). The loaded wage rate is 

$69.74 for managerial labor; $61.71 for technical labor; and $28.98 for clerical labor. Table 1 presents 

the basic data used to calculate the loaded wage rates for all three categories of labor. Appendix A:

provides more information on the wage rates and inflators used in this analysis.

Table 1: Loaded Industry Wage Rates, December 2010

Labor 

Category Data Sources Date

Wage

(2010$)

Fringe 

Benefit

(2010$)

Fringes 

as % 

wage

Overhead 

% 

wage2

Fringe + 

overhead 

factor

Loaded 

Wages

(2010$)

1

(a) (b) (c) 

=(b)/(a)

(d) (e)=(c)+

(d)+1

(f)=(a) 

x (e)

Managerial

BLS ECEC, Private 

Manufacturing industries,

“Mgt, Business, and 

Financial”

Dec10 3

$42.82 $19.64 45.87% 17% 1.63 $69.74

Professional/

Technical

BLS ECEC, Private 

Manufacturing industries, 

“Professional and related“

Dec3 10 $36.93 $18.50 50.09% 17% 1.67 $61.71

Clerical

BLS ECEC, Private 

Manufacturing industries, 

“Office and Administrative 

Support”

Dec10 3

$17.36 $8.67 49.94% 17% 1.67 $28.98

1 Wage data are rounded to the closest pennies in this table; however, in calculations using these numbers for this report, 

unrounded values were used.

2 An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release 

Inventory Program (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report 

(EPA, 2002a).3 Employer Costs for Employee Compensation Supplementary Tables December 2010, U.S. Bureau of Labor 

Statistics, March 9, 2011 (BLS, 2011a).

3.2 Unit Industry Compliance Costs

3.2.1 Rule Familiarization

The proposed rule requires submitters and their staff to become familiar with the SNUR and its various 

requirements. Rule familiarization is estimated to require 0.55 hours of technical labor and 0.27 hours of 

managerial labor, as described in the Economic Analysis of the Premanufacture Notification Electronic 

Reporting Final Rule (EPA, 2009a), which measures the costs of mandatory electronic reporting of 

SNUNs and other TSCA Section 5 notices. As shown in Table 2, the total labor cost associated with rule 

familiarization is $52.54.
Economic Analysis for SNUR, Docket OPPT-2010-0994 7 November 2011

Table 2: Rule Familiarization Burden and Cost for SNUR Submitters

Reporting Activity

Clerical Labor

($29.98/hour)

Technical Labor 

($61.71/hour)

Managerial Labor 

($69.74/hour)

Total Labor 

Cost

(2010 dollars)

Burden Cost Burden Cost Burden Cost Burden Cost

Rule Familiarization 0.00 $0.00 0.55 $33.94 0.27 $18.60 0.82 $52.54

Note: Costs may not equal labor wage rate times burden hours as shown, due to rounding. Unrounded estimates were used during 

the actual cost calculations. 

Source: See Table 1; EPA, 2009a.

3.2.2 CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup

The proposed SNUR requires first-time submitters of any TSCA section 5 notice (including 

Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Test Market Exemption (TME) 

applications, Low Volume Exemption (LVE) notices, Low Exposure/Low Release (LoREX) exemption 

notices, Biotechnology Notices for genetically modified microorganisms, Notices of Commencement of 

Manufacture or Import (NOCs), and support documents to Section 5 notices) to register their company 

and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and 

use a Pay.gov E-payment account.1 These activities are only required of first-time submitters of any 

Section 5 notice

• CDX registration: EPA estimates that companies will spend approximately 0.18 hours per 

employee to register with CDX, and that an average of four technical staff members and one 

manager will need to register for each company, totaling approximately 0.92 hours of burden per 

company.

. These activities are estimated to require the following burdens, based on the estimates 

presented in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule

(EPA, 2009a):

• CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, 

submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA 

per employee. This burden will apply to four technical staff members and one manager per 

company, totaling 1.25 hours of burden per company. In addition, EPA estimates that a manager 

will spend an additional 0.50 hours accessing, preparing, and submitting verification forms 

(Verification of Authorization) for all authorized submitters to EPA. The total burden incurred 

by companies submitting and then verifying electronic signature agreements is 1.75 hours. Note 

that this burden does not include any additional time required to contact EPA’s CDX help desk to 

notify a change of submitter status, should one occur.

Filing the electronic signature agreement requires an additional mailing cost of $2.30 per

company (including five $0.44 stamps and five $0.02 business envelopes).

• Payment via Pay.gov account: EPA estimates that one manager per company will spend 

approximately 0.13 hours setting up a Pay.gov ID account, logging into the system, finding the 

appropriate form, and filling it out. This burden does not include the time required to click 

‘submit’ on the form and wait for payment processing.

As shown in Table 3, the labor cost associated with CDX registration, CDX electronic signature, and 

Pay.gov account setup by a first-time submitter is $181.34. As noted above, an additional $2.30 in 

 1 Although the proposed rule does not require submitters to establish and use a Pay.gov account, the burden 

estimates in this analysis are conservative insofar as to include the use of Pay.gov as a required activity.
Economic Analysis for SNUR, Docket OPPT-2010-0994 8 November 2011

mailing cost per company is attributable to these activities, for a total cost of approximately $184 per 

company.

Table 3: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden and 

Cost for First-Time Submitters

Reporting Activity

Clerical Labor 

(at $29.98/hour)

Technical Labor 

(at $61.71/hour)

Managerial Labor 

(at $69.74/hour)

Total Labor Cost

(2010 dollars)

Burden Cost Burden Cost Burden Cost Burden Cost

CDX Registration 0.00 $0.00 0.73 $45.25 0.18 $12.78 0.92 $58.03

CDX Electronic 

Signature 0.00 $0.00 1.00 $61.71 0.75 $52.30 1.75 $114.01

Mailing Cost $2.30

E-Payment (Pay.gov ID) 0.00 $0.00 0.00 $0.00 0.13 $9.30 0.13 $9.30

Total 0.00 $0.00 1.73 $106.96 1.07 $74.38 2.80 $183.64

Note: Costs may not equal labor wage rate times burden hours as shown, due to rounding. Unrounded estimates were used during 

the actual cost calculations. 

Source: See Table 1; EPA, 2009a.

3.2.3 Form Completion and Submission Fee

Respondents who choose to submit a SNUN are required to gather and submit information regarding the 

data elements identified in the applicable SNUN reporting form. The methodology and calculations used 

in this analysis assume that the employee responsible for collecting, filling out, and submitting the 

requested information has a reasonable level of familiarity with the company and knowledge of 

operations at the site. It is assumed that for most entities these tasks are similar to other employee duties 

that require familiarity with EPA, State, and other Federal agency requests for chemical information and 

do not require additional familiarization or training beyond the basic rule familiarization described above. 

In addition, this analysis focuses on the marginal costs of submitting information for the proposed rule 

and not the total costs for the company to comply with a range of other Federal and State environmental, 

health, and safety regulations or accounting requirements that rely on this type of information.

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. 

The PMN submission costs came from EPA's 1994 Regulatory Impact Analysis of Amendments to 

Regulations for TSCA Section 5 Premanufacture Notifications, which relied on industry estimates of the 

effort needed to collect and compile all data required for a PMN submission, prepare the form, submit the 

form and data to EPA, and maintain a file of the submission (EPA, 1994, Table III-2 and pages III-11, -

12, and -13). The 1994 estimates were based on a survey conducted by the Chemical Manufacturers 

Association, which became the American Chemistry Council. These burdens include “the time spent 

reading and becoming familiar with the form, gathering the required information and preparing the report, 

producing sanitized responses for items claimed as confidential business information, and maintaining a 

file of the submission” (EPA, 1994. p. III 11-13). The burden associated with SNUN submission and 

preparation has been adjusted to reflect burden reductions resulting from the 2009 final PMN Electronic 

Reporting (ePMN) Rule that requires the electronic submission of all TSCA section 5 notices. Electronic 

submission of SNUN forms is expected to remove all clerical burden and reduce the recordkeeping 
Economic Analysis for SNUR, Docket OPPT-2010-0994 9 November 2011

burden associated with preparing a SNUN (EPA, 2009a).

2

SNUN form completion and electronic submission is estimated to require 73.68 hours of technical labor 

and 18.00 hours of managerial labor (EPA, 2009a). 

In addition, electronic submission is expected 

to generate and an additional 0.18 hours of technical burden, for the completion of the User Fee Payment 

Identification Number and email address data elements on the electronic SNUN form.

Table 4 combines the estimated reporting burden and 

loaded wage rates for all three labor categories to estimate the per-SNUN cost of form completion. The 

labor cost incurred by a SNUN submission for both large and small business submitters is $5,802.

Table 4: Industry Cost Estimate to Complete the SNUN Form

Reporting 

Activity

Clerical Labor 

($29.98/hour)

Technical Labor 

($61.71/hour)

Managerial Labor 

($69.74/hour)

Total Labor Cost

(2010 dollars)

Burden Cost Burden Cost Burden Cost Burden Cost

Form 

Completion 0.00 $0.00 73.68 $4,546.65 18.00 $1,255.31 91.68 $5,802

Note: Costs may not equal labor wage rate times burden hours as shown, due to rounding. Unrounded estimates were used during 

the actual cost calculations. 

Source: Loaded wages include fringe benefits and overhead. See Table 1 of this report for derivation. Wage rates presented in 

this table are rounded values; however, unrounded values are used to calculate total labor costs. For this reason, total labor costs 

may not equal the product of rounded values.

The estimate of no clerical burden is taken from the Economic Analysis of the Premanufacture Notice Electronic Reporting 

Final Rule (EPA, 2009a, page 7)

Technical and managerial labor burden is from the PMN Amendments RIA (EPA, 1994, Table III-2). An additional eleven 

minutes (0.18 hours) of technical burden is estimated to complete the User Fee Payment Identification Number and Email 

Address data elements on the Electronic SNUN form (EPA, 2009a page 15).

In addition, each submitting large business must pay a $2,500 per-SNUN submission fee, and each 

submitting small business must pay a $100 per-SNUN submission fee. Table 5 adds the labor cost and 

submission fee to estimate the total cost of a SNUN submission. The total cost of a SNUN submission is 

$8,302 for large business submitters and $5,902 for small business submitters.

Table 5: Industry Cost Estimate to Complete and Submit the SNUN Form

Reporting Population Labor Cost Submission Fee Total Cost

(2010 Dollars)

Large Business Submitters $5,802 $2,500 $8,302 

Small Business Submitters $5,802 $100 $5,902 

Source: Table 4; EPA, 1994

3.2.4 Recordkeeping for Companies Choosing to Submit a SNUN

Companies submitting a SNUN must, under 40 CFR §721.40, keep records of the information contained in 

the SNUN. Some EPA reports have assumed that SNUN recordkeeping hours would be five percent of 

 2 The Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) 

estimates a 0.5 hour clerical and a 0.5 hour technical burden associated with recordkeeping in addition to the burden 

estimates from the 1994 RIA, which include the burden for recordkeeping (EPA, 1994, p. III-14). These burden 

estimates are based on the recordkeeping burden for polymer exceptions and not the recordkeeping burden 

associated with PMN submissions. Therefore, for this analysis we assume that any reduction in recordkeeping 

burden is captured in the reduction of the clerical burden, and we do not consider the one hour recordkeeping burden 

from the ePMN EA in order to avoid double counting.
Economic Analysis for SNUR, Docket OPPT-2010-0994 10 November 2011

SNUN submission hours, or about five to six hours.3

3.2.3

For this report, the SNUN recordkeeping hours were 

included in the SNUN submission hours (see Section ) and the SNUN recordkeeping costs under 40 

CFR §721.40 were not separately estimated.4

3.2.5 Recordkeeping for Companies that do not Submit a SNUN

If a firm that manufactures, imports, or processes the microbe subject to the proposed SNUR chooses not 

to submit a SNUN, they must keep records that document compliance with SNUR conditions for avoiding 

a Significant New Use. Such recordkeeping requirements essentially involve copying and filing relevant 

records. Records must be maintained for five years from the date of their creation (40 CFR 721.40). For 

firms that choose to not submit a SNUN, costs for compliance with the recordkeeping requirements are 

estimated to be five percent of the reporting burden for reporting information for a specific section of the 

SNUN form and are performed by clerical staff (EPA, 2005b, pages 10 and 14). EPA used the peractivity burden for reporting, the description of manufacturing and processing and disposal presented in the

Regulatory Impact Analysis for the Regulation of Microbial Products of Biotechnology (EPA, 1997). 

Any clerical burden associated with these activities was removed to reflect the burden reduction 

associated with electronic submissions (EPA, 2009a).

The total recordkeeping burden for a company that does not submit a SNUN is estimated to be 1.9 hours and 

$55, and is derived in Table 6.

Table 6: Annual Per-Chemical Costs of Recordkeeping Requirement for Companies that Choose 

not to Submit a SNUN

Reporting Activity 

Total Burden 

Associated 

per Activity

(Hours)

Percent of 

Reporting Burden 

Attributed to 

Recordkeeping

Recordkeeping Burden

(hours) (2010

dollars)

Description of 

manufacturing/processing and disposal 38 5% 1.9 $55.06

Source:

US EPA, 1997 Office of Pollution Prevention and Toxics Regulatory Impact Analysis for the Regulation of Microbial 

Products of Biotechnology. January 1997.

3.2.6 Customer Notification

Manufacturers, processors, and importers of substances subject to SNURs must notify recipients of such 

substances of the SNUR or verify that knowledge of the SNUR has been otherwise acquired by recipients, 

or that the recipients are unable to engage in significant new uses. Since it is not expected that all such 

entities will have complete knowledge of all uses of any products subject to a SNUR, and because filing a 

SNUN could require significantly more burden, it is assumed that manufacturers, processors, and 

importers will most often choose to notify their customers of SNUR regulatory activities. As this 

notification may be accomplished by simply annotating an MSDS, EPA estimates the associated burden 

 3 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 15). 4 SNUN submission costs estimated in Section 3.2.3 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 (EPA, 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 EPA 1994) included recordkeeping hours.
Economic Analysis for SNUR, Docket OPPT-2010-0994 11 November 2011

to be about one hour of a technical employee's time or $61.71 per manufacturer, processor, or importer 

per chemical substance.

3.2.7 Import Certification

In general, promulgation of a final SNUR triggers a TSCA Section 13 import certification requirement 

and the corresponding regulations at 19 CFR §12.118 to 12.127 and 19 CFR §127.28 for all imports of 

the microorganism. Thus, any U.S. manufacturer, importer, or processor receiving an imported shipment 

of the microbe subject to the proposed SNUR would have to certify that the microbe in the shipment 

either complies with all applicable rules and orders under TSCA or that the microbe in the shipment is not 

subject to TSCA.5

In practice, import certification is fulfilled by checking a box on an invoice or entry document and 

generally imposes no additional burden or cost on the importer (EPA, 2009c). Any potential burden 

associated with a submitter’s familiarization with this requirement is assumed to be included in the more 

general SNUR familiarization burden discussed above.

The statement must be on or attached to a commercial invoice or entry document 

belonging to the imported shipment.

3.2.8 Export Notification

Under Section 12(b) of TSCA, exporters must notify EPA if they export or intend to export a chemical 

substance subject to various TSCA sections (40 CFR §707.60 through 75). For TSCA 5(a)(2) (the section 

under which EPA promulgates significant new use rules) and certain other TSCA sections, this is a onetime notification requirement6

Most underlying data in this section come from the 2009 TSCA Section 12(b) ICR, ICR No.: 0795.13

[Information Collection Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting 

Statement for Request for OMB Review under the Paperwork Reduction Act (EPA, 2009b), with 

updating for inflation.

per destination country for each exporter of a chemical substance. After 

receiving a notification from a firm, EPA notifies the importing country and the United States State 

Department (40 CFR §707.70). To calculate the burden associated with making a single export 

notification, EPA first estimated the average annual number of export notifications made by an exporter. 

EPA then derived the annual and per notification burden associated with preparing and submitting an 

export notification. EPA estimated the average burden associated with making a single notification.

Estimated Number of Annual Export Notifications per Exporter

EPA’s 2009 TSCA Section 12(b) ICR estimated that the average exporter making notifications will make 

12 notifications per year.

7

 5 The exact statements are as follows: For imports of chemical substances subject to TSCA, “I certify that all 

chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not 

offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” For 

imports of chemical substances not subject to TSCA (e.g., pesticides), “I certify that all chemicals in this shipment 

are not subject to TSCA.” (40 CFR 707.20)

This includes notifications resulting from SNURs and notifications resulting 

from other TSCA activities. Therefore, it is likely that an exporter will make less than 12 notifications per 

6 On November 14, 2006, EPA revised the export notification requirement for chemicals subject to TSCA §5(a)(2), 

5(b), 5(e)(1) and 5(e)(2) from an annual to a one-time requirement per destination country for each exporter 

(November 14, 2006, 71 FR 66234).

7

EPA calculated the average number of export notifications per exporter in the 2009 TSCA Section 12(b) ICR (EPA,

2009b) by dividing the estimated number of submitted notifications (3,500) by the estimated number of exporters 

(300).
Economic Analysis for SNUR, Docket OPPT-2010-0994 12 November 2011

year as a result of this proposed SNUR. A notification is typically no more than one page per 

chemical/country combination, and one notification mailing often includes multiple chemicals and/or 

destination countries.8

The percent of notifications resulting from SNURs in general is unknown, and it is also unknown how 

many notifications may result from this rulemaking, as not all manufacturers may choose to export the 

microbe, or they may make several notifications for a single chemical substance.

Exporter Costs

The 2009 TSCA Section 12(b) ICR (EPA, 2009b, page 11, Table 3), estimated the annual export 

notification cost for an exporter under the one-time export notification requirement. These costs include 

the cost to the exporter of compiling a list of their products that are subject to TSCA Section 12(b) 

requirements, writing or revising an export notification letter to EPA, checking the outgoing shipments, 

and sending the notification letters with the associated shipping costs.

The per-notification cost was calculated based on the average burden per firm. Exporters who make a 

larger number of notifications per year may benefit from economies of scale and have lower costs per 

notification; conversely firms making fewer notifications may have a higher cost per notification.

Estimated Submission (Mailing) Costs.

Table 7

Regulated companies will incur mailing costs for export 

notifications delivered to EPA. Notifications are assumed shipped via the U.S. Postal Service (USPS) as 

first-class registered mail with a return receipt (USPS, 2010). The estimated per-shipment and annual 

mailing costs incurred by individual submitters are detailed in .

Table 7: Derivation of Total Mailing Cost for 12 Notices

Postal Service Cost

Registered mail, regular, with $0 declared value $10.60

Return receipt, requested at time of mailing (receive by mail) $2.30

Postage, regular First Class, up to 1 ounce $0.44

Cost per export notice - Subtotal $13.34

× 12

Total Mailing Cost for 12 Notices $160

Source: Mailing rates are from the US Postal Service web site as of April 2010 (http://www.usps.com/prices/). The mailing 

method comes from the Economic Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, 

November 2005 (EPA, 2005a), as clarified in a later SNUR economic analysis (EPA, 2007c, Table 8).

Note: Calculations may be rounded.

Compile and Maintain the List of Products.

 8 Based on review by an EPA economist of notifications received under TSCA Sections 4, 5 and 6 over 

approximately three weeks in early 2010.

Since TSCA §12(b) information collection activity has 

been in place for twenty years, most respondents will have already developed a list of their products 

subject to TSCA §12(b) export notification. Respondents need only check for new regulations 

promulgated and any new products exported by the company. Updating the list is estimated to take an 

average of one hour of technical time, which may also include some proportion of legal time (EPA, 

2009b). The total burden can vary from two hours per year up to two hours per month, depending on the 

number of products exported by the company and the number of their products subject to TSCA §12(b) 

(EPA, 2009b).
Economic Analysis for SNUR, Docket OPPT-2010-0994 13 November 2011

The number of submitters per year who report under TSCA §12(b) has varied over time, rising from 

around 160 in 1991 to over 460 in 2000, and declining since. In the most recent TSCA §12(b) ICR, EPA 

estimated there would be approximately 300 submitters per year in near-future years (EPA, 2009b). Of 

these 300 submitters, EPA estimated that 200 companies were near the lower burden estimate of two

hours per year, and 100 companies were near the upper estimate of 24 hours per year. Compiling the list 

for all respondents was therefore estimated to take 2,800 hours (2 hours x 200 firms plus 24 hours x 100 

firms), or an average of about 9.3 hours of technical time per firm per year for 12 notifications per year 

(EPA, 2009b).

Write or Revise Export Notification. Companies that export chemicals subject to TSCA §12(b) 

reporting must prepare an export notification to send to EPA when export shipments are made. Time for

initial preparation of the export notice may vary depending on whether the company has prior experience 

with this requirement. This step is estimated to take an average of one hour of technical time (which may 

also include some proportion of legal time) per firm per year for 12 notifications per year (EPA, 2009b).

Check Orders and Send Notifications.

The burdens and associated costs for each notification activity are provided in 

Companies that export chemicals subject to TSCA §12(b) 

reporting must check outgoing shipments against the list of their products described above. A form letter 

notifying EPA and providing the required data must be printed and mailed within the required time 

period. This process is estimated to take an average one half hour of clerical time per export notification 

or six hours for 12 notifications (EPA, 2009b).

Table 8. EPA estimates 

that the burden associated with making one notification is approximately 1.36 hours and $80.80.

Table 8: TSCA 12(b) Export Notification Cost per Notification

Technical Clerical Total

$/Hr Hours 2010$ $/Hr Hours 2010$ Hours 2010$

Compile list $61.71 9.30 $574 -- -- -- 9.30 $574 

Write letter $61.71 1.00 $62 -- -- -- 1.00 $62 

Check order and send 

notice -- -- -- $28.98 6.00 $174 6.00 $174 

Mailing cost -- 1 -- -- -- -- -- -- $160 

Total per average facility2` 10.30 $635.59 6.00 $173.89 16.30 $969.56 

Total per Notification $0.86 $52.97 0.50 $14.49 1.36 $80.80 

Notes: Costs may not equal labor wage rate times burden hours as shown due to rounding. Unrounded estimates were used during 

the actual cost calculations. 1 Mailing costs reflect April 2010 USPS rates and can be found in Table 7. 2

Source: Appendix A of this report derives technical and clerical hourly labor costs. Other costs are from ICR No.: 0795.13

[Information Collection Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting Statement for Request 

for OMB Review under the Paperwork Reduction Act (EPA, 2009b, p.10), and are updated to 2010 dollars. 

An average facility submitting notifications is assumed to submit 12 export notifications per year.

3.3 Summary of Per Submission Costs, by Option

The number of firms affected by not making submissions to EPA is not known; therefore, costs are not 

aggregated across the affected entities. The following table summarizes the costs to comply with the 

proposed rule amendment, as described in more detail in section 3.2 above.
Economic Analysis for SNUR, Docket OPPT-2010-0994 14 November 2011

Table 9: Compliance Options and Associated Costs Incurred by a Firm Due to the Proposed SNUR

Option1 Costs Quantified Costs per Chemical (2010 dollars)

2

1.

Electronic submission of a 

Significant New Use 

Notice (SNUN), 

indicating to EPA that the 

firm would like to 

manufacture, import, or 

process the chemical for a 

Significant New Use as 

defined in the SNUR.

Costs of submitting a 

SNUN, including rule 

familiarization, CDX 

registration (for companies 

that are first-time 

submitters), form 

completion, user fee, 

export notification, and 

any test costs, Rarely, a 

firm may choose to 

conduct toxicity or fate 

testing to support the 

SNUN, but such testing is 

not

$52.54 rule familiarization cost; $8,302 submission 

cost (including SNUN recordkeeping and fee 

$2,500 for large businesses). EPA usually receives 

well under ten SNUNs per year. Export 

notifications costs are estimated at $80.80 per 

notification; total cost per company will vary. First 

time submitters would incur $183.64 for CDX 

registration and associated activities. Companies 

manufacturing, importing, or processing a chemical 

currently used in commerce in the United States 

will incur a cost $61.71 for notifying consumers of 

SNUR regulatory activities. required by law.

2.

Manufacture, import, or 

process in a way that 

avoids a Significant New 

Use.

Cost of the profit foregone 

as a result of not engaging 

in the commercial activity 

originally planned

(opportunity costs), 

recordkeeping, and export 

notification costs.

Opportunity costs are not quantified. Other costs 

include rule familiarization ($52.54), recordkeeping 

($55.06), export notification costs ($80.80 per 

notification), and costumer notification ($61.71)

may apply. Recordkeeping costs include costs for 

use type and marketing and production volume.

Notes:

1 Firms may be subject to both options at once since submission of a SNUN results in profits foregone as a result of not 

manufacturing, importing, or processing the chemical.

2 

3.2

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

detailed in Section . 3 EPA does not require the development of test data for submission of a SNUN, although a firm may submit test data already in 

its possession and/or describe any other available data. Because EPA does not require the development of test data, EPA assumes 

that no firms will incur testing costs as a result of the proposed SNUR.

3.4 Likelihood of SNUN Submission

This analysis assumes that very few entities are expected to submit a SNUN. EPA has, over the years, 

promulgated SNURs that cover a total of more than 1,000 chemicals. In response, the Agency receives 

only a handful of SNUNs per year. For example, the number of SNUNs received was four in Federal 

fiscal year (FY) 2005, eight in FY2006, six in FY2007, and eight in FY2008, seven in FY2009, two in 

FY2010, and ten in FY20119

3.5 Potential for Subsequent Regulatory Actions 

.

The Agency recognizes that if submission of a SNUN does result from a SNUR, the Agency may take 

additional regulatory actions under TSCA. These additional regulatory actions might be necessary to 

further evaluate an intended new use and associated activities, or to prohibit or limit that activity before it 

occurs to prevent unreasonable risk of injury to human health or the environment. It is not known what 

specific subsequent regulatory actions, if any, the Agency may determine are necessary after reviewing a 

SNUN. Any such actions are highly dependent on the circumstances surrounding the individual SNUN 

 9 In-person count of SNUNs conducted by Kimberly Wilson of Abt Associates Inc, on April 8, 2010 at EPA’s 

Confidential Information Business Center (CBIC) and updated values for FY2010 and FY2011 provided by Lynn 

Blake-Hedges of US EPA on September 1, 2011.
Economic Analysis for SNUR, Docket OPPT-2010-0994 15 November 2011

(e.g., available information and scientific understanding about the microbe and its risks at the time the 

SNUN is being reviewed).

Should the Agency’s review of the SNUN result in further regulatory actions, the Agency will initiate and 

follow the appropriate procedures for taking those actions. Included in those procedures would be an 

assessment of the costs and benefits of those actions.
Economic Analysis for SNUR, Docket OPPT-2010-0994 16 November 2011

4 Agency Costs

As described in the following sections, EPA’s costs to review and process SNUN submissions are 

assumed to be the same as EPA costs to review PMNs. 

4.1 Labor Rates for EPA Staff 

Agency labor costs are calculated based on annual Federal salaries for the Washington-Baltimore area 

published by the Office of Personnel Management effective January 2010 (OPM, 2010). EPA assumes 

that, on average, a federal GS-13, Step 5 full-time equivalent (FTE) will conduct its collection and 

administrative activities under the proposed rule. 10

Table 10

The average salary for a GS-13 Step 5 employee was 

$100,904 in 2010 without fringe benefits and overhead costs. In order to derive the fully loaded salary, 

EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and 

overhead, which results in a fully loaded annual salary of $161,446.40 (see ). Dividing the fully 

loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an hourly FTE wage 

rate of $77.62.

The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information 

Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled 

“the benefits multiplication factor” in the EPA guide, but has been used in many EPA OPPT ICRs to 

reflect both fringe benefits and overhead for federal staff. For example, it was used in a document 

supporting EPA ICR No. 1139.06 (EPA, 2000), with the following explanation:

The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits 

multiplication factor). The multiplication factor used is recommended in EPA’s Office of Policy, 

Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs)

(June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl 

Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits 

but also overhead.

Fully loaded costs for Agency labor are shown in Table 10.

 10 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007) (EPA, 2007a), which covers PMN SNURs. Use of this 

grade level follows the approach introduced in EPA, 2007b. That report represented a change from an earlier PMN SNUR 

economic analysis (EPA, 2003), which used an average of GS-12 Step 1 and GS-12 Step 10 salaries.
Economic Analysis for SNUR, Docket OPPT-2010-0994 17 November 2011

Table 10: Derivation of Loaded Agency Wage Rates

Labor 

Category

Data Source for Wage 

Information Date Wage Fringe 

Benefit

Fringes 

as % 

wage

Overhead 

as % 

wage

Fringe + 

overhead 

factor

Loaded 

Wages

(a) (b) (c)=(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a)*(e)

EPA staff 

FTE

Annual Federal staff cost: 

OPM WashingtonBaltimore-Northern 

Virginia, DC-MD-PA-VAWV, area, GS-13 Step 5 

pay rates, with 60% 

overheads a

Jan 

6 

2010

.

$100,904.00

(annual)

--

[Included 

in 60% 

overhead]

60% 1.60 b

$161,446.40

(annual)

$48.51

(hourly)

$77.62

(hourly)

Notes: a The Agency salary is the unloaded federal GS-13 Step 5 salary ($100,904 for 2010),from the OPM salary table for the 

Washington-Baltimore-Northern Virginia Locality Pay Area (OPM, 2010). Hourly rates are based on annual salary divided by 

2,080 hours.

b The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) 

(EPA, 1992, page 30, footnote 9).

4.2 SNUN Processing Costs 

The list of review steps, estimates of extramural costs, and the percent of chemicals requiring a particular 

review step are derived from the costs for processing PMN submissions in Table VII-1 of a 1994 EPA 

report, Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture 

Notifications (EPA, 1994). The Agency burden associated with processing a PMN has been adjusted to 

reflect burden reductions resulting from the 2009 final PMN Electronic Reporting (ePMN) Rule that 

requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms 

is expected reduce Agency burden by 16.5 percent (EPA, 2009b, p.28).

For each review step, the “EPA staff” cost is calculated by multiplying the number of FTEs (in the first 

column) by the fully loaded hourly 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, and is inflated from 1993 prices using the Bureau of Labor 

Statistics (BLS) Employment Cost Index (ECI) data (BLS, 2011b). The not seasonally adjusted ECI for 

total compensation of private industry professional and related workers (Series ID CIU2010000120000I) 

is used because it is the only series with continuous data since 1985, and that includes professional and 

technical labor, which perform the majority of Agency extramural activities. Table 11 contains the 

derivation of inflation factors for Agency extramural costs.
Economic Analysis for SNUR, Docket OPPT-2010-0994 18 November 2011

Table 11: Derivation of Inflation Factors for Agency Extramural Costs

Item Inflation Index Source1 Starting 

year

Index for 

starting 

year

(a)

Index 

for 

2010

(b)

Inflation 

factor

(b)/(a) 2

Agency Extramural costs 

White collar labor; 

equipment; supplies

BLS ECI, Total comp, Private 

industry, Professional and related, 4th

Q [BLS , 201lb]

1993 3

67.0 113.5 1.694

Notes:

1 In 2006, Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series “were rebased to December 2005 = 100 from 

June 1989 = 100.” The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index 

News Release Text: Employment Cost Index, March 2006 (BLS, 2006b). The Consumer Price Index (CPI) was not rebased. 2 Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values. 3 

Source:

Beginning with the report Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA 

Docket OPPT-2009-0922 (EPA 2010d), we began to use the not-seasonally adjusted CIU2010000120000I for private industry 

Professional, and Related workers, instead of SA CIS2010000W00000I for private industry white collar workers because BLS 

retired the “white-collar” series.

(BLS 2011b) Bureau of Labor Statistics. Employment Cost Index – Total Compensation: Professional and Related Private 

Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted June 16, 2011. (BLS, 2011b).

The Percent of Cases column in Table 12 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 un-weighted Costs (EPA staff cost plus 

extramural costs) by the percentage of cases requiring this review step. Weighted costs are then 

multiplied by the burden reduction of 16.5 percent to account for burden savings generated electronic 

submission. This calculation yields total Agency costs of $5,049, per SNUN, for submission review and 

processing, as shown in Table 12.
Economic Analysis for SNUR, Docket OPPT-2010-0994 19 November 2011

Table 12: 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 

Cost3

ePMN 

Burden 

Reduction4

Weighted Cost 

with ePMN 

Burden 

Reduction

FTE 

fraction

Cost per 

FTE 1

FTE Total 

($2009)

1993 

dollars

2010 

dollars

(a) (b) (c)=(a)*(b) (d) (e) (f)=(c)+(e) (g) (h)=(f)*(g) (i) (j)=(h)*(1-(i))

Pre-notice consultation 0.0024 $161,446 $387.47 $4.00 $6.78 $394 41% $161.64 0.165 $135 

Administrative prescreen/ 

notice receipt/user fee 0.0024 $161,446 $387.47 $92.00 $155.85 $543 100% $543.32 0.165 $454 

CRSS (Chemical Review and 

Search Strategy) 0.0025 $161,446 $403.62 $268.00 $454.00 $858 100% $857.62 0.165 $716 

SAT (Structure Activity 

Team) 0.0006 $161,446 $96.87 $14.00 $23.72 $121 100% $120.58 0.165 $101 

Engineering/Exposure 0.0015 $161,446 $242.17 $56.00 $94.87 $337 100% $337.04 0.165 $281 

Exposure/Fate 0.0008 $161,446 $129.16 $0.00 $0.00 $129 100% $129.16 0.165 $108 

Focus 0.0009 $161,446 $145.30 $23.00 $38.96 $184 100% $184.26 0.165 $154 

Standard Review Functions 0.0219 $161,446 $3,535.68 $511.00 $865.65 $4,401 29% $1,276.38 0.165 $1,066 

Division Directors Meeting 0.0129 $161,446 $2,082.66 $113.00 $191.43 $2,274 15% $341.11 0.165 $285 

Order 

Development/Negotiation 

Review

0.0171 $161,446 $2,760.73 $22.00 $37.27 $2,798 3% $83.94 0.165 $70 

Post Order Data Review 0.0886 $161,446 $14,304. $0.00 $0.00 $14,304 3% $429.12 0.165 $358 

Order Modification 0.2167 $161,446 $34,985.43 $0.00 $0.00 $34,985 3% $1,049.56 0.165 $876 

New Chemical SNUR 

Development 0.0277 $161,446 $4,472.07 $85.00 $143.99 $4,616 7% $323.12 0.165 $270 

Notices of Commencement 0.0012 $161,446 $193.74 $40.00 $67.76 $261 31% $81.06 0.165 $68 

FOIA (Freedom of 

Information Act) Requests 0.0333 $161,446 $5,376.17 $287.00 $486.19 $5,862 1% $58.62 0.165 $49 

CBI (Confidential Business 

Information) Substantiation 0.0004 $161,446 $64.58 $3.00 $5.08 $70 100% $69.66 0.165 $58 

TOTAL $6,046 0.165 $5,049 

Notes:

1 GS-13 Step 5 salaries loaded with benefits and overhead. See Table 10 for derivation. 2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993 prices using Table 11. 3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table. 4

Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM, 2010.

Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28).
Economic Analysis for SNUR, Docket OPPT-2010-0994 20 November 2011

4.3 Export Notification Cost 

Under TSCA Section 12(b), exporters must notify EPA if they intend to export chemicals subject to 

SNURs, as described in Section 3.2.8. The Agency burden and cost due to TSCA §12(b) export 

notification result from three tasks. In the first task, EPA receives export notifications from companies 

that intend to export one of the chemicals subject to TSCA §12(b) (EPA, 2009b). In the second task, 

EPA staff prepares separate notification letters that are subsequently reviewed and delivered to importing 

countries, their embassies, or representatives, and to the importing country’s US embassies (EPA, 2009b). 

(See Table 7 for the cost of mailing one notification). The third task is comprised of EPA staff responses 

to public inquiries and other TSCA 12(b) activities. The work of responding to non-routine requests for 

information and clarification from industry and importing countries, and of handling other tasks 

associated with the TSCA §12(b) program, was estimated to require roughly 400 hours per year (EPA, 

2009b). Since the current rulemaking covers only a very small percent of the chemicals subject to TSCA 

12(b) reporting, a very small percent of such activity will be attributable to the current rulemaking.

Because it is unknown how many, if any, notifications EPA will receive or send as a result of the current 

rulemaking, the costs to the Agency are presented per activity. The burden for the first two Agency 

activities is provided in Table 13. To estimate the Agency cost, hourly burdens are multiplied by the 

loaded wage rate of a GS-13, Step 5, which is derived in Table 13.

Table 13: TSCA 12(b) Export Notification Cost: Agency Burden per Activity (2010$)

Agency Activity

Hours 

per 

Activity

FTE per 

Activity1

Loaded Mailing 

Cost

Total Agency Cost 

per Activity GS-13, Step 5 

FTE Wage Rate

(a) (b) = (a)/2,080 (c) (d) (e) = ((b)*(c))+(d)

Process an incoming 

notification from an 

exporting company

0.1 0.000048 $161,446 $0.00 $7.75 

Prepare and mail a 

notification to an importing 

country

0.5 0.00024 $161,446 $13.34 $52.09 

Notes:

1

Source: Appendix A of this report derives Agency labor costs. Mailing costs are from 

The burden associated with an Agency activity is the burden for the Agency to process one incoming notification, or to prepare 

and mail an outgoing notification 

Table 7 of this report. Other burdens are 

from ICR No.: 0795.13 [Information Collection Request for] Notification of Chemical Exports - TSCA Section 12(b) Supporting 

Statement for Request for OMB Review under the Paperwork Reduction Act (EPA 2009b), updated for inflation.
Economic Analysis for SNUR, Docket OPPT-2010-0994 21 November 2011

5 Benefits

A SNUN submission provides EPA with the opportunity to evaluate the intended use and, if necessary, to 

prohibit or limit that activity before it occurs. It allows the Agency to take immediate action to mitigate 

an activity that the Agency deems harmful to the environment or human health. The proposed SNUR 

allows EPA to evaluate the use of, or exposure to the microbe and allow the Agency to take preventive 

action to limit or prohibit any Significant New Use. EPA believes this action is necessary because EPA 

has identified concerns for opportunistic infections to immune compromised persons from exposures to 

large quantities of the MCAN substance. For the uses described in the MCAN, human and environmental 

exposures are minimal based on adequate containment and inactivation controls listed in the notice. 

However, EPA has determined that use of the substance without adequate containment and inactivation 

controls may cause serious health effects. EPA expects that the proposed rule may restrict future uses or 

exposure to the microbe, as a company may choose modify planned uses, and general population or 

worker exposure to the microbe in such a way that does not trigger a SNUR, as opposed to submitting a 

SNUN. Therefore, the proposed SNUR may limit future exposure to the microbe.
Economic Analysis for SNUR, Docket OPPT-2010-0994 22 November 2011

6 Additional Analyses

6.1 Regulatory Flexibility Act 

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 1,000 chemicals, the Agency receives only a handful of notices per year. For 

example, the number of SNUNs was 4 in Federal fiscal year 2005, 8 in FY2006, 6 in FY2007, 8 in 

FY2008, and seven in FY2009.11 During this five-year period, three small entities submitted a SNUN, 

considering the criteria for ‘small business’ to be that the company checked the box on the PMN form, 

page 2, stating that it was a small business for the purpose of paying the $100 fee instead of the normal 

fee.

12,13

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 such small businesses affected by the current rule.

Based on past 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.

Small businesses may be affected by this proposed SNUR 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 (approximately $55.06) and/or of 

changing workplace practices to comply with any new restrictions. If modifying practices would be 

overly costly, the small business may instead forego production, thus sacrificing profits. The lost profits, 

if any, were not quantified for this report.

6.2 Unfunded Mandates Reform Act (UMRA)

The proposed rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise 

have any effect on small governments because none of the current producers of the microbe are 

governments. Additionally, it is not expected that any governments will initiate production of the microbe.

6.3 Paperwork Reduction Act (PRA)

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 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 OMB 

approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB 

control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing 

in the Federal Register, are listed in 40 CFR, part 9, and included on the related collection instrument, or 

 11 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and Toxics, to Tulika Narayan and Kimberly 

Wilson, Abt Associates. The counts include both “valid” and “invalid” SNUNs. SNUN numbering is according to Federal fiscal 

year, ending September 30. 

12 February 5, 2009 email from Carol Rawie, EPA Office of Pollution Prevention and Toxics to Tulika Narayan and Kimberly 

Wilson, Abt Associates.

13 In order to submit SNUN as a “small business” a company needs to be classified as small using the TSCA based definition of 

annual revenue of less than $4,000,000 per year. This definition is not consistent with the definition of a small business using 

Small Business Administration (SBA) NAICs based definitions.
Economic Analysis for SNUR, Docket OPPT-2010-0994 23 November 2011

form, if applicable. The information collection requirements related to this action have already been 

approved by OMB pursuant to the PRA under OMB control number 2010–0994.

This action does not impose any burden requiring additional OMB approval. If an entity were to submit a 

SNUN to the Agency, the annual burden is estimated to average 97.66 hours per response: 0.82 hours for 

rule familiarization (Section 3.2.1), 2.80 hours for CDX registration, CDX electronic signature, and 

pay.gov account setup (Section 3.2.2), 91.68 hours for form completion, submission and recordkeeping 

(Sections 3.2.3), 1 hour for consumer notifications (Section 3.2.6) and 1.36 hours for export notification 

(Section 3.2.8).

6.4 Executive Order 13132, Federalism

Executive Order 13132, entitled 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.” Policies that have federalism 

implications are defined in the Executive Order to include regulations that have “substantial direct effects 

on the 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” (64 FR 43255, August 10, 1999).

The proposed rule establishes reporting and recordkeeping requirements that apply to manufacturers 

(including importers) and processors of a certain genetically engineered microbe. EPA has no 

information to indicate that any state or local government manufactures or processes the microbe covered 

by this action.

6.5 Executive Order 12898, Environmental Justice

Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and 

Low Income Populations” (59 FR 7629, February 16, 1994), establishes federal executive policy on 

environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and 

permitted by law, to make environmental justice part of their mission by identifying and addressing, as 

appropriate, disproportionately high and adverse human health or environmental effects of their programs, 

policies, and activities on minority populations and low-income populations in the United States.

The information collected under this proposed rule, if finalized, will assist EPA and others in determining 

the potential hazards and risks associated with a genetically engineered microorganism. Although not 

directly impacting environmental justice-related concerns, this information will enable the Agency to 

better protect human health and the environment, including in low-income and minority communities.

6.6 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 this SNUR will be less than $100 million and 

therefore no analysis of such impacts on children is required.

6.7 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 EPA has no 
Economic Analysis for SNUR, Docket OPPT-2010-0994 24 November 2011

information to indicate that any tribal government manufactures or processes the microbe covered by 

this action.

6.8 Executive Order 13211, Energy Supply, Distribution, or Use

Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy 

Supply, Distribution, or Use (66 FR 28355 [May 22, 2001]) requires Agencies to prepare a Statement of 

Energy Effects for any action that is likely to have a significant adverse effect on the supply, distribution, 

or use of energy.

The Agency expects that if there is any effect of this rule on the Nation’s energy supply, distribution, 

and use, it would be modest and not significant. Firms that wish to use the T. reesei organism for 

ethanol production may either follow the containment and inactivation procedures outlined in MCAN 

J-10-02 or incur the modest cost of submitting a SNUN. A firm may also choose to use another 

organism that is not subject to the proposed SNUR. Therefore, it is highly unlikely that the proposed 

SNUR will inhibit the production of ethanol in any significant way.
Economic Analysis for SNUR, Docket OPPT-2010-0994 25 November 2011

7 References

40 CFR 721 Toxic Substances Control Act, Significant New Uses for Chemical Substances Code of 

Federal Regulations. Part 721 Title 40, July 27, 1988, as amended, June 23, 1993.

BLS, 2006a. U.S. Bureau of Labor Statistics, Employer Costs for Employee Compensation: Changes to 

NAICS and SOC, Table 2. ECEC Occupational Comparability between SOC and OCS. Downloaded 

February 2006 from http://www.bls.gov/ncs/ect/sp/ecsm0003.htm.

BLS, 2006b. U.S. Bureau of Labor Statistics, Employment Cost Index News Release Text: Employment 

Cost Index, March 2006 (April 28, 2006), at http://www.bls.gov.

BLS, 2006c. U.S. Bureau of Labor Statistics. Change has Come to the ECI (June 14, 2006) at 

http://www.bls.gov/ncs/ect/sp/ecsm0001.htm.

BLS, 2011a. U.S. Bureau of Labor Statistics. “Employer Costs for Employee Compensation 

Supplementary Tables December 2010.” Accessed March 9, 2011. 

http://www.bls.gov/ncs/ect/sp/ecsuptc17.pdf . (Note: The BLS report title and content is updated 

periodically to include more recent data, on the same website.)

BLS, 2011b. Bureau of Labor Statistics. Employment Cost Index – Total Compensation: Professional and 

Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted 

June 16, 2011. http:/data.bls.gov/cgi-bin/srgate.

BLS, 2011c. U.S. Bureau of Labor Statistics. Consumer Price Index- All Urban Consumers, U.S. City 

Average (Series ID: CUUR0000SA0), extracted June 16, 2011. Available through 

http:/data.bls.gov/cgi-bin/srgate.

Branch, 2006. Raphael E. Branch and Lowell Mason. U.S. Bureau of Labor Statistics, “Seasonal 

adjustment in the ECI and the conversion to NAICS and SOC.” Monthly Labor Review. Vol. 129, 

No. 4, April 2006. Available at www.bls.gov

Caroll, 2006. Richard E. Caroll. U.S. Bureau of Labor Statistics, “Changes affecting the Employment 

Cost Index: an overview.” Monthly Labor Review. Vol. 129, No. 4, April 2006. Available at 

www.bls.gov.

.

EPA, 1992. U.S. EPA, Office of Policy, Planning, and Evaluation. Instructions for Preparing Information 

Collection Requests (ICRs). Washington, DC, June 1, 1992.

EPA, 1994. U. S. EPA, Office of Toxic Substances, Regulatory Impacts Branch. Regulatory Impact 

Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications. 

Washington, DC, September 9, 1994. (OTS/RIB later became OPPT/EPAB.)EPA, 1997. Office of 

Toxic Substances Regulatory Impact Analysis for the Regulation of Microbial Products of 

Biotechnology. January 21, 1997.

EPA, 2000. U.S. EPA, Office of Pollution Prevention and Toxics, ICR No. 1139.06. OMB Control No.: 

2070-0033 [Information Collection Request for] TSCA Existing Chemical Test Rules, Consent 

Orders, Test Rule Exemptions, and Voluntary Test Data Submissions: Supporting Statement for 

Request for OMB Review under the Paperwork Reduction Act. Attachment 5, Wage Rates Estimation, 

August 29, 2000.

EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. 

Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC. 

August 2002.
Economic Analysis for SNUR, Docket OPPT-2010-0994 26 November 2011

EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis

Branch, Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, 

DC: June 10, 2002.

EPA, 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.

EPA, 2005a. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Economic 

Analysis of the Proposed Change to TSCA Section 12(b) Export Notification Requirements, November 

2005, available from the Federal Docket Management System as EPA-HQ-OPPT-2005-005 8-0017 at 

http://www.regulations.gov.

EPA, 2005b. U.S. EPA, Office of Pollution Prevention and Toxics ICR No. 118.08. [Information 

Collection Request for] TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals 

(Renewal). Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act, 

October 11, 2005.

EPA, 2007a. U.S. EPA, Office of Pollution Prevention and Toxics, EPA ICR No. 0574.14. OMB Control 

No.: 2070-0014 [Information Collection Request for] Pre-Manufacture Review Reporting and 

Exemption Requirements for New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances: Supporting Statement for a Request for OMB Review under the 

Paperwork Reduction Act, December 6, 2007.

EPA, 2007b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. 

Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances (EPA Docket 

OPPT-2003-0063), December 4, 2006 (Revised March 12, 2007).

EPA, 2007c. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. 

Economic Analysis of Expedited Significant New Use Rules for 38 Chemical Substances (EPA Docket 

OPPT-2006-0898), August 17, 2007.

EPA, 2009a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis 

Branch. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule. 

(EPA-HQ-OPPT-2008-0296). July 13, 2009.

EPA, 2009b. U.S. EPA, Office of Pollution Prevention and Toxics. EPA ICR No.: 0795.13 OMB Control 

Number 2070-0030 [Information Collection Request for] Notification of Chemical Exports - TSCA 

Section 12(b) Supporting Statement for Request for OMB Review under the Paperwork Reduction 

Act. March 6, 2009 at http://www.regulations.gov.

EPA, 2009c, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics. 2009. 

Section 13 Import Certification. Available at: http://www.epa.gov/opptintr/importexport/pubs/sec13.html. Accessed March 30, 2010.

EPA, 2010. U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics. Economic 

Analysis of Expedited Significant New Use Rules for 25 Chemical Substances, (EPA Docket OPPT2009-0922).

OPM, 2010. Office of Personnel Management, Salary Table 2010-DCB, Washington BaltimoreNorthern 

Virginia, DC-MD-PA-VA-WV. Accessed from http://www.opm.gov/oca/10tables/pdf/DCB.pdf.

Sleemi, 2006. Fehimida Sleemi. U.S. Bureau of Labor Statistics, “Employment Cost Index Publication 

Plans”. Monthly Labor Review. Vol. 129, No. 4, April 2006. available at 

www.bls.gov/opub/mlr/2006/04/art2full.pdf.
Economic Analysis for SNUR, Docket OPPT-2010-0994 27 November 2011

U.S. Postal Service (U.S. PS). 2010. “Prices” <http://www.usps.com/prices/>. Accessed 2010.

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 http://www.bls.gov/opub/cwc/cm20040823ar01p1.htm.
Economic Analysis for SNUR, Docket OPPT-2010-0994 28 November 2011

Appendix A: Inflators and Wage Rates 

This appendix describes the derivation of the fully loaded labor rates and inflation factors used in 

calculating costs of labor, materials, and other inputs. Costs for this report are for year-end 2010.

A.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 (EPA, 2002b). The resulting loaded labor rates are given in Table 14. Costs 

are calculated for several labor categories: Managerial, Professional/Technical, Clerical, 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).

A.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,14

for December, for manufacturing industries.15

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 2010, the average wage rate for professional/technical16

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 

labor was 

$36.93; the average fringe benefit was $18.50. Fringe benefits as a percent of wages were $18.50/$36.93, 

or approximately 50.1 percent.

 14 This follows the approach introduced in Economic Analysis of Expedited Significant New Use Rules for 65 Chemical 

Substances: EPA Docket OPPT-2003-0063 (EPAB, 2007a). 15 Employer Costs for Employee Compensation Supplementary Tables December 2010. (BLS, 2011a). This follows the 

approach introduced in EPAB, 2007a. Earlier PMN SNUR economic analyses, such as EPA, 2003, used ECEC data for “All 

Goods Producing” sectors (manufacturing, mining, and construction). However, the manufacturing sector data seem more 

relevant since the SNURs mainly affect the chemicals industry. 16 This follows terminology introduced in EPAB, 2007a. Earlier SNUR economic analyses 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).
Economic Analysis for SNUR, Docket OPPT-2010-0994 29 November 2011

rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), 

and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). 

This overhead loading factor is added to the benefits loading factor, and the total is then applied to the 

base wage to derive the fully loaded wage. For example, the December 2010 fully loaded wage for 

professional/technical labor is $36.93 × (1+0.5009 + 0.17) = $61.71.

Fully loaded costs for managerial, clerical, and production labor are calculated in a similar manner, as 

shown in Table 14.

A.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 2010 (OPM, 2010). The average 

salary for one FTE staff member is estimated as the salary for a GS-13 Step 5 employee.17

Multiplying the annual pay by an assumed loading factor of 1.6 to reflect Federal fringe benefits and 

overhead, the loaded annual salary of EPA staff was calculated to be $161,446.

The Agency loading factor is from an EPA guide, Instructions for Preparing Information Collection 

Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled “the benefits 

multiplication factor” in the EPA Guide, but has been used in many EPA Office of Pollution Prevention 

and Toxics ICRs to reflect both fringe benefits and overhead for Federal staff. For example, it was used 

in an August 2000 document supporting ICR No. 1139.06 (EPA, 2000), with the following explanation:

“The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits 

multiplication factor). The multiplication factor used is recommended in EPA’s Office of Policy, 

Planning, and Evaluation’s Instructions for Preparing Information Collection Requests (ICRs)

(June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl 

Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits 

but also overhead.” (ICR No.1139.06)

 17 The GS-13 Step 5 is consistent with ICR No. 0574.14 (12/18/2007), which covers PMN SNURs. Use of this grade level 

follows the approach introduced in EPAB, 2007a. That report represented a change from the earlier PMN SNUR economic

analysis (EPA, 2003), which used an average of GS-12 Step 1 and GS-12 Step 10 salaries.
Economic Analysis for SNUR, Docket OPPT-2010-0994 30 November 2011

Table 14: Derivation of Loaded Wage Rates

EPAB Labor 

Category Data Sources Date Wage Fringe 

Benefit

Fringes as 

% Wage

Overhead % 

Wage2

Fringe + 

Overhead 

Factor

Loaded Wages1

(a) (b) (c) =(b)/(a) (d) (e)=(c)+(d)+1 (f)=(a) x (e)

Managerial

BLS ECEC, Private Manufacturing 

industries, “Mgt, Business, and 

Financial”

Dec-10 3

$42.82 $19.64 45.87% 17% 1.63 $69.74

Professional/

Technical

BLS ECEC, Private Manufacturing 

industries, “Professional and 

related“

Dec-10 3

$36.93 $18.50 50.09% 17% 1.67 $61.71

Clerical

BLS ECEC, Private Manufacturing 

industries, “Office and 

Administrative Support”

Dec-10 3

$17.36 $8.67 49.94% 17% 1.67 $28.98

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.

Jan-10

4

$100,904

(annual) --

[Included in 

60% 

overhead]

60% 1.6 $161,446.40

(annual)

Notes:

1

Wage data are rounded to the closest penny in this table; however, in calculations using these numbers for this report, unrounded values were used. 2

An overhead rate of 17% was used based on assumptions in Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), and the Revised Economic Analysis 

for the Amended Inventory Update Rule: Final Report (EPA, 2002a). 3

Employer Costs for Employee Compensation Supplementary Tables December 2010, US Bureau of Labor Statistics, March 9, 2011 (BLS, 2011a). 43

The Federal salary is the unloaded Federal GS-13 Step 5 salary ($100,904) for 2010, from the Office of Personnel Management salary table for Washington-Baltimore-Northern Virginia 

(OPM, 2010). The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9).
Economic Analysis for SNUR, Docket OPPT-2010-0994 31 November 2011

A.2 Derivation of Inflation Factors

Complete information on the derivation of the inflation factors used is given in Table 15. In 2006, the 

Bureau of Labor Statistics (BLS) made several changes to the Employment Cost Index. The changes are 

described on a BLS web page, “Change has come to the ECI,” (BLS, 2006c) and in several April 2006 

Monthly Labor Review articles posted on the BLS web site: “Changes affecting the Employment Cost 

Index: an overview” (Caroll, 2006); “Employment Cost Index Publication Plans” (Sleemi, 2006); and 

“Seasonal adjustment in the ECI and the conversion to NAICS and SOC” (Branch, 2006).

Under a mandate from OMB, BLS changed its classification of industries and occupations from the 

Standard Industrial Classification (SIC) and Occupational Classification System (OCS) to the North 

American Industry Classification System (NAICS) and Standard Occupational Classification (SOC) 

system. In 2006, BLS adjusted all ECI series to reflect this change.

In addition to changing the industry and occupational classification systems, in 2006, BLS rebased the 

ECI from June 1989 = 100 to December 2005 = 100 for all current and historical non-seasonally adjusted 

series, including the NAICS and SIC based series. (Seasonally adjusted indices, including those in Table 

15 of this report, may not exactly equal 100 for December 2005 as a result of the seasonal adjustment. 

Seasonal adjustments are explained in Branch, 2006.)

According to BLS, the official ECI for the years 1975-2005 is the SIC-OCS based series, and for 

subsequent years, the official ECI is the NAICS-SOC based series (Sleemi, 2006, p.8).18

“Starting year” indices in Table 15 continue to be SIC-OCS based. Current year indices are NAICS-SOC 

based. We use indices from both the NAICS-SOC and the SIC-OCS based ECI series because neither 

series spans the entire period over which testing and other costs need to be inflated.

 18 BLS has been publishing the NIACS-SOC based ECI series since March 2001 and it became official in March 2006. The SICOCS based series and NAICS-SOC series have different series ID numbers, even when they describe essentially the same 

population. For example the series ID for seasonally adjusted total compensation for all private industry workers is 

ECS10002I for the SIC-OCS series and CIS2010000000000I for the NAICS-SOC series. 
Economic Analysis for SNUR, Docket OPPT-2010-0994 32 November 2011

Table 15: Derivation of Inflation Factors

Item Inflation Index Source1 Starting 

Year

Index for 

Starting Year 

(a)

Index for 

2009

(b)

Inflation 

Factor 

(b)/(a)2

Export notification

BLS ECI, ,Total comp, Private 

industry, Professional and 

related, 4th Q [BLS, 2011b ]

1992 364.9 113.5 1.749

Agency Extramural costs 

White collar labor; 

equipment; supplies

BLS ECI, Total comp, Private 

industry, Professional and 

related, 4th Q [BLS, 2011b]

1993

3

67 113.5 1.694

Labels, placards etc. BLS CPI, All urban consumers, 

not SA. CUUR0000SA0, Annual 

[BLS, 2011c]

1997 160.5 218.056 1.359

File cabinet

Photocopies BLS CPI, All urban consumers, 

not SA. CUUR0000SA0, Annual 

[BLS, 201lc]

Record keeping materials 1988 118.3 218.056 1.843

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. 

Notes:

1 

“Starting year” ECI indices are SIC-OCS based: Seasonally Adjusted (SA) ECS10002I for private industry All Workers, and not SA 

ECU11122I for private industry Professional and Related Workers. 

In 2006, Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series “were rebased to December 2005 = 100 from June 

1989 = 100.” The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index News 

Release Text: Employment Cost Index, March 2006 (BLS, 2006b). The Consumer Price Index (CPI) was not rebased. 

After 2006, ECI indices are NAICS-SOC based: Seasonally Adjusted (SA) CIS2010000000000I for private industry All Workers, and

not SA CIU2010000120000I (B) for private industry Professional, and Related workers. 2

Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values. BLS CPI 

values were published with one decimal place through 2006 and with three decimal places after that.

3 Beginning with the report Economic Analysis of Expedited Significant New Use Rules for 25 Chemical Substances: EPA Docket 

OPPT-2009-0922 (EPA, 2010) we began to use the not-seasonally adjusted CIU2010000120000I for private industry Professional, and 

Related workers, instead of SA CIS2010000W00000I for private industry white collar workers because BLS retired the “white-collar” 

series.