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Supporting Statement for a Request for OMB Review under

the Paperwork Reduction Act

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title and Number of the Information Collection

Title: TSCA Section 5(a)(2) Significant New Use Rules for Existing 

Chemicals

EPA ICR No.: 1188.12 OMB Control No.: 2070-0038

1(b) Short Characterization

Section 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2604 (see Attachment 

1), 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 notice to EPA at least 

90 days before they manufacture, import or process the substance for that use. Regulations 

implementing significant new uses appear at 40 CFR part 721 (see Attachment 2).

Once EPA receives a significant new use rule (SNUR) notice, EPA may take regulatory

action under TSCA sections 5(e), 5(f), 6 or 7 to control the activities for which it has received a 

SNUR notice. If EPA does not take action, TSCA section 5(g) requires EPA to explain in the 

Federal Register its reasons for not taking action.

Persons who intend to export a substance identified in a proposed or final SNUR are 

subject to the export notification provisions of TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 40 CFR part 707.

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need/Authority for the Collection

TSCA section 5(a)(2) provides the Office of Pollution Prevention and Toxics (OPPT) 

with the authority to monitor and control significant new uses of existing chemical substances. 

The factors considered by the Administrator in determining a significant new use are:

1) The projected volume of manufacturing and processing of a chemical substance;

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

or the environment to a chemical substance;

3) The extent to which a use increases the magnitude and duration of exposure of 

human beings or the environment to a chemical substance; and
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4) The reasonably anticipated manner and methods of manufacturing, processing, 

distribution in commerce, and disposal of a chemical substance.

Once the Administrator makes such a designation, the Agency proposes a Significant 

New Use Rule (SNUR). If a final rule is promulgated, a person who intends to engage in a 

significant new use of a chemical covered by a SNUR must notify EPA of his/her intentions. 

This notification, made via the Significant New Use Notice (SNUN), must occur at least 90 days 

prior to commencing the new use of the identified substance. The required notice must be 

submitted electronically, via the Central Data Exchange (CDX), using the Agency’s e-PMN 

software. The PMN form provides data on the identity and use of, and possible exposures to, the 

chemical substance. In addition, the PMN form provides test data plus descriptions of health and 

environmental effects data based on the manufacture, processing, use, distribution in commerce, 

and disposal of the chemical.

The Agency has 90 days to evaluate a SNUN once it has been received. This evaluation 

focuses on the health and environmental effects of the substance’s significant new use. Should 

EPA find cause for concern, the Agency can take regulatory action as per TSCA sections 5(e) 

and 5(f)1. Likewise, the Agency may extend the evaluation period by up to 90 days with good 

cause. If EPA takes no action at the end of the review period, the submitter can engage in the 

intended new use without any restrictions.

2(b) Practical Utility/Users of the Data

EPA uses this information to evaluate the health and environmental effects of the 

significant new use. During the evaluation period EPA can take further regulatory action 

pursuant to TSCA sections 5(e) and 5(f). Under TSCA section 5(e), the Administrator may issue 

an order to prohibit or limit the manufacture, import, processing, distribution in commerce, use, 

or disposal of such substance. TSCA section 5(f) allows the Administrator to, among other 

things, prohibit or limit the manufacture of the chemical substance, if the substance presents or 

will present an unreasonable risk of injury to health or the environment.

To date EPA has promulgated SNURs on 388 existing chemicals. Presented in 

Attachment 5 are selected case history abstracts for some of these substances. These abstracts 

highlight the needs of a particular office and the facts surrounding a substance. This information 

when applied to the Regulatory Selection Criteria has resulted in final SNURs.

 

 

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TSCA section 5(e) allows the Administrator to prohibit or limit the manufacture, import, processing, distribution in 

commerce, use, or disposal of the substance when the substance may present an unreasonable risk. TSCA section 5(f) allows the 

Administrator to use a TSCA section 6 regulation to prohibit or limit the manufacture of the substance when the substance will

present an unreasonable risk.
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3. NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION 

CRITERIA

3(a) Non-Duplication

EPA is the only federal agency that collects information on significant new uses of 

chemical substances. A notification of an intent to engage in a significant new use serves two 

functions: as a notice, and as a document that contains information about a chemical substance 

and potential exposures to that substance. The notification element is unique to SNURs and 

therefore not obtainable elsewhere. The chemical information aspect will also contain unique 

information. Only the person who intends to commence a significant new use of a chemical 

substance will know the potential for human and environmental exposures to that substance, the 

quantity intended to be produced, imported, or processed, and the manner in which the person 

will engage in the significant new use.

A person submitting a significant new use notice is not required to develop test data. 

However, the person must submit data that are known to or reasonably ascertainable by that 

person. For published data the submitter need only provide a literature citation (40 CFR 

720.50(d)(3)(ii)). For existing chemicals that are related to the chemical substance that is the 

subject of the SNUR (e.g., impurities, byproducts), neither the published data nor a literature 

citation need be submitted. Also, notices need not include information previously submitted to 

EPA (unless the previously submitted information was claimed confidential, in which case it 

must be resubmitted).

3(b) Public Notice Required Prior to ICR Submission to OMB

In proposing to renew this ICR, EPA provided a 60-day public notice and comment 

period that ended on June 8, 2012 (77 FR 21096, April 9, 2012). EPA received no comments 

during the comment period.

3(c) Consultations

Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential 

ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB 

for review and approval. In accordance with this regulation, EPA submitted questions to nine

parties via email. The individuals contacted were:

Mike Walls, Director

Regulatory and Technical Affairs

American Chemistry Council, Inc.

1300 Wilson Boulevard

Arlington, Virginia 22209

Tel: (703) 741-5167

Fax: (703) 741-6000

E-mail: mike_walls@americanchemistry.com 
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Jim Ford, Director, Federal Government Affairs

American Petroleum Institute

1220 L Street, NW

Washington, D.C. 20005

Tel: (202) 682-8210 

Fax: (202) 682-8031

E-mail: fordj@api.org

Brigid Klein, General Counsel

Consumer Specialty Products Association

900 17th Street, NW, Suite 300

Washington, D.C. 20006

Tel: (202) 833-7309

Fax: (202) 872-8114

E-mail: bklein@cspa.org

John Carroll, Chair, Enzyme Technical Association 

Director, Regulatory Affairs

Novozymes North America, Inc.

77 Perry Chapel Church Road

P.O. Box 576

Franklinton, NC 27525

Tel.: (919)494-3150

Fax: (919)494-3420

E-mail: john@novozymes.com

Lee O. Fuller, Vice President of Government Relations

Independent Petroleum Association of America

1201 15th Street, N.W., Suite 300

Washington, D.C. 20005

Tel: (202) 857-4722

Fax: (202) 857-4799

E-mail: lfuller@ipaa.org

Stephen R. Sides, Vice President, EHIA

National Paint and Coatings Association

1500 Rhode Island Avenue, NW

Washington, D.C. 20005-5597

Tel: (202) 462-6272 

Fax: (202) 462-8549

E-mail: ssides@paint.org

Jim Cooper, Director, Petrochemical

National Petrochemical & Refiners Association

1899 L Street, N.W.

Suite 1000
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Washington, D.C. 20036-3896

Phone: (202) 552-8450

Email: jcooper@npra.org

William Carteaux, President

Society of the Plastics Industry, Inc.

1667 K Street, N.W. 

Washington, DC 20006

Tel: (202) 974-5200

Fax: (202) 293-0309

E-mail: wcarteaux@plasticsindustry.org

Bill Allmond, Director, Government Relations

Synthetic Organic Chemical Manufacturers Association

1850 M Street, N.W., Suite 700

Washington, D.C. 20036-5810

Tel.: (202)721-4122

Fax: (202)296-8548

E-mail: allmondb@socma.org

EPA received no responses to its solicitation for consultations. A copy of EPA’s 

consultation e-mail to the above potential respondents is included in Attachment 6.

3(d) Effects of Less Frequent Collection

Whenever a person intends to engage in a significant new use, they must notify EPA. 

This is an explicit requirement of TSCA. TSCA section 5(a)(1)(B) states, “... no person may ... 

manufacture or process any chemical substance for a use which the Administrator has 

determined ... is a significant new use ... unless such person submits to the Administrator ... a 

notice ...” The consequence of less frequent collection of information (i.e., requiring only the 

first person who intends to engage in a significant new use to submit notice) is a violation of 

TSCA and would allow manufacturers, importers and processors to use a substance in a manner 

that EPA has determined may cause significant adverse exposures to the substance without prior 

notification to EPA.

3(e) General Guidelines

This information collection activity is necessary to implement the statutory requirements 

of TSCA section 5(a)(2) and is consistent with the requirements of 5 CFR 1320.6.

EPA has developed e-PMN software for use in preparing and submitting PMNs and other 

TSCA section 5 notices such as SNUNS, and support documents electronically to the Agency via 

(CDX). EPA’s CDX is the point of entry on the Environmental Information Exchange Network 

(Exchange Network) for environmental data submissions to the Agency. CDX provides the 

capability for submitters to access their data through the use of web services. CDX enables EPA 

and participating program offices to work with stakeholders–including State, tribal, and local 
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governments and regulated industries–to enable streamlined electronic submission of data via the 

Internet. For more information about CDX, go to http://www.epa.gov/cdx. The use of CDX for 

submission of TSCA section 5 notices and support documents is consistent with the Government 

Paperwork Elimination and Reduction Act (GPERA) that requires Federal agencies to provide 

electronic submission, maintenance, or disclosure of information, when practicable as a 

substitute for paper.

 The e-PMN software and electronic submission via CDX changes the way that 

companies interact with the Agency regarding many TSCA section 5 submissions including 

SNUNS. Companies register with EPA to submit their data electronically to the Agency via 

CDX and the Agency benefits from receiving electronic submissions. Data systems that once 

were populated manually are now populated electronically, reducing the potential for error that 

exists when data are entered by hand. Agency personnel are able to communicate more 

efficiently with submitters electronically compared to using U.S. mail or courier services. 

PMN/SNUN electronic reporting software allows for more efficient data transmittal, and the 

software’s validation mechanism should help industry users submit fewer incomplete notices, 

which ultimately will save EPA and industry processing resources and reduce transaction times. 

EPA believes the adoption of electronic communications reduces the reporting burden on 

industry by reducing both the cost and the time required to review, edit, and transmit data to the 

Agency. It also allows submitters to share a draft notice within the company during the creation 

of a notice and to save a copy of the final file for future use.

3(f) Confidentiality

Information provided in a significant new use notice may receive confidential treatment. 

TSCA section 14 allows a manufacturer, importer or processor to designate submitted 

information as confidential business information (CBI). The Agency has developed a 

comprehensive system to prevent the unauthorized disclosure of CBI. This system includes 

procedures for logging CBI in and out of designated locked file cabinets, for photocopying and 

transmitting CBI, and for restricting confidential information only to personnel with CBI security

clearance. No one is allowed access to CBI until they have received instructions for handling 

CBI.

EPA will ensure secure transmission of SNUN data submitted through CDX via the 

Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 is a widely used approach for securing 

Internet transactions, and is endorsed by the National Institute of Standards and Technology

(NIST) for protecting data sent over the Internet. See NIST Special Publication 800–52, 

‘‘Guidelines for the Selection and Use of Transport Layer Security (TLS) Implementations,’’

http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf. In addition, e-PMN software 

enables the SNUN submitter to electronically sign, encrypt, and submit reports which EPA 

subsequently provides back to the submitter as an unaltered copy of record. This assures the 

submitter that the Agency has received exactly what the submitter sent to EPA. The current 

version of the e-PMN encrypts using Federal Information Processing Standards (FIPS)-validated 

RSA BSAFE Crypto-J. EPA may incorporate other encryption modules into future versions of ePMN. Information submitted via CDX is processed within EPA by secure systems certified for 

compliance with FIPS.
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Additionally, special procedures also restrict access to computerized CBI. These security

measures apply to CBI submitted by manufacturers as well as CBI generated by EPA staff in the 

course of their review. 

3(g) Sensitive Questions

This section is not applicable. The information requested is not sensitive in nature.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondent NAICS Codes

Respondents affected by this collection activity are mainly NAICS categories 325 -

Chemicals and Allied Products Manufacturers and 32411- Petroleum Refining.

4(b) Information Requested

(i) Data items, including record keeping requirements

Information submitted under this collection must include, insofar as it is known to or 

reasonably ascertainable by the submitter, information described in TSCA section 8(a)(2) (i.e., 

chemical identity, use, and exposure data), as well as test data, and descriptions of other data 

related to the effects on health and the environment of the manufacture, processing, use, 

distribution in commerce, and disposal of the chemical substance (TSCA section 5(d)). After a 

notice has been received, EPA has 90 days (extendable to 180 days) to evaluate the notice’s 

content.

(ii) Respondent Activities

 Only those persons who intend to engage in a significant new use of a chemical substance 

must submit notice of their intentions to EPA. According to 40 CFR 721.1(c), persons 

submitting a SNUN must comply with the same notice requirements and EPA regulatory

procedures as persons submitting a PMN, including submission of test data on health and 

environmental effects as described in 720.50. SNUNs must be on EPA Form No. 7710–25, 

generated using e-PMN software, and submitted to the Agency in accordance with the 

procedures set forth in 721.25 and 720.40. E-PMN software is available electronically at 

http://www.epa.gov/opptintr/newchems.
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5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

A significant new use rule (SNUR) on an existing chemical substance is the product of a 

process that is designed to develop the appropriate information-gathering collection for a 

substance. This process has three major steps: Chemical Referral, Regulatory Selection, and 

Regulation Development.

Step 1. Chemical Referral: EPA offices that have identified information-gathering or 

follow-up monitoring needs for a particular chemical may refer the substance to OPPT. A 

systematic process has been developed for receiving and handling chemical referrals. Offices 

referring substances are asked to prepare concise summaries of relevant data. This information 

is used to select a regulatory approach and for rulemaking activities.

Step 2. The Regulatory Selection Process - Referral and Review: Once an office has 

detailed its need for information, an information collection approach is determined that best 

satisfies that office’s needs. The rulemaking options are: a TSCA section 8(a) reporting rule, a 

TSCA section 8(c) call-in, a TSCA section 8(d) health and safety data reporting rule, a TSCA 

section 5(a)(2) SNUR, or any combination of the above. It may also be determined that an 

alternative approach is more appropriate (e.g., use of existing data sources, no data-gathering at 

the present time, TSCA section 4 or 6 action, or referral to another office for informationgathering under a different statutory authority).

Step 3. Regulatory Development: Prior to the development of a rule, the recommended 

rulemaking approach must be reviewed by the referring office and approved by the Office 

Director of OPPT. If the recommendation is approved, then the rulemaking process begins.

A SNUR is drafted only if it is an appropriate approach for a particular substance that has 

received approval prior to the development of the rule. The proposal then undergoes intraagency review, OMB review and public comment. Once a decision has been made to 

promulgate an information collection rule, the next decision is to determine whether a TSCA 

section 8(a) rule or a TSCA section 5 SNUR is most appropriate. Attachment 5 identifies the 

selection criteria that are applied in determining whether a TSCA section 8(a) rule or SNUR is 

proposed.

5(b) Collection Methodology and Management

For the past two years, submitters have been able to generate TSCA section 5 notices, 

including SNUNs, using the e-PMN available at the EPA New Chemicals Program website 

(https://cdx.epa.gov/ssl/pmn/download.asp). The e-PMN software is available as a free internet 

download. The data being transmitted electronically via CDX is encrypted to protect CBI. The 

software works with Windows, Macs, Linux, and UNIX-based computers, using XML for more 

efficient data transmittal to Agency data systems. CDX is the mechanism for submission of 

section 5 notices to the Agency. An electronic signature will be required for TSCA section 5 
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notices submitted to the Agency via CDX. Electronic signatures are granted as part of the CDX 

user-registration process. 

The electronic submission software changes the way that companies now interact with 

the Agency with many of its submissions. EPA believes this change to electronic 

communications potentially reduces the reporting burden on industry because it reduces both the 

cost and the time required to enter, review, edit and transmit data to the Agency. The electronic 

submission software also improves data quality because it facilitates data correction and 

validation by highlighting fields with omitted data prior to submission. The protection of 

encrypted TSCA CBI data and the generation of an electronic Copy of Record that is returned to 

the submitter are other critical advantages of submitting data electronically through CDX.

Because companies will be registered with EPA to submit their data electronically to the 

Agency via CDX, the Agency in turn is be able to communicate electronically with submitters 

via CDX. Some examples of routine communications from EPA that could go through CDX 

include the Acknowledgment Letter (acknowledging receipt of a submission) and the Incomplete 

Letter (stating why a submission has been declared incomplete). Previously, these 

communications were sent through the mail. An electronic means of communication provides 

significant time and resource savings for both parties.

SNUN submitters are required to use the e-PMN software to generate section 5 notices 

and support documents. The e-PMN software includes many useful features for section 5 notice 

preparers. One feature is a built-in validation mechanism which will alert users that information, 

required by regulation, is missing or potentially incorrect. This should help reduce the number 

of incomplete section 5 notices, saving submitter and EPA processing resources and time. Also, 

the new e-PMN software allows for the creation of a sanitized non-CBI version from the 

complete section 5 notices submission containing CBI. It also allows submitters to share a draft 

notice within their company during the creation of a section 5 notice and to save a copy of the 

final file for future reference. The software allows the submitter to create a profile with his/her 

contact information, which saves the submitter time in reentering that information on subsequent 

notices.

In addition to support provided with the e-PMN software, OPPT has set up a TSCA 

Hotline that provides information regarding TSCA section 5(a)(2) reporting as well as other 

regulatory information. When Hotline staff are unable to answer questions regarding TSCA 

section 5(a)(2), the questions are referred to the OPPT Chemical Control Division (CCD) staff 

for resolution.

5(c) Small Entity Flexibility

All business, regardless of size, must comply with the requirements of TSCA section 5. 

However, OPPT has taken a number of steps intended to minimize the burden placed on small 

business. For instance, TSCA section 26(d) established an Assistance Office to provide 

technical and other nonfinancial assistance to manufacturers, importers and processors of 

chemical substances and mixtures. This office has established a toll-free hotline, performs onsite field visits and consultations, and has hired a contractor to assist small businesses, free of 
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charge, in complying with TSCA requirements.

5(d) Collection Schedule

Whenever any person intends to engage in a significant new use of a chemical substance, 

they are required to submit a notice of their intentions to EPA not less than 90 days before 

beginning to manufacture, import or process the substance for the intended use.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

This section presents estimates of the cost and burden associated with the recordkeeping 

and reporting requirements for significant new use rules for existing chemicals under TSCA 

section 5(a)(2). The methodology used to estimate the recordkeeping costs, reporting costs, and 

burden for this ICR renewal is largely based on previous experience with SNURs, and is 

consistent with the analysis presented in the supporting statement prepared for the previous ICR. 

This ICR is updated from the previous ICR (February, 2009) to account for the changes in 

burden resulting from Updated assumptions and corrections to prior analyses.

To comply with the regulation, manufacturers (including importers) must complete the 

activities listed in Table 1. Table 1 also provides a cross-walk of the related Information 

Collection that corresponds to each activity.

Table 1: Cross-Walk between Industry Activities and Related Information Collections 

(ICs)

Activity Description Related IC(s)

Chemical 

verification

When a SNUR is published, companies must review 

the rule to verify whether a chemical they manufacture 

or import is subject to the rule

Chemical Verification

Rule 

familiarization

Site staff must familiarize themselves with the 

requirements of the rule. This entails reading the rule, 

understanding the various reporting and administrative 

requirements, and determining the manner in which 

the reporting requirements will be met.

Rule Familiarization

CDX 

registration, 

electronic 

signature 

agreement, and 

Pay.gov 

account set up

Before submitting a SNUN, all respondents must 

register with CDX. In addition, respondents must 

complete an Electronic Signature Agreement form, 

which is signed, dated, and either submitted 

electronically or mailed back to EPA, and register for 

a Pay.gov account.

CDX Registration Activities

Preparation of 

reports (form 

completion 

and form 

submission)

Site staff must collect all information required for a 

SNUN and submit an electronic SNUN form. Firms 

must also keep records supporting their submissions. 

Prepare and Submit Report, 

and Maintain Records
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6(a) Estimating Respondent Burden

Number Of Significant New Use Notices Projected

During the years 2008 through 2011, EPA proposed two existing chemical SNURs under 

TSCA section 5(a)(2). This activity may increase over the next three-year period as EPA initiates 

a comprehensive approach to enhance the Agency’s existing chemicals management program.

However, EPA cannot estimate future SNUR activity with certainty.

Therefore, based on past ICRs and the best professional judgment of Agency staff, EPA is 

estimating it will promulgate an average of five existing chemical SNURs per year under TSCA 

section 5(a)(2) during the time period covered by this ICR2.

EPA may receive SNUNs as a result of SNURs. EPA’s experience is that in response to 

promulgation of well over 1,000 SNURs under both its new and existing chemicals programs, 

the Agency receives on average only 7 SNUNs per year, based on fiscal year (FY) 2001 –

FY2011 submissions. Of those SNUNs, only a fraction result from existing chemical SNURs 

promulgated under section 5(a)(2). 

 Table 2: Anticipated Number of SNURs and SNUNs

Year Anticipated Number of SNURs Anticipated Number of SNUNS

First Year 5 7

Second Year 5 7

Third Year 5 7

Three Year Totals 15 21

Using SNUN submission data from the ten year period of FY2001 through FY2011, EPA 

estimates that the average firm submits 1.65 SNUNs. This may be an overestimate because it 

was not determined whether the SNUN submissions were in response to new or existing 

chemical SNURs. The exact number of firms engaging in new uses cannot be estimated, 

however given the estimated number of SNUNs and firms submitting SNUNs, EPA estimates a 

total of 4.24 firms will be impacted annually (7 SNUNs/1.65 firms). Given the uncertainty in 

projecting possible new uses for existing chemicals, it is not possible to determine whether a 

large or small number of firms would be affected by any given SNUR.

(i) Alternative Responses

The burden associated with a SNUR could involve a number of possible industry

responses. That is, when a SNUR is promulgated, a firm seeking to engage in a new use for a 

subject chemical has five options regarding possible courses of action that may generate burden:

 

2

EPA develops SNURs for a number of reasons, some based on findings from its new chemicals program in order to bind 

manufacturers and processors of chemicals reviewed under its Premanufacture Notice (PMN) review process to certain 

requirements. However, this ICR covers only SNURs that are developed by EPA’s existing chemical program under TSCA 

section 5(a)(2), and therefore, only the SNUNs received based on those SNURs are estimated here.
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1) The company could submit a SNUN. This option would be chosen by any 

company not intending to abide by the provisions of the SNUR. 

2) In the event that a significant new use is described as the failure to establish and 

implement programs for providing for the use of specific measures to control 

worker exposure to or release of substances, a company can request an 

equivalency determination. This option would be chosen if a 

manufacturer/importer had reason to believe that there may be alternative 

methods not considered by EPA that provide equivalent or superior protection 

from worker exposure or environmental release of the subject chemical. 

3) The company can comply with the SNUR, ensuring that all provisions of the 

SNUR are implemented in connection with the planned use of the subject 

chemical. 

4) The company can request review of the SNUR for possible modification or 

revocation.

5) The company may simply decide to forgo the new use, avoiding regulatory

compliance activities altogether.

Additionally, under current regulations at 40 CFR 721.5(a)(2), all manufacturers, 

processors, and importers of chemicals subject to SNURs are subject to certain requirements 

regardless of whether they engage in a significant new use unless certain information can be 

demonstrated3. However, without prior knowledge of chemicals which would be the subject of 

future SNURs, estimating the number of potentially affected entities subject to 40 CFR 

721.5(a)(2) is not possible.

The following section estimates the cost of submitting a SNUN (option 1) and then 

discusses the other options.

(ii) Burden Estimates

TSCA section 5(a)(2) imposes two requirements on industry. First, manufacturers, 

processors, and importers of chemicals must choose among the options mentioned above. This 

section presents estimates of submitting SNUNs (i.e., the first option) and then briefly discusses 

the other four options. Second, manufacturers, processors, and importers of chemicals covered 

by SNURs will incur burden and costs to notify customers of the hazards posed by the covered 

chemical. Therefore, they must first determine if their chemical is subject to the SNUR and then 

must determine how to notify their customers.

 

3 Unless manufacturers, processors, and importers of chemicals subject to SNURs have either notified recipients of such 

chemicals and all significant new uses, verified that knowledge of the SNUR has been otherwise acquired by recipients, or 

verified that recipients are unable to engage in significant new uses, manufacturers, processors, and importers must file a SNUN.
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Chemical Verification

When a SNUR is published, companies must review the rule to verify whether their 

chemical is subject to the rule. From 2007 to 2011, the majority of SNURs promulgated by the 

Agency under TSCA section 5(a) applied to new chemicals submitted to the Agency under the 

Premanufacture Notice Program. Only two SNURs applying to existing chemicals were 

proposed during the same time period but were not finalized. These SNURs proposed to regulate 

an average of seven chemicals. The Agency typically notifies the manufacturer(s) of chemicals 

subject to a SNUR prior to its issuance. Therefore it is estimated that no more than 0.167 hours 

(10 minutes) of technical labor time per chemical is used to verify that a chemical is subject to 

the rule. This is equivalent to 1.17 hours (0.167 hours/chemical x 7 chemicals/SNUR) per 

SNUR.

Rule Familiarization

Staff at firms who are subject to the SNUR must become familiar with the SNUR and its 

various requirements. In EPA’s best professional judgment, rule familiarization is estimated to 

be equivalent to the burden for companies to become familiar with the Premanufacture 

Notification Electronic Reporting Rule, which requires the mandatory electronic reporting of 

SNUNs and other TSCA section 5 notices; 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). 

Table 3: Rule Familiarization Burden for SNUR Submitters

Activity Clerical Hours Technical Hours Managerial Hours Total Hours

Rule 

familiarization 0.00 0.55 0.27 0.83

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

First-time submitters of any 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) are required 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. These activities are only 

required of first-time submitters of any section 5 notice. It is not known how many submitters of 

SNUNs from existing chemical SNURs will be first-time submitters of any section 5 notices, 

therefore, EPA assumes that all submitters will incur these costs. 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 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 
14

and one manager will need to register for each company, totaling approximately 0.92 

hours of burden per company.

 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. 

 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.

Table 4: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden 

for First-Time Submitters

Activity Clerical Hours Technical Hours Managerial Hours Total Hours

CDX registration 0.00 0.73 0.18 0.92

CDX electronic 

signature

0.00 1.00 0.75 1.75

E-payment (Pay.gov ID) 0.00 0.00 0.13 0.13

Total 0.00 1.73 1.07 2.80

Submitting a SNUN

When submitting a SNUN, individuals at different occupational levels must spend time 

on the required recordkeeping and reporting activities. SNUN submitters are required to gather 

and submit information regarding the data elements identified in the applicable SNUN reporting 

form. The methodology and calculations 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.

Estimates of the burden of completing a SNUN form are based on the burden of 

completing a PMN submission, since the data requirements are the same and the same form is used 

for both. EPA has harmonized estimates of the reporting and recordkeeping burden related to the 

submission of both new and existing chemical SNUNs. 

Baseline reporting and recordkeeping burden for Existing Chemical SNUNs is estimated to be 

92.2 hours reporting burden and 1 hour recordkeeping burden (for a total of 93.2 hours) based on 
15

the estimates in the April 2010 Request for a Non-substantive Change to an Existing ICR (OMB 

Control No. 2070-0038). However, the 93.2 hours for response burden per SNUN submission is

adjusted in this ICR because recordkeeping burden has been miscalculated. Prior to the April 

2010 Request for a Non-substantive Change to an Existing ICR, the estimate of SNUN reporting 

burden was 105 hours based on the1994 Regulatory Impact Analysis of Amendments(RIA) to 

Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). Reporting burden 

was adjusted to 92.2 hours in the April 2010 non-substantive change with an additional hour 

added for recordkeeping burden so that total reporting and recordkeeping burden is estimated to 

be 93.2 hours. However, the RIA estimate of 105 hours accounted for both reporting and 

recordkeeping because the burden estimates “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” (emphasis added) (EPA 1994, pg. III-14). Therefore, the 1 hour 

recordkeeping burden included in EPA’s 93.2 hour estimate of response burden for submitting a 

SNUN double counts recordkeeping burden. Correcting for this error revises the total estimated 

response burden for SNUN submissions in this ICR to 92.2 hours/SNUN (Table 5).

Table 5: Adjusted Reporting and Recordkeeping Burden Hours for SNUN Submissions 

Existing Chemicals 

SNUN Submission 

Activity

Baseline Response 

Burden Adjustment Estimated 

Reporting and 

Recordkeeping 93.2 -1 92.2

Alternative Options

Should a company choose to request an equivalency determination (i.e., the second 

option), or review for modification/revocation (i.e., the fourth option), EPA estimates that a data 

collection and preparation effort similar to that of a SNUN would be required, and thus the 

burden is estimated to range up to 92.2 hours for these alternatives, the same as for submitting a 

SNUN.

In complying with a SNUR, a company would incur costs to ensure all provisions of the 

SNUR were implemented at the subject facility (i.e., the third option). Since the nature of such 

provisions will vary depending on the significant new uses identified in each respective SNUR, 

estimating burden at this time is not possible. In addition to costs of implementation, firms 

choosing this option will have minor costs associated with keeping records that document 

compliance with SNUR conditions for avoiding a Significant New Use. Such recordkeeping 

requirements may involve copying and filing relevant records, including those related to: category

of use and marketing, and production volume. Records would typically be required to be 

maintained for five years from the date of their creation. Previous existing chemical SNUR ICRs 

have estimated recordkeeping requirements to be five percent of the reporting burden for a certain 

activity (EPA, 2009b). Per-activity burdens are taken from the midpoint estimate burdens of each 

section of the SNUN form (EPA, 1994). The recordkeeping burdens per significant new use are 

estimated to range from 0.01 hours (0.25 * 0.05) for keeping records of trade names and chemical 

synonyms to 0.76 hours (15.25 * 0.05) for keeping records of sites controlled by others. The total 
16

recordkeeping burden per firm will depend on the significant new use(s) identified. 

The final alternative for a company considering a significant new use of a chemical 

which is the subject of a SNUR is to forgo the new use (i.e., the fifth option). In carrying out 

such a response, the company would incur no direct regulatory burden or costs.

Customer Notification

Manufacturers, processors, and importers of chemicals subject to SNURs must notify

recipients of such chemicals 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 to be about one hour of a 

technical employee's time per manufacturer, processor, or importer per chemical. EPA estimates 

that each SNUR will cover approximately 7 chemicals. Furthermore, EPA assumes that there are 

two manufacturers, processors, or importers per chemical.4Therefore, the burden per SNUR is 

estimated to be 14 hours per SNUR.

Summary of Unit Burdens

The following table summarizes the burdens for the activities required under a SNUR, 

under compliance option 1. 

 Table 6: Summary of Unit Burdens

Collection Activity Estimated Burden Hours

Chemical verification (per SNUR) 1.17

Rule Familiarization (per company) 0.83

CDX registration, electronic signature, and 

Pay.gov account set-up (per company) 2.8

SNUN preparation (per report) 92.2

Notifying customers (per SNUR) 14

6(b) Estimating Respondent Costs

The unit costs of filing a SNUN are estimated by monetizing the labor time spent 

preparing the SNUN and then adding any fixed costs associated with filing a SNUN. This 

section derives these unit costs.

 

4 The assumption that there are two manufacturers, processors, or importers per chemical follows from previous ICRs for these 

requirements.
17

(i) Wages

EPA multiplied burden estimates by standard wage rates for managerial, technical, and 

clerical levels developed from information published by the Bureau of Labor Statistics (BLS) 

and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release 

Inventory Program (EPA, 2002b). Wage data for the three occupational categories were gathered 

for manufacturing industries from Employer Costs for Employee Compensation Supplementary 

Tables: Historical Data December 2006 – December 2010 (BLS, 2011a).

The cost of fringe benefits, such as health insurance and vacation, is taken for each labor 

category from the same ECEC series. Following the methodology outlined in EPA 2002b, fringe 

benefits are calculated as a percentage of total wages for each category. EPA added 17 percent to 

the wages in each category to account for overhead, based on information provided by the 

chemical industry and chemical industry trade associations in the Revised Economic Analysis for 

the Amended Inventory Update Rule: Final Report (EPA, 2002a). The wages for each of the 

three categories were then multiplied by benefits and overhead factors to estimate loaded, annual 

salaries in year 2010 dollars. Table 7 contains the loaded wage rates for the managerial, technical 

and clerical occupation categories. 

Table 7: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in 2010$ 

Wage1

Fringe 

Benefits1

Fringes as 

% of Wage

Overhead 

% of 

Wage2

Fringe + 

Overhead 

Factor

Loaded 

Wages

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

Clerical $17.36 $8.67 48.37% 17% 1.67 $28.98

Technical $36.93 $18.50 47.58% 17% 1.67 $61.71

Managerial $42.82 $19.64 45.03% 17% 1.63 $69.74 

1 Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006 –

December 2010, US Bureau of Labor Statistics, March 2011 (BLS, 2011a).

2 An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic Analysis 

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

(ii) Summary of Unit Costs

Costs for Chemical Verification

The Agency estimates that chemical verification will require 1.17 technical hours per 

SNUR. The total estimated cost per SNUR is estimated to be $72.14 (1.17 hours per SNUR x 

$61.71).

Costs for Rule Familiarization

EPA estimates rule familiarization costs will require 0.83 hours per firm and total costs 

are expected to be $52.54. 
18

Costs for CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup

First-time submitters of any section 5 notice are required 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. EPA estimates that companies will spend approximately

$58.03 on CDX registration, $114.01 on completing the Electronic Signature Agreements, $2.30 

mailing electronic signature agreements, and $9.30 setting up a Pay.gov account. Therefore the 

total expected costs associated with CDX registration, completing and mailing an electronic 

signature agreement and setting up a Pay.gov account is approximately $184. 

Table 8: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Cost 

for First-Time Submitters

Activity

Clerical Labor 

(at 

$29.98/hour)

Technical 

Labor (at 

$61.71/hour)

Managerial 

Labor (at 

$69.74/hour)

Total Labor Cost 

(2010 dollars)

CDX registration $0.00 $45.25 $12.78 $58.03 

CDX electronic signature $0.00 $61.71 $52.30 $114.01 

Mailing cost $2.30

E-payment (Pay.gov ID) $0.00 $0.00 $9.30 $9.30 

Total $0.00 $106.96 $74.38 $183.64

Costs for Submitting a SNUN

Using these labor wage rates and midpoint burden estimates presented above, EPA 

estimates that the labor cost associated with filing a SNUN is $5,802. In addition, SNUN filers 

must pay a $2,500 user fee to EPA. Thus, the total cost of filing a SNUN is approximately

$8,302. 

Table 9: Unit Reporting Cost Estimates, Associated with Filing a SNUN by Labor Category 

Activity

Clerical Labor 

(at 

$29.98/hour)

Technical 

Labor (at 

$61.71/hour)

Managerial 

Labor (at 

$69.74/hour)

Total Labor Cost 

(2010 dollars)

SNUN preparation $0.00 $4,546.79 $1,255.32 $5,802

User fee $2,500

Total $0.00 $4,546.79 $1,255.32 $8,302

Alternative Responses

As noted in section 4, five alternative responses to any particular SNUR could be chosen 

by firms planning to engage in significant new uses of subject chemicals. Although EPA has not 

projected or quantified how frequently these alternatives might be selected, the unit costs 

associated with each option are discussed briefly below.

The estimated burden of requesting an equivalency determination (the second option) or 

review for modification/revocation (the fourth option) was judged to be similar to filing the 

SNUN; thus, total costs including the EPA user fee were estimated to be $8,302. However, the 

firm may incur additional costs in developing the data necessary to justify the alternative. This 
19

option will be preferable to compliance with the SNUR if the total cost of obtaining EPA 

approval of a request is less than the costs of SNUR compliance.

Firms choosing to comply with a SNUR (the third option), will incur costs to ensure all 

provisions of the SNUR were implemented at the subject facility and to implement 

recordkeeping. The costs of implementing provisions at a facility were not quantified for this 

ICR. Recordkeeping is expected to range from 0.01 hours to 0.76 hours for each significant new 

use. All recordkeeping activities are expected to be conducted by clerical staff, therefore 

recordkeeping costs range from $0.36 to $22.10 per significant new use. The total recordkeeping 

burden per firm will depend on the significant new use(s) identified. 

Customer Notification

EPA assumes that the customer notification requirement will be handled by technical 

labor. Section 5 of this analysis assumed that one hour of labor per chemical would be required 

to perform the notification, thus the unit cost of notification is estimated to be $61.71 (i.e., the 

hourly wage for technical labor). EPA estimates that each SNUR will cover approximately 7 

chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers 

per chemical5. Therefore, the burden per SNUR is estimated to be 14 hours per SNUR ([7 

chemicals per SNUR]*[1 hour per manufacturer, processor, or importer]*[2 manufacturers, 

processors, or importers per chemical]), and the cost per SNUR is equal to $863.90 [($61.71per 

hour)*(14 hours per SNUR)].

Summary

Table 10 summarizes the unit costs estimated in this section. Reviewing a SNUR to 

verify that a chemical is included is estimated to cost $419.63 per SNUR and notifying 

customers is $863.90 per SNUR. The cost of completing and submitting a SNUN is 

approximately $8,302.11. EPA estimates the costs associated with rule familiarization to be 

$50.92 per company, and CDX registration activities to be $183.64 per company.

 Table 10: Summary of Unit Costs

Collection Activity Estimated Cost

Chemical verification (per SNUR) $72.14

Rule familiarization (per company) $52.54

CDX registration, electronic signature, and 

Pay.gov account set-up (per company) $183.64

SNUN preparation* $8,302.11 

Notifying customers (per SNUR) $863.90

* Includes $2,500 user fee per SNUN.

 

5

The assumption that there are two manufacturers, processors, or importers per chemical follows from previous ICRs for these 

requirements.
20

(iii) Total Burden and Costs to Industry

This section provides estimates of the total burden and costs imposed by the TSCA 

section 5(a) requirements. These estimates can be divided into five categories: chemical 

verification, rule familiarization, submitting SNUNs, CDX registration activities, and notifying 

customers.

The total cost and burden imposed on industry by TSCA section 5(a)(2) requirements can 

be calculated by multiplying the unit burden and cost estimates by the expected number of 

SNURs, SNUNs, and firms. As noted above, this analysis assumes that EPA will promulgate five 

SNURs and receive seven SNUNs per year. Table 11 presents the annual burden and cost to the 

industry. EPA estimates the total annual industry burden of existing chemical SNUR action is 

736 hours and $63,799. 

Table 11: Estimated Annual Respondent Burden and Cost

Information 

Collection Activity

Total 

Burden per 

Activity 

(hours)

Total Cost 

per 

Activity

(2010$)

Total 

Number of 

Units

Annually

Total 

Annual 

Burden 

(hours)

Total Annual 

Cost (2010$)

Rule familiarization 

(per firm) 0.83 $53 4.24 firms 3.52 $225

Preparation, 

submission, and 

recordkeeping for 

SNUN (per report)

92.2 $8,302 7 SNUNs 645 $58,114

CDX registration, 

electronic signature, 

Pay.gov set-up (per 

firm)

2.8 $184 4.24 firms 11.88 $781

Chemical verification 

(per SNUR) 1.17 $72 5 SNURs 5.85 $360

Notifying customers 

(per SNUR) 14 $864 5 SNURs 70.00 $4,320

Total Industry Burden and Cost 736 $63,799

Some burden estimate totals may not calculate due to rounding of unit burden estimates 

Table 12 presents the total burden and cost to the industry over the three-year ICR period. 

EPA estimates the total annual industry burden of existing chemical SNUR action is 2,208 hours 

and $191,398.
21

Table 12: Estimated Total Respondent Burden and Cost, Three Year Totals

Information Collection 

Activity

Total 

Burden per 

Activity 

(hours)

Total 

Cost per 

Activity

(2010$)

Total 

Number 

of Units

Total 

Annual 

Burden 

(hours)

Total Annual 

Cost (2010$)

Rule familiarization (per 

firm) 0.83 $53 12.72firms 10.56 $675

Preparation, submission, 

and recordkeeping for 

SNUN (per report)

92.2 $8,302 21

SNUNs 1,936 $174,342

CDX registration. 

electronic signature, 

Pay.gov set-up (per firm)

2.8 $184 12.72

firms 35.64 $2,342

Chemical verification (per 

SNUR) 1.17 $72 15 SNURs

18 $1,080

Notifying customers (per 

SNUR) 14 $864 15 SNURs

210 $12,960

Total Industry Burden and Cost 2,210 $191,398

Some burden estimate totals may not calculate due to rounding of unit burden estimates 

Table 13 presents the annual burden by collection activity. Chemical verification is 

expected to have a total burden of 5.85 hours annually. Notifying consumers is expected to have 

burden of 70 hours annually. Companies are expected to incur a total of 3.52 hours for rule 

familiarization, 11.87 hours for CDX registration activities and a total of 645 hours for SNUN 

completion, each year.
22

Table 13: Annual Information Collection Tally for ICR Reporting Period (2012-2015)

Information 

Collection

No. of 

Respondents

No. of 

Responses / 

Respondent

Responses 

Subtotal

Annual

Burden 

Hours per 

Response

Annual

Burden 

Hours per 

Activity

Per Firm Activities

Rule familiarization 4.24 1 4.24 0.83 3.52

CDX registration 

activities 4.24 1 4.24 2.80 11.87

 CDX registration 4.24 1 4.24 0.92 3.90

 ESA 4.24 1 4.24 1.75 7.42

 Pay.gov account 4.24 1 4.24 0.13 0.55

Preparation, 

submission, and 

recordkeeping for 

SNUN

4.24 1.65 7 92.2 645

Per SNUR Activities

Chemical verification 5 1 5 1.17 5.85

Notifying customers 

(per SNUR) 35 2 70 1 70.00

Total

736.24

Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

Table 14 presents the total burden hours for the ICR period (2012–2015), organized by

information collection. Chemical verification is expected to have burden of 17.55 hours over the 

three year period. Notifying consumers is expected to have burden of 210 hours over the three 

year period. Companies are expected to incur at total of 10.56 hours for rule familiarization, 

35.64 hours for CDX registration activities and a total of 1,936 hours for SNUN completion, 

submission and recordkeeping over the three year period.
23

Table 14: Total Information Collection Tally for ICR Reporting Period (2012- 2015)

Information 

Collection

No. of 

Respondents

No. of 

Responses / 

Respondent

Responses 

Subtotal

Total Burden 

Hours per 

Response

Total Burden 

Hours 

Subtotal

Per Firm Activities

Rule familiarization 12.72 1 13 0.83 10.56

CDX registration 

activities 12.72 1 13 2.80 35.64

 CDX registration 12.72 1 13 0.92 11.67

 ESA 12.72 1 13 1.75 22.27

 Pay.gov account 12.72 1 13 0.13 1.70

Preparation, 

submission, and 

recordkeeping for 

SNUN

12.72 1.65 21 92.2 1,936

Per SNUR Activities

Chemical verification 15 1 15 1.17 17.55

Notifying customers 

(per SNUR) 105 2 210 1 210

Some burden estimate subtotals may not calculate due to rounding of unit burden estimates 

6(c) Estimating Agency Burden and Cost

(i) SNUN Processing

EPA’s costs to review and process SNUNs are assumed to be the same as EPA costs to 

review PMNs. 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 EPA’s 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 ePMN 

rule that requires the electronic submission of all TSCA section 5 notices. Electronic submission 

of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28). 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 15 contains the derivation of inflation factors for Agency extramural 

costs.
24

 Table 15: 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, NSA, Total 

comp, Private industry, 

Professional and related, 

4

th Q [BLS 2011 b]

1993 67.0 113.5 1.694

1

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

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

Index News Release Text: Employment Cost Index, March 2006 (BLS, 2006).

The “Starting year” ECI index is SIC-OCS based: ECS11102I for private industry White Collar Workers. The index is 

Seasonally Adjusted (SA).

The year 2010 ECI index is NAICS-SOC based: CIU2010000120000I (B) for private industry White Collar Workers. The index 

is Seasonally Adjusted (SA).

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.

Agency labor costs are calculated based on annual federal salaries for the WashingtonBaltimore 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 activities6. 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 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.

Total Agency costs are expected to be $5,049, per SNUN, for submission review and 

processing, as shown in Table 16.

_____________________________________________________________________________________________

6

The GS-13, Step 5 is consistent with ICR OMB Control Number 2070-0012, EPA Tracking Number 0574.13, EPA 2007.
25

Table 16: 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

Weighted 

FTE with 

ePMN 

Burden 

Reduction

FTE 

fraction

Cost per 

FTE 1

FTE Total 

($2010)

1993 

dollars

2010 

dollars

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

1-(i))

Pre-notice consultation 0.0024 $161,446 $387.47 $4.00 $6.78 $394 41% $161.64 0.165 $135 0.0008

Administrative prescreen/ 

notice receipt/user fee 0.0024 $161,446 $387.47 $92.00 $155.85 $543 100% $543.32 0.165 $454 0.0020

CRSS (Chemical Review and 

Search Strategy) 0.0025 $161,446 $403.62 $268.00 $454.00 $858 100% $857.62 0.165 $716 0.0021

SAT (Structure Activity 

Team) 0.0006 $161,446 $96.87 $14.00 $23.72 $121 100% $120.58 0.165 $101 0.0005

Engineering/Exposure 0.0015 $161,446 $242.17 $56.00 $94.87 $337 100% $337.04 0.165 $281 0.0013

Exposure/Fate 0.0008 $161,446 $129.16 $0.00 $0.00 $129 100% $129.16 0.165 $108 0.0007

Focus 0.0009 $161,446 $145.30 $23.00 $38.96 $184 100% $184.26 0.165 $154 0.0008

Standard Review Functions 0.0219 $161,446 $3,535.68 $511.00 $865.65 $4,401 29% $1,276.38 0.165 $1,066 0.0053

Division Directors Meeting 0.0129 $161,446 $2,082.66 $113.00 $191.43 $2,274 15% $341.11 0.165 $285 0.0016

Order 

Development/Negotiation 

Review

0.0171 $161,446 $2,760.73 $22.00 $37.27 $2,798 3% $83.94 0.165 $70 0.0004

Post Order Data Review 0.0886 $161,446 $14,304. $0.00 $0.00 $14,304 3% $429.12 0.165 $358 0.0022

Order Modification 0.2167 $161,446 $34,985.43 $0.00 $0.00 $34,985 3% $1,049.56 0.165 $876 0.0054

New Chemical SNUR 

Development 0.0277 $161,446 $4,472.07 $85.00 $143.99 $4,616 7% $323.12 0.165 $270 0.0016

Notices of Commencement 0.0012 $161,446 $193.74 $40.00 $67.76 $261 31% $81.06 0.165 $68 0.0003

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 0.0003

CBI (Confidential Business 

Information) Substantiation 0.0004 $161,446 $64.58 $3.00 $5.08 $70 100% $69.66 0.165 $58 0.0003

TOTAL $6,046 0.165 $5,049 0.0256

Notes:

1 GS-13 Step 5 salaries loaded with benefits and overhead. 2 Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 

1993. 

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

4 Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28).

Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM, 2010.
26

Using the estimates of annual SNUR promulgation and SNUR notice submissions 

presented above, EPA’s estimated costs are presented in Table 17. Processing SNUNs is

estimated to cost the Agency $35,343 annually. The Agency may also incur a cost for modifying 

a SNUR if submitted data indicate a need for such an action. Costs to perform such a 

modification have not been estimated.

Table 17: Annual Agency Costs

Activity

Total 

Burden per 

Activity 

(FTE)

Total 

Burden per 

Activity 

(Hours)

Total Cost

per Activity 

(2010$)

Total 

Number 

of Units

Total Annual 

Burden 

(hours)

Total 

Annual 

Cost 

(2010$)

SNUN 

processing 0.0256 $53 $5,049 7 SNUNs 373.07 $35,343 

Some burden estimate subtotals may not calculate due to rounding of unit burden estimates 

Table 18 presents the total Agency cost for SNUN processing over the three year ICR 

period, $106,029. 

Table 18: Total Agency Costs

Activity

Total 

Burden per 

Activity 

(FTE)

Total 

Burden per 

Activity 

(Hours)

Total Cost

per Activity 

(2010$)

Total 

Number 

of Units

Total Annual 

Burden 

(hours)

Total 

Annual 

Cost 

(2010$)

SNUN 

processing 0.0256 $53 $5,049 21 SNUNs 1,119 $106,029 

Some burden estimate subtotals may not calculate due to rounding of unit burden estimates

6(d) Reasons for Change in Burden

There is a decrease of 440 hours (from 1,176 hours to 736 hours) in the total estimated 

respondent burden compared with that identified in the ICR currently approved by OMB

(Request for a Non-Substantive Change to an Existing Approved Information Collection

submitted April 2010). This change results from updates to the number of affected sites and

responses and the correction of estimates in the previous ICR. More details on the changes are 

outlined below. The change is an adjustment.

Adjustment Changes

The currently approved ICR estimated that, on average, 10 SNUNs will be submitted 

annually. Upon review of past SNUN submissions from FY 2001 through FY 2011, this number 

was reduced from 10 SNUNs per year to 7 SNUNs per year. The previous ICR also assumed that 

one company will submit a single SNUN. However, reviews of past submissions indicate that the 

average company will submit 1.65 SNUNs. In addition, a review of SNUNs since 2008 reduced 

the number of expected chemicals that are affected from 41 to 7 per SNUR. 

The previous ICR used an estimate of 93.3 hours for reporting and recordkeeping for a 

SNUN. This ICR adjusts that number to 92.2 because the 1 hour of recordkeeping included in the 
27

previous ICR is a result of double counting.

Table 19: Estimate of Changes in Annual Burden Hours from Previous ICR by Activity

Activity Annual Burden Increase Due 

from Adjustment (to 

Baseline) for Addendum 

Period

Total Burden Increase 

from Adjustment (to 

Baseline) for Addendum 

Period

Rule familiarization (per firm) 1.03 3

Preparation, submission, and 

recordkeeping for SNUN (per report)

-286.6 -860

CDX registration (per firm) 1.9 6

CDX signature 2.02 6

e Pay -0.45 -1

Chemical verification (per SNUR) -28.15 -84

Notifying customers (per SNUR) -130 -390

Totals -440.24 -1,321

6(e) Burden Statement

The annual public burden for this collection of information, which is approved under 

OMB Control No. 2070-0038, is estimated to average approximately 8.1 hours per response. 

Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is 

not required to respond to a collection of information unless it displays a current and 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 form, if applicable.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQOPPT-2011-0778, which is available for online viewing at www.regulations.gov, or in person 

viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). 

The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 

Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 

8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number 

for the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the 

Pollution Prevention and Toxics Docket is (202) 566-0280.

You may submit comments regarding the Agency's need for this information, the 

accuracy of the provided burden estimates and any suggested methods for minimizing 

respondent burden, including the use of automated collection techniques. Submit your 

comments, referencing Docket ID No. EPA-HQ- OPPT-2011-0778 and OMB Control No. 2070-

0038, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: 

Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center 

(EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) 

OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and 

Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
28

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