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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.: 1188.13 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, which is generated by the e-PMN software, provides data on the 

identity of, 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 413 existing chemicals. 

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 

 

 

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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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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 November 2, 2015 (80 FR 53151, September 2, 2015). EPA received two

comments, from the American Chemistry Council and the Society of Chemical Manufacturers 

and Affiliates (SOCMA), during the comment period. Copies of the comments are included as 

Attachment 4, and EPA’s response to the comments is found at Attachment 5.

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 e-mail. The individuals contacted were:

Mike Walls

American Chemistry Council, Inc.

mike_walls@americanchemistry.com 

Jim Ford

American Petroleum Institute

fordj@api.org

Brigid Klein

Consumer Specialty Products Association

bklein@cspa.org

John Carroll

Novozymes North America, Inc.

john@novozymes.com
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Lee O. Fuller

Independent Petroleum Association of America

lfuller@ipaa.org

Stephen R. Sides

National Paint and Coatings Association

ssides@paint.org

Jim Cooper

National Petrochemical & Refiners Association

jcooper@npra.org

William Carteaux

Society of the Plastics Industry, Inc.

wcarteaux@plasticsindustry.org

Bill Allmond

Synthetic Organic Chemical Manufacturers Association

allmondb@socma.org

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

consultation e-mail to the above nine 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. Note also that EPA is in the process of updating its e-PMN software so that it will more 

efficiently operate as a “cloud” software system rather than as a downloadable software system. 

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 
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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 

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.

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) protocol. TLS 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 Revision 1, 

“Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) 

Implementations, (dated April 2014)”

http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-52r1.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. 

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.
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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 

receipt of a notice, 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/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/howsubmit-e-pmn.

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.
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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 appropriate for a particular substance that has received 

approval prior to the development of the rule. The proposal then undergoes intra-agency 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. See Attachment 3 for selection criteria.

5(b) Collection Methodology and Management

Submitters are able to generate TSCA section 5 notices, including SNUNs, using the ePMN software 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. CDX 

is the mechanism for submission of section 5 notices to the Agency. An electronic signature will 

be required for TSCA section 5 notices submitted to the Agency via CDX. Electronic signatures 

are granted as part of the CDX user-registration process. 

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

Agency via CDX, the Agency in turn is 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). 

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.
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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 

charge, in complying with TSCA requirements. Small businesses also pay a lower fee for SNUN 

submissions.

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 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.
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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

6(a) Estimating Respondent Burden

Number of Significant New Use Notices Projected

During the years 2012 through May 2015, EPA proposed five and finalized five existing 

chemical SNURs under TSCA section 5(a)(2). 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 an average of only 10 SNUNs per year, based on January 2012 – June 2015 

data. Of those SNUNs, only a small fraction result from existing chemical SNURs promulgated 

under section 5(a)(2). 

 

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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Table 2: Anticipated Number of SNURs and SNUNs

Year Anticipated Number of SNURs Anticipated Number of SNUNS

First Year 5 10

Second Year 5 10

Third Year 5 10

Three Year Totals 15 30

Using SNUN submission data from the three and a half year period of January 2012 

through June 2015, 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. 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. However, EPA has looked at historical data to determine 

the number of SNUNs submitted as well as the number of firms submitting SNUNs in the past 

and has estimated that a total of 6.06 firms will be impacted annually (10 SNUNs/1.65 SNUNs 

per firm). 

(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:

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 
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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 associated with notifying 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.

Chemical Verification

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

chemical is subject to the rule. From 2012 to 2015, 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. A total of ten SNURs applying to existing chemicals were 

issued during the same time period, including 5 SNURS that were finalized and an additional 

five SNURs that were proposed but were not finalized. These SNURs proposed to regulate an 

average of eight 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 1.34 hours (0.167 hours/chemical x 8 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). 

 

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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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 0.82

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

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 burden, 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 0.1833 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 0.917

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.
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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

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

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. The reporting and recordkeeping burden for Existing 

Chemical SNUNs is estimated to be 91.68 hours and is based on the1994 Regulatory Impact 

Analysis of Amendments (RIA) to Regulations for TSCA Section 5 Premanufacture Notifications 

(EPA, 1994) and 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 burden associated with preparing and submitting a SNUN 

(EPA, 2009a). In addition, electronic submission is expected to generate an additional 0.18 hours 

of technical burden associated with the completion of the User Fee Payment Identification 

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

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 91.68 hours for these alternatives, the same as for submitting a 

SNUN.
14

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 burden is taken from the midpoint estimated burden of each 

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

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 

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 eight chemicals. Furthermore, EPA assumes that there 

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

is estimated to be 16 hours per SNUR.

Summary of Unit Burdens

The following table summarizes the burden associated with the activities required under a 

SNUR, under compliance option 1. 

 

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

requirements.
15

 Table 5: Summary of Unit Burdens

Collection Activity Estimated Burden Hours

Chemical verification (per SNUR) 1.34

Rule Familiarization (per company) 0.82

CDX registration, electronic signature, and 

Pay.gov account set-up (per company) 2.80

SNUN preparation (per report) 91.68

Notifying customers (per SNUR) 16

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.

(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 – March 2015 (BLS, 2015).

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 2014 dollars. Table 6 contains the loaded wage rates for the managerial, technical 

and clerical occupational categories. 

Table 6: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in 2014$

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 $18.68 $9.40 50.3% 17% 1.67 $31.26 

Technical $42.19 $22.86 54.2% 17% 1.71 $72.22 

Managerial $47.90 $24.18 50.5% 17% 1.67 $80.22 

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

2015, US Bureau of Labor Statistics, June 2015 (BLS, 2015).

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).
16

(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 $96.78 (1.34 hours per SNUR x 

$72.22).

Costs for Rule Familiarization

EPA estimates rule familiarization costs will require 0.82 hours per firm and total costs 

are expected to be $63.62. 

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

$67.67 on CDX registration, $132 on completing the Electronic Signature Agreements, $2.79

mailing electronic signature agreements, and $10.69 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 $214. 

Table 7: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Cost 

for First-Time Submitters

Activity Clerical Labor 

($31.26/hour)

Technical Labor 

($72.22/hour)

Managerial Labor 

($80.22/hour)

Total Labor 

Cost 

(2014$)

CDX registration $0.00 $52.96 $14.70 $67.67 

CDX electronic 

signature $0.00 $72.22 $60.17 $132 

Mailing cost $2.79

E-payment (Pay.gov 

ID) $0.00 $0.00 $10.69 $10.69 

Total $0.00 $125 $85.57 $214

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 $6,765. In addition, SNUN filers 

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

$9,265. 

Table 8: Unit Reporting Cost Estimates, Associated with Filing a SNUN by Labor Category 

Activity Clerical Labor 

($31.26/hour)

Technical Labor 

($72.22/hour)

Managerial Labor 

($80.22/hour)

Total Labor 

Cost 

(2014$)
17

SNUN 

preparation $0.00 $5,321 $1,444 $6,765 

User fee $2,500

Total $0.00 $5,321 $1,444 $9,265 

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 $9,265. However, the 

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

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 $0.31 to $23.75 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 $72.22 (i.e., the 

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

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

per chemical5. Therefore, the burden per SNUR is estimated to be 16 hours per SNUR ([8 

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 $1,156 [($72.22 per 

hour)*(16 hours per SNUR)].

Summary

Table 9 summarizes the unit costs estimated in this section. Reviewing a SNUR to verify

that a chemical is included is estimated to cost $96.87 per SNUR and notifying customers is 

$1,156 per SNUR. The cost of completing and submitting a SNUN is approximately $9,265. 

 

5

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

requirements.
18

EPA estimates the costs associated with rule familiarization to be $63.62 per company, and CDX 

registration activities to be $214 per company.

 Table 9: Summary of Unit Costs

Collection Activity Estimated Cost

Chemical verification (per SNUR) $96.78

Rule familiarization (per company) $63.62

CDX registration, electronic signature, and 

Pay.gov account set-up (per company) $214

SNUN preparation* $9,265

Notifying customers (per SNUR) $1,156

* Includes $2,500 user fee per SNUN.

(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, completing and 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 10 SNUNs per year. Table 10 presents the annual burden and cost to 

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

1,025 hours and $99,811. 
19

Table 10: Estimated Annual Respondent Burden and Cost

Information 

Collection Activity

Total 

Burden per 

Activity 

(hours)

Total Cost 

per 

Activity

(2014$)

Total 

Number of 

Units

Annually

Total 

Annual 

Burden 

(hours)

Total Annual 

Cost (2014$)

Rule familiarization 

(per firm) 0.82 $64 6.06 Firms 5.0 $386

Preparation, 

submission, and 

recordkeeping for 

SNUN (per report)

91.68 $9,265 10 SNUNs 917 $92,654

CDX registration, 

electronic signature, 

Pay.gov set-up (per 

firm)

2.8 $214 6.06 Firms 17 $1,294

Chemical verification 

(per SNUR) 1.34 $97 5 SNURs 6.7 $484

Notifying customers 

(per SNUR) 16 $1,156 5 SNURs 80.0 $5,778

Total Industry Burden and Cost 1,025 $100,595

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

Table 11 presents the total burden and cost to industry over the three-year ICR period. 

EPA estimates the total annual industry burden of existing chemical SNUR action to be 3,076

hours and $301,784.
20

Table 11: Estimated Total Respondent Burden and Cost, Three Year Totals

Information 

Collection Activity

Total 

Burden per 

Activity 

(hours)

Total Cost 

per Activity

(2014$)

Total Number 

of Units 

Total 

Annual 

Burden 

(hours)

Total Annual 

Cost (2014$)

Rule familiarization 

(per firm) 0.82 $64 18.18 Firms 14.9 $1,157

Preparation, 

submission, and 

recordkeeping for 

SNUN (per report)

91.68 $9,265 30 SNUNs 2,750 $277,961

CDX registration. 

electronic signature, 

Pay.gov set-up (per 

firm)

2.8 $214 18.18 Firms 50.9 $3,882

Chemical 

verification (per 

SNUR)

1.34 $97 15 SNURs 20 $1,452

Notifying customers 

(per SNUR) 16 $1,156 15 SNURs 240 $17,333

Total Industry Burden and Cost 3,076 $301,784

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

Table 12 presents the annual burden by collection activity. Chemical verification is 

expected to have a total burden of 6.70 hours annually. Notifying consumers is expected to have 

a total burden of 80 hours annually. Companies are expected to incur a total burden of 4.97 hours 

for rule familiarization, 16.97 hours for CDX registration activities and a total of 917 hours for 

SNUN completion, each year.
21

Table 12: Annual Information Collection Tally for ICR Reporting Period (2016-2019)

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 6.06 1 6.06 0.82 4.97

CDX registration 

activities 6.06 1 6.06 2.80 16.97

 CDX registration 6.06 1 6.06 0.92 5.56

 ESA 6.06 1 6.06 1.75 10.61

 Pay.gov account 6.06 1 6.06 0.13 0.81

Preparation, 

submission, and 

recordkeeping for 

SNUN

6.06 1.65 10 91.68 917

Per SNUR Activities

Chemical verification 5 1 5 1.34 6.70

Notifying customers 

(per SNUR) 40 2 80 1 80.00

Total 1,025

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

Table 13 presents the total burden hours for the ICR period (2016–2019), organized by

information collection. Chemical verification is expected to result in a total burden of 20.1 hours 

over the three-year ICR period. Notifying consumers is expected to result in a total burden of 

240 hours over the three-year ICR period. Companies are expected to incur at total of 14.91

hours in burden for rule familiarization, 50.91 hours for CDX registration activities and a total of 

2,750 hours for SNUN completion, submission and recordkeeping over the three-year ICR 

period.
22

Table 13: Total Information Collection Tally for ICR Reporting Period (2016- 2019)

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 18.18 1 18.18 0.83 14.91

CDX registration 

activities 18.18 1 18.18 2.80 50.91

 CDX registration 18.18 1 18.18 0.92 16.67

 ESA 18.18 1 18.18 1.75 31.82

 Pay.gov account 18.18 1 18.18 0.13 2.42

Preparation, 

submission, and 

recordkeeping for 

SNUN

18.18 1.65 30.00 91.68 2,750

Per SNUR Activities

Chemical verification 15 1 15 1.34 20.1

Notifying customers 

(per SNUR) 120 2 240 1 240

Total 3,076

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 14 contains the derivation of inflation factors for Agency extramural 

costs.
23

 Table 14: Derivation of Inflation Factors for Agency Extramural Costs 

Item Inflation index source1 Starting

year

Index 

for 

starting 

year (a)

Index 

for 

2014

(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 2015b]

1993 67.0 122.9 1.834

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 2014 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 2014 (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 $101,914 in 2014, 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 

$163,062.40. 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 $78.40.

Total Agency costs are expected to be $5,166, per SNUN, for submission review and 

processing, as shown in Table 15.

_____________________________________________________________________________________________

6

The GS-13, Step 5 is consistent with ICR OMB Control Number 2070-0012, EPA Tracking Number 0574.13, EPA 2007.
24

Table 15: 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 

(2014$)

1993 

dollars

2014

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 $163,062 $391.35 $4.00 $7.34 $399 41% $163.46 0.165 $136 0.001

Administrative prescreen/ 

notice receipt/user fee 0.0024 $163,062 $391.35 $92.00 $168.76 $560 100% $560.11 0.165 $468 0.002

CRSS (Chemical Review and 

Search Strategy) 0.0025 $163,062 $407.66 $268.00 $491.60 $899 100% $899.26 0.165 $751 0.002

SAT (Structure Activity 

Team) 0.0006 $163,062 $97.84 $14.00 $25.68 $124 100% $123.52 0.165 $103 0.001

Engineering/Exposure 0.0015 $163,062 $244.59 $56.00 $102.72 $347 100% $347.32 0.165 $290 0.001

Exposure/Fate 0.0008 $163,062 $130.45 $0.00 $0.00 $130 100% $130.45 0.165 $109 0.001

Focus 0.0009 $163,062 $146.76 $23.00 $42.19 $189 100% $188.95 0.165 $158 0.001

Standard Review Functions 0.0219 $163,062 $3,571.07 $511.00 $937.34 $4,508 29% $1,307.44 0.165 $1,092 0.005

Division Directors Meeting 0.0129 $163,062 $2,103.50 $113.00 $207.28 $2,311 15% $346.62 0.165 $289 0.002

Order 

Development/Negotiation 

Review

0.0171 $163,062 $2,788.37 $22.00 $40.36 $2,829 3% $84.86 0.165 $71 0.000

Post Order Data Review 0.0886 $163,062 $14,447.33 $0.00 $0.00 $14,447 3% $433.42 0.165 $362 0.002

Order Modification 0.2167 $163,062 $35,335.62 $0.00 $0.00 $35,336 3% $1,060.07 0.165 $885 0.005

New Chemical SNUR 

Development 0.0277 $163,062 $4,516.83 $85.00 $155.92 $4,673 7% $327.09 0.165 $273 0.002

Notices of Commencement 0.0012 $163,062 $195.67 $40.00 $73.37 $269 31% $83.40 0.165 $70 0.000

FOIA (Freedom of 

Information Act) Requests 0.0333 $163,062 $5,429.98 $287.00 $526.45 $5,956 1% $59.56 0.165 $50 0.000

CBI (Confidential Business 

Information) Substantiation 0.0004 $163,062 $65.22 $3.00 $5.50 $71 100% $70.73 0.165 $59 0.000

TOTAL $6,186 0.165 $5,166 0.026

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, 2014.
25

Using the estimates of annual SNUR promulgation and SNUR notice submissions 

presented above, EPA’s estimated costs are presented in Table 16. Processing SNUNs is

estimated to cost the Agency $51,655 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 16: Annual Agency Costs

Activity

Total 

Burden per 

Activity 

(FTE)

Total 

Burden per 

Activity 

(Hours)

Total Cost

per 

Activity 

(2014$)

Total 

Number 

of Units

Total Annual 

Burden 

(hours)

Total Annual 

Cost (2014$)

SNUN 

processing 0.026 53.30 $5,166 10 SNUNs 533 $51,655

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

Table 17 presents the total Agency cost for SNUN processing over the three-year ICR 

period, which is $154,966. 

Table 17: Total Agency Costs

Activity

Total 

Burden per 

Activity

(FTE)

Total 

Burden per 

Activity 

(Hours)

Total Cost

per Activity 

(2014$)

Total 

Number 

of Units

Total Annual 

Burden 

(hours)

Total 

Annual 

Cost 

(2014$)

SNUN 

processing 0.026 53.30 $5,166 30 SNUNs 1,599 $154,966

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

6(d) Reasons for Change in Burden

There is an increase of 289 hours (from 736 hours to 1,025 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 September 2012). This change results from adjustment changes that updated the 

number of affected sites (from 4.24 to 6.06 per year), average number of SNUNs submitted 

annually (from 7 SNUNs to 10 SNUNS per year), from recalculating the average number of 

chemicals per SNUR (7 chemicals to 8 chemicals), and correcting rounding errors in the burden 

estimate for completing a SNUN, (92.2 hours to 91.68 hours), and rule familiarization (0.83 

hours to 0.82 hours). 
26

Table 18: Estimate of Changes in Annual Burden Hours from Previous ICR by Activity

Annual Burden Hours

Current OMB Inventory 736

Change in Burden due to Adjustments 289

Due to correction of rounding error -4

Updating number of sites and SNUN submissions 282

Updating average number of chemicals per SNUR 11

Change in Burden due to Program Changes 0

Total Change in Burden 289

Total Burden 1,025

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 16.3 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-2015-0273, 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-2015-0273 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.
27

REFERENCES

BLS, 2006. 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, 2015a. U.S. Bureau of Labor Statistics. “Employer Costs for Employee Compensation 

Supplementary Tables: Historic Data December 2006 – March 2015” Accessed July 1, 2015. 

http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf

BLS, 2015b. Bureau of Labor Statistics. Employment Cost Index – Total Compensation: 

Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: 

CIU2010000120000I (B)), extracted July 1, 2015. http://data.bls.gov/cgi-bin/srgate.

EPA, 1994. U.S. EPA, Office of Pollution Prevention and Toxics,Regulatory Impacts Branch.

Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 

Premanufacture Notifications. Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9, 

1994.

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Washington, DC. August 2002.

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Washington, DC: June 10, 2002.

EPA, 2007. U.S. EPA Office of Pollution Prevention and Toxics, Supporting Statement for

Information Collection Request: Pre-Manufacture Review Reporting and Exemption 

Requirements for New Chemical Substances and Significant New Use Reporting 

Requirements for Chemical Substances. OMB Control Number 2070-0012, EPA Tracking 

Number 0574.13, December 11, 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 ICR No. 118.09. [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 

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https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salarytables/pdf/2014/DCB.pdf
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ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public docket established for 

this ICR under docket identification number EPA-HQ-OPPT-2015-0273. These attachments are 

available for online viewing at www.regulations.gov or otherwise accessed as described in 

section 6(f) of the supporting statement.

Attachment 1: Toxic Substances Control Act Section 5 - 15 U.S.C. 2604

Attachment 2: 40 CFR Part 721 (Subpart A through Subpart D) - Significant New Uses 

of Chemical Substances

Attachment 3: Selection Criteria -- TSCA section 8(a) Rule vs. SNUR

Attachment 4: Public Comments Received and EPA’s Response to Public Comments

Attachment 5: EPA’s Response to Public Comments

Attachment 6: Copy of Consultations Message Sent by EPA to Potential Respondents