1 **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.: 1188.1**  **3 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 day s 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 t ake 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 subst ance; 2) The extent to which a use changes the ty pe 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 chemic al substance; and2

4) The reasonabl y 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 Rul e (SNUR). If a final rule is promulgated, a person who intends to engage in a significant new use of a chemical covered b y a SNUR must notify EPA of his/her intentions. This notification, made via the Significant New Use Notice (SNUN), must occur at leas t 90 day s prior to commencing the new use of the identified substance. The required notice must be submitted electronicall y, via the Central Data Exchange (CDX), using the Agency’s e

- PMN software. The PMN form , which is generated b y 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 co mmerce, and disposal of the chemical. The Agency

has 90 day s 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 day s with good cause. If EPA takes no action at the end of the review period, the submitter can engage in the intended n ew 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 sub stance. 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 n otification 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

1 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.3

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 exposure s 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 reasonabl y ascertainable b y 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 substanc e that is the subject of the SNUR (e.g., impurities, by products), 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 w as 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 I CR, 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 Soc iety 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 ap proval. 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 Novozy mes North America, Inc. john@novozy

mes.com4

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 Sy nthetic 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 d etermined ... 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 SNUN s 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 efficientl y operate as a “cloud” software system rather than as a downloadable software s ys tem. 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 the5

capability for submitters to access thei r 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 Interne t. 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**  In formation 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 s ys tem to prevent the unauthorized disclosure of CBI. This sy stem 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 CB I until they have received instructions for handling CBI. EPA will ensure secure transmission of SNUN data submitted through CDX via the Transport Layer Security (TL S) protocol. TL S is a widely used approach for securing Internet transactions, and is endo rsed by the National Institute of Standards and Technology (NI ST) 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/NI ST.SP.800

- 52r1.pdf

. In addition, e

- PMN software enables the SNUN submitter to electronically sign, encry

pt, 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 exactl y what the submitter sent to EPA

. Additionally , s pecial proced ures also restrict access to computerized CBI. These security measures appl y 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 informati on requested is not sensitive in nature.6

**4. THE RESPONDENTS AND THE INFORMATION REQUESTED**  **4(a) Respondent NAICS Codes**  Respondents affected b y 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
In formation submitted under this collection must include, insofar as it is known to or reasonabl y ascertainable by the submitter, information de scribed 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 day s (extendable to 180 day s) to evaluate the notice’s content. (ii) Respondent Activities Only those persons who intend to engage in a significant new u se 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, inc luding 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 electronicall y at http://www.epa.gov/reviewing

- new - chemicals

- under

- toxic

- substances

- control

- act

- tsca/how

submit

- 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 d evelop 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 sy stematic 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.7

Step 2. **The Regulatory Selection Process**
**- Referral and Review:**  Once an office has detailed its need for information, an information collection appro ach 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 information

gathering un der a different statutory authority). Step 3. **Regulatory Development:** Prior to the development of a rule, the recommended rulemaking approach must be reviewed b y 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 onl y 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 co llection 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**  S ubmitters are able to generate TSCA section 5 notices, including SNUNs, using the e

PMN 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 inte rnet download. The data being transmitted electronically via CDX is encry

pted 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 Agen cy 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 incompl ete). 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 b y 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 fo r 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 f ile 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.8

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 on

site 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 day s 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 largel y based on previous experience with SNURs, and is consistent wi th the anal ysis presented in the supporting statement prepared for the previous IC R. This I CR is updated from the previous ICR to account for the changes in burden resulting from u pdated assumptions and corrections to prior analyses. To comply

with the re gulation, 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

.9

**Table 1**  **: Cross**
**- w**  **alk between Industry Activities and Related Information Collections**  **( ICs)**  **Activity Description**  **Related IC(s)** Chemical v erification 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 f amiliarization 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 r egistration , 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 El ectronic 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

P reparation 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 o f Significant New Use Notices Projected During the years 201 2 through May 201 5 , EPA proposed five and finalized f ive 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 ye ar under TSCA section 5(a)(2) during the time period covered b y this I CR2

. EPA may receive SNUNs as a result of SNUR s. 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 onl y 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 EP A 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 on ly 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.10

**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 b y 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 annuall y ( 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 b y any company not intending to abide b y the provisions of the SNUR. 2) In the ev ent 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) Th e 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 requirements11

regardless of whether they engage in a significant new use unless certain information can be demonstrated 3 . 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 briefl y discusses the other four options. Second, manufacturer s, 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 20 1 2 to 201 5 , the majority of SNURs promulgated b y 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 Familiariz ation Staff at f irms who are subject to the SNUR must become familiar with the SNUR and its various requirements. In EPA’s best professional judgment, r ule 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 s ection 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, 2009 a)

.

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.12

**Table 3**  **: Rule Familiarization Burden for SNUR Submitters**  **Activity Clerical Hours**  **Technical Hours Managerial Hours**  **Total Hours** Rule f amiliarization 0.00 0.55 0.27 **0.8 2**  **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, L ow Volume Exemption (LVE) notices, Low Exposure/L ow Release (LoREX) exemption notices, Biotechnology

Notices for geneticall y modified microorganisms, Notices of Commencement of Manufacture or Import (N OCs), and support documents to s ection 5 notices ) are required to register their company and key users with the CDX reporting tool, deli ver a CDX electronic signature to EPA, and establish and use a Pay .gov E

- pay ment account. These activities are onl y required o f first

- time submitters of any s ection 5 notice

. Itis 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 Premanufa cture Notification Electronic Reporting Final Rule (EPA, 2009 a):

 CDX registration: EPA estimates that companies will spend approximately 0.18 33 hours per emplo yee to register with CDX, and that an average of four technical staff members and one manager wi ll need to register for each company , totaling approximately 0. 9 17 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 Id entity) 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 b y companies submitting and then verifying electronic signature agreements is 1.75 hours. Note that this burden doe s 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 sy stem, 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 pay ment processing.13

**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

-p ayment (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. Itis 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 f amiliarization 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 the 1 994 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 require s 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 Pay ment I dentification 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 thu s 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., th e 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 typi call y be required to be maintained for five years from the date of their creation. Previous existing chemical SNUR I CRs have estimated recordkeeping requirements to be five percent of the reporting burden for a certain activity (EPA, 200 9 b). P er- activity burden is taken from the midpoint estimate d burden of each section of the SNUN form (EPA, 1994). The recordkeep ing 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 sy nony ms to 0.76 hours (15.25 * 0.05) for keeping records of sites controlled by others. The total recordkeeping burden p er 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 re sponse, 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 h as been otherwise acquired b y 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 significantl y 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 emplo ye e'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. 4 Therefore, 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 c ompliance 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 (p er SNUR) 16 **6(b )**  **Estimating Respondent Costs**  The unit costs of filing a SNUN are estimated b y 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 dev eloped from information published by the Bureau of Labor Statistics (BL S) 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 gath ered for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006

– March 2015 (BLS, 201 5 ). 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 Repo rt (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 f or the managerial, technical and clerical occupation al categories. **Table 6**  **: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in**  **201 4**  **$**

**Wage 1**  **Fringe**

**Benefits 1**  **Fringes as**

**% of Wage Overhead** 

**% of Wage**  **2 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, 201 5)

. 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. 8 2 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

- ti me submitters of any section 5 n otice 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 approx imately $ 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

-p ayment (Pay.gov ID) $0.00 $0.00 $10.69 **$10.69 Total**  **$0.00 $125**  **$85.57 $21**  **4** 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 f iling 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 f ee **$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 briefl y 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 b y cl erical 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 b y technical labor. Section 5 of this analy sis 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 approx imately eight chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers per chemical 5 . 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. Th e 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 c ustomers (p er 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 b y multiplying the unit burden and cost estimates by the expected number of SNURs, SNUNs, and firms. As noted above, this anal ys is assumes that EPA will promulgate five SNURs and receive 10 SNUNs per ye ar. Table 10 presents the annual burden and cost to industry . EP A 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**  **(201 4**  **$) Total** 

**Number of Units**  **Annually Total** 

**Annual Burden**  **(hours) Total**  **Annual**

**Cost (201**  **4 $)** 
Rule f amiliarization (per f irm) 0. 82 $64 6.06 Firms 5.0 $386 Preparation, s ubmission, and r ecordkeeping 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 v erification (per SNUR) 1.34 $97 5 SNURs 6.7 $484 Notifying c ustomers (p er 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

- ye ar ICR period. EPA estimates the total annual industry burden of existing chemical SNUR action to be 3,0 76 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 (201**  **4 $)**  **Total Number**

**of Units**  **Total**

**Annual Burden**  **(hours) Total**  **Annual**

**Cost (201 4**  **$)**
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 b y collection activity. Ch emical 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 (201**  **6**
**- 201**  **9 )** 
**Information Collection**  **No. of**

**Respondents No. of** 

**Res ponses /**  **Respondent Responses** 

**Subtotal Annual** 

**Burden Hours per**  **Response Annual** 

**Burden Hours**  **per Activity**  **Per Firm Activities** Rule f amiliarization 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 a ccount 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 v erification 5 1 5 1.34 **6.70** Notifying c ustomers (p er SNUR) 40 2 80 1 **80.00 Total**  **1,0 25**  Some burden estimate subtotals may not calculate due to ro unding 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

- ye ar ICR period. Notifying consumers is expected to result in a total burden of 240 hours over the three

- ye ar ICR period. Companies are expected to incur at total of 14.91 hours in burden for rule familiarization, 50.91 hours for CDX registration activiti es 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 (**  **201 6** 
**- 201**  **9 )**  **Information C**  **ollection No. of** 

**Respondents No. of** 

**Responses / Respondent**  **Responses**

**Subtotal Total Burden** 

**Hours per Response**  **Total Burden**

**Hours Subtotal**  **Per Firm Activities** Rule f amiliarization 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 a ccount 18.18 1 18.18 0.13 **2.42** Preparation, s ubmission, and r ecordkeeping for SNUN 18.18 1.65 30.00 91.68 **2,750**
**Per SNUR Activities** Chemical v erification 15 1 15 1.34 **20.1** Notifying c ustomers (p er 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 reduction s resulting from the ePMN r ule 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, 2009 a , 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) Employ ment Cost Index (ECI) data (BLS, 2011b). The not seasonall y adjusted E CI for tot al 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 Agen cy 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 source**  1 **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 201 4 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 dec imal 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 Washington

Baltimore area published by the Office of Personnel Management effective January 201 4 (OPM, 2010). EPA assumes that, on average, a federal GS

- 13, Step 5 full

- time equivalent (FTE) will conduct its collection and administrative activities 6

. The average salary for a GS

- 13 Step 5 employee was $ 101,914 in 201 4 , without fringe benefits and over head 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 ye ar) yi elds 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 Extram** **ural Cost 2**  **Unw eighted**  **Cost Pct. of** 

**Cases Weighted** 

**Cost 3**  **ePMN**

**Burden Reduction**  **4 Weighted** 

**Cost with ePMN Burden**  **Reduction Weighted** 

**FTE with**  **ePMN Burden**  **Reduction FTE**  **fraction Cost per** 

**FTE 1**  **FTE Total**

**(201 4$**  **) 1993** 

**dollars 201**  **4**

**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, 201 4
.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 annuall y. 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**  **( 201**  **4 $**  **) Total** 

**Number of**  **Units Total**  **Annual**

**Burden (hours)**  **Total Annual** 

**Cost (201**  **4 $)** 
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

- ye ar 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 (**  **201 4**  **$ )**  **Total**

**Number of**  **Units Total**  **Annual**

**Burden (hours)**  **Total**

**Annual Cost**  **(201 4**  **$)** 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 I CR currentl y approved by OMB ( Request for a Non

- Substantive Change to an Existing Approved Information Collection submitted September 2012 ). Th is change result s from adjustment changes that updated the number of affected sites (from 4.24 to 6.06 per ye ar), 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 error s 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 73 6 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 condu ct 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 I CR under Docket ID No. EPA

- HQ

OPPT

- 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 holiday s. 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, re ferencing 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 b y mail to: Pollution Prevention and Toxics Docket, Environmental Protec tion Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB b y 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

. BL S, 201 5 a. 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
BL S, 201 5 b. Bureau of Labor Statistics. Employ ment Cost Index

– Total Compensation: Professional and Related Private Industry , Not Seasonally Adjusted. (Series ID: CIU2010000120000 I (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 Preman ufacture Notifications . Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9, 1994. EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report. Washington, DC. August 2002. EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics, Economic and Policy Analy sis Branch, Wage Rates for Economic Analysis of the Toxics Release Inventory Program. 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 Analy sis Branch . Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule

. (EPA

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- 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 (Renewa l) . Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act , February 6, 2009. Office of Personnel Management (OPM), 201 4 . Salary Tables 201 4

- DCB for the Locality Pay Area of Washington

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tables/pdf/2014/DCB.pdf28 **ATTACHMENT S TO THE SUPPORTING STATEMENT**  Attachments to the supporting statement are available in the public docket established for this I CR under docket identification number **EP A** 
**- HQ** 
**- OPPT** 
**- 201**  **5**
**- 0**  **2 73**  . 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 S ection 5

- 15 U.S.C. 2604 Attachment 2: 40 CFR Part 721 (Subpart A through Su bpart 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