            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.:  1188.11	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
      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 on EPA's Premanufacture Notice (PMN) form.  The PMN form provides data on the identity and use of, and possible exposures to, the chemical substance.  In addition, the PMN form provides test data plus descriptions of health and environmental effects data based on the manufacture, processing, use, distribution in commerce, and disposal of the chemical.

      The Agency has 90 days to evaluate a SNUN once it has been received.  This evaluation focuses on the health and environmental effects of the substance's significant new use.  Should EPA find cause for concern, the Agency can take regulatory action as per TSCA sections 5(e) and 5(f).  Likewise, the Agency may extend the evaluation period by up to 90 days with good cause.  If EPA takes no action at the end of the review period, the submitter can engage in the intended new use without any restrictions.

      2(b)	Practical Utility/Users of the Data

      EPA uses this information to evaluate the health and environmental effects of the significant new use.  During the evaluation period EPA can take further regulatory action pursuant to TSCA sections 5(e) and 5(f).  Under TSCA section 5(e), the Administrator may issue an order to prohibit or limit the manufacture, import, processing,  distribution in commerce, use, or disposal of such substance.  TSCA section 5(f) allows the Administrator to, among other things, prohibit or limit the manufacture of the chemical substance, if the substance presents or will present an unreasonable risk of injury to health or the environment.

      To date EPA has promulgated SNURs on 388 existing chemicals.  Presented in Attachment 5 are selected case history abstracts for some of these substances.  These abstracts highlight the needs of a particular office and the facts surrounding a substance.  This information when applied to the Regulatory Selection Criteria has resulted in final SNURs.
      
 3.	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA

      3(a)	Non-Duplication

      EPA is the only federal agency that collects information on significant new uses of chemical substances.  A notification of an intent to engage in a significant new use serves two functions: as a notice, and as a document that contains information about a chemical substance and potential exposures to that substance.  The notification element is unique to SNURs and therefore not obtainable elsewhere.  The chemical information aspect will also contain unique information.  Only the person who intends to commence a significant new use of a chemical substance will know the potential for human and environmental exposures to that substance, the quantity intended to be produced, imported, or processed, and the manner in which the person will engage in the significant new use.

      A person submitting a significant new use notice is not required to develop test data.  However, the person must submit data that are known to or reasonably ascertainable by that person.  For published data the submitter need only provide a literature citation (40 CFR 720.50(d)(3)(ii)).  For existing chemicals that are related to the chemical substance that is the subject of the SNUR (e.g., impurities, byproducts), neither the published data nor a literature citation need be submitted.  Also, notices need not include information previously submitted to EPA (unless the previously submitted information was claimed confidential, in which case it must be resubmitted).

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

      Prior to submission to OMB, this ICR will be made available to the public for comment through a Federal Register notice.  The public will have 60 days to provide comments.  Any comments received will be given consideration when completing the supporting statement that is submitted to OMB.

      3(c)	Consultations

      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 original or renewal ICR to OMB for review and approval.  In accordance with this regulation, EPA will pursue additional consultations with interested parties during the development of the renewal of this collection.

      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.

      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.

      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.  A wrongful disclosure of CBI may result in either a fine or imprisonment.

      3(g)	Sensitive Questions

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


4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondent NAICS Codes

      Respondents affected by this collection activity are mainly NAICS categories 325 - Chemicals and Allied Products Manufacturers and 32411- Petroleum Refining.

      4(b)	Information Requested

       (i) Data items, including record keeping requirements

      Information submitted under this collection must include, insofar as it is known to or reasonably ascertainable by the submitter, information described in TSCA section 8(a)(2) (i.e., chemical identity, use, and exposure data), as well as test data, and descriptions of other data related to the effects on health and the environment of the manufacture, processing, use, distribution in commerce, and disposal of the chemical substance (TSCA section 5(d)).  After a notice has been received, EPA has 90 days (extendable to 180 days) to evaluate the notice's content.

       (ii) Respondent Activities

           Only those persons who intend to engage in a significant new use of a chemical substance must submit notice of their intentions to EPA.  According to 40 CFR § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be on EPA Form No. 7710 - 25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.


5. 	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION  
	METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities

      A significant new use rule (SNUR) on an existing chemical substance is the product of a process that is designed to develop the appropriate information-gathering collection for a substance.  This process has three major steps: Chemical Referral, Regulatory Selection, and Regulation Development.

      Step 1.  Chemical Referral:  EPA offices that have identified information-gathering or follow-up monitoring needs for a particular chemical may refer the substance to OPPT.  A systematic process has been developed for receiving and handling chemical referrals.  Offices referring substances are asked to prepare concise summaries of relevant data.  This information is used to select a regulatory approach and for rulemaking activities.

      Step 2.  The Regulatory Selection Process - Referral and Review:  Once an office has detailed its need for information, an information collection approach is determined that best satisfies that office's needs.  The rulemaking options are: a TSCA section 8(a) reporting rule, a TSCA section 8(c) call-in, a TSCA section 8(d) health and safety data reporting rule, a TSCA section 5(a)(2) SNUR, or any combination of the above.  It may also be determined that an alternative approach is more appropriate (e.g., use of existing data sources, no data-gathering at the present time, TSCA section 4 or 6 action, or referral to another office for information-gathering under a different statutory authority).

      Step 3.  Regulatory Development:  Prior to the development of a rule, the recommended rulemaking approach must be reviewed by the referring office and approved by the Office Director of OPPT.  If the recommendation is approved, then the rulemaking process begins.

      A SNUR is drafted only if it is an appropriate approach for a particular substance that has received approval prior to the development of the rule.  The proposal then undergoes 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.  Attachment 5 identifies the selection criteria that are applied in determining whether a TSCA section 8(a) rule or SNUR is proposed.

      5(b)	Collection Methodology and Management

      EPA has not been able to identify a more efficient, less expensive or more flexible means of obtaining the required data and remain within the constraints of TSCA.  There is no new technology applicable to the collection of this information that would minimize the collection burden.

      To aid persons subject to this information collection, 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.

      5(d)	Collection Schedule

      Whenever any person intends to engage in a significant new use of a chemical substance, they are required to submit a notice of their intentions to EPA not less than 90 days before beginning to manufacture, import or process the substance for the intended use.


6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

      This section presents estimates of the cost and burden associated with the recordkeeping and reporting requirements for significant new use rules for existing chemicals under TSCA section 5(a)(2). The methodology used to estimate the recordkeeping costs, reporting costs, and burden for this ICR renewal is largely based on previous experience with SNURs, and is consistent with the analysis presented in the supporting statement prepared for the previous ICR. This ICR is updated from the previous ICR (February, 2009) to account for the changes in burden resulting from Updated assumptions and corrections to prior analyses.
      
      To comply with the regulation, manufacturers (including importers) must complete the activities listed in Table 1. Table 1 also provides a cross-walk of the related Information Collection that corresponds to each activity.
      
Table 1: Cross-Walk between Industry Activities and Related Information Collections (ICs)
Activity
Description
Related IC(s)
Chemical verification 
When a SNUR is published, companies must review the rule to verify whether a chemical they manufacture or import is subject to the rule
Chemical Verification

Rule familiarization
Site staff must familiarize themselves with the requirements of the rule. This entails reading the rule, understanding the various reporting and administrative requirements, and determining the manner in which the reporting requirements will be met.
Rule Familiarization
CDX registration, electronic signature agreement, and Pay.gov account set up 
Before submitting a SNUN, all respondents must register with CDX. In addition, respondents must complete an Electronic Signature Agreement form, which is signed, dated, and either submitted electronically or mailed back to EPA, and register for a Pay.gov account.
CDX Registration Activities
Preparation of reports (form completion and form submission)
Site staff must collect all information required for a SNUN and submit an electronic SNUN form. Firms must also keep records supporting their submissions. 
Prepare and Submit Report, and Maintain Records
      
    6(a) 	Estimating Respondent Burden

    Number Of Significant New Use Notices Projected

    During the years 2008 through 2011, EPA proposed two existing chemical SNURs under TSCA section 5(a)(2). This activity may increase over the next three-year period as EPA initiates a comprehensive approach to enhance the Agency's existing chemicals management program.  However, EPA cannot estimate future SNUR activity with certainty.
    
    Therefore, based on past ICRs and the best professional judgment of Agency staff, EPA is estimating it will promulgate an average of five existing chemical SNURs per year under TSCA section 5(a)(2) during the time period covered by this ICR.

      EPA may receive SNUNs as a result of SNURs.  EPA's experience is that in response to promulgation of well over 1,000 SNURs under both its new and existing chemicals programs, the Agency receives on average only 7 SNUNs per year, based on fiscal year (FY) 2001  -  FY2011 submissions. Of those SNUNs, only a fraction result from existing chemical SNURs promulgated under section 5(a)(2). 
       
           Table 2: Anticipated Number of SNURs and SNUNs
                                     Year
                          Anticipated Number of SNURs
                          Anticipated Number of SNUNS
                                  First Year
                                        5
                                       7
                                  Second Year
                                        5
                                       7
                                  Third Year
                                        5
                                       7
                               Three Year Totals
                                      15
                                      21

      Using SNUN submission data from the ten year period of FY2001 through FY2011, EPA estimates that the average firm submits 1.65 SNUNs. This may be an overestimate because it was not determined whether the SNUN submissions were in response to new or existing chemical SNURs. The exact number of firms engaging in new uses cannot be estimated, however given the estimated number of SNUNs and firms submitting SNUNs, EPA estimates a total of 4.24 firms will be impacted annually (7 SNUNs/1.65 firms). Given the uncertainty in projecting possible new uses for existing chemicals, it is not possible to determine whether a large or small number of firms would be affected by any given SNUR.

      6(a)	Estimating Respondent Burden

      (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 regardless of whether they engage in a significant new use unless certain information can be demonstrated.  However, without prior knowledge of chemicals which would be the subject of future SNURs, estimating the number of potentially affected entities subject to 40 CFR 721.5(a)(2) is not possible.

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

      (ii) Burden Estimates

      TSCA section 5(a)(2) imposes two requirements on industry. First, manufacturers, processors, and importers of chemicals must choose among the options mentioned above. This section presents estimates of submitting SNUNs (i.e., the first option) and then briefly discusses the other four options. Second, manufacturers, processors, and importers of chemicals covered by SNURs will incur burden and costs to notify customers of the hazards posed by the covered chemical. Therefore, they must first determine if their chemical is subject to the SNUR and then must determine how to notify their customers.
      
      Chemical Verification

      When a SNUR is published, companies must review the rule to verify whether their chemical is subject to the rule. From 2007 to 2011, the majority of SNURs promulgated by the Agency under TSCA section 5(a) applied to new chemicals submitted to the Agency under the Premanufacture Notice Program. Only two SNURs applying to existing chemicals were proposed during the same time period but were not finalized. These SNURs proposed to regulate an average of seven chemicals. The Agency typically notifies the manufacturer(s) of chemicals subject to a SNUR prior to its issuance. Therefore it is estimated that no more than 0.167 hours (10 minutes) of technical labor time per chemical is used to verify that a chemical is subject to the rule. This is equivalent to 1.17 hours (0.167 hours/chemical x 7 chemicals/SNUR) per SNUR.
      
      Rule Familiarization

      Staff at firms who are subject to the SNUR must become familiar with the SNUR and its various requirements. In EPA's best professional judgment, rule familiarization is estimated to be equivalent to the burden for companies to become familiar with the Premanufacture Notification Electronic Reporting Rule, which requires the mandatory electronic reporting of SNUNs and other TSCA section 5 notices; 0.55 hours of technical labor and 0.27 hours of managerial labor, as described in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a). 
      
Table 3: Rule Familiarization Burden for SNUR Submitters
Activity
                                Clerical Hours
                                Technical Hours
                               Managerial Hours
                                  Total Hours





Rule familiarization
                                     0.00
                                     0.55
                                     0.27
                                     0.83






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

      First-time submitters of any section 5 notice (including Premanufacture Notices (PMNs), Significant New Use Notices (SNUNs), Test Market Exemption (TME) applications, Low Volume Exemption (LVE) notices, Low Exposure/Low Release (LoREX) exemption notices, Biotechnology Notices for genetically modified microorganisms, Notices of Commencement of Manufacture or Import (NOCs), and support documents to section 5 notices) are required to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account.  These activities are only required of first-time submitters of any section 5 notice. It is not known how many submitters of  SNUNs from existing chemical SNURs will be first-time submitters of any section 5 notices, therefore, EPA assumes that all submitters will incur these costs. These activities are estimated to require the following burdens, based on the estimates presented in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a):
      
               *       CDX registration: EPA estimates that companies will spend approximately 0.18 hours per employee to register with CDX, and that an average of four technical staff members and one manager will need to register for each company, totaling approximately 0.92 hours of burden per company.
               *       CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee. This burden will apply to four technical staff members and one manager per company, totaling 1.25 hours of burden per company. In addition, EPA estimates that a manager will spend an additional 0.50 hours accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by companies submitting and then verifying electronic signature agreements is 1.75 hours. Note that this burden does not include any additional time required to contact EPA's CDX help desk to notify a change of submitter status, should one occur. 
               *       Payment via Pay.gov account: EPA estimates that one manager per company will spend approximately 0.13 hours setting up a Pay.gov ID account, logging into the system, finding the appropriate form, and filling it out. This burden does not include the time required to click `submit' on the form and wait for payment processing.
      
Table 4: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Burden for First-Time Submitters
Activity
                                Clerical Hours
                                Technical Hours
                               Managerial Hours
                                  Total Hours





CDX registration
                                     0.00
                                     0.73
                                     0.18
                                     0.92
CDX electronic signature
                                     0.00
                                     1.00
                                     0.75
                                     1.75
E-payment (Pay.gov ID)
                                     0.00
                                     0.00
                                     0.13
                                     0.13
Total
                                     0.00
                                     1.73
                                     1.07
                                     2.80

      Submitting a SNUN 
      
      In 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. Under the ICR for PMNs, OMB Control No. 2070-0012, EPA used mid-range burden estimates of 105 hours for reporting and two hours for recordkeeping per response (total 107 hours) for new chemical SNUNs. This approach was also followed in EPA's April 2010 Request for a Non-Substantive Change to an Existing Approved Information Collection for this ICR (OMB Control No. 2070-0038). The 105 hour reporting burden estimate originated from EPA's 1994 Regulatory Impact Analysis (RIA) of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994) .
      
       The April 2010 non-substantive change also reallocated certain paperwork activities or information collections from a rule-related ICR (OMB Control No. 2070-0173) reflecting the burden from the Agency's e-PMN rule (75 FR 773), thereby adjusting reporting and recordkeeping burden for Existing Chemical SNUNs to 92.2 hours reporting burden and 1 hour recordkeeping burden for a total of 93.2 hours as shown in Table 5 below. 

 
Table 5: Reporting and Recordkeeping Burden Hour Program Changes due to e-PMN Rule (Per Response) as Reported in OMB No. 2070-0012, EPA ICR No. 0574.14
                               Existing Chemicals
                           SNUN Submission Activity
                    Response Burden prior to e-PMN[1] rule
                            Burden Reduction due to
                                  e-PMN rule
                                Response Burden
                               after e-PMN rule
Reporting
                                      105
                                     -12.8
                                     92.2
Recordkeeping
                                       2
                                      -1
                                       1
Total
                                      107
                                     13.8
                                     93.2

The 93.2 hours for response burden after the e-PM rule serve as the baseline SNUN reporting and recordkeeping hours for this ICR must be adjusted because recordkeeping burden has been miscalculated.  As noted above, the reporting burden of 105 from which the 93.2 hours is ultimately estimated, is based on a the 1994 Regulatory Impact Analysis of Amendments(RIA) to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994).  The RIA estimates already accounted for recordkeeping  because the burden estimates "include the time spent reading and becoming familiar with the form, gathering the required information and preparing the report, producing sanitized responses for items claimed as confidential business information, and maintaining a file of the submission" (emphasis added) (EPA 1994, pg. III-14). The 2 hour recordkeeping burden included in the response burden prior to the e-PMN rule is actually based on the recordkeeping burden for polymer exemptions (EPA 1994, pg. III-14) and adds to those already included in the 105 reporting burden hours.  Therefore this additional 2 hours is actually double counting the recordkeeping burden.  Correcting for this error removes the entire recordkeeping hours from the response burden prior to the e-PMN rule.  Additionally, the 12.8 hours of burden reduction due to the e-PMN rule is clerical burden and accounts for the burden reduction from electronic submission (EPA, 2009a). EPA assumes that any reduction in recordkeeping burden was captured in the reduction of the clerical burden, and does not consider the one hour recordkeeping burden reduction from the e-PMN rule in order to avoid double counting. Therefore, the total response burden for SNUN submissions has been adjusted in this ICR to 92.2 hours/SNUN (Table 6).  
Table 6: Adjusted Reporting and Recordkeeping Burden Hours for SNUN Submissions 
 Existing Chemicals 
 SNUN Submission Activity
                     Response Burden prior to e-PMN[1] rule
                            Burden Reduction due to 
                                   e-PMN rule
                                Response Burden 
                                after e-PMN rule
 Reporting and recordkeeping
                                      105
                                     -12.8
                                      92.2

Table 7 shows the adjusted burden hours for filing a SNUN by labor category.
Table 7: Adjusted Unit Reporting Burden Estimates, Associated with Filing a SNUN by Labor Category
Activity
                                Clerical Hours
                                Technical Hours
                               Managerial Hours
                                  Total Hours





Burden hours prior to e-PMN rule[1]
                                   12 to 14
                                  (Avg. =13)
                                   67 to 80
                                  (Avg.=73.5)
                                   16 to 20
                                  (Avg. = 36)
                                    105[1]
e-PMN rule change
                                      -13
                                     .18 
                                       
                                     12.8
Totals
                                       0
                                67.18 to 80.18
                                (Avg. = 73.68)
                                   16 to 20
                                  (Avg. = 18)
                                83.18 to 100.18
                                (Avg. = 91.68)
                                   92.2[2] 
[1]Rounded from 104.5.
[2]Based on the calculation using the rounded 105 hours  -  12.8 hours = 92.2 hours.
      
      Alternative Options

      Should a company choose to request an equivalency determination (i.e., the second option), or review for modification/revocation (i.e., the fourth option), EPA estimates that a data collection and preparation effort similar to that of a SNUN would be required, and thus the burden is estimated to range up to 92.2 hours for these alternatives, the same as for submitting a SNUN.

      In complying with a SNUR, a company would incur costs to ensure all provisions of the SNUR were implemented at the subject facility (i.e., the third option). Since the nature of such provisions will vary depending on the significant new uses identified in each respective SNUR, estimating burden at this time is not possible. In addition to costs of implementation, firms choosing this option will have minor costs associated with keeping records that document compliance with SNUR conditions for avoiding a Significant New Use. Such recordkeeping requirements may involve copying and filing relevant records, including those related to: category of use and marketing, and production volume. Records would typically be required to be maintained for five years from the date of their creation. Previous existing chemical SNUR ICRs have estimated recordkeeping requirements to be five percent of the reporting burden for a certain activity (EPA, 2009b). Per-activity burdens are taken from the midpoint estimate burdens of each section of the SNUN form (EPA, 1994).  The recordkeeping burdens per significant new use are estimated to range from 0.01 hours (0.25 * 0.05) for keeping records of trade names and chemical synonyms to 0.76 hours (15.25 * 0.05) for keeping records of sites controlled by others. The total recordkeeping burden per firm will depend on the significant new use(s) identified.   

      The final alternative for a company considering a significant new use of a chemical which is the subject of a SNUR is to forgo the new use (i.e., the fifth option). In carrying out such a response, the company would incur no direct regulatory burden or costs.

      Customer Notification
      
      Manufacturers, processors, and importers of chemicals subject to SNURs must notify recipients of such chemicals of the SNUR or verify that knowledge of the SNUR has been otherwise acquired by recipients, or that the recipients are unable to engage in significant new uses. Since it is not expected that all such entities will have complete knowledge of all uses of any products subject to a SNUR, and because filing a SNUN could require significantly more burden, it is assumed that manufacturers, processors, and importers will most often choose to notify their customers of SNUR regulatory activities. As this notification may be accomplished by simply annotating an MSDS, EPA estimates the associated burden to be about one hour of a technical employee's time per manufacturer, processor, or importer per chemical. EPA estimates that each SNUR will cover approximately 7 chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers per chemical. Therefore, the burden per SNUR is estimated to be 14 hours per SNUR.

      Summary of Unit Burdens
      
      The following table summarizes the burdens for the activities required under a SNUR, under compliance option 1. 
      
                  Table 8: Summary of Unit Burdens
Collection Activity
                            Estimated Burden Hours
Chemical verification (per SNUR)
                                     1.17


Rule Familiarization (per company)
                                     0.83
CDX registration, electronic signature, and Pay.gov account set-up (per company) 
                                      2.8
SNUN preparation (per report)
                                     92.2


Notifying customers (per SNUR)
                                      14





6(b)	Estimating Respondent Costs

The unit costs of filing a SNUN are estimated by monetizing the labor time spent preparing the SNUN and then adding any fixed costs associated with filing a SNUN. This section derives these unit costs.

      (i) 	Wages

      EPA multiplied burden estimates by standard wage rates for managerial, technical, and clerical levels developed from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b). Wage data for the three occupational categories were gathered for manufacturing industries from Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006  -  December 2010 (BLS, 2011a).

      The cost of fringe benefits, such as health insurance and vacation, is taken for each labor category from the same ECEC series. Following the methodology outlined in EPA 2002b, fringe benefits are calculated as a percentage of total wages for each category. EPA added 17 percent to the wages in each category to account for overhead, based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). The wages for each of the three categories were then multiplied by benefits and overhead factors to estimate loaded, annual salaries in year 2010 dollars. Table 9 contains the loaded wage rates for the managerial, technical and clerical occupation categories. 

Table 9: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in 2010$ 
                                       
                                       
                                       
                                    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
                                    $17.36 
                                    $8.67 
                                    48.37%
                                      17%
                                     1.67
                                    $28.98
Technical
                                    $36.93 
                                    $18.50 
                                    47.58%
                                      17%
                                     1.67
                                    $61.71
Managerial
                                    $42.82 
                                    $19.64 
                                    45.03%
                                      17%
                                     1.63
                                    $69.74 
[1] Employer Costs for Employee Compensation Supplementary Tables: Historical Data December 2006  -  December 2010, US Bureau of Labor Statistics, March 2011 (BLS, 2011a).
[2] An overhead rate of 17 percent was estimated based on industry data gathered for the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a).
 
      (ii) 	Summary of Unit Costs

	Costs for Chemical Verification

      The Agency estimates that chemical verification will require 1.17 technical hours per SNUR. The total estimated cost per SNUR is estimated to be $72.14 (1.17 hours per SNUR x $61.71) 
      
      Costs for Rule Familiarization

      EPA estimates rule familiarization costs will require 0.83 hours per firm and total costs are expected to be $52.54. 
      
	Costs for CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup

      First-time submitters of any section 5 Notice are required to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account. EPA estimates that companies will spend approximately $58.03 on CDX registration, $114.01 on completing the Electronic Signature Agreements, $2.30 mailing electronic signature agreements, and $9.30 setting up a Pay.gov account. Therefore the total expected costs associated with CDX registration, completing and mailing an electronic signature agreement and setting up a Pay.gov account is approximately $184. 
       
Table 10: CDX Registration, CDX Electronic Signature, and Pay.gov Account Setup Cost for First-Time Submitters
Activity
                        Clerical Labor (at $29.98/hour)
                       Technical Labor (at $61.71/hour)
                       Managerial Labor (at $69.74/hour)
                        Total Labor Cost (2010 dollars)





CDX registration
                                     $0.00
                                    $45.25 
                                    $12.78 
                                    $58.03 
CDX electronic signature
                                     $0.00
                                    $61.71 
                                    $52.30 
                                   $114.01 
Mailing cost
                                       
                                     $2.30
E-payment (Pay.gov ID)
                                     $0.00
                                    $0.00 
                                    $9.30 
                                    $9.30 
Total
                                     $0.00
                                    $106.96
                                    $74.38
                                    $183.64

      Costs for Submitting a SNUN

      Using these labor wage rates and midpoint burden estimates presented above, EPA estimates that the labor cost associated with filing a SNUN is $5,802. In addition, SNUN filers must pay a $2,500 user fee to EPA. Thus, the total cost of filing a SNUN is approximately $8,302. 

Table 11: Unit Reporting Cost Estimates, Associated with Filing a SNUN by Labor Category 
Activity
                        Clerical Labor (at $29.98/hour)
                       Technical Labor (at $61.71/hour)
                       Managerial Labor (at $69.74/hour)
                        Total Labor Cost (2010 dollars)





SNUN preparation
                                     $0.00
                                   $4,546.79
                                   $1,255.32
                                    $5,802
User fee
                                       
                                    $2,500
Total
                                     $0.00
                                   $4,546.79
                                   $1,255.32
                                    $8,302

	Alternative Responses
	
      As noted in section 4, five alternative responses to any particular SNUR could be chosen by firms planning to engage in significant new uses of subject chemicals. Although EPA has not projected or quantified how frequently these alternatives might be selected, the unit costs associated with each option are discussed briefly below.
      
      The estimated burden of requesting an equivalency determination (the second option) or review for modification/revocation (the fourth option) was judged to be similar to filing the SNUN; thus, total costs including the EPA user fee were estimated to be $8,302. However, the firm may incur additional costs in developing the data necessary to justify the alternative.  This option will be preferable to compliance with the SNUR if the total cost of obtaining EPA approval of a request is less than the costs of SNUR compliance.
      
      Firms choosing to comply with a SNUR (the third option), will incur costs to ensure all provisions of the SNUR were implemented at the subject facility and to implement recordkeeping. The costs of implementing provisions at a facility were not quantified for this ICR. Recordkeeping is expected to range from 0.01 hours to 0.76 hours for each significant new use. All recordkeeping activities are expected to be conducted by clerical staff, therefore recordkeeping costs range from $0.36 to $22.10 per significant new use. The total recordkeeping burden per firm will depend on the significant new use(s) identified.      
      
	Customer Notification

      EPA assumes that the customer notification requirement will be handled by technical labor. Section 5 of this analysis assumed that one hour of labor per chemical would be required to perform the notification, thus the unit cost of notification is estimated to be $61.71 (i.e., the hourly wage for technical labor). EPA estimates that each SNUR will cover approximately 7 chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers per chemical. Therefore, the burden per SNUR is estimated to be 14 hours per SNUR ([7 chemicals per SNUR]*[1 hour per manufacturer, processor, or importer]*[2 manufacturers, processors, or importers per chemical]), and the cost per SNUR is equal to $863.90 [($61.71per hour)*(14 hours per SNUR)].

	Summary

      Table 12 summarizes the unit costs estimated in this section. Reviewing a SNUR to verify that a chemical is included is estimated to cost $419.63 per SNUR and notifying customers is $863.90 per SNUR. The cost of completing and submitting a SNUN is approximately $8,302.11. EPA estimates the costs associated with rule familiarization to be $50.92 per company, and CDX registration activities to be $183.64 per company 
      
                  Table 12: Summary of Unit Costs
Collection Activity
Estimated Cost
Chemical verification (per SNUR)
     $72.14


Rule familiarization (per company)
     $52.54
CDX registration, electronic signature, and Pay.gov account set-up (per company) 
   $183.64
SNUN preparation* 
$8,302.11 
Notifying customers (per SNUR)
   $863.90


		* Includes $2,500 user fee per SNUN.

      (i) Total Burden and Costs to Industry 

      This section provides estimates of the total burden and costs imposed by the TSCA section 5(a) requirements. These estimates can be divided into five categories: chemical verification, rule familiarization, submitting SNUNs, CDX registration activities, and notifying customers.

      The total cost and burden imposed on industry by TSCA section 5(a)(2) requirements can be calculated by multiplying the unit burden and cost estimates by the expected number of SNURs, SNUNs, and firms. As noted above, this analysis assumes that EPA will promulgate five SNURs and receive seven SNUNs per year. Table 13 presents the annual burden and cost to the industry. EPA estimates the total annual industry burden of existing chemical SNUR action is 736 hours and $63,799. 
            
Table 13: Estimated Annual Respondent Burden and Cost
                        Information Collection Activity
                       Total Burden per Activity (hours)
                            Total Cost per Activity
                                    (2010$)
                        Total Number of Units Annually
                          Total Annual Burden (hours)
                           Total Annual Cost (2010$)
Rule familiarization (per firm)
                                     0.83
                                      $53
                                  4.24 Firms
                                     3.52
                                     $225
Preparation, submission, and recordkeeping for SNUN (per report)
                                     92.2
                                    $8,302 
                                    7 SNUNs
                                      645
                                    $58,114
CDX registration, electronic signature, Pay.gov set-up  (per firm)
                                      2.8
                                     $184
                                  4.24 Firms
                                     11.88
                                     $781
Chemical verification (per SNUR)
                                     1.17
                                      $72
                                    5 SNURs
                                     5.85
                                     $360
Notifying customers (per SNUR)
                                      14
                                     $864
                                    5 SNURs
                                     70.00
                                    $4,320
Total Industry Burden and Cost 
                                      736
                                    $63,799
Some burden estimate totals may not calculate due to rounding of unit burden estimates 
      
      Table 14 presents the total burden and cost to the industry over the three-year ICR period. EPA estimates the total annual industry burden of existing chemical SNUR action is 2,208 hours and $191,398.
       
Table 14: Estimated Total Respondent Burden and Cost, Three Year Totals
                        Information Collection Activity
                       Total Burden per Activity (hours)
                            Total Cost per Activity
                                    (2010$)
                            Total Number of Units 
                          Total Annual Burden (hours)
                           Total Annual Cost (2010$)
Rule familiarization (per firm)
                                     0.83
                                      $53
                                  12.72 Firms
                                     10.56
                                     $675
Preparation, submission, and recordkeeping for SNUN (per report)
                                     92.2
                                    $8,302 
                                   21 SNUNs
                                     1,936
                                   $174,342
CDX registration. electronic signature, Pay.gov set-up (per firm)
                                      2.8
                                     $184
                                 12.72 Firms 
                                     35.64
                                    $2,342
Chemical verification (per SNUR)
                                     1.17
                                      $72
                                   15 SNURs
                                      18
                                    $1,080
Notifying customers (per SNUR)
                                      14
                                     $864
                                   15 SNURs
                                      210
                                    $12,960
Total Industry Burden and Cost 
                                     2,210
                                   $191,398
Some burden estimate totals may not calculate due to rounding of unit burden estimates 
      
      Table 15 presents the annual burden by collection activity. Chemical verification is expected to have a total burden of 5.85 hours annually. Notifying consumers is expected to have burden of 70 hours annually. Companies are expected to incur a total of 3.52 hours for rule familiarization, 11.88 hours for CDX registration activities and a total of 645 hours for SNUN completion, each year.


Table 15: Annual Information Collection Tally for ICR Reporting Period (2012-2015)
                            Information Collection
                                    No. of 
                                  Respondents
                         No. of Responses / Respondent
                              Responses Subtotal
                       Annual Burden Hours per Response
                       Annual Burden Hours per Activity
                              Per Firm Activities
Rule familiarization
                                     4.24
                                       1
                                     4.24
                                     0.83
                                      3.52
CDX registration activities
                                     4.24
                                       1
                                     4.24
                                     2.80
                                     11.88
   oo    CDX registration
                                     4.24
                                       1
                                     4.24
                                     0.92
                                      3.89
   oo    ESA
                                     4.24
                                       1
                                     4.24
                                     1.75
                                      7.42
   oo    Pay.gov account 
                                     4.24
                                       1
                                     4.24
                                     0.13
                                      0.57
Preparation, submission, and recordkeeping for SNUN
                                     4.24
                                     1.65
                                       7
                                     92.2
                                      645
                              Per SNUR Activities
Chemical verification
                                       5
                                       1
                                       5
                                     1.17
                                     5.85
Notifying customers (per SNUR)
                                      35
                                       2
                                      70
                                       1
                                     70.00
 Some burden estimate subtotals may not calculate due to rounding of unit burden estimates 

      Table 16 presents the total burden hours for the ICR period (2012 - 2015), organized by information collection. Chemical verification is expected to have burden of 17.55 hours over the three year period. Notifying consumers is expected to have burden of 210 hours over the three year period. Companies are expected to incur at total of 10.56 hours for rule familiarization, 35.64 hours for CDX registration activities and a total of 1,936 hours for SNUN completion, submission and recordkeeping over the three year period.

Table 16: Total Information Collection Tally for ICR Reporting Period (2012- 2015)
                            Information Collection
                                    No. of 
                                  Respondents
                         No. of Responses / Respondent
                              Responses Subtotal
                        Total Burden Hours per Response
                          Total Burden Hours Subtotal
                              Per Firm Activities
Rule familiarization
                                     12.72
                                       1
                                      13
                                     0.83
                                     10.56
CDX registration activities
                                     12.72
                                       1
                                      13
                                     2.80
                                     35.64
   oo    CDX registration
                                     12.72
                                       1
                                      13
                                     0.92
                                     11.67
   oo    ESA
                                     12.72
                                       1
                                      13
                                     1.75
                                     22.27
   oo    Pay.gov account 
                                     12.72
                                       1
                                      13
                                     0.13
                                     1.70
Preparation, submission, and recordkeeping for SNUN
                                     12.72
                                     1.65
                                      21
                                     92.2
                                     1,936
                              Per SNUR Activities
Chemical verification
                                      15
                                       1
                                      15
                                     1.17
                                     17.55
Notifying customers (per SNUR)
                                      105
                                       2
                                      210
                                       1
                                      210
 Some burden estimate subtotals may not calculate due to rounding of unit burden estimates 

	6(c)	Estimating Agency Burden and Cost 

      (i) SNUN Processing

      EPA's costs to review and process SNUNs are assumed to be the same as EPA costs to review PMNs. The list of review steps, estimates of extramural costs, and the percent of chemicals requiring a particular review step are derived from the costs for processing PMN submissions in Table VII-1 of EPA's Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications (EPA, 1994). The Agency burden associated with processing a PMN has been adjusted to reflect burden reductions resulting from the ePMN rule that requires the electronic submission of all TSCA section 5 notices. Electronic submission of SNUN forms is expected to reduce Agency burden by 16.5 percent (EPA, 2009a, p.28). The Extramural Cost column shows costs for contractor support and other outside purchases for chemicals requiring the selected review step, and is inflated from 1993 prices using the Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) data (BLS, 2011b). The not seasonally adjusted ECI for total compensation of private industry professional and related workers (Series ID CIU2010000120000I) is used because it is the only series with continuous data since 1985, and that includes professional and technical labor, which perform the majority of Agency extramural activities. Table 17 contains the derivation of inflation factors for Agency extramural costs.


      
   Table 17: Derivation of Inflation Factors for Agency Extramural Costs 
                                     Item
                           Inflation index source[1]
                                 Starting year
                          Index for starting year (a)
                              Index for 2010
(b)
                         Inflation factor 
(b)/(a)[2]
                           Agency extramural costs 
                    White collar labor; equipment; supplies
BLS ECI, NSA, Total comp, Private industry, Professional and related, 4[th] Q [BLS 2011 b]
                                     1993
                                     67.0
                                     113.5
                                     1.694
Notes:
[1] In 2006, Bureau of Labor Statistics (BLS) Employment Cost Index (ECI) series "were rebased to December 2005 = 100 from June 1989 = 100."  The change is reflected in the indices in this table and explained on the BLS website, Employment Cost Index News Release Text: Employment Cost Index, March 2006 (BLS, 2006).
The "Starting year" ECI index is SIC-OCS based: ECS11102I for private industry White Collar Workers.  The index is Seasonally Adjusted (SA).
The year 2010 ECI index is NAICS-SOC based: CIU2010000120000I (B) for private industry White Collar Workers.  The index is Seasonally Adjusted (SA).
2 Inflation factors are rounded to three decimal places in this table, but calculations in this report use the unrounded values.  BLS CPI values were published with one decimal place through 2006 and with three decimal places after that.
      
      Agency labor costs are calculated based on annual federal salaries for the Washington-Baltimore area published by the Office of Personnel Management effective January 2010 (OPM, 2010). EPA assumes that, on average, a federal GS-13, Step 5 full-time equivalent (FTE) will conduct its collection and administrative activities7. The average salary for a GS-13 Step 5 employee was $100,904 in 2010 without fringe benefits and overhead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary of $161,446.40 Dividing the fully loaded annual salary by 2,080 hours (i.e., the number of hours in a work year) yields an hourly FTE wage rate of $77.62.
      
      Total Agency costs are expected to be $5,049, per SNUN, for submission review and processing, as shown in Table 18.
      
      
      



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

Table 18: Agency Costs for SNUN and Other Submission Review and Processing
Review Steps
EPA staff (FTE) Cost
Extramural Cost [2]
Unweighted Cost
Pct. of Cases
Weighted Cost[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 ($2010)
1993 dollars
2010 dollars







(a)
(b)
(c)=(a)*(b)
(d)
(e)
(f)=(c)+(e)
(g)
(h)=(f)*(g)
(i)
(j)=(h)*(1-(i))
(k)=(a)*(g)*(1-(i))
Pre-notice consultation
                                    0.0024
                                   $161,446
                                    $387.47
                                     $4.00
                                     $6.78
                                     $394
                                      41%
                                    $161.64
                                     0.165
                                     $135
                                    0.0008
Administrative prescreen/ notice receipt/user fee
                                    0.0024
                                   $161,446
                                    $387.47
                                    $92.00
                                    $155.85
                                     $543
                                     100%
                                    $543.32
                                     0.165
                                     $454
                                    0.0020
CRSS (Chemical Review and Search Strategy)
                                    0.0025
                                   $161,446
                                    $403.62
                                    $268.00
                                    $454.00
                                     $858
                                     100%
                                    $857.62
                                     0.165
                                     $716
                                    0.0021
SAT (Structure Activity Team)
                                    0.0006
                                   $161,446
                                    $96.87
                                    $14.00
                                    $23.72
                                     $121
                                     100%
                                    $120.58
                                     0.165
                                     $101
                                    0.0005
Engineering/Exposure
                                    0.0015
                                   $161,446
                                    $242.17
                                    $56.00
                                    $94.87
                                     $337
                                     100%
                                    $337.04
                                     0.165
                                     $281
                                    0.0013
Exposure/Fate
                                    0.0008
                                   $161,446
                                    $129.16
                                     $0.00
                                     $0.00
                                     $129
                                     100%
                                    $129.16
                                     0.165
                                     $108
                                    0.0007
Focus
                                    0.0009
                                   $161,446
                                    $145.30
                                    $23.00
                                    $38.96
                                     $184
                                     100%
                                    $184.26
                                     0.165
                                     $154
                                    0.0008
Standard Review Functions
                                    0.0219
                                   $161,446
                                   $3,535.68
                                    $511.00
                                    $865.65
                                    $4,401
                                      29%
                                   $1,276.38
                                     0.165
                                    $1,066
                                    0.0053
Division Directors Meeting
                                    0.0129
                                   $161,446
                                   $2,082.66
                                    $113.00
                                    $191.43
                                    $2,274
                                      15%
                                    $341.11
                                     0.165
                                     $285
                                    0.0016
Order Development/Negotiation Review
                                    0.0171
                                   $161,446
                                   $2,760.73
                                    $22.00
                                    $37.27
                                    $2,798
                                      3%
                                    $83.94
                                     0.165
                                      $70
                                    0.0004
Post Order Data Review
                                    0.0886
                                   $161,446
                                   $14,304.
                                     $0.00
                                     $0.00
                                    $14,304
                                      3%
                                    $429.12
                                     0.165
                                     $358
                                    0.0022
Order Modification
                                    0.2167
                                   $161,446
                                  $34,985.43
                                     $0.00
                                     $0.00
                                    $34,985
                                      3%
                                   $1,049.56
                                     0.165
                                     $876
                                    0.0054
New Chemical SNUR Development
                                    0.0277
                                   $161,446
                                   $4,472.07
                                    $85.00
                                    $143.99
                                    $4,616
                                      7%
                                    $323.12
                                     0.165
                                     $270
                                    0.0016
Notices of Commencement
                                    0.0012
                                   $161,446
                                    $193.74
                                    $40.00
                                    $67.76
                                     $261
                                      31%
                                    $81.06
                                     0.165
                                      $68
                                    0.0003
FOIA (Freedom of Information Act) Requests
                                    0.0333
                                   $161,446
                                   $5,376.17
                                    $287.00
                                    $486.19
                                    $5,862
                                      1%
                                    $58.62
                                     0.165
                                      $49
                                    0.0003
CBI (Confidential Business Information) Substantiation
                                    0.0004
                                   $161,446
                                    $64.58
                                     $3.00
                                     $5.08
                                      $70
                                     100%
                                    $69.66
                                     0.165
                                      $58
                                    0.0003
TOTAL
                                    $6,046 
                                     0.165
                                    $5,049 
                                    0.0256
Notes:
[1] GS-13 Step 5 salaries loaded with benefits and overhead. [2] Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process inflated from 1993. 
3 Weighted costs were calculated using unrounded unit cost estimates, so results may differ from calculations using the rounded values shown in this table. 
[4] Electronic submission is expected to generate a cost savings of 16.5% to the Agency (EPA 2009a, p. 28).
Sources: FTEs per review step, 1993 extramural costs, and percents of cases are from EPA, 1994 Table VII-1, GS-13 salaries are from OPM, 2010.


      Using the estimates of annual SNUR promulgation and SNUR notice submissions presented above, EPA's estimated costs are presented in Table 19. Processing SNUNs is estimated to cost the Agency $35,343 annually. The Agency may also incur a cost for modifying a SNUR if submitted data indicate a need for such an action. Costs to perform such a modification have not been estimated.

Table 19: Annual Agency Costs
                                   Activity
                        Total Burden per Activity (FTE)
                       Total Burden per Activity (Hours)
                        Total Cost per Activity (2010$)
                            Total Number of Units 
                          Total Annual Burden (hours)
                           Total Annual Cost (2010$)
SNUN processing
                                    0.0256
                                     $53 
                                    $5,049 
                                    7 SNUNs
                                    373.07
                                   $35,343 
Some burden estimate subtotals may not calculate due to rounding of unit burden estimates 
	
	Table 20 presents the total Agency cost for SNUN processing over the three year ICR period, $106,029. 
                                       
Table 20: Total Agency Costs
                                   Activity
                        Total Burden per Activity (FTE)
                       Total Burden per Activity (Hours)
                        Total Cost per Activity (2010$)
                            Total Number of Units 
                          Total Annual Burden (hours)
                           Total Annual Cost (2010$)
SNUN processing
                                    0.0256
                                     $53 
                                    $5,049 
                                   21 SNUNs
                                     1,119
                                   $106,029 
 Some burden estimate subtotals may not calculate due to rounding of unit burden estimates
       
       6(d)	Reasons for Change in Burden
      
      EPA estimates industry will incur a decrease of 440 hours in annual burden compared to the estimate of 1,176 hours in the information collection inventory most recently approved by OMB (Request for a Non-Substantive Change to an Existing Approved Information Collection submitted April 2010). The change is from 1,176 hours in the currently approved inventory to 737 hours as estimated in section 6(b) above. Differences in burden and costs are attributed to adjustments. Adjustments capture changes in the baseline burden not included in the currently approved ICR. These changes result from updates to the number of affected sites and responses, and the correction of estimates in the previous ICR. As shown in Table 21, EPA estimates an annual 440 hour burden decrease as a result of adjustment changes. More details on the adjustments are outlined below.

            Adjustment Changes

      The currently approved ICR estimated that, on average, 10 SNUNs will be submitted annually. Upon review of past SNUN submissions from FY 2001 through FY 2011, this number was reduced from 10 SNUNs per year to 7 SNUNs per year. The previous ICR also assumed that one company will submit a single SNUN. However, reviews of past submissions indicate that the average company will submit 1.65 SNUNs. In addition, a review of SNUNs since 2008 reduced the number of expected chemicals that are affected from 41 to 7 per SNUR. 
      
      The previous ICR used an estimate of 93.3 hours for reporting and recordkeeping for a SNUN. This ICR adjusts that number to 92.2 because the 1 hour of recordkeeping included in the previous ICR is a result of double counting.
      
Table 21: Estimate of Changes in Annual Burden Hours from Previous ICR by Activity
                                   Activity
Annual Burden Increase Due from Adjustment (to Baseline) for R Addendum Period
    Total Burden Increase from Adjustment (to Baseline) for Addendum Period
Rule familiarization (per firm)
                                     1.03
                                       3
Preparation, submission, and recordkeeping for SNUN (per report)
                                    -286.6
                                     -860
CDX registration (per firm)
                                      1.9
                                       6
CDX signature
                                     2.02
                                       6
e Pay
                                     -0.45
                                      -1
Chemical verification (per SNUR)
                                    -28.15
                                      -84
Notifying customers (per SNUR)
                                     -130
                                     -390
Totals
                                    -440.24
                                    -1,321

	6(e)	Burden Statement

      The annual public burden for this collection of information, which is approved under OMB Control No. 2070-0038, is estimated to be approximately 8.1 hours per response. According to the Paperwork Reduction Act, burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above.  In addition, the OMB control numbers for EPA's regulation, after initial display in the final rule, are listed in 40 CFR part 9.

	The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2011-0778, which is available for online viewing at www.regulations.gov, or in person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC.  The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566-0280. You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.

      Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2011-0778 and OMB Control No. 2070-0038, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave., NW, Washington, D.C. 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.

                                  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, 2011a. U.S. Bureau of Labor Statistics. "Employer Costs for Employee Compensation Supplementary Tables December 2010." Accessed March 9, 2011. http://www.bls.gov/ncs/ect/sp/ecsuptc17.pdf .

BLS, 2011b. Bureau of Labor Statistics. Employment Cost Index  -  Total Compensation: Professional and Related Private Industry, Not Seasonally Adjusted. (Series ID: CIU2010000120000I (B)), extracted June 16, 2011. http:/data.bls.gov/cgi-bin/srgate.
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.
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 Analysis 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 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 Paperwork Reduction Act, February 6, 2009.
Office of Personnel Management (OPM), 2010.  Salary Tables 2010-DCB for the Locality Pay Area of Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA.   http://www.opm.gov/oca/10tables/pdf/DCB.pdf 

