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.: 1188.08 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 1TSCA 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.

 2 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) 1. Likewise, the Agency may extend the evaluation period by up to 90 days with good cause. If EPA takes no action at the end of the review period, the submitter can engage in the intended new use without any restrictions.

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

To date EPA has promulgated SNURs on 156 existing chemicals. Presented in Attachment 6 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 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 EPA received comments in response to several individual proposed SNURs. All comments were considered in developing the final rules. It is EPA policy to consider all comments received in response to proposed SNURs.

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  4 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  5 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. Submitters are required to use the Premanufacture Notice ( PMN) form ( EPA Form 7710 25; see Attachment 3), which was developed to facilitate the information collection process for new chemical substances.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities A significant new use rule ( SNUR) on an existing chemical substance is the product of a process that is designed to develop the appropriate information gathering collection for a substance. This process has three major steps: Chemical Referral, Regulatory Selection, and Regulation Development.

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

Step 2. The Regulatory Selection Process  Referral and Review: Once an office has detailed its need for information, an information collection approach is determined that best satisfies that office's needs. The rulemaking options are: a TSCA section 8( a) reporting rule, a TSCA section 8( c) call in, a TSCA section 8( d) health and safety data reporting rule, a TSCA section 5( a)( 2) SNUR, or any combination of the above. It may also be determined that an alternative approach is more appropriate ( e. g., use of existing data sources, no data gathering at the present time, TSCA section 4 or 6 action, or referral to another office for informationgathering under a different statutory authority).  6 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.  7 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 largely consistent with the analysis presented in the supporting statement prepared for the previous ICR. A summary of the steps employed in this analysis is shown below:

Step 1: The total number of SNURs promulgated and SNUNs to be submitted, on an annual basis and for the three year period during which this ICR will be in effect, was projected. The estimate is based on the Agency's experience with SNURs and submission of SNUNs from data covering 2001 2004 fiscal year time frame.

Step 2: The average industry burden associated with recordkeeping, reporting, and customer notification was estimated. The reporting burden estimates used here are taken from an analysis performed in connection with OPPT's amendments to its PMN program.

Step 3: The unit costs for the different activities associated with TSCA section 5( a)( 2) were estimated next ( e. g., submitting a SNUN). The costs were derived by multiplying current estimates of unit labor costs by the burden estimates presented in Step 2.

Step 4: Total industry costs and burden were computed by multiplying the average burden and cost per activity by the expected number of activities.

Step 5: The final step estimates the cost to EPA.

6( a) Estimating Respondent Burden During the years 2001  2004, EPA promulgated two SNURs for existing chemicals and received two existing chemical SNUNs ( US EPA, 2004). The average number of chemicals per existing chemical SNUR during this time period was 41. Based upon the historic information and projected SNUR activity by the Agency, EPA maintains its estimate of three SNURs promulgated and five SNUNs submitted per year consistent with the previous ICR. Furthermore, it is estimated that a total of nine SNURs will be promulgated and 15 SNUNs will be received over the three year time period during which this ICR is effective. These estimates are summarized in Table 1.  8 TABLE 1 ANTICIPATED NUMBER OF SNURs AND SNUNs Year Anticipated Number of SNURs Anticipated Number of SNUNS First Year 3 5 Second Year 3 5 Third Year 3 5 Three Year Totals 9 15 Given the uncertainty in projecting possible new uses for existing chemicals, it is not possible to determine if a large or small number of firms would be affected by any given SNUR, or whether any one firm might engage in more than one new use. Thus, this analysis makes the assumption that no firm submits more than one SNUN. The total number of firms engaging in new uses cannot be estimated.

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 5 options regarding possible courses of action that may generate reporting 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) 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 exposure or 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. 2Unless 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.

 9 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 documented. 2 However, without prior knowledge of chemicals that 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.

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.

Burden Estimates  Chemical Verification When a SNUR is published, companies must review the rule to verify if their chemical is subject to the rule. During the 2001 2004 time frame, 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 promulgated during the same time period. 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) or of technical time per chemical is used to verify if a chemical is subject to the rule. This is equivalent to 6.8 hours ( 0.167 hours/ chemical x 41 chemicals) per SNUR.

Burden Estimates  Submitting a SNUN In submitting a SNUN, individuals at different occupational levels must spend time on the required recordkeeping and reporting activities. In estimating the burden required to prepare a SNUN, the analysis uses the breakdown of activities and activity estimates as developed for the premanufacture notification ( PMN) baseline model in the Agency's " Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications" ( OPPT, 3The burden estimates presented in Table 2 differ from the PMN Amendments analysis, which were based on a Chemical Manufacturers Association survey, only in that burden for researching synonyms and generic chemical names was not included in this analysis. This is because subject chemicals would be existing chemicals, and such information would already be known.

 10 1994). The PMN reporting cost estimates were used because SNUNs would be filed on the standard PMN form. Table 2 presents EPA's estimate of respondent reporting burden associated with the filing of a SNUN. 3 When submitting an SNUN, manufacturers must maintain records associated with the SNUN for five years. In keeping with the conservative assumptions already employed, the high end of the range of reporting burden hours ( i. e., 113.25 hours) will be used in subsequent cost calculations. The recordkeeping associated with preparing and filing a SNUN is assumed to require five percent of the time spent on reporting. Thus, 5.67 record keeping hours ([ 113.25 hours]*[ 5 percent]) will be spent in preparation of a SNUN. The average industry burden per notice, then, is 118.92 hours ( 113.25 + 5.67).

The estimates shown in Table 2 are average burden levels. Thus, it is entirely possible that certain respondents may incur burden above or below the estimates shown above; nevertheless, EPA believes the upper bound of the range of average burden hours to be an appropriate estimate for the calculations performed in this analysis.

Burden Estimates  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 118.92 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.

The final alternative for a company considering a significant new use of a chemical that is the subject of a SNUR is to forgo the new use ( i. e., the fifth option). In carrying out such a response, no direct regulatory burden or costs, would be incurred.  11 Burden Estimates  Customer Notification As noted above, 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. 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 a Material Safety Data Sheet ( MSDS), EPA estimates the associated burden to be about one hour of a technical employee's time per manufacturer, processor, or importer per chemical.  12 TABLE 2 UNIT REPORTING BURDEN ESTIMATES ASSOCIATED WITH FILING A SNUN, BY LABOR CATEGORY Activity Secretarial Hours Technical Hours Managerial Hours Total Hours General information/ instructions 2  2.5 1.5  2 3  4 6.5  8.5 Chemical identity 1.5  2 3  6 1 5.5  9 Trade name ID .25 .25 Byproducts/ impurities identification 1 1 Production & marketing data 1.5 2  3 3.5  4.5 Production volume 1 1 Category of use 3 3 Hazard information 3  4 3  4 Human exposure and environmental release 2.5  3.5 6  7 8.5 10.5 Site information 14  16 14  16 Occupational exposure 13  14 13  14 Environmental release/ disposal 9  10 9  10 Sites controlled by others 2 10  12 2  2.5 14  16.5 List of attachments 2 6  8 1  1.5 9  11.5 Certification .5 .5 Data submissions .5 1.5  2 .5 2.5  3 Totals 12  14 66.25  79.25 16  20 94.25  113.25 Source: OPPT, 1994.

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.  13 Estimating Labor Costs The basic methodology for estimating the industry wage rates used in this analysis is presented in Appendix A. Wage data used to develop the basic industry wage rates are derived from the U. S. Department of Labor, Bureau of Labor Statistics ( BLS) for all goods producing private industries. The annual salary estimates were adjusted to final quarter ( December) 2003 dollars using the BLS Employment Cost Index ( ECI) for white collar occupations for all private industries.

An overhead rate of 17 percent was applied to all wages based on information provided by the chemical industry and chemical industry trade associations. Benefit rates were applied to wages as follows: managerial, 46.6 percent; technical, 45.5 percent; and secretarial, 45.1 percent. Thus, total load factors are 63.6 percent for managerial labor, 62.5 percent for technical labor, and 62.1 percent for secretarial labor. The estimated hourly wage rates are presented in Table 3. Details on the calculation of the wage rates can be found in Appendix A.

TABLE 3 HOURLY WAGE AND LOAD RATES FOR INDUSTRY Labor Category Wage Rate Managerial $ 53.82 Technical $ 46.08 Secretarial $ 24.47 Note: Details on the calculation of these wages can be found in Appendix A.

Labor Costs  Chemical Verification The Agency estimates that chemical verification will require 6.8 hours per SNUR. The total estimated cost per SNUR is estimated to be $ 313 ( 6.8 hours per SNUR x $ 46.08).

Labor Costs  Submitting a SNUN Using these labor wage rates and the burden estimates presented above, EPA estimates that the labor cost associated with filing a SNUN ranges from $ 4,208 to $ 5,071. In addition, SNUN filers must pay a $ 2,500 user fee to EPA. Thus, the total cost of filing a SNUN ranges from $ 6,708 to $ 7,571.  14 TABLE 4 UNIT REPORTING BURDEN ESTIMATES ASSOCIATED WITH FILING A SNUN, BY LABOR CATEGORY Hours Wage Rate Total Cost Secretarial 12 14 $ 24.47 $ 294$ 343 Technical 66.25 79.25 $ 46.08 $ 3,053$ 3,652 Managerial 16 20 $ 53.82 $ 861$ 1,076 Totals 94.25 113.25  $ 4,208$ 5071 Labor Costs  Recordkeeping Recordkeeping requires 5.67 hours per SNUN. Assuming that the recordkeeping is performed by clerical staff, the costs for recordkeeping are $ 139 [ 5.67 hours * $ 24.47 ( clerical labor)].

Labor Costs  Alternative Responses As noted above, 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 range from between $ 6,708 and $ 7,751. 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.

Labor Costs  Customer Notification EPA assumes that the customer notification requirement will be handled by technical labor. 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 $ 46.08 ( i. e., the hourly wage for technical labor). EPA estimates that each SNUR will cover approximately 41 chemicals. Furthermore, EPA assumes that there are two manufacturers, processors, or importers per 4The assumption that there are two manufacturers, processors, or importers per chemical follows from previous ICRs for these requirements.

5This percentage increase is composed of three annual increases: a 4.77 percent increase in 2002, and a 4.27 percent increase in 2003. ( Office of Personnel Management, 2005).

 15 chemical4. Therefore, the burden per SNUR is estimated to be 82 hours per SNUR ([ 41 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 $ 3,779 [($ 46.08 per hour)*( 82 hours per SNUR)].

Labor Costs  Summary Table 5 summarizes the unit costs estimated in this section. Reviewing a SNUR to verify that a chemical is included is estimated to cost $ 313 per SNUR. Submitting a SNUN is estimated to cost between $ 6,708 to $ 7,751 per SNUN and notifying customers is estimated to cost $ 3,779 per SNUR. As noted above, the upper bound cost for filing a SNUN ($ 7,751) will be used in subsequent calculations.

TABLE 5 SUMMARY OF UNIT COSTS Unit Cost Estimated Cost Chemical Verification $ 313 per SNUR Submitting a SNUN Between $ 6,708 and $ 7,751 per SNUN SNUN Record Keeping $ 139 per SNUN Notifying Customers $ 3,779 per SNUR 6( c) Estimating Agency Burden and Cost EPA will incur costs associated with the promulgation of SNURs and the processing of SNUNs. The previous ICR estimated that the cost for issuing a SNUR can be as high as $ 33,207 in 2001 dollars. The Office of Personnel Management reports that federal salaries increased by 9.04 percent ( Washington, D. C. salary including locality adjustment) from 2001 to 2003 ( Office of Personnel Management, 2005) 5. The annual salary for EPA staff used for calculations of Agency costs is an average of the OPM year 2003 annual salaries for GS 12 Steps 1 and 10   $ 58,070 and $ 75,492, respectively, or $ 66,781. Multiplying by an assumed loading factor of 1.6 to reflect fringe benefits and overhead ( Office of Policy Planning and Evaluation, 1992), the loaded annual salary of EPA staff was calculated to be $ 106,850. Dividing the wage by a 12 person months/ year results in $ 8,904/ person month. Consistent with the previous ICR, it is 6The 3.94 person months estimate is from a memorandum from Michael Shapiro, Economics and Technology Division, to Susan Hazen, Office of Toxic Substances ( Shapiro, 1984).

 16 estimated that it will take 3.94 person months of EPA staff time to develop a final SNUR. Therefore, the wage per person month ($ 8,904) multiplied by a 3.94 person months/ SNUR yields an EPA cost per SNUR of $ 35,0826.

EPA's costs to review and process SNUNs are assumed to be the same as EPA costs to review PMNs. These costs are estimated at $ 4,203 per case. The Agency actions required, fulltime equivalent ( FTE) staff needs, and extramural costs such as for contractor support are derived in Appendix B from EPA's analysis of the Agency costs of processing PMN submissions ( RIB, 1994), with updates to 2003 dollars. The original EPA analysis used a range of salaries, but this analysis uses only the average salary.

Using the estimates of annual SNUR promulgation and SNUR notice submissions presented above, EPA's estimated costs are presented in Table 6. Promulgating SNURs and processing SNUNs are estimated to cost the Agency $ 126,261 annually, and $ 378,783 for three years. 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 6 AGENCY COSTS Activity Number Per Year Cost Per Action Annual Cost Three Year Cost SNURs 3 $ 35,082 $ 105,246 $ 315,738 SNUNs 5 $ 4,203 $ 21,015 $ 63,045 Totals 8 $ 39,285 $ 126,261 $ 378,783 Note: Estimates may contain some rounding error caused by rounding dollar values to the nearest whole dollar.

6( d) Total Burden and Cost 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 three categories: chemical verification, submitting SNUNs and notifying customers.

Total Burden and Cost to Industry  Verifying Chemicals 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. As noted above, this analysis assumes that EPA will promulgate three SNURs per year. 7In deriving the totals for this analysis, EPA uses the upper bound estimates for the number of hours and the cost of submitting SNUNs.

 17 Total burden and costs for chemical verification are presented in Tables 7 and 8.

TABLE 7 TOTAL INDUSTRY BURDEN ASSOCIATED WITH CHEMICAL VERIFICATION Activity Hours Per SNUR SNURs per Year Total hours Chemical Verification 6.8 3 20.4 TABLE 8 TOTAL INDUSTRY COSTS ASSOCIATED WITH CHEMICAL VERIFICATION SNURs Per Year Cost Per SNUR Total Annual Cost Three Year Cost 3 $ 313 $ 939 $ 2,817 Note: Estimates may contain some rounding error caused by rounding dollar values to the nearest whole dollar.

Total Burden and Cost to Industry  Submitting SNUNs 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 and SNUNs. As noted above, this analysis assumes that EPA will promulgate three SNURs and receive five SNUNs per year.

Table 9 presents the total burden of submitting SNUNs. This analysis estimated that the reporting requirements for submitting SNUNs would impose 113.25 hours for each SNUN. An additional 5.67 hours are assumed to be required to satisfy recordkeeping requirements. Thus, a total of 118.92 hours are required for each SNUN7. Also in this analysis, EPA estimates that it will receive five SNUNs per year. Thus, the total burden imposed on industry is estimated to be 594.6 hours annually, or 1,783.6 hours over a three year period.  18 TABLE 9 TOTAL INDUSTRY BURDEN ASSOCIATED WITH SUBMITTING SNUNs Activity Hours Per SNUN SNUNs per Year Total hours Reporting 113.25 5 566.25 Recordkeeping 5.67 5 28.35 Total Annual Burden 118.92 5 594.6 Three Year Burden   1,783.6 The total cost of submitting SNUNs is presented in Table 10. This analysis estimated that submitting SNUNs will cost affected parties $ 7,751 per SNUN. Assuming five SNUNs per year ( see above) implies a total annual cost of $ 38,755 ([ 5 SNUNs]*[$ 7,710 per SNUN]) and a threeyear cost of $ 116,265 ([$ 38,755 per year]*[ 3 years]).

TABLE 10 TOTAL INDUSTRY COSTS ASSOCIATED WITH SUBMITTING SNUNs SNUNs Per Year Cost Per SNUN Total Annual Cost Three Year Cost 5 $ 7,710 $ 38,755 $ 116,265 Note: Estimates may contain some rounding error caused by rounding dollar values to the nearest whole dollar.

Total Burden and Cost to Industry  Customer Notification Table 11 presents estimates of the customer notification burden and costs. EPA estimates that burden for customer notification is 82 hours per SNUR. EPA estimates that three SNURs will be promulgated per year. The annual burden associated with customer notification is estimated to be 246 hours ( 82 hours/ SNUR * 3 SNURs/ year). The three year burden is estimated to be 738 hours.

The cost of customer notification is estimated by multiplying the burden hours by the unit cost of notification. This analysis assumed that notification would be accomplished using technical labor, valued at $ 46.08 per hour. Thus, the total annual cost of customer notification is $ 11,336 and the three year cost is $ 34,008.  19 TABLE 11 ESTIMATED BURDEN AND COST FOR CUSTOMER NOTIFICATION Cost Element Value/ Estimate Burden Chemicals per SNUR [ a] 41 Hours per manufacturers/ processors/ importers [ b] 1.0 Manufacturers/ processors/ importers per chemical [ c] 2 SNURs per year [ d] 3 Total annual burden [ e] = [ a]*[ b]*[ c]*[ d] 246 Three year burden [ f] = 3*[ e] 738 Cost Cost per hour [ g] $ 46.08 Total annual cost [ h] = [ e]*[ g] $ 11,336 Three year cost [ j] = 3*[ h] $ 34,008 Total Burden and Cost to Industry  Summary of Industry Costs The total estimated industry burden associated with SNURs is equal to the total of chemical verification burden ( 20.4 hours annually), reporting and record keeping burden ( 594.6 hours annually) plus the total customer notification burden ( 246 hours annually), which is equal to 861 hours annually. The associated cost is estimated to be $ 51,030 annually. Over a three year period, the burden is estimated to be 2,583 hours and costs are estimated to be $ 153,090.

6( e) Bottom Line Burden Hours and Cost Tables ( i) Respondent Tally Annual Respondent Burden: 861 hours.

Annual Respondent Costs: $ 51,030.

( ii) The Agency Tally Annual Agency Costs: $ 126,261.  20 6( f) Reasons for Change in Burden Since the last clearance, annual industry burden estimates have decreased from 1020.3 hours to 861 hours. This change results from updating estimates based upon historical information on the number of chemicals per SNUR ( adjustment). Based upon revised estimates, the number of chemicals per SNUR has decreased from 65.5 to 41. The overall result of this adjustment is a decrease in estimated annual burden of 159.3 hours.

6( f) Regulatory Flexibility TSCA section 5( a)( c) affects new uses of chemicals and requires those interested in engaging in such a use to notify the Agency of his/ her intentions. Because the rule only covers uses that a small business does not currently undertake, a small business is not expected to immediately be affected by the SNUR unless it is considering such a use in the future. Although there may be some small businesses that may decide to engage in significant new uses associated with certain chemicals, it is impossible to estimate the number at this time. Additionally, the Agency has only received two SNUNs related to existing chemical SNURs in the past three years, suggesting that few, if any small business would be affected. This, coupled with the low unit costs associated with filing a SNUN suggest that the overall impact will be low for any business that may choose to file a SNUN or notify customers of SNUR activity. These costs are not differentiated between small and large businesses.

6( g) Burden Statement The annual public burden for this collection of information, which is approved under OMB Control No. 2070 0038, is estimated to be 118.9 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. 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.

To comment on 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, EPA has established a public docket for this ICR under  21 Docket ID No. OPPT 2005 0009, which is available for public viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center 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 Reading Room is ( 202) 566 1544 and the telephone number for the Pollution Prevention and Toxics Docket is ( 202) 566 0280. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OPPT 2005 0009 and OMB control number 2070 0038 in any correspondence. 8 Many Labor hourly rates in this analysis are lower than hourly rates for the same labor categories in an earlier SNUR economic analysis ( EPAB, 1999). EPA does not mean to suggest that actual hourly rates declined. Rather, the apparent decline is due to a changed method of calculating hourly costs for the same labor categories. There were three changes: ( 1) Previously the 17% overhead was applied to wages plus fringe benefits. Now it is applied only to wages. This change reduces calculated overhead. ( 2) Before, most wage rates were based on older data and then inflated to current dollars. Here, most wage rates are based on recent data. ( 3) Finally, fringe benefits were based on an assumed percent of wages. Here, private industry fringe benefits are based on actual fringe benefits taken from recent BLS data.

9 Employer Costs for Employee Compensation, Private industry workers, Goods producing industries, white collar occupations, as published by the U. S. Department of Labor, Bureau of Labor Statistics. The December 2003 values for these series were extracted on June 21, 2004.

 22 APPENDIX A INFLATORS AND WAGE RATES This appendix provides a brief discussion of the wage rates, inflators, and methods that were used to derive the final " fully loaded" wages used in the calculation of quantified costs. Base hourly wages for relevant labor categories were loaded with factors for benefits and overhead to derive a loaded hourly rate. If the loaded hourly rate was not already in year 2003 dollars, it was then inflated to year 2003 dollars by multiplying by the appropriate inflation factor. The derivation of fully loaded wages in year 2003 dollars, for each of the labor categories used in the report, is discussed in Section A. 1 and is summarized in Table A. 1. The derivation of the different inflation factors used to inflate wages to year 2003 dollars is discussed in Section A. 2 and is summarized in Table A. 2.

A. 1. Derivation of Loaded Wage Rates8 A. 1.1 Technical, Managerial, and Clerical Labor The basic method used to derive loaded wage rates for technical, managerial, and clerical personnel is described more fully in Wage Rates for Economic Analysis of the Toxics Release Inventory Program ( Rice, 2002).

December 2003 average wages for technical, managerial, and clerical labor were taken from the Employer Costs for Employee Compensation ( ECEC) report from the Bureau of Labor Statistics for all goods producing, private industries ( BLS, 2004) 9.

The additional cost of benefits, such as paid leave and insurance (" fringe benefits"), specific to each labor category, are also taken from the same BLS series. Fringe benefit as a percentage of wage is then calculated separately for each labor category. For example, the average wage rate in December 2003 for technical labor was $ 28.36; the average fringe benefit was $ 12.90. So fringe benefit as a percentage of wage rate for technical labor was 12.90/ 28.36, or approximately 45.5%. 10An overhead rate of 17 percent applied to wages is used for consistency with recent EPAB economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 10, 2002, and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report, August 2002. In reports for an earlier SNUR ( EPAB, 1999), the 17% was applied to wages plus fringe benefits. Applying it only to wages reduces calculated overhead.

 23 An additional loading factor of 17 percent is applied to wages for overhead10. This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. The fully loaded wage for technical labor, for example, is $ 28.36*( 1+ 0.455 + 0.17) = $ 28.36*( 1.625) = $ 46.08.

Fully loaded costs for managerial and clerical labor were calculated in a similar manner.  24

Table A. 1 Derivation of Loaded Wage Rates Labor Category Data Sources Uninflated wages and fringes / hour Fringe benefits as % of wage Overhead as %

of wage* Fringe + Overhead factor Loaded Wage Rate before inflation Inflation factor Loaded Wage Rate ( 2003 dollars)

Date Wages $ Fringe benefits $

Technical BLS Employer Costs for Employee Compensation.

Private industry,

goodsproducing industries, Profess.

specialty & technical. Dec 03.

[ BLS, 2004] Dec 2003 $ 28.36 $ 12.90 45.5% 17% 1.625 $ 46.08 1 $ 46.08 Managerial BLS Employer Costs for Employee Compensation.

Private industry,

goodsproducing industries, Exec,

admin, & managerial. Dec 03.

[ BLS, 2004] Dec 2003 $ 32.90 $ 15.33 46.6% 17% 1.636 $ 53.82 1 $ 53.82 Clerical BLS Employer Costs for Employee Compensation.

Private industry,

goodsproducing industries, Admin support, incl. clerical. Dec 03.

[ BLS, 2004] Dec 2003 $ 15.09 $ 6.81 45.1% 17% 1.621 $ 24.47 1 $ 24.47 * An overhead rate of 17 percent applied to wages is used for consistency with recent EPAB economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 10, 2002, and the Revised Economic Analysis for the Amended Inventory Update Rule:

Final Report, August 2002.

Note: Calculations are based on unrounded values, so the total may not equal the product of the rounded factors.  25 A. 2. Derivation of Inflation Factors In general, wages were inflated using the appropriate Employment Cost Index ( ECI), seasonally adjusted. Complete information on the derivation of the inflation factors used is given in Table A. 2 below.

Table A. 2 Derivation of Inflation Factors Report section Item Inflator data source Starting year Inflator for starting year ( A) Inflator for 2003 ( B) Inflation factor ( B) / ( A)

Section 3 Export notificatio n BLS Employ. Cost Index, Seas. Adj., White Collar Occupations Series ECS11102I, Fourth Q, 2003 1992 116.1 172.5 1.486 Appendix C Agency Extramural costs BLS Employ. Cost Index, Seas. Adj., White Collar Occupations Series ECS11102I, Fourth Q, 2003 1993 120.4 172.5 1.433  26 APPENDIX B AGENCY COSTS EPA's costs to review and process industry submissions ( SNUNs, requests to modify SNUR, and requests for equivalency determination) are assumed to be the same as EPA costs to review PMNs. EPA's costs associated with SNUR submissions are presented in Table B. 1. The EPA staff level ( GS 12), staff year full time equivalents ( FTEs) and extramural costs such as costs for contractor support are derived from the costs estimated for processing PMN submissions ( RIB, 1994). The percent of cases are from RIB 1994 and from an 1999 SNUR economic analysis ( EPAB, 1999). FTE costs have been calculated using 2003 GS 12 salary data ( OPM, 2003) and a loading factor of 1.6 to reflect fringe benefits and overhead ( OPPE, 1992).

The original PMN cost estimates were presented as low and high estimates, based on the most junior ( Step 1) and the most senior ( Step 10) GS 12 pay rates, respectively. For simplicity, this analysis uses the average of the two pay rates.

The GS 12 costs in the table below are calculated by multiplying the number of FTEs ( in the first column) by the fully loaded average salary, $ 106,850. This shows EPA staff cost for those chemicals requiring this review step. The Extramural Cost column shows costs for contractor support and other outside purchases for those chemicals requiring this review step, inflated from 1993 prices to 2003 using the Employment Cost Index, Total Compensation for White Collar Occupations ( BLS, 2003a). The Weighted Cost column is calculated by multiplying GS 12 staff cost plus extramural costs ( Unweighted Cost) by the percentage of cases requiring this review step. This calculation yields total Agency costs for submission review and processing of $ 4,203 per case.  27 Table C. 1 Agency Costs for SNUN and Other Submission Review and Processing Review Step EPA FTE EPA staff ( GS 12) ( a) Extramural Cost Unweighted Cost Pct. of Cases Weighted Cost 1993 dollars 2003 dollars ( b)

( 1) ( 2) ( 3) ( 4) ( 5)=( 2)+( 4) ( 6) ( 7)=( 5)*( 6)

Prenotice consultation 0.0024 $ 256.44 4 $ 5.73 $ 262.17 41% $ 107.49 Administrative prescreen/ notice receipt/ user fee 0.0024 $ 256.44 92 $ 131.84 $ 388.28 100% $ 388.28 CRSS ( Chemical Review and Search Strategy) 0.0025 $ 267.12 268 $ 384.04 $ 651.17 100% $ 651.17 SAT ( Structure Activity Team) 0.0006 $ 64.11 14 $ 20.06 $ 84.17 100% $ 84.17 Engineering/ Exposure 0.0015 $ 160.27 56 $ 80.25 $ 240.52 100% $ 240.52 Exposure/ Fate 0.0008 $ 85.48 0 $ 0.00 $ 85.48 100% $ 85.48 Focus 0.0009 $ 96.16 23 $ 32.96 $ 129.12 100% $ 129.12 Standard Review Functions 0.0219 $ 2,340.01 511 $ 732.26 $ 3,072.27 29% $ 890.96 Division Directors Meeting 0.0129 $ 1,378.36 113 $ 161.93 $ 1,540.29 15% $ 231.04 Order Development/ Negotiation Review 0.0171 $ 1,827.13 22 $ 31.53 $ 1,858.65 3% $ 55.76 Post Order Data Review 0.0886 $ 9,466.87 0 $ 0.00 $ 9,466.87 3% $ 284.01 Order Modification 0.2167 $ 23,154.31 0 $ 0.00 $ 23,154.31 3% $ 694.63 New Chemical SNUR Development 0.0277 $ 2,959.73 85 $ 121.81 $ 3,081.54 7% $ 215.71 Notices of Commencement 0.0012 $ 128.22 40 $ 57.32 $ 185.54 31% $ 57.52 FOIA ( Freedom of Information Act) Requests 0.0333 $ 3,558.09 287 $ 411.27 $ 3,969.36 1% $ 39.69 CBI ( Confidential Business Information) Substantiation 0.0004 $ 42.74 3 $ 4.30 $ 47.04 100% $ 47.04 TOTAL $ 4,203 Sources: FTEs per review step and 1993 extramural costs are from RIB 1994. Percentages of cases are from RIB, 1994 and EPAB, 1999. GS 12 salaries are from OPM, 2005. ( a) The average of GS 12 Step 1 and GS 12 Step 10 salaries for 2003 was ($ 58,070 + $ 75,492) / 2 = $ 66,781. This was multiplied by an assumed loading factor of 1.6 to reflect fringe benefits and overhead, resulting in a fully loaded cost per FTE of 1.6 X $ 66,781 = $ 106,850. ( b) Extramural costs consist of contracting support and other purchases directly attributable to the PMN review process. They were inflated from 1993 prices to 2003 prices using a factor of 1.433 ( see Appendix A). REFERENCES BLS, 2004a. Bureau of Labor Statistics. Employment Cost Index, Total Compensation: White Collar Occupations ( Series ID: ECS11102I), http:// data. bls. gov/ cgi bin/ srgate, extracted June 21, 2004.

BLS, 2004b. Bureau of Labor Statistics. Employer Costs for Employee Compensation  December 2003: Private industry, goods producing workers by occupational group, wages and total benefits ( Series IDs CCU420000112000D, CCU420000111000D, CCU420000114000D, CCU430000112000D, CCU430000111000D, CCU430000114000D), http:// data. bls. gov/ cgi bin/ srgate, extracted June 21, 2004.

EPAB, 1999. Economic Analysis of Expedited Significant New Use Rules for 41 Chemical Substances and Background Support Document for Economic Analysis of Significant New Use Rules. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, July 20, 1999. EPA Docket.

Office of Personnel Management ( OPM), 2005. Salary Tables 2002 DCB, 2003 DCB. www. opm. gov.

Office of Policy, Planning, and Evaluation ( OPPE), 1992. Instructions for Preparing Information Collection Requests ( ICRs). Washington, DC: U. S. EPA, June 1, 1992.

Office of Pollution Prevention and Toxics ( OPPT), 1994. Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications.

RIB, 1994. 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.

Rice, 2002. Cody Rice. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. Washington, DC: U. S. EPA/ OPPT/ EETD/ EPAB, June 10, 2002.

Shapiro, Michael, 1984. " Review of Agency SNUR Costs", Memorandum to Susan Hazen, Office of Toxic Substances, November 16.

US EPA, 2004. MITS report on SNUNs received, Years 2001  2004. Management Information Tracking System Module of Confidential Business Information Tracking System. December 21.

US EPA, 1985. Response times and Labor Costs Final Data Element List Comprehensive Assessment Information Rule, April 30, pp. 94 106.