1 Supporting Statement for a Request for OMB Review under

T he Paperwork Reduction Act 1. IDENTIFICATION OF THE INFORMATION COLLECTION l(a) Title of the Information Collection TITLE: Chemical - Specific Rules, Toxic Substances Control Act Section 8(a) EPA ICR No.: 1198.09 OMB Control No: 2070 - 0067 1(b) Short Characterization This information collection request requires OMB’s approval for the continued collection of chemical - specific information under secti on 8(a) of the Toxic Substance Control Act (TSCA , 15 U.S.C. 2607 ); see Attachment 1. TSCA section 8(a) authorizes the Administrator of the EPA to promulgate rules that require persons who manufacture, import or process chemical substances and mixtures, or who propose to manufacture, import, or process chemical substances and mixtures, to maintain such records and submit such reports to EPA as may be reasonabl y required. Information that may be collected under TSCA section 8(a) includes, but is not limited to, chemical names, categories of use, production volume, by products of chemical production, existing data on deaths and environmental effects, exposure data, and disposal information. These data are collected by the Office of Pollution Prevention and To xics (OPPT) and may be used by other EPA offices and/or Federal agencies to ensure knowledge of specific practices that may affect human health and the environment. There may

be circumstances when EPA may require different information than is readil y available or information that is different from that available through existing regulatory information collection tools, like the TSCA section 8(a) Preliminary Assessment Information Rule (PAIR) which is discussed in another I CR under a different OMB control number. EPA promulgated PAIR on June 22, 1982 (see 40 CFR Part 712). Whenever a substance is added to the PAIR, manufacturers and importers of the substance are required to complete a PAIR report form. The PAIR report requests a very limited amount of i nformation on listed chemicals regarding activities occurring over a specific time period. Any chemical covered by

TSCA for which OPPT, other EPA Offices or another Federal agency has a reasonable need for information, and which cannot be satisfied via r eadil y available sources or b y use of PAIR, is a proper potential subject for a chemical - specific TSCA section 8(a) rulemaking. For instance EPA may wish to ask detailed questions in regard to how industry oversees the use and production of a chemical. T hese specific monitoring capabilities could allow EPA to react to change in market conditions that may warrant a change in EPA’s regulatory

strategy . Therefore, EPA could promulgate a TSCA section 8(a) rule to gather this2

information by

requesting that current or potential manufacturers, importers or processors of the substance provide chemical - specific information. EPA’s OPPT, other EPA Offices and/or other Federal agencies will generally be the primary groups for which information will be collected. H owever, to the extent that reported information is not considered to be confidential business information (CBI), environmental groups, environmental justice advocates, state and local government entities and other members of the public will have access to this information for their own use. Rather than requiring respondents to submit information on reporting forms such as those used for PAIR, EPA has in the past allowed individual firms to choose the reporting means and format that is best suited to their recordkeeping resources. EPA believes that for TSCA section 8(a) chemical - specific rules, this allowance keeps reporting costs low. Total annual cost of a rule varies depending upon the number of chemicals per rule and the number of respondents per che mical. Based on the recent past usage of chemical - specific TSCA section 8(a) rules and expected future usage, EPA assumes that it will promulgate one TSCA section 8(a) chemical - specific rule with four respondents (notices) per year for the three ye ar duration of the ICR (see Section 6(b), below). The maximum total annual number of burden hours for respondents range from 134 hours to 594 hours per TSCA section 8(a) chemical - specific rule. The maximum cost associated with the promulgation of a TSCA secti on 8(a) chemical - specific rule is $6,868 to $30,504. However, the cost per respondent varies with the ty pe of chemical - specific information requested, and subsequentl y, the tasks required to comply with a TSCA section 8(a) chemical - specific rule. Because all respondents may not have to provide information on all data items listed (see Sections 3 and 6(b), below), the ranges presented above are maximums. Assuming that all respondents do not have to complete all tasks identified to comply

with a TSCA sectio n 8(a) chemical - specific rule, total annual reporting costs to all respondents range from $3,375 to $14,080 per rule. 2. NEED FOR AND USE OF THE COLLECTION 2(a) Need/Authority for the Collection Generally , EPA may

need chemical - specific information under TSCA section 8(a) to evaluate the potential for adverse human health and environmental effects caused by the manufacture, importation, processing, use or disposal of identified chemical substances and mixtures. Additionally , EPA may use TSCA section 8(a) information to assess the need or set priorities for testing and/or further regulatory action. The information required in TSCA section 8(a) chemical - specific rules can be custom tailored to aid in achieving EPA’s goals of protecting human health a nd the environment. In formation collected may vary depending on the substance, its current and potential uses and3

EPA’s concerns about potential human or environmental risks caused b y exposures to the substance. Promulgated TSCA section 8(a) rules may re quire persons manufacturing, importing or processing the chemical substance to report to EPA on specific information such as: a chemical’s composition, by products, quantity

produced, employee exposure and environmental release. Persons have in the past al so been required to notify EPA of a management decision to initiate the manufacturing, importing, or processing of a chemical substance or mixture. The legal authority for this information collection is TSCA section 8(a), U.S.C. 2607(a). TSCA section 8( a) chemical - specific rules have been co dified at 40 CFR 704, subpart B; see Attachment 2. 2(b) Use/Users of the Data EPA will use the information obtained through the TSCA section 8(a) reporting rules to satisfy specificall y identified data needs. The information collected will be relevant to risk identification, all stages of risk assessment, and/or control action functions. Receipt of TSCA section 8(a) information may also give the Agency

an opportunity

to work with the respondent, if necessary , to minimize exposure risks associated with specific uses. Generally , a specific information collection request would be made b y the Chemical Control Division, Chemical Management Division, or the Chemical Screening and Risk Assessment Division in OPPT. Howe ver, other regulatory agencies and departments, such as Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA), and other members of the Interagency

Testing Committee (ITC) may also present a need for and subsequently use TSCA section 8(a) data to, for example, assess worker or consumer exposures. An example of a use of a TSCA section 8(a) chemical - specific rule that was key in affecting a benefit to human health was 1,1 - aminoundecanoic acid (1,1 - AA). From submitted TSCA section 8(e) “substantial risk” reports, EPA discovered that 1,1 - AA is a carcinogen in one sex of one rodent species (male rat), and that exposure is limited to workers producing the nyl on in which the chemical is an ingredient. The manufacturer was contacted to obtain exposure data for this chemical. From this contact EPA learned: (1) 1,1 - AA was imported and converted into nylon by one company

and there was no domestic manufacture; (2) 1,1 - AA was handled and transferred in a closed s ystem and all 1, 1 - AA was converted during the reaction to produce nylon. Consequentl y, because of limited exposure potential, 1,1 - AA was dropped from further review. However, concern would arise if 1,1 - AA were to be manufactured domestically because of the greater likel ihood for worker exposure. To alert EPA to domestic manufacture, on May 28, 1987, OPPT promulgated a TSCA section 8(a)/5 (SNUR) rule for 1,1 - AA (52 FR 19860) . Users of TSCA section 8(a) chemical - specific data rarel y make a judgment based solel y on the c ontent of the TSCA section 8(a) information received but rather use the TSCA section 8(a) chemical - specific information as part of the larger risk management strategy . 1,1 - AA TSCA section 8(a) information would be instrumental in affecting a benefit to human health if a compan y were to begin to manufacture the substance.4

3. NON - DUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA 3(a) Non - Duplication Section 8(a)(2) of TSCA states, “To the extent feasible, the Administrator shall not require an y reporting which is unnecessary or duplicative.” The reporting requirements of TSCA section 8(a) rules only

require information that EPA believes will assist in a reasoned evaluation of the human health and environmental effects of chemical substances and mixtures. This information is unlikely

to be duplicative since, (1) EPA estimates that each rule will generate only a few notices, (2) the information required by the TSCA section 8(a) rule is unique to the manufacturer, importer or processor (e.g., the proposed date of production or importation, the amount produced or imported, the chemical composition, and uses of the chemical substance or mixture), and (3) EPA thoroughl y checks other public and unpublished sources to see if the required data may

already be available. Finall y, once EPA became aware of a source of substantially

similar information, for example via comments on a proposed rule, EPA would not continue with the information collection. 3(b) Public Notice Required Prior to ICR Submission to OMB Prior to submission to OMB, this I CR will be made available to the public for comment through a Federal Register notice. The public will have 60 day s to provide comments. Any comments received will be given consideration when completing the supporting statement that is submitted to OMB. 3(c) Consultations EPA has not published a proposed or final TSCA section 8(a) chemical - specific information gathering rule for more than fifteen ye ars and, therefore, has received no comme nts since that time. EPA has received comments on the use of TSCA section 8(a) reporting rules through published Federal Register notices. Various organizations responded to EPA’s request for comments during the 1985 to 1988 I CR period. For example, the Agency originally proposed a SNUR for 4,4,1 - methylenebis (2 - chloroaniline) (MBOCA) but public comments received in July

and August of 1986 on the proposed SNUR suggested that a TSCA section 8(a) rule would be more appropriate. This suggestion was follow ed, reducing the burden on the public since the TSCA section 8(a) rule exempted small manufacturers, whereas the proposed SNUR would not have had this exemption. Also, after receiving public comment on the proposed SNUR/8(a) rule for 1,1 - aminoundecanoic acid (July 22, 1986), the proposed definition of the term “enclosed process” was modified to account for possible releases through emergency pressure relief, thus expanding the number of processes that would be considered “enclosed” and lessening complian ce costs.5

The Natural Resources Defense Council (NRDC) has also responded to several TSCA section 8(a) chemical - specific rules. The NRDC is a national nonprofit environmental organization dedicated to the protection of human health and the environment. The NRDC generall y urges EPA to adopt a more extensive, detailed set of information requirements. Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential I CR respondents and data users about specific aspects of I CR s before submitting an original or renewal I CR 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 Generally companies are required to report onl y once under a TSCA section 8(a) reporting rule. EPA may consider requiring reporting on an annual, semiannual, monthly or other basis if the Administrator deems this necessary to p rotect human health and the environment. EPA tailors each rule to meet chemical - specific data requirements, thus reducing the potential for too frequent data collections. 3(e) General Guidelines This information collection activity is necessary

to imp lement the statutory requirements of section 8(a) of TSCA and is consistent with the requirements of 5 CFR 1320.6. 3(f) Confidentiality Submitters may

designate information as confidential, trade secret or proprietary . EPA has implemented procedures t o protect an y confidential, trade secret or proprietary information from disclosure. These procedure s compl y with EPA’s confidentiality regulation, 40 CFR Part 2, Subpart B. 3(g) Sensitive Questions This section is not applicable. TSCA section 8(a) reporting rules do not include any questions of a sensitive nature.6

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4(a) Respondents/North American Industrial Classification System (NAICS) Codes Respondents affected b y this collection activity pr imarily include those businesses that fall under NAI CS codes 325, Chemical Manufacturers and Processors, and 324110, Petroleum Refineries. 4(b) Information Requested 4(b)(i) Data Items Section 8(a) of TSCA specificall y lists a wide range of data ite ms that may be required by EPA, including information on use, production volume, exposure, and health and safety. Data items requested of manufacturers, importers, or processors of certain chemicals vary with each collection request, but will not repeat i nformation previously requested in the PAIR or other information gathering tools. Some data items requested under TSCA section 8(a) chemical specific rules in the past include: notification and description of changes in the end use of identified substance s and mixtures, information on planned manufacturing and on - site processing, and notification of changes to the method of manufacturing the substance (see 40 CFR subpart B). An example of a past TSCA section 8(a) chemical - specific rule is one issued on 4 ,4,1 - methylenebis (2 - chloroaniline) (MBOCA). It required persons who propose to manufacture MBOCA to notify

EPA of that intent and to submit information on their planned manufacturing and on - site processing activities. The rule also required persons who are manufacturing MBOCA to notify

the Agency

if they propose to alter their manner or method of manufacturing the substance. 4(b)(ii) Respondent Activities Activities a respondent may be required to perform as a result of TSCA section 8(a) chemical - sp ecific rule are as follows: 9 to 29.5 Hours of Managerial Labor

- Identify listed chemicals;

- Assign principal technical contact person;

- Identify by- product;

- Review marketing data;

- Research the date of the initiation of manufacture or importation of the chemical;

- Research occupational exposure, environmental release, health and environmental data, disposal methods; and7

- Process, compile, and review information for accuracy , substantiate a claim of confidential business information. 17.5 to 98 H ours of Technical Labor

- Identify chemical and trade name and chemical composition;

- Identify by- product;

- Describe use of chemical;

- Report quantity

manufactured or imported;

- Research workplace exposures, environmental releases, health and environm ental data, and disposal methods; and

- Provide occupational description. 7 to 21 Hours of Clerical Labor

- Format research on occupational exposures, environmental releases, health and environmental data;

- Format attachments; and

- Prepare notice. Rec ordkeeping Estimate TSCA section 8(a) chemical - specific rules may contain recordkeeping requirements. The recordkeeping estimate is rough, but it is reasonably related to the maximum reporting burden. EPA estimates that recordkeeping will account for a pproximately

five percent of the reporting burden, or a maximum of 12 hours (see Table 2.) 5. THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT 5(a) Agency Activities Inventory For an y TSCA section 8(a) chemical - specific rule the Agency would have to perform a number of tasks. They

are: o Industry

/Public Assistance (answering questions regarding rule) o Data Processing and Sy stem Support Personnel o Storage and Distribution o Compliance Monitoring8

5(b) Collection Methodology and Management An improved information technology to minimize burden of a TSCA section 8(a) chemical - specific rule has not been found. EPA has not been able to identify a more efficient, less expensive, or more flexib le means of obtaining the required data than the one currentl y being used. To the extent data are not CBI, all information collected is made available to the public through the public docket office. At the present time, EPA is not requiring firms to subm it this information on one standard reporting form. Reporting facilities will be able to choose the format that best suits their reporting resources. TSCA section 8(a) chemical - specific rules ty pically require one - time reporting. As future data needs arise, EPA will consider the use of electronic or other typ es of reporting methods. EPA believes the flexibility already allowed in the reporting structure significantly eases burden. 5(c) Small Entity Flexibility Section 8(a) of TSCA generall y exempts small manufacturers and processors. However, under TSCA section 8(a)(3), EPA may require small manufacturers and processors to report or keep records if the substance or mixture is subject to a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6 or with respect to which relief has been granted pursuant to a civil action brought under sections 5 or 7 of TSCA. All respondents to TSCA section 8(a) chemical specific rules, including small businesses, are granted flexibility in their reporting me thods. 5(d) Collection Schedule TSCA section 8(a) chemical - specific rules are generall y one - time collections of specific information, usually

regarding one chemical substance. Proposed TSCA section 8(a) chemical specific rules request comments. The c omments are then addressed and incorporated as appropriate in the final rule, which specifies the reporting deadline. Generally , EPA requires that information be reported no sooner than 30 day s after the effective date of a final rule. 6. ESTIMATING TH E BURDEN AND COST OF THE COLLECTION 6(a) Estimating Respondent Burden Wage rates including fringe benefits and overhead for three broad categories of labor (managerial, technical, and clerical) were used in this analy sis. The labor categories and meth ods for estimating loaded wage rates were developed during previous studies. The basis for estimating wage rates for these purposes is the Bureau of Labor Statistics (BL S) Employer Costs for Employee Compensation: Private Manufacturing Industry by Occupation, December 2005 . The data series used for this and other anal ys es is no longer published directly by the BL S, but the BLS continues to make this data available to EPA. Based on the BLS data, the average hourly wage rates (as of December 2005) are $ 38.22 for managerial personnel, $31.02 for9

technical personnel and $15.73 for clerical personnel. The benefits and overhead loading factors are calculated from the BL S data on the cost of benefits, with 17 percent of the average wage added for overhead. The ov erhead factor of 17 percent is based on information provided by the chemical industry

and chemical industry

trade associations. The loaded hourly wage rates are $63.61 for managerial personnel, $53.02 for technical personnel and $26.37 for clerical personn el , as shown in Table 1 . TABLE 1 : LOADED HOURLY WAGE RATES BY LABOR CATEGORY Labor Category December 2005

Average Wages Decemb er 2005

Benefits and Overhead Loading Factor December 2005 Loaded Hourly Rate Managerial $38.22 1.66 $63.61 Technical $31.02 1.71 $53.02 Clerical $15.73 1.68 $26.37 Sources: Unpublished Employer Costs for Employee Compensation: Private Manufacturing Industry by Occupation, December 2005 . Data received by Carol Rawie, US EPA, from Raphael Branch, US Bureau of Labor Statistics, May 10, 2006. This I CR maintains the assumption of the previous I CR that on average four not ices per ye ar are submitted in response to one section 8(a) c hemical - s pecific rule per year. Current labor rates and burden hours used to calculate cost to respo ndents are listed below. Labor Category Burden Hours Hourly Rate Managerial 9 to 29.5 $ 63.61 Technical 17.5 to 98 $ 53.02 Clerical 7 to 21 $ 26.37 6(b) Estimating Respondent Costs The following are the tasks that managers, te chnical, and clerical personnel are expected to perform in preparing a notice. However, as discussed at the end of this section and presented in Table 1, not all respondents are likel y to be required to perform all tasks under each labor category . Theref

ore, the ranges of labor hours presented below for each labor category ( e.g ., 9 to 29.5 hours for managers) are the maximums and are based on the assumption that all tasks are performed for each notice. Managerial Labor 1. Manufacturer identifies listed chemicals; 2. Assign principal technical contact person;10

3. I dentify

by- product; 4. Review marketing data; 5. Research the date of the initiation of manufacture or importation of the chemical; 6. Research occupational exposure, environmental rel ease, health and environmental data, disposal methods; 7. Process, compile, and review information for accuracy , substantiate a claim of confidential business information. In performing these tasks, managerial labor hours have been estimated to range from 9.5 to 29.5 hours per TSCA section 8(a) ch emical - specific rule. At $63.61 per hour for management labor times the range of hours predicted, [$63.61 x (9.5 to 29.5)], the range of cost for m anagement work is $604 to $1,876 per notice resulting from a TSCA section 8(a) chemical specific rule. With an average of four notices per year for the three - ye ar ICR period, the range of costs per year fo r managerial labor is [4 x ($604 to $1,876)] = $2,416 to $7,504 . Technical Labor 1. I dentify

chemical and trade name and chemical composition; 2. I dentify

by- product; 3. Describe use of chemical; 4. Report quantity

manufactured or imported; 5. Research occupational exposures, environmental releases, health and environmental data, and disposal metho ds; 6. Provide occupational description. In performing these tasks, technical labor hours have been estimated to range from 17.5 to 98 hours per notice resulting from a TSCA section 8(a) ch emical - specific rule. At $53.02 per hour for technical labor , times the range of hours predicted, ($53.02 x [17.5 to 98]), a range of cost for technical work is estimated to be $928 to $5,196 per notice resulting from a TSCA section 8(a) chemical - specific rule. With four notices per year for a three - year period, the range of annual costs f

or technical labor is [4 x ($928 to $5,196)] = $3,712 to $20,784 .11

Clerical Labor 1. Format research on occupational exposure, environmental releases, health and environmental data; 2. Format attachments; 3. Prepare Notice. In performing these tasks, clerical labor has been estimated to range from 7 to 21 hours per notice resulting from a TSCA section 8(a) ch emical - specific rule. At $26.37 per hour for clerical labor, times the r ange of hours predicted, ($26.37 x [ 7 to 21]), the range of cost for cleri cal work is estimated to be $185 to $554 per notice resulting from a TSCA section 8(a) chemical - specific rule. With four notices per TSCA section 8(a) chemical - specific rule, the range of costs per ye ar for clerical l abor is [4 x ($185 to $554)] = $740 to $2,216 . The cost to a respondent for filing a TSCA section 8(a) notice depends upon the various tasks performed. These tasks could include gathering the required data, preparing and submitting the TSCA section 8(a) notice, and possibly keeping records. Based on promulgated TSCA section 8(a) rules, EPA estimates that each respondent will submit one notice per TSCA section 8(a) chemical - specific rule. EPA anticipates issuing one TSCA section 8(a) rule per year and e xpects to receive an average of four no tices per year. The cost to a respondent for submitting a TSCA section 8(a) notice is a function of the number of hours and the hourly labor costs for the individuals developing and preparing the notice. The annual estimated range of cost to the respondent is $1,717 ($604 + $928 + $185) to $7,626 ($1,876 + $5,196 + $554 ) per not ice, and $6,868 to $ 30,504 per TSCA section 8(a) chemical - specific rule (above estimates multiplied by four, the number of notices expected per rule.) However, as mentioned above, these figures are likel y to overstate the true cost because not all respondents may

be required to supply

information regarding each activity . Thus, the average actual cost to the respondent will be lower than the $ 1,717 to $7,626 per notice estimate calculated above. The estimated frequency of each activity , along with total respondent cost and burden calculations, is presented in Table 1. The total cost to all respondents of reporting under a TSCA section 8(a) che mical - specific rule is estimated to range from $3,375 to $14,080 per ye ar. On a per respondent basis, the annual cost is estimated to range from $894 to $3,520 per notice, based on four notices per ye ar.12

Table 2 . T otal Annual Respondent Burden and Cost s Associated with Preparing and Filing a TSCA Section 8(a) Notice Activity Managerial

Hours $92.33/hr Technical

Hours $68.35/hr Clerical

Hours $27.24/hr Notices

per Year Annual

Burden Hours Annual

Costs Manufacturer ID and Principal Technical Contact 1 - 4 4 4 - 16 $254 - $1,018 Chemical and Trade Name 1 - 4 3 3 - 12 $159 - $ 636 Chemical Composition 0.5 - 2 4 2 - 8 $106 - $424 By product ID 1 1 - 4 2 4 - 10 $23 3 - $551 Use Description 1 - 4 4 4 - 16 $212 - $848 Quantity Manufactured or Imported 1 - 4 4 4 - 16 $212 - $848 Marketing Data 1 - 2 2 2 - 4 $127 - $254 Date of Initiation of Manufacture or Importation 0.5 4 2 $127 Occupational Exposure 1 - 4 2 - 16 1 - 3 2 8 - 46 $392 - $2,364 Environmental Release 1 - 4 1 - 8 1 - 3 2 6 - 30 $286 - $1,515 Occupational Description 1 - 10 1 1 - 10 $5 3 - $530 Health and Envi ronmental Data 2 - 8 8 - 40 1 - 3 1 11 - 51 $578 - $2,709 Disposal Methods 1 - 2 1 - 6 1 2 - 8 $117 - $44513

Attachments 2 - 6 1 2 - 6 $53 - $158 Prep aration of Notice 1 - 3 4 4 - 12 $105 - $316 Managerial/Legal Review of Submission 1 - 4 4 4 - 16 $254 - $1,018 Recordkeeping 1 - 3 4 4 - 12 $105 - $316 TOTAL 9.5 - 29.5 17.5 - 98 7 - 21 67 - 275 $3,375 - $1 4,080 6(c) Estimating Agency Burd en and Cost The Agency

has developed the following burden hour estimates for activities related to promulgating a section 8(a) Chemical Specific rule. Activity Burden o Industry

/Public Assistance (answering 0 .1 FTE questions regarding the rule) o Data processing and sy stems support personnel 0.2 FTE o Storage and Distribution 0 .1 FTE o Compliance monitoring 0 .1 FTE Total FTEs 0. 5 FTE The Office of Pollution Prevention and Toxics bases its burden hour an d labor cost estimates on prior experience in gathering and processing information associated with other information collections. Because these activities involve a team approach, the Agency has used a composite burden hour estimate containing workers at various GS levels and calculated hourly costs based upon the wage rate fo r a GS - 12 Step 1. The 2006 annual salary for a GS - 12 Step 1 in the Washington DC area is $65,048. The cost for 0 .5 FTE is $ 32,524 . Incorporation of an overhead and bene fits factor of .6 yi elds a full y loaded cost of $52,038 to the Agency for promulgating and supporting a TSCA section 8(a) chemical - specific rule. The full - time work ye ar is considered to be 2,080 so that there are 1,040 burden hours associated with 0.5 FTE.14

6( d) Bottom Line Burden Hours and Costs The following table display s the annual burden and costs borne by respondents and EPA associated with preparing, filing and reviewing a notice resulting from a TSCA section 8(a) chemical - specific rule. Table 3 . Ann ual Burden and Cost of a TSCA Section 8(a) Chemical - Specific Rule Annual Burden Hours Annual Costs Industry 67 to 275 $ 3,375 to $ 14,080 Agency 1,040 $ 52,038 6(e) Reasons for Change in Burden The current request for renewal estimates a total annu al burden to respondents of 275 hours, which is unchanged from the previous ICR renewal. EPA anticipates issuing one TSCA section 8(a) chemical - specific rule per year with an average of four respondents submitting notices per rule. EPA may promulgate m ore than one TSCA section 8(a) chemical - specific rule per ye ar over the next three ye ars. If EPA does this, the Agency

will submit a technical amendment to OMB to reflect the change in estimated burden to the regulated industry

and the government. 6(f) Burden Statement The public burden for this collection of information is estimated to average 68.8 hours per response (one - quarter of maximum annual burden of 275 hours for four notices). Of the 68.8 hours, 65.8 hours are associated with reporting tasks such as reviewing instructions, gathering the data needed, and completing and reviewing the collection of information. The remaining three hours are associated with recordkeeping. Burden means the total time, effort, or financial resources expended b y p ersons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and s ys tems for the purposes of collecting, validating, and verifying information; adjust the existing way s to comply with an y previously

applicable instructions and requirements; train personnel to be able to respond to a collection of information; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor such a request and a person or facility is not required to respond to a collection of information unless it display s a currently valid OMB control number. The OMB control numbers for EPA’s regulation s 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 I CR under Docket ID No. EPA - HQ - OPPT - 20 10 - 0 488 . The docket is available for publi c viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday , excluding legal holiday s. The telephone number for the EPA/DC Public Reading Room is (202) 566 - 1744, and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566 - 0280. An electro nic version of the public docket is available through the Federal Docket Management S ys tem (FDMS) at www.regulations.gov . Use FDMS to submit or view public comments, access the index listing of the contents of t he public docket, and to access those documents in the public docket that are available electronically . Once in the sy stem, 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. EPA - HQ - OPPT - 20 10 - 0 488 and OMB control number 2070 - 0067 in any

correspondence.