Document ID: EPA-HQ-OPPT-2017-0317-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2018-07-25T04:00Z

Supporting Statement for a Request for OMB Review under
                          The Paperwork Reduction Act

1.  	IDENTIFICATION OF THE INFORMATION COLLECTION

	l(a)	Title and Number of the Information Collection

	TITLE:   Chemical-Specific Rules, TSCA Section 8(a)

	EPA ICR No.:   1198.11	OMB Control No:   2070-0067

      Docket ID No.:   EPA-HQ-OPPT-2017-0317

	1(b)	Short Characterization

	This information collection request (ICR) covers reporting and recordkeeping requirements for persons who manufacture (the term "manufacture" includes import) or process chemical substances subject to chemical-specific rules promulgated under section 8(a) of the Toxic Substance Control Act (TSCA, 15 U.S.C. 2607).  EPA is seeking to reinstate the OMB approval for this ICR, which expired on June 30, 2018. Although not a currently active collection, the collection is contained in a regulation and would apply to anyone entering the marketplace to manufacture (import) or process one of the chemical substances listed in 40 CFR part 704.

	TSCA section 8(a) authorizes the Administrator of the EPA to promulgate rules that require persons who manufacture or process chemical substances and mixtures, or who propose to manufacture or process chemical substances and mixtures, to maintain such records and submit such reports to EPA as may be reasonably required. Information that may be collected under TSCA section 8(a) includes, but is not limited to, chemical names, categories of use, production volume, byproducts of chemical production, existing data on health and environmental effects, exposure data, and disposal information. These data are collected by the Office of Pollution Prevention and Toxics (OPPT) and may be used by other EPA offices and/or federal agencies as needed.

	There may be circumstances when EPA may require different information than is readily 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 ICR 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 of the substance are required to complete a PAIR report form. The PAIR report requests a very limited amount of information 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 readily available sources or by 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. These specific monitoring capabilities could allow EPA to react to change in market conditions or emerging markets that may warrant a change in EPA's regulatory strategy. Therefore, EPA could promulgate a TSCA section 8(a) rule to gather this information by requesting that current or potential manufacturers 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. However, to the extent that reported information is not considered to be confidential business information (CBI), EPA will make this information available to state and local government entities, environmental groups, environmental justice advocates, and members of the public 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. Alternatively, under a TSCA section 8(a) chemical-specific rule, EPA may require reporting companies to submit information electronically to EPA via the Central Data Exchange (CDX), EPA's electronic system for receiving environmental information.
	
	Total annual cost of a rule varies depending upon the number of chemicals per rule and the number of respondents per chemical. 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-year duration of the ICR (see section 6(b), below). The maximum total annual number of burden hours for respondents range from 73 hours to 281 hours (or 60 to 242 hours for electronic reporting) per TSCA section 8(a) chemical-specific rule. The maximum cost associated with the promulgation of a TSCA section 8(a) chemical-specific rule is $5,130 to $20,480 (or $4,800 to $18,478 for electronic reporting). However, the cost, burden hours, or number of respondents may vary depending on each chemical-specific TSCA section 8(a) rule. If a significant difference is expected from a new rule, EPA will submit an ICR addendum to this ICR. For example, an addendum has been submitted regarding the TSCA section 8(a) rule for Certain Nanoscale Materials, identified under OMB control number 2070-0194. Also, 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. 

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 exposure and/or adverse human health and environmental effects caused by the manufacture, 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 and the environment. Information collected may vary depending on the substance, its current and potential uses and EPA's concerns about potential human or environmental risks caused by exposures to the substance. As noted above, TSCA section 8(a) rules may require persons manufacturing, or processing the chemical substance, or intending to manufacture or process, to report to EPA on specific information such as: a chemical's composition, byproducts, quantity produced, employee exposure and environmental release. 

	The legal authority for this information collection is TSCA section 8(a), 15 U.S.C. 2607(a) (Attachment 1) and TSCA section 26(p), 15 U.S.C. 2625 (Attachment 2). TSCA section 8(a) chemical-specific rules have been codified at 40 CFR 704, subpart B; see Attachment 3.

	2(b)	Use/Users of the Data

	EPA will use the information obtained through the TSCA section 8(a) reporting rules to satisfy specifically-identified data needs. The information collected will be relevant to prioritization, all stages of risk evaluation, and/or risk management. 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 by the Chemical Control Division or another division in OPPT. However, 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 11-aminoundecanoic acid (11-AA). From submitted TSCA section 8(e) "substantial risk" reports, EPA discovered that 11-AA is a carcinogen in one sex of one rodent species (male rat), and that exposure is limited to workers producing the nylon in which the chemical is an ingredient. The manufacturer was contacted to obtain exposure data for this chemical. From this contact EPA learned: (1) 11-AA was imported and converted into nylon by one company and there was no domestic manufacture; (2) 11-AA was handled and transferred in a closed system and all 11-AA was converted during the reaction to produce nylon. Consequently, because of limited exposure potential, 11-AA was dropped from further review. However, concern would arise if 11-AA were to be manufactured domestically because of the greater likelihood for worker exposure. To alert EPA to domestic manufacture, on May 28, 1987, OPPT promulgated a rule under TSCA section 8(a) and a Significant New Use Rule (SNUR) under section 5 for 11-AA (52 FR 19860). Users of TSCA section 8(a) chemical-specific information rarely make a judgment based solely on the content 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 evaluation and management strategy. 11-AA TSCA section 8(a) information would be instrumental in affecting a benefit to human health if a company were to begin to manufacture the substance.

3.  	NON-DUPLICATION, CONSULTATION, AND OTHER COLLECTION 
	CRITERIA

	3(a)	Non-Duplication

	Section 8(a)(5) of TSCA states, "the Administrator shall, to the extent feasible... not require 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 submissions, (2) the information required by the TSCA section 8(a) rule is unique to the manufacturer 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 thoroughly checks other public and unpublished sources to see if the required data may already be available prior to issuing such rules. If EPA were to become 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 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 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 only once under a TSCA section 8(a) chemical-specific reporting rule, although EPA may consider requiring reporting on an annual, semiannual, monthly or other basis if the Administrator deems this necessary to protect human health and the environment. EPA tailors each rule to meet chemical-specific information requirements, thus reducing the potential for too frequent data collections.

	3(e)	General Guidelines

	This information collection activity is necessary to implement 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 to protect any confidential, trade secret or proprietary information from disclosure. These procedures comply with TSCA section 14 and 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.

4.  	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents/North American Industrial Classification System (NAICS) 
		Codes

	Respondents affected by this collection activity primarily include those businesses that fall under NAICS codes 325, Chemical Manufacturers and Processors, and 324110, Petroleum Refineries.

	4(b)	Information Requested

	4(b)(i)	 Data Items

	Section 8(a) of TSCA specifically lists a wide range of data items that may be required by EPA, including information on use, production volume, exposure, and health and safety. Data items requested of manufacturers or processors of certain chemicals vary with each collection request, but will not repeat information previously requested through 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 substances 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'-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 manufacture MBOCA to notify the Agency if they propose to alter the manner or method of manufacturing the substance.

	

      4(b)(ii) Respondent Activities

	Activities a respondent may be required to perform as a result of a TSCA section 8(a) chemical-specific rule are as follows:

0.75 Hours of Attorney Labor

	- Gather and prepare information to substantiate a claim of confidentiality.

10.25 to 30.25 Hours of Managerial Labor

      - Identify listed chemicals;
      - Assign principal technical contact person;
      - Identify by-product; impurities; physical properties;
      - Review marketing data;
      - Research the date of the initiation of manufacture of the chemical;
      - Research occupational exposure, environmental release, health and environmental information, disposal methods; risk management practices; and
      - Process, compile, and review information for accuracy, substantiate a claim of confidential business information.

17.5 to 98 Hours of Technical Labor

      - Identify chemical and trade name and chemical composition;
      - Identify by-product; impurities; physical properties;
      - Describe use of chemical;
      - Report quantity manufactured;
      - Research workplace exposures, environmental releases, health and environmental information, and disposal methods; risk management practices; and
      - Provide occupational description.

7 to 21 Hours of Clerical Labor (0.5 - 1.5 Hours for Electronic Reporting)

      - Format research on occupational exposures, environmental releases, health and environmental information; risk management practices;
      - Format attachments;
      - Prepare notice; and
	- Recordkeeping.

Recordkeeping Estimate

	TSCA section 8(a) chemical-specific rules may contain recordkeeping requirements. The recordkeeping estimate is reasonably related to the maximum reporting burden. EPA estimates that recordkeeping will account for approximately four percent of the reporting burden for paper-based submission and less than one percent for electronic submission.

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

	5(a)	Agency Activities Inventory

	For any TSCA section 8(a) chemical-specific rule the Agency would have to perform a number of tasks. They are:

        	- Industry/Public Assistance (answering questions regarding rule);
        	- Data Processing and System Support Personnel;
        	- Review the information submitted;
      	- Analyze submissions for confidentiality and provide appropriate protection for   	 	confidential data;
      	- Storage and Distribution; and
        	- Compliance Monitoring.

	5(b)	Collection Methodology and Management

	For past rules, EPA has not required firms to submit this information on any one standard reporting form, and reporting facilities have been able to choose the format that best suits their reporting resources. EPA believes the flexibility already allowed in the reporting format significantly eases burden. TSCA section 8(a) chemical-specific rules typically require one-time reporting. As future data needs arise, EPA will consider requiring the use of electronic reporting methods. To the extent data are not CBI, all information collected is made available to the public through the public docket office.

	5(c)	Small Entity Flexibility

	Section 8(a) of TSCA generally 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 format.

	5(d)	Collection Schedule

	TSCA section 8(a) chemical-specific rules are generally one-time collections of specific information, usually regarding one chemical substance. Proposed TSCA section 8(a) chemical-specific rules request comments. The comments 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 days after the effective date of a final rule.

6.  	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a) 	Estimating Respondent Burden

	Wage rates, including fringe benefits and overhead, for four categories of labor (legal (attorney), managerial, technical, and clerical) were used in this analysis. The basis for estimating wage rates for the purposes of this analysis is the Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data, for December 2016, for manufacturing industries. Based on the BLS data, the average hourly wage rates (as of December 2016) are $69.97 for legal (attorney) personnel, $50.09for managerial personnel, $45.66 for technical personnel and $20.29 for clerical personnel.

	The cost of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same ECEC series and an additional loading factor of 17 percent is applied to wages to account for overhead. The overhead factor of 17 percent is used in accordance with Office of Pollution Prevention and Toxics economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a). 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 loaded hourly wage rates are $116.15 for legal (attorney) personnel, $83.15for managerial personnel, $78.08for technical personnel and $34,29 for clerical personnel, as shown in Table 1.

Table 1: Loaded Hourly Wage Rates by Labor Category in 2016$
                                Labor Category
                                       
                                     Wage
                                Fringe Benefits
                             Fringes as % of Wage
                             Overhead % of Wage[3]
                           Fringe + Overhead Factor
                                 Loaded Wages
                                       
                                      (a)
                                      (b)
                                 (c) = (b)/(a)
                                      (d)
                                (e)=(1)+(c)+(d)
                                (f) = (a) x (e)
Attorney[1]
                                    $69.97
                                    $34.40
                                    49.17%
                                      17%
                                     1.66
                                    $116.15
Managerial[2]
                                    $50.09
                                    $24.63
                                    49.17%
                                      17%
                                     1.66
                                    $83.15
Technical[2]
                                    $45.66
                                    $24.98
                                    54.70%
                                      17%
                                     1.71
                                    $78.08
Clerical[2]
                                    $20.29
                                    $10.52
                                    51.848%
                                      17%
                                     1.69
                                    $34.29
Sources: [1] BLS Occupational Employment Statistics (OES) May 2016 National Industry-Specific Occupational Employment and Wage Estimates (BLS, 2016b) [2]Employer Costs for Employee Compensation Supplementary Tables: December 2006-December 2016, US Bureau of Labor Statistics (BLS, 2016a)
[3]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) and Wage Rates for Economic Analyses of the Toxics Release Inventory Program. (EPA, 2002b)

	This ICR maintains the assumption of the previous ICR that, on average, four notices per year are submitted in response to one section 8(a) chemical-specific rule per year. The current labor rates and burden hours used to calculate the cost to respondents for paper-based reporting are listed below. 

                                Labor Category
                                 Burden Hours
                                  Hourly Rate
Attorney 
                                     0.75
                                    $116.15
Managerial
                                10.25  -  30.25
                                    $83.15
Technical
                                 17.5  -  98.0
                                    $78.08
Clerical
                                 7.0  -  21.0
                                    $34.29

           The current reporting and recordkeeping labor rates and burden hours used to calculate the cost to respondents for electronic reporting are listed below: 

                                Labor Category
                                 Burden Hours
                                  Hourly Rate
Attorney[1]
                                     0.75
     $116.15
Managerial
                                10.25  -  30.25
                                    $83.15
Technical
                                 17.5  -  98.0
                                    $78.08
Clerical
                                  0.5  -  1.5
                                    $34.29
                  Notes: 1- Attorney burden hours estimate is consistent with the Economic Analysis for the Final TSCA Section 8(a) Reporting Requirements for Certain Chemical Substance as Nanoscale Materials (2016)
                  
	6(b) 	Estimating Respondent Costs
	
	The following are the tasks that attorneys, managers, technical, and clerical personnel are expected to perform when preparing to submit a notice in response to an 8(a) chemical-specific rule. However, as discussed at the end of this section, not all respondents are likely to be required to perform all tasks under each labor category. Therefore, the ranges of labor hours presented below for each labor category (e.g., 10.25 to 30.25 hours for managers) are the maximums and are based on the assumption that all tasks are performed for each notice.

Attorney Labor 

 Gather and prepare information to substantiate a claim of data confidentiality.

	In performing these tasks, attorney labor hours have been estimated to 0.75 hours per TSCA section 8(a) chemical-specific rule.  At $116.15 per hour for attorney labor times the hours predicted ($116.15 x 0.75) the cost for legal work is $ 87.11. With an average of four notices per year for the three-year ICR period, the range of costs per year for attorney labor is (4 x $87.11) is $348.45.

Managerial Labor

 Manufacturer identifies listed chemicals;
 Assign principal technical contact person;
 Identify byproduct, impurities, and physical properties;
 Review marketing data;
 Research the date of the initiation of manufacture of the chemical;
 Research occupational exposure, environmental release, health and environmental information, disposal methods, risk management practices;
 Process, compile, and review information for accuracy; and
 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) chemical-specific rule. At $83.15 per hour for management labor times, the range of hours predicted [$83.15 x (9.5 to 29.5)], the range of cost for management work is $790 to $2,453 per notice resulting from a TSCA section 8(a) chemical-specific rule. With an average of four notices per year for the three-year ICR period, the range of costs per year for managerial labor is [4 x ($790 to $2,453)] = $3,160 to $9,812.

Technical Labor

 Identify chemical and trade name and chemical composition;
 Identify byproduct, impurities, and physical properties;
 Describe use of chemical;
 Report quantity manufactured;
 Research occupational exposures, environmental releases, health and environmental information, disposal methods, and risk management practices; and 
 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) chemical-specific rule. At $78.08 per hour for technical labor, times the range of hours predicted [$78.08 x (17.5 to 98)], a range of cost for technical work is estimated to be $1,366 to $7,652 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 for technical labor is [4 x ($1,366 to $7,652)] = $5,464 to $30,608.

Clerical Labor 

 Format research on occupational exposure, environmental releases, health and 	     environmental information; risk management practices;
 Format attachments;
 Prepare notice; and
 Recordkeeping.
	
	In performing these tasks, clerical labor has been estimated to range from 7 to 21 hours per paper-based notice resulting from a TSCA section 8(a) chemical-specific rule. At $34.29 per hour for clerical labor, times the range of hours predicted [$34.29 x (7 to 21)], the range of cost for clerical work is estimated to be $240 to $720 per notice resulting from a TSCA section 8(a) chemical-specific rule. With four notices per TSCA section 8(a) chemical-specific rule for paper-based submission, the range of costs per year for clerical labor is [4 x ($240 to $720)] = $920 to $2,880.

	Consistent with the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (July 13, 2009), EPA assumed that the entire reporting burden for clerical/administrative staff associated with submitting section 8(a) PAIR would be 0.05 hours for electronic reporting. EPA assumed that the recording burden associated with maintaining records of the information submitted to EPA would be reduced by 50 percent, making the maximum overall recordkeeping burden for this rule 1.5 hours. (see table 3).  

	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 the notice, substantiating CBI, 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 expects to receive an average of four notices 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 $2,483 ($87.11+ $790 + $1,366 + $240) to $10,912 ($87.11+ $2,453 + $7,652 + $720) per notice, and $9,932 to $43,648 per TSCA section 8(a) chemical-specific rule [4 notices per rule x ($2,483 to $10,912 per notice)] for paper-based submission. The estimated frequency of each activity, along with total respondent cost and burden calculations, is presented in Table 2. The annual estimated range to respondent is $2,260 ($87.11 + $790 + $1,366 + $17.15) to $10,243 ($87.11 + $2,453 + $7,652 + 51.43) per notice and $9,040 to $40,972 per TSCA section 8(a) chemical-specific rule [4 notices per rule x ($2,260 to $10,243 per notice)] for electronic-based submission. Estimated frequency of each activity, along with total respondent cost and burden calculations, is presented in Table 3.  However, as mentioned above, these figures are likely 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 $2483 to $10,912 per notice estimate calculated above for paper-based submission and lower than $2,260 to $10,243 per notice estimate calculated above for electronic submission. The total cost to all respondents reporting under a TSCA section 8(a) chemical-specific rule is estimated to range from $5,275 to $20,430 per year for paper-based reporting and from $4,828 to $18,428 for electronic reporting.

Table 2. Total Annual Respondent Burden and Costs Associated with Preparing and Filing a TSCA Section 8(a) Notice. (for paper-based reporting)
                                   Activity
                          Managerial Hours $83.15/hr
                                   Attorney
                                    Hours 
                                  $116.15/hr 
                           Technical Hours $78.08/hr
                                       
                             Clerical Hours $34.29
                               Notices per Year
                              Annual Burden Hours
                                 Annual Costs
Manufacturer Information 
and Principal Technical Contact
                                     1 - 4
                                       
                                       
                                       
                                       4
                                    4 - 16
                                     $332-
                                    $1,330
Chemical and
Trade Name
                                       
                                       
                                     1 - 4
                                       
                                       3
                                    3 - 12
                                     $234-
                                     $937
Chemical
Composition
                                       
                                       
                                    0.5 - 2
                                       
                                       4
                                     2 - 8
                                     $156-
                                     $625
Byproduct Information
                                       1
                                       
                                     1 - 4
                                       
                                       2
                                    4 - 10
                                     $322-
                                     $791
Use Description
                                       
                                       
                                     1 - 4
                                       
                                       4
                                    4 - 16
                                     $312-
                                    $1,249
Quantity Manufactured 
                                       
                                       
                                     1 - 4
                                       
                                       4
                                    4 - 16
                                     $312-
                                    $1,249
Marketing Data
                                     1 - 2
                                       
                                       
                                       
                                       2
                                     2 - 4
                                     $166-
                                     $333
Date of Initiation
of Manufacture 
                                      0.5
                                       
                                       
                                       
                                       4
                                       2
                                     $166
Occupational Exposure
                                     1 - 4
                                       
                                    2 - 16
                                     1 - 3
                                       2
                                    8 - 46
                                     $547-
                                    $3,369
Environmental Release
                                     1 - 4
                                       
                                     1 - 8
                                     1 - 3
                                       2
                                    6 - 30
                                     $391-
                                    $2,120
Occupational Description
                                       
                                       
                                    1 - 10
                                       
                                       1
                                    1 - 10
                                    $78.08-
                                     $781
Health and Environmental Information
                                     2 - 8
                                       
                                    8 - 40
                                     1 - 3
                                       1
                                    11 - 51
                                     $825-
                                    $3,891
Disposal Methods
                                     1 - 2
                                       
                                     1 - 6
                                       
                                       1
                                     2 - 8
                                     $161-
                                     $634
Attachments
                                       
                                       
                                       
                                     2 - 6
                                       1
                                     2 - 6
                                     $69-
                                     $206
Preparation of
Notice
                                       
                                       
                                       
                                     1 - 3
                                       4
                                    4 - 12
                                     $137-
                                     $411
Managerial Review of Submission
                                     1 - 4
                                       
                                       
                                       
                                       4
                                    4 - 16
                                     $333-
                                    $1,330
Legal Review of Submission
(CBI Substantiation) 
                                     0.75
                                     0.75
                                       
                                       
                                       4
                                       6
                                     $597
Recordkeeping
                                       
                                       
                                       
                                     1 - 3
                                       4
                                    4 - 12
                                     $137-
                                     $411
TOTAL
                                10.25  -  30.25
                                     0.75
                                   17.5 - 98
                                    7 - 21
                                       
                                   73 - 281
                                   $5,275 -
                                    $20,430

Table 3: Total Annual Respondent Burden and Costs Associated with Preparing and Filing a TSCA Section 8(a) Notice.  (for electronic reporting)
                                   Activity
                          Managerial Hours $83.15/hr
                                   Attorney
                                    Hours 
                                  $116.15/hr 
                           Technical Hours $78.08/hr
                                       
                             Clerical Hours $34.29
                               Notices per Year
                              Annual Burden Hours
                                 Annual Costs
Manufacturer Information 
and Principal Technical Contact
                                     1 - 4
                                       
                                       
                                       
                                       4
                                    4 - 16
                                     $332-
                                    $1,330
Chemical and
Trade Name
                                       
                                       
                                     1 - 4
                                       
                                       3
                                    3 - 12
                                     $234-
                                     $937
Chemical
Composition
                                       
                                       
                                    0.5 - 2
                                       
                                       4
                                     2 - 8
                                     $156-
                                     $625
Byproduct Information
                                       1
                                       
                                     1 - 4
                                       
                                       2
                                    4 - 10
                                     $322-
                                     $791
Use Description
                                       
                                       
                                     1 - 4
                                       
                                       4
                                    4 - 16
                                     $312-
                                    $1,249
Quantity Manufactured (Including Imported)
                                       
                                       
                                     1 - 4
                                       
                                       4
                                    4 - 16
                                     $312-
                                    $1,249
Marketing Data
                                     1 - 2
                                       
                                       
                                       
                                       2
                                     2 - 4
                                     $166-
                                     $333
Date of Initiation
of Manufacture (Including Importation)
                                      0.5
                                       
                                       
                                       
                                       4
                                       2
                                     $166
Occupational Exposure
                                     1 - 4
                                       
                                    2 - 16
                                       
                                       2
                                    6 - 40
                                     $478-
                                    $3,163
Environmental Release
                                     1 - 4
                                       
                                     1 - 8

                                       2
                                     4- 24
                                     $322
                                    $1,914
Occupational Description
                                       
                                       
                                    1 - 10
                                       
                                       1
                                    1 - 10
                                    $78.15-
                                     $781
Health and Environmental Information
                                     2 - 8
                                       
                                    8 - 40
                                       
                                       1
                                     10-48
                                     $791-
                                    $3,123
Disposal Methods
                                     1 - 2
                                       
                                     1 - 6
                                       
                                       1
                                     2 - 8
                                     $161-
                                     $634
Managerial Review of Submission
                                     1 - 4
                                       
                                       
                                       
                                       4
                                    4 - 16
                                     $333-
                                    $1,330
Legal Review of
Submission (CBI Substantiation) 
                                     0.75
                                     0.75
                                       
                                       
                                       4
                                       6
                                     $597
Recordkeeping
                                       
                                       
                                       
                                 0.5  -  1.5 
                                       4
                                     2 - 6
                                    $68.58
                                     $206
TOTAL
                                10.25  -  30.25
                                     0.75
                                   17.5 - 98
                                   0.5 -1.5
                                       
                                   60 - 242
                                    $4,828
                                    $18,428

One-Time Electronic Reporting Burden and Cost

	Electronic reporting costs are presented in Table 4.  Electronic reporting costs for first time registrants are estimated to be $282 and subsequent year costs are to be $1.71. EPA estimated the per-company one-time burden associated with CDX registration, set-up, and familiarization by multiplying the unit burden hour estimates by fully loaded hourly rates for workers of appropriate labor categories.  

	In addition to the one-time CDX registration and familiarization cost, a company would incur recurring burden associated with the time it takes to submit reports via CDX.  However, EPA assumed that this burden would be less than the reporting cost incurred by industry for submitting paper-based reports.  EPA estimated the time it would take to prepare and submit a report electronically by conducting a simulation of this process for the TSCA sections 4, 5, 8(a) PAIR, and 8(d).  For the purpose of renewing this ICR, the average estimate for the electronic reporting burden for section 8(a) PAIR (0.05) was multiplied by the loaded hourly wage for clerical workers estimated above ($34.29) to determine the recurring cost associated with submitting a report via CDX.  More information on the derivation of these costs is found in the Economic Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Proposed Rule (EPA, 2011).

Table 4.  Industry Burden, by Activity for Electronic Reporting
                                   Activity
                                Clerical Burden
                                 ($34.29/hr.)
                               Technical Burden
                                  ($78.08/hr)
                              Managerial Burden 
                                  ($83.15/hr)
                          Number of Annual Activities
                                 Total Burden
                                    (hours)
                                       
                                       
                                       
                                 Annual Cost 

                                      (a)
                                      (b)
                                      (c)
                                      (d)
                             (e) =[(a)+(b)+(c)]*d
                                       
                             ELECTRONIC REPORTING
                                       
First-time registration

CDX Registration
                                                                           0.00
                                                                           0.73
                                                                           0.18
                                                                           1.00
                                                                           0.91
                                                                            $72
CDX Electronic Signature
                                                                           0.00
                                                                           1.00
                                                                           0.75
                                                                           1.00
                                                                           1.75
                                                                               
                                                                           $140
Rule Familiarization 
                                                                           0.00
                                                                           0.27
                                                                           0.55
                                                                           1.00
                                                                           0.82
                                                                            $67
Total
                                                                           0.00
                                                                           2.00
                                                                           1.48
                                                                               
                                                                           3.48
                                                                           $279
Non-Labor Cost[1]
CDX Electronic Signature 
                                       -
                                                                          $2.60
                                               Total First Time Burden per firm
                                                                           3.48
                                                                           $282
Recurring Electronic 
Recurring Burden per Submission (hours) 
Number of Annual Activities 
Recurring Cost per Submission (2017$)
           Annual Cost 
                                                                           0.05
                                                                           1.00
                                                                          $1.71
                                                                          $1.71
                                               Total Subsequent Burden per firm
                                                                           0.05
                                                                          $1.17
[1] Non-labor costs include a $0.49 stamp and a $0.03.

	6(c) 	Estimating Agency Burden and Cost

      EPA is responsible for the following activities associated with administering the TSCA section 8(a) rule: 
          Industry and public information assistance;
          Data processing and systems support;

      The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016, and became immediately effective.  EPA has estimated the Agency burden resulting from the new requirements in the act for substantiation of CBI claims made as a result of this rule.  EPA will further refine these estimates when it revises the cost and estimates for the ICR for 40 CFR part 2 based on the new CBI substantiation requirements.   

      Agency personnel are responsible for all tasks associated with the rule, and none of the work is estimated to be completed by contractor staff. EPA labor costs are based on annual federal wage rates published by the Office of Personnel Management for the Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV Locality Pay Area for 2017 (OPM, 2017). Wages are presented in terms of GS-level and step. A federal GS-12, Step 1 employee will conduct the collection and administrative activities under the rule. A federal GS-12, Step 1 will assist with the review of the CBI claim substantiations. Unloaded wage rates for 2017 for both of these employees are presented in Table 5. Following the methodology outlined in Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992), EPA added 60 percent to the wage rate to account for fringe benefits and overhead costs. Table 5 derives the loaded annual wage rates for Agency staff at the GS-12 Step 1, 

Table 5: Derivation of Loaded Agency Wage Rates (2017$)
                                Labor Category
                                   Pay Grade
                                Annual salary  
                                       
                   Overhead and Fringe Benefits (% of wage) 
                                      (c)
 Overhead and Fringe Benefit Cost  

                                       
                                       
Total
                                Technical Labor
  GS 12 Step 1                                                              
                                   $ 79,720
                                       
                                       
                                      60%
                                       
$ 47,832

$ 127,553 

                                       
                                Attorney Labor
                                 GS 12 Step 1
                                       
                                   $ 79,720
                                       
                                      60%
                                       
$ 47,832
                                       
                                       
                                       
                                   $ 127,553
                                       

The Agency has developed the following burden hour estimates for activities related to promulgating a TSCA section 8(a) chemical-specific rule.

Table 6: Processing One Report

                                 EPA Activity
                               Technical Labor 
                                Attorney Labor
                               Total Labor Cost

                                Burden (Hours)
                                Burden (Hours)
                                    Burden
                                    (Hours)
                          Industry/Public Assistance
                                    0.1 FTE
                                       0
                                      0.1
                     Data Processing and Systems Support 
                                    0.2 FTE
          0
                                      0.2
                           Storage and Distribution
                                    0.1 FTE
                                       0
                                      0.1
                             Compliance monitoring
                                    0.1 FTE
                                       0
                                      0.1
                      Review of CBI claim substantiations
                                   0.5 FTE 
                                      1.5
                                       2
                             Total FTE, per report
                                   1.00 FTE 
                                    1.5 FTE
                                       
                                       
                                    2.5 FTE
                                       
                                       

	The Office of Pollution Prevention and Toxics bases its burden hour and 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 for a GS-12 Step 1 employee. The 2017 annual salary for a GS-12 Step 1 employee in the Washington, DC area is $79,720. The cost for 2.5 FTE is $199,300. Incorporation of an overhead and benefits factor of 1.6 yields a fully loaded cost of $318,880 to the Agency for promulgating and supporting a TSCA section 8(a) chemical-specific rule. The full-time work year is considered to be 2,080 hours, so that there are 5,200 burden hours associated with 2.5 FTE.

	6(d) 	Bottom Line Burden Hours and Costs

	The following table displays 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.  The industry burden and cost for electronic reporting includes the average of the electronic reporting for the three years of this rule.  The registration burden and cost in the first year of the rule are 3.48 hours and $282 respectively.  In the second and third year the electronic reporting burden and costs are 0.05 hour and $1,17 respectively per year. Thus, an average cost of $95 per year over a three-year period.

Table 7. Annual Burden and Cost of a TSCA Section 8(a) Chemical-Specific Rule.

                              Annual Burden Hours
                                 Annual Costs
                       Industry (paper-based reporting)
                                   73 to 281
                               $5,130 to $20,480
                                   Industry
                          (for electronic reporting)
                                   61 to 242
                               $4,923 to $18,523
                                    Agency
                                     5,200
                                   $318,880
      
      6(e) 	Reasons for Change in Burden
	
	This request represents a net increase of 6 hours from that currently in the OMB inventory (from 275 to 281 hours). EPA estimates that industry will incur an increase of 6 hours of burden for a total burden of 281 hours if respondents continue with paper-based reporting.  This increase is due to new reporting requirements in the Lautenberg Act to substantiate CBI claims. The EPA estimates that the industry will incur a net decrease of 33 hours of burden for a net total of 242 hours if respondents submit reports electronically despite the increase in burden due to new reporting requirements in the Lautenberg Act to substantiate CBI claims.   

Table 8: Total Estimate of Annual Burden Hours and Annualized Cost Comparisons (Paper-based Reporting)
                                       
                              Annual Burden Hours
Current OMB Inventory
                                      275
Change in Burden due to Adjustments
                                       0
Change in Burden due to Lautenberg Act 
                                       6
Total Change in Burden
                                       6
Total Burden
                                      281

Table 9: Total Estimate of Annual Burden Hours and Annualized Cost Comparisons (Electronic Reporting)
                                       
                              Annual Burden Hours
Current OMB Inventory
                                      275
Change in Burden due to Adjustments
                                       0
Change in Burden due to Lautenberg Act and electronic reporting 
                                     -33 
Total Change in Burden
                                      -33
Total Burden
                                      242

	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 more than one TSCA section 8(a) chemical-specific rule per year over the next three years or promulgate a rule expected to have a significantly different burden than the burden estimated within this ICR. If EPA does this, the Agency will submit a technical addendum 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 between 60.75 hours (for electronic reporting) and 70.75 hours (for paper-based reporting) per response. Burden is defined in 5 CFR 1320.3(b). 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 displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.
	
	The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2017-0317, which is available for online viewing at http://www.regulations.gov, or in-person viewing at the EPA Docket Center (EPA/DC), EPA West, Room 3334, 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) 566-1744, 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-2017-0317 and OMB Control No. 2070-0067, as follows:

	-  To EPA online using http://www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and

	-  To OMB by e-mail to: oira_submission@omb.eop.gov. Address comments to OMB Desk Officer for EPA.

                    ATTACHMENTS TO THE SUPPORTING STATEMENT

      Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2017-0317. These attachments are available for online viewing at http://www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement, above.
      
Attachment 1		Toxic Substances Control Act Section 8(a), 15 U.S.C. 2607

Attachment 2		Toxic Substances Control Act Section 26(p), 15 U.S.C. 2625
      
Attachment 3		General Reporting and Recordkeeping Provisions for Section 8(a)
            Information-Gathering Rules, 40 CFR 704