Document ID: EPA-HQ-OPPT-2010-0572-0196
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-01-28T05:00Z

Supporting Statement for an Information Collection Request (ICR)
                    Under the Paperwork Reduction Act (PRA)
	
Table of Contents
1.	EXECUTIVE SUMMARY	3
1(a).	Identification of the Information Collection  -  Title and Numbers	3
1(b).	Docket Information	3
1(c).	ICR Status	3
1(d).	Abstract	4
2.	NECESSITY OF THE INFORMATION COLLECTION	5
2(a).	Related Legal and/or Administrative Requirements	5
2(b).	Necessity of the Information Collection	7
2(c).	Uses, Users, and Purpose of the Information Collection	7
3.   NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA	8
3(a).	Non-Duplication	8
3(b).	Public Notice and Consultations	8
3(d).	Small Entity Flexibility	8
3(e).	General PRA Related Guidelines	9
3(f).	Effects of Less Frequent Collection	9
3(g).	General Guidelines	9
3(h).	Confidentiality	9
3(i).	Sensitive Questions	9
4.	AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT	9
    4(a).	Agency Activities	9
4(b).   Collection Methodology and Management	10
4(c).   Collection Schedule	10
5.	The RESPONDENTS AND INFORMATION COLLECTION (IC) ACTIVITIES	10
5(a).   Methodology for Estimating Respondent Burden and Costs	10
5(b).	11
IC #1: Manufacture Form Completion, CBI Substantiation, Form Submission, and Recordkeeping	11
IC #2: Processor Form Completion, CBI Substantiatin, Form Submission and Recordkeeping	12
5(c).  Total Estimated Respondent Burden and Costs	13
6.	PRA Burden Statement	14
7.	Attachments to the Supporting Statement	15

______________________________________________________________________

 EXECUTIVE SUMMARY
 Identification of the Information Collection  -  Title and Numbers 
	Title: Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials 
	ICR Numbers: EPA ICR No.: 2517.03; OMB Control No.: 2070-0194.
	EPA Form Numbers:  EPA Form 9600-07: TSCA §8(a) Reporting for Chemical  Substances when Manufactured or Processed as Nanoscale Materials: Data Submission Form 
	Docket ID Number: EPA-HQ-OPPT-2010-0572.

 Docket Information
The information collection request (ICR) that explains the information collection activities and related burden and cost estimates, as well as other supporting documents related to the ICR, are available in the docket established for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave., NW., Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

 ICR Status 
Under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid control number issued by the Office of Management and Budget (OMB). The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Before submitting an ICR to OMB for review and approval under the PRA, an agency must solicit comments pursuant to PRA §3506(c)(2)(A) and 5 CFR 1320.8(d)(1). After considering comments received on the draft ICR, the agency must submit the ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. In announcing the submission of the final ICR to OMB for review and approval, the agency must provide another opportunity for public review and comments on the revised ICR pursuant to 5 CFR 1320.12(c).

This is an ICR renewal for the information collection activities that are currently approved by OMB for: 

OMB Control No. 2070-0194; EPA ICR No. 2517.02; entitled "Addendum to the Existing 
EPA ICR Entitled: Chemical-Specific Rules, Toxic Substances Control Act Section 8(a)",
approved through August 31, 2020.
 Abstract
This information collection request (ICR) covers reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials and is related to a final rule issued under the authority of section 8(a) of the Toxic Substances Control Act (TSCA). Although approved as an ICR addendum to revise an existing approved ICR to incorporate reporting and recordkeeping requirements in the TSCA section 8(a) rule for Certain Nanoscale Materials (identified under RIN 2070-AJ54), it was not incorporated into the existing ICR after its approval. As a result, EPA is seeking to renew the approval of the addendum and will work to consolidate the ICRs during the next approval time period.

Legal authority: The Toxic Substances Control Act (TSCA) section 8(a), U. S. C. 2607 and implementing regulations in 40 CFR part 704.20. More details are provided in Unit 2(a) of this Supporting Statement.

Respondents/affected entities: Entities potentially affected by this ICR include persons 
persons who manufacture or process chemical substances as nanoscale materials as defined in the final rule codified at 40 CFR part 704.20.

Respondent's obligation to respond: Responses are mandatory under TSCA (see also 40 CFR part 704.20).

Confidentiality of responses: Respondents may claim all or part of a document submitted to be as confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

Estimated total number of potential respondents:  285 per year
Frequency of response: On occasion .
Estimated total annual burden hours: 40,089 hours. Burden is defined at 5 CFR 1320.3(b).
Estimated total annual costs:  $3,067,546, includes no annualized capital investment or maintenance and operational costs.

Changes in the estimates: There is decrease of 26,861 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease reflects EPA's expectation of decreased submissions. In the previous ICR period, the rule required an initial one-time reporting on current nanomaterials, while the reporting covered in this period only requires the reporting of new nanomaterials. Furthermore, burden estimates assume that the same manufacturers will report each year and, therefore, will have already undertaken rule familiarization in the previous ICR period. Wage rates were also updated to reflect 2018 dollars. 

 NECESSITY OF THE INFORMATION COLLECTION
 Related Legal and/or Administrative Requirements
The related legal authority is The Toxic Substances Control Act (TSCA) section 8(a), U. S. C. 2607 and implementing regulations in 40 CFR part 704.20
In addition, the EPA has developed guidance and other materials that are available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/control-nanoscale-materials-under#info rule. 
The following provides a general overview for requirements covered in this ICR:

	EPA is requiring that respondents provide all the information described below to the extent it is known or reasonably ascertainable. EPA is not requiring that respondents develop additional data for this information collection request. 

1. Company name and other identifying information, address of company and site, technical contact and related information.

2. Common or trade name of the chemical substance.
Chemical identity and molecular structure of substance.  

3. The following physical and environmental fate properties:

      Physical state 
      Vapor pressure
      Density Solubility in water or other solvents
      Melting temperature 
      Boiling/sublimation temperature
      Spectra Dissociation constant
      Particle size distribution 
      Octanol/water partition coefficient
      Henry's Law constant 
      Volatilization from water
      pH Volatilization from soil
      Flammability Explodability
      Adsorption coefficient Shape
      Agglomeration state/dispersion state
      Crystal structure
      Chemical composition  -  including spatially averaged (bulk) and spatially resolved 
          heterogeneous composition
      Surface area Surface chemistry
      Surface charge Porosity
      Surface reactivity average particle weight
      Average particle surface area rate of sorption
      Aggregation rate of diffusion
      Wet and dry transport rate of gravitational settling
      Bioaccumulation/biomagnification biodegradation
      Particle count rate of deposition
      Surface/volume ratio average aerodynamic diameter
      Mobility through soil
      Influence of Redox and photochemical reaction

4. Description of all uses including expected consumer uses.

5. Estimate of the total amount of the chemicals substance to be manufactured including the amount for each use category.

6. Description of byproducts and impurities resulting from manufacture, process, use or disposal of the chemical substance.

7. For each type of workplace in the lifecycle, the same information requested on pp. 8-10 of the EPA PMN form (7710-25) would be helpful for releases and exposures, with the following additions.

8. A brief overview of the lifecycle including all workplaces that manufacture, process, or use the chemical substance and all expected consumer uses.

9. For each release point for which control technology is used, the rationale for selecting the control, and, if available, data and measurement methods of waste treatment or purification efficiency studies for the chemical substance.

10. Regarding worker exposure information, personal or area monitoring data (in mass concentrations, surface area per mass, number of particles, etc.) for the chemical substance, including the measurement method(s) used to generate the data.

11. For each protective equipment or engineering control listed as worker protection, the rationale for selecting the protective equipment or engineering controls, and data (and methods used to generate the data) that were used in making the selection or that may help to indicate the effectiveness of the protective equipment or engineering controls.

12. Information on cleaning/reuse/disposal of used protective equipment (gloves, respirator cartridges, etc.).

13. Additional procedures or other equipment intended to mitigate exposures to the chemical substance.

14. Description of worker training and hazard communication (MSDS, other) specific to the chemical substance.

15. Estimate of the total number of individuals other than workers exposed to the chemical substance and duration of exposure.

16. Manner or method of disposal for consumer use of products containing the chemical substance. 

17. Any information in the submitter's possession regarding health or environmental effects, environmental fate, worker safety, and material characterization, including any information related to characterization of the chemical substance in the subject organism and test medium.

 Necessity of the Information Collection 
Nanoscale materials or nanomaterials are chemical substances organized in structures in the scale of approximately 1 to 100 nanometers and may have different organizations and properties than the same chemical substances in a larger size. Nanoscale materials can be found in a wide variety of products, including electronics, automotive products, paints and coatings, metal-cutting tools, sports equipment, stain-free clothing and mattresses, and ink.   There are hundreds of products already on the market that utilize nanoscale materials. It is recognized that some of these substances, because of their small size, exhibit novel and enhanced properties not present in substances of larger dimensions. It is also widely recognized that there is limited data available on these types of substances. 
   
Some nanoscale materials are recognized as new chemical substances subject to notification requirements under TSCA section 5 because they are not contained on the TSCA Inventory. Therefore, they are subject to review for potential human health and environmental risks before they are manufactured and enter commerce. EPA has identified over 200 nanoscale materials submitted as new chemicals under TSCA since January 2005.  Other nanoscale materials have the same molecular identity as chemical substances which are already on the TSCA Inventory and as such are not subject to new chemical notification. The Agency has authority under TSCA §8(a) to collect information regarding chemical substances in commerce.

EPA issued the section 8(a) reporting rule to require reporting of certain new nanoscale materials that are not reportable as new chemical substances. The reporting of information associated with these nanoscale materials will provide EPA with data needed to determine appropriate action(s) under TSCA to reduce any risk to human health or the environment. 

Recordkeeping and reporting requirements are necessary to ensure effective implementation.

 Uses, Users, and Purpose of the Information Collection
The information collected through the rule will provide important baseline information  on health and environmental effects, exposures, risks, management practices, and data needs that will assist EPA and others in properly assessing and managing risks related to nanoscale materials.
   
Non-confidential portions of this information will also be made available to help the public understand how nanoscale materials are being used.  Information collected through this rule will be used by EPA scientists to assist in determining how and whether certain nanoscale materials may present risks to human health and the environment. If the hazard, exposure, and risk information submitted by participants indicate that potential unreasonable risks may exist, the data will be used by EPA and the manufacturer to determine the appropriate action necessary to avoid or mitigate the risks. Furthermore, such information could be used for risk management, hazard communication and right-to-know purposes, and product labels. EPA may also use the information to identify nanoscale materials that may not warrant future concerns or actions or should otherwise be treated as a lower priority for further consideration. 
   
The information may also be used by other Federal agencies. Non-confidential portions of this information may be used by the public, academics, states, local and tribal government, as well as foreign governments and international organizations. 
   
 NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
 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 rule indicates that any person who submitted a TSCA new chemical notice on or after January 1, 2005 under 40 CFR part 720 or 723 for a nanoscale material subject that would be subject to the rule does not need to submit a report for the nanoscale material previously submitted.   
     3(b).    Public Notice and Consultations

 In renewing this ICR, EPA will provide a 60-day public notice and comment period. In addition to the public notice and comment period, EPA will consult with potential ICR respondents and data users according to OMB regulations, at 5 CFR 1320.8(d)(1).

   3(c). Small Entity Flexibility
The rule exempts some small manufacturers and processors.  However, as described in the rule some small manufacturers and processors would be required to report and keep records.  Based on EPA's economic analysis for the rule, EPA has determined that the rule is not expected to have a significant adverse economic impact on a substantial number of small entities.  All respondents to TSCA section 8(a) chemical-specific rules, including small businesses, are granted flexibility in their reporting methods.

   3(d). General PRA Related Guidelines
 This ICR is consistent with OMB's general guidelines. Firms are required to maintain records for three years. The rule requires reporting only once for manufacturers and processors for new discrete nanoscale materials before they are manufactured or processed
 
     3(e).  Effects of Less Frequent Collection

	The 8(a) rule requires reporting only once for manufacturers and processors for new discrete nanoscale materials before they are manufactured or processed.  

     3(f).   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(g).   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 EPA's confidentiality regulation, 40 CFR Part 2, Subpart B.

      3(h).  Sensitive Questions

	This section is not applicable.  TSCA section 8(a) reporting rules do not include any questions of a sensitive nature.

 AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND  INFORMATION MANAGEMENT 

4(a).	Agency Activities

      EPA will perform the following activities:
      - review the information submitted;
            - analyze submissions for confidentiality and provide appropriate protection for  confidential data;
      - file and store submissions;
            - use the data to inform the assessment and management of any risks from nanoscale materials; and
           	- provide an aggregated report of the information submitted.

4(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 flexible means of obtaining the required information than the one currently being used.  To the extent information is not CBI, all information collected is made available to the public through the public docket office.  EPA is requiring firms to submit this information on one standard reporting form.  TSCA section 8(a) chemical-specific rules typically require one-time reporting.  As future data needs arise, EPA will consider the use of other types of reporting methods.  EPA believes the flexibility already allowed in the reporting structure significantly eases burden.

4(c).	Collection Schedule
      
      This is a one-time collection of information.  Respondents will normally report 135 days before new discrete forms of reportable nanoscale materials are intended to be manufactured or processed but no later than 30 days after forming that intent.   

 The RESPONDENTS AND INFORMATION COLLECTION (IC) ACTIVITIES
For each respondent category, this section of the ICR describes the respondents, the information collection activities and related estimates for burden and costs associated with those activities. 

 Methodology for Estimating Respondent Burden and Costs

This information collection request (ICR) specifies the reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials and is related to a final rule issued under the authority of Section 8(a) of the Toxic Substances Control Act (TSCA).

The North American Industrial Classification System (NAICS) codes associated with industries most likely affected by the paperwork requirements are described below: 

325		Chemical Manufacturers and Processors
325130	Synthetic Dye and Pigment Manufacturing
324110	Petroleum Refineries
325180	Other Basic Inorganic Chemical Manufacturing
331221	Rolled Steel Shape Manufacturing
334413	Semiconductor and Related Device Manufacturing
335991	Carbon and Graphite Product Manufacturing
423220	Home Furnishing Merchant Wholesalers
423330	Roofing, Sliding, and Insulation Material Merchant Wholesalers
423510	Metal Service Centers and Other Metal Merchant Wholesalers

 
   IC #1: Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping 
Respondent NAICS Codes
325		Chemical Manufacturers and Processors
325130	Synthetic Dye and Pigment Manufacturing
324110	Petroleum Refineries
325180	Other Basic Inorganic Chemical Manufacturing
331221	Rolled Steel Shape Manufacturing
334413	Semiconductor and Related Device Manufacturing
335991	Carbon and Graphite Product Manufacturing
423220	Home Furnishing Merchant Wholesalers
423330	Roofing, Sliding, and Insulation Material Merchant Wholesalers
423510	Metal Service Centers and Other Metal Merchant Wholesalers
Information Collection Activities

Based on the rule requirements, manufactures will complete four procedural tasks: form completion, CBI claim substantiation, form submission and recordkeeping. EPA estimates a total of 165 nanomaterial manufacturers will respond each year. It is expected that the same 165 manufactures will submit 0.52 reports per year on average. All of the following estimates of burden hours take into account the expectation that each manufacturer will submit 0.52 reports per year.

Form completion involves the time and cost for providing the information listed above. It is estimated that it will take manufactures approximately 71 hours per year for form completion. If a manufacturer claims certain data elements as CBI, they must substantiate the claim by providing certain information to support the need to keep information confidential. It is estimated that it will take a manufacturer approximately 0.78 hours per year to substantiate a CBI claim. Form submission involves the time to electronically submit the report to EPA via CDX, EPA's electronic system for environmental data exchange. Because the same manufacturers are expected to report each year, it is estimated to take 0.17 hours per year to electronically submit the report. Recordkeeping involves the time taken to maintain records of the reported information. It is estimated to take approximately a half hour per year for a manufacturer to maintain its records of the information reported.

The total burden is estimated to be approximately 73 hours per year per manufacturer. There are no material costs associated with this rule. 

IC#1. Manufacturer Form Completion, CBI Substantiation, Form Submission and Recordkeeping
                            Citation: 40 CFR 704.20
Data Element
Form
Total Responses
Total Burden(hours)
Materials
Total Cost ($) 
Form Completion

                                                                          257.4
                                                                         35,161
N/A
                                                                     $2,686,999
CBI Substantiation

                                                                          257.4
                                                                            386
N/A
                                                                        $38,322
Form Submission (Electronic Reporting)

                                                                            495
                                                                          84.15
N/A
                                                                         $6,574
Recordkeeping

                                                                          257.4
                                                                            257
N/A
                                                                        $14,134
                                                                   Grand Total 
                                                                         35,888

                                                                     $2,746,028
Total responses, burden and cost estimates are based on the expectation that 165 manufactures will submit 0.52 responses each year over the three-year period.
Values may not sum due to rounding.
                                                                               

            
   IC #2: Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping 

Respondent NAICS Codes

325		Chemical Manufacturers and Processors
325130	Synthetic Dye and Pigment Manufacturing
324110	Petroleum Refineries
325180	Other Basic Inorganic Chemical Manufacturing
331221	Rolled Steel Shape Manufacturing
334413	Semiconductor and Related Device Manufacturing
335991	Carbon and Graphite Product Manufacturing
423220	Home Furnishing Merchant Wholesalers
423330	Roofing, Sliding, and Insulation Material Merchant Wholesalers
423510	Metal Service Centers and Other Metal Merchant Wholesalers

Information Collection Activities

Based on the rule requirements, processors will complete five procedural tasks: rule familiarization, form completion, CBI claim substantiation, form submission and recordkeeping. 

It is expected that 199 new processors will submit one report each year and, therefore, engage in rule familiarization.  Rule familiarization involves the time and cost required for processors to review the rule and set up procedures for meeting the requirements. EPA estimates that the one-time burden related to learning the rule and setting up compliance procedures is 0.82 hours. 

Form completion involves the time and cost for providing the information listed above. It is estimated to take 136.6 hours per year to complete the form. If a processor claims certain data elements as CBI, it must substantiate the claim by providing certain information to support the need to keep information confidential. It is estimated to take 1.5 hours per year for a processor to substantiate a CBI claim. Form submission involves the time to electronically submit the report to EPA via CDX, EPA's electronic system for environmental data exchange. Because it is expected that new processors will submit the form each year, it is estimated to take 1.42 hours per year for a processor to register and submit the form. Recordkeeping involves the time taken to maintain records of the reported information. It is estimated to take one hour per year for a processor to maintain its records of the information reported.

The total burden is estimated to be 141 hours per year per processor. There are no material costs associated with this rule.

   

IC#2. Processor Form Completion, CBI Substantiation, Form Submission and Recordkeeping
                            Citation: 40 CFR 704.20
Data Element
Form
Total Responses
Total Burden(hours)
Materials
Total Cost ($) 
Rule Familiarization

                                                                            597
                                                                           490 
N/A
                                                                        $37,641
Form Completion

                                                                            597
                                                                         81,550
N/A
                                                                     $6,232,083
CBI Substantiation

                                                                            597
                                                                           896 
N/A
                                                                        $88,881
Form Submission (Electronic Reporting)

                                                                            597
                                                                           848 
N/A
                                                                        $65,222
Recordkeeping

                                                                            597
                                                                           597 
N/A
                                                                        $32,781
                                                                               
                                                                    Grand Total
                                                                        84,380 

                                                                     $6,456,609
Total responses, burden and cost estimates are based on the expectation that 199 processors will submit one response each year over the three-year period.
Values may not sum due to rounding.

 Total Estimated Respondent Burden and Costs
                               IC Summary Table
IC Category
Responses
Burden (hours)
Cost ($)
IC 1: Manufacturers
                                                                            258
                                                                        35,888 
                                                                     $2,746,028
IC 2: Processors
                                                                            597
                                                                         84,380
                                                                     $6,456,609
Total
                                                                            855
                                                                        120,269
                                                                     $9,202,637

 PRA BURDEN STATEMENT
Under the PRA, burden is defined at 5 CFR 1320.3(b).

The annual public burden for this collection of information, which is approved under OMB Control No. 2070-0194, is estimated to average approximately 121 hours per report. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a current and valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable. The burden from the previously approved ICR was 147,130 hours. The total burden requested for this ICR is 120,269 hours, or a decrease of 26,861 hours from the previous total burden. The difference between the current burden request and the previously approved requests are due to adjustments in EPA's estimates of the burden. Several adjustments to the estimates were made, including:
 In the previous ICR period, the rule required an initial one-time reporting on current nanomaterials, while the reporting covered in this period only requires the reporting of new nanomaterials. Therefore, a large portion of the adjustment in estimates stems from the decrease in the number of submissions expected after the initial one-time reporting on current nanomaterials. 
 Burden estimates include a one-time burden that firms incur to become familiar with the rule and its various requirements. In the first year of the rule, the manufacturers that submitted reports incurred the one-time rule familiarization burden. EPA assumes that the same manufacturers will submit reports on new nanomaterials during subsequent years and do not need to familiarize themselves with the rule. Therefore, part of the decrease in burden estimates, relative to the previous ICR period that included the first year of the rule, is due to the same manufacturers submitting reports without incurring the rule familiarization burden.
   
The total combined cost burden of the previously approved ICR was $33,978,455 million. The total cost requested for this ICR is $9,202,637. The difference of $24,775,818 between the current cost burden request and the previously approved requests are due primarily to adjustments in EPA's estimates of the burden. In addition to the adjustments listed above, the wage rates were revised to reflect 2018 dollars for this information collection request.

ATTACHMENT     

Supporting Attachment: Burden Calculation

This document serves the purpose of supporting the burden calculations included in the ICR renewal. EPA estimates that a total of 165 nanomaterial manufacturers will submit 0.52 responses per year and 199 nanomaterial processors will submit one response per year in each year of the ICR period, for a total of 285 reports per year and 855 reports over the three-year period. Table 1 shows the yearly number of responses for the various activities for manufacturers and processors, respectively. 

Table 1: Annual Number of Responses per Activity 
                                   Activity
                                 Manufacturers
                                  Processors
                           Total Number of Responses
                                  (per year)
                                       
                           Total Number of Companies
                        Number of Responses/ Respondent
                           Total Number of Companies
                        Number of Responses/ Respondent
                                       
Rule Familiarization 
                                      165
                                       0
                                      199
                                       1
                                      199
Form Completion 
                                      165
                                     0.52
                                      199
                                       1
                                      285
CBI Substantiation 
                                      165
                                     0.52
                                      199
                                       1
                                      285
Electronic Submission 
                                      165
                                       1
                                      199
                                       1
                                      364
Recordkeeping 
                                      165
                                     0.52
                                      199
                                       1
                                      285
  
Estimating Respondent Burden

Table 2 provides a summary of typical respondent burden by respondent type for rule familiarization, completion of a report, CBI claim substantiation, and recordkeeping. Because it is expected that the same manufacturers will report each year, manufacturers do not have to undertake rule familiarization. On the other hand, it is expected that new processors will report each year and, therefore, undertake rule familiarization.  

Table 2: Industry Burden, by Activity for Rule Familiarization, Form Completion, and Recordkeeping
                                   Activity
                                Clerical Burden
                                    (hours)
                               Technical Burden
                                    (hours)
                               Managerial Burden
                                    (hours)
                                Attorney Burden
                                    (hours)
                                 Total Burden 
                                    (hours)
Rule Familiarization
                                                                              0
                                                                           0.55
                                                                           0.27
                                                                              0
                                                                           0.82
Form Completion
                                                                              0
                                                                          105.2
                                                                           31.4
                                                                              0
                                                                          136.6
CBI Claim Substantiation
                                                                              0
                                                                              0
                                                                           0.75
                                                                           0.75
                                                                            1.5
Recordkeeping
                                                                            0.5
                                                                            0.5
                                                                              0
                                                                            0 
                                                                              1
Total Burden per Report
                                                                            0.5
                                                                         106.25
                                                                          32.42
                                                                         0.75 
                                                                            140
Values may not sum due to rounding.

The burden associated with electronic submission is presented in Table 3. This burden depends on whether a firm is registering for the first time with CDX or has previously registered with CDX. 

Table 3: Industry Burden, by Activity for Electronic Reporting
                                   Activity
                                Clerical Burden
                                    (hours)
                               Technical Burden
                                    (hours)
                           Managerial Burden (hours)
                          Number of Annual Activities
                                 Total Burden
                                    (hours)
First-time registration
CDX Registration
                                                                           0.00
                                                                           0.67
                                                                           0.17
                                                                           1.00
                                                                           0.84
Electronic Subscriber Agreement/ Electronic Signature
                                                                           0.00
                                                                           0.00
                                                                           0.25
                                                                           1.00
                                                                           0.25
Help Desk
                                                                           0.00
                                                                           0.24
                                                                           0.06
                                                                           1.00
                                                                           0.30
Problem Resolution
                                                                           0.00
                                                                           1.00
                                                                           0.00
                                                                           0.03
                                                                           0.03
                                               Total First Time Burden per firm
                                                                           1.42
Subsequent registration
CDX Registration
                                                                           0.00
                                                                           0.67
                                                                           0.17
                                                                           0.10
                                                                           0.08
Electronic Subscriber Agreement/Electronic Signature
                                                                           0.00
                                                                           0.00
                                                                           0.25
                                                                           0.10
                                                                           0.03
Help Desk
                                                                           0.00
                                                                           0.24
                                                                           0.06
                                                                           0.10
                                                                           0.03
Report Compromised Signature
                                                                           0.00
                                                                           0.00
                                                                           0.40
                                                                           0.01
                                                                           0.00
Problem Resolution
                                                                           0.00
                                                                           1.00
                                                                           0.00
                                                                           0.03
                                                                           0.03
                                               Total Subsequent Burden per firm
                                                                           0.17

EPA estimates the total burden for one firm to complete one form to be approximately 141 hours including rule familiarization and electronic reporting. 

Given the expectation that the same manufacturers will submit 0.52 reports per year, the burden per year per manufacturer is estimated by:

                                          Form Completion, CBI Claim
                                  Substantiation and Recordkeeping         E-Reporting
Annual Burden per Manufacturer= 0.52 136.6+1.5+1      +          0.17       =72.5.

Therefore, the total annual burden across all 165 manufacturers is estimated by:

Annual Manufacturer Burden  =165    x    72.5=11,962.83

and the total burden incurred by manufacturers over the three-year period is estimated by:

         Total ICR Manufactuer Burden =3     x    11,962.83=35,888.49.

Given the expectation that each new processor will submit one report per year, the burden per year per processor is estimated by:
                                            Form Completion,
                                      Rule 	        CBI Claim Substantiation
                                     Familiarization      and Recordkeeping                E-Reporting
Annual Burden per Processor= 0.82     +     136.6+1.5+1        +        1.42  =141.34.

Therefore, the total annual burden across all 199 processors is estimated by:

            Annual Processor Burden  =199    x    141.34=28,126.66
                                       
and the total burden for processors over the three-year period is estimated by:

          Total ICR Processor Burden =3    x    28,126.66=84,379.98 .

Table 4 summarizes the annual and total burden over the course of the ICR to manufactures, processors and industry as a whole based on the above estimates.

Table 4: Total Industry Burden
IC Category
                                 Annual Burden
                                    (hours)
                        Total ICR Burden (over 3 years)
                                    (hours)
IC 1: Manufacturers
                                    11,963
                                    35,888
IC 2: Processors
                                    28,127
                                    84,380
Total Industry Burden
                                 40,089 hours
                                 120,269 hours
Values may not sum due to rounding.

Estimating Cost
      Table 5 contains the cost per activity of completing a form for one respondent. Burden hours presented in Table 2 were multiplied by the corresponding loaded wage rate. EPA estimates that the total cost for a new firm to review the rule, complete, and submit one report with record keeping is approximately $10,815. Because new processors are estimated to report each year, they will undertake rule familiarization and first-time registration for electronic reporting. Because the same manufacturers are expected to submit reports each year, their cost for submitting one report would be approximately $10,656 when excluding the cost burden associated with rule familiarization and accounting for a lower burden associated with electronic reporting for subsequent submissions. 

Table 5: Industry Cost, by Activity (2018$)
                                   Activity
                        Clerical Burden  ($34.50/hour)
                               Technical Burden
                                 ($75.32/hour)
                               Managerial Burden
                                 ($80.09/hour)
                                Attorney Burden
                                ($118.42/hour)
                                  Total Cost
Rule Familiarization
                                     $0.00
                                    $41.43
                                    $21.62
                                     $0.00
                                    $63.05
Form Completion
                                     $0.00
                                    $7,924
                                    $2,515
                                     $0.00
                                    $10,439
CBI Claim Substantiation
                                     $0.00
                                     $0.00
                                    $60.07
                                    $88.82
                                    $148.88
Recordkeeping
                                    $17.25
                                    $37.66
                                     $0.00
                                     $0.00
                                    $54.91
Total Burden per Report
                                    $17.25
                                    $8,003
                                    $2,597
                                    $88.82
                                    $10,706
Values may not sum due to rounding.
Estimates for manufacturer totals assume that rule familiarization does not occur. Because there are new processors estimated to report each year, the cost for those entities includes rule familiarization.
      
      Electronic reporting costs are presented in Table 6. Because not all firms are expected incur all costs, the number of annual activities per firm may be less than one. Electronic reporting costs for first time registrants are estimated to be $109.25 per firm and subsequent year costs are to be $13.28 per firm. Because the same nanomaterial manufacturers are reporting each year, they are expected to incur a cost of $13.28 per firm per year, while processors, who are new respondents each year, are expected to incur $109.25 per firm each year. More information on the derivation of these costs is found in the Economic Analysis for the Final TSCA Section 8(a) Reporting Requirements for Certain Chemical Substances as Nanoscale Materials (EPA, 2016).

Table 6: Industry Cost for Electronic Reporting (2018$)
                                   Activity
                         Clerical Cost  ($34.50/hour)
                                Technical Cost
                                 ($76.32/hour)
                                Managerial Cost
                                 ($80.09/hour)
                          Number of Annual Activities
                                       
                                  Total Cost
                                       
                             ELECTRONIC REPORTING
First-time registration
CDX Registration
                                     $0.00
                                    $50.46
                                    $13.62
                                       1
                                    $64.08
Electronic Subscriber Agreement/ Electronic Signature
                                     $0.00
                                     $0.00
                                    $20.02
                                       1
                                    $20.02
Help Desk
                                     $0.00
                                    $18.08
                                     $4.81
                                       1
                                    $22.89
Problem Resolution
                                     $0.00
                                    $75.32
                                     $0.00
                                     0.03
                                     $2.26
                                                 Total First Time Cost per firm
                                    $109.25
Subsequent registration
CDX Registration
                                     $0.00
                                    $50.46
                                    $13.62
                                     0.10
                                     $6.41
Electronic Subscriber Agreement/Electronic Signature
                                     $0.00
                                     $0.00
                                    $20.02
                                     0.10
                                     $2.00
Help Desk
                                     $0.00
                                    $18.08
                                     $4.81
                                     0.10
                                     $2.29
Report Compromised Signature
                                     $0.00
                                     $0.00
                                    $32.04
                                     0.01
                                     $0.32
Problem Resolution
                                     $0.00
                                    $75.32
                                     $0.00
                                     0.03
                                     $2.26
                                                 Total Subsequent Cost per firm
                                    $13.28
Values may not sum due to rounding.

Given the expectation that the same manufacturers will submit 0.52 reports each year, the annual cost per manufacturer is estimated by:
                                          Form Completion, CBI Claim
                                Substantiation and Recordkeeping      E-Reporting
     Annual Cost per Manufacturer=0.5210,439+148.88+54.91+13.28=$5,547.53.
Therefore, the annual cost across all 165 manufacturers is estimated by:
Annual Cost to Manufacturers=165    x    5,547.53=$915,342.6
and total cost incurred by manufacturers over the three-year ICR period is estimated by:
Total ICR Cost to Manufacturers =3    x  915,342.6=$2,746,028.  
Given the expectation that each new processor will submit one report per year, the annual cost per processor is estimated by:
                    Rule 	               Form Completion, CBI Claim
                           Familiarization        Substantiation and Recordkeeping        E-Reporting
Annual Cost per Processor=63.05     +      10,439+148.88+54.91    +    109.25=$10,815.09.
Therefore, the annual cost across all 199 processors is estimated by:
Annual Cost to Processor=199    x  10,815.09=$2,152,203   
and the total cost incurred by processors over the three-year ICR period is estimated by:
         Total ICR Cost to Manufacturers=3   x   2,152,203=$6,456,609.

Table 7 summarizes the annual and total cost over the course of the ICR to manufactures, processors and industry as a whole based on the above estimates.

Table 7: Total Industry Cost (2018$)
IC Category
                                  Annual Cost
                         Total ICR Cost (over 3 years)
IC 1: Manufacturers
                                   $915,343
                                  $2,746,028
IC 2: Processors
                                  $2,152,203
                                  $6,456,609
Total Industry Burden
                                  $3,067,546
                                  $9,202,637
Values may not sum due to rounding.

Estimating Agency Burden and Cost
      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 2018 (OPM, 2018). Wages are presented in terms of GS-level and step. A federal GS-13, Step 5 employee will conduct the collection and administrative activities under the rule. A federal GS-14, Step 5 will assist with the review of the CBI claim substantiations. Unloaded wage rates for 2018 for both of these employees are presented in Table 8. 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 8 derives the loaded wage rates for Agency staff at the GS-13 Step 5 and GS-14 Step 4 levels.

Table 8: Derivation of Loaded Agency Wage Rates (2018$)
                                Labor Category
                                   Pay Grade
                                 Annual Salary
                         Overhead and Fringe Benefits
                                 (% of wages 
                       Overhead and Fringe Benefit Cost 
                                    Total 
                                  Hourly Rate
                                Technical Labor
                                 GS 13 Step 5
                                   $109,900
                                      60%
                                    $65,940
                                   $175,840
                                    $84.54
                                Attorney Labor
                                 GS 14 Step 5
                                   $129,869
                                      60%
                                    $77,181
                                   $207,050
                                    $99.54
Source: The unloaded Federal salary for 2018 is from the Office of Personnel Management salary table for Washington-Baltimore-Northern Virginia (OPM, 2018). 

Table 9 provides the total annual cost and burden of Agency activities based on the loaded wages derived in Table 8. The annual burden to the Agency is estimated to be 1,818 hours and the total burden to the Agency over the three-year period of the ICR is estimated to be 5,454 hours. The annual cost ot the Agency is estimated to be $160,200 and the total cost to the Agency over the three-year period is estimated to be $480,600.
 
Table 9: Total Annual Cost and Burden of Agency Activities (2018$)
                                   Activity
                                     Staff
                           Total Burden per Activity
                                    (hours)
                             Total Number of Units
                             Annual Burden (hours)
                            Annual Cost (Thousands)
Industry/Public Assistance
                          EPA Employee (GS 13 Step 5/
                                 $84.54/hour)
                                     1.25
                                      285
                                      356
                                    $30,100
Data Processing and System Support Personnel

                                     3.13
                                      285
                                      892
                                    $75,400
Review of CBI Claim Substantiations

                                      0.5
                                      285
                                      143
                                    $12,100
Review of CBI Claim Substantiations
                          EPA Employee (GS 14 Step 5/
                                 $99.54/hour)
                                      1.5
                                      285
                                      428
                                    $42,600
                                                         Annual Cost and Burden
                                  1,818 hours
                                   $160,200
                                   Total Cost and Burden Over 3-Year ICR Period
                                  5,454 hours
                                   $480,600
Values may not sum due to rounding.

References
U.S. Office of Personnel Management. (2018). Salary Table 2018- DCB, Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Retrieved September 18, 2019 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/DCB.pdf. 
U.S. EPA, (2009). ICR Handbook EPA's Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Revised 10/2009 Washington, D.C.: U.S. EPA, Office of Environmental Information.

ATTACHMENT B

WAGE RATE CALCULATIONS

      To estimate costs, EPA multiplies burden estimates by standard wage rates for managerial, technical, and clerical levels developed from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (EPA, 2002b). Wage data for these three occupational categories was gathered for manufacturing industries from Employer Costs for Employee Compensation Supplemental Tables: December 2006  -  March 2019 (U.S. BLS, 2019). Additionally, wage rates for the attorney level were gathered from the BLS Occupational Employment Statistics (OES) May 2018 National Industry-Specific Occupational Employment and Wage Estimates (U.S. BLS, 2018).
      The cost of fringe benefits, such as health insurance and vacation, is taken for each labor category from the same ECEC series. Following the methodology outlined in (U.S. EPA, 2002), fringe benefits are calculated as a percentage of total wages for each category. Since the fringe benefits for attorney were not available from the BLS report, EPA applied the managerial fringe benefit to wage ratio to this wage as well. EPA added 17 percent to the wages in each category to account for overhead, based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002a) and Wage Rates for Economic Analyses of the Toxics Release Inventory Program (Rice, 2002). The wages for each of the four categories were then multiplied by benefits and overhead factors to estimate loaded, annual salaries in year 2018 dollars. Table 1 contains the loaded wage rates for the attorney, managerial, technical and clerical occupation categories. 

Table 1: Derivation of Loaded Wage Rates for the Private Manufacturing Sector in 2018$
                                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]
                                    $72.21
                                    $33.94
                                      47%
                                      17%
                                     1.64
                                    $118.42
Managerial[2]
                                    $48.73
                                    $23.08
                                      47%
                                      17%
                                     1.64
                                    $80.09
Technical[2]
                                    $44.35
                                    $24.43
                                      55%
                                      17%
                                     1.72
                                    $75.32
Clerical[2]
                                    $20.77
                                    $20.77
                                      49%
                                      17%
                                     1.66
                                    $34.50
Sources: [1]  Bureau of Labor Statistics Occupational Employment Statistics (OES) May 2018 National Industry-Specific Occupational Employment and Wage Estimates (U.S. BLS, 2018) 
[2]Employer Costs for Employee Compensation Supplementary Tables: December 2006  -  March 2019 (U.S. BLS, 2019).
[3]An overhead rate of 17 percent was estimated based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (U.S. EPA, 2002) and Wage Rates for Economic Analyses of the Toxics Release Inventory Program. (Rice, 2002)

References

Rice, C. (2002). Wage Rates for Economic Analysis of the Toxic Release Inventory Program. 	Washington, D.C.: U.S. EPA, Office of Pollution Prevention and Toxics, Economics and 	Policy Analysis Branch.
U.S. Bureau of Labor Statistics. (2018). May 2018 National Industry-Specific Occupational 	Employment and Wage Estimates. Retrieved September 18, 2019 from 	https://www.bls.gov/oes/current/naics4_541100.htm#23-0000.
U.S. Bureau of Labor Statistics (2019). Employer Costs for Employee Compensation (ECEC) Supplemental Tables: December 2006 to March 2019, US Bureau of Labor Statistics, September 17, 2019. 
U.S. EPA. (2002). Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA-HQ-OPPT-2002-0054-0279). Washington, D.C.: Office of Pollution Prevention and Toxics, Economics and Policy Analysis Branch.
U.S. EPA, (2009a). ICR Handbook EPA's Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Revised 10/2009 Washington, D.C.: U.S. EPA, Office of Environmental Information.

U.S. EPA. (2019). Economic Analysis for the Proposed Rule: Procedures for Review of CBI 	Claims	for the Identity of Chemicals on the TSCA Inventory (April 2, 2019).
U.S. Office of Personnel Management. (2018). Salary Table 2018- DCB, Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Retrieved September 18, 2019 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/DCB.pdf.