Document ID: EPA-HQ-OPPT-2010-0572-0050
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-04-06T04:00Z

SEQ CHAPTER \h \r 1 Supporting Statement for a Request for OMB Review
under

The Paperwork Reduction Act

  SEQ CHAPTER \h \r 1 1.  IDENTIFICATION OF THE INFORMATION COLLECTION

	l(a)	Title of the Information Collection

	TITLE:           Proposed Rule Related Addendum to the Existing EPA ICR
Entitled: 

  			Chemical-Specific Rules, Toxic Substances Control Act Section 8(a)

	EPA ICR No.:	2517.01	OMB Control No:	2070-NEW

	1(b)	Short Characterization  

	This information collection request (ICR) addendum covers reporting and
recordkeeping requirements for persons who manufacture or process
(defined by statute to include import) chemical substances as nanoscale
materials (also referred to as “nanoscale materials” or
“nanomaterials”) and is related to a proposed rule issued under the
authority of section 8(a) of the Toxic Substances Control Act (TSCA). 
This ICR addendum will revise the existing approved ICR to incorporate
reporting and recordkeeping requirements proposed in the TSCA section
8(a) rule for Certain Chemical Substances When Manufactured or Processed
as Nanoscale Materials, identified under RIN 2070-AJ54 (Attachment A). 

 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 deaths 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 to ensure knowledge of
specific practices that may affect human health and the environment.  

Under TSCA section 8(a), EPA is proposing to establish reporting and
recordkeeping requirements for certain chemical substances as nanoscale
materials.  The rule proposes that persons who manufacture or process
these nanoscale materials notify EPA of certain information which
includes production volume, methods of manufacture and processing,
exposure and release information, and available health and safety data. 
The proposed reporting of these activities will provide EPA with an
opportunity to evaluate the information and consider appropriate action
under TSCA to reduce any risk to human health or the environment. The
data will also inform EPA’s assessments of new chemical nanoscale
materials submitted to EPA under section 5 of TSCA. 

	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), environmental groups,
environmental justice advocates, state and local government entities and
other members of the public will have access to this information for
their own use.

2.  NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the 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
electronics, sunscreens, cosmetics, automotive and medical products as
well as 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 160
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 section 8(a) to collect information regarding chemical
substances in commerce.

	EPA developed a voluntary Nanoscale Materials Stewardship Program
(“NMSP” or “the program”) to complement and support its
regulatory activities on nanoscale materials. For more details on the
NMSP, read the program’s interim report which is available in the
docket for the proposed rule.  EPA initiated the NMSP to quickly learn
about commercially available nanoscale materials by gathering existing
data and information from manufacturers, processors, and users of
nanoscale materials.  In the January 2009 interim report, EPA identified
data gaps for existing nanoscale material production, uses, and
exposures, based on the information EPA received through the NMSP prior
to the report publication.  For example, EPA estimated that companies
provided information on only about 10 percent of the nanomaterials that
may be commercially available.   

	 EPA is proposing this rule to address some of the data gaps identified
in the NMSP interim report.  The proposed reporting of information
associated with 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. 

	The legal authority for this information collection is TSCA section
8(a), U.S.C. 2607(a).  TSCA section 8(a) chemical-specific rules have
been codified at 40 CFR 704, subpart B.

 

2(b)	Use/Users of the Data

	The information collected through the proposed 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.  Data collected through this proposed 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 data 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 data 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. 

 

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

	3(a)	Non-Duplication

	Section 8(a)(2) of TSCA states, “To the extent feasible, the
Administrator shall not require any reporting which is unnecessary or
duplicative.”  The NMSP described above is the only other effort that
EPA has identified to systematically collect such comprehensive
information.   In the 8(a) rule EPA is proposing that persons that
participated in the NMSP are not required to report any data already
submitted to EPA.  The rule also proposes 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 Required Prior to ICR Submission to OMB

	  SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 In proposing this ICR
addendum, EPA is providing a 90-day public notice and comment period
that coincides with the comment period for the proposed 8(a) rule. 

	3(c)	Consultations

	 During the comment period EPA will contact stakeholders and solicit
comment on the estimates and findings in the ICR.

  SEQ CHAPTER \h \r 1 	3(d)	Effects of Less Frequent Collection

	The proposed 8(a) rule would require reporting only once for existing
nanoscale materials and for new discrete nanoscale materials before they
are manufactured or processed.  As noted in the preamble EPA is
considering periodic reporting of nanoscale materials identified in the
rule similar to reporting that occurs under the Inventory Update Rule
(IUR) at 40 CFR part 710.  EPA will consider any comments received when
proposing any further reporting for nanoscale materials under section
8(a).

	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 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 the North American Industrial Classification
System (NAICS) codes 325, Chemical Manufacturers and Processors, and
324110, Petroleum Refineries, 325130 Synthetic Dye and Pigment
Manufacturing, 325180, Other Basic Inorganic Chemical Manufacturing,
331221, Rolled Steel Shape Manufacturing, 334413, Semiconductor and
Related Device Manufacturing, 335991, Carbon and Graphite Product
Manufacturing, 423330, Home Furnishing Merchant Wholesalers, 423330,
Roofing, Sliding, and Insulation Material Merchant Wholesalers, 423510,
Metal Service Centers and Other Metal Merchant Wholesalers.  The NAICS
codes have been provided to indicate which entities might be affected by
this information collection activity. This listing is not intended to be
exhaustive and other types of entities not listed in this table could
also be affected.

	4(b)	Information Requested

		4(b)(i)	 Data Items

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

To facilitate this information collection request, EPA has developed a
form based on the

PMN reporting form (EPA Form 7710-25).  Copies of both the PMN form and
the proposed form (EPA Form 7710-[tbd])(Attachment B) for this
information collection request are attached. By supplying the
information described in the form to the extent it is known or
reasonably ascertainable, respondents do not incur the burden of
providing unnecessary information. In addition, many of the potential
respondents are familiar with the PMN form, thus further reducing the
reporting burden.

 

EPA has limited the level of detail of information described in the form
to the information which would be most useful in facilitating EPA’s
evaluation of the potential risks of the chemical substance. However,
respondents may include additional or optional information that they
believe EPA should consider when evaluating the chemical substance. For
example, respondents may identify pollution prevention techniques being
employed by the submitter that may be relevant to the Agency's
assessment. EPA encourages submitters to provide information on the
benefits of the chemical substance in comparison to existing chemical
substances including macroscale forms of the same chemical substance,
information on the substitutes, and any additional information available
to them on waste management techniques.

	4(b)(ii)  Respondent Activities

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

Managerial Labor

- Identify listed chemical substances;

- 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
substance;

- Research occupational exposure, environmental release, health and
environmental data, disposal methods; risk management practices; and

- Process, compile, and review information for accuracy, substantiate a
claim of confidential business information.

Technical Labor 

- Identify chemical and trade name and chemical composition;

- Identify by-product; impurities; physical properties

- Describe use of the chemical substance;

- Report quantity manufactured;

- Research workplace exposures, environmental releases, health and
environmental data, and disposal methods; risk management practices; and

- Provide occupational description.

Clerical Labor

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

- Format attachments; 

- Prepare notice; and

- Recordkeeping.

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

	5(a)	Agency Activities Inventory

EPA will perform the following activities:

- review the data 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 data submitted.

	5(b)	Collection Methodology and Management

	An improved information technology to minimize burden of a TSCA section
8(a) chemical-specific rule has not been found.  EPA has not been able
to identify a more efficient, less expensive, or more flexible means of
obtaining the required data than the one currently being used.  To the
extent data are 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 electronic or
other types of reporting methods.  EPA believes the flexibility already
allowed in the reporting structure significantly eases burden.

	5(c)    Small Entity Flexibility

	The proposed rule would exempt some small manufacturers and processors.
 However, as described in the proposed 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.

	5(d)	Collection Schedule

	This is a one-time collection of data.  Respondents will have 6 months
to collect and submit data for existing nanoscale materials and will
report at least 135 days before new discrete nanoscale materials are
manufactured or processed.  As noted in the preamble to the proposed
rule EPA is considering periodic reporting of nanoscale materials
identified in the rule similar to reporting that occurs under the
Inventory Update Rule (IUR) at 40 CFR part 710.  EPA will consider any
comments received when proposing any further reporting for nanoscale
materials under section 8(a).

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

	This section presents the burden and cost estimates incurred by all
affected entities over the first three years of the rule as a result of
the proposed reporting requirements for certain chemical substances as
nanoscale materials under the authority of section 8(a) of TSCA. This
supporting statement provides burden and cost estimates for the
information collection and is incremental to the burden already
accounted for in the existing, approved ICR, Information Collection
Request for Chemical Specific Rules, Toxic Substances Control Act
Section 8(a) EPA ICR No: 1198.08, OMB Control No: 2070-0067. All costs
are presented in year 2013 dollars. The proposed information collection
requires reporting at the company level. EPA estimates that a total of
295 respondents will respond to this information collection.

Burden and cost calculations are based on the assumption that EPA will
receive 1,823 reports in the first three years of the rule.  Each report
is for a single nanomaterial/company combination. Each company is
expected to submit an average of 5.06 reports in the first year and 0.56
reports in subsequent years. The average burden per respondent is
estimated to be approximately 284 hours over the three year period. 

	6(a)	Estimating Respondent Burden

	

The proposed rule requires manufacturers and processors of certain
chemical substances as nanoscale materials to incur costs associated
with rule familiarization, preparation of reports, and recordkeeping.
While firms are expected to incur some recurring costs associated with
maintaining their records, these costs are expected to be minimal; as a
result, all costs are assumed to be one-time costs. In addition, rule
familiarization costs are only incurred in the first year of the rule.  

Companies will be required to report a variety of information about
nanoscale materials including, chemical identity, physical properties,
uses, human exposure and environmental release, production technology,
and test data on nanomaterial’s effects on health and the environment.
Four procedural tasks are considered in the estimation of respondent
burden. The four respondent activities include: rule familiarization;
form completion; form submission; and recordkeeping. Rule
familiarization requires that reporting entities learn the proposed 8(a)
rule and its various requirements. Entities must then complete a form
providing the information listed above. The third task requires
reporting businesses to submit electronically to EPA via CDX, EPA’s
electronic system for environmental data exchange. Lastly, entities must
maintain records of the reported information in Table 1.  Table 1
provides a detailed description of the related Information Collection
that corresponds to each activity.

Table   SEQ Table \* ARABIC  1 : Cross-Walk between Industry Activities
and Related Information Collections (ICs)

Activity	Description	Related IC(s)

Rule Familiarization	Site staff must familiarize themselves with the
requirements of the rule. This entails reading the rule, understanding
the various reporting and administrative requirements, and determining
the manner in which the reporting requirements will be met.	Rule
Familiarization

Preparation of Reports (Form Completion and Form Submission)	Site staff
must collect all required information regarding nanomaterial
information, production technologies, and health / environmental
impacts. Firms are required to submit one form for each nanomaterial.
The information must be collected and reviewed internally before
submission. 	Prepare Report, Electronic Submission

Recordkeeping	Respondents must keep records supporting their
submissions.	Prepare and Submit Report, and Maintain Records - 

Partial Report 

Prepare and Submit Report, and Maintain Records- 

Full Report

	The following descriptions provide an overview of the reporting
activities for the three labor categories: managerial, technical and
clerical.  Table 2 lists more specifically the tasks within each
activity group.

Managerial Labor

Manufacturer identifies listed chemicals: specify the chemicals to
report and include chemical identity information.

Assign principal technical contact person: designate a representative
from the technical labor category as primary contact for reporting.

Identify by-product: list additional by-products and uses of the
chemical.

Review marketing data: provide producer/manufacturer business
information.

Research the date of the initiation of manufacture or importation of the
chemical: find and report this initiation date.

Research occupational exposure, environmental release, health and
environmental data, disposal methods: a majority of the managerial
staff’s burden includes a review of human exposure, environmental
release information and associated physical properties after disposal. 

Process, compile, and review information for accuracy, substantiate a
claim of confidential business information: collect and check for
accurately reported information.

Register for CDX, sign electronic signature agreements, and report
compromised electronic signatures. 

Technical Labor

Identify chemical and trade name and chemical composition: find and
report chemical identity information and physical properties.  

Identify by-product: list additional by-products.  

Describe use of chemical: report other uses or applications of the
substance.

Report quantity manufactured or imported: include volumes of the
chemical.

Research occupational exposures, environmental releases, health and
environmental data, and disposal methods: a majority of the technical
staff’s burden entails researching and reporting the possibilities of
human exposure and environmental release of the chemical as well as
physical properties of the substance after release or exposure. 

Provide occupational description: outline worker exposure information
and technologies used to mitigate the risk.  

Register for CDX for electronic reporting.

Maintain records.

Clerical Labor

Format research on occupational exposure, environmental releases, health
and environmental data: a majority of the technical staff’s burden
includes researching and reporting human and environmental effects after
release or exposure.

Format attachments: organize additional reported information.

Maintain records.

EPA calculated burden estimates for each element of the proposed
collection form based on the Supporting Statement for EPA ICR No.
2250.01: Information Collection in Support of EPA’s Stewardship
Program for Nanoscale Material (EPA, 2007), economic analyses for other
rules with similar requirements (such as the Premanufacture Notification
Electronic Reporting final rule), and EPA’s best professional
judgment. More detailed information on the derivation of these estimates
is found in the Economic Analysis for the Proposed Reporting
Requirements for Certain Nanoscale Materials (EPA, 2015). 

	Table 2 illustrates the burden for a typical respondent on a
per-activity basis, including the time required to complete the form.
EPA estimates the total burden for one firm to complete one form to be
approximately137 hours. Electronic submission of the form is expected to
require approximately 2.4 hours the first year and 2.8 hours in each of
the second and third years of the ICR, however, not all respondents will
perform all activities related to electronic reporting in all years.
Each of the 295 companies is expected to submit an average of 5.06 full
reports in the first year and 0.56 full reports in all subsequent years,
for a total of 1,823 reports over the three year period. 

	

Table   SEQ Table \* ARABIC  2 : Industry Burden, by Activity

Activity	Clerical Burden

(hours)	Technical Burden

(hours)	Managerial Burden

(hours)	Total Burden

(hours)

	(a)	(b)	(c)	(d) = (a)+(b)+(c)

Rule Familiarization (Year 1 Only) 

Staff Reviews Rule 8(a) and its Various Requirements	0.00	0.55	0.27	0.82

Total 	0.00	0.55	0.27	0.82

Form Completion

Submitter Information	0.00	2.00	1.00	3.00

Chemical Identity Information	0.00	7.50	1.00	8.50

Physical Properties	0.00	2.00	0.50	2.50

Additional Physical Properties	0.00	4.00	1.00	5.00

Description of Uses	0.00	3.00	1.50	4.50

Amount of Substance to be Manufactures / Imported	0.00	1.00	1.50	2.50

Description of Byproducts	0.00	0.50	0.00	0.50

Human Exposure and Environmental Release	0.00	52.00	9.50	61.50

Physical Properties Related to Understanding and Assessing Exposures and
Release	0.00	4.00	1.00	5.00

Overview of Lifecycles	0.00	10.00	2.00	12.00

Release Point Control Technology	0.00	2.00	0.40	2.40

Worker Exposure Information	0.00	2.00	0.40	2.40

Protective Equipment or Engineering Control	0.00	2.00	0.40	2.40

Information on Cleaning / Reuse / Disposal of Used Protective Equipment
0.00	1.00	0.20	1.20

Additional Procedures or Other Equipment Intended to Mitigate Exposure
to Nanoscale Materials	0.00	1.00	0.20	1.20

Description of Worker Training and Hazardous Communication	0.00	1.00
0.20	1.20

Number of Individual  Other than Workers Exposed to the Chemical or
Duration of the Exposure 	0.00	1.00	0.20	1.20

Manner or Method of Disposal for Consumer Use of Products	0.00	2.00	0.40
2.40

Test Data in the Submitter’s Possession of Information on Health /
Environmental Effects	0.00	7.20	10.00	17.20

Total 	0.00	105.20	31.40	136.60

Electronic Reporting

CDX Registration	0.00	0.67	0.17	0.84

Electronic Subscriber Agreement/Electronic Signature	0.00	0.00	0.25	0.25

Help Desk	0.00	0.24	0.06	0.30

Report Compromised Signature (Years 2 and 3 Only)	0.00	0.00	0.40	0.40

Problem Resolution	0.00	1.00	0.00	1.00

Total Year 1	0.00	1.91	0.48	2.39

Total Year 2 and 3	0.00	1.91	0.88	2.79

RECORDKEEPING

Maintain Records of Collected Information	0.50	0.50	0.00	1.00

Total	0.50	0.50	0.00	1.00

TOTAL BURDEN PER REPORT

 Year 1 Total	0.50	108.16	32.15	140.81

 Year 2 and 3 Totals	0.50	107.61	32.28	140.39

	6(b) Estimating Cost

EPA multiplied burden estimates by standard wage rates for managerial,
technical, and clerical levels developed from information published by
the Bureau of Labor Statistics (BLS) and a method outlined in the
document Wage Rates for Economic Analyses of the Toxics Release
Inventory Program (EPA, 2002b). Wage data for the three occupational
categories was gathered for manufacturing industries from Employer Costs
for Employee Compensation Supplemental Tables: December 2006 – March
2014 (BLS, 2014).

The cost of fringe benefits, such as health insurance and vacation, is
taken for each labor category from the same ECEC series. Following the
methodology outlined in (EPA, 2002b), fringe benefits are calculated as
a percentage of total wages for each category. EPA added 17 percent to
the wages in each category to account for overhead, based on information
provided by the chemical industry and chemical industry trade
associations in the Revised Economic Analysis for the Amended Inventory
Update Rule: Final Report (EPA, 2002a) and Wage Rates for Economic
Analyses of the Toxics Release Inventory Program (2002b). The wages for
each of the three categories were then multiplied by benefits and
overhead factors to estimate loaded, annual salaries in year 2013
dollars. Table 3 contains the loaded wage rates for the managerial,
technical and clerical occupation categories. 

Table   SEQ Table \* ARABIC  3 : Derivation of Loaded Wage Rates for the
Private Manufacturing Sector in 2013$ 

	

Wage1	Fringe Benefits1	Fringes as % of Wage	Overhead % of Wage2	Fringe +
Overhead Factor	Loaded Wages

	(a)	(b)	(c) = (b)/(a)	(d)	(e)=(1)+(c)+(d)	(f) = (a) x (e)

Managerial	$46.25 	$23.71 	51%	17%	1.68	$77.82

Technical	$38.16 	$19.90 	52%	17%	1.69	$64.55

Clerical	$18.05 	$9.23 	51%	17%	1.68	$30.35

Sources: 1 Employer Costs for Employee Compensation Supplementary
Tables: December 2006-March 2014, US Bureau of Labor Statistics, June
11, 2014 (pp 29,33,37) (http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf,
accessed July 7, 2014).

2 An overhead rate of 17 percent was estimated based on industry data
gathered for the Revised Economic Analysis for the Amended Inventory
Update Rule: Final Report (EPA, 2002a) and Wage Rates for Economic
Analyses of the Toxics Release Inventory Program. (EPA, 2002b)

Table 4 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 in Table 3. EPA estimates that the total
cost for reviewing the rule and completing and submitting one report is
approximately $9,499 in the first year and approximately $9,473 in each
of years 2 and 3 of the ICR. More information on the derivation of these
costs is found in the Economic Analysis for the Proposed Reporting
Requirements for Certain Nanoscale Materials (EPA, 2015).

Table   SEQ Table \* ARABIC  4 : Industry Cost, by Activity

Activity	Clerical Burden ($2013)	Technical Burden

($2013)	Managerial Burden

($2013)	Total Burden

($2013)

	(a)	(b)	(c)	(d) = (a)+(b)+(c)

Rule Familiarization (Year 1 Only) 

Staff Reviews Rule 8(a) and its Various Requirements	$0.00 	$35.50 
$21.01 	$56.51 

Total 	$0.00 	$35.50 	$21.01 	$56.51 

Form Completion

Submitter Information	$0.00 	$129.09 	$77.82 	$206.92 

Chemical Identity Information	$0.00 	$484.10 	$77.82 	$561.93 

Physical Properties	$0.00 	$129.09 	$38.91 	$168.01 

Additional Physical Properties	$0.00 	$258.19 	$77.82 	$336.01 

Description of Uses	$0.00 	$193.64 	$116.73 	$310.38 

Amount of Substance to be Manufactures / Imported	$0.00 	$64.55 	$116.73
	$181.28 

Description of Byproducts	$0.00 	$32.27 	$0.00 	$32.27 

Human Exposure and Environmental Release	$0.00 	$3,356.45 	$739.31 
$4,095.77 

Physical Properties Related to Understanding and Assessing Exposures and
Release	$0.00 	$258.19 	$77.82 	$336.01 

Overview of Lifecycles	$0.00 	$645.47 	$155.65 	$801.12 

Release Point Control Technology	$0.00 	$129.09 	$31.13 	$160.22 

Worker Exposure Information	$0.00 	$129.09 	$31.13 	$160.22 

Protective Equipment or Engineering Control	$0.00 	$129.09 	$31.13 
$160.22 

Information on Cleaning / Reuse / Disposal of Used Protective Equipment
$0.00 	$64.55 	$15.56 	$80.11 

Additional Procedures or Other Equipment Intended to Mitigate Exposure
to Nanoscale Materials	$0.00 	$64.55 	$15.56 	$80.11 

Description of Worker Training and Hazardous Communication	$0.00 	$64.55
	$15.56 	$80.11 

Number of Individual Other than Workers Exposed to the Chemical or
Duration of the Exposure 	$0.00 	$64.55 	$15.56 	$80.11 

Manner or Method of Disposal for Consumer Use of Products	$0.00 	$129.09
	$31.13 	$160.22 

Test Data in the Submitter’s Possession of Information on Health /
Environmental Effects	$0.00 	$464.74 	$778.23 	$1,242.96 

Total 	$0.00 	$6,790.37 	$2,443.63 	$9,233.99 

ELECTRONIC SUBMISSION OF FORM

CDX Registration	$0.00	$43.25	$13.23	$56.48

Electronic Subscriber Agreement/Electronic Signature	$0.00	$0.00	$19.46
$19.46

Help Desk	$0.00	$15.49	$4.67	$20.16

Report Compromised Signature (Years 2 and 3 Only) 	$0.00	$0.00	$31.13
$31.13

Problem Resolution	$0.00	$64.55	$0.00	$64.55

Total Year 1 	$0.00	$123.29	$37.35	$160.64

Total Years 2 and 3	$0.00	$123.29	$68.48	$191.77

RECORDKEEPING

Maintain Records of Collected Information	$15.17 	$32.27 	$0.00 	$47.44 

Total	$15.17 	$32.27 	$0.00 	$47.44 

 TOTAL BURDEN PER REPORT

Year 1 Totals	$15.17 	$6,981.43 	$2,501.99 	$9,498.59 

Year 2 and 3 Totals	$15.17 	$6,945.93 	$2,512.11 	$9,473.21 

	6(c)	Estimating Agency Burden and Cost

EPA is responsible for the following activities associated with
administering the proposed Section 8(a) rule: 

Industry and public assistance;

Data processing and systems support;

Costs related to EPA activities that involve using the data are not
included. 

Agency personnel are responsible for all tasks associated with the
proposed rule, and none of the work is expected 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 2013 (OPM, 2013). Wages are presented in terms of GS-level and step,
and a federal GS-13, Step 5 employee with an unloaded wage rate of
$100,904 for 2013 (OPM, 2013) will conduct the collection and
administrative activities under the proposed rule. 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 wage rates for Agency staff at the GS-13 Step 5 level.

Table   SEQ Table \* ARABIC  5 : Derivation of Loaded Agency Wage Rates
(2013$)

Pay Grade	Annual Salary	Overhead and Fringe Benefits 

(% of wages)	Overhead and Fringe Benefit Cost 	Total 

GS 13 Step 5	$100,904 	60%	$60,542 	$161,446 

Source: The unloaded Federal salary for 2013 is from the Office of
Personnel Management salary table for Washington-Baltimore-Northern
Virginia (OPM, 2013). 

Table 6 contains the burden and cost per report for all EPA staff
activities. All activities performed by the GS-13 level staff member are
dependent on the number of reports submitted to EPA. The burden for
industry and public assistance is approximately 0.00060 FTE per report
and the total cost per-report is approximately $97. The burden for data
processing and systems support is approximately 0.0015 FTE and the cost
per-report is approximately $242. The burden and cost of processing each
form is derived in the Economic Analysis for the Proposed Reporting
Requirements for Certain Nanoscale Materials (EPA, 2015). 

Table   SEQ Table \* ARABIC  6 : EPA Staff Burden and Cost of Processing
One Report

	Activity	Agency Burden per Activity (FTE)	Agency Burden	Agency Cost 

per Actvity	per Activity

           (FTE)	(2013$)

GS-13 Step 5 per-Report Burden

Industry and public assistance	0.000601	1.25	$97.02 

Data processing and systems support	0.001505	3.13	$242.14 

Total Agency Burden, per report	0.002106	4.38	$338.84 

Note: Some burden estimate subtotals may not calculate due to rounding
of unit burden estimates.

	6(d) 	Bottom-Line Industry Burden and Cost Estimates

		

	This section describes the estimated total social paperwork burden and
cost of the proposed section 8(a) rule over its first three years. 

Respondent tally

EPA estimated the number of U.S.-based nanomaterials manufacturers and
processors using three sources:

Lux Research: Nanotech Report™, 5th ed. (2007)

BCC Research: Nanotechnology: A Realistic Market Assessment (2008)

Nanowerk: Company & Labs Directory (2009)

Once the universe of U.S. nanomaterial manufacturersand processors was
estimated, EPA then calculated the number of companies that would be
subject to the proposed rule. EPA estimated that approximately 295 firms
will be subject to the proposed section 8(a) information collection.
Each firm is expected to submit an average of 5.06 reports in the first
year and 0.56 reports in subsequent years. More information of the
derivation of these numbers can be found in the Economic Analysis for
the Proposed Reporting Requirements for Certain Nanoscale Materials
(EPA, 2015).

Affected facilities would incur l burden and cost due to the electronic
reporting requirements. This includes costs in the first year to
complete a subscriber agreement and register with CDX. Some respondents
will incur CDX costs in subsequent years due to employee turnover or
compromised electronic signatures; therefore, response rate for some
activities will vary across years. Table 7 shows the number of responses
for the various activities for the three years.

 Table 7: Number of Responses per Activity  

Activity	Total Number of Companies	Response Rate	Number of Responses per
Activity	No. of Responses/Respondent	Total Number of Responses

Year 1

Rule Familiarization 

(per company)	295	100%	1	1.00	295

Form Completion

(per report)	295	100%	5.06	5.06	1,493

Electronic Submission

(Per Company) 	CDX Registration	295	100%	1	1.00	295

	Electronic Subscriber Agreement/Electronic Signature	295	100%	1	1.00
295

	Help Desk	295	100%	1	1.00	295

	Problem Resolution	295	3%	1	0.03	9

Recordkeeping 

(per report)	295	100%	5.06	5.06	1,493

Years 2 and 3

Rule Familiarization (

per company)	295	0%	1	0	0

Form Completion

(per report)	295	100%	5.06	5.06	1,493

Electronic Submission

(Per Company) 	CDX Registration	295	10%	1	0.10	30

	Electronic Subscriber Agreement/Electronic Signature	295	10%	1	0.10	30

	Help Desk	295	10%	1	0.10	30

	Report Compromised Signature	295	1%	1	0.10	3

	Problem Resolution	295	3%	1	0.03	9

Recordkeeping 

(per report)	295	100%	5.06	5.06	1,493

Table 8 and Table 9 present the total estimated respondent burden and
costs in the first year and subsequent years, respectively. As presented
in Table 8, EPA estimates the total industry burden to be approximately
206,098 hours and the total industry cost to be approximately $13.9
million in the first year of this ICR. Burden is estimated to be
approximately 22,755 hours and the industry cost is estimated to be
approximately $1.5 million annually in second year and the third year of
the ICR period. These estimates are presented in Table 9.

Table 8: Total Estimated Annual Respondent Burden and Cost Associated
with this ICR Addendum in First Year

Activity	Total Number of    Companies          (a)	Total Burden per
Activity (hours)                 (b)	Total Cost per Activity            
           (c)

(2013$)	No. of Responses/ Respondent  (e)	Total Number of Responses 
(a*e)	Total Burden (hours)	Total Cost (Millions 2013$)1

Rule Familiarization  (per Company)	295	$0.02	$56.51 	1.00	295	242	$0.02

Report Completion	295	$13.79	$9,233.94 	5.06	1493	203,944	$13.47

Electronic Reporting

 	 

CDX Registration	295	$0.02	$56.48 	1.00	295	248	$0.02

Electronic Subscriber Agreement/Electronic Signature	295	$0.01	$17.68 
1.00	295	74	$0.01

Help Desk	295	$0.01	$20.16 	1.00	295	89	$0.01

Problem Resolution	295	$0.00	$64.55 	0.03	9	9	$0.00

Recordkeeping	295	$0.07	$47.44 	5.06	1493	1,493	$0.07

Total	206,098	$13.91

Table 9:  Total Estimated Annual Respondent Burden and Cost Associated
with this ICR Addendum in Second and Third Year

Activity	Total Number of Companies	Total Burden per Activity (hours)
Total Cost per Activity

(2013$)	Number of Responses/Respondent	Total Number of Responses	Total
Burden (hours)	Total Cost (Millions 2013$)1

Rule Familiarization  (per Company)	295	0.82	$56.51 	0.00	0.00	0	$0.00

Form Completion	295	136.60	$9,233.94 	0.56	165.00	22,539	$1.52

Electronic Reporting

	 

 

CDX Registration	295	0.84	$56.48 	0.10	29.50	24	$0.00

Electronic Subscriber Agreement/Electronic Signature	295	0.25	$19.46 
0.10	29.50	9	$0.00

Help Desk	295	0.30	$20.16 	0.10	29.50	9	$0.00

Report Compromised Signature	295	0.40	$31.13 	0.01	2.95	0	$0.00

Problem Resolution	295	1.00	$64.55 	0.03	8.85	9	$0.00

Recordkeeping	295	1.00	$47.44 	0.56	165.00	165	$0.01

Total	22,755	$1.53

Table 10 presents the estimated total and average annual burden and cost
associated with this ICR addendum. EPA estimates the annual average
burden and cost over three years at approximately 84,000 hours and 5.7
million dollars, respectively, with a total burden of approximately
252,000 hours and $17.0 million over the three year period



Table 10: Estimated Annual Average Burden and Cost Associated with this
ICR Addendum

Activity	Year 1	Year 2	Year 3	Three Year Average

	Annual Burden	Annual Cost	Annual Burden	Annual Cost	Annual Burden
Annual Cost	Total Burden	Total Cost	Average Burden	Average Cost

	(hours)	(Millions 2013$)	(hours)	(Millions 2013$)	(hours)	(Millions
2013$)	(hours)	(Millions 2013$)	(hours)	(Millions 2013$)

	 	 	 	 	 	 	 	 	 	 

Rule Familiarization  (per Company)	242	$0.02	0	$0.00	0	$0.00	242	$0.02
81	$0.01

Form Completion	203,944	$13.79	22,539	$1.520	22,539	$1.52	249,022	$16.83
83,007	$5.61

Electronic Reporting	419	$0.04	51	$0.003	51	$0.003	521	$0.05	174	$0.02

Recordkeeping	1,493	$0.07	165	$0.01	165	$0.01	1,823	$0.09	608	$0.03

Total	251,608	$16.99	83,870	$5.67

$16.99

$5.67



As shown in Table 11, the Agency estimates the typical respondent burden
for this information collection activity over all three years to be 853
hours. The Agency estimates the annual average burden for the
information collection activity to be 284 hours. This burden estimate
assumes that each respondent will submit an average of 5.06 reports in
the first year and 0.56 reports in subsequent years. 

Table 11: Average Burden per Company

Activity	Burden Hours	Total Hours per Activity	No. of Responses /
Respondent	Total Burden (hours per average site)	Average Annual Burden
(hours per average site)

	Clerical	Technical	Managerial

Year 1	Year 2	Year 3

Rule Familiarization.	0.00	0.55	0.27	0.82	1.00	0	0	0.82	0.27

Form Completion (per Report)	0.00	105.20	31.40	136.60	5.06	0.56	0.56
844.19	281.40

Electronic Reporting

	CDX Registration	0.00	0.67	0.17	0.84	1.00	0.10	0.10	1.01	0.34

Electronic Subscriber Agreement/Electronic Signature	0.00	0.00	0.25	0.25
1.00	0.10	0.10	0.30	0.10

Help Desk	0.00	0.24	0.06	0.30	1.00	0.10	0.10	0.36	0.12

Report Compromised Signature	0.00	0.00	0.40	0.40	0.00	0.01	0.01	0.01
0.00

Problem Resolution	0.00	1.00	0.00	1.00	0.03	0.03	0.03	0.09	0.03

Recordkeeping	0.50	0.50	0.00	1.00	5.06	0.56	0.56	6.18	2.06

Total Hours

	852.96	284.32

Table 12 presents the average cost per site, by activity, for completion
of a reporting form. EPA estimates that the average site will submit
5.06 reports in the first year and 0.56 reports in subsequent years and
incur a cost of approximately $57,500 over the three year collection
period. The Agency estimates that a site will incur an average annual
cost of approximately $19,200. Table 13 presents the burden hours,
organized by information collection, for the proposed rule. 

Table 12: Average Cost per Company

Activity	Cost	Total Cost per Activity	No. of Responses / Respondent
Total Cost ($2013)	Average Annual Cost ($2013)

	Clerical	Technical	Managerial

Year 1	Year 2	Year 3

Rule Familiarization.	$0.00	$35.50	$21.01	$56.51	1	0	0	$57	$19

Form Completion (per Report)	$0.00	$6,790.34	$2,443.60	$9,234.00	5.06
0.56	0.56	$57,066	$19,022

Electronic Reporting

CDX Registration	$0.00	$43.25	$13.23	$56.48	1.00	0.10	0.10	$68	$23

Electronic Subscriber Agreement/Electronic Signature	$0.00	$0.00	$19.46
$19.46	1.00	0.10	0.10	$23	$8

Help Desk	$0.00	$15.49	$4.67	$20.16	1.00	0.10	0.10	$19	$6

Report Compromised Signature	$0.00	$0.00	$31.13	$31.13	0.00	0.01	0.01	$1
$0

Problem Resolution	$0.00	$64.55	$0.00	$64.55	0.03	0.03	0.03	$6	$2

Recordkeeping	$15.17	$32.27	$0.00	$47.44	5.06	0.56	0.56	$293	$98

Total Cost

	$57,533	$19,178

Note: Base wages are estimated in the ECEC Supplemental Tables (BLS,
2014). Some burden estimate subtotals may not calculate due to rounding
of unit burden estimates

Table 13: Information Collection Tally

Information Collection	No. of 	No. of Responses / Respondent	Responses
Subtotal	Burden Hours per Response	 Burden Hours Subtotal

	Respondents

First 1

Rule Familiarization	295	1.00	295	0.82	242

Prepare Form	295	5.06	1493	136.60	203,944

Electronic Reporting

      CDX Registration	295	1.00	295	0.84	248

Electronic Subscriber Agreement/Electronic Signature	295	1.00	295	0.25
74

Help Desk	295	1.00	295	0.30	89

 Problem Resolution	295	0.03	9.00	1.00	9

Maintain Records	295	5.06	1,493	1.00	1,493

 Total 

	4,175	141	206,098

Years 2 and 3 

Rule Familiarization	295	0.00	0	0.82	0

Prepare Form	295	0.56	165	136.60	22,539

Electronic Reporting 

CDX Registration	295	0.10	30	0.84	25

Electronic Subscriber Agreement/Electronic Signature	295	0.10	30	0.25	8

Help Desk	295	0.10	30	0.06	9

Report Compromised Signature	295	0.01	3	0.400	0

Problem Resolution	295	0.03	9	1.00	9

Maintain Records	295	0.56	165	1.00	165

  Total	 	 	459	141	22,755

Average Burden for ICR Addendum Period

Rule Familiarization	295	0.33	97	0.82	81

Prepare Form	295	2.06	608	136.60	83,007

Electronic Reporting	295	0.27	80	0.54	174

Maintain Records	295	2.06	608	1.00	608

   Total

	1,393	139	83,870

Note: Some burden estimate subtotals may not calculate due to rounding
of unit burden estimates.



Agency Tally

Table 14 presents the Agency costs in the first year. EPA multiplied the
costs per report by the total number of reports to calculate the total
burden and cost associated with the number of reports EPA expects to be
submitted. The total Agency burden for year one is approximately 3.15
FTEs and the total cost is $0.51 million. 

Table 14: Total Cost and Burden of Agency Activities in the First Year
(2013$)

Activity	Staff	Total Burden per Activity (FTE)	Total Number of Units
Total Cost per Activity

(2013$)	Total Burden (FTE)	Total Cost (Millions 2013$)

Industry/Public Assistance	EPA Employee

(GS-13 Step 5)	0.000601	1,493	$97	0.90	$0.14

Data Processing and System Support Personnel

0.001505	1,493	$243	2.25	$0.36

Total Cost and Burden	3.15	$0.51 

Note: Some burden estimate subtotals may not calculate due to rounding
of unit burden estimates.

Table 15 presents the Agency costs associated with the proposed rule in
the second and third year. EPA multiplied the costs per report by the
total number of reports to calculate the total burden and cost
associated with the number of reports EPA expects to be submitted. The
total Agency burden for the second and third year is approximately 0.35
FTEs and the total cost is $0.06 million. 

Table 15: Total Cost and Burden of Agency Activities in the Second and
Third Year (2013$)

Activity	Staff	Total Burden per Activity (FTE)	Total Number of Units
Total Cost per Activity

(2013$)	Total Burden (FTE)	Total Cost (Millions 2013$)

Industry/Public Assistance	EPA Employee

(GS-13 Step 5)	0.000601	165	$97	0.10	$0.02

Data Processing and System Support Personnel

0.001505	165	$243	0.25	$0.045

Total Cost and Burden	0.35	$0.06 

Note: Some burden estimate subtotals may not calculate due to rounding
of unit burden estimates.

Table 16 presents the Agency’s estimated annual average burden and
cost associated with this ICR addendum. The three year average annual
burden, from 2012 to 2014, is approximately 1.28 FTEs and average annual
cost is approximately $0.21 million.

Table 16: Estimated Annual Average Burden and Cost Associated with this
ICR Addendum

Activity	2012	2013	2014	2012-2014 Average

	Annual Burden	Annual Cost	Annual Burden	Annual Cost	Annual Burden
Annual Cost	Average Burden	Average Cost

	(FTE)	(Millions 2013$)	(FTE)	(Millions 2013$)	(FTE)	(2011$)	(FTE)
(Millions 2013$)

	 	 	 	 	 	 	 	 

Document receipt, tracking, and data entry	0.90	0.14	0.10	0.02	0.10
$0.02	0.37	$0.06

Quality Control of Data	2.25	0.36	0.25	0.04	0.25	$0.04	0.91	$0.15

Total	1.28	$0.21

	

6(e)	Reasons for Change in Burden

EPA estimates that industry will incur an increase of 83,870 hours in
annual burden for a total burden of 84,145 hours. This increase solely
due program changes that result from the new proposed reporting
requirements for manufacturers and processors of certain chemical
substances as nanoscale materials. 

Table 17: Total Estimate of Annual Burden Hours and Annualized Cost
Comparisons

 	Annual Burden Hours

Current OMB Inventory	275

Change in Burden due to Adjustments	0

Change in Burden due to Program Changes	83,870

Total Change in Burden	83,870

Total Burden	84,145

	6(f)	Burden Statement

	The annual public burden for this collection of information is
estimated to average 137 hours per response, and with an estimated 5
responses per respondent, the average per respondent burden is estimated
to be 284 hours over the three year period covered by this ICR.
According to the Paperwork Reduction Act, “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal
agency. For this collection it includes the time needed to review and
understand instructions; prepare and submit reports (including searching
data sources); complete and review the collection of information;
transmit the information; and keep records. 

	An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control number for this information
collection appears above. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR Part 9, 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 in certain EPA regulations is
consolidated in 40 CFR Part 9.

	To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a docket for this ICR under Docket ID No.
EPA-HQ-OPPT-2010-0572 which is available for public viewing at the
Pollution Prevention and Toxics Docket in the EPA Docket Center
(EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is (202) 566-1544 and the
telephone number for the Pollution Prevention and Toxics Docket is (202)
566-0280. 

	An electronic version of this docket is available at   HYPERLINK
"http://www.regulations.gov/"  http://www.regulations.gov/ . Use the
federal government wide electronic docket and comment system at  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov  to submit
or view public comments, access the index listing of the docket
contents, and to access those documents in the docket that are available
electronically. Once in the system, select “advance search,” then
key in the docket ID number identified above. Also, you can send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA. Please include the EPA Docket ID No.
EPA-HQ-OPPT-2010-0572and OMB control number 2070-0162 in any
correspondence. 

Sources

BCC Research. 2006. Nanotechnology: A Realistic Market Assessment.

BLS, 2014. U.S. Bureau of Labor Statistics. Employer Costs for Employee
Compensation (ECEC) Supplemental Tables: December 2006 to March 2014, US
Bureau of Labor Statistics, June 11, 2014 (pp 29, 33, 37)
(http://www.bls.gov/ncs/ect/sp/ecsuphst.pdf, accessed July 7, 2014).

EPA, 2002a. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Economic Analysis for the Amended
Inventory Update Rule: Final Report (EPA-HQ-OPPT-2002-0054-0260). August
2002.

EPA, 2002b. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Wage Rates for Economic Analysis of
the Toxics Release Inventory Program. June 10, 2002.

EPA, 2007. U.S. EPA, Office of Pollution Prevention and Toxics.
Supporting Statement for EPA ICR No. 2250.01: Information Collection in
Support of EPA’s Stewardship Program for Nanoscale Materials. 2007. 

EPA, 2015. U.S. EPA, Office of Pollution Prevention and Toxics. Economic
and Policy Analysis Branch. Economic Analysis of the Proposed Reporting
Requirements for Certain Nanoscale Materials. March 12, 2015. 

Lux Research. 2007. The Nanotech Report™. 5th Ed.

Nanowerk. 2009. “Company & Labs Directory.” Available at:
http://www.nanowerk.com/nanotechnology/research/nanotechnology_links.php
. Accessed October 08, 2009.

OPM. 2013. U.S. Office of Personnel Management “Salary Table 2013 for
the Locality Pay Area of Washington-Baltimore-Northern Virginia,
DC-MD-VA-WV-PA.” Effective January 2013. Available at:
http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2013/g
eneral-schedule/washington-baltimore-northern-virginia-dc-md-va-wv-pa-ho
urlyovertime-rates-by-grade-and-step/. Accessed July 9, 2014.

8.	Attachments to the Supporting Statement

	All of the attachments listed below can be found in the docket for this
ICR; accessible electronically through   HYPERLINK
"http://regulations.gov"  http://regulations.gov . On the main page,
select Advanced Search from the menu bar at the top and select Docket
Search.  Enter the Docket ID Number, EPA-HQ-OPPT-2010-0572 in the Docket
ID field.  Click on the Submit button.  From the results page, you will
be able to link to the docket view or directly open select documents
found in the docket.

Attachment A:	2015. EPA. Chemical Substances When Manufactured or
Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping
Requirements; Proposed Rule. (Pending publication in the Federal
Register, XX FR XX, DATE). 

Attachment B:	EPA Form 7710-[tbd] - TSCA §8(a) Reporting For Chemical
Substances When Manufactured or Processed as Nanoscale Materials; Data
Submission Form (Draft).

March 26, 2015

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