[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Proposed Rules]
[Pages 8212-8235]
[FR Doc No: 2018-02928]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 700, 720, 723, 725, 790, and 791

[EPA-HQ-OPPT-2016-0401; FRL-9974-31]
RIN 2070-AK27

User Fees for the Administration of the Toxic Substances Control
Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: As permissible under section 26(b) of the Toxic Substances
Control Act (TSCA or the Act), the Environmental Protection Agency (EPA
or the Agency) is proposing to set user fees applicable to any person
required to submit information to EPA under the TSCA section 4 or a
notice, including an exemption or other information, to be reviewed by
the Administrator under TSCA section 5, or who manufactures (including
imports) a chemical substance that is the subject of a risk evaluation
under TSCA section 6(b). This notice of proposed rulemaking provides a
description of proposed TSCA fees and fee categories for fiscal years
2019, 2020, and 2021, and explains the methodology by which the
proposed TSCA user fees were determined and would be determined for
subsequent fiscal years. In proposing these new TSCA user fees, the
Agency also proposes amending long standing user fee regulations
governing the review of premanufacture notices, exemption applications
and notices, and significant new use notices. After implementation of
final TSCA user fees regulations, certain manufacturers and processors
would be required to pay a prescribed fee for each notice, exemption
application and data set submitted or chemical substance subject to a
risk evaluation in order for EPA to recover certain costs associated
with carrying out certain work under TSCA. With this action, EPA is
also proposing standards for determining which persons qualify as small
business concerns and thus would be subject to lower fee payments.

DATES: Comments must be received on or before April 27, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0401, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Mark Hartman, Immediate Office,
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number: (202)

564-3810; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be affected by this action if you manufacture (including
import), distribute in commerce, or process a chemical substance (or
any combination of such activities) and are required to submit
information to EPA under TSCA sections 4 or 5 or if you manufacture a
chemical substance that is the subject of a risk evaluation under TSCA
section 6(b). The following list of North American Industry
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include
companies found in major NAICS groups:
     Chemical Manufacturers (NAICS code 325),
     Petroleum and Coal Products (NAICS code 324), and
     Chemical, Petroleum and Merchant Wholesalers (NAICS code
424).

B. What is the Agency's authority for taking this action?

    The Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., as
amended by the Frank R. Lautenberg Chemical Safety for the 21st Century
Act (Pub. L. 114-182) (Ref. 1), provides EPA with authority to
establish fees to defray a portion of the costs associated with
administering TSCA sections 4, 5, and 6, as amended, as well as the
costs of collecting, processing, reviewing, and providing access to and
protecting information about chemical substances from disclosure as
appropriate under TSCA section 14. EPA is proposing this rule under
TSCA section 26(b), 15 U.S.C. 2625(b).

C. What action is the Agency taking?

    Pursuant to TSCA section 26(b), EPA is proposing to establish and
collect fees from certain manufacturers (including importers) and
processors to defray some of the Agency costs related to activities
under TSCA sections 4, 5, 6 and 14. EPA is requesting comment on its
proposed user fees and the methodology used for determining the
amounts. EPA is also proposing and taking comment on standards for
determining which persons qualify as small business concerns and thus
would be subject to lower fee payments. Paragraph 4 of TSCA section
26(b) requires that EPA, in setting fees, establish lower fees for
small businesses.

D. Why is the Agency taking this action?

    The 2016 amendments to TSCA authorize EPA to establish fees to
defray some of the costs of administering certain provisions of the
law. The TSCA Service Fee Fund (the Fund) in the U.S. Treasury will
hold funds to defray some of the costs of administering TSCA sections
4, 5, and 6 and of ``collecting, processing, reviewing, and providing
access to and protecting from disclosure as appropriate'' information
on chemical substances under TSCA section 14. The Agency proposes to
collect payment from manufacturers and processors, as appropriate, who:
Are required to submit information under TSCA section 4; submit a
notice, exemption application, or other information under TSCA section
5; and who manufacture a chemical substance that is the subject of a
risk evaluation under TSCA section 6(b). These fees are intended to
achieve the goals articulated by Congress to provide a sustainable
source of funds for EPA to fulfill its legal obligations to conduct
activities such as risk-based screenings, designation of applicable
substances as High- and Low-Priority, conducting risk evaluations to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment, requiring testing of chemical
substances and mixtures, and evaluating and reviewing manufacturing and
processing notices, as required under TSCA sections 4, 5 and 6, as well
as management of chemical information under TSCA section 14.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential incremental economic impacts of
this action. The Agency analyzed a three-year period, since the statute
requires EPA to reevaluate and adjust, as necessary, the fees every
three years. The Economic Analysis (Ref. 2), which is available in the
docket, is briefly summarized here and discussed in more detail in Unit
IV.
    The annualized fees collected from industry for the proposed option
(identified as Option C in the Economic Analysis (Ref. 2)), are
approximately $20.05 million. This total does not include the fees
collected for manufacturer-requested risk evaluations. Total fee
collections were calculated by multiplying the estimated number of
actions per fee category anticipated each year, by the corresponding
proposed fee. For the proposed option, TSCA section 4 fees account for
less than one percent of the total fee collection, TSCA section 5 fees
for approximately 43 percent, and TSCA section 6 fees for approximately
56 percent. Annual fees collected by EPA are expected to total
approximately $20.05 million.
    Under the proposed option, the total fees collected from industry
for a risk evaluation requested by manufactures are estimated to be
$1.3 million for chemicals included in the Work Plan and $2.6 million
for chemicals not included in the Work Plan.
    EPA estimates that 18.5 percent of TSCA section 5 submissions will
be from small businesses that are eligible to pay discounted fees
because they have average annual sales of less than $91 million in the
three preceding years. Total annualized fees for TSCA section 5
collected from small businesses are estimated to be $550,000 (Ref. 2).
    For TSCA sections 4 and 6, discounted fees for eligible small
businesses and fees for all other affected firms may differ over the
three-year period that was analyzed, since the fee paid by each firm is
dependent on the number of affected firms per action. Based on past
TSCA section 4 actions and data related to the first ten chemicals
identified for risk evaluations under TSCA as amended, EPA estimates
annualized fees collected from small businesses for TSCA section 4 and
TSCA section 6 to be approximately $37,000 and $2.6 million,
respectively.
    EPA estimates that total fees paid by small businesses will account
for about 16 percent of the approximately $20.05 million fees to be
collected for TSCA sections 4, 5, and 6 actions. The annualized total
industry fee collection for small businesses is estimated to be
approximately $3.2 million.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, information so marked will not be disclosed except in accordance
with

procedures set forth in 40 CFR part 2. A copy of the comment that does
not contain the information claimed as CBI must be submitted for
inclusion in the public docket.
    2. Tips for preparing your comments. When preparing, and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. History of Fees Under TSCA

    In 1976, TSCA section 26(b) provided EPA with authority to require,
by rule, the payment of fees by persons required to submit data under
TSCA sections 4 and 5. TSCA section 26(b) capped the maximum fees for
small business at $100 and fees for all other entities at $2,500. It
was not until the Agency published a final a rule in 1988 that EPA
began requiring and collecting fees from manufacturers and processors
to pay for premanufacture notices (PMNs), and other submissions under
TSCA section 5. Although authorized under the statute, the Agency has
not historically collected fees for data submitted under TSCA section 4
and no TSCA section 4 fees rule was ever promulgated by EPA.
    Since 1988, with regard to submissions by small business concerns,
the Agency has collected $100 for each TSCA section 5 PMN, consolidated
PMN, significant new use notice (SNUN), and certain exemption
applications and notices. For submissions by all other manufacturers or
processors, EPA has collected $2,500 for each TSCA section 5 PMN, and
consolidated PMN notices other than intermediate PMNs, SNUNs and
certain exemption applications and notices and $1,000 for intermediate
PMNs. These fees were set prior to the June 2016 amendments to TSCA and
do not reflect the current cost of administering the TSCA sections
associated with these submissions. In the past several fiscal years,
EPA has consistently generated approximately $1.1 million annually in
fee revenue. The fees go to the General Fund of the U.S. Treasury and
do not defray EPA's costs. With the finalization of the TSCA User Fees
rule, EPA's annually appropriated funds will be supplemented with the
user fees to cover some of the costs of administering TSCA, including
the costs incurred by the Agency in addressing additional requirements
imposed by the June 2016 amendments.

B. Recent Amendments to TSCA

    On June 22, 2016, the ``Frank R. Lautenberg Chemical Safety for the
21st Century Act'' was signed into law, amending numerous sections of
TSCA. The amendments give EPA improved authority to take actions to
protect people and the environment from the effects of chemicals. The
amendments also expand EPA's existing TSCA fee authority and allow the
Agency to establish and collect fees sufficient to defray some of the
costs of administering certain TSCA requirements.
    The amendments remove the $100 cap on fees collected from small
businesses and the $2,500 cap on fees from other manufacturers and
processors. Instead, the amendments require that, if fees are
established for work under TSCA sections 4, 5 and/or 6, the Agency set
lower fees for small business concerns and establish the fees so that
they are designed to collect 25% of the Agency's costs to carry out
work under section 4, 5, 6 and 14 of the Act or $25,000,000, whichever
is lower. In addition, in the case of a manufacturer-requested risk
evaluation, the Agency is authorized to establish fees sufficient to
defray 50% of the costs associated with conducting a manufacturer-
requested risk evaluation on a chemical included in the TSCA Work Plan
for Chemical Assessments: 2014 Update, and the full costs of conducting
a manufacturer-requested risk evaluation for all other chemicals. The
amendments also authorize fee revenue to be deposited into a new TSCA
Service Fee Fund. This is intended to ensure that resources are made
available to the Agency to defray some of the costs that EPA incurs in
carrying out activities under section 4, 5, 6 and 14 of TSCA.
    Currently, fees are only collected for certain submissions under
section 5 of TSCA. These fees are established in 40 CFR 700.45. Under
the Lautenberg Act's amendments to TSCA, EPA has authority to require
payment from manufacturers and processors who:
     Are required to submit information by test rule, test
order or enforceable consent agreement (TSCA section 4);
     Submit notification of or information related to intent to
manufacture a new chemical or significant new use of a chemical (TSCA
section 5);
     Manufacture or process a chemical substance that is
subject to a risk evaluation, including a risk evaluation conducted at
the request of a manufacturer (TSCA section 6(b)).
    Beginning in fiscal year 2019 (October 1, 2018 through September
30, 2019), EPA is required to adjust fees, as necessary, every three
years to reflect inflation and ensure that fees are sufficient to
collect 25% of the costs to the Agency in administering sections 4, 5,
6 and 14 of the Act. Before establishing new fees or revising any
existing fees, the Agency is required to consult with manufacturers and
processors, or their representatives.
    Additional information on the new law is available on EPA's website
at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.

C. Stakeholder Involvement

    Prior to this notice of proposed rulemaking, EPA engaged with
members of the public (or their representatives) potentially subject to
the fees. The Agency held a public meeting and webinar on August 11,
2016, and an industry-specific consultation meeting and webinar on
September 13, 2016, in accordance with TSCA section 26(b)(4)(E). The
Agency sought comments from industry on various aspects of the proposed
rulemaking, including the amendment of existing TSCA section 5 fees,
the establishment of new fees for TSCA sections 4 and 6 activities, and
small business considerations. As part of EPA's efforts to consult with
industry on the proposed fees and the methodology for establishing the
fees, the Agency also opened a docket and collected written comments
from stakeholders. To view the comments received prior to this notice
of proposed rulemaking, go to http://www.regulation.gov and search for
docket number: EPA-HQ-OPPT-2016-0401.
    The commenters included representatives from industry, trade
associations, and an environmental group and provided a diversity of
perspectives. Overall, there was a general expression of support for
the new law, for ensuring that the Agency has the funding necessary to
implement the requirements of the recent amendments to TSCA, and for
EPA's inclusive approach for gathering industry input into the setting
of fees. Most of the commenters expressed support for a fair, simple,
and efficient fee structure. The majority of commenters also expressed
support for industry consortia-based management of fee collection for
TSCA sections 4 and 6 activities.
    EPA sought input from industry on the relative apportionment of
fees that should be assessed for administering TSCA sections 4, 5, and
6 activities and on the factors that the Agency should consider when
structuring the fees. All industry commenters recommended that fees be
assessed based on the level of effort required of EPA for undertaking

the activity supported by the fee. A number of commenters opposed
assessment of fees under TSCA section 4. Others indicated a willingness
to accept nominal fees under TSCA section 4 or fees solely to account
for EPA's effort in reviewing submissions. Many commenters expressed
concern that higher fees imposed on bringing new chemicals to market
(i.e., TSCA section 5 submissions) could create an economic barrier to
innovation. Several commenters recommended that the bulk of the fees
the rule establishes should be from manufacturers and processors of
chemicals subject to risk evaluation under TSCA section 6.
    The Agency also sought comment from industry on lower fees for
small businesses. Many trade associations reaffirmed the need for lower
fees for small businesses. All commenters that mentioned small
businesses recommended that the TSCA definition of a small business be
updated, though there was diverse opinion on how; recommendations
included an inflation-adjusted, revenue-based standard and an employee-
based definition.
    EPA considered all of these comments in the development of the
proposed rule. EPA welcomes comment from stakeholders on all aspects of
the Agency's proposed fee structure during the public comment period
opened with this document.

D. Federal User Fee Design Guidance

    EPA also looked to federal user fee guidance in designing the
proposed TSCA user fees. Office of Management and Budget Circular A-25
on User Charges (Ref. 3) and the GAO User Fees Design Guide (Ref. 4)
contain information that is relevant to the administrative processes of
setting, revising, collecting, and administration of fees. As EPA
discusses its rationale for setting the TSCA fees in the remainder of
this preamble, the Agency will rely on the policies and principles
identified in these two federal guidance documents. Circular A-25
explains, for executive agencies, the scope and type of activities
subject to user fee charges and the basis on which user fees should be
set. EPA followed the Circular A-25 guidance in identifying the
relevant direct and indirect costs to be recovered by user fees
including, but not limited to, an appropriate share of personnel costs,
including salaries and fringe benefits; management and supervisory
costs; costs of research, establishment of standards and regulations;
physical overhead; and other indirect costs including supply costs and
travel.
    The Agency plans to periodically review the user fees to provide
assurance that existing charges are adjusted to reflect unanticipated
changes in costs, and plans to readjust, as necessary, the fees to
account for these changes, as well as inflation. TSCA 26(b)(4)(F) sets
the readjustment schedule at three year intervals. As required in TSCA
section 26 and discussed in the GAO Guide, parties potentially subject
to fees or their representatives will be consulted and asked to provide
input when the fees are reviewed and updated to reflect changes in
program costs.
    The Agency is proposing a process by which TSCA user fees would be
established for fiscal year 2019 through 2022 and then adjusted for
inflation every three years, beginning in fiscal year 2022, based on
applicable Producer Price Index (PPI) values available from the U.S.
Department of Labor. Fees for fiscal year 2022 and later would be
calculated by multiplying each fee identified for fiscal years 2019
through 2021 by the most current PPI value available at the beginning
of the three-year adjustment period, beginning with October 1, 2021.
EPA would provide public notice of the inflation-adjusted fee amounts
most likely through posting to the Agency's web page by the beginning
of each three-year fee adjustment cycle (i.e., October 1, 2021, October
1, 2024, etc.). The Agency may also identify the need to update program
costs underlying the fee amounts, and/or propose any changes to the
fees beside adjustment for inflation. The Agency will initiate industry
consultation as required under TSCA 26(b)(4)(E) in either case and
provide public notice for any fee changes based on inflation. EPA
expects to undertake notice and comment rulemaking for more substantial
changes to the fees. EPA seeks comment on this approach for readjusting
fees every three years.

III. Detailed Discussion of the Proposed Rule

    EPA is proposing to establish and collect fees from manufacturers
and processors of chemical substances pursuant to TSCA section 26(b).
As discussed previously in Unit II.A., EPA currently collects fees for
PMNs, certain PMN exemption applications and notices, and SNUNs
submitted under TSCA section 5. The Agency is proposing to expand the
categories of activities for which fees are collected and increase the
amount of fees required for certain activities under TSCA sections 4, 5
and 6. This proposal lays out the fee categories and payment amounts
that the Agency believes are both reasonable and appropriate to begin
collecting in fiscal year 2019; they are intended to provide a
sustainable source of funds to defray approximately 25 percent of the
costs to carry out the activities specified in TSCA section 26(b), as
well as 50% or 100% of the costs of risk evaluations requested by
manufacturers, depending on the chemical.
    Because EPA will not begin collecting fees until fiscal year 2019,
EPA believes it is appropriate to look to TSCA section 26(b)(4)(F) for
the parameters which must be applied for setting fees. TSCA section
26(b)(4)(F) requires EPA, ``beginning with the fiscal year that is 3
years after the date of enactment [June 22, 2016],'' to adjust fees as
necessary so they are sufficient to defray approximately 25 percent of
the costs to carry out the activities of TSCA sections 4, 5, 6 and 14,
other than the costs of manufacturer-requested risk evaluations.
Further, the fees shall defray 50% or 100% of the costs of risk
evaluations requested by manufacturers, depending on the chemical. EPA
acknowledges that fees were initially to be established under the
authority of TSCA section 26(b)(4)(B), which provides different
parameters, most notably a cap on fees of $25 million. However, given
the timing of this fee rule proposal such that fees won't be collected
under fiscal year 2019, EPA believes it is more appropriate to set
these fees based on the parameters that are required to be in effect by
fiscal year 2019. EPA also notes that because the estimated costs for
covered activities are under $100 million and costs defrayed under $25
million, the cap on fees found in TSCA 26(b)(4)(B) would have had no
bearing on the proposed fees in any case.
    EPA considered industry comments regarding the fee structure.
Several predominant themes emerged through consultation with industry.
Many commenters felt that EPA should charge fees that are proportional
to EPA costs for undertaking the activities. This was consistent with
one the considerations that EPA applied in setting the proposed fees--
equity as determined by proportionality between EPA costs and the fee
associated with each activity. EPA notes that the statute does not
require such proportionality. In fact, the fee triggers under the law
(for example, submission of a section 5 notice) are distinct from EPA
activities for which costs can be defrayed by the fees collected. Thus,
EPA could, consistent with TSCA, collect fees for section 5 submissions
that exceed the cost of processing the section 5 submissions, so long
as the fees in the aggregate are not designed to exceed 25% of the
costs to EPA of carrying out sections 4, 5, 6 and

14. Nonetheless, none of the fees that EPA is proposing exceed the
Agency's costs associated with the activities associated with a given
fee.

A. Who will be charged fees?

    As mentioned previously in Unit II.B., EPA has authority to collect
fees from manufacturers and processors who:
     Are required by test rule, test order or enforceable
consent agreement to submit information (TSCA section 4);
     Submit notification of or information related to intent to
manufacture a new chemical or significant new use of a chemical (TSCA
section 5);
     Manufacture or process a chemical substance that is
subject to a risk evaluation, including a risk evaluation conducted at
the request of a manufacturer (TSCA section 6(b)).
    Although EPA has authority to collect fees from both manufacturers
and processors of chemical substances, EPA is proposing to focus fee
collection on manufacturers. EPA is proposing to collect fees from
processors only when processors submit a SNUN under section 5 or when a
section 4 activity is tied to a SNUN submission by a processor. The
Agency feels the effort of trying to identify a representative group of
processors for the other three fee-triggering actions would be overly
burdensome and expects many processors would be missed. The Agency
believes this approach is the simplest and most straightforward way to
assess fees for conducting risk evaluations under TSCA section 6 and
other TSCA section 4 testing. Furthermore, EPA expects that
manufacturers required to pay user fees will have a better sense of the
universe of processors and will pass some of the costs on to them. The
Agency is seeking public comment on this approach.
    For certain actions for which a fee will be charged, such as new
chemical submissions under section 5, fee payers will self-identify by
virtue of the submission they make to the Agency. For others, such as
risk evaluations under section 6, EPA plans to look to recent Chemical
Data Reporting (CDR) submissions to identify manufacturers (including
importers) subject to section 6 fees. The CDR Rule, issued under the
authority of TSCA section 8(a), requires chemical substance
manufacturers to give EPA information on the chemicals they manufacture
domestically or import into the United States. Information is collected
every four years; data were most recently collected in 2016, including
2012-2015 production volume information and 2015 manufacturing,
processing and use information. The next submission period will be in
2020. EPA acknowledges that CDR data may not contain the entire list of
companies subject to a fee, and failure by EPA to identify companies
subject to a fee does not remove their obligation to pay. EPA proposes
to use CDR data to identify a preliminary list of companies. EPA also
seeks comment on whether to adopt a process that would allow time for
public input for adding to that preliminary list before finalization.
EPA seeks public comment on this approach.
    The Agency is also interested in comments on using other sources to
identify those subject to payment of fees. These sources include, for
example, information reported to the Toxics Release Inventory (TRI),
and notice of commencement (NOC) submissions under EPA's TSCA New
Chemicals Review Program. EPA may also look to information reported to
the Agency under the TSCA inventory active/inactive notification rule.
Each of these data sources provides information that may be useful in
identifying manufacturers and processors of chemical substances who may
be required to pay TSCA user fees. The TRI under section 313 of the
Emergency Planning and Community Right-to-Know Act, currently covers
over 650 chemicals. Facilities that manufacture, process or otherwise
use these chemicals in amounts above established levels must submit
annual TRI reports on each chemical. Facilities that report to TRI
include larger facilities involved in chemical manufacturing. Under
section 5 of TSCA, manufacturers are required to submit a NOC to the
Agency within 30 days following the start of manufacture of a new
chemical substance (i.e., any substance that is not on the TSCA
Inventory). Upon receipt of the NOC form, EPA places the substance on
the TSCA Inventory. EPA finalized the TSCA inventory active/inactive
notification rule in June 2017. The rule requires manufacturers to
report to EPA chemical substances on the TSCA Inventory that were in
U.S. commerce during the 10-year period prior to the TSCA amendments of
June 2016. The rule also requires manufacturers and processors to
notify EPA in the future when they intend to re-introduce an
``inactive'' substance on the Inventory into U.S. commerce. The Agency
plans to include a limitation in the final regulatory text to ensure a
manageable approach for the identification of manufacturers who are
subject to a particular fee. EPA welcomes comment on these approaches
for identifying those subject to TSCA user fees.

B. How did EPA calculate user fees?

    1. Background. EPA is presenting for comment its proposed
methodology for determining the user fees that will be assessed under
amended TSCA. The Act provides EPA authority to establish fees to
defray a portion of the costs associated with administering TSCA
sections 4, 5 and 6, as well as the costs of collecting, processing,
reviewing, and providing access to and protecting from disclosure, as
appropriate, information on chemical substances under TSCA section 14.
The events that trigger a fee payment however, involve a narrower set
of activities under TSCA sections 4, 5 and 6. While the collection of
fees is tied to the submission of particular information under sections
4 and 5 or the manufacturing of a particular chemical substance
undergoing a risk evaluation under section 6, in general, the use of
these fees is not limited to defraying the cost of the action that was
the basis for payment of the fee.
    EPA believes that assigning fees across TSCA sections 4, 5 and 6 is
the most equitable and efficient approach for allocating costs to the
manufacturers and processors detailed in Unit III.A. Those
manufacturers and processors would be expected to bear the burden, and
receive benefits, of TSCA reviews conducted by the Agency.
    The Agency's proposed fee methodology is intended to fully recover
the amount specified in the statute per TSCA section 26(b)(4)(F). The
estimated annual Agency costs of carrying out TSCA section 4, 5, 6 and
14, without including the costs associated with manufacturer-requested
chemical risk evaluations, are approximately $80.2 million. Based on
these cost estimates, EPA anticipates collecting approximately $20.05
million in fees each year. In addition, the Agency intends to collect
fees from manufacturers to recover a portion of costs incurred by EPA
in conducting chemical risk evaluations requested by manufacturers. EPA
expects this fee amount will be $1.3 million for per chemical for
chemicals on the Work Plan and $2.6 million per chemical for chemicals
not on the Work Plan.
    EPA determined the anticipated costs associated with TSCA sections
4, 5, 6 and 14 activities, including both program costs and indirect
costs (see Table 1). For fiscal year 2019 through fiscal year 2021,
these costs were estimated to be approximately $80.2 million per year.
More detail on how anticipated costs were calculated follows in Unit
III.B.2.

                                     Table 1--Estimated Annual Costs to EPA
                                   [Fiscal Year 2019 through Fiscal Year 2021]
----------------------------------------------------------------------------------------------------------------
                                                                  Direct program
                                                                       costs      Indirect costs   Annual costs
----------------------------------------------------------------------------------------------------------------
TSCA Section 4..................................................      $2,765,000        $778,000      $3,543,000
TSCA Section 5..................................................      22,375,000       6,296,000      28,672,000
TSCA Section 6..................................................      34,073,000       9,545,000      43,618,000
TSCA Section 14.................................................       3,531,000         814,000       4,345,000
                                                                 -----------------------------------------------
    Total:......................................................      62,744,000      17,425,000      80,178,000
----------------------------------------------------------------------------------------------------------------
Notes: Numbers may not add due to rounding The indirect cost rate for Office of Chemical Safety and Pollution
  Prevention is estimated at 28.14% for the purposes of this analysis.

    After estimating the annual costs of administering TSCA section 4,
5, 6 and 14, the Agency had to determine how the costs would be
allocated over the narrower set of activities under TSCA section 4, 5
and 6, which trigger a fee. The Agency took an approach to determining
user fees that parsed the fees based on the type of submission or fee
triggering event. This allows allocation of costs more equitably among
the submissions and their related costs.
    2. Program costs. To determine the program costs for implementing
sections 4, 5, 6 and 14 of TSCA, the Agency accounted for the
intramural and extramural costs for activities under these sections.
Intramural costs are those costs related to the efforts exerted by EPA
staff and management in operating the program, collecting and
processing information and funds, conducting reviews, and related
activities. Extramural costs are those costs related to the acquisition
of contractors to conduct activities such as analyzing data, developing
IT systems and supporting the TSCA Help Desk. The Agency then added
indirect costs to the direct program cost estimates. The Agency used an
indirect cost rate of 28.14% to calculate the indirect costs associated
will all TSCA section 4, 5, 6 and 14 direct program cost estimates.
    a. TSCA section 4 program costs. TSCA section 4, Testing of
Chemical Substances and Mixtures, gives EPA the authority to require,
by rule, order, or enforceable consent agreement (ECA), manufacturers
and processors to conduct testing of identified chemical substances or
mixtures. EPA estimated TSCA section 4 submission costs based on prior
experience with developing test rules and ECAs, reviewing study plans,
and reviewing the data received. EPA estimates that, on average, it
will undertake work associated with 10 test orders, one test rule and
one ECA each year. While EPA expects to work on one test rule and one
ECA each year, we expect to initiate each of these activities about
every other year. It takes approximately two years to complete the work
associated with both of these activities.
    Costs assume that each TSCA section 4 activity will cover one to 7
chemicals. While testing required by test orders is likely to be
completed in under a year, test rules and enforceable consent
agreements are likely to take two years to complete. This estimate is
based on EPA's prior experience with test rules and ECAs. To estimate
the costs of reviewing test data, we assume that on average, data will
be submitted to EPA for seven tests on each chemical.
    The estimated cost to the Agency of each test order is
approximately $279,000. Each test rule is estimated to cost
approximately $844,000 and each enforceable consent agreement is
estimated to cost approximately $652,000. These cost estimates include
submission review and are based on projected full-time equivalent (FTE)
and extramural support needed for each activity divided by the number
of orders, rules and ECAs EPA assumes will be worked on over a three-
year period. Several of these activities (rules and ECAs) are expected
to span two years, as noted earlier so those estimates are based on the
annual estimated costs multiplied by two. The annual cost estimate of
administering TSCA section 4 in fiscal year 2019 through fiscal year
2021 is $3,543,000 (Ref. 5: Table 8).
    b. TSCA section 5 program costs. TSCA section 5, Manufacturing and
Processing Notices, requires that manufacturers and processors provide
EPA with notice before initiating the manufacture of a new chemical
substance or initiating the manufacturing or processing for a
significant new use of a chemical substance. EPA is required to review
and make determinations on the notices and take risk management action,
as needed.
    Examples of the notices or other information that manufacturers and
processors are required to submit under TSCA section 5 are PMNs,
significant new use notifications (SNUNs), microbial commercial
activity notices (MCANs), and numerous types of exemption notices and
applications (e.g., low-volume exemptions [LVEs], test-marketing
exemptions [TMEs], low exposure/low release exemptions [LoREXs], TSCA
experimental release applications [TERAs], certain new microorganism
[Tier II] exemptions, film article exemptions, etc.).
    EPA's TSCA section 5 efforts under the previous law are well
understood through experience that spans several decades. The Agency
has historical data on costs, as well as the number of different
section 5 submission types sent to the Agency each year. In 1987, the
costs for the Agency to process a PMN were approximately up to $15,000
per submission, depending on the amount of detailed analysis necessary;
these estimates did not include indirect costs. Recent data on the
number of annual submissions is found at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review. (Ref. 6) In calendar year 2016, EPA received 577
PMNs, SNUNs and MCANs, and another 560 exemption notices and
applications, most of which were LVEs.
    The provisions of TSCA, as amended, result in additional TSCA
section 5 Agency costs that arise primarily from the requirement to
review the intended, known or reasonably foreseen activities associated
with the chemical, and the requirement to make an affirmative risk
determination, and from development of significant new use rules
(SNURs) and orders that result from our analysis and findings under
TSCA, as amended. Therefore, the Agency used the cost estimates from
prior experience as a starting point and then added estimates for the
costs of these additional responsibilities.
    EPA's cost estimates include the costs of processing, reviewing,
and making determinations, and the Agency's costs of taking any
regulatory action such as

with a SNUR or an order. Costs of reviewing any data that is submitted
to EPA as a result of an order is also included. EPA's cost estimates
for administering TSCA section 5 also include the costs associated with
processing, retaining records, related to a NOC submission. NOC costs
also include the cost of registering the chemical with the Chemical
Abstracts Service. EPA has lumped the costs associated with NOCs
(totaling an estimated $1,700,000 per year) with those of PMNs, MCANs
and SNUNs. The average cost of a PMN, MCAN and SNUN is approximately
$55,200. This estimate is based on projected FTE and extramural support
needed for these actions divided by the number of submissions the
Agency assumes will be received each year once fees are in place which
is 462. Our estimate of number of submissions is based on submissions
received FY 16 reduced by 20% due to the anticipated impact of higher
fees on the number of submissions (Ref. 5: Table 9).
    Costs associated with section 5 exemption notices and applications
include processing and reviewing the application, retaining records,
and related activities. The average cost of an exemption is $5,600.
This estimate is based on projected FTE and extramural support needed
for these actions divided by the number of submissions the Agency
assumes will be received each year once fees are in place which is 560.
Our estimate of number of submissions is based on submissions received
in FY 16 (Ref. 5: Table 10).
    The annual cost estimate of administering TSCA section 5 in fiscal
year 2019 through fiscal year 2021 is $28,600,000. Approximately
$25,500,000 is attributed to PMNs, SNUNs and MCANs; another
approximately $3,149,000 is attributed to section 5 exemptions notices
and applications for LVEs, LoREXs, TMEs, TERAs, Tier IIs and film
articles.
    c. TSCA section 6 program costs. TSCA section 6, Prioritization,
Risk Evaluation, and Regulation of Chemical Substances and Mixtures,
describes EPA's process for assessing and managing chemical safety
under TSCA. TSCA section 6 addresses: (a) Prioritizing chemicals for
evaluation; (b) evaluating risks from chemicals; and (c) addressing
unreasonable risks identified through the risk evaluation. Under TSCA,
EPA is now required to undergo a risk-based prioritization process to
designate existing chemicals on the TSCA Inventory as either high-
priority for risk evaluation or low-priority. For chemicals designated
as high-priority substances, EPA must evaluate existing chemicals to
determine whether they ``present an unreasonable risk of injury to
health or the environment.'' Under the conditions of use for each
chemical, the Agency will assess the hazard(s), exposure(s), and the
potentially exposed or susceptible subpopulation(s) that EPA determines
are relevant. This information will be used to make a final
determination as to whether the chemical presents an unreasonable risk
under the conditions of use. The first step in the risk evaluation
process, as outlined in TSCA, is to issue a scoping document for each
chemical substance within six months of its designation in the Federal
Register. The scoping document will include information about the
chemical substance, such as conditions of use, exposures, including
potentially exposed or susceptible subpopulations, and hazards, that
the Agency expects to consider in the risk evaluation. TSCA requires
that these chemical risk evaluations be completed within three years of
initiation, allowing for a 6-month extension. By the end of calendar
year 2019, EPA must have at least 20 chemical risk evaluations ongoing
at any given time on high-priority chemicals plus industry-requested
evaluations. For each risk evaluation that the Agency completes, TSCA
requires that EPA begin another. The Agency expects to have between 20
and 30 risk evaluations ongoing in any given year at different stages
in the review process.
    TSCA section 6 cost estimates have been informed by the Agency's
experience completing assessments for several TSCA Work Plan Chemicals,
including N-methylpyrrolidone, antimony trioxide, methylene chloride,
trichloroethylene, and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta[[gamma]]-2-benzopyran (HHCB) and by the Agency's
experience addressing risks identified from particular uses of a
chemical. TSCA section 6 risk evaluation costs include the cost of
information gathering, considering human and environmental hazard,
environmental fate, and exposure assessments. Costs also include the
use of the ECOTOX knowledge and Health and Environmental Research
Online (HERO) databases, among others. Other costs include scoping
(including problem formulation, conceptual model and analysis plan),
developing and publishing the draft evaluation, conducting and
responding to peer review and public comment, and developing the final
evaluation, which includes a risk determination.
    Under TSCA section 6, the Agency also has obligations to take
action to address any unreasonable risks identified from a chemical.
Cost estimates for risk management activities have been informed, in
part, by EPA's recent risk reduction actions on several chemicals,
including the use of N-methylpyrrolidone in paint and coating removal
and trichloroethylene in both commercial vapor degreasing and aerosol
degreasing and for spot cleaning in dry cleaning facilities. Section
6(a) of TSCA provides authority for EPA to ban or restrict the
manufacture, processing, distribution in commerce, and commercial use
of chemicals, as well as any manner or method of disposal of chemicals.
    In addition to considering previous experience with TSCA Workplan
chemicals described above, EPA also benchmarked risk evaluation costs
against cost associated with conducting risk assessments for pesticides
under the Pesticide Registration Improvement Act (PRIA). The Agency
chose the costs of conducting reviews for new conventional food-use
pesticide active ingredients as the most relevant comparison to an
existing chemical review under TSCA based on the scope and complexity
of the assessments and the data considered in conducting the reviews.
EPA estimates the cost of completing a risk assessment and risk
management decision for a new conventional food use pesticide active
ingredient to be approximately $2,900,000 which includes direct cost
estimates provided by the Office of Pesticide Programs and indirect
costs at 28.14%. The primary rationale for the increased cost estimate
for a risk evaluation under TSCA when compared to a new pesticide
review under PRIA are that the scope of an existing chemical assessment
under TSCA is expected to be broader in terms of conditions of use and
exposure scenarios that must be assessed and uncertainties associated
with implementing a new evaluation program. EPA also expects that risk
management costs will be higher under TSCA since rulemaking is required
to implement any mitigation that is considered appropriate whereas most
mitigation for a pesticide can be achieved directly through changes to
the product labeling and/or terms and conditions of the registration.
    The breakdown of costs for an average three-year EPA-initiated
chemical risk evaluation is shown in Table 2.

    Table 2--Estimated Costs (Direct and Indirect) Associated With an
             Average EPA-Initiated Chemical Risk Evaluation
------------------------------------------------------------------------
                Risk evaluation activity                  Estimated cost
------------------------------------------------------------------------
Risk Evaluation: Data Gathering (i.e., literature               $395,000
 search)................................................
Risk Evaluation: Databases (e.g., ECOTOX and HERO)......         147,000
Risk Evaluation: Hazard Assessment......................       1,008,000
Risk Evaluation: Exposure Assessment....................       1,038,000
Risk Evaluation: Scoping................................         235,000
Risk Evaluation: Draft Evaluation.......................         502,000
Risk Evaluation: Peer Review & Responding to Comment....         230,000
Risk Evaluation: Final Evaluation.......................         329,000
                                                         ---------------
    Total...............................................       3,884,000
------------------------------------------------------------------------

    For purposes of this proposal, EPA is estimating that manufacturer-
requested risk evaluations will cost less than EPA-initiated risk
evaluations on high-priority substances. Specifically, EPA is
estimating the average actual cost of a manufacturer-requested risk
evaluation to be $2,600,000. There are a number of factors supporting
this cost estimate and the assumption that manufacturer-requested risk
evaluations will actually cost less than EPA-initiated risk
evaluations. First, as required in the Risk Evaluation rule finalized
in June 2017, (40 CFR 702.37) manufacturers requesting a risk
evaluation must provide EPA with a list of existing information that
would be adequate for EPA to conduct an evaluation. The upfront
provision of data by manufacturers would limit the amount of subsequent
work that the Agency would need to undertake to evaluate the chemical.
Second, EPA believes that manufacturers who choose to submit risk
evaluation requests to EPA will likely do so in cases where they
believe the chemical is less likely to present an unreasonable risk. At
this time, EPA believes that manufacturers are more likely to request
risk evaluations on chemicals that are low hazard or low exposure, or
are otherwise fairly straightforward to analyze. As such, EPA is
estimating that these risk evaluations will be less costly than an
average EPA-initiated risk evaluation on a high-priority chemical.
While EPA does not yet have experience in receiving these types of
requests from manufacturers, or undertaking these risk evaluations,
these cost estimates represent EPA's best judgment based on past and
current activities and the expectation that manufacturers are more
likely to submit low hazard, low exposure chemicals for review. For the
first 10 chemical risk evaluations that EPA is currently undergoing,
for example, there are significant differences in the level of effort
necessary to complete the evaluations, with some being substantially
less complicated and therefore less burdensome than others. EPA expects
manufacturer-requested risk evaluations to be on the less complicated
end of the spectrum.
    The annual cost estimate of administering TSCA section 6 in fiscal
year 2019 through 2021 is $43,618,000. Approximately $32,370,000 is
attributed to risk evaluation work on 25 chemical risk evaluations;
another approximately $6,584,000 is attributed to risk management
efforts; another approximately $2,091,000 is attributed to support from
the Office of Research and Development (ORD) for alternative animal
testing and methods development and enhancement, and approximately
$2,573,000 is attributed to the annual process of designating chemicals
as High- or Low-priority substances (Ref. 5: Table 11).
    d. TSCA section 14 program costs. The June 2016 amendments to TSCA
provided EPA with new obligations under section 14, Confidential
Information. EPA must now review most chemical identity CBI claims
within 90 days and 25 percent of a subset of other types of CBI claims
within 90 days. This increased workload, along with the IT
infrastructure to support this work was included in EPA's cost
estimates for administering section 14. The annual cost estimate of
administering TSCA section 14 from fiscal year 2019 through 2021 is
$4,346,000. These estimates include FTE and extramural costs of
conducting CBI reviews and operating and maintaining the CBI Local Area
Network (LAN) (Ref. 5).
    3. Indirect costs. Indirect costs are the intramural and extramural
costs that are not accounted for in the direct program costs, but are
important to capture because of their necessary enabling and supporting
nature, and so that our proposed user fees will accomplish full cost
recovery up to that provided by law. Indirect costs typically include
such cost items as accounting, budgeting, payroll preparation,
personnel services, purchasing, centralized data processing, and rent.
Indirect costs are disparate and more difficult to track than the other
cost categories, because they are typically incurred as part of the
normal flow of work (e.g., briefings and decision meetings involving
upper management) at many offices across the Agency.
    EPA accounts for some indirect costs in the costs associated with
TSCA sections 4, 5, 6 and 14 by the inclusion of an indirect cost
factor. This rate is multiplied by and then added to the program costs.
An indirect cost rate is determined annually for all of EPA offices by
the Agency's Office of the Controller, according to EPA's indirect cost
methodology and as required by Federal Accounting Standards Advisory
Board's Statement of Federal Financial Accounting Standards No. 4:
Managerial Cost Accounting Standards and Concepts. An indirect cost
rate of 28.14% was applied to direct program costs of work conducted by
EPA's Office of Chemical Safety and Pollution Prevention, based on FY
2016 data (Ref. 7). Some of the direct program costs included in the
TSCA sections 4, 5, 6 and 14 estimates are for work performed in other
Agency offices (e.g., the Office of Research and Development and the
Office of General Counsel). Appropriate indirect cost rates were
applied to those cost estimates (i.e., 25.56% and 8.05%). These
indirect rates are based on EPA's existing indirect cost methodology
(Ref. 7). Indirect cost rates are calculated each year and therefore
subject to change. Indirect costs were included in the program cost
estimates in the previous sections.
    4. Fee categories. In addition to Agency costs, another piece of
information relevant to determining applicable user fees is the type of
events that trigger a fee payment (e.g., information submission,
exemption notice). Under this proposal, EPA would

require payment of fees for most types of fee triggering events under
TSCA sections 4, 5 and 6. This includes the requirement to submit
information to comply with a test order, test rule, or enforceable
consent agreement under TSCA section 4. Payment would also be required
for the following TSCA section 5 notices and exemptions: PMNs and
consolidated PMNs, SNUNs, MCANs and consolidated MCANs, TMEs, LoREXs,
LVEs, Tier II, film article exemptions and TSCA experimental release
applications TERAs. Payment would also be required for chemicals
undergoing both EPA-initiated and manufacturer-requested risk
evaluations under TSCA section 6. See Unit III.D. for a detailed
discussion of small business concerns.
    EPA is proposing three fee categories for TSCA section 4
activities. The proposed fee associated with a test order is $10,000.
The proposed fee associated with a test rule is $32,000 and the fee
proposed for an enforceable consent agreement is $25,000. EPA expects
these fees will be paid by consortia, assuming that multiple companies
manufacture the same chemical, and is requesting consortia assign
comparatively lower fees for small businesses than for large businesses
in the consortia. Consistent with comments previously received, the
Agency is proposing to provide flexibility to manufacturers to form
consortia to allocate these fees amongst those members involved in each
submission activity.
    Two categories of fees, with different fee amounts, are being
proposed for TSCA section 5 submissions. EPA chose to lump activities
with similar Agency costs together in order to develop a simple fee
structure. The fee being proposed for each PMN, SNUN and MCAN is
$16,000. The proposed fee for each LoREX, LVE, TME, Tier II, film
article and TERA is $4,700.
    EPA is proposing to continue the practice of allowing consolidation
of PMNs, consolidation of MCANs, and in some cases, consolidation of a
synthetic sequence, for up to six closely similar chemical substances
with similar use, structure, and probable toxicology at the same time
and for the same fee as a single chemical substance. See 48 FR 21734,
May 13, 1983. Consolidated PMNs (and MCANs) benefit submitters by
reducing the administrative burden of developing multiple section 5
submission forms for manufacture of two or more structurally related
new chemical substances that have similar use, exposure, environmental
release, and test data. EPA's review process is also better facilitated
by reviewing similar substances simultaneously.
    EPA limits the number of substances that may be included in a
consolidated PMN to six. EPA announced a policy that it would accept
submission of consolidated notices, subject to the approval of each
submission, in the preamble of the May 13, 1983 Federal Register (Ref.
8). When EPA initially accepted consolidations, there was no limit on
the number of substances which could be submitted in one consolidation.
A consolidation, though less demanding of EPA's resources than the same
number of separate submissions of related chemicals, still requires a
substantially increased amount of effort over the assessment of a
single submission. EPA has decided that it is appropriate to continue
to limit the number of substances in a consolidation to six.
    Persons who intend to submit a consolidated notice should first
contact EPA for approval before submission of the notice; through that
process, EPA can determine if the criteria for consolidation are met.
Substances should be adequately similar chemically and toxicologically;
planned uses must should be similar enough for combined review; and
intended volumes must should not be excessively different.
Consolidations are typically not granted for more than six substances
in one notice, nor for substances which are not chemically and
toxicologically similar. Novel or category chemicals are more likely to
be approved for consolidation if the intended uses and volumes are
similar.
    EPA intends to eliminate the ``intermediate PMN'' fee class. EPA
currently charges a reduced fee of $1,000 for the submission of PMN for
each chemical intermediate in a synthetic pathway when accompanied by a
PMN for the final substance on that pathway, and a full $2,500 user fee
for the final substance. The original intent of this reduced fee was to
encourage manufacturers to submit these notices together. The Agency
however, has not realized advantages in reviewing these notices
together; each intermediate takes about the same amount of effort to
review as does the ``final'' chemical substance on that pathway. For
this reason, the Agency proposes to eliminate the reduced fee for
intermediate PMN submissions and will take comment on this approach.
    EPA is not proposing to assess greater fees for submissions
containing CBI claims. At least six commenters opposed fees for such
claims, or suggested that the Agency collect only nominal payments
under TSCA section 14. While the CBI costs are considered in the fee-
defrayable costs, EPA is not proposing to charge an additional fee for
submissions and activities that contain CBI.
    In order to distribute the full costs to be defrayed among the fee
payment-triggering events in a way that is proportional to the costs of
the work associated with those events, EPA identified different fee
categories, based on the section of TSCA under which the event is
covered and the effort and burden for EPA to conduct the work
associated with the triggering event. EPA identified eight distinct fee
categories. The two fee categories under section 5 are further broken
out below for transparency.
    The annual estimated costs for fee categories under TSCA section 4,
including both direct and indirect program costs are shown in Table 3.
Please note that the costs presented in Tables 3, 4 and 5 do not
include costs associated with CBI reviews, alternative testing methods
development, risk management for existing chemicals or prioritization
of existing chemicals. Costs associated with those activities are part
of the overall costs of administering sections 4, 5, 6 and 14 and, as
such, are included in the overall cost estimates previously in Table 1.

                                         Table 3--TSCA Section 4 Costs *
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of    Estimated cost     Estimated
                          Fee category                                ongoing       to Agency/    annual cost to
                                                                   actions/year       action          Agency
----------------------------------------------------------------------------------------------------------------
Test Order......................................................              10        $279,000      $2,795,000
Test Rule.......................................................               1         844,000         422,000
Enforceable Consent Agreement...................................               1         652,000         326,000
----------------------------------------------------------------------------------------------------------------
* Numbers may not add due to rounding.

    The estimated annual costs for fee categories under TSCA section 5,
including both direct and indirect program costs are shown in Table 4.

                                         Table 4--TSCA Section 5 Costs *
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of    Estimated cost     Estimated
                          Fee category                                ongoing       to Agency/    annual cost to
                                                                   actions/year       action          Agency
----------------------------------------------------------------------------------------------------------------
PMN and consolidated PMN, SNUN, MCAN and consolidated MCAN......             462         $55,200     $25,500,000
LoREX, LVE, TME, Tier II exemption, TERA, Film Article..........             560           5,600       3,149,000
----------------------------------------------------------------------------------------------------------------
* Numbers may not add due to rounding.

    The estimated annual costs for fee categories under TSCA section 6,
including both program and indirect costs are shown in Table 5.

                                         Table 5--TSCA Section 6 Costs *
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of    Estimated cost     Estimated
                          Fee category                                ongoing       to Agency/    annual cost to
                                                                   actions/year       action          Agency
----------------------------------------------------------------------------------------------------------------
EPA-initiated risk evaluation...................................              25      $3,884,000     $32,370,000
Manufacturer-requested risk evaluation: Work Plan chemical......               2       2,600,000       1,733,000
Manufacturer-requested risk evaluation: Non-Work Plan chemical..               3       2,600,000       2,600,000
----------------------------------------------------------------------------------------------------------------
* Numbers may not add due to rounding.

    5. Calculating user fees. Almost all industry commenters expressed
support for a fair, simple, and efficient fee structure and all
industry commenters recommended that fees be assessed based on the
level of effort required of EPA as a result of the submission or
undertaking the activity for which a fee is charged. The Agency
considered these comments in developing this proposal. The Agency is
proposing a general fee structure that is generally proportional to the
Agency's costs, yet takes into account the numerous comments received
from industry regarding the desire to limit costs associated with
information submission under TSCA section 4. Two other alternate fee
structure proposals are included in this preamble. When providing
comments to the Agency on the various options, please recognize that
there are tradeoffs between decreasing fees in one area and increasing
fees in another. At the end of the day, the fee structure that the
Agency finalizes, must result in the collection of funds sufficient to
defray ``approximately but not more than 25 percent'' of the costs to
the Administrator of carrying out section 4, 5, 6, and of collecting,
processing, reviewing, and providing access to and protecting from
disclosure as appropriate under section 14.
    Because of the different costs associated with the different fee
triggering events, the Agency chose to start by differentiating fees
among the 8 categories discussed in Table 6. Fees for each triggering
activity were then calculated for each of these separate fee categories
using the following mathematical expression:
[GRAPHIC] [TIFF OMITTED] TP26FE18.002

Where:

cat x = category of similar types of submissions from manufacturers
and processors requiring similar effort and burden on the part of
EPA.
Program Costs = All EPA intramural costs and extramural costs
associated with a particular category of similar submission types
under TSCA section 4, 5 or 6.

    6. Amount of fees. EPA used the formula in Unit III.B.5. to
calculate the fees per submission for each fee category. However, the
Agency needed to further adjust the fees to ensure that 25% of the
costs of administering TSCA sections 4, 5, 6 and 14 would be collected
in any given year (i.e., approximately $20.05 million annually in
fiscal year 2019 through 2021). Because the Agency includes the costs
of administering TSCA section 14, risk management activities under
section 6, prioritization of chemicals for evaluation and ORD support
for alternative testing and methods development\enhancement in the
costs, but can't collect a specific fee for these actions, the Agency
calculated fees at 33% of the associated costs for TSCA sections 4, 5
and 6, as a baseline to ensure collecting 25% of costs and then
adjusted the fees from there.
    During the public meeting in August 2016 and the Industry-specific
consultation meeting in September 2016, some commenters suggested that
the bulk of the Agency's cost recovery should fall under TSCA section
6. About half of the industry commenters explicitly opposed assessment
of fees for submission of information under TSCA section 4. Several of
these and other commenters were willing to consider fees for TSCA
section 4 submissions, but only to account for the Agency's effort to
review the data from these submissions and only if the fees were kept
to a nominal amount, representing a minimal portion of EPA'S overall
cost recovery. Further, commenters requested that the Agency

consider impacts of fees on innovation and competitive standing.
    EPA considered a number of options for setting fee levels taking
into account feedback received during the consultation with industry
stakeholders. With respect to the section 4 fees, the Agency is
proposing to set fee levels for each subcategory at roughly 3.5% of the
activity cost. This low fee level relative to program costs was chosen
in part to take into account the fact that manufacturers and processors
are investing resources already in conducting the testing yet
recognizes that the Agency does expend resources issuing orders and
reviewing data under this section of the statute (Ref. 5).
    With respect to the section 5 fees, the Agency is proposing to set
two basic fee levels as mentioned above. The Agency is proposing to set
fee levels for each notice subcategory at roughly 29% of the activity
cost. Exemption category fees were then set at roughly \1/3\ of the PMN
amount which accounts for approximately 89% of the cost of the activity
(Ref. 5).
    To make up the difference in funds that would not be collected
under TSCA section 4 or 5 based on these proposed fee levels, the
Agency proposes to set the risk evaluation fee to be approximately 35%
of the costs of those (Ref. 5). Overall, that results in the bulk of
the fees expected to be collected under this proposed allocation coming
from manufacturers of chemicals subject to EPA-initiated risk
evaluations. The Agency considered this approach in part to try to set
section 5 fees at levels that would minimize the potential impact on
innovation and competitive standing.
    TSCA states the percentage of costs to be collected for
manufacturer-requested risk evaluations. Namely, TSCA specifies that
manufacturers be assessed fifty percent of the costs of a risk
evaluation for a chemical on EPA's Work Plan and 100 percent of the
costs incurred by the Agency to conduct a risk evaluation for a
chemical not on the Work Plan.
    The fee amounts being proposed today are summarized in Table 6.

                    Table 6--Proposed TSCA User Fees
------------------------------------------------------------------------
                  Proposed fee category                    Proposed fee
------------------------------------------------------------------------
TSCA Section 4:
    Test order..........................................          $9,800
    Test rule...........................................          29,500
    Enforceable consent agreement.......................          22,800
TSCA Section 5:
    PMN and consolidated PMN, SNUN, MCAN and                      16,000
     consolidated MCAN..................................
LoREX, LVE, TME *, Tier II exemption, TERA, Film                   4,700
 Articles...............................................
TSCA Section 6:
    EPA-initiated risk evaluation.......................       1,350,000
    Manufacturer-requested risk evaluation on a chemical       1,300,000
     included in the Work Plan..........................
    Manufacturer-requested risk evaluation on a chemical       2,600,000
     not included in the Work Plan......................
------------------------------------------------------------------------
* EPA is proposing to waive the TME fee for submissions from companies
  that have graduated from EPA's Sustainable Futures program.

    The Agency is interested in hearing from stakeholders regarding
this approach for setting fees for the different categories of
activities.
    EPA's Sustainable Futures program encourages chemical developers to
use the Agency's models and methods to screen new chemicals for
potential risk early in the development process, with the goal of
producing safer chemicals more reliably and more quickly, saving time
and money, and in turn, getting safer chemicals into the market.
Companies that graduate from Sustainable Futures can earn expedited
review of TSCA section 5 for prescreened new chemical notices.
Prescreening chemicals for hazard concerns helps companies anticipate
and avoid developing chemicals of concern. As described in the Federal
Register Notice announcing Sustainable Futures (Ref. 9), the expedited
review is achieved by allowing the graduate's submission to be
considered both as a PMN and a TME. The graduate simultaneously submits
two separate notices, the PMN, MCAN or SNUN and the TME, as a combined
Sustainable Futures submission. The advantage of the simultaneous
submission is that the case will be considered a TME and the submitter
will be able to manufacture at day 45 instead of having to wait until
the PMN 90-day review period ends. This in effect cuts the review time
in half. EPA would like to encourage companies to graduate from the
Sustainable Futures program and is proposing to waive the TME fee for
submissions from graduates that come in with a valid PMN, MCAN or SNUN.
In fiscal year 2016, 13 Sustainable Futures graduates accounted for
7.6% of the PMNs, 37.5% of MCANs and 0% of SNUNs submitted to the
Agency.
    The annualized fees estimated to be collected under this proposed
approach total approximately $20.05 million in fiscal year 2019 through
2021, with an additional $3.5 million in annualized fees expected from
manufacturer-requested chemical risk evaluations during the three-year
period. While TSCA section 6(b)(4)(E)(ii) sets minimum requirements on
the number of ongoing manufacturer-requested risk evaluations if EPA
receives a sufficient number of compliant requests (25% of the number
of ongoing EPA-initiated chemical risk evaluations), we do not expect
to receive a sufficient number of manufacturer requests over the next
three years to meet this threshold. Manufacturers are likely to wait
until the initial chemical risk evaluations are completed to see how
the process plays out. The Agency estimates receiving a total of five
manufacturer requests for chemical risk evaluations during the next
three years--two for risk evaluations on Work Plan chemicals and three
for risk evaluations on chemicals not included in the Work Plan.
    In developing this proposal, the Agency considered its experiences
in implementing its fee collection program for pesticide registration
actions. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
amendments passed by Congress in 2004 created a registration service
fee system for applications for specific pesticide registration,
amended registration, and associated tolerance actions.
    Activities conducted as part of the pesticide registration program
and those to be conducted as part of the new chemical approval review
program are similar in many respects. Both involve applications to the
Agency to make a risk determination for a chemical substance prior to
its introduction into the marketplace. In each program, the Agency
conducts an independent

evaluation of potential risks presented by the proposed uses of the
chemical based on the best available scientific information and in the
event that risks are identified seeks to manage those risks as needed
through various mitigation strategies.
    In conducting this analysis, the Agency recognizes that while there
are valuable insights to be gained from its experiences implementing
PRIA for the past 13 years that there are also important differences
that also need to be understood when applying lessons learned from that
program to a fee collection program under TSCA. One difference is that
comprehensive data requirements have been established for pesticide
registration applications under 40 CFR 158 whereas similar data
requirements are not in place for chemical substances under TSCA.
    Another difference is the time frames allowed for making a
determination on a pesticide registration application vs. reviews of
chemical substances. The time frames for pesticide registration
decisions vary significantly based on the type of application being
submitted to the Agency. For a new pesticide active or inert
ingredient, the closest relatable set of categories to a new chemical
under TSCA, the time frames for a decision range from 8 to 24 months.
Under TSCA, the Agency has a shorter time frame, 90 days with possible
extension to 180 days, in which to make a decision on most new
chemicals. The length of the decision time frames can have an impact on
the queuing of actions and resources in that having to conduct a
similarly scoped review in a shorter time period would be more resource
intensive.
    In seeking to benchmark the fees being proposed for new chemical
activities under TSCA, the Agency compared expected level of effort for
a new chemical review to PRIA categories which might be expected to
have a similar level of effort. EPA focused on the categories for the
registration of new active ingredients in pesticides. The time frames
associated with these reviews range from 8 months (new inert ingredient
not for use on food) to 24 months (several categories). The fees for
these categories range from $11,025 for a new non-food inert ingredient
to $627,568 for a new conventional active ingredient for use on food
crops. The most analogous PRIA categories to a new chemical review
under TSCA based on data and/or the nature of the assessments needed
are believed to be: PRIA Category I004- Approval of new non-food use
inert ingredient ($11,025 fee and 8-month review period), and PRIA
Category B600--New biopesticide active ingredient; non-food use
($19,146 fee and 13-month review period). The fees identified in this
proposal for new chemicals fall within the range of these analogous
categories.
    Considering the 90-day review period for a new chemical under TSCA,
the Agency also considered PRIA categories with a similar decision time
frame. Only six of the 189 PRIA categories have decision time frames of
three months. One of these is to repackage an existing end use product
as a manufacturing use product with identical uses (a relatively small
change to a product label with no data review) while the others are for
reviewing a single study protocol, reviewing a rebuttal to an Agency
protocol review or to make a preliminary determination on a waiver
request for a biopesticide. Each have a fee of $2,530. All of these
categories are very limited in terms of data review and the scope of
the decision to be made and would not be considered analogous to a new
chemical determination under TSCA.

C. What other options were considered?

    In addition to the proposed fee structure, the Agency considered
two other methodologies for calculating user fees. Option A involved
setting the fees for each fee category at 33% of the estimated costs to
the Agency in conducting work associated with that particular activity
without further adjustment. In this option, fees for test orders, test
rules, and enforceable consent agreements are considerably higher than
the fees being proposed today and new chemical notices fees are
increased while risk evaluations and new chemical exemptions are lower.
    The Agency also considered an approach, Option B, in which test
orders, test rule and ECA fees were set at 10% of the estimated costs
to the Agency but PMN fees were set based on the inflation-adjusted
amount of currently existing fees. That resulted in lower PMN, MCAN,
and SNUN fees. Exemption fees were set at \1/3\ the amount of the PMN
fees. To make up the difference, EPA adjusted the risk evaluation fees
resulting in an increase in risk evaluation fees to approximately 43%
of the estimated costs to the Agency. See Table 7 for a summary of
alternate fees associated with Alternate Options A and B.

          Table 7--Other Alternative TSCA User Fees Considered
------------------------------------------------------------------------
                                           Alternate fee   Alternate fee
        Alternative fee category               ``A''           ``B''
------------------------------------------------------------------------
TSCA Section 4:
    Test order..........................         $92,000         $28,000
    Test rule...........................         278,000          84,000
    Enforceable consent agreement.......         215,000          65,000
TSCA Section 5:
PMN and consolidated PMN, SNUN, MCAN and          18,200          10,400
 consolidated MCAN, LoREX, LVE..........
TME, Tier II exemption, TERA............           1,850           3,500
TSCA Section 6:
    EPA-initiated risk evaluation.......       1,280,000       1,670,000
    Manufacturer-requested risk               1,300,0000       1,300,000
     evaluation on a chemical included
     in the Work Plan...................
    Manufacturer-requested risk                2,600,000       2,600,000
     evaluation on a chemical not
     included in the Work Plan..........
------------------------------------------------------------------------

    The annualized fees estimated to be collected under these
alternative approaches are approximately the same as those estimated to
be collected under the approach being proposed today.

C. How did EPA take into account small business concerns?

    EPA is proposing reduced fees for small businesses. These reduced
fees are summarized in Table 8.

          Table 8--Proposed TSCA User Fees for Small Businesses
------------------------------------------------------------------------
                                                          Proposed small
                  Proposed fee category                    business fee
------------------------------------------------------------------------
TSCA Section 4:
    Test order..........................................          $1,950
    Test rule...........................................           5,900
    ECA.................................................           4,600
TSCA Section 5:
    PMN and consolidated PMN, SNUN, MCAN and                       2,800
     consolidated MCAN..................................
    LoREX, LVE, TME, Tier II exemption, TERA............             940
TSCA Section 6:
    EPA-initiated risk evaluation.......................         270,000
    Manufacturer-requested risk evaluation on a chemical       1,300,000
     included in the Work Plan..........................
    Manufacturer-requested risk evaluation on a chemical       2,600,000
     not included in the Work Plan......................
------------------------------------------------------------------------

    EPA set the proposed small business fees at an 80% reduction
compared to the base fee for each category. In one case, for PMN and
related actions, the proposed small business fee reduction is 82.5%.
This slightly higher percentage reduction is due to the concern for the
potential impact on small businesses of higher fee levels. The proposed
small business fees for each category fee is only triggered when there
is one entity subject to the fee, and that entity is a small business
or if there is a consortium paying the fee and all members of that
consortium are small businesses. By way of comparison, PRIA fees may be
reduced for small businesses by a maximum of 75% under certain
conditions.
    EPA is also proposing to revise the size standard used to identify
businesses that can qualify as a ``small business concern'' under TSCA
for the purposes of fee collection. A regulatory definition for a small
business that makes a submission under TSCA section 5 was promulgated
in 1988 and is based on the annual sales value of the business's parent
company. 40 CFR 700.43 currently states: ``Small business concern means
any person whose total annual sales in the person's fiscal year
preceding the date of the submission of the applicable section 5
notice, when combined with those of the parent company (if any), are
less than $40 million.''
    The Agency is proposing several changes to this definition.
Consistent with the definition of small manufacturer or importer at 40
CFR 704.3, EPA proposes to increase the current revenue threshold of
$40 million using the Producer Price Index (PPI) for Chemicals and
Allied Products, as compiled by the U.S. Bureau of Labor Statistics.
[Data series WPU06 at http://data.bls.gov/cgi-bin/srgatet.] Using a
base year of 1988 and inflating to 2015 dollars results in a value of
approximately $91 million (Ref. 10).
    Pursuant to 13 CFR 121.903(a)(1)(ii), the Agency also proposes to
change the time frame over which annual sales values are used when
accounting for a business's revenue. Instead of using just one year
preceding the date of submission, the Agency is proposing to average
annual sales values over the three years preceding the submission. EPA
proposes to apply this updated definition--adjusted for inflation and
averaging sales revenue over three years--to not only TSCA section 5
submissions, but also to TSCA sections 4 and 6 submissions as well.
    The Agency is seeking comment on this approach and is specifically
interested in comment on whether an employee-based size standard would
be more appropriate than a receipts-based size standard and what that
employee level should be; whether the size standard, be it receipts-
based or employee-based, should vary from industry to industry to
reflect differences among the impacted industries; and what other
factors and data sources the Agency should consider, besides inflation,
when developing the size standard to qualify for reduced fee amounts.
    Further, with respect to small business size standards, the Agency
has recently committed to revisiting the definition of small businesses
as it relates to the TSCA section 8(a) data reporting regulations (82
FR 56824). Due to the urgent need for the Agency to promulgate this
regulation and expeditiously collect the fees, the Agency believes that
upcoming rulemaking will provide a venue for a more expansive
consideration of appropriate size standards for industries subject to
TSCA and offer the public with further opportunities to comment on the
size standard. In addition to considering comments submitted in
response to this proposal, the Agency is committed to evaluating the
results of the 8(a) rulemaking process and, in the event that the
reporting and fee standards differ, to determine if the size standards
set through that process should be harmonized with the small business
definition for fees. This harmonization could be implemented in a
subsequent rulemaking for the next three-year fee cycle (FY22-FY25).

D. How would the Agency handle fees from multiple parties?

    Not every person subject to this rule must individually submit fees
to EPA. TSCA section 26(b)(4)(C) allows for payment of fees by
consortia of manufacturers and processors. EPA is proposing to allow
joint submissions under TSCA section 5 and is permitting the formation
of, and payment by, consortia for submissions under TSCA sections 4 and
6. Joint submitters of a TSCA section 5 notice would be required to
remit the applicable fee identified in paragraph (b) of this section
for each section 5 notice submitted. Only one fee is required for each
submission, regardless of the number of joint submitters for that
notice. To qualify for the fee identified in paragraph (b)(1) of this
section, each joint submitter of a TSCA section 5 notice must qualify
as a small business concern under Sec.  700.43. This approach aligns
with comments received from industry during the consultation process.
    Any consortium formed to jointly submit TSCA user fees would be
expected to notify EPA of such intent. Once established, it would be up
to the consortium to determine how the user fee would be split among
the members. EPA strongly encourages consortia to set lower fees for
small business concerns; Congress intended small business to be
afforded lower fee payments (TSCA 26(b)(4)(A)).
    If, after 30 days, a consortium is unable to reach agreement on
splitting the user fee, the principal sponsor must notify EPA, so EPA
can calculate the

individual fee for each consortium member. The Agency proposes to
divide the total fee by the number of members. Small businesses will be
afforded an 80% discount, which the remaining consortium members will
be required to cover in equal amounts. EPA requests comment on this
default approach.

F. What methods of payment would be accepted?

    The U.S. Department of the Treasury has determined that federal
agencies should move away from receiving payments by check, and
transition to electronic methods of payment. EPA proposes to accept
payment of fees through two different electronic payment options:
Pay.gov and Fedwire.
    Pay.gov is a secure government-wide collection portal that helps
federal agencies meet the directives outlined in the Government
Paperwork Elimination Act (Pub. L. 105-277) (Ref. 11), primarily by
reducing the number of paper transactions and utilizing electronic
transaction processing. pay.gov, accessible online at http://www.Pay.gov, currently processes payments for hundreds of federal
government agencies. It provides a full suite of services, allowing
federal agencies to process collections quickly and easily; it also
provides reports that can assist in integrating information into other
financial systems. Pay.gov provides customers the ability to
electronically complete forms and make payments twenty-four hours a
day. Because the application is web-based, customers can access their
accounts from any computer with internet access.
    Fedwire is generally used for foreign payments. With this method of
electronic payment, payers authorize a financial institution to
initiate an electronic (wire transfer) payment to the Federal Reserve
Bank of New York. Credit Gateway, which is operated by a commercial
bank, then allows federal agencies to access their money from Fedwire.
Credit Gateway processes transactions and settles them at Federal
Reserve Banks.
    EPA proposes that those subject to fees could use any payment
method of their choice supported by the Department of the Treasury's
Pay.gov electronic payment collection services (or any applicable
alternative or successor to Pay.gov developed by Treasury) or Fedwire,
as long as EPA's financial tracking systems are able to obtain and
process the selected method of payment. Specifically, manufacturers and
processors would be expected to create payment accounts in Pay.gov and
use one of the electronic payment methods currently supported by
Pay.gov (e.g., Automated Clearing House debits (ACH) from bank
accounts, credit card payments, debit card payments, PayPal or Dwolla)
or use Fedwire to authorize an electronic payment. Because Pay.gov and
Fedwire do not accept paper checks as payment, EPA will not accept
paper checks as payment for TSCA services. Additional instructions for
making payments to EPA using Pay.gov and Fedwire are found at https://www.epa.gov/financial/additional-instructions-making-payments-epa. The
Agency requests comment on this approach.

G. When would payment of fees be required?

    There is precedent for advance payments of user fees in several of
the Agency's existing user fee programs. For example, EPA's Office of
Pesticide Programs and EPA's Office of Air and Radiation fee programs
typically require advance payment prior to administering program
services involving the review of applications for the various
certifications and registrations administered by those programs. This
follows the guidance outlined in OMB Circular No. A-25, which states
that user charges will ``be collected in advance of, or simultaneously
with, the rendering of services.'' (Ref. 3)
    EPA is proposing to collect lump sum payment of the entire user fee
for section 5 notices prior to reviewing each submission or undertaking
the activity associated with the fee. EPA is proposing to require fee
payment at the time a TSCA section 5 notice (this includes an
exemption) is submitted.
    EPA is proposing to allow fee submitters for test orders, test
rules, ECAs and EPA-initiated chemical risk evaluations time to
associate with a consortium and work out fee payments within that
consortium. Payment for fee categories under TSCA section 4 (i.e., test
orders, test rules and ECAs) is due within 60 days of the effective
date of the order or rule, or 60 days upon signing of an enforceable
consent agreement. For EPA-initiated risk evaluations, full payment is
due within 60 days of EPA publishing the final scope of a chemical risk
evaluation. EPA believes this provides sufficient time for
manufacturers to associate as a consortium, if they so choose, and to
decide on the partial fee payments each member of the consortium will
be responsible for. Manufacturers will have ample warning that a risk
evaluation is underway, well before the final scope is published in the
Federal Register.
    For manufacturer-requested risk evaluations, EPA is proposing to
collect a fee when EPA grants the request to conduct the evaluation.
Payment will be required within 30 days of EPA providing such notice.
    EPA is also proposing that user fees will begin to be incurred
starting on October 1, 2018. As discussed above, TSCA section
26(b)(4)(F) requires EPA, ``beginning with the fiscal year that is 3
years after the date of enactment [June 22, 2016],'' to adjust fees as
necessary so they are sufficient to defray a portion of EPA's costs.
Since Congress expected fees to already be in place by October 1, 2018
such that they may need adjusting, EPA believes it is reasonable for
all actions for which a fee is proposed to be subject to fees as of
October 1, 2018. EPA will not, however, collect any fees until the
final rule resulting from this proposal is effective. Instead, EPA
intends to record actions that would be expected to trigger payment of
fees and once the rule is final send invoices to the affected parties
indicating. The invoices would reflect timing for payments and amounts
based on the final rule.

H. Under what circumstances will EPA refund payments?

    EPA will continue to refund any fee paid for a section 5 notice
whenever EPA determines that the notice or fee was not required. See,
e.g., 40 CFR 720.62. This can happen, for example, when the intended
use described in the PMN is not actually subject to TSCA jurisdiction
or when the substance is already on the Inventory.
    TSCA section 26(b)(4)(G) permits EPA to refund fees, or a portion
of fees, for notices submitted under TSCA section 5 that are later
withdrawn and for which the Agency conducts no substantive work unless
the Agency determines that the submitter unduly delayed the process.
EPA proposes to refund a consistent 75% of the user fee to the
submitter if the notice is withdrawn within 10 business days. This
percentage is consistent with the approach for refunds for withdrawn
actions under PRIA. Beyond ten business days, EPA is likely to have
already conducted substantial review work that qualifies as substantive
work for which no refund is authorized under TSCA 26(b)(4)(G). Up to
three significant milestones of the PMN review process can take place
within 10 business days. The Chemical Review/Search Strategy Meeting
occurs between Day 8 and 12; the Structure Activity Team Meeting occurs
between Day 9 and 13; and Development of Exposure/Release Assessments
occurs between Day 10 and 19. EPA feels that tying the refund time
period to a certain number of days is a simpler and more efficient

approach than tying it to a specific milestone of the review process.
    EPA does not have authority to, and therefore will not, provide
refunds under any other circumstances.

I. What are the consequences of failing to pay a fee?

    Failure to comply with any requirement of a rule promulgated under
TSCA is a prohibited act under TSCA section 15 and is subject to
penalties under TSCA section 16. When the fee payment requirements are
finalized, failure to pay the appropriate fee at the required time
would subject each manufacturer and processor who is subject to the fee
payment to penalties of as much as the maximum statutory amount per day
($38,114 as of January 2017) until the required fee is paid. Each
person subject to fees would be subject to such penalties regardless of
whether they intend to pay independently, as a joint submitter or
through consortia. Specifically, each member of a consortium, and each
joint submitter, is individually responsible for payment of the fee,
and subject to penalties for non-payment, until the fee is actually
paid.

J. Compliance Date

    EPA is proposing to start collecting fees the day after the final
TSCA user fees regulations are published in the Federal Register.
Stakeholders were provided notice during public meetings in August of
2016 requesting comment through EPA Docket: EPA-HQ-2016-0401 and
indicating that the Agency intended to start collecting new fees for
TSCA section 4 and section 6 activities and that fees associated with
the submission of notices under TSCA section 5 would increase. EPA
believes that we have provided sufficient notice to, and opportunity
for, industry to provide comment regarding the user fees. (See Unit
II.C. titled, ``Stakeholder Involvement''.) Furthermore, for EPA to
sufficiently address the increased workload under TSCA as amended in
June 2016, the Agency must start collecting fees as soon as possible
for use in defraying some of the costs of activities spelled out in
TSCA section 26 paragraph (b)(1). EPA is seeking comment on this
approach.

K. What other amendments are being proposed?

    EPA is proposing minor changes to several of its regulations that
cross-reference the part 700 fees regulations, specifically parts 720,
723, 725, 790 and 791. Amending the regulatory text in these parts will
ensure that existing regulations appropriately reference the regulatory
text being proposed. EPA is proposing minor updates for implementing
the fee requirements for test marketing exemptions at Sec.  720.38;
premanufacture notification regulations at Sec.  720.45(a)(5); instant
photographic and peel-apart film articles exemptions at Sec.  723.175;
amendments to regulations covering MCANs and exemption requests at
Sec.  725.25 and Sec.  725.33; minor amendments at Sec.  790.45 and
Sec.  790.59; and a modification to the general provisions for data
reimbursement found at Sec.  791.39.

IV. Projected Economic Impacts of TSCA User Fees

    EPA has evaluated the potential costs for manufacturers and
processors of chemical substances for this proposed rule. Overall, EPA
developed eight fee categories for activities under TSCA sections 4, 5,
and 6. TSCA section 4 fee categories include test orders, test rules,
and ECAs. TSCA section 5 fee categories include PMNs and consolidated
PMNs, SNUNs, MCANs and consolidated MCANs, LoREXs, LVEs, TMEs, Tier II
exemptions and TERAs. Finally, TSCA section 6 fee categories include
Agency-initiated risk evaluations, manufacturer-requested risk
evaluations for Work Plan chemicals, and manufacturer-requested risk
evaluations for non-Work Plan chemicals.
    For the baseline, EPA used a historical average of the 2013 through
2016 submissions for each TSCA section 5 action (Ref. 12) as the
estimate of the number of submissions per fee category for the next
three years. TSCA section 4 test orders are new under TSCA and the
average number of such actions expected per year represents an EPA
estimate. For the other TSCA section 4 actions (test rules and ECAs),
EPA also estimated the expected number of such actions per year. The
amended TSCA regulations specify the number of risk evaluations that
EPA must have ongoing over the next three years. EPA uses the mandated
number of risk evaluations to estimate the cost of the proposed rule
for TSCA section 6 activities. Under the recent amendments to TSCA, EPA
assumes that the number of TSCA section 4 activities (test rules and
ECAs) would change from the baseline as the Agency seeks additional
test data and information on chemical substances, TSCA section 5
activities would decrease as a result of higher fees and the new
statutory requirement for affirmative determination, and TSCA section 6
risk evaluations initiated over the next several years would increase
before leveling off in accordance with statutory requirements. The
Agency expects to have between 20 and 30 risk evaluations ongoing in
any given year at different stages in the review process, including
manufacturer-requested evaluations. The Agency seeks comment on these
assumptions.
    EPA estimates the total fee collection by multiplying the proposed
fees with the number of expected activities under full implementation
for each section. For test rules and ECAs, EPA has not promulgated any
in the recent past and has estimated the number of activities that EPA
will likely need to issue to meet our requirements. EPA based the
estimates of the future number of TSCA section 5 submissions on the
historical number of submissions for all TSCA section 5 notices and
exemptions. EPA further assumes that the number of submissions under
each TSCA section 5 fee category will decline by approximately 10% as a
result of (a) higher fees on PMNs, MCANs, and SNUNs; (b) new fees for
exemption notices; and (c) the requirement that EPA make an affirmative
determination on every new chemical. Previously, new chemicals could
enter the marketplace unless EPA made a specific determination that
regulatory controls were needed. Now, an affirmative safety
determination must be made before a new chemical can enter the
marketplace and before a significant new use is allowed for an existing
chemical. EPA's assumption that there will be a 10% decrease in
submissions under TSCA section 5 follows the same assumption made back
in 1987 when TSCA section 5 fees were first proposed (Ref. 12).
    TSCA section 6 risk evaluations are a new activity under the
amended TSCA. In the past, EPA developed risk assessments. This risk
assessment process has been replaced by risk evaluations and EPA uses
manufacturer data for the first 10 chemicals identified for this
process to estimate the average number of impacted firms per chemical
and proportion of firms impacted that are small businesses.
    The annualized fees collected from industry for the proposed option
(identified as Option C in the Economic Analysis (Ref. 2)) are
approximately $20.05 million. This total does not include the fees
collected for manufacturer-requested risk evaluations. Total fee
collections were calculated by multiplying the estimated number of
actions per fee category anticipated each year, by the corresponding
proposed fee. For the proposed option, TSCA section 4 fees account for
less than one percent of the total fee collection, TSCA section 5 fees
for approximately 43 percent, and TSCA section 6 fees for approximately
56 percent. Annual fees collected by EPA

are expected to total approximately $20.05 million.
    Under the proposed option, the total fees collected from industry
for a risk evaluation requested by manufactures are estimated to be
$1.3 million for chemicals included in the Work Plan and $2.6 million
for chemicals not included in the Work Plan.
    For small businesses, EPA estimates that 18.5 percent of TSCA
section 5 submissions will be from small businesses that are eligible
to pay discounted fees because they have average annual sales of less
than $91 million in the three preceding years. Total annualized fees
for TSCA section 5 collected from small businesses are estimated to be
$550,000 (Ref. 2).
    For TSCA sections 4 and 6, discounted fees for eligible small
businesses and fees for all other affected firms may differ over the
three-year period that was analyzed, since the fee paid by each firm is
dependent on the number of affected firms per action. Based on past
TSCA section 4 actions and data related to the first ten chemicals
identified for risk evaluations under TSCA as amended, EPA estimates
annualized fees collected from small businesses for TSCA section 4 and
TSCA section 6 to be approximately $37,000 and $2.6 million,
respectively.
    For each of the three years to be covered by this proposed rule,
EPA estimates that total fees paid by small businesses will account for
about 16 percent of the approximately $20.05 million fees to be
collected for TSCA sections 4, 5, and 6 actions. The annualized total
industry fee collection for small businesses is estimated to be
approximately $3.2 million.
    For this proposed rule, affected manufacturers (including
importers) and processors of chemical substances would be required to
pay a specified user fee to be established for actions regulated under
TSCA. The fees to be paid by industry would defray the cost for EPA to
administer TSCA sections 4, 5, 6, and 14. Absent this proposed
regulation, EPA costs to administer these sections of TSCA would be
borne by taxpayers through budget appropriations from general revenue.
As a result of this proposed rule, 25% of EPA costs to administer TSCA
section 4, 5, 6, and 14 and activities paid from general revenue would
be transferred via the user fees to industry. Although these user fees
may be perceived by industry as direct private costs, from an economic
perspective, they are transfer payments rather than real social costs.
Therefore, the total social cost of this proposed rule does not include
the fees collected from industry by EPA. Rather, it includes the
opportunity costs incurred by industry, such as the cost to read and
familiarize themselves with the proposed rule, determine their
eligibility for paying reduced fees, notify EPA of participation in a
consortium, and arrange to submit fee payments. The total social cost
of the proposed rule also includes the additional costs to EPA to
administer TSCA sections 4, 5, 6, and 14.
    The total opportunity cost to industry is approximately $58,000 and
the additional Agency burden is approximately $1,000, yielding a total
social cost of approximately $59,000 for this proposed rule.

V. Request for Comments

A. Affected Industry

    EPA is specifically seeking additional information and data that
the Agency could consider in developing the final economic analysis. In
particular, EPA is seeking data that could facilitate EPA's further
evaluation of the potentially affected industry and firms, including
data related to potential impacts on those small businesses that would
be subject to user fees.

B. User Fees Categories

    EPA seeks comments on all aspects of the fee categories being
proposed for manufacturers and processors in Unit III.B.4 and welcomes
comments on how the various fees and fee categories discussed could be
combined in different ways to achieve an overall fee structure
amounting to 25% of the Agency's costs to administer TSCA sections 4,
5, 6 and 14.
    In addition, the Agency would appreciate specific comments on the
decision to not include a fee category for risk management under TSCA
section 6(a) and the decision to eliminate the existing intermediate
PMN fee category, which currently provides a discount to manufacturers
who submit intermediate PMNs at the same time as a final PMN. The
Agency will still accept intermediate PMN submissions, but will charge
a full PMN fee for each chemical. We recognize there may be minimal
efficiencies with intermediate submissions submitted at the same time
as a final PMN and are seeking comment on the elimination of this fee
category for PMN submissions.
    The Agency is interested in comments on the fee amounts being
proposed today, as well as the alternative fees considered; proposed
and alternative fee amounts are shown in Table 9. EPA is also
interested in comments on the proposal to waive exemption fees on TMEs
submitted at the same time as a PMN, SNUN, or MCAN from a company that
has graduated from the Agency's Sustainable Futures program.

               Table 9--Comparison of Proposed TSCA User Fees and the Alternative Fees Considered
----------------------------------------------------------------------------------------------------------------
                                                                                Alternate fee   Alternate fee
                      Proposed fee category                        Proposed fee        ``A''           ``B''
----------------------------------------------------------------------------------------------------------------
TSCA Section 4:
    Test order..................................................          $9,800         $92,000         $28,000
    Test rule...................................................          29,500         278,000          84,000
    Enforceable consent agreement...............................          22,800         215,000          65,000
TSCA Section 5:
    PMN and consolidated PMN....................................          16,000          18,200          10,400
    SNUN, MCAN and consolidated MCAN............................
    LoREX, LVE, TME, Tier II exemption, TERA....................           4,700           1,850           3,500
TSCA Section 6:
    EPA-initiated risk evaluation...............................       1,350,000       1,280,000       1,670,000
    Manufacturer-requested risk evaluation on a chemical               1,300,000       1,300,000       1,300,000
     included in the Work Plan..................................
    Manufacturer-requested risk evaluation on a chemical not           2,600,000       2,600,000       2,600,000
     included in the Work Plan..................................
----------------------------------------------------------------------------------------------------------------

C. Small Business Concerns

    EPA is proposing several changes to the size standard used to
identify businesses that can qualify as a ``small business concern''
for purposes of fees and seeks comment on the proposed approach as
discussed in Unit III. The Agency is also interested in comments on the
reduced fee amounts being proposed for those businesses that can
qualify as a ``small business concern.''
    The Agency is seeking comment on this approach and is specifically
interested in comment on whether an employee-based size standard would
be more appropriate than a receipts-based size standard and what that
employee level should be; whether the size standard, be it receipts-
based or employee-based, should vary from industry to industry to
reflect differences among the impacted industries; and what other
factors and data sources the Agency should consider, besides inflation,
when developing the size standard to qualify for reduced fee amounts.
    Further, with respect to small business size standards, the Agency
has recently committed to revisiting the definition of small businesses
as it relates to the TSCA Section 8(a) data reporting regulations (82
FR 56824). Due to the urgent need for the Agency to promulgate this
regulation and expeditiously collect fees, the Agency believes that
upcoming rulemaking will provide a venue for a more expansive
consideration of appropriate size standards for industries subject to
TSCA and offer the public with further opportunities to comment on the
size standard. In addition to considering comments submitted in
response to this proposal, the Agency is committed to evaluating the
results of the 8(a) rulemaking process and, in the event that the
reporting and fee standards differ, to determine if the size standards
set through that process should be harmonized with the small business
definition for fees. This harmonization could be implemented in a
subsequent rulemaking for the next three-year fee cycle (FY22-FY25).

D. Electronic Payment of Fees

    The Agency is interested in comments pertaining to the electronic
payment of fees. If, for some reason, neither Pay.gov nor Fedwire meets
the needs of those required to pay user fees, the Agency would
appreciate the identification of other appropriate electronic payment
methods to consider.

VI. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. 2016. The Frank R. Lautenberg Chemical Safety for the 21st
Century Act. June 22, 2016.
2. 2017. EPA. Economic Analysis for the TSCA Section 26(b) Proposed
Fees Rule. December 2017.
3. 1993 OMB. Circular No. A-25 Revised. July 8, 1993.
4. 2008. GAO. Federal User Fees: A Design Guide. Report to
Congressional Requesters. GAO-08-386SP. May 2008.
5. 2017. EPA. Technical Background Document for TSCA Fees. December
2017.
6. 2017. EPA. Statistics for the New Chemicals Review Program under
TSCA. https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review.
7. 2017. EPA. Interagency Agreement and Oil Indirect Cost Rates for
FY 2018 and Beyond. September 28, 2017.
8. 1983. EPA. 48 FR 21722, 27134-35.
9. 2002. EPA. 67 FR 238. Sustainable Futures--Voluntary Pilot
Project Under the TSCA New Chemicals Program.
10. 2016. Abt Associates. Memorandum: Inflation of Small Business
Definition under section 5 of TSCA. August 31, 2016.
11. 1998. Government Paperwork Elimination Act. Public Law 105-277.
12. 1987. EPA. Proposed Fees for Processing Premanufacture Notices,
Exemption Applications and Notices, and Significant New Use Notices.
42 FR 12940.
13. 2017. EPA. Information Collection Request for the TSCA Section
26(b) Proposed Reporting Requirements Associated with the Payment of
TSCA Fees (EPA ICR No. 2569.01; OMB Control No. 2070-[NEW]).
December 2017.

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).
    Any changes made in response to OMB recommendations have been
documented in the docket for this action as required by section
6(a)(3)(E) of Executive Order 12866. EPA prepared an economic analysis
of the potential costs and benefits associated with this action (Ref.
2), which is available in the docket and discussed in Unit IV.

B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is expected to be subject to the requirements for
regulatory actions specified in Executive Order 13771 (82 FR 9339,
February 3, 2017). Details on the estimated costs of this proposed rule
can be found in EPA's analysis (Ref. 2) of the potential costs and
benefits associated with this action, which is available in the docket
and is summarized in Unit IV.

C. Paperwork Reduction Act (PRA)

    The information collection requirements in this proposed rule have
been submitted to OMB for review and approval under the PRA, 44 U.S.C.
3501 et seq. The Information Collection Request (ICR) prepared by EPA
has been assigned EPA ICR number 2569.01. You can find a copy of the
ICR in the docket for this proposed rule (Ref. 13), and it is briefly
summarized here.
    The information collection activities associated with the proposed
rule include familiarization with the regulation, small business
discount eligibility determination, informing EPA of participation in
consortia, and electronic payment of fees through Pay.gov or Fedwire.
    Respondents/affected entities: Persons who manufacture, distribute
in commerce, use, dispose, process a chemical substance (or any
combination of such activities) and are required to submit information
to EPA under TSCA sections 4, 5, or 6, or if you manufacture or process
a chemical substance that is the subject of a risk evaluation under
TSCA section 6(b).
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 1,414 respondents.
    Frequency of response: On occasion to EPA as needed.
    Total estimated burden: 740 hours (per year). Burden is defined at
5 CFR 1320.3(b).
    Total estimated cost: $59,540 (per year).
    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 numbers for EPA's regulations in 40 CFR are listed in 40 CFR
part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to EPA using the docket identified at
the beginning of this proposed rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs via
email to [email protected], Attention: Desk Officer for EPA.
Since OMB is required to make a decision concerning the ICR between 30
and 60 days after receipt, OMB must receive your ICR-related comments
no later than March 28, 2018. EPA will respond to any ICR-related
comments with the final rule.

D. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
certify that this action will not have a significant economic impact on
a substantial number of small entities under the RFA. The small
entities expected to be subject to the requirements of this action are
small chemical manufacturers and processors, small petroleum
refineries, and small chemical and petroleum wholesalers. There may be
some potentially affected firms within other sectors, but not all firms
within those sectors will be potentially affected firms.
    EPA has determined that 84 small businesses may be affected
annually by section 4 actions; 190 small businesses may be affected by
section 5 actions (164 may pay discounted fees and the remaining 26
would pay the general industry fee); and 24 small business firms may be
affected by section 6 actions. As a result, EPA estimates that, of the
298 small businesses paying fees every year, all may have annual cost-
revenue impacts less than 1%.
    EPA continues to be interested in the potential impacts of this
proposed rule on small entities that are required to pay user fees and
welcomes comments on issues related to such impacts.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. As such, the
requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-
1538, do not apply to this action.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications because it will not
have any effect on tribal governments, on the relationship between the
Federal government and the Indian tribes, or on the distribution of
power and responsibilities between the Federal government and Indian
tribes, as specified in Executive Order 13175 (65 FR 67249, November 9,
2000).

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern environmental
health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of Executive Order 13045. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate environmental
health risks or safety risks.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy 1 Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on energy supply,
distribution, or use. This action is proposing service fees for TSCA,
which will not have a significant effect on the supply, distribution or
use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA
section 12(d) (15 U.S.C. 272 note) does not apply to this action.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA believes that this action does not have disproportionately high
and adverse human health or environmental effects on minority
populations, low-income populations and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This action does not affect the level of protection provided to human
health or the environment.
    When implemented, the user fees collected under this proposed rule
will assist the Agency in carrying out various requirements under TSCA,
including conducting risk evaluations, risk-based screenings,
authorizing testing of chemical substances and mixtures, and evaluating
and reviewing manufacturing and processing notices, as required under
TSCA sections 4, 5, and 6. Although not directly impacting
environmental justice-related concerns, the fees will enable the Agency
to better protect human health and the environment, including in low-
income and minority communities.

List of Subjects

40 CFR Part 700

    Chemicals, Environmental protection, Hazardous substances,
Reporting and recordkeeping requirements, User fees.

40 CFR Part 720

    Chemicals, Environmental protection, Hazardous substances, Imports,
Reporting and recordkeeping requirements.

40 CFR Part 723

    Chemicals, Environmental protection, Hazardous substances,
Phosphate, Reporting and recordkeeping requirements.

40 CFR Part 725

    Administrative practice and procedure, Chemicals, Environmental
protection, Hazardous substances, Imports, Labeling, Occupational
safety and health, Reporting and recordkeeping requirements.

40 CFR Part 790

    Administrative practice and procedure, Chemicals, Confidential
business information, Environmental protection, Hazardous substances,
Reporting and recordkeeping requirements.

40 CFR Part 791

    Administrative practice and procedure, Chemicals, Environmental

protection, Hazardous substances, Reporting and recordkeeping
requirements.

    Dated: February 7, 2018,
E. Scott Pruitt,
Administrator.
    Therefore, EPA proposes to amend 40 CFR parts 700, 720, 723, 725,
790 and 791 as follows:

PART 700--[AMENDED]

0
 1. The authority citation for part 700 is revised to read as follows:

    Authority:  15 U.S.C. 2625 and 2665, 44 U.S.C. 3504.

0
 2. Section 700.40 is revised to read as follows:

Sec.  700.40  Purpose and applicability.

    (a) Purpose. The purpose of this subpart is to establish and
collect fees from manufacturers (including importers) and processors to
defray part of EPA's cost of administering the Toxic Substances Control
Act (15 U.S.C. 2601-2692), as amended by the Frank R. Lautenberg
Chemical Safety for the 21st Century Act (Pub. L. 114-182).
    (b) Applicability. This subpart applies to all manufacturers
(including importers) and processors who are required to submit
information under section 4 of the Act; who submit certain notices and
exemption requests to EPA under section 5 of the Act; and who
manufacture a chemical substance that is subject to a risk evaluation
under TSCA section 6(b)(4) of the Act.
    (c) After [DATE 1 DAY AFTER PUBLICATION OF THE FINAL RULE IN THE
Federal Register], all persons specified in Sec.  700.45 and paragraph
(a) of this section must comply with this subpart.
0
 3. Section 700.43 is amended by:
0
 a. Revising the section heading;
0
 c. Revising the introductory text;
0
 d. Adding in alphabetical order definitions for ``Consortium'',
``Enforceable consent agreement'', and ``EPA-initiated risk
evaluation'';
0
e. Removing the definitions of ``Exemption application'' and
``Intermediate premanufacture notice'';
0
 f. Revising the definition of ``Joint submitters'';
0
 g. Adding in alphabetical order a definition for ``Manufacturer-
requested risk evaluation'';
0
 h. Revising the definition of ``Person'';
0
 i. Adding in alphabetical order definitions for ``Principal sponsor''
and ``Risk evaluation'';
0
 i. Revising the definitions of ``Significant new use notice'' and
``Small business concern''; and
0
 k. Adding in alphabetical order definitions for ``Test order'' and
``Test rule''.
    The revisions and additions read as follows:

Sec.  700.43  Definitions applicable to this subpart.

    Definitions in section 3 of the Act (15 U.S.C. 2602), as well as
definitions contained in Sec. Sec.  704.3, 720.3, 723.175(b), 725.3,
and 790.3 of this chapter, apply to this subpart unless otherwise
specified in this section. In addition, the following definitions
apply:
* * * * *
    Consortium means an association of manufacturers (including
importers) and/or processors who have made an agreement to jointly
split the cost of applicable user fees.
* * * * *
    Enforceable consent agreement means a consent agreement used by EPA
to accomplish testing where a consensus exists among EPA and interested
parties (as identified in Sec.  790.22(b)(2)) concerning the need for
and scope of testing under section 4 of the Act.
    EPA-initiated risk evaluation means any risk evaluation conducted
pursuant to section 6(b)(4)(C)(i) of the Act.
* * * * *
    Joint submitters mean two or more persons who submit a TSCA section
5 notice together.
    Manufacturer-requested risk evaluation means any chemical substance
risk evaluation conducted at the request of one or more manufacturers
of that chemical substance pursuant to section 6(b)(4)(C)(ii) of the
Act.
* * * * *
    Person means a manufacturer (including importer) or processor.
* * * * *
    Principal sponsor means a person who assumes primary responsibility
for the direction of study, the payment of user fees to EPA, and for