[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Proposed Rules]
[Pages 8212-8235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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)

[[Page 8213]]

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

[[Page 8214]]

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

[[Page 8215]]

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

[[Page 8216]]

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.

[[Page 8217]]



                                     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

[[Page 8218]]

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.

[[Page 8219]]



    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

[[Page 8220]]

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.


[[Page 8221]]

    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

[[Page 8222]]

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

[[Page 8223]]

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.

[[Page 8224]]



          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

[[Page 8225]]

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

[[Page 8226]]

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

[[Page 8227]]

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..................................
----------------------------------------------------------------------------------------------------------------


[[Page 8228]]

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

[[Page 8229]]

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

[[Page 8230]]

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 
oral and written communication with EPA.
    Risk evaluation means any risk evaluation conducted pursuant to 
section 6(b) of the Act.
* * * * *
    Significant new use notice or SNUN means any notice submitted to 
EPA pursuant to section 5(a)(1)(B) of the Act in accordance with part 
721 of this chapter.
    Small business concern means any person whose average total annual 
sales over the person's three fiscal years preceding the date the fee 
is assessed, when combined with those of the parent company (if any), 
are less than $91 million.
    Test order means an order to develop information pursuant to 
section 4(a) of the Act.
    Test rule refers to a regulation requiring the development of 
information pursuant to section 4(a) of the Act.
0
 4. Section 700.45 is revised to read as follows:


Sec.  700.45  Fee payments.

    (a) Persons who must pay fees. (1) Manufacturers and/or processors 
submitting a TSCA section 5 notice to EPA shall remit for each such 
notice the applicable fee identified in paragraph (b) of this section 
in accordance with the procedures in paragraphs (d) and (e) of this 
section.
    (2) Manufacturers and/or processors of chemical substances and 
mixtures required to test these chemical substance and mixtures under a 
TSCA section 4(a) test rule, test order, or enforceable consent 
agreement shall remit for each such test rule, order, or enforceable 
consent agreement the applicable fee identified in paragraph (b) of 
this section in accordance with the procedures in paragraphs (d) and 
(e) of this section.
    (3) Manufacturers of chemical substances and mixtures required to 
test these chemical substance and mixtures under a TSCA section 4(a) 
test rule, test order, or enforceable consent agreement other than a 
test rule, test order, or enforceable consent agreement described in 
paragraph (a)(2) of this section shall remit for each such test rule, 
order, or enforceable consent agreement the applicable fee identified 
in paragraph (b) of this section in accordance with the procedures in 
paragraphs (d) and (e) of this section.
    (4) Manufacturers of a chemical substance that is subject to a risk 
evaluation under section 6(b) of the Act, shall remit for each such 
chemical risk evaluation the applicable fee identified in paragraph (b) 
of this section in accordance with the procedures in paragraphs (d) and 
(e) of this section. Manufacturers will be identified through the most 
current Chemical Data Reporting (CDR) submissions. While EPA will 
attempt to identify manufacturers through CDR data, failure to identify 
a manufacturer that is subject to a risk evaluation fee does not remove 
their obligation to pay the associated fee.
    (b) Fees for the 2019, 2020 and 2021 fiscal years. Persons shall 
remit fee payments to EPA as follows:
    (1) Small business concerns. Small business concerns shall remit 
fees as follows:

[[Page 8231]]

    (i) Premanufacture notice and consolidated premanufacture notice. 
Persons shall remit a fee totaling $2,800 for each premanufacture 
notice (PMN) or consolidated (PMN) submitted in accordance with part 
720 of this chapter.
    (ii) Significant new use notice. Persons shall remit a fee totaling 
$2,800 for each significant new use notice (SNUN) submitted in 
accordance with part 721 of this chapter.
    (iii) Exemption application. Persons shall remit a fee totaling 
$940 for each of the following exemption requests submitted under 
section 5 of the Act:
    (A) Low releases and low exposures exemption or LoREX request 
submitted to EPA pursuant to section 5(a)(1) of the Act in accordance 
with Sec.  723.50(a)(1)(ii) of this chapter.
    (B) Low volume exemption or LVE request submitted to EPA pursuant 
to section 5(a)(1) of the Act in accordance with Sec.  723.50(a)(1)(i) 
of this chapter.
    (C) Test marketing exemption or TME application submitted to EPA 
pursuant to section 5 of the Act in accordance with Sec. Sec.  725.300 
through 725.355 of this chapter.
    (D) TSCA Experimental Release Application or TERA application 
submitted to EPA pursuant to section 5 of the Act for research and 
development activities involving microorganisms in accordance with 
Sec. Sec.  725.200 through 725.260 of this chapter.
    (E) Tier II exemption application submitted to EPA pursuant to 
section 5 of the Act in accordance with Sec. Sec.  725.428 through 
725.455 of this chapter.
    (iv) Instant photographic film article exemption notice. Persons 
shall remit a fee totaling $940 for each instant photographic film 
article exemption notice submitted in accordance with Sec.  723.175 of 
this chapter.
    (v) Microbial commercial activity notice and consolidated microbial 
commercial activity notice. Persons shall remit a fee totaling $2,800 
for each microbial commercial activity notice (MCAN) or consolidated 
MCAN submitted in accordance with Sec. Sec.  725.25 through 725.36 of 
this chapter.
    (vi) Persons shall remit a total of twenty percent of the 
applicable user fee under paragraph (b)(2)(vi), (b)(2)(vii) or 
(b)(2)(viii) of this section for a test rule, test order, or 
enforceable consent agreement.
    (vii) Persons shall remit a total fee of twenty percent of the 
applicable user fee under paragraphs (b)(2)(ix) of this section for an 
EPA-initiated risk evaluation.
    (2) Others. Persons other than small business concerns shall remit 
fees as follows:
    (i) PMN and consolidated PMN. Persons shall remit a fee totaling 
$16,000 for each PMN or consolidated PMN submitted in accordance with 
part 720 of this chapter.
    (ii) SNUN. Persons shall remit a fee totaling $16,000 for each 
significant new use notice submitted in accordance with part 721 of 
this chapter.
    (iii) Exemption applications. Persons shall remit a fee totaling 
$4,700 for each of the following exemption requests, and modifications 
to previous exemption requests, submitted under section 5 of the Act:
    (A) Low releases and low exposures exemption or LoREX request 
submitted to EPA pursuant to section 5(a)(1) of the Act in accordance 
with Sec.  723.50 (a)(1)(ii) of this chapter.
    (B) Low volume exemption or LVE request submitted to EPA pursuant 
to section 5(a)(1) of the Act in accordance with Sec.  723.50 (a)(1)(i) 
of this chapter.
    (C) Test marketing exemption or TME application submitted to EPA 
pursuant to section 5 of the Act in accordance with Sec. Sec.  725.300 
through 725.355 of this chapter, unless the submitting company has 
graduated from EPA's Sustainable Futures program, in which case this 
exemption fee is waived.
    (D) TSCA Experimental Release Application or TERA application 
submitted to EPA pursuant to section 5 of the Act for research and 
development activities involving microorganisms in accordance with 
Sec. Sec.  725.200 through 725.260 of this chapter.
    (E) Tier II exemption application submitted to EPA pursuant to 
section 5 of the Act in accordance with Sec. Sec.  725.428 through 
725.455 of this chapter.
    (iv) Instant photographic film article exemption notice. Persons 
shall remit a fee totaling $4,700 for each exemption notice submitted 
in accordance with Sec.  723.175 of this chapter.
    (v) MCAN and consolidated MCAN. Persons shall remit a fee totaling 
$16,000 for each MCAN or consolidated MCAN submitted in accordance with 
Sec. Sec.  725.25 through 725.36 of this chapter.
    (vi) Test rule. Persons shall remit a fee totaling $9,800 for each 
test rule.
    (vii) Test order. Persons shall remit a fee totaling $29,500 for 
each test order.
    (viii) Enforceable consent agreement. Persons shall remit a fee 
totaling $22,800 for each enforceable consent agreement.
    (ix) EPA-initiated chemical risk evaluation. Persons shall remit a 
fee totaling $1,350,000.
    (x) Manufacturer-requested risk evaluation of a Work Plan Chemical. 
Persons shall remit a fee totaling $1,300,000.
    (xi) Manufacturer-requested risk evaluation of a Non-Work Plan 
Chemical. Persons shall remit a fee totaling $2,600,000.
    (c) Fees for 2022 fiscal year and beyond. (1) Fees for the 2022 and 
later fiscal years will be adjusted on a three-year cycle by 
multiplying the fees in paragraph (b) by the current PPI index value 
with a base year of 2019 using the following formula:

FA = F x I

Where:

FA = the inflation-adjusted future year fee amount.
F = the user fee specified in paragraph (b) of this section.
I = Producer Price Index for Chemicals and Allied Products inflation 
value with 2019 as a base year.

    (2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption 
applications and manufacturer-requested chemical risk evaluation 
requests apply to submissions received by the Agency on or after 
October 1 of every three-year fee adjustment cycle beginning in fiscal 
year 2022 (October 1, 2021). Updated fee amounts also apply to test 
rules, test orders, enforceable consent agreements and EPA-initiated 
chemical evaluations that are ``noticed'' on or after October 1 of 
every three-year fee adjustment cycle, beginning in fiscal 2022.
    (3) The Agency will initiate industry consultation prior to making 
fee adjustments. If it is determined that no additional adjustment is 
necessary beyond for inflation, EPA will 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.). If the Agency 
determines that adjustments beyond inflation are necessary, EPA will 
provide public notice of that determination and the process to be 
followed to make those adjustments.
    (d) No fee required. Persons are exempt from remitting any fee for 
Tier I exemption submissions under Sec.  725.424 and polymer exemption 
reports submitted under Sec.  723.250 of this chapter.
    (e) Multiple parties, including joint submitters and consortia. (1) 
Joint submitters of a TSCA section 5 notice are 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

[[Page 8232]]

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 of this chapter.
    (2) Any consortium formed to split the cost of the applicable user 
fee under section 4 of the Act is required to remit the appropriate fee 
identified in paragraph (b) of this section for each test rule, test 
order, or enforceable consent agreement regardless of the number of 
manufacturers and/or processors in that consortium. For the consortium 
to qualify for the fee identified in paragraph (b)(1) of this section, 
each person in the consortium must qualify as a small business concern 
under Sec.  700.43 of this chapter. Failure to provide notice or submit 
fee payment pursuant to this paragraph (e)(2) constitutes a violation 
by each consortium member.
    (i) Notification must be provided to EPA that a consortium has 
formed. The notification must be accomplished within 30 days of the 
effective date of a test order or test rule under section 4 of the Act 
or within 30 days of the signing of an enforceable consent agreement 
under section 4 of the Act. If timely notification has occurred, 
additional entities may join the consortia after the notification 
period.
    (ii) Notification must be rendered in a .pdf file and submitted 
electronically via the Agency's electronic reporting software (e.g., 
Central Data Exchange (CDX)). The following information must be 
included:
    (A) Full name, address, telephone number and signature of principal 
sponsor;
    (B) Name(s) and contact information for each manufacturer and/or 
processor associating with the consortium.
    (iii) It is up to the consortium to determine how fees will be 
split among the persons in the consortium.
    (iv) Consortia are encouraged to set lower fees for small business 
concerns participating in the consortium.
    (v) If a consortium is unable to come to terms on how user fees 
will be split among the persons in the consortium, the principal 
sponsor must notify EPA in writing before the user fee is due under 
paragraph (e)(2) of this section.
    (vi) If a consortium provides notice to EPA under paragraph 
(e)(2)(v) of this section, EPA will assess fees to all persons of the 
consortium as described under paragraph (e)(4) of this section and 
provide an additional 30 days for those persons to submit fees.
    (3) Any consortium formed to split the cost of the applicable user 
fee supporting a risk evaluation under section 6(b) of the Act is 
required to remit the appropriate fee identified in paragraph (b) of 
this section for each risk evaluation, regardless of the number of 
manufacturers in that consortium. For the consortium to qualify for the 
fee identified in paragraph (b)(1)(vii) of this section, each person in 
the consortium must qualify as a small business concern under Sec.  
700.43 of this chapter. Failure to provide notice or submit fee payment 
pursuant to this paragraph (e)(3) constitutes a violation by each 
consortium member.
    (i) Notification must be provided to EPA that a consortium has 
formed. The notification must be accomplished within 30 days of the 
publication of the final scope of a chemical risk evaluation under 
section 6(b)(4)(D) of the Act or within 30 days of EPA providing 
notification to a manufacturer that a manufacturer-requested risk 
evaluation has been granted.
    (ii) Notification must be rendered in a .pdf file and submitted 
electronically via the Agency's electronic reporting software (e.g., 
CDX). The following information must be included:
    (A) Full name, address, telephone number and signature of principal 
sponsor;
    (B) Name(s) and contact information for each manufacturer and/or 
processor associating with the consortium.
    (iii) It is up to the consortium to determine how fees will be 
split among the persons in the consortium.
    (iv) Consortia are encouraged to set lower fees for small business 
concerns participating in the consortium.
    (v) If a consortium is unable to come to terms on how user fees 
will be split among the persons in the consortium, the principal 
sponsor must notify EPA in writing before the user fee is due.
    (vi) If a consortium provides notice to EPA under paragraph 
(e)(3)(v) of this section, EPA will assess fees to all persons of the 
consortium as described under paragraph (e)(4) of this section and 
provide an additional 30 days for those persons to submit fees.
    (4) If multiple persons are subject to user fees triggered by 
section 4 or 6(b) of the Act and no consortium is formed, EPA will 
determine the portion of the total applicable user fee to be remitted 
by each person subject to the requirement. Each person's share of the 
applicable user fee specified in paragraph (b) of this section shall be 
in proportion to the total number of manufacturers and/or processors of 
the chemical substance, with lower fees for small businesses:

[GRAPHIC] [TIFF OMITTED] TP26FE18.003

Where:

Ps = the portion of the user fee under paragraph (b) of 
this section that is owed by a person who qualifies as a small 
business concern under Sec.  700.43 of this chapter.
Po = the portion of the user fee owed by a person other 
than a small business concern.
F = the total user fee required under paragraph (b) of this section.
Mt = the total number of persons subject to the user fee 
requirement.
Ms = the number of persons subject to the user fee 
requirement who qualify as a small business concern.

    (5) If multiple persons are subject to user fees triggered by 
section 4 or 6(b) of the Act and some inform EPA of their intent to 
form a consortium while others choose not to associate with the 
consortium, EPA will determine the portion of the total applicable user 
fee to be remitted by each person outside the consortium and by the 
consortium, per paragraph (e)(4) of this section. For purposes of 
calculating the portion of the total applicable user fee to be remitted 
by each person outside the consortium, EPA will consider each person 
within the consortium as ``one'' person. The balance of the applicable 
user fee remaining is the responsibility of the consortium; EPA will 
inform consortium of this requisite user fee amount.
    (f) Remittance procedure. (1) Electronic payment: Each remittance 
under this section shall be paid electronically in U.S. dollars, using 
one of the electronic payment methods supported by the Department of 
the Treasury's Pay.gov or Fedwire online electronic payment service, or 
any applicable additional or successor online electronic payment 
service offered by the Department of Treasury.
    (2) Timing of payment for user fees incurred between October 1, 
2018 and [the effective date of this rule will be inserted at the final 
rule stage]. User fees required by paragraph (b) of this section for 
which the fee-triggering action or

[[Page 8233]]

event occurred between October 1, 2018, and [EFFECTIVE DATE OF FINAL 
RULE] shall be paid in response to invoices EPA will send within 30 
days of the effective date of this rule.
    (3) Timing of payment for user fees incurred after [EFFECTIVE DATE 
OF FINAL RULE]. User fees required by paragraph (b) of this section for 
which the fee-triggering action or event occurred after [EFFECTIVE DATE 
OF FINAL RULE] shall be paid at the following time:
    (i) Test orders and test rules. The applicable user fee specified 
in paragraph (b) of this section shall be paid in full not later than 
60 days after the effective date of a test rule or test order under 
section 4 of the Act.
    (ii) Enforceable consent agreements. The applicable user fee 
specified in paragraph (b) of this section shall be paid in full not 
later than 60 days after the signing of an enforceable consent 
agreement under section 4 of the Act.
    (iii) Section 5 notice. The applicable user fee specified in 
paragraph (b) of this section shall be paid in full immediately upon 
submission of a TSCA section 5 notice.
    (iv) Risk evaluations. (A) For EPA-initiated risk evaluations, the 
applicable user fee specified in paragraph (b) of this section shall be 
paid in full not later than 60 days after EPA publishes the final scope 
of a chemical risk evaluation under section 6(b)(4)(D) of the Act.
    (B) For manufacturer-requested risk evaluations under section 
6(b)(4)(C)(ii) of the Act, the applicable user fee specified in 
paragraph (b) of this section shall be paid in full not later than 30 
days after EPA provides the submitting manufacture(s) notice that it 
has granted the request.
    (4)(i) Persons who submit a TSCA section 5 notice shall place an 
identifying number and a payment identity number on the front page of 
each TSCA section 5 notice submitted. The identifying number must 
include the letters ``TS'' followed by a combination of 6 numbers 
(letters may be substituted for some numbers). The payment identity 
number may be a ``Pay.gov'' transaction number or FedWire wire transfer 
number used to transmit the user fee. The same TS number and the 
submitter's name must appear on the corresponding fee remittance under 
this section. If a remittance applies to more than one TSCA section 5 
notice, the person shall include the name of the submitter and a new TS 
number for each TSCA section 5 notice to which the remittance applies, 
and the amount of the remittance that applies to each notice.
    (ii) Persons who are required to submit a letter of intent to 
conduct testing per Sec.  790.45 of this chapter shall place a payment 
identity number on the front page of each letter submitted. The 
identifying number must include the letters ``TS'' followed by a 
combination of 6 numbers (letters may be substituted for some numbers). 
The payment identity number may be a ``Pay.gov'' transaction number or 
FedWire wire transfer number used to transmit the user fee. The same TS 
number and the submitter's name must appear on the corresponding fee 
remittance under this section. If a remittance applies to more than one 
letter of intent to conduct testing, the person shall include the name 
of the submitter and a new TS number for each letter of intent to 
conduct testing to which the remittance applies, and the amount of the 
remittance that applies to each letter of intent.
    (iii) Persons who sign an enforceable consent agreement per Sec.  
790.60 of this chapter shall place a payment identity number within the 
contents of the signed agreement. The identifying number must include 
the letters ``TS'' followed by a combination of 6 numbers (letters may 
be substituted for some numbers). The payment identity number may be a 
``Pay.gov'' transaction number or FedWire wire transfer number used to 
transmit the user fee. The same TS number and the submitter's name must 
appear on the corresponding fee remittance under this section. If a 
remittance applies to more than one enforceable consent agreement, the 
party or parties shall include the name of the submitter(s) and a new 
TS number for each enforceable consent agreement to which the 
remittance applies, and the amount of the remittance that applies to 
each enforceable consent agreement.
    (5)(i) Each person who remits the fee identified in paragraph 
(b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, 
or SNUN shall insert a check mark for the statement, ``The company 
named in part 1, section A is a small business concern under 40 CFR 
700.43 and has remitted a fee of $2,800 in accordance with 40 CFR 
700.45(b).'' under ``CERTIFICATION'' on page 2 of the Premanufacture 
Notice for New Chemical Substances (EPA Form 7710-25). This form is 
available on EPA's website at https://cdx.epa.gov/SSL/PMN/Outbound/Electronic_PMN_Form_version2.pdf.
    (ii) Each person who remits the fee identified in paragraph (b)(1) 
of this section for a LVE, LoREX, TERA, TMEA, or Tier II exemption 
request under TSCA section 5 shall insert a check mark for the 
statement, ``The company named in part 1, section A is a small business 
concern under 40 CFR 700.43 and has remitted a fee of $940 in 
accordance with 40 CFR 700.45(b).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (b)(1) 
of this section for an exemption notice under Sec.  723.175 of this 
chapter shall include the words, ``The company or companies identified 
in this notice is/are a small business concern under 40 CFR 700.43 and 
has/have remitted a fee of $940 in accordance with 40 CFR 700.45(b).'' 
in the certification required in Sec.  723.175(i)(1)(x) of this 
chapter.
    (iv) Each person who remits the fee identified in paragraph (b)(1) 
of this section for a MCAN or consolidated MCAN for a microorganism 
shall insert a check mark for the statement, ``The company named in 
part 1, section A is a small business concern under 40 CFR 700.43 and 
has remitted a fee of $2,800 in accordance with 40 CFR 700.45(b).'' in 
the certification required in Sec.  725.25(b) of this chapter.
    (6)(i) Each person who remits a fee identified in paragraph (b)(2) 
of this section for a PMN, consolidated PMN, intermediate PMN, or SNUN 
shall insert a check mark for the statement, ``The company named in 
part 1, section A has remitted the fee of $16,000 specified in 40 CFR 
700.45(b).'' under ``CERTIFICATION'' on page 2 of the Premanufacture 
Notice for New Chemical Substances (EPA Form 7710-25).
    (ii) Each person who remits a fee identified in paragraph (b)(2) of 
this section for a LVE, LoREX, TERA, TMEA, or Tier II exemption request 
under TSCA section 5 shall insert a check mark for the statement, ``The 
company named in part 1, section A has remitted the fee of $4,700 
specified in 40 CFR 700.45(b).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (b)(2) 
of this section for an exemption notice under Sec.  723.175 of this 
chapter shall include the words, ``The company or companies identified 
in this notice has/have remitted a fee of $4,700 in accordance with 40 
CFR 700.45(b).'' in the certification required in Sec.  
723.175(i)(1)(x) of this chapter.
    (iv) Each person who remits the fee identified in paragraph (b)(2) 
of this section for a MCAN for a microorganism shall insert a check 
mark for the statement, ``The company named in part 1, section A has 
remitted the fee of $16,000 in accordance with 40 CFR 700.45(b).'' in 
the certification required in Sec.  725.25(b) of this chapter.

[[Page 8234]]

    (g) Full fee refunds. EPA will refund, in totality, any fee paid 
for a section 5 notice whenever the Agency determines:
    (i) That the chemical substance that is the subject of a PMN, 
consolidated PMN, exemption request, or exemption notice, is not a new 
chemical substance as of the date of submission of the notice,
    (ii) In the case of a SNUN, that the notice was not required,
    (iii) The notice is incomplete under either Sec.  720.65(c), Sec.  
723.50(e)(3) or Sec.  725.33, of this chapter,
    (iv) That as of the date of submission of the notice: The 
microorganism that is the subject of a MCAN or consolidated MCAN is not 
a new microorganism; nor is the use involving the microorganism a 
significant new use; or
    (v) When the Agency fails to make a determination on a notice by 
the end of the applicable notice review period under Sec.  720.75 or 
Sec.  725.50 of this chapter, unless the Agency determines that the 
submitter unduly delayed the process, or
    (vi) When the Agency fails to approve, or deny an exemption request 
within the applicable period under Sec.  720.38(d), Sec.  723.50(g) or 
Sec.  725.50(b) of this chapter, unless the Agency determines that the 
submitter unduly delayed the process.
    (h) Partial fee refunds. (1) If a TSCA section 5 notice is 
withdrawn during the first 10 business days after the beginning of the 
applicable review period under Sec.  720.75(a) of this chapter, the 
Agency will refund all but 25% of the user fee as soon as practicable.
    (2) Once withdrawn, any future submission related to the TSCA 
section 5 notice must be submitted as a new notice.
0
5. Section 700.49 is revised to read as follows:


Sec.  700.49  Failure to remit fees.

    (a) EPA will not consider a TSCA section 5 notice to be complete 
unless the appropriate certification under Sec.  700.45(e) is included 
and until the appropriate remittance under Sec.  700.45(b) has been 
submitted as provided in Sec.  700.45(e). EPA will notify the submitter 
of a section 5 notice that it is incomplete in accordance with 
Sec. Sec.  720.65(c) and 725.33(b)(1) of this chapter.
    (b) Failure to submit the appropriate remittance specified under 
Sec.  700.45(b) for a test order, test rule, enforceable consent 
agreement, or EPA-initiated risk evaluation as provided in Sec.  
700.45(e) is a violation of TSCA and enforceable under section 15 of 
the Act.
    (c) EPA will not initiate a manufacturer-requested risk evaluation 
that the Agency has otherwise determined to be complete unless the 
appropriate remittance under Sec.  700.45(b) has been submitted as 
provided in Sec.  700.45(e).

PART 720--[AMENDED]

0
 6. The authority citation for part 720 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2613.

0
 7. Section 720.38 is amended by adding paragraphs (b)(6) and (f) to 
read as follows:


Sec.  720.38  Exemptions for test marketing.

* * * * *
    (b) * * *
    (6) A user fee payment identity number, as required in 40 CFR 
700.45(e)(3).
* * * * *
    (f) When applying for a test marketing exemption, persons are 
subject to user fees in accordance with 40 CFR 700.45.
0
 8. Section 720.45 is amended by revising paragraph (a)(5) to read as 
follows:


Sec.  720.45  Information that must be included in the notice form.

* * * * *
    (a) * * *
    (5) If a manufacturer cannot provide all the information specified 
in paragraphs (a) (1) and (2) of this section because the new chemical 
substance is manufactured using a reactant having a specific chemical 
identity claimed as confidential by its supplier, the manufacturer must 
submit a notice directly to EPA containing all the information known by 
the manufacturer about the chemical identity of the reported substance 
and its proprietary reactant. In addition, the manufacturer must ensure 
that the supplier of the confidential reactant submit a letter of 
support directly to EPA providing the specific chemical identity of the 
confidential reactant, including the CAS number, if available, and the 
appropriate PMN or exemption number, if applicable. The letter of 
support must reference the manufacturer's name and PMN User Fee 
Identification Number. The statutory review period will commence upon 
receipt of both the notice and the letter of support.
* * * * *

PART 723--[AMENDED]

0
 9. The authority citation for part 723 continues to read as follows:

    Authority:  15 U.S.C. 2604.

0
 10. Section 723.175 is amended by adding paragraph (a)(2)(iv) and by 
revising paragraphs (h)(3)(i)(1)(ii)(C) and (h)(3)(i)(1)(iii), and 
adding paragraph (h)(3)(i)(1)(xi) to read as follows:


Sec.  723.175  Chemical substances used in or for the manufacture or 
processing of instant photographic and peel-apart film articles.

    (a) * * *
    (2) * * *
    (iv) Remit the applicable user fee specified in Sec.  700.45(b) of 
this chapter.
* * * * *
    (h) * * *
    (3) * * *
    (1) * * *
    (ii) * * *
* * * * *
    (C) Polymers. For a polymer, the notice must identify monomers and 
other reactants used in the manufacture of the polymer by chemical name 
and CAS Registry Number. The notice must indicate the amount of each 
monomer used (by weight percent of total monomer); the maximum residual 
of each monomer present in the polymer; and a partial or incomplete 
structural diagram, if available. The notice must indicate the number 
average molecular weight of the polymer and characterize the 
anticipated low molecular weight species. The notice must include this 
information for each typical average molecular weight composition of 
the polymer to be manufactured.
    (iii) Impurities. The notice must identify the impurities that can 
be reasonably anticipated to be present in the new chemical substance 
when manufactured under the exemption by name and CAS Registry Number, 
by class of substances, or by process or source. The notice also must 
estimate the maximum percent (by weight) of each impurity in the new 
chemical substance and the percent of unknown impurities present.
* * * * *
    (xi) User fee payment ID number. The manufacturer or processor must 
include a payment identity number on the front page of the notice.
* * * * *

PART 725--[AMENDED]

0
 11. The authority citation for part 725 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, 2613, and 2625.

0
 12. Section 725.25 is amended by adding paragraph (i) to read as 
follows:


Sec.  725.25  General administrative requirements.

* * * * *
    (i) Fees. Persons submitting MCANs and exemption requests to EPA 
under this part are subject to the applicable

[[Page 8235]]

user fees and conditions specified in Sec. Sec.  700.40, 700.45(b), and 
700.49 of this chapter.
0
 13. Section 725.33 is amended by revising paragraphs (a)(9) and (10) 
to read as follows:


Sec.  725.33  Incomplete submissions.

    (a) * * *
    (9) The submitter does not remit the fees required by Sec.  
700.45(b) of this chapter.
    (10) The submitter does not include an identifying number and a 
payment identity number.
* * * * *

PART 790--[AMENDED]

0
 14. The authority citation for part 790 continues to read as follows:

    Authority:  15 U.S.C. 2603.

0
 15. Section 790.45 is amended by adding paragraphs (c)(7) and (g) to 
read as follows:


Sec.  790.45  Submission of letter of intent to conduct testing or 
exemption application.

* * * * *
    (c) * * *
    (7) A payment identity number on the front page of the letter, as 
required in Sec.  700.45(e)(3) of this chapter.
* * * * *
    (g) Manufacturers and processors subject to a test rule described 
in Sec.  790.40 and required to comply with the requirements of that 
test rule as provided in Sec.  790.42(a) must remit the applicable user 
fee specified in Sec.  700.45(b) of this chapter.
0
 16. Section 790.59 is amended by adding paragraph (c) to reads as 
follows:


Sec.  790.59  Failure to comply with a test rule.

* * * * *
    (c) Persons who fail to pay the requisite user fee as specified in 
Sec.  700.45(b) of this chapter will be in violation of the rule.
0
 17. Section 790.60 is amended by adding paragraphs (a)(18) and (d) to 
read as follows:


Sec.  790.60  Contents of consent agreements.

    (a) * * *
    (18) Payment identity number, as required in Sec.  700.45(e)(3) of 
this chapter.
* * * * *
    (d) Fees. Manufacturers and/or processors signing the consent 
agreement are subject to the applicable user fee specified in Sec.  
700.45(b) of this chapter.
0
 18. Section 790.65 is amended by revising paragraph (b) to read as 
follows:


Sec.  790.65  Failure to comply with a consent agreement.

* * * * *
    (b) The Agency considers failure to comply with any aspect of a 
consent agreement, including the failure to pay requisite user fees as 
specified in Sec.  700.45 of this chapter, to be a ``prohibited act'' 
under section 15 of TSCA, subject to all the provisions of the Act 
applicable to violations of section 15. Section 15(1) of TSCA makes it 
unlawful for any person to fail or refuse to comply with any rule or 
order issued under section 4. Consent agreements adopted pursuant to 
this part are ``orders issued under section 4'' for purposes of section 
15(1) of TSCA.
* * * * *

PART 791--[AMENDED]

0
 19. The authority citation for part 791 continues to read as follows:

    Authority:  15 U.S.C. 2603 and 2607.

0
 20. Section 791.39 is amended by removing paragraph (a)(3) and 
revising paragraph (b).
    The revision reads as follows:


Sec.  791.39  Fees and expenses.

* * * * *
    (b) Expenses. All expenses of the hearing, including the cost of 
recording (though not transcribing) the hearing and required traveling 
and other expenses of the hearing officer and of American Arbitration 
Association representatives, and the expenses of any witness or the 
cost of any proofs produced at the direct request of the hearing 
officer, shall be borne equally by the parties, unless they agree 
otherwise, or unless the hearing officer, in the award, assesses such 
expenses or any part thereof against any specified party or parties.
* * * * *
[FR Doc. 2018-02928 Filed 2-23-18; 8:45 am]
 BILLING CODE 6560-50-P


