[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Rules and Regulations]
[Pages 52694-52724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22252]



[[Page 52693]]

Vol. 83

Wednesday,

No. 201

October 17, 2018

Part III





Environmental Protection Agency





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40 CFR Parts 700, 720, 723 et al.





Fees for the Administration of the Toxic Substances Control Act; Rules

  Federal Register / Vol. 83 , No. 201 / Wednesday, October 17, 2018 / 
Rules and Regulations  

[[Page 52694]]


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ENVIRONMENTAL PROTECTION AGENCY

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

[EPA-HQ-OPPT-2016-0401; FRL-9984-41]
RIN 2070-AK27


Fees for the Administration of the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: As permissible under the Toxic Substances Control Act (TSCA or 
the Act), EPA is establishing fees applicable to any person required to 
submit information to EPA; or a notice, including an exemption or other 
information, to be reviewed by EPA; or who manufactures (including 
imports) a chemical substance that is the subject of a risk evaluation. 
This final rulemaking describes the final TSCA fees and fee categories 
for fiscal years 2019, 2020, and 2021, and explains the methodology by 
which the final TSCA fees were determined. It identifies some factors 
and considerations for determining fees for subsequent fiscal years; 
and includes amendments to existing fee regulations governing the 
review of premanufacture notices, exemption applications and notices, 
and significant new use notices. As required in TSCA, EPA is also 
establishing standards for determining which persons qualify as ``small 
business concerns'' and thus would be subject to lower fee payments. 
Requiring manufacturers and processors of certain chemical substances 
to pay a fee for specific fee-triggering events under TSCA, will defray 
part of the EPA cost of administering TSCA.

DATES: This final rule is effective on October 18, 2018.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2016-0401, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Mark Hartman, Immediate Office, 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: (202) 564-3810; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

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

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 of 2016 (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 finalizing 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 finalizing a rule to 
establish and collect fees from manufacturers (including importers) 
and, in some cases, processors, to defray some of the Agency's costs 
related to activities under TSCA sections 4, 5, and 6, and collecting, 
processing, reviewing, and providing access to and protecting 
information about chemical substances from disclosure as appropriate 
under TSCA section 14. EPA is also finalizing standards for determining 
which persons qualify as small business concerns and thus would be 
subject to lower fee amounts. TSCA section 26(b)(4) 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 a portion of the costs of administering TSCA sections 4, 5, and 
6 and collecting, processing, reviewing, providing access to, and 
protecting information about chemical substances from disclosure as 
appropriate under TSCA section 14. Pursuant to the final rule, the 
Agency will collect payment from manufacturers who: Are required to 
submit information under TSCA section 4; are required to submit a 
notice, exemption application, or other information under TSCA section 
5; or manufacture a chemical substance that is the subject of a risk 
evaluation under TSCA section 6(b). The Agency will also collect 
payment from processors in limited scenarios, i.e., where a processor 
submits a Significant New Use Notice (SNUN) under TSCA section 5; or 
where a fee-triggering TSCA section 4 activity is tied to a SNUN 
submission by a processor. These fees are intended to achieve the goals 
articulated by Congress by providing a sustainable source of funds for 
EPA to fulfill its legal obligations to conduct activities such as 
designating 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 new chemical submissions, as required under TSCA sections 4, 
5 and 6, as well as and collecting, processing, reviewing, and 
providing access to and protecting information about chemical 
substances from disclosure as appropriate under TSCA section 14.

[[Page 52695]]

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

    EPA has evaluated the potential incremental economic impacts of 
this final rule. 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 are approximately $20 
million, excluding fees collected for manufacturer-requested risk 
evaluations. Total annualized fee collection was calculated by 
multiplying the estimated number of fee-triggering events anticipated 
each year by the corresponding fees. EPA estimates that section 4 fees 
account for less than one percent of the total fee collection, section 
5 fees for approximately 43 percent, and section 6 fees for 
approximately 56 percent.
    Total annual fee collection for manufacturer-requested risk 
evaluations is estimated to be $1.3 million for chemicals included in 
the 2014 TSCA Work Plan (TSCA Work Plan) (based on two requests over 
the three-year period) and approximately $3.9 million for chemicals not 
included in the TSCA Work Plan (based on three requests over the three-
year period).
    EPA estimates that 18.6 percent of section 5 submissions will be 
from small businesses that are eligible to pay the section 5 small 
business fee because they meet the definition of ``small business 
concern.'' Total annualized fee collection from small businesses 
submitting under section 5 is estimated to be $339,000 (Ref. 2). For 
sections 4 and 6, reduced fees paid by eligible small businesses and 
fees paid by non-small businesses may differ over the three-year period 
that was analyzed, since the fee paid by each entity is dependent on 
the number of entities identified per fee-triggering event. EPA 
estimates that average annual fee collection from small businesses 
impacted by section 4 and section 6 would be approximately $7,000 and 
$926,000, respectively. For each of the three years covered by this 
rule, EPA estimates that total fee revenue collected from small 
businesses will account for about 6 percent of the approximately $20 
million total fee collection, for an annual average total of 
approximately $1.3 million. For fees paid through consortia for 
activities under section 4 and 6, since consortia will be required to 
pay the full fee amount, general industry firms that are not eligible 
for reduced fees will pay more to ensure the fee is covered. Therefore, 
although more firms are eligible for small business discounts under the 
SBA definition used in the final rule, the total annual fee revenue 
estimate remains relatively stable at approximately $20 million.
    Total social cost represents the total burden a regulation will 
impose on the economy. It can be defined as the sum of all opportunity 
costs incurred as a result of the regulation. The opportunity cost 
incurred by industry to carry out these activities is the foregone 
value of the time (burden) and investments required to comply with 
rule. Total social cost for this final rule does not include the fees 
collected from industry by EPA, as these fees are considered transfer 
payments. Rather, total social cost includes the opportunity costs 
incurred by industry, such as the cost to read and familiarize 
themselves with the rule; determine their eligibility for paying 
reduced fees; register for CDX; form, manage and notify EPA of 
participation in consortia; notify EPA and certify whether they will be 
subject to the action or not; and arrange to submit fee payments via 
Pay.gov. Total social costs also include the additional costs to EPA to 
administer fee assessment and collection for TSCA sections 4, 5, and 6, 
and collecting, processing, reviewing, and providing access to and 
protecting information about chemical substances from disclosure as 
appropriate under TSCA section 14. The total annualized opportunity 
cost to industry is approximately $231,000 and the additional 
annualized Agency cost is approximately $7,000, yielding a total 
annualized social cost of approximately $238,000.

II. Background

A. Statutory Requirements for TSCA Fees

    The proposed rule provides a robust overview of the history of fees 
under TSCA and the 2016 amendments to TSCA (83 FR 8212, February 26, 
2018) (FRL-9974-31). TSCA authorizes EPA to establish, by rule, fees 
for activities under TSCA sections 4, 5 and/or 6. In so doing, the 
Agency must set lower fees for small business concerns and establish 
the fees at a level such that they'll offset 25% of the Agency's costs 
to carry out a broader set of activities under sections 4, 5, and 6 and 
of collecting, processing, reviewing, and providing access to and 
protecting from disclosure as appropriate under section 14 information 
on chemical substances under TSCA. 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 100% of the costs of conducting a manufacturer-requested risk 
evaluation for all other chemicals. TSCA now requires fee revenue to be 
deposited into a new dedicated TSCA fund 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 sections 4, 5, and 6, 
and of collecting, processing, reviewing, and providing access to and 
protecting from disclosure as appropriate under section 14 information 
on chemical substances under TSCA. EPA is also required in TSCA section 
26(b)(4)(F) to review and adjust the fees established in this rule 
every three years, and to consult with parties potentially subject to 
fees when the fees are reviewed and updated to reflect changes in 
program costs.

B. Overview of Final Rule

    Pursuant to TSCA section 26(b), this final rule establishes fees 
for certain activities under TSCA sections 4, 5, and 6 to defray 
approximately 25% of the costs to carry out a broader set of activities 
under these sections of TSCA and of collecting, processing, reviewing, 
and providing access to and protecting from disclosure, as appropriate 
under TSCA section 14, information on chemical substances under TSCA. 
In addition, the final rule establishes fees for risk evaluations 
requested by manufacturers to defray 50% or 100% of the costs, 
depending on whether the chemical is listed on the TSCA Work Plan or 
not, respectively.
    After consideration of public comments, EPA is finalizing a number 
of provisions from the proposed rule without modification, including 
the general methodology for calculating fees (except in the case of 
manufacturer-requested risk evaluations), the program cost estimates, 
the eight proposed fee categories, the fee amounts, the allowance of 
payment of fees through consortia, the discounted fees for small 
business concerns, and the provision of refunds under certain 
circumstances.
    Based on consideration of public comments, the final rule also 
includes certain modifications and clarifications related to the 
proposal. For example, in response to comments, the final rule includes 
a new process for identifying manufacturers subject to fee obligations 
for TSCA section 4 test rules and TSCA section 6 EPA-initiated risk 
evaluations, including publication of a preliminary

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list, opportunity for public comment, self-identification, and/or 
certification of no manufacture, and publication of a final list 
defining the universe of manufacturers obligated to pay. The final rule 
also reflects modifications to the proposed methodology for calculating 
fees for manufacturer-requested risk evaluations, the timing for 
consortia formation, payment due dates, and the standard for small 
business concerns. Finally, the final rule provides the additional 
clarity requested by commenters in areas including: The allocation of 
fees in complex multi-payer scenarios, the estimation of program costs 
and activity level assumptions, and the circumstances for providing 
refunds. The content of the final rule and these changes are discussed 
in greater detail in Unit III.

III. Discussion of the Final Rule and Response to Comments

A. Purpose and Applicability

    As described in 40 CFR 700.40, the purpose of the final rule is to 
establish and collect fees from manufacturers (including importers) and 
processors to defray a portion of EPA's TSCA implementation costs. The 
rule applies to manufacturers who are required to submit information 
under TSCA section 4, manufacturers and processors who submit certain 
notices and exemptions under TSCA section 5, and to manufacturers who 
are subject to risk evaluation under TSCA section 6(b), including 
manufacturers who submit requests for risk evaluation under TSCA 
section 6(b)(4)(C)(ii).

B. Entities Subject to Fees

    Although EPA has authority to collect fees from both manufacturers 
and processors of chemical substances, the final rule focuses fee 
collection primarily on manufacturers. EPA will collect fees from 
processors only when processors submit a SNUN or test-marketing 
exemptions (TME) under section 5, when a section 4 activity is tied to 
a SNUN submission by a processor, or when a processor voluntarily joins 
a consortium and therefore agrees to provide payment as part of the 
consortium. This approach is consistent with the proposed rule and with 
most comments received. Although a few commenters urged EPA to allocate 
more of the fee burden to processors, EPA is declining to do so at this 
time. EPA believes the allocation primarily to manufacturers, and, in 
limited circumstances, to processors, is an appropriate balance as 
required in TSCA. As noted in the proposal, the effort of trying to 
identify relevant processors for all fee-triggering actions would be 
overly burdensome and EPA expected many processors would be missed. 
Generally limiting fee obligations to manufacturers is the simplest and 
most straightforward way to assess fees for conducting risk evaluations 
under TSCA section 6 and most TSCA section 4 testing activities. 
Furthermore, EPA expects that manufacturers required to pay fees will 
have a better sense of the universe of processors and will pass some of 
the costs on to them.

C. Identifying Manufacturers Subject to Fee Obligations

    The proposed rule suggested that EPA would use Chemical Data 
Reporting (CDR) data to identify manufacturers subject to fee 
obligations, but would also rely on self-identification from other 
manufacturers not subject to CDR reporting requirements. EPA also 
proposed to include a ``manageable approach'' in the final rule for 
identifying manufacturers subject to fees for TSCA section 4 and 6 
activities, and requested public comment in this area. See 83 FR 8212, 
8216. EPA also requested comment on whether to adopt a process that 
would allow time for public input before finalizing a list. A number of 
commenters agreed that such a process was necessary, and EPA is 
codifying a process in the final rule to provide the necessary clarity 
and certainty for those potentially subject to fees.
    1. In general. EPA intends the process to include publication of a 
preliminary list that identifies manufacturers (based on information 
available to EPA through CDR reporting and other sources), a public 
comment period (to allow for self-identification, correction of errors, 
and certification of no-manufacture and no intention to manufacture in 
the next five years), and publication of a final list defining the 
universe of manufacturers responsible for payment. Further, EPA will 
follow this process for only two fee-triggering events: TSCA section 4 
test rules and TSCA section 6 EPA-initiated risk evaluations. EPA 
believes that for all other fee-triggering events, the relevant 
manufacturer(s) will already be apparent to the Agency and a specific 
identification process will not be necessary. This process is not 
necessary for TSCA section 5 activities, TSCA section 4 enforceable 
consent agreements (ECAs), or TSCA section 6 manufacturer-requested 
risk evaluations as manufacturers are self-identified through those 
activities. The process is also not necessary for TSCA section 4 test 
orders, as EPA will ultimately select the manufacturer(s) subject to 
the order prior to or during the development of the order.
    2. Data sources. To compile the preliminary list, EPA will use the 
most up-to-date information available, including information submitted 
to the Agency (e.g., information submitted under TSCA sections 5(a), 
8(a) (including CDR), 8(b), and to the Toxics Release Inventory) as 
well as other information available to the Agency, such as publicly 
available information (e.g., Panjiva) or information submitted to other 
agencies to which EPA has access (e.g., U.S. Custom and Border Patrol 
data). To be able to include the most recent CDR data (collected every 
four years) and to account for annual or other typical fluctuations in 
manufacturing (including import), EPA will use five years of data 
submitted or available to the Agency to create the preliminary list. 
Although some commenters suggested looking back a greater or fewer 
number of years, EPA believes that a five-year period enables EPA to 
utilize a number of data sources described earlier and increase 
accuracy.
    3. Publication of preliminary list. EPA will publish this 
preliminary list in the Federal Register concurrently with a relevant 
milestone for each action. For risk evaluations initiated by EPA under 
TSCA section 6, the preliminary list will be published at the time of 
final designation of the chemical substance as a High-Priority 
Substance. For test rules under TSCA section 4, the preliminary list 
will be published with the proposed test rule.
    4. Public comment period. Publication of the preliminary list will 
be followed by a comment period of no less than 30 days, during which 
manufacturers and the public will have the opportunity to correct 
errors, self-identify as a manufacturer, and/or certify to already 
having exited the market and that they will not return for a period of 
5 years. EPA believes this process is largely consistent with comments 
on the proposal encouraging EPA to publish a preliminary list and 
engage with stakeholders to identify others who may be missing, correct 
errors, and provide an opportunity for manufacturers to be removed from 
the list under certain circumstances.
    5. Self-identification and certification. If a manufacturer is on 
the preliminary list, or is not on the preliminary list but is a 
manufacturer of the chemical substance at issue, they must report to 
EPA and self-identify with certain basic contact information. Although 
EPA expects reporting to occur through CDX, EPA has developed a form to 
reflect the self-identification statements, for reference purposes. 
(Ref. 9.)

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Manufacturers on the preliminary list also have an opportunity to 
certify through CDX that (1) they have already ceased manufacturing 
prior to the defined cutoff dates and will not manufacture for five 
years into the future, or (2) they have not ever manufactured the 
chemical substance. If EPA receives such a certification statement from 
a manufacturer, the manufacturer will not be obligated to pay the fee. 
Manufacturers who are not listed on the preliminary list and otherwise 
believe they can ``certify out'' as described previously, may choose to 
attest these facts to EPA. However, if information received during the 
public comment period would prompt the addition of manufacturers to the 
final list, EPA will first notify those manufacturers. Manufacturers 
who plan to cease manufacture in the future (but have not yet done so), 
or those who have already ceased but may re-enter the market within the 
next five years, would not be permitted to certify out, and would still 
be subject to the fee obligation. The cutoff date (i.e., the date by 
which manufacture must have ceased in order to certify out) for an EPA-
initiated risk evaluation is the date upon which the prioritization 
process is initiated for that chemical (i.e., approximately 9-12 months 
before the risk evaluation begins and 9-12 months before the 
preliminary list is published). The cutoff date for a TSCA section 4 
test rule is the date upon which the proposed test rule is published. 
EPA chose an earlier cutoff date for risk evaluations to provide 
greater assurance that the manufacturer has exited the market and will 
not return for five years. Numerous commenters expressed concerns that 
some manufacturers may only temporarily stop manufacture to avoid 
potentially significant fee obligations, and subsequently return to the 
market. The earlier cutoff date provides an extra measure of protection 
against that scenario. See paragraph 7 for additional discussion 
regarding free riders and late entrants.
    6. Publication of final list. After the comment period for the 
preliminary list of entities subject to a fee obligation, EPA will make 
any associated updates or corrections, and then publish a final list of 
manufacturers. This list will indicate if any manufacturers were 
identified in error, any additional manufacturers that were identified 
through the comment period and/or reporting form, and if any 
manufacturers have certified that they have already ceased manufacture 
prior to the cutoff date described earlier and will not manufacture the 
subject chemical substance for five years into the future. The final 
list will be published concurrently with the final scope document for 
risk evaluations initiated by EPA under TSCA section 6, and with the 
final test rule under TSCA section 4.
    7. Free riders and late entrants. A number of commenters raised 
concerns about the potential for manufacturers to exit the market 
shortly before or during the fee-triggering event, and avoid their fee 
obligations. Commenters expressed further concern about those same 
manufacturers re-entering the market shortly after the fee-triggering 
event, thereby getting a ``free ride.'' Other commenters suggested that 
EPA also impose fees on ``late entrants'' (i.e., manufacturers who 
enter the market after the fee-triggering event has concluded), and 
reallocate fees accordingly, and provide partial refunds as 
appropriate. EPA believes that the identification process will help 
prevent the problems identified by some commenters regarding free 
riders and manufacturers who may otherwise too easily exit and reenter 
the market to avoid fee obligations. Specifically, the final rule 
requires manufacturers to self-identify, and, for those who have exited 
the market, certify that they will not manufacturer for at least 5 
years or face penalties for violating TSCA. For chemicals with ongoing 
uses, there is no requirement for new market entrants to provide notice 
to EPA. Furthermore, it is impracticable for EPA to administer fees to 
such late entrants by reallocating fee amounts, collecting additional 
monies, and providing partial refunds to previously identified 
manufacturers. Those entities who truly begin to manufacture during or 
after the fee event would not be subject to fees, late charges or other 
penalties, but this is consistent with how TSCA operates in the new 
chemicals context: New manufacturers, not subsequent chemical 
manufacturers, are required to submit PMNs and pay fees and subsequent 
manufacturers are not obligated to reimburse a PMN submitter.
    Existing manufacturers who fail to identify themselves as required 
by this rule is a prohibited act under TSCA section 15(1) and therefore 
subject to a penalty under TSCA section 16. EPA views each day of 
failed identification by a manufacturer past the payment due date as a 
separate event subject to penalty. Likewise, manufacturers who falsely 
certify to having ceased manufacture and/or not re-initiating 
manufacture within five years will also be subject to penalty.

D. Methodology for Calculating Fees

    For the proposed rule, EPA calculated fees by estimating the total 
annual costs of administering TSCA sections 4, 5, and 6 (excluding the 
costs of manufacturer-requested risk evaluations) and of collecting, 
processing, reviewing, and providing access to and protecting from 
disclosure as appropriate under TSCA section 14; identifying the full 
cost amount to be defrayed by fees under TSCA section 26(b) (i.e., 25% 
of those annual costs); and allocating that amount across the fee-
triggering events in TSCA sections 4, 5, and 6, weighted more heavily 
toward TSCA section 6 based on early industry feedback. EPA 
specifically requested comment on this methodology. While a number of 
commenters generally supported the allocation as an appropriate balance 
of fees amongst activities in TSCA sections 4, 5, and 6, many 
commenters offered alternative suggestions for calculating fees, such 
as an actual cost approach or level-of-effort approach.
    A common theme from commenters was that fees, particularly those 
for TSCA section 6 activities, should more closely align with EPA's 
actual costs for carrying out the specific activity on the specific 
chemical. Some commenters pointed to the likelihood for variability in 
costs stemming from the number of uses evaluated, extent of exposures, 
amount of existing information such as assessments from other 
government bodies, the level of contractor support necessary, the 
complexity and number of tests required, and other factors.
    As a general matter, EPA believes it is important to track costs on 
a chemical and activity basis in light of the increased 
responsibilities under TSCA and the need to better understand 
associated new costs. The Agency is working towards building this 
capability and, consistent with commenters' suggestions, expects to 
begin tracking actual costs on a chemical basis as soon as feasible. 
EPA plans to use our time reporting system to track employee hours and 
contract expenditures for each chemical undergoing risk evaluation and 
at the fee category level for section 4 and 5 activities. EPA also 
plans to track CBI claim review direct and programmatic support costs 
as well as cross cutting costs, direct costs and indirect costs 
associated with section 4, 5, 6, and collecting, processing, reviewing, 
and providing access to and protecting from disclosure as appropriate 
under section 14 information on chemical substances under TSCA. 
However, EPA does not currently track costs with this level of

[[Page 52698]]

specificity and, as with any new activity, expects there to be some 
initial challenges as it works to do so. As such, EPA does not believe 
it would be feasible or appropriate to implement an actual cost 
approach for all fee-triggering events at this time. Furthermore, 
because actual costs of individual activities are unknown at this time 
and unknowable in advance (i.e., every activity will be unique and bear 
different actual costs), and because the fee-triggering events are a 
narrower subset of the activities that TSCA fees must defray, it is 
unclear how EPA could ensure that an actual cost approach would yield 
fee revenue sufficient to defray 25% of the overall TSCA implementation 
costs associated with section 4, 5, and 6, and collecting, processing, 
reviewing, and providing access to and protecting from disclosure as 
appropriate under section 14 information on chemical substances under 
TSCA, absent a better understanding of the actual costs of these new 
activities. More generally, EPA has many new responsibilities under 
TSCA and relatively little information and experience to inform 
assumptions on costs or activity levels. EPA expects to gain valuable 
experience implementing this initial fee structure. Ultimately, EPA 
believes this initial experience and information gained from tracking 
actual costs will help EPA to continue refining methodologies for 
calculating fees, and will inform potential revisions to the fee 
structure in the future. To inform these revisions EPA plans to use our 
time reporting system to track employee hours and contract expenditures 
for each chemical undergoing risk evaluation and at the fee category 
level for section 4 and 5 activities. EPA also plans to track CBI claim 
review direct and programmatic support costs as well as cross cutting 
costs, direct costs and indirect costs associated with section 4, 5, 6, 
and collecting, processing, reviewing, and providing access to and 
protecting from disclosure as appropriate under section 14 information 
on chemical substances under TSCA. Congress implicitly recognized the 
benefit of gained experience and understanding over time by requiring 
EPA to revisit the fees structure every three years. Therefore, after 
considering the comments, for the final rule, EPA has determined to 
calculate the fees using the same approach as used in the proposed rule 
for most fee categories.
    EPA is, however, finalizing an actual cost approach for calculating 
fees for manufacturer-requested risk evaluations. Although EPA proposed 
a static fee for manufacturer-requested risk evaluations based on 
general cost estimates for risk evaluation activities, upon further 
consideration and in light of public comments received, EPA will 
include a provision in the final rule to align this fee with the actual 
costs of the activity as a plain reading of TSCA would require. 
Specifically, EPA will require an initial payment of $1,250,000 (for a 
chemical on the TSCA Work Plan) or $2,500,000 (for a chemical not on 
the TSCA Work Plan), payable within 30 days after granting the request, 
and a final invoice to total either 50% or 100% of the actual costs in 
line with the percentage requirements in TSCA, or a refund to achieve 
these requirements, if warranted. As described in this unit, EPA 
estimates the cost of a manufacturer-requested risk evaluation to be 
approximately $3.88M. The initial payment amounts were calculated to 
capture approximately two thirds of either 50% or 100% of that 
estimated cost, with the expectation that approximately the last third 
would come from the final payment. This approach is well-supported in 
the language of TSCA, which explicitly requires the Agency to collect a 
percentage of costs incurred ``in conducting the risk evaluation'' 
(i.e., 50% or 100%, depending on whether or not the chemical is on the 
TSCA Work Plan). TSCA section 26(b)(4)(D) specifies that EPA shall 
establish a fee for manufacturer-requested risk evaluations sufficient 
to defray the full costs (or 50% of the costs for TSCA Work Plan 
chemicals) and the approach being finalized is consistent with that. 
Commenters had a variety of suggestions for how to implement an actual 
cost approach (e.g., multiple payments at various milestones, small 
upfront payments or application fees followed by one or more additional 
payments, multiple payments based on target cost estimate ranges, 
etc.), but EPA determined that a simple two-payment approach--an 
initial payment, followed a final invoice at the conclusion of the risk 
evaluation for the total remaining due, or a refund--was a fair, 
understandable and practical approach in line with EPA's goals for the 
rulemaking.
    EPA is confident that the actual cost approach for manufacturer-
requested risk evaluations will be implementable for these activities 
beginning in FY19. Because fees collected for manufacturer-requested 
risk evaluations do not count towards the requirement that fees defray 
25% of overall implementation costs in TSCA section 26(b)(4)(F), there 
is not a need to count manufacturer-requested risk evaluation fees 
towards achieving a specific percentage of total revenue collected. 
Additionally, EPA continues to believe that these types of requests 
will generally be less complex (i.e., companies will request risk 
evaluations on chemicals that are likely to present fewer significant 
risk issues) than most EPA-initiated risk evaluations, and therefore 
easier/simpler to assess and track for actual costs.

E. Fee Categories

    EPA proposed 8 distinct fee categories: (1) Test orders, (2) test 
rules and (3) enforceable consent agreements, all under TSCA section 4; 
(4) notices and (5) exemptions, both under TSCA section 5; and (6) EPA-
initiated risk evaluations, (7) manufacturer-requested risk evaluations 
for chemicals on the TSCA Work Plan, and (8) manufacturer-requested 
risk evaluations for chemicals not on the TSCA Work Plan, all under 
TSCA section 6. Although EPA received some comment on these and other 
potential fee categories as described later in this discussion, EPA is 
not altering these fee categories for the final rule. The activities in 
these categories are fee-triggering events that result in obligations 
to pay fees under this final rule.
    As a general matter, EPA received very few comments on the 
categories proposed for TSCA section 4 activities. One commenter 
expressed concern that testing requirements that are associated with 
TSCA section 5 or 6 activities should not be subject to a separate TSCA 
section 4 fee, otherwise it would amount to double-charging. EPA 
disagrees with this characterization. Cost estimates for TSCA section 4 
activities do not overlap with cost estimates for TSCA section 5 or 6 
activities, and the expenses defrayed by the fees are different. There 
is a cost to the Agency to (1) develop an order, rule or consent 
agreement, and (2) to review the data. These costs are separate from 
and in addition to the costs associated with review of a TSCA section 5 
notice or exemption, or undertaking a TSCA section 6 risk evaluation.
    EPA received a number of comments related to TSCA section 5 fee 
categories--most pertaining to the proposed fees for low-volume 
exemptions (LVEs) and other exemptions. A number of commenters sought 
to eliminate the exemption fee category entirely, and particularly for 
LVE fees. Historically, EPA has not charged a fee for TSCA section 5 
exemption applications (e.g., LVE, low exposure/low release exemptions 
(LoREX), test-marketing exemptions (TME), TSCA experimental release

[[Page 52699]]

applications (TERA), etc.). EPA's prior fee structure was set in 1988 
and, while TSCA authorized EPA to collect fees for exemption 
applications, EPA only implemented fees for PMNs, SNUNs, and MCANs. EPA 
is imposing fees in this rule for all exemption submissions, except 
Tier I and polymer exemptions because the expected revenue from those 
activities would be largely negated by the administrative costs of 
collection. Some commenters suggested that fees for any exemption 
application would become a barrier to research, development and 
innovation. While EPA shares commenters' general concerns for impacts 
to innovation, EPA does not believe the LVE fee--a onetime $4,700 cost 
per submission ($940 for small business concerns)--will be a 
significant barrier to chemical industries seeking to introduce a new 
chemical to market. There is already a regulatory exemption from the 
TSCA section 5 notice requirements for those who manufacture only for 
research and development purposes (see 40 CFR 720.36). Another 
commenter asked EPA to clarify whether there would be a fee for bona 
fide submissions to ascertain whether or not a chemical is on the TSCA 
Inventory. EPA did not propose a fee for bona fide submissions, and 
there is no fee in the final rule for such submissions. Moreover, if a 
PMN was determined not to be a new chemical substance, the submitter 
would be due a full refund.
    No commenters opposed the proposed fee categories for TSCA section 
6 activities. However, several suggested exclusions or discounts for 
those who manufacture a chemical as an impurity or byproduct, or those 
who manufacturer chemicals for small, niche markets as their revenue 
may be insufficient to support a risk evaluation. As indicated earlier, 
EPA is not adjusting the fee categories in the final rule. TSCA 
requires EPA to evaluate chemicals under their conditions of use, and 
conditions of use evaluated may involve manufacture of impurities or 
byproducts, or chemicals used in niche market applications. As such, 
EPA does not believe it would be appropriate to exclude these 
manufacturers from fee obligations for TSCA section 6 activities.
    Finally, EPA solicited comment in the proposed rule about the 
potential for additional fee categories for other TSCA activities such 
as CBI claims or risk management activities. A majority of commenters 
opposed fee categories or surcharges associated with submission of CBI 
claims, with the exception of some who noted that requiring payment of 
fees could help reduce the number of unwarranted claims. Commenters 
were split regarding a separate risk management fee. Several opposed a 
separate fee, suggesting there was no authority in TSCA to implement 
one. Other commenters encouraged EPA to include a separate fee category 
for risk management activities to both place the costs of this activity 
on companies choosing to use more dangerous chemicals, and to 
incentivize companies to move to safer chemistries. After further 
consideration, EPA has determined not to add these additional 
categories. EPA already accounted for both CBI and risk management 
activities in the baseline cost estimates in the proposed rule, meaning 
that EPA will recover a portion of these costs through the other fee 
categories. EPA believes this approach is in line with TSCA section 26, 
which does not explicitly authorize EPA to assign fees for CBI claims 
or risk management activities. EPA expects that the historical problem 
of unwarranted CBI claiming will be mitigated to a certain extent by 
enhanced CBI review requirements for EPA and substantiation 
requirements in TSCA. Similarly, EPA believes that the new general 
requirements for prioritization and evaluation of existing chemicals 
will themselves be a disincentive to manufacturing chemicals with more 
significant risks.

F. Program Cost Estimates and Activity Assumptions

    The estimated annual Agency costs of carrying out TSCA section 4, 
5, and 6, and of collecting, processing, reviewing, and providing 
access to and protecting from disclosure as appropriate under TSCA 
section 14 information on chemical substances under TSCA, are 
approximately $80.2 million excluding the estimated cost of having 5 
manufacturer-requested risk evaluations underway each year. Because the 
25% cap on cost recovery does not apply to manufacturer-requested risk 
evaluations, the total cost to which the cap applies is $80.2 million. 
Based on these cost estimates, EPA anticipates collecting approximately 
$20 million in fees not associated with manufacturer-requested risk 
evaluations. In addition, the Agency intends to collect fees from 
manufacturers to recover 50% or 100% of the actual costs incurred by 
EPA in conducting chemical risk evaluations requested by manufacturers. 
EPA expects the amount collected will be approximately $1.94 million 
per chemical for chemicals on the TSCA Work Plan and $3.9 million per 
chemical for chemicals not on the TSCA Work Plan.
    EPA determined the anticipated costs associated with TSCA sections 
4, 5, and 6 of collecting, processing, reviewing, and providing access 
to and protecting from disclosure as appropriate under TSCA section 14 
information on chemical substances under TSCA, including both direct 
program costs and indirect costs (see Table 1). For fiscal year 2019 
through fiscal year 2021, these costs were estimated to be 
approximately $80.2 million per year. More detail on how anticipated 
costs were calculated follows in Unit III.B.2.

                                     Table 1--Estimated Annual Costs to EPA
                                   [Fiscal Year 2019 through Fiscal Year 2021]
----------------------------------------------------------------------------------------------------------------
                                                                  Direct program
                                                                       costs      Indirect costs   Annual costs
----------------------------------------------------------------------------------------------------------------
TSCA Section 4..................................................      $2,765,000        $778,000      $3,543,000
TSCA Section 5..................................................      22,375,000       6,296,000      28,672,000
TSCA Section 6..................................................      34,073,000       9,545,000      43,618,000
TSCA Chemical Information Management............................       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.


[[Page 52700]]

    After estimating the annual costs of administering TSCA section 4, 
5, and 6, and of collecting, processing, reviewing, and providing 
access to and protecting from disclosure as appropriate under TSCA 
section 14 information on chemical substances under TSCA, 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 fees that tied the payment of 
fees to individual distinct activity types or ``fee-triggering 
events''. This allows allocation of costs more equitably among the 
activity types and their related costs.
    1. Program costs. To determine the program costs for implementing 
TSCA sections 4, 5, and 6, of collecting, processing, reviewing, and 
providing access to and protecting from disclosure as appropriate under 
TSCA section 14 information on chemical substances under 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 with all direct program cost estimates for 
TSCA sections 4, 5, 6 and collecting, processing, reviewing, and 
providing access to and protecting from disclosure as appropriate under 
TSCA section 14 information on chemical substances under TSCA.
    Some commenters expressed concerns that agency cost estimates and 
fee amounts were too low while other commenters expressed concerns that 
general or specific cost estimates, or fee amounts were too high or 
were not well substantiated. EPA continues to believe that the 
estimates presented represent the best estimates possible given our 
reliance, to the extent possible, on past experience and consideration 
of the additional work under the expanded authorities in the amended 
statute. Given this limited experience with novel obligations and 
authorities, our costs are estimates and subject to change and become 
more precise over time. However, EPA informed these estimates by 
relying on past experience with similar activities coupled with 
significant interaction and discussion with programmatic staff and 
management to develop estimates.
    Because of the novelty and expanded scope of many aspects of the 
program under amended TSCA, EPA is not able to fully benchmark or 
substantiate all our estimates through past staffing or contract budget 
needs for identical activities. However, EPA carefully took into 
account the expanded requirements for risk evaluation, risk management, 
and new chemical review activities as well as the new test order 
authority when developing the cost estimates. Furthermore, EPA believes 
that Congress understood the uncertainty in standing up a new chemical 
review and management program and therefore required EPA to perform 
annual audits and reassess fees every three-years to allow for costs 
estimates and the associated fees to be refined.
    a. TSCA section 4 program costs. TSCA section 4 gives EPA the 
authority to require (by rule, order, or ECA) manufacturers and 
processors to conduct testing of identified chemical substances or 
mixtures. EPA estimated TSCA section 4 activity costs based on prior 
experience with developing test rules and ECAs, reviewing study plans, 
and reviewing the data received. These activity level assumptions 
represent EPA's best professional judgment on how the program will be 
implemented in the first 3-year fees cycle. 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 as it takes approximately two years 
to complete the work associated with both of these activities. While 
not EPA's current practice, these estimates represent EPA's best 
estimate on the work that will be required as a result of the 2016 
amendments to TSCA, including the requirements to prioritize chemicals 
for risk evaluation review and to have 20 risk evaluations underway at 
all times beginning in December 2019.
    EPA used historical averages of the number of affected firms per 
chemical from the three most recent section 4 test rules for high 
production volume (HPV) chemicals (71 FR 13708, March 16, 2006) (FRL-
7335-2); (76 FR 4549, January 26, 2011) (FRL-8862-6); and (76 FR 65385, 
October 21, 2011) (FRL-8885-5) and assumed an average of seven 
chemicals involved per TSCA section 4 action and four affected firms 
per chemical. EPA based Section 4 costs on our general experience with 
the rulemaking process, our experience with the developing an ECA for 
Octamethylcyclotetrasiloxane (D4) and costs associated with reviewing 
information received, and administration of, the HPV Voluntary Testing 
Program. EPA relied on this past experience augmented thorough a 
process of coordination with programmatic staff and management to 
estimate the TSCA section 4 costs.
    EPA's cost estimates included a full suite of activities related to 
developing and implementing actions under the TSCA section 4 
authorities including development of screening-level hazard and 
environmental fate information, including tests that provide 
information on the toxicity of a chemical (e.g., aquatic toxicity, and 
mammalian toxicity). EPA also included estimates of the costs of 
reviewing physical/chemical properties and environmental fate and 
pathways data and tests.
    Some commenters felt that EPA cost estimates were too low. However, 
EPA's estimates reflect the best estimates currently available, rely on 
past programmatic experience, and fully consider the information needs 
under amended TSCA for section 4 activities. In addition, TSCA section 
4 actions have historically included multiple chemicals per action. EPA 
TSCA section 4 test orders, for example, could cover a group of similar 
chemicals allowing EPA to collect information on more than 10 chemicals 
in a given year. Further, if EPA learns that more activities are needed 
per year or that costs are higher than expected, EPA will appropriately 
revise the requirements during the annual and three-year review of 
fees.
    Based on previous experience and expected work under TSCA as 
amended, EPA assumed that testing required by test orders is likely to 
be completed in under a year, and test rules and ECAs are likely to 
take two years to complete. To estimate the costs of reviewing test 
data, we assume that on average, data will be submitted to EPA for 
seven chemicals in each TSCA section 4 activity and that each chemical 
would have 4 associated companies to test for a total of 28 firms per 
action.
    Based on this approach, 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

[[Page 52701]]

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. 3: Table 8).
    b. TSCA section 5 program costs. TSCA section 5 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 affirmative 
determinations for new chemical submission 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 prior to the 2016 amendments to TSCA 
are well understood through experience that spans several decades. The 
Agency has 40 years of experience and historical data on costs, as well 
as the number of different TSCA section 5 submission types sent to the 
Agency each year under the previous statute. 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. In calendar year 2016, EPA received 577 PMNs, SNUNs 
and MCANs, and another 560 exemption notices and applications, most of 
which were LVEs.
    Cost estimates were developed based on our historical understanding 
of costs, extensive consultation with programmatic staff and management 
and careful consideration of the requirements for new chemical reviews 
under amended TSCA, including the requirement to make an affirmative 
safety determination, and costs of pre-notice consultation. Based on 
the extent of past experience to rely upon for costs estimation, TSCA 
section 5 costs are some the best understood in terms of anticipated 
activity level and per activity cost.
    Some commenters commented that EPA did not fully consider the 
statutory requirements under amended TSCA. However, EPA feels the costs 
are developed using our robust historical cost understanding, extensive 
discussion with programmatic staff and management, and consideration of 
the requirements under amended TSCA to evaluate intended, known, or 
reasonably foreseen conditions of use and the Agency's costs of taking 
any related required regulatory action such as with a SNUR and/or a 
consent order. Costs of reviewing any data that is submitted to EPA as 
a result of an order is also included in EPA's estimates. EPA's cost 
estimates for administering TSCA section 5 also include the costs 
associated with processing and retaining records related to a Notice of 
Commencement (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 estimated average 
cost for EPA to review 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. EPA 
estimated that there will be 462 submissions annually. EPA's estimate 
of number of submissions is based on submissions received in FY 16, and 
reduced by 20% due to the anticipated impact of increased fees on the 
number of submissions (Ref. 3: Table 9). EPA does not believe that this 
estimated reduction in submissions will translate into a reduction in 
new chemicals entering commerce as only roughly 57% of new chemicals 
reviewed by EPA have historically entered commerce. Furthermore, EPA 
acknowledges that these activity level assumptions are only estimates 
and there is underlying uncertainty regarding the true impact of these 
fees.
    Estimated costs associated with TSCA section 5 exemption notices 
and applications include pre-notice consultation, processing and 
reviewing the application, retaining records, and related activities. 
The average cost for EPA to review 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. EPA estimates that 
there will be 560 exemptions submitted annually. While EPA did not 
assume a reduction in the number of exemption submissions, EPA 
acknowledges that these activity level assumptions are only estimates 
and there is underlying uncertainty regarding the true impact of fees 
on exemption submissions. Our estimate of number of submissions is 
based on submissions received in FY 16 (Ref. 3: 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 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. EPA is also currently considering 
approaches for identifying potential candidates for prioritization and 
has included estimates for this the EPA costs for TSCA section 6. 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'' (TSCA section 6(a)). 
Under the conditions of use the Agency expects to consider 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

[[Page 52702]]

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, have identified at least 20 low-priority substances for 
which risk evaluation is not warranted at this time, and have an 
additional 5-10 manufacturer-requested risk evaluations underway, if 
sufficient requests and fee payments have been made. For each risk 
evaluation that the Agency completes for a High-Priority Substance, 
TSCA requires that EPA identify another High-Priority Substance. The 
Agency expects to have between 25 and 30 risk evaluations ongoing at 
any time 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 with risk management actions addressing risks identified 
from particular uses of a chemical. In addition, EPA relied on our 
experience with work to date on the first ten 10 chemicals currently 
undergoing risk evaluation. 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 the unreasonable risks identified from a chemical. 
TSCA section 6(a) provides authority for EPA to prohibit or otherwise 
restrict the manufacture, processing, distribution in commerce, and 
commercial use of chemicals, as well as any manner or method of 
disposal of chemicals. Cost estimates for risk management activities 
have been informed, in part, by EPA's recent risk reduction actions on 
several chemicals, including development of the proposed rules 
regarding the use of N-methylpyrrolidone and methylene chloride in 
paint and coating removal and trichloroethylene in both commercial 
vapor degreasing and aerosol degreasing and for spot cleaning in dry 
cleaning facilities.
    In addition to considering previous experience with TSCA Work Plan 
chemicals described in this Unit, 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 will be assessed.
    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. Some commenters commented that risk 
evaluation costs were over-estimated since risk assessments by private 
firms are less expensive. EPA does not agree with this as the scope of 
an assessment from a private firm could be significantly lower than 
that required under amended TSCA.
    The breakdown of costs for an average three-year EPA-initiated 
chemical risk evaluation is shown in Table 2.

    Table 2--Estimated Costs (Direct and Indirect) Associated With an
                    Average Chemical Risk Evaluation
------------------------------------------------------------------------
                                                               Estimated
                  Risk evaluation activity                       cost
------------------------------------------------------------------------
Risk Evaluation: Data Gathering (i.e., literature search)...    $395,000
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
------------------------------------------------------------------------

    Upon further consideration and in light of public comments 
received, EPA cost estimates for manufacturer-requested risk 
evaluations were revised from those in the proposed rule to be 
consistent with the costs of EPA-initiated risk evaluations and to 
increase accountability and transparency by using an actual cost 
approach when determining the fee for a specific manufacturer-requested 
chemical review. In the proposed rule, EPA estimated the costs of a 
manufacturer-requested risk evaluation to be $2.6M, and the costs of an 
EPA-initiated risk evaluation to be $3.88M. Upon consideration of 
comments and further analysis, for purposes of the economic analysis 
and burden analysis, EPA estimated the same costs for both 
manufacturer-requested and EPA-initiated risk evaluations at $3.88M. 
However, EPA also carefully considered commenters that expressed 
concern that some risk evaluations may be less burdensome. In order to 
address concerns with potentially overcharging for some risk 
evaluations, EPA is implementing an actual cost approach to fees for 
manufacturer-requested risk evaluations as described in Unit III.
    The estimated annual cost 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 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, data integration, 
meta-analysis of studies, and providing access to other models, tools 
and information already developed by ORD, and approximately $2,573,000 
is attributed to the process of designating chemicals as High- or Low-
priority substances (Ref. 3: Table 11).

[[Page 52703]]

    d. Costs of collecting, processing, reviewing, and providing access 
to and protecting from disclosure as appropriate under section 14 
information on chemical substances under TSCA. EPA's cost estimates for 
TSCA section 14 as presented for the proposed rule are unchanged for 
the final rule.
    Some commenters thought that the statutory requirement that EPA 
collect fees to defray 25% of the costs of ``collecting, processing, 
reviewing, and providing access to and protecting from disclosure as 
appropriate under section 14'' would apply to costs beyond those to 
manage information related to activities in TSCA section 4, 5 and 6. 
EPA generally agrees and is clarifying that cost estimates do fully 
consider these costs of general information management but do not 
include the costs of administering other authorities for collection 
such as those in TSCA section 8 and 11. EPA does not believe that 
Congress intended EPA to offset costs associated with administering 
authorities under these other sections. The statutory text clearly 
points to the authorities of sections 4, 5, 6 and 14 but not others. If 
the costs of administering activities under sections 8 and 11 were 
intended to be defrayed with fees, Congress would have specifically 
included those authorities in the statutory text. Therefore, cost 
estimates in the proposed rule already considered costs associated with 
managing information that for instance, comes in pursuant to a TSCA 
section 8 rule, but not the costs of developing the TSCA section 8 
rule.
    In response to commenter's requests to better substantiate costs 
related to information management, EPA expanded upon the categories in 
the cost estimates provided in the Technical Background Document (Ref. 
3) from those released in the proposed rule to provide a cost breakout 
that better elaborates which activities were included and the 
associated cost estimates. Specific activities considered when 
developing this estimate for these activities include: Prescreening/
initial review; substantive review and making final determinations; 
documents review and sanitization; regulation development; IT systems 
development; and transparency/communications. Estimates also include 
Office of General Counsel costs associated with issuing TSCA CBI claim 
final determinations, and supporting guidance, policy and regulation 
development for TSCA Section 14 activities, e.g., implementing the 
unique identifier provisions, access to TSCA CBI for emergency 
personnel, states, tribes and local governments, the TSCA CBI sunset 
provisions, among others.
    Other chemical information management activities included in the 
analysis are: The costs for implementation of the Unique Identifier 
Rule; costs for implementing the requirements in TSCA section 14(d); 
costs for implementing the CBI sunset requirements; costs for Notice of 
Activity chemical identity CBI claim reviews, costs for Freedom of 
Information Act-Related CBI claim reviews; and costs for providing 
public access to Non-CBI Data and IT costs for operating and 
maintaining the CBI Local Area Network (LAN). The annual cost estimate 
of collecting, processing, reviewing, and providing access to and 
protecting from disclosure as appropriate under TSCA section 14 
information on chemical substances under TSCA, including FTE and 
extramural costs, from fiscal year 2019 through fiscal year 2021 is 
$4,346,000 (Ref. 3).
    1. 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, and 6, costs of collecting, processing, reviewing, 
and providing access to and protecting from disclosure as appropriate 
under TSCA section 14 information on chemical substances under TSCA 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. 
4). Some of the direct program costs included in the estimates for TSCA 
sections 4, 5, and 6 and collecting, processing, reviewing, and 
providing access to and protecting from disclosure as appropriate under 
TSCA section 14 information on chemical substances under TSCA 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 an EPA's existing 
indirect cost methodology (Ref. 4). 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.
    2. Total costs of fee-triggering events. The annual estimated costs 
for fee categories under TSCA section 4, including both direct and 
indirect program costs are shown in Table 3. Note that the costs 
presented in Tables 3, 4 and 5 include only the costs of fee-triggering 
events and so 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 
TSCA sections 4, 5, 6 and of collecting, processing, reviewing, and 
providing access to and protecting from disclosure as appropriate under 
TSCA section 14 information on chemical substances under TSCA and, as 
such, are included in the overall cost estimates previously in Table 1.

[[Page 52704]]



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

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

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

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

                                         Table 5--TSCA Section 6 Costs *
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of    Estimated cost     Estimated
                          Fee category                                ongoing       to agency/    annual cost to
                                                                   actions/year       action          agency
----------------------------------------------------------------------------------------------------------------
EPA-initiated risk evaluation...................................              25      $3,884,000     $32,370,000
Manufacturer-requested risk evaluation: Work Plan chemical......               2       3,884,000       2,589,000
Manufacturer-requested risk evaluation: Non-Work Plan chemical..               3       3,884,000       3,884,000
----------------------------------------------------------------------------------------------------------------
* Numbers may not add due to rounding.

G. Fee Amounts

    With the exception of manufacturer-requested risk evaluations, EPA 
is finalizing the fee amounts as described in the proposed rule. EPA 
applied the same formula to calculate the fees per submission for each 
fee category as used in the proposal to ensure that 25% 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 under TSCA section 14 information on chemical substances 
under TSCA would be collected in any given year (i.e., approximately 
$20 million annually in fiscal years 2019 through 2021). Because the 
eight fee categories do not span all of the activities (e.g., costs of 
administering TSCA section 14, risk management activities under section 
6, prioritization of chemicals for evaluation, support for alternative 
testing and methods development and enhancement, etc.), EPA set fee 
amounts to ensure these costs were captured.
    1. Fee amounts in general. EPA received a number of comments on the 
specific fee amounts in the proposed rule. Commenters generally had 
suggestions for adjusting fee amounts in various ways: Some specific to 
fee categories (described in the subsequent paragraphs) and some more 
generally applicable across all fee categories. For example, one 
commenter suggested a maximum fee for scenarios where there is a small 
number of manufacturers subject to a large fee. Another commenter 
suggested that fee amounts should be adjustable based on the number of 
identified manufacturers for the particular chemical and activity. 
Ultimately, EPA determined not to adjust fee amounts for the final rule 
based on these general comments. As a primary matter, EPA does not know 
in advance how many manufacturers will be identified for a particular 
fee-triggering activity. As such, it would be impossible to provide 
some type of discount when the number of identified manufacturers is 
low, while still ensuring that EPA collects sufficient fees overall to 
defray 25% of implementation costs. EPA made a significant effort to 
explain its methodology for calculating fees and basis for determining 
fee amounts in the proposed rule, and has further clarified certain 
aspects in the final rule. EPA has many new responsibilities under 
TSCA, and this presents challenges for developing cost estimates for 
the fees rule. With more experience, EPA may be able to refine 
estimates and potentially adjust fee amounts when revisiting this rule 
in the future as required under TSCA.
    2. Fee amounts for TSCA section 4 activities. EPA is finalizing 
three fee amounts--one for each of the TSCA section 4 fee categories: 
Test orders, test rules and ECAs. These fees amount to approximately 
3.5% of the total estimated activity cost. Several commenters expressed 
general support for the lower fee amounts for TSCA section 4 
activities. Another commenter felt that section 4 fees were set too

[[Page 52705]]

low--that they should be more proportional to actual costs, noting that 
Congress set a national policy that industry should pay for development 
of information. One commenter suggested that EPA consider assigning 
lower fees when companies agree to collaborate and produce data. EPA 
recognizes that manufacturers will be responsible for paying to develop 
the test information in addition to paying the TSCA fee, and reflected 
this in assigning lower fee amounts in the proposed rule. While EPA 
strongly encourages collaboration amongst manufacturers when developing 
data, EPA does not believe that such collaboration should result in 
lower fees. If manufacturers collaborate to voluntarily produce and 
provide data that EPA needs, that may obviate the need for a test rule 
or order. If, however, EPA issues a test rule and companies 
subsequently form a consortium to jointly produce data, no discount 
would be warranted. EPA would still incur the cost of developing the 
test rule and reviewing data regardless of the extent of collaboration 
amongst manufacturers.
    3. Fee amounts for TSCA section 5 activities. EPA is finalizing two 
fee amounts for TSCA section 5 activities--one for notices (PMNs, SNUNs 
and MCANs) at approximately 29% of the estimated cost of the 
activities, and one for exemptions (LVEs, LoREX, TME, Tier II, TERA and 
film articles) at approximately 89% of the estimated cost of the 
activities.
    A number of commenters indicated that the proposed TSCA section 5 
fees were too high and should be kept as low as possible to promote 
innovation. Some of these commenters argued that these fees will result 
in reduced new chemical submissions and lost social benefits, and will 
reduce research and development efforts in the industry. Another 
commented that EPA was not permitted under TSCA to set fees based on 
promoting innovation. Others had more specific comments or requests. 
Some commenters, for example, suggested that EPA also apply a PMN 
discount for graduates of EPA's Sustainable Futures program (Ref. 5). 
Another commenter expressed concern regarding EPA's proposal to 
establish the same fee amount for both individual and consolidated 
notices, even though EPA acknowledges that consolidated submissions are 
more costly to review.
    EPA appreciates commenters' concerns regarding increased TSCA 
section 5 fees and potential impacts to chemical innovation. First, 
amongst the fee categories for TSCA sections 4, 5, and 6 activities, 
EPA proposed to collect the bulk of fees from manufacturers subject to 
TSCA section 6 EPA-initiated risk evaluations, in part, to minimize 
impacts to innovation and competitive standing for new chemical 
manufacturers. TSCA calls for EPA to implement TSCA in a manner that 
does not ``impede'' or create ``unnecessary barriers to technological 
innovation.'' See TSCA section 2(b)(3). Second, the proposed fee amount 
for PMNs, MCANs and SNUNs was only moderately higher than the current 
fee adjusted for inflation (i.e., $10,400). As discussed in the 
proposed rule preamble, EPA also benchmarked the proposed new chemicals 
fees against similar activities conducted in EPA's pesticide program 
and found them to fall within an appropriate range of costs. With 
respect to specific requests to lower fee amounts, EPA has similarly 
determined not to make any adjustments for the final rule. Sustainable 
Futures program graduates do not currently receive a PMN discount and 
EPA did not propose to provide one. While one aim of the program is to 
encourage better quality submissions, there is no evidence to support 
that such submissions are categorically any less complex or expensive 
to review. EPA chose to lump PMN, MCAN and SNUN fees into a single 
category, setting a single fee applicable to each, for practical 
implementation reasons. Although certain activities (i.e., consolidated 
PMNs and MCANs) may cost the agency more than other activities in the 
same category (i.e., individual PMNs and MCANs), EPA chose to assign 
the same fee amount for individual and consolidated submissions in 
furtherance of EPA's goal to develop a practicable, implementable TSCA 
fee structure. EPA believes that there is value in keeping the fee 
structure relatively simple from an implementation perspective, but 
also because EPA currently lacks the experience and information to more 
narrowly tailor fees while still meeting the collection requirements in 
TSCA. Finally, EPA is finalizing the fee amount for section 5 
exemptions. EPA is finalizing the proposal to eliminate the 
``intermediate PMN'' fee category. As discussed in the preamble to 
proposed rule, discounted fees are not warranted for intermediate PMNs 
as EPA has not realized costs savings in review of these submissions. 
Reviewing and processing these exemptions is not an insignificant 
amount of work, and EPA believes the exemption fee--set at a fraction 
of the fee for PMNs and other notices--is well within reason.
    4. Fee amounts for TSCA section 6 activities. EPA is finalizing one 
fee amount for EPA-initiated risk evaluations at approximately 35% of 
the estimated cost of the activity. As indicated earlier, EPA is 
finalizing an actual cost approach for manufacturer-requested risk 
evaluations, whereby the requesting manufacturer (or requesting 
consortia of manufacturers) would be obligated to pay either 50% or 
100% of the actual costs of the activity, depending on whether or not 
the chemical was listed on the TSCA Work Plan, respectively. EPA 
received a number of comments on the proposed section 6 fee amounts. 
Some expressed concern that the amounts were too high, and could result 
in manufacturers abandoning production of critical substances. Others 
suggested discounts when data/analytical needs were low, when companies 
voluntarily submit additional data, or if a company would--prior to or 
during the risk evaluation--agree to voluntarily phase out manufacture 
of the substance. One commenter requested clarification that only one 
fee will be required for a risk evaluation, even if it is completed in 
phases as contemplated in the Risk Evaluation framework rule, and that 
only one fee will be required for risk evaluations performed on 
categories of chemicals.
    While EPA recognizes the possibility for variation in complexity of 
a risk evaluation for any number of reasons (e.g., availability of 
data, number and type of associated uses, etc.), and therefore 
variation in cost, EPA has limited experience in conducting risk 
evaluations under new TSCA except for that related to ongoing work 
associated with the first 10 chemicals, and no experience or evidence 
to justify specific cost reductions related to number or type of uses, 
availability of more information, etc. In assigning fees across 
activities in TSCA sections 4, 5, and 6, EPA believes it achieved an 
appropriate balance in the proposal: a structure that was both 
efficient and practical to implement, while also distributing the fee 
burden across the fee-triggering events consistent with stakeholder 
input and the goals and policies of TSCA. With respect to commenter's 
request for clarification, EPA will only charge one fee for each risk 
evaluation activity, including risk evaluations on a category of 
substances, regardless of how unreasonable risk determinations may be 
communicated.
    The final fee amounts are described in Table 6.

[[Page 52706]]



                     Table 6--Final TSCA Fee Amounts
------------------------------------------------------------------------
              Fee category                          Fee amount
------------------------------------------------------------------------
TSCA Section 4:
    Test order.........................  $9,800.
    Test rule..........................  $29,500.
    Enforceable consent agreement......  $22,800.
TSCA Section 5:
    PMN and consolidated PMN, SNUN,      $16,000.
     MCAN and consolidated MCAN.
    LoREX, LVE, TME,* Tier II            $4,700.
     exemption, TERA, Film Articles.
TSCA Section 6:
    EPA-initiated risk evaluation......  $1,350,000.
    Manufacturer-requested risk          Initial payment of $1.25M, with
     evaluation on a chemical included    final invoice to recover 50%
     in the TSCA Work Plan.               of Actual Costs.
    Manufacturer-requested risk          Initial payment of $2.5M, with
     evaluation on a chemical not         final invoice to recover 100%
     included in the TSCA Work Plan.      of Actual Costs.
------------------------------------------------------------------------
* EPA will waive the TME fee for submissions from companies that have
  graduated from EPA's Sustainable Futures program.

    5. Fee amounts for small businesses. EPA is finalizing reduced fee 
amounts for small businesses, consistent with the proposed rule and 
without change. EPA is, however, adjusting the small business size 
standard as discussed in Unit III. The reduced fee amounts are 
summarized in Table 7. These fee amounts represent an approximate 80% 
reduction compared to the base fee for each category. In one case, for 
TSCA section 5 notices (i.e., PMNs, MCANs and SNUNs), the small 
business reduction is 82.5%. For all fee categories, the reduced fee is 
only available when the only entity or entities are small businesses, 
including when a consortium is paying the fee and all members of that 
consortium are small businesses. Consistent with the proposed rule, 
reduced fees are not available for small business manufacturers 
requesting a risk evaluation, as TSCA requires those fees to be set at 
a specific percentage of the actual costs of the activity.
    Some commenters expressed concern regarding accommodations made to 
small businesses in the proposed rule. For example, a few commenters 
argue that reduced fees for companies with annual sales of $91 million 
is an undue accommodation for companies that can clearly support fees, 
and the discount relief was unjustified and excessive. Another 
commenter urged EPA to clarify and better support its proposed discount 
of 80%. With respect to the approximate 80% discount in the proposed 
rule, EPA continues to believe this is appropriate. The discount is 
generally in line with EPA's discount for small businesses in the 
pesticides program (i.e., 75%), but slightly higher in line with 
significant stakeholder input regarding the need to minimize impacts to 
small businesses.

              Table 7--Final TSCA Fees for Small Businesses
------------------------------------------------------------------------
              Fee category                      Small business fee
------------------------------------------------------------------------
TSCA Section 4:
    Test order.........................  $1,950.
    Test rule..........................  $5,900.
    ECA................................  $4,600.
TSCA Section 5:
    PMN and consolidated PMN, SNUN,      $2,800.
     MCAN and consolidated MCAN.
    LoREX, LVE, TME, Tier II exemption,  $940.
     TERA, Film Articles.
TSCA Section 6:
    EPA-initiated risk evaluation......  $270,000.
    Manufacturer-requested risk          $1,250,000 initial payment +
     evaluation on a chemical included    50% of total actual costs.
     in the Work Plan.
    Manufacturer-requested risk          $2,500,000 initial payment +
     evaluation on a chemical not         100% of total actual costs.
     included in the Work Plan.
------------------------------------------------------------------------

H. Definition for ``Small Business Concerns''

    EPA is also finalizing a revision to the size standard used to 
identify businesses that can qualify as a ``small business concern'' 
under TSCA for the purposes of fee collection. EPA proposed to adjust 
the 1988 size standard used to identify businesses that can qualify as 
a ``small business concern'' from a prior revenue threshold of $40 
million to approximately $91 million (See Ref. 6). EPA also proposed to 
use average annual sales values over the three years preceding the 
activity, instead of just one year. Further, EPA proposed to apply this 
definition to all fee categories in TSCA, not just TSCA section 5 
submissions.
    EPA specifically requested comment on this proposal and some 
alternative approaches, and commenters provided a variety of views. A 
number of commenters expressed support for SBA's employee based 
definition. Other commenters suggested that EPA apply only the 
inflation-adjusted approach in proposal, or else risk over-identifying 
small business concerns. At least one commenter expressed support for 
the proposed revenue-based definition, arguing that an employee-based 
metric is antiquated. A number of commenters supported an ``either/or'' 
approach, where a company could choose to certify as a small business 
under either the EPA's proposed revenue standard or SBA's employee-
based standards. One commenter suggested that EPA consider

[[Page 52707]]

an additional ``micro business'' category of 1-9 employees with an 
associated fee cap of $100.
    After further consideration, review of the public comments and 
consultation with SBA, including the Office of Advocacy, EPA has 
determined to adopt an employee-based size standard modeled after SBA's 
standards. When establishing its size standards, SBA examines various 
industry characteristics such as average firm size, degree of 
competition within an industry, start-up costs and entry barriers, and 
distribution of firms by size. SBA also evaluates federal market 
factors including a small business's share in total industry's 
receipts. For more details, please see the ``SBA's Standards 
Methodology'' white paper, available at www.sba.gov/size. The SBA size 
standards are industry-specific mostly based on either average annual 
revenue or number of employees, for reference please see the SBA size 
standards at 13 CFR 121.202. In order for an entity to be classified as 
a small business for federal contracting and other small business 
programs, its enterprise level revenue or number of employees 
(including all affiliates) shall not exceed the size standard for the 
applicable industry. These size thresholds are determined at the 6-
digit North American Industry Classification System (NAICS) levels. 
SBA's employee-based size thresholds range from 100 to 1,500 employees 
to account for differences among NAICS codes.
    The Small Business Jobs Act of 2010 (Jobs Act) (Pub. L. 111-240, 
124 Stat. 2504, Sept. 27, 2010) requires SBA to review every five years 
all size standards and make adjustments to reflect current industry and 
market conditions. SBA completed the first 5-year review of size 
standards in early 2016 and is currently performing the second 5-year 
review. As part of that effort, SBA plans to publish for public 
comments a series of proposed rules on size standards revisions in the 
coming years.
    For the final rule, EPA has incorporated the 2017 NAICS codes and 
SBA's associated size thresholds most likely to apply to manufacturers 
and processors subject to TSCA fees, see table 700.43. For those NAICS 
codes not represented on the table provided in 700.43 of the final 
rule, the manufacturer or processor must have 500 or fewer employees to 
be considered as a ``small business concern'' under TSCA for the 
purposes of fee collection. As a general matter, the reduction in 
revenue collection was minimal when applying an employee-based standard 
versus a revenue-based standard, and EPA deferred to the expertise of 
SBA in relying on an employee-based standard for this rulemaking. The 
definition in the final rule is updated accordingly, as well as 
supporting materials.
    EPA considered several other options offered by commenters 
including an ``either/or'' approach and a ``micro-business'' category. 
With respect to the first, EPA did not believe it was appropriate to 
allow small businesses to choose to certify either under a revenue-
based standard, or an employee-based standard. Doing so would 
potentially result in a significant increase to the total number of 
businesses identified as small, resulting in a shortfall in EPA's 
overall fee revenue and the need to adjust the fee structure--either by 
providing small businesses with a lower discount, or by increasing fees 
for other businesses. Adding a ``micro-business'' category would likely 
create similar issues with revenue shortfalls for EPA and a need to 
increase fee amounts elsewhere. Further, such a standard is not 
currently used anywhere in the federal government, including SBA. 
Ultimately, EPA did not believe the TSCA fees rule was an appropriate 
venue to introduce a micro-business standard. As indicated in the 
proposed rule, EPA believes a forthcoming TSCA section 8(a) rulemaking 
will provide for more consideration of appropriate size standards for 
industries subject to TSCA and offer the public further opportunities 
to comment on small business size standards, and EPA is committed to 
considering the results of that rulemaking, as well as the experience 
and information gained from implementing this final rule and future 
rulemaking to update the TSCA fees rule for the next three-year cycle.

I. Payment of Fees and Refunds

    1. Timing. The final rule generally requires upfront payment of 
fees (i.e., payment due prior to reviewing a TSCA section 5 notice, 
within 120 days of publication of final test rule, within 120 days of 
issuance of a test order, within 120 days of signing an ECA, within 30 
days of granting a manufacturer-requested risk evaluation, and within 
120 days of publishing the final scope of a risk evaluations). However, 
for manufacturer-requested risk evaluations, payment will now be 
collected in two installments over the course of the activity.
    A number of commenters encouraged EPA to allow for phased payments, 
particularly for TSCA section 6 activities. Some of these commenters 
suggested that payment at specific milestones would better hold EPA 
accountable and assist with business planning efforts. EPA is 
finalizing an actual cost approach for manufacturer-requested risk 
evaluations which will, in effect, allow for phased payments (i.e., 
initial payment followed later by a final invoice).
    This final rule is effective the day after publication and will 
apply to all submissions that are received starting October 1, 2018. 
Section 553(d)(3) of the Administrative Procedure Act (``APA''), 5 
U.S.C. 553(d), provides that final rules shall not become effective 
until 30 days after publication in the Federal Register ``except . . . 
as otherwise provided by the agency for good cause.'' The purpose of 
this provision is to ``give affected parties a reasonable time to 
adjust their behavior before the final rule takes effect.'' Omnipoint 
Corp. v. Fed. Commc'n Comm'n, 78 F.3d 620, 630 (D.C. Cir. 1996); see 
also United States v. Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) 
(quoting legislative history). Thus, in determining whether good cause 
exists to waive the 30-day delay, an agency should ``balance the 
necessity for immediate implementation against principles of 
fundamental fairness which require that all affected persons be 
afforded a reasonable amount of time to prepare for the effective date 
of its ruling.'' Gavrilovic, 551 F.2d at 1105. EPA has determined that 
there is good cause for making this final rule effective immediately 
because, under TSCA, as amended, EPA was directed to institute a fee 
collection program to ensure that the Agency has a sustainable source 
of funding to ensure successful implementation of TSCA as Congress 
intended. As is clear by the fact that Congress provided different 
parameters for setting fees both before October 1, 2018 (26(b)(4)(B)) 
and after (26(b)(4)(F)), EPA believes it was Congress' intent for EPA 
to be able to start assessing fees as quickly as possible after the 
enactment of the fee provisions and that fees would already be in place 
by October 1, 2018 when they would need to be updated. As required by 
TSCA 26(b)(4)(E), EPA consulted and met with stakeholders that were 
potentially subject to fees in August 2016, held and industry-specific 
consultation meeting and webinar in September 2016, participated in a 
Small Business Roundtable discussion in March 2018, and had several 
meetings with individual stakeholders through the development of the 
final rule, always stressing the urgency of collecting fees and the 
expected timing of collections. In addition, EPA provided public notice 
when including this effective date in the proposed rule, did not 
receive any comments on this

[[Page 52708]]

provision, and proposed that all submissions starting October 1 would 
be subject to fees regardless of when the rule becomes effective. The 
fee amounts being finalized have not changed from the proposal other 
than those for manufacturer-requested risk evaluations, which will 
initially incur a smaller upfront fee. For these reasons, EPA believes 
that reasonable notice, including opportunity for comment has been 
provided regarding the date when fee collections will occur and that 
persons subject to the fees have had reasonable time to prepare to pay 
the fees. Between October 1, 2018 and when the rule is effective, EPA 
will track submissions and then send invoices to affected companies 
within 30 days of the effective date. Since all submitters will be 
subject to the fees starting October 1, 2018, and to minimize the need 
for after-the-submission invoicing, EPA believes there is good cause 
for an effective date one day after publication. For these reasons, the 
agency finds that good cause exists under APA section 553(d)(3) to make 
finalize its proposed approach to collect fees for all submissions that 
are received starting October 1, 2018.
    2. Consortium formation and payment. Additionally, EPA is extending 
the amount of time for manufacturers to notify EPA of their intent to 
form a consortium and the time to provide payment for certain TSCA 
section 4 and 6 activities. EPA believes this additional time will be 
useful for businesses to financially plan for the additional expense. 
Specifically, the final rule allows manufacturers subject to 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 120 days of certain 
events as described previously. For EPA-initiated risk evaluations, 
full payment is due within 120 days of EPA publishing the final scope 
of a chemical risk evaluation. The proposed rule provided 60 days for 
these activities. EPA believes this additional time will assist 
manufacturers with the process of joining a consortium, if they so 
choose, and 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. However, for manufacturer-
requested risk evaluations, EPA will still require the initial payment 
within 30 days of when EPA grants the request to conduct the 
evaluation, as indicated in the proposed rule. A manufacturer or 
manufacturers who make such a request have complete control of the 
timing of the request, and are better positioned to sort out payment 
and fee allocation issues related to a consortium before the request is 
ever sent to EPA.
    3. Applicability to ongoing activities. As described at length in 
the proposed rule, EPA proposed to begin recording fee obligations 
starting on October 1, 2018, even if the final rule is not yet 
effective. EPA is codifying this approach in the final rule. 
Specifically, EPA intends to record actions that would trigger payment 
of fees per the final rule and, once the final rule is effective, send 
invoices to the affected parties within 30 days containing information 
on timing, fee amounts and other details based on this final rule.
    A number of commenters requested that EPA explicitly state whether 
fees will apply to certain ongoing activities, such as the first 10 
chemical risk evaluations and TSCA section 5 submissions under review 
at the time the rule is finalized. To be clear, EPA will not collect 
fees for events that started prior to October 1, 2018 such as the first 
ten risk evaluations, or any TSCA section 5 activities initiated before 
that date. In these cases, the fee event is already ongoing, and EPA 
has determined not to retroactively apply fee obligations on these 
manufacturers. In addition, the costs of completing these risk 
evaluations has been included in the overall program cost estimates for 
TSCA section 6 activities, and EPA expects to recover 25% of these 
costs through implementation of this rule.
    4. Payment method. EPA originally proposed to accept payment of 
fees through two different electronic payment options: Pay.gov and 
Fedwire. However, upon further review, EPA has determined that Fedwire 
is not a viable option for the Agency's current financial systems. As 
such, the final rule will only allow electronic payment through the 
secure, Pay.gov collection portal. As indicated in the proposed rule, 
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. Manufacturers (and processors, where appropriate) 
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). Because Pay.gov does 
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 are found at https://www.epa.gov/financial/additional-instructions-making-payments-epa.
    5. Refunds. EPA proposed to issue full and partial refunds in 
certain circumstance related to TSCA section 5 activities, consistent 
with EPA's authority under TSCA sections 5(a)(4)(B) and 26(b)(4)(G). 
EPA is finalizing those provisions, with some additional clarifications 
and corrections in light of public comments. EPA will issue full 
refunds for (1) PMN submissions that are determined not to be a new 
chemical substance, (2) MCAN submissions when the microorganism is 
determined not to be a new microorganism or significant new use, (3) 
SNUN submissions if the use is determined not to be a significant new 
use, (4) when the Agency fails to make a determination on a notice by 
the end of the applicable notice review period, unless the submitter 
unduly delayed the process, and (5) when the Agency fails to approve or 
deny an exemption with the applicable review period, unless the 
submitter unduly delayed the process. EPA will issue partial refunds 
(i.e., 75% of the fee amount) if a TSCA section 5 submission is 
withdrawn during the first 10 business days after the beginning of the 
applicable review period. EPA is not able to issue refunds for the 
entire fee amount because work begins as soon as EPA receives and 
application. Due to concerns with administrative burden and potential 
delays in issuing refunds, EPA will not calculate and refund a unique 
amount for each withdrawn submission. Although EPA originally proposed 
to issue a full refund for certain incomplete submissions, EPA's 
existing regulations already provide a process and timeline for EPA and 
the submitter to correct the issue. EPA believes the existing approach 
is more efficient than immediately issuing a full refund, and requiring 
the submitter to provide a new, complete submission.
    A number of commenters had suggestions with respect to the refund 
provisions in the proposed rule. Several asked EPA to clarify the 
circumstances under which a full refund would be granted in the event 
the review is not completed within the applicable review period and 
what was meant by ``undue delay'' by the submitter that would prevent 
the submitter from receiving that full refund. Relatedly, a few 
commenters argued that voluntary

[[Page 52709]]

suspensions shouldn't pause the review period.
    With respect to full refunds, EPA is generally required to complete 
TSCA section 5 reviews within 90 days, and can unilaterally extend that 
period to 180 days under certain circumstances in TSCA. Consistent with 
longstanding practice, EPA and the submitter can, and often do, agree 
to suspend the review period to allow the submitter to develop new 
information, or to provide EPA with time to review new information. EPA 
has also historically allowed the submitter to amend their submission 
at any time during the review period. EPA intends to continue these 
practices. A voluntary suspension pauses the applicable review period. 
``Undue delay'' by the submitter, as contemplated in the proposal, 
might occur if the submitter submits an amended submission or 
significant new information late in the review process and does not 
agree to suspend the review period. In such a case, EPA does not 
believe it should be required to issue a refund if the TSCA review 
period expires. As a practical matter, EPA believes that a scenario in 
which as EPA has authority to unilaterally extend the review period for 
an additional 90 days. Moreover, most submitters have appreciated the 
flexibility to suspend the review period, as doing so is often in their 
best interest.
    A few commenters asked EPA to clarify the circumstances, if any, 
where EPA would issue refunds in the TSCA sections 4 or 6 context, such 
as when a manufacturer-requested risk evaluation fee exceeds the actual 
costs. EPA did not propose any refund provisions for TSCA sections 4 or 
6 EPA-initiated risk evaluation activities. EPA does not expect to 
exceed actual costs for these costs given that fee amounts are set 
significantly below estimated costs of these activities. See Technical 
Background Document, (Ref. 3). For example, fees for TSCA section 4 
activities are set at approximately 3.5% of the estimated costs of 
those activities. For both categories of fee-triggering events, EPA 
also believe that refunds are not appropriate based on late entrants or 
other timing reasons. In the context of manufacturer-requested risk 
evaluations, EPA is finalizing an actual cost approach, so there may 
be--in rare circumstances--a scenario where a manufacturer might be 
charged more than the cost of completing the activity and would be 
entitled to a refund. EPA has updated the final regulatory text to 
account for this possibility.

J. Multiple Parties Subject to Fee Obligations

    The final rule allows joint submissions under TSCA section 5, and 
the formation of, and payment by, consortia for submissions under TSCA 
sections 4 and 6. Manufacturers who seek to jointly submit a TSCA 
section 5 notice would be required to remit the applicable fee for each 
TSCA 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 small business discount, each joint 
submitter of a TSCA section 5 notice must qualify as a small business 
concern as defined in this rule. Manufacturers may also form a 
consortium to pay TSCA user fees for section 4 and 6 activities. The 
consortium must notify EPA of such intent. Once established, the 
consortium determines how the user fee would be split among the 
members, and ultimately paid to EPA. In response to comments, EPA made 
some minor modifications to this process, and provides some additional 
clarification on related issues:
    1. Consortia: Timing of formation and payment. Under the proposed 
rule, manufacturers would have been required to notify EPA of their 
intent to form a consortium within 30 days of the fee-triggering event 
and pay EPA within 60 days of the fee-triggering event. A significant 
number of commenters urged EPA to extend the time for consortia to form 
and pay, with suggestions of anywhere from 90 to 180 days. EPA 
recognizes the likelihood of challenges and complexities associated 
with forming consortia and managing payments. In response to public 
comments, EPA will extend the amount of time for consortia to notify 
EPA of their intent to form, as well as the payment due date, each by 
30 days. Thus, manufacturers will have 60 days to notify EPA of their 
intent to form a consortium from the triggering event, and 120 days 
total from the triggering event for payment.
    2. Consortia: Complex scenarios. EPA is providing some additional 
clarification on the division of costs amongst consortia and individual 
manufacturers for certain complex scenarios identified by commenters. 
The ideal scenario is that a single consortium forms and independently 
agrees upon allocation of payment amongst its members. In such a 
scenario, EPA would send a single invoice to the consortium, and 
receive a single payment in return. It is possible, however, for any 
number of more complicated scenarios to arise, such as formation of 
multiple consortia, or a combination of consortia and individual 
manufacturers not associated with the consortia. Adding discounts for 
small business concerns further complicates the allocation of fees in 
these scenarios.
    Consistent with the formula in the proposed rule, in any scenario 
where there is not a single consortium comprised of all manufacturers 
subject to a single fee, EPA will take the following steps to allocate 
fees:
     Count the total number of manufacturers, including the 
number of manufacturers within any consortia.
     Divide the total fee amount by the total number of 
manufacturers, and allocate equally on a per capita basis to generate a 
base fee.
     Provide all small businesses who are either (a) not 
associated with a consortium, or (b) associated with an all-small 
business consortium with an 80% discount from the base fee referenced 
previously.
     Calculate the total remaining fee and total number of 
remaining manufacturers by subtracting out the discounted fees and the 
number of small businesses identified.
     Reallocate the remaining fee across those remaining 
individuals and groups in equal amounts, counting each manufacturer in 
a consortium as one person.
    Small businesses in a successfully-formed consortium (other than an 
all-small business consortium) cannot be afforded the 80% discount by 
EPA. Association with consortia for purposes of jointly paying fees is 
a voluntary activity; EPA lacks the authority to compel consortia 
managers to provide small businesses with discounts. However, consortia 
are strongly encouraged to provide a discount for small business 
concerns.
    For example, consider a scenario in which there is one consortium 
formed (with a mix of small businesses and non-small businesses), plus 
some additional individual small businesses and non-small businesses 
not associated with the consortium. There are 10 total manufacturers, 
with 5 in the consortium and 5 individuals (2 small businesses and 3 
non-small businesses). Assume the total fee is $100,000. The base fee 
would be $10,000 ($100,000 divided by 10 manufacturers). The two 
individual small businesses (not associated with consortium) would be 
responsible for $2,000 each ($10,000 base fee x 0.2). That leaves 
$96,000 to be paid across 8 total remaining manufacturers. The 
consortium (5 of 8 remaining manufacturers) would responsible for 62.5% 
of the remaining fee or $60,000,

[[Page 52710]]

and they would be free to determine how to allocate that amount amongst 
their membership. Any small businesses within the consortium are not 
provided a discount by EPA. Each of the 3 individual non-small business 
manufacturers would be responsible for 12.5% of the remaining fee or 
$12,000.
    3. Consortia: Failure to reach agreement. If a consortium is unable 
to reach agreement on splitting the fee, the principal sponsor must 
notify EPA prior to the expiration of the 60-day notification period. 
EPA defines the principal sponsor as a person who assumes primary 
responsibility for the direction of the study, the payment of fees to 
EPA, and for oral and written communication with EPA. This notification 
by the principal sponsor effectively nullifies the formation of the 
consortium, and each member will be treated as an individual 
manufacturer, and must pay their portion of the fee--as calculated by 
EPA--within the time period remaining. The Agency will divide the total 
fee by the number of manufacturers. Small businesses will be afforded 
an 80% discount.
    4. Consortia: Small business concerns. EPA strongly encourages 
consortia to set lower fees for small business concerns; Congress 
generally intended small businesses to be afforded lower fee payments 
(TSCA section 26(b)(4)(A)). Some commenters suggested that EPA should 
go further in prescribing fairness in consortia dealings, including 
dealings with small businesses. At least one commenter suggested that 
an expectation that consortia would assign lower fees to small 
businesses is unrealistic. Another commenter suggested EPA should 
require consortia to give a small business discount. One commenter 
suggested that the proposal would result in formation of all small 
business consortia every time, given that small businesses would 
surrender their small business protections by consorting with non-small 
businesses. However, association with a consortium is a voluntary 
activity; a small business will always have the choice to not associate 
with a consortium and to receive the small business discount. Further, 
EPA does not believe it has the authority in TSCA to compel consortia 
managers to provide a discount to small businesses. Nevertheless, EPA 
strongly encourage consortia to do so.
    5. Consortia: Administrative costs and burden. Several commenters 
suggested that EPA recognize administrative costs associated with 
consortia formation and management that companies would be expected to 
bear, and to set those expectations in final rule. The administrative 
costs of consortia management would be set by third parties and 
completely outside the control of EPA, and would not be appropriate for 
EPA to factor this into program cost estimates or otherwise reflect in 
the fee amounts. However, based on public comments, EPA is including 
some minor updates to the economic analysis to reflect this additional 
administrative burden and costs associated with forming consortia for 
the distinct purpose of submitting fee payments.

K. Enforcement

    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. 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 a consortium. 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. EPA may develop enforcement response policy 
guidance provisions for this rule. In the meantime, EPA's Office of 
Enforcement will rely on TSCA section 16(a)(2)(B) and GM 21 at https://www.epa.gov/enforcement/policy-civil-penalties-epa-general-enforcement-policy-gm-21.

L. Compliance Date

    EPA will be able to start collecting fees the day after the final 
TSCA user fees regulations are published in the Federal Register. For 
EPA to sufficiently address the increased workload under TSCA, the 
Agency must start collecting fees as soon as possible for use in 
defraying implementation costs. All submissions starting October 1, 
2018 are subject to the fees in this rule regardless of when the rule 
becomes effective. For submissions received between October 1, 2018 and 
the effective date of the rule, EPA will invoice submitters within 30 
days.

M. Conforming and Other Technical Amendments

    EPA is finalizing minor changes to several of its regulations that 
cross-reference the part 700 fees regulations, specifically 40 CFR 
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 finalized today. These include 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

    EPA has evaluated the potential costs for entities potentially 
subject to this final rule. More details can be found in the Economic 
Analysis (Ref. 2) for this rule.
    For the baseline, EPA used the number of section 5 submissions 
received in FY 2016 for each of the types of fee-triggering section 5 
categories (Ref. 7) as the estimate of the number of submissions per 
section 5 fee category for the next three years in the absence of the 
rule. As a result of the final rule, EPA expects that the number of 
PMNs, MCANs, and SNUNs submitted would decline by 20% from the 
baseline, while the number of exemptions would remain the same, on 
average. Test orders under section 4 are new under TSCA as amended and 
the average number of test orders expected per year represents an EPA 
estimate based on previous experience and expected work under TSCA as 
amended. Similarly, for the other fee categories under section 4 (test 
rules and ECAs), EPA also estimated the expected number of such actions 
per year based on previous experience and expected work under TSCA as 
amended. The amended TSCA regulations specify the number of risk 
evaluations that EPA must have ongoing over the next three years. 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.
    EPA calculated fees by estimating the total annual costs of 
administering TSCA sections 4, 5, and 6 (excluding the costs of 
manufacturer-requested risk evaluations) and of collecting, processing, 
reviewing, and providing access to and protecting from disclosure as 
appropriate under section 14; identifying the full amount to be 
defrayed by fees under TSCA section 26(b) (i.e., 25% of those annual 
costs);

[[Page 52711]]

and allocating that amount across the fee--triggering events in 
sections 4, 5, and 6, weighted more heavily toward section 6 based on 
early industry feedback. EPA estimates the total fee collection by 
multiplying the fees with the number of expected fee-triggering events 
under full implementation for each fee category, for a total of 
approximately $20 million in average annual fee revenue. This total 
does not include the fees collected for manufacturer-requested risk 
evaluations. EPA estimates that section 4 fees account for less than 
one percent of the total fee collection, section 5 fees for 
approximately 43 percent, and section 6 fees for approximately 56 
percent.
    Total annual fee collection for manufacturer-requested risk 
evaluations is estimated to be $1.3 million for chemicals included in 
the Work Plan (based on two requests over the three-year period) and 
approximately $3.9 million for chemicals not included in the Work Plan 
(based on three requests over the three-year period).
    For small businesses, EPA estimates that 18.6 percent of section 5 
submissions will be from small businesses that are eligible to pay the 
small business fee because they are classified as small businesses 
based on the SBA small business thresholds. Total annualized fee 
collection from small businesses submitting under section 5 is 
estimated to be $339,000 (Ref. 2). For sections 4 and 6, reduced fees 
paid by eligible small businesses and fees by paid non-small businesses 
may differ over the three-year period that was analyzed, since the fee 
paid by each entity is dependent on the number of entities identified 
per fee-triggering event. EPA relied on past experience with Test Rules 
for HPV chemicals under section 4 as well as work to date on the first 
ten 10 chemicals currently undergoing risk evaluation under section 6 
to inform its estimates of average number of small businesses impacted 
per action, and estimates that average annual fee collection from small 
businesses impacted by section 4 and section 6 would be approximately 
$7,000 and $926,000, respectively. For each of the three years covered 
by this rule, EPA estimates that total fee revenue collected from small 
businesses will account for about 6 percent of the approximately $20 
million total fee collection, for an annual average total of 
approximately $1.3 million.
    This rule establishes fee requirements for affected manufacturers 
(including importers) and, in some cases, processors of chemical 
substances. The fees to be paid by industry would defray the cost for 
EPA to administer TSCA sections 4, 5, 6, and collecting, processing, 
reviewing, and providing access to and protecting information about 
chemical substances from disclosure as appropriate under TSCA section 
14. Absent this 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 rule, 25% of EPA costs to 
administer TSCA section 4, 5, 6, and collecting, processing, reviewing, 
and providing access to and protecting information about chemical 
substances from disclosure as appropriate under TSCA section 14, and 
activities paid from general revenue would be transferred via the 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 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 rule; 
determine their eligibility for paying reduced fees; register for CDX; 
form, manage and notify EPA of participation in consortia; notify EPA 
and certify whether they will be subject to the action or not; and 
arrange to submit fee payments via Pay.gov. Total social costs also 
include the additional costs to EPA to administer fee assessment and 
collection for TSCA sections 4, 5, 6, and collecting, processing, 
reviewing, and providing access to and protecting information about 
chemical substances from disclosure as appropriate under TSCA section 
14. The total annualized opportunity cost to industry is approximately 
$231,000 and the additional annualized Agency cost is $7,000, yielding 
a total annualized social cost of approximately $238,000.

V. 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. 2018. EPA. Updated Technical Background Document for TSCA Fees. 
September 2018.
4. 2017. EPA. Interagency Agreement and Oil Indirect Cost Rates for 
FY 2018 and Beyond. September 28, 2017.
5. 2002. EPA. 67 FR 76282. Sustainable Futures--Voluntary Pilot 
Project Under the TSCA New Chemicals Program.
6. 2016. Abt Associates. Memorandum: Inflation of Small Business 
Definition under section 5 of TSCA. August 31, 2016.
7. 1987. EPA. Proposed Fees for Processing Premanufacture Notices, 
Exemption Applications and Notices, and Significant New Use Notices. 
42 FR 12940.
8. 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.
9. 2018. EPA. TSCA Fee Reporting Notice. September 2018.

VI. 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 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 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.

[[Page 52712]]

C. Paperwork Reduction Act (PRA)

    The information collection requirements in this final 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 No. 2569.01 and OMB Control No. 2070-0208. 
You can find a copy of the ICR in the docket (Ref. 8), and it is 
briefly summarized here.
    The information collection activities associated with the rule 
include familiarization with the regulation; reduced fee eligibility 
determination; CDX registration; formation, management and notification 
to EPA of participation in consortia; self-identification and 
certification; and electronic payment of fees through Pay.gov.
    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 or 5, or 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: 1,418 respondents.
    Frequency of response: On occasion to EPA as needed.
    Total estimated burden: 539 hours (per year). Burden is defined at 
5 CFR 1320.3(b).
    Total estimated cost: $230,607 (per year), includes $0 annualized 
capital or operation and maintenance costs.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers are 
displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The OMB control numbers for certain EPA 
regulations are listed in 40 CFR part 9.

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; and 24 small businesses may be affected by section 6 
actions. For section 5 actions, the total discounted annual fee 
collections and opportunity cost for the affected small businesses is 
expected to be about $344,000. For section 4 and section 6 actions, 
total discounted annual fee collections and opportunity cost for the 
affected small business is expected to be about $14,000 and $927,000 
respectively. In total, the annual fee collections and opportunity 
costs for the 298 affected small businesses is expected to be about 
$1.3 million.
    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 estimates the median annual sales for small businesses likely to be 
affected by TSCA section 4 and TSCA section 6 actions to be 
approximately $5,445,000; and $3,475,000 for small businesses likely to 
be affected by TSCA section 5 actions. The average annual cost per 
affected small business is expected to be about $170 for section 4; 
$1,800 for section 5, and $38,600 for section 6.

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 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 would establish 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

    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.
    The fees collected under this rule will assist the Agency in 
carrying out various requirements under TSCA, including conducting risk 
evaluations, requiring testing of chemical substances and mixtures, and 
evaluating and reviewing new chemical submissions, as required under 
TSCA sections 4, 5, and 6.

[[Page 52713]]

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.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to the U.S. Senate, and the U.S. House of 
Representatives, and the Comptroller General of the United States. This 
action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 700

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

40 CFR Part 720

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

40 CFR Part 723

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

40 CFR Part 725

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

40 CFR Part 790

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

40 CFR Part 791

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

    Dated: September 27, 2018.
Andrew R. Wheeler,
Acting Administrator.

    Therefore, 40 CFR chapter I, subchapter R, is amended 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 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 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, who manufacture a chemical substance that is subject to a risk 
evaluation under TSCA section 6(b)(4) of the Act, and who process a 
chemical substance that is the subject of a Significant New Use Notice 
(SNUN) or Test Market Exemption (TME) under section 5 of the Act and 
who are required to submit information under section 4 of the Act 
related to a SNUN submission.
    (c) Effective date. After October 18, 2018, 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
b. Revising the introductory text;
0
c. Adding in alphabetical order definitions for ``Consortium'', 
``Enforceable consent agreement'', and ``EPA-initiated risk 
evaluation'';
0
d. Removing the definitions of ``Exemption application'' and 
``Intermediate premanufacture notice'';
0
e. Revising the definition of ``Joint submitters'';
0
f. Adding in alphabetical order a definition for ``Manufacturer-
requested risk evaluation'';
0
g. Revising the definition of ``Person'';
0
h. 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 and/or processors 
who have made an agreement to jointly split the cost of applicable 
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 or processor.
* * * * *
    Principal sponsor means a person who assumes primary responsibility 
for the direction of study, the payment of 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 a manufacturer or processor who meets 
the size standards identified in the following table. The number of 
employees indicates the maximum allowed for a manufacturer or processor 
to be considered small. If the North American Industry Classification 
System (NAICS) code of a manufacturer or processor is not represented 
in the table, it will be considered small if it has 500 or fewer 
employees. When calculating the number of employees, a manufacturer or 
processor must include the employees of all of its ``parent companies'' 
(if any) and all companies it ``owns or controls,'' as defined by 40 
CFR 704.3. The number of employees are calculated as the average number 
of people employed for each pay period of

[[Page 52714]]

the business' latest 12 calendar months, regardless of hours worked or 
temporary status.

----------------------------------------------------------------------------------------------------------------
                                                                         Small business concern size standards
     Potentially affected NAICS              NAICS description                   (number of employees)
----------------------------------------------------------------------------------------------------------------
324110..............................  Petroleum Refineries...........  1,500 or fewer.
325110..............................  Petrochemical Manufacturing....  1,000 or fewer.
325120..............................  Industrial Gas Manufacturing...  1,000 or fewer.
325130..............................  Synthetic Dye and Pigment        1,000 or fewer.
                                       Manufacturing.
325180..............................  Other Basic Inorganic Chemical   1,000 or fewer.
                                       Manufacturing.
325193..............................  Ethyl Alcohol Manufacturing....  1,000 or fewer.
325194..............................  Cyclic Crude, Intermediate, and  1,250 or fewer.
                                       Gum and Wood Chemical
                                       Manufacturing.
325199..............................  All Other Basic Organic          1,250 or fewer.
                                       Chemical Manufacturing.
325211..............................  Plastics Material and Resin      1,250 or fewer.
                                       Manufacturing.
325212..............................  Synthetic Rubber Manufacturing.  1,000 or fewer.
325220..............................  Artificial and Synthetic Fibers  1,000 or fewer.
                                       and Filaments Manufacturing.
325311..............................  Nitrogenous Fertilizer           1,000 or fewer.
                                       Manufacturing.
325312..............................  Phosphatic Fertilizer            750 or fewer.
                                       Manufacturing.
325314..............................  Fertilizer (Mixing Only)         500 or fewer.
                                       Manufacturing.
325320..............................  Pesticide and Other              1,000 or fewer.
                                       Agricultural Chemical
                                       Manufacturing.
325411..............................  Medicinal and Botanical          1,000 or fewer.
                                       Manufacturing.
325412..............................  Pharmaceutical Preparation       1,250 or fewer.
                                       Manufacturing.
325413..............................  InVitro Diagnostic Substance     1,250 or fewer.
                                       Manufacturing.
325414..............................  Biological Product (except       1,250 or fewer.
                                       Diagnostic) Manufacturing.
325510..............................  Paint and Coating Manufacturing  1,000 or fewer.
325520..............................  Adhesive Manufacturing.........  500 or fewer.
325611..............................  Soap and Other Detergent         1,000 or fewer.
                                       Manufacturing.
325612..............................  Polish and Other Sanitation      750 or fewer.
                                       Good Manufacturing.
325613..............................  Surface Active Agent             750 or fewer.
                                       Manufacturing.
325620..............................  Toilet Preparation               1,250 or fewer.
                                       Manufacturing.
325910..............................  Printing Ink Manufacturing.....  500 or fewer.
325920..............................  Explosives Manufacturing.......  750 or fewer.
325991..............................  Custom Compounding of Purchased  500 or fewer.
                                       Resins.
325992..............................  Photographic Film, Paper, Plate  1,500 or fewer.
                                       and Chemical Manufacturing.
325998..............................  All Other Miscellaneous          500 or fewer.
                                       Chemical Product and
                                       Preparation Manufacturing.
424690..............................  Other Chemical and Allied        150 or fewer.
                                       Products Merchant Wholesalers.
424710..............................  Petroleum Bulk Stations and      200 or fewer.
                                       Terminals.
424720..............................  Petroleum and Petroleum          200 or fewer.
                                       Products Merchant Wholesalers
                                       (except Bulk Stations and
                                       Terminals).
----------------------------------------------------------------------------------------------------------------

    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 submitting a TSCA 
section 5 notice to EPA shall remit for each such notice the applicable 
fee identified in paragraph (c) of this section in accordance with the 
procedures in paragraphs (f) and (g) of this section.
    (2) 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 shall remit for 
each such test rule, order, or enforceable consent agreement the 
applicable fee identified in paragraph (c) of this section in 
accordance with the procedures in paragraphs (f) and (g) of this 
section.
    (3) 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 (c) 
of this section in accordance with the procedures in paragraphs (f) and 
(g) of this section.
    (4) Processors submitting a SNUN or TME under TSCA section 5 to EPA 
shall remit for each such notice the applicable fee identified in 
paragraph (c) of this section in accordance with the procedures in 
paragraphs (f) and (g) of this section.
    (5) Processors of chemical substances and mixtures subject to a 
TSCA section 4(a) test rule, test order, or enforceable consent 
agreement in association with a SNUN submission referenced in paragraph 
(a)(4) of this section shall remit for each such test rule, order, or 
enforceable consent agreement the applicable fee identified in 
paragraph (c) of this section in accordance with the procedures in 
paragraphs (f) and (g) of this section.
    (b) Identifying manufacturers subject to fees--(1) In general. For 
purposes of identifying manufacturers subject to fees for section 4 
test rules and section 6 EPA-initiated risk evaluations, EPA will 
publish a preliminary list of manufacturers identified through a review 
of data sources described in paragraph (b)(2) of this subsection; 
provide an opportunity for public comment; and publish a final list 
specifying the manufacturers responsible for payment.
    (2) Data sources. To compile the preliminary list, EPA will rely on 
information submitted to the Agency (such as the information submitted 
under sections 5(a), 8(a), 8(b), and to the Toxics Release Inventory) 
as well as other information available to the Agency, including 
publicly available information or information submitted to other 
agencies to which EPA has access. To be able to include the most recent 
CDR data and to account for annual or other typical fluctuations in 
manufacturing, EPA will use the five most recent years of data 
submitted or

[[Page 52715]]

available to the Agency to develop the preliminary list.
    (3) Publication of preliminary list. (i) For risk evaluations 
initiated by EPA under section 6, the preliminary list will be 
published at the time of final designation of the chemical substance as 
a High-Priority Substance.
    (ii) For test rules under section 4, the preliminary list will be 
published with the proposed test rule.
    (4) Public comment period. Following publication of the preliminary 
list, EPA will provide a period of public comment that is no less than 
30 days.
    (5) Self-identification. All manufacturers who have manufactured or 
imported the chemical substance in the previous five years, must submit 
notice to EPA, irrespective of whether they are included in the 
preliminary list specified in paragraph (b)(3) of this section. The 
notice must be submitted electronically via EPA's Central Data Exchange 
(CDX), the Agency's electronic reporting portal, using the Chemical 
Information Submission System (CISS) reporting tool, and must contain 
the following information:
    (i) Contact information. The name and address of the submitting 
company, the name and address of the authorized official for the 
submitting company, and the name and telephone number of a person who 
will serve as technical contact for the submitting company and who will 
be able to answer questions about the information submitted by the 
company to EPA.
    (ii) Certification of cessation. If a manufacturer has manufactured 
in the five-year period preceding publication of the preliminary list, 
but has ceased manufacturer prior to the certification cutoff dates 
identified in paragraph (b)(6) of this section and will not manufacture 
the substance again in the successive five years, the manufacturer may 
submit a certification statement attesting to these facts. If EPA 
receives such a certification statement from a manufacturer, the 
manufacturer will not be obligated to pay the fee under this section.
    (iii) Certification of no manufacture. If a manufacturer is 
identified on the preliminary list, but has not manufactured the 
chemical in the five-year period preceding publication of the 
preliminary list, the manufacturer may submit a certification statement 
attesting to these facts. If EPA receives such a certification 
statement from a manufacturer, the manufacturer will not be obligated 
to pay the fee under this section.
    (6) Certification cutoff date. (i) For a section 6 EPA-initiated 
risk evaluation, the cutoff date for purposes of paragraph (b)(5)(ii) 
of this section is the day prior to initiation of the prioritization 
process for the applicable chemical substance.
    (ii) For a section 4 test rule, the cutoff date for purposes of 
paragraph (b)(5)(ii) of this section is the day prior to publication of 
the proposed test rule for the applicable chemical substance.
    (7) Publication of final list. EPA expects to publish a final list 
of manufacturers to identify the specific manufacturers subject to the 
applicable fee. This list will indicate if additional manufacturers 
self-identified pursuant to paragraph (b)(5) of this section, if other 
manufacturers were identified through credible public comment, and if 
manufacturers submitted certification of cessation or no manufacture 
pursuant to paragraph (b)(5)(ii) or (iii). The final list will be 
published no later than concurrently with the final scope document for 
risk evaluations initiated by EPA under section 6, and with the final 
test rule for test rules under section 4.
    (8) Effect of final list. Manufacturers who are listed on the final 
list are subject to the applicable fee identified in paragraph (c) of 
this section.
    (9) Identifying manufacturers for other fee categories. For Section 
4 Test Orders and enforceable consent agreements, and Section 6 
Manufacturer-Requested Risk Evaluations, EPA will not conduct the 
identification process described in paragraphs (b)(1) through (8) of 
this section, as manufacturers self-identify through a submission or 
are already otherwise known to Agency. However, those manufacturers are 
required to provide an information submission to EPA for the purposes 
of fee administration. The notice must be submitted electronically via 
the Agency's electronic reporting software (e.g., Central Data Exchange 
(CDX)) and must contain the manufacturers: Full name, address, 
telephone number and email address. Timing of this submission must be 
as follows:
    (i) For section 4 test orders and enforceable consent agreements, 
the informational submission in this paragraph (b)(9) must be provided 
within 30 days following notification from EPA.
    (ii) For section 6 manufacturer-requested risk evaluations, the 
informational submission in this paragraph (b)(9) is required as part 
of the procedural process for making such requests, and must be 
completed at the time of making the request.
    (c) 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:
    (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 fee under paragraph (c)(2)(vi), (vii) or (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 fee under paragraphs (c)(2)(ix) of this section for an EPA-
initiated risk evaluation.

[[Page 52716]]

    (viii) Persons shall remit the total fee under paragraph (c)(2)(x) 
or (xi) of this section, as applicable, for a manufacturer-requested 
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 an initial fee of $1,250,000, and final payment to 
total 50% of the actual costs of this activity, in accordance with the 
procedures in paragraph (g) of this section. The final payment amount 
will be determined by EPA, and invoice issued to the requesting 
manufacturer.
    (xi) Manufacturer-requested risk evaluation of a non-work plan 
chemical. Persons shall remit an initial fee of $2,500,000, and final 
payment to total 100% of the actual costs of the activity, in 
accordance with the procedures in paragraph (g) of this section. The 
final payment amount will be determined by EPA, and invoice issued to 
the requesting manufacturer.
    (d) 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 (c) of this section 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 fee specified in paragraph (c) 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 public consultation through notice-
and-comment rulemaking prior to making fee adjustments beyond 
inflation. 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.
    (e) 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.
    (f) 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 (c) 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 (c)(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 fee 
under section 4 of the Act is required to remit the appropriate fee 
identified in paragraph (c) 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 (c)(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 submit fee payment 
pursuant to this paragraph, or to provide notice of failure to reach 
agreement pursuant to paragraph (f)(2)(v) of this section constitutes a 
violation by each consortium member.
    (i) The consortium must identify a principal sponsor and provide 
notification to EPA that a consortium has formed. The notification must 
be accomplished within 60 days of the publication date of a test rule 
under section 4 of the Act, or within 60 days of the issuance of a test 
order under Section 4 of the Act, or within 60 days of the signing of 
an enforceable consent agreement under section 4 of the Act. EPA may 
permit additional entities to join an existing consortium prior to the 
expiration of the notification period if the principal sponsor provides 
updated notification.
    (ii) Notification must be submitted electronically via the Agency's 
electronic reporting software--Central Data Exchange (CDX)--and include 
the following information:

[[Page 52717]]

    (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 strongly 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 fees will be 
split among the persons in the consortium, the principal sponsor must 
notify EPA in writing before the end of the notification period in 
paragraph (f)(2)(i) of this section.
    (vi) If a consortium provides notice to EPA under paragraph 
(f)(2)(v) of this section that they failed to reach agreement on 
payment, EPA will assess fees to all persons as individuals described 
under paragraph (f)(4) of this section.
    (3) Any consortium formed to split the cost of the applicable fee 
supporting a risk evaluation under section 6(b) of the Act is required 
to remit the appropriate fee identified in paragraph (c) 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 (c)(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 (f)(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 60 days of the 
publication of the final scope of a chemical risk evaluation under 
section 6(b)(4)(D) of the Act or within 60 days of EPA providing 
notification to a manufacturer that a manufacturer-requested risk 
evaluation has been granted.
    (ii) Notification must be submitted electronically via the Agency's 
electronic reporting software--Central Data Exchange (CDX)--and include 
the following information:
    (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 strongly 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 fees will be 
split among the persons in the consortium, the principal sponsor must 
notify EPA in writing before the end of the notification period in 
paragraph (f)(3)(i) of this section.
    (vi) If a consortium provides notice to EPA under paragraph 
(f)(3)(v) of this section that they failed to reach agreement on 
payment, EPA will assess fees to all persons as individuals as 
described under paragraph (f)(4) of this section.
    (4) If multiple persons are subject to 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 fee to be remitted by each person 
subject to the requirement. Each person's share of the applicable fee 
specified in paragraph (c) 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] TR17OC18.018


Where:

Ps = the portion of the fee under paragraph (c) 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 fee owed by a person other than a 
small business concern.
F = the total fee required under paragraph (c) of this section.
Mt = the total number of persons subject to the fee 
requirement.
Ms = the number of persons subject to the fee requirement 
who qualify as a small business concern.

    (5) If multiple persons are subject to 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 take the following steps to allocate fee amounts:
    (i) Count the total number of manufacturers, including the number 
of manufacturers within any consortia; divide the total fee amount by 
the total number of manufacturers; and allocate equally on a per capita 
basis to generate a base fee.
    (ii) Provide all small businesses who are either not associated 
with a consortium, or associated with an all-small business consortium 
with an 80% discount from the base fee referenced previously.
    (iii) Calculate the total remaining fee and total number of 
remaining manufacturers by subtracting out the discounted fees and the 
number of small businesses identified;
    (iv) Reallocate the remaining fee across those remaining 
individuals and groups in equal amounts, counting each manufacturer in 
a consortium as one person; and
    (v) Inform consortia and individuals of their requisite fee amount.
    Small businesses in a successfully-formed consortium, other than a 
consortium of all small businesses will not be afforded the 80% 
discount by EPA, but consortia managers are strongly encouraged to 
provide a discount for small business concerns.
    (g) 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 online electronic payment service, or any 
applicable additional or successor online electronic

[[Page 52718]]

payment service offered by the Department of Treasury.
    (2) Fees incurred prior to October 18, 2018. Timing of payment for 
fees incurred between October 1, 2018 and October 18, 2018. Fees 
required by paragraph (c) of this section for which the fee-triggering 
action or event occurred between October 1, 2018, and October 18, 2018 
shall be paid in response to invoices EPA will send within 30 days of 
October 18, 2018.
    (3) Fees incurred after October 18, 2018. Timing of payment for 
fees incurred after October 18, 2018. Fees required by paragraph (c) of 
this section for which the fee-triggering action or event occurred 
after October 18, 2018 shall be paid at the following time:
    (i) Test orders and test rules. The applicable fee specified in 
paragraph (c) of this section shall be paid in full not later than 120 
days after the effective date of a test rule or test order under 
section 4 of the Act.
    (ii) Enforceable consent agreements. The applicable fee specified 
in paragraph (c) of this section shall be paid in full not later than 
120 days after the signing of an enforceable consent agreement under 
section 4 of the Act.
    (iii) Section 5 notice. The applicable fee specified in paragraph 
(c) 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 fee specified in paragraph (c) of this section shall be paid 
in full not later than 120 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 fees specified in paragraph 
(c) of this section shall be paid as follows:
    (1) The first payment towards the applicable fee specified in 
paragraph (c) 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.
    (2) The final payment towards the applicable fee specific in 
paragraph (c) of this section shall be paid in full not later than 30 
days after EPA publishes a final risk evaluation in the Federal 
Register.
    (4) Payment identity. (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 
used to transmit the 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 
used to transmit the 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 used to transmit the 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) Small business certification. (i) Each person who remits the 
fee identified in paragraph (c)(1) of this section for a PMN, 
consolidated 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(c).'' 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 (c)(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(c).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (c)(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(c).'' 
in the certification required in Sec.  723.175(i)(1)(x) of this 
chapter.
    (iv) Each person who remits the fee identified in paragraph (c)(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(c).'' in 
the certification required in Sec.  725.25(b) of this chapter.
    (6) Payment certification statement. (i) Each person who remits a 
fee identified in paragraph (c)(2) of this section for a PMN, 
consolidated 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(c).'' 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 (c)(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(c).'' in the exemption application.
    (iii) Each person who remits the fee identified in paragraph (c)(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

[[Page 52719]]

with 40 CFR 700.45(c).'' in the certification required in Sec.  
723.175(i)(1)(x) of this chapter.
    (iv) Each person who remits the fee identified in paragraph (c)(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(c).'' in 
the certification required in Sec.  725.25(b) of this chapter.
    (h) Full fee refunds. EPA will refund, in totality, any fee paid 
for a section 5 notice whenever the Agency determines:
    (1) 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,
    (2) In the case of a SNUN, that the notice was not required,
    (3) 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
    (4) 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
    (5) 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.
    (i) 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 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.
    (3) If EPA determines that the initial payment for a manufacturer-
requested risk evaluation exceed the applicable fee in paragraph (c) of 
this section, EPA will refund the difference.

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(g) is included 
and until the appropriate remittance under Sec.  700.45(c) has been 
submitted as provided in Sec.  700.45(g). 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(c) for a test order, test rule, enforceable consent 
agreement, or EPA-initiated risk evaluation as provided in Sec.  
700.45(g) is a violation of TSCA and enforceable under section 15 of 
the Act.
    (c) EPA will not initiate a manufacturer-requested risk evaluation 
the request for which the Agency has otherwise determined to be 
complete unless EPA has determined to grant the request and the 
appropriate initial remittance under Sec.  700.45(c) has been submitted 
as provided in Sec.  700.45(g).
    (d) Failure to submit the appropriate final remittance specified 
under Sec.  700.45(c) for a manufacturer-requested risk evaluation as 
provided in Sec.  700.45(g) is a violation of TSCA and enforceable 
under section 15 of the Act.

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 fee payment identity number, as required in 40 CFR 
700.45(g)(4).
* * * * *
    (f) When applying for a test marketing exemption, persons are 
subject to 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 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. Revise section 723.175 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) Purpose and scope. (1) This section grants an exemption from 
the premanufacture notice requirements of section 5(a)(1)(A) of the 
Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the 
manufacture and processing of new chemical substances used in or for 
the manufacture or processing of instant photographic and peel-apart 
film articles. This section does not apply to microorganisms subject to 
part 725 of this chapter.
    (2) To manufacture a new chemical substance under the terms of this 
exemption, a manufacturer of instant photographic or peel-apart film 
articles must:
    (i) Submit an exemption notice when manufacture begins under 
paragraph (i) of this section.
    (ii) Comply with certain requirements to limit exposure to the new 
chemical substance under paragraphs (e) through (h) of this section.
    (iii) Comply with all recordkeeping requirements under paragraph 
(j) of this section.
    (iv) Remit the applicable fee specified in Sec.  700.45(c) of this 
chapter.
    (b) Definitions--(1) Act means the Toxic Substances Control Act (15 
U.S.C. 2601 et seq.).
    (2) An article is a manufactured item--
    (i) Which is formed to a specific shape or design during 
manufacture;
    (ii) Which has end use function(s) dependent in whole or in part 
upon its shape or design during end use; and
    (iii) Which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial

[[Page 52720]]

purpose separate from that of the article and that may occur as 
described in Sec.  710.2 of this chapter except that fluids and 
particles are not considered articles regardless of shape or design.
    (3) The terms byproduct, EPA, impurities, person, and site have the 
same meanings as in Sec.  710.3 of this chapter.
    (4) The term category of chemical substances has the same meaning 
as in section 26(c)(2) of the Act (15 U.S.C. 2625).
    (5) The terms chemical substance, distribute in commerce, 
distribution in commerce, environment, manufacture, new chemical 
substance, and process have the same meanings as in section 3 of the 
Act (15 U.S.C. 2602).
    (6) Director of the Office of Pollution Prevention and Toxics means 
the Director of the EPA Office of Pollution Prevention and Toxics or 
any EPA employee designated by the Office Director to carry out the 
Office Director's functions under this section.
    (7) The term exemption category means a category of chemical 
substances for which a person(s) has applied for or been granted an 
exemption under section 5(h)(4) of the Act (15 U.S.C. 2604).
    (8) The term instant photographic film article means a self-
developing photographic film article designed so that all the chemical 
substances contained in the article, including the chemical substances 
required to process the film, remain sealed during distribution and 
use.
    (9) Intermediate means any chemical substance which is consumed in 
whole or in part in a chemical reaction(s) used for the intentional 
manufacture of another chemical substance.
    (10) Known to or reasonably ascertainable means all information in 
a person's possession or control, plus all information that a 
reasonable person similarly situated might be expected to possess, 
control, or know, or could obtain without unreasonable burden or cost.
    (11) The term peel-apart film article means a self-developing 
photographic film article consisting of a positive image receiving 
sheet, a light sensitive negative sheet, and a sealed reagent pod 
containing a developer reagent and designed so that all the chemical 
substances required to develop or process the film will not remain 
sealed within the article during and after the development of the film.
    (12) Photographic article means any article which will become a 
component of an instant photographic or peel-apart film article.
    (13) Special production area means a demarcated area within which 
all manufacturing, processing, and use of a new chemical substance 
takes place, except as provided in paragraph (f) of this section, in 
accordance with the requirements of paragraph (e) of this section.
    (14) Test data means:
    (i) Data from a formal or informal study, test, experiment, 
recorded observation, monitoring, or measurement.
    (ii) Information concerning the objectives, experimental methods 
and materials, protocols, results, data analyses (including risk 
assessments), and conclusions from a study, test, experiment, recorded 
observation, monitoring, or measurement.
    (15) Used in or for the manufacturing or processing of an instant 
photographic or peel-apart film article, when used to describe 
activities involving a new chemical substance, means the new chemical 
substance--
    (i) Is included in the article; or
    (ii) Is an intermediate to a chemical substance included in the 
article or is one of a series of intermediates used to manufacture a 
chemical substance included in the article.
    (16) Wet mixture means a water or organic solvent-based suspension, 
solution, dispersion, or emulsion used in the manufacture of an instant 
photographic or peel-apart film article.
    (c) Exemption category. The exemption category includes new 
chemical substances used in or for the manufacture or processing of 
instant photographic or peel-apart film articles which are manufactured 
and processed under the terms of this section.
    (d) Applicability. This exemption applies only to manufacturers of 
instant photographic or peel-apart film articles who:
    (1) Manufacture the new chemical substances used in or for the 
manufacture or processing of the instant photographic or peel-apart 
film articles.
    (2) Limit manufacture and processing of a new chemical substance to 
the site(s) listed in the exemption notice for that new chemical 
substance submitted under paragraph (i) of this section.
    (3) Comply with the requirements of paragraphs (e), (f), (g), (h), 
and (j) of this section.
    (4) Do not distribute in commerce or use a peel-apart film article 
containing a new chemical substance until submission of a 
premanufacture notice under section 5(a)(1)(A) of the Act (15 U.S.C. 
2604) and until the review period for the notice has ended without EPA 
action to prevent distribution or use.
    (e) Conditions of manufacture and processing in the special 
production area. All manufacturing, processing, and use operations 
involving the new chemical substance must be performed in a special 
production area under the conditions set forth in this paragraph until 
the new chemical substance has been incorporated into a wet mixture, 
photographic article, or instant photographic or peel-apart film 
article.
    (1) Exposure limits. In the special production area, the ambient 
air concentration of the new chemical substance during manufacture, 
processing, and use cannot exceed an 8-hour time weighted average (TWA) 
of 10 ppm for gases and vapors and 50 [micro]g/m\3\ for particulates, 
with an allowable TWA excursion of 50 percent above those 
concentrations for a duration of 30 minutes or less.
    (2) Respiratory protection--(i) Respirator requirement. Except as 
specified in paragraph (e)(2)(ii) of this section, each person in the 
special production area must wear an appropriate respiratory protection 
device to protect against dusts, fumes, vapors, and other airborne 
contaminants, as described in 29 CFR 1910.134. Selection of an 
appropriate respirator must be made according to the guidance of 
American National Standard Practices for Respiratory Protection Z88.2-
1969 and the NIOSH Certified Equipment List, U.S. Department of Health 
and Human Services, NIOSH publication No. 80-144.
    (ii) Waiver of respirator requirement. Employees are not required 
to wear respirators if monitoring information collected and analyzed in 
accordance with paragraph (e)(3) of this section demonstrates that the 
ambient 8-hour TWA concentration of the new chemical substance in the 
area is less than 1 ppm for gases and vapors and 5 [micro]g/m\3\ for 
particulates with an allowable TWA excursion of 50 percent above these 
concentrations for a duration of 30 minutes or less.
    (iii) Quantitative fit test. Each respirator must be issued to a 
specific individual for personal use. A quantitative fit test must be 
performed for each respirator before its first use by that person in a 
special production area.
    (3) Monitoring--(i) When to monitor. (A) When suitable sampling and 
analytic methods exist, periodic monitoring in accordance with this 
paragraph must be done to ensure compliance with the exposure limits of 
paragraphs (e)(1) and (e)(2)(ii) of this section.
    (B) When suitable sampling and analytic methods do not exist,

[[Page 52721]]

compliance with the exposure limits of paragraph (e)(1) and the 
requirements of paragraph (e)(10) of this section must be determined by 
an evaluation of monitoring data developed for a surrogate chemical 
substance possessing comparable physical-chemical properties under 
similar manufacturing and processing conditions.
    (ii) Monitoring methods. A suitable air sampling method must permit 
personal or fixed location sampling by conventional collection methods. 
A suitable analytic method must have adequate sensitivity for the 
volume of sample available and be specific for the new chemical 
substance being monitored. If chemical-specific monitoring methods are 
not available, nonspecific methods may be used if the concentration of 
the new chemical substance is assumed to be the total concentration of 
chemical substances monitored.
    (iii) Monitoring frequency. (A) When suitable air sampling and 
analytical procedures are available, monitoring must be done in each 
special production area during the first three 8-hour work shifts 
involving the manufacture or processing of each new chemical substance. 
Thereafter, monitoring must be done in each special production area for 
at least one 8-hour period per month, during a production run in which 
the new chemical substance is manufactured or processed. Samples must 
be of such frequency and pattern as to represent with reasonable 
accuracy the mean level and maximum 30-minute level of employee 
exposure during an 8-hour work shift. In monitoring for an 8-hour work 
shift or the equivalent, samples must be collected periodically or 
continuously for the duration of the 8-hour work shift. Samples must be 
taken during a period which is likely to represent the maximum employee 
exposure.
    (B) If the manufacturer demonstrates compliance with the exposure 
limits for 3 consecutive months, further monitoring of the identical 
process must be performed only every 6 months thereafter, unless there 
is a significant change in the process, process design, or equipment. 
If there is such a change, the manufacturer must begin monitoring again 
according to the schedule in paragraph (e)(3)(iii)(A) of this section.
    (iv) Location of monitoring. Air samples must be taken so as to 
ensure that the samples adequately represent the ambient air 
concentration of a new chemical substance present in each worker's 
breathing zone.
    (4) Engineering controls and exposure safeguards. Engineering 
controls such as, but not limited to, isolation, enclosure, local 
exhaust ventilation, and dust collection must be used to ensure 
compliance with the exposure limits prescribed in paragraph (e)(1) or 
(e)(2)(ii) of this section.
    (5) Training, hygiene, and work practices--(i) Training. No 
employee may enter a special production area before the completion of a 
training program. The training program must be adapted to the 
individual circumstances of the manufacturer and must address: The 
known physical-chemical and toxicological properties of the chemical 
substances handled in the area; procedures for using and maintaining 
respirators and other personal safeguards; applicable principles of 
hygiene; special handling procedures designed to limit personal 
exposure to, and inadvertent release of, chemical substances; and 
procedures for responding to emergencies or spills.
    (ii) Hygiene. Appropriate standards of hygiene must be observed by 
all employees handling a new chemical substance in manufacturing, 
processing, or transfer operations. The manufacturer must provide 
appropriate facilities for employee changing and wash-up. Food, 
beverages, tobacco products, and cosmetics must not be allowed in 
special production areas.
    (iii) Work practices. Operating procedures such as those related to 
chemical weighing and filtering, or the charging, discharging and 
clean-up of process equipment, must be designed and conducted to ensure 
compliance with the exposure limits prescribed in paragraph (e)(1) or 
(e)(2)(ii) of this section. Written procedures and all materials 
necessary for responding to emergency situations must be immediately 
accessible to all employees in a special production area. Any spill or 
unanticipated emission must be controlled by specially trained 
personnel using the equipment and protective clothing described in 
paragraph (e)(6) of this section.
    (6) Personal protection devices. All workers engaged in the 
manufacture and processing of a new chemical substance in the special 
production area must wear suitable protective clothing or equipment, 
such as chemical-resistant coveralls, protective eyewear, and gloves.
    (7) Caution signs. Each special production area must be clearly 
posted with signs identifying the area as a special production area 
where new chemical substances are manufactured and processed under 
controlled conditions. Each sign must clearly restrict entry into the 
special production area to qualified personnel who are properly trained 
and equipped with appropriate personal exposure safeguards.
    (8) Removal for storage or transportation. A new chemical substance 
that is not incorporated into a wet mixture, photographic article, or 
instant photographic or peel-apart film article may be removed from the 
special production area for purposes of storage between operational 
steps or for purposes of transportation to another special production 
area. Such storage or transportation must be conducted in a manner that 
limits worker and environmental exposure through the use of engineering 
controls, training, hygiene, work practices, and personal protective 
devices appropriate to the chemical substance in question.
    (9) Labeling. (i) Any new chemical substance removed from a special 
production area or stored or transported between operational steps must 
be clearly labeled. The label must show the identity of the new 
chemical substance or an appropriate identification code, a statement 
of any known hazards associated with it, a list of special handling 
instructions, first aid information, spill control directions, and 
where applicable, the appropriate U.S. Department of Transportation 
notations.
    (ii) No label is required if the new chemical substance has been 
incorporated into a photographic article, or if it is contained in a 
sealed reaction vessel or pipeline, or if it has been incorporated into 
an instant photographic or peel-apart film article.
    (10) Areas immediately adjacent to the special production area. The 
ambient air concentration of the new chemical substance in areas 
immediately adjacent to the special production area must not exceed the 
exposure limit established in paragraph (e)(2)(ii) of this section for 
waiver of respirator protection within the special production area. 
Periodic monitoring in accordance with paragraph (e)(3) of this section 
must be performed in immediately adjacent areas where it is reasonable 
to expect a risk of inhalation exposure.
    (f) Conditions of processing outside the special production area. A 
wet mixture may be incorporated into a photographic article or an 
instant photographic or peel-apart film article outside the special 
production area under the conditions listed in this paragraph:
    (1) Engineering controls and exposure safeguards. Engineering 
controls must limit the exposure to a new chemical substance contained 
in a wet mixture.
    (2) Training, hygiene and work practices--(i) Training. Training of

[[Page 52722]]

employees involved in the handling of wet mixtures containing a new 
chemical substance must be adapted to the individual circumstances of 
the employees' activities and must address: Procedures for using 
personal exposure safeguards, applicable principles of hygiene, 
handling procedures designed to limit personal exposure, and procedures 
for responding to emergencies and spills.
    (ii) Hygiene. Appropriate standards of hygiene that limit exposure 
must be observed by all employees handling wet mixtures that contain 
new chemical substances.
    (iii) Work practices. Work practices and operating procedures must 
be designed to limit exposure to any new chemical substance contained 
in wet mixtures. Any spills or unanticipated releases of a wet mixture 
must be controlled by trained personnel wearing appropriate protective 
clothing or equipment such as gloves, eye protection, and, where 
necessary, respirators or chemically impervious clothing.
    (3) Personal protection devices. All workers engaged in the 
processing of a wet mixture containing a new chemical substance must 
wear suitable protective clothing or equipment such as coveralls, 
protective eyewear, respirators, and gloves.
    (g) Incorporation of photographic articles into instant 
photographic and peel-apart film articles. A photographic article may 
be incorporated into the instant photographic or peel-apart film 
article outside the special production area. The manufacturer must take 
measures to limit worker and environmental exposure to new chemical 
substances during these operations using engineering controls, 
training, hygiene, work practices, and personal protective devices.
    (h) Environmental release and waste treatment--(1) Release to land. 
Process waste from manufacturing and processing operations in the 
special production area that contain a new chemical substance are 
considered to be hazardous waste and must be handled in accordance with 
the requirements of parts 262 through 267 and parts 122 and 124 of this 
chapter.
    (2) Release to water. All wastewater or discharge which contain the 
new chemical substance must be appropriately pretreated before release 
to a Publicly Owned Treatment Works (POTW) or other receiving body of 
water. In the case of release to a POTW, the pretreatment must prevent 
structural damage to, obstruction of, or interference with the 
operation of the POTW. The treatment of direct release to a receiving 
body of water must be appropriate for the new chemical substance's 
physical-chemical properties and potential toxicity.
    (3) Release to air. All process emissions released to the air which 
contain the new chemical substance must be vented through control 
devices appropriate for the new chemical substance's physical-chemical 
properties and potential toxicity.
    (i) Exemption notice. An exemption notices must be submitted to EPA 
when manufacture of the new chemical substance begins.
    (1) Contents of exemption notice. The exemption notice must include 
the following information:
    (i) Manufacturer and sites. The notice must identify the 
manufacturer and the sites and locations where the new chemical 
substance and the instant photographic or peel-apart film articles will 
be manufactured and processed.
    (ii) Chemical identification. The notice must identify the new 
chemical substance as follows:
    (A) Class 1 substances. For chemical substances whose composition 
can be represented by a definite structural diagram (Class 1 
substances), the notice must provide the chemical name (preferably CAS 
or IUPAC nomenclature), the molecular formula, CAS Registry Number (if 
available), known synonyms (including trade names), and a structural 
diagram.
    (B) Class 2 substances. For chemical substances that cannot be 
fully represented by a structural diagram, (Class 2 substances), the 
notice must provide the chemical name, the molecular formula, the CAS 
Registry Number (if available), and known synonyms (including trade 
names). The notice must identify the immediate precursors and reactants 
by name and CAS Registry Number (if available). The notice must include 
a partial or incomplete structural diagram, if available.
    (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.
    (iv) Physical-chemical properties. The notice must describe the 
physical-chemical properties of the new chemical substance. Where 
specific physical-chemical data are not available, reasonable estimates 
and the techniques used to develop these estimates must be provided.
    (v) Byproducts. The notice must identify the name, CAS Registry 
number (if available), and the volume of each byproduct that would be 
manufactured during manufacture of the new chemical substance.
    (vi) Production volume. The notice must include an estimate of the 
anticipated maximum annual production volume.
    (vii) Test data. The notice must include all information and test 
data on the new chemical substance's health and environmental effects 
that are known to or reasonably ascertainable by the manufacturer.
    (viii) Identity of the article. The notice must identify and 
describe the instant photographic film article(s) or peel-apart film 
article(s) that will contain the new chemical substance.
    (ix) Release to water. The notice must include a description of the 
methods used to control and treat wastewater or discharge released to a 
POTW or other receiving body of water. The notice must also identify 
the POTW or receiving body of water.
    (x) Certification. The manufacturer must certify in the notice that 
it is familiar with the terms of the exemption and that the 
manufacture, processing, distribution, use, and disposal of the new 
chemical substance will comply with those terms.
    (xi) Fee payment ID number. The manufacturer or processor must 
include a payment identity number on the front page of the notice.
    (2) Duplication of information in premanufacture notice. If a 
manufacturer who submits an exemption notice under this paragraph has 
already submitted, or simultaneously submits, a premanufacture notice 
under section 5(a)(1)(A) of the Act for the new chemical substance, it 
may, in lieu of submitting the information required by

[[Page 52723]]

this paragraph, reference the required information to the extent it is 
included in the premanufacture notice. At a minimum, the exemption 
notice must identify the manufacturer and the new chemical substance, 
and contain the certification required by paragraph (i)(1)(x) of this 
section.
    (3) Address. The exemption notice must be addressed to the Document 
Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics 
(OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001.
    (j) Recordkeeping. (1) Manufacturers of a new chemical substance 
under this exemption must keep the following records for 30 years from 
the final date of manufacture.
    (i) Production records. Each manufacturer must maintain records of 
the annual production volume of each new chemical substance 
manufactured under the terms of the exemption. This record must 
indicate when manufacture of the new chemical substance began.
    (ii) Exposure monitoring records. Manufacturers must maintain an 
accurate record of all monitoring required by this section. Monitoring 
records may be adapted to the individual circumstances of the 
manufacturer but, at a minimum, must contain the following information: 
The chemical identity of the new chemical substance, date of the 
monitoring, the actual monitoring data for each monitoring location and 
sampling, and a reference to or description of the collection and 
analytic techniques. If the manufacturer does not monitor, the 
manufacturer must maintain a record of the reasons for not monitoring 
and the methods used to determine compliance with the exposure limits 
of paragraph (e)(1) of this section.
    (iii) Training and exposure records. For each employee engaged in 
the manufacture or processing of a new chemical substance, the company 
must develop and maintain a record of the worker's participation in 
required training. This record must also demonstrate the regular use of 
personal exposure safeguards, including the results of any personal 
exposure monitoring, the results of the quantitative fit test for the 
worker's personal respirator, and any additional information related to 
the worker's occupational exposure.
    (iv) Treatment records. Manufacturers who release treated 
wastewater or discharge containing a new chemical substance to a POTW 
or other receiving body of water must maintain records of the method of 
treatment.
    (2) The manufacturer must make the records listed in paragraph 
(j)(1) of this section available to EPA upon written request by the 
Director of the Office of Pollution Prevention and Toxics. The 
manufacturer must provide these records within 15 working days of 
receipt of this request.
    (k) Confidentiality. If the manufacturer submits information under 
paragraph (i) or (j) of this section which it claims to be confidential 
business information, the manufacturer must clearly identify the 
information at the time of submission to the Agency by bracketing, 
circling, or underlining it and stamping it with ``CONFIDENTIAL'' or 
some other appropriate designation. Any information so identified will 
be treated in accordance with the procedures in part 2 of this chapter. 
Any information not claimed confidential at the time of submission will 
be made available to the public without further notice to the 
submitter.
    (l) Amendment and repeal. (1) EPA may amend or repeal any term of 
this exemption if it determines that the manufacture, processing, 
distribution, use, and disposal of new chemical substances under the 
terms of the exemption may present an unreasonable risk of injury to 
health or the environment. EPA also may amend this exemption to enlarge 
the exemption category or to reduce the restrictions or conditions of 
the exemption.
    (2) As required by section 5(h)(4) of the Act, EPA will amend or 
repeal the substantive terms of an exemption granted under this part 
only by the formal rulemaking procedures described in section 6(c)(2) 
and (3) of the Act (15 U.S.C. 2605(c)).
    (m) Prohibition of use of the exemption. The Director of the Office 
of Pollution Prevention and Toxics may prohibit the manufacture, 
processing, distribution, use, or disposal of any new chemical 
substance under the terms of this exemption if he or she determines 
that the manufacture, processing, distribution in commerce, use, or 
disposal of the new chemical substance may present an unreasonable risk 
of injury to health or the environment.
    (n) Enforcement. (1) A failure to comply with any provision of this 
part is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Submitting materially misleading or false information in 
connection with the requirements of any provision of this part is a 
violation of this regulation and therefore a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (3) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (4) EPA may seek to enjoin the manufacture of a new chemical 
substance in violation of this exemption or act to seize any chemical 
substances manufactured in violation of the exemption under the 
authority of section 17 of the Act (15 U.S.C. 2616).

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 fees and conditions 
specified in Sec. Sec.  700.40, 700.45(c), 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(c) 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(g)(4) 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 fee 
specified in Sec.  700.45(c) of this chapter.

0
16. Section 790.59 is amended by adding paragraph (c) to reads as 
follows:

[[Page 52724]]

Sec.  790.59  Failure to comply with a test rule.

* * * * *
    (c) Persons who fail to pay the requisite fee as specified in Sec.  
700.45(c) 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(g)(4) of 
this chapter.
* * * * *
    (d) Fees. Manufacturers and/or processors signing the consent 
agreement are subject to the applicable fee specified in Sec.  
700.45(c) 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 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. 2018-22252 Filed 10-16-18; 8:45 am]
 BILLING CODE 6560-50-P


