83 FR 8212 - User Fees for the Administration of the Toxic Substances Control Act
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 38 (February 26, 2018)
Federal Register Volume 83, Issue 38 (February 26, 2018)
| Page Range | 8212-8235 | |
| FR Document | 2018-02928 |
[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)] [Proposed Rules] [Pages 8212-8235] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02928] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 700, 720, 723, 725, 790, and 791 [EPA-HQ-OPPT-2016-0401; FRL-9974-31] RIN 2070-AK27 User Fees for the Administration of the Toxic Substances Control Act AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: As permissible under section 26(b) of the Toxic Substances Control Act (TSCA or the Act), the Environmental Protection Agency (EPA or the Agency) is proposing to set user fees applicable to any person required to submit information to EPA under the TSCA section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA section 6(b). This notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years. In proposing these new TSCA user fees, the Agency also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices. After implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each notice, exemption application and data set submitted or chemical substance subject to a risk evaluation in order for EPA to recover certain costs associated with carrying out certain work under TSCA. With this action, EPA is also proposing standards for determining which persons qualify as small business concerns and thus would be subject to lower fee payments. DATES: Comments must be received on or before April 27, 2018. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0401, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Mark Hartman, Immediate Office, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) [[Page 8213]] 564-3810; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Does this action apply to me? You may be affected by this action if you manufacture (including import), distribute in commerce, or process a chemical substance (or any combination of such activities) and are required to submit information to EPA under TSCA sections 4 or 5 or if you manufacture a chemical substance that is the subject of a risk evaluation under TSCA section 6(b). The following list of North American Industry Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include companies found in major NAICS groups: Chemical Manufacturers (NAICS code 325), Petroleum and Coal Products (NAICS code 324), and Chemical, Petroleum and Merchant Wholesalers (NAICS code 424). B. What is the Agency's authority for taking this action? The Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182) (Ref. 1), provides EPA with authority to establish fees to defray a portion of the costs associated with administering TSCA sections 4, 5, and 6, as amended, as well as the costs of collecting, processing, reviewing, and providing access to and protecting information about chemical substances from disclosure as appropriate under TSCA section 14. EPA is proposing this rule under TSCA section 26(b), 15 U.S.C. 2625(b). C. What action is the Agency taking? Pursuant to TSCA section 26(b), EPA is proposing to establish and collect fees from certain manufacturers (including importers) and processors to defray some of the Agency costs related to activities under TSCA sections 4, 5, 6 and 14. EPA is requesting comment on its proposed user fees and the methodology used for determining the amounts. EPA is also proposing and taking comment on standards for determining which persons qualify as small business concerns and thus would be subject to lower fee payments. Paragraph 4 of TSCA section 26(b) requires that EPA, in setting fees, establish lower fees for small businesses. D. Why is the Agency taking this action? The 2016 amendments to TSCA authorize EPA to establish fees to defray some of the costs of administering certain provisions of the law. The TSCA Service Fee Fund (the Fund) in the U.S. Treasury will hold funds to defray some of the costs of administering TSCA sections 4, 5, and 6 and of ``collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate'' information on chemical substances under TSCA section 14. The Agency proposes to collect payment from manufacturers and processors, as appropriate, who: Are required to submit information under TSCA section 4; submit a notice, exemption application, or other information under TSCA section 5; and who manufacture a chemical substance that is the subject of a risk evaluation under TSCA section 6(b). These fees are intended to achieve the goals articulated by Congress to provide a sustainable source of funds for EPA to fulfill its legal obligations to conduct activities such as risk-based screenings, designation of applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing manufacturing and processing notices, as required under TSCA sections 4, 5 and 6, as well as management of chemical information under TSCA section 14. E. What are the estimated incremental impacts of this action? EPA has evaluated the potential incremental economic impacts of this action. The Agency analyzed a three-year period, since the statute requires EPA to reevaluate and adjust, as necessary, the fees every three years. The Economic Analysis (Ref. 2), which is available in the docket, is briefly summarized here and discussed in more detail in Unit IV. The annualized fees collected from industry for the proposed option (identified as Option C in the Economic Analysis (Ref. 2)), are approximately $20.05 million. This total does not include the fees collected for manufacturer-requested risk evaluations. Total fee collections were calculated by multiplying the estimated number of actions per fee category anticipated each year, by the corresponding proposed fee. For the proposed option, TSCA section 4 fees account for less than one percent of the total fee collection, TSCA section 5 fees for approximately 43 percent, and TSCA section 6 fees for approximately 56 percent. Annual fees collected by EPA are expected to total approximately $20.05 million. Under the proposed option, the total fees collected from industry for a risk evaluation requested by manufactures are estimated to be $1.3 million for chemicals included in the Work Plan and $2.6 million for chemicals not included in the Work Plan. EPA estimates that 18.5 percent of TSCA section 5 submissions will be from small businesses that are eligible to pay discounted fees because they have average annual sales of less than $91 million in the three preceding years. Total annualized fees for TSCA section 5 collected from small businesses are estimated to be $550,000 (Ref. 2). For TSCA sections 4 and 6, discounted fees for eligible small businesses and fees for all other affected firms may differ over the three-year period that was analyzed, since the fee paid by each firm is dependent on the number of affected firms per action. Based on past TSCA section 4 actions and data related to the first ten chemicals identified for risk evaluations under TSCA as amended, EPA estimates annualized fees collected from small businesses for TSCA section 4 and TSCA section 6 to be approximately $37,000 and $2.6 million, respectively. EPA estimates that total fees paid by small businesses will account for about 16 percent of the approximately $20.05 million fees to be collected for TSCA sections 4, 5, and 6 actions. The annualized total industry fee collection for small businesses is estimated to be approximately $3.2 million. F. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, information so marked will not be disclosed except in accordance with [[Page 8214]] procedures set forth in 40 CFR part 2. A copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. 2. Tips for preparing your comments. When preparing, and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. History of Fees Under TSCA In 1976, TSCA section 26(b) provided EPA with authority to require, by rule, the payment of fees by persons required to submit data under TSCA sections 4 and 5. TSCA section 26(b) capped the maximum fees for small business at $100 and fees for all other entities at $2,500. It was not until the Agency published a final a rule in 1988 that EPA began requiring and collecting fees from manufacturers and processors to pay for premanufacture notices (PMNs), and other submissions under TSCA section 5. Although authorized under the statute, the Agency has not historically collected fees for data submitted under TSCA section 4 and no TSCA section 4 fees rule was ever promulgated by EPA. Since 1988, with regard to submissions by small business concerns, the Agency has collected $100 for each TSCA section 5 PMN, consolidated PMN, significant new use notice (SNUN), and certain exemption applications and notices. For submissions by all other manufacturers or processors, EPA has collected $2,500 for each TSCA section 5 PMN, and consolidated PMN notices other than intermediate PMNs, SNUNs and certain exemption applications and notices and $1,000 for intermediate PMNs. These fees were set prior to the June 2016 amendments to TSCA and do not reflect the current cost of administering the TSCA sections associated with these submissions. In the past several fiscal years, EPA has consistently generated approximately $1.1 million annually in fee revenue. The fees go to the General Fund of the U.S. Treasury and do not defray EPA's costs. With the finalization of the TSCA User Fees rule, EPA's annually appropriated funds will be supplemented with the user fees to cover some of the costs of administering TSCA, including the costs incurred by the Agency in addressing additional requirements imposed by the June 2016 amendments. B. Recent Amendments to TSCA On June 22, 2016, the ``Frank R. Lautenberg Chemical Safety for the 21st Century Act'' was signed into law, amending numerous sections of TSCA. The amendments give EPA improved authority to take actions to protect people and the environment from the effects of chemicals. The amendments also expand EPA's existing TSCA fee authority and allow the Agency to establish and collect fees sufficient to defray some of the costs of administering certain TSCA requirements. The amendments remove the $100 cap on fees collected from small businesses and the $2,500 cap on fees from other manufacturers and processors. Instead, the amendments require that, if fees are established for work under TSCA sections 4, 5 and/or 6, the Agency set lower fees for small business concerns and establish the fees so that they are designed to collect 25% of the Agency's costs to carry out work under section 4, 5, 6 and 14 of the Act or $25,000,000, whichever is lower. In addition, in the case of a manufacturer-requested risk evaluation, the Agency is authorized to establish fees sufficient to defray 50% of the costs associated with conducting a manufacturer- requested risk evaluation on a chemical included in the TSCA Work Plan for Chemical Assessments: 2014 Update, and the full costs of conducting a manufacturer-requested risk evaluation for all other chemicals. The amendments also authorize fee revenue to be deposited into a new TSCA Service Fee Fund. This is intended to ensure that resources are made available to the Agency to defray some of the costs that EPA incurs in carrying out activities under section 4, 5, 6 and 14 of TSCA. Currently, fees are only collected for certain submissions under section 5 of TSCA. These fees are established in 40 CFR 700.45. Under the Lautenberg Act's amendments to TSCA, EPA has authority to require payment from manufacturers and processors who: Are required to submit information by test rule, test order or enforceable consent agreement (TSCA section 4); Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA section 5); Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA section 6(b)). Beginning in fiscal year 2019 (October 1, 2018 through September 30, 2019), EPA is required to adjust fees, as necessary, every three years to reflect inflation and ensure that fees are sufficient to collect 25% of the costs to the Agency in administering sections 4, 5, 6 and 14 of the Act. Before establishing new fees or revising any existing fees, the Agency is required to consult with manufacturers and processors, or their representatives. Additional information on the new law is available on EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. C. Stakeholder Involvement Prior to this notice of proposed rulemaking, EPA engaged with members of the public (or their representatives) potentially subject to the fees. The Agency held a public meeting and webinar on August 11, 2016, and an industry-specific consultation meeting and webinar on September 13, 2016, in accordance with TSCA section 26(b)(4)(E). The Agency sought comments from industry on various aspects of the proposed rulemaking, including the amendment of existing TSCA section 5 fees, the establishment of new fees for TSCA sections 4 and 6 activities, and small business considerations. As part of EPA's efforts to consult with industry on the proposed fees and the methodology for establishing the fees, the Agency also opened a docket and collected written comments from stakeholders. To view the comments received prior to this notice of proposed rulemaking, go to http://www.regulation.gov and search for docket number: EPA-HQ-OPPT-2016-0401. The commenters included representatives from industry, trade associations, and an environmental group and provided a diversity of perspectives. Overall, there was a general expression of support for the new law, for ensuring that the Agency has the funding necessary to implement the requirements of the recent amendments to TSCA, and for EPA's inclusive approach for gathering industry input into the setting of fees. Most of the commenters expressed support for a fair, simple, and efficient fee structure. The majority of commenters also expressed support for industry consortia-based management of fee collection for TSCA sections 4 and 6 activities. EPA sought input from industry on the relative apportionment of fees that should be assessed for administering TSCA sections 4, 5, and 6 activities and on the factors that the Agency should consider when structuring the fees. All industry commenters recommended that fees be assessed based on the level of effort required of EPA for undertaking [[Page 8215]] the activity supported by the fee. A number of commenters opposed assessment of fees under TSCA section 4. Others indicated a willingness to accept nominal fees under TSCA section 4 or fees solely to account for EPA's effort in reviewing submissions. Many commenters expressed concern that higher fees imposed on bringing new chemicals to market (i.e., TSCA section 5 submissions) could create an economic barrier to innovation. Several commenters recommended that the bulk of the fees the rule establishes should be from manufacturers and processors of chemicals subject to risk evaluation under TSCA section 6. The Agency also sought comment from industry on lower fees for small businesses. Many trade associations reaffirmed the need for lower fees for small businesses. All commenters that mentioned small businesses recommended that the TSCA definition of a small business be updated, though there was diverse opinion on how; recommendations included an inflation-adjusted, revenue-based standard and an employee- based definition. EPA considered all of these comments in the development of the proposed rule. EPA welcomes comment from stakeholders on all aspects of the Agency's proposed fee structure during the public comment period opened with this document. D. Federal User Fee Design Guidance EPA also looked to federal user fee guidance in designing the proposed TSCA user fees. Office of Management and Budget Circular A-25 on User Charges (Ref. 3) and the GAO User Fees Design Guide (Ref. 4) contain information that is relevant to the administrative processes of setting, revising, collecting, and administration of fees. As EPA discusses its rationale for setting the TSCA fees in the remainder of this preamble, the Agency will rely on the policies and principles identified in these two federal guidance documents. Circular A-25 explains, for executive agencies, the scope and type of activities subject to user fee charges and the basis on which user fees should be set. EPA followed the Circular A-25 guidance in identifying the relevant direct and indirect costs to be recovered by user fees including, but not limited to, an appropriate share of personnel costs, including salaries and fringe benefits; management and supervisory costs; costs of research, establishment of standards and regulations; physical overhead; and other indirect costs including supply costs and travel. The Agency plans to periodically review the user fees to provide assurance that existing charges are adjusted to reflect unanticipated changes in costs, and plans to readjust, as necessary, the fees to account for these changes, as well as inflation. TSCA 26(b)(4)(F) sets the readjustment schedule at three year intervals. As required in TSCA section 26 and discussed in the GAO Guide, parties potentially subject to fees or their representatives will be consulted and asked to provide input when the fees are reviewed and updated to reflect changes in program costs. The Agency is proposing a process by which TSCA user fees would be established for fiscal year 2019 through 2022 and then adjusted for inflation every three years, beginning in fiscal year 2022, based on applicable Producer Price Index (PPI) values available from the U.S. Department of Labor. Fees for fiscal year 2022 and later would be calculated by multiplying each fee identified for fiscal years 2019 through 2021 by the most current PPI value available at the beginning of the three-year adjustment period, beginning with October 1, 2021. EPA would provide public notice of the inflation-adjusted fee amounts most likely through posting to the Agency's web page by the beginning of each three-year fee adjustment cycle (i.e., October 1, 2021, October 1, 2024, etc.). The Agency may also identify the need to update program costs underlying the fee amounts, and/or propose any changes to the fees beside adjustment for inflation. The Agency will initiate industry consultation as required under TSCA 26(b)(4)(E) in either case and provide public notice for any fee changes based on inflation. EPA expects to undertake notice and comment rulemaking for more substantial changes to the fees. EPA seeks comment on this approach for readjusting fees every three years. III. Detailed Discussion of the Proposed Rule EPA is proposing to establish and collect fees from manufacturers and processors of chemical substances pursuant to TSCA section 26(b). As discussed previously in Unit II.A., EPA currently collects fees for PMNs, certain PMN exemption applications and notices, and SNUNs submitted under TSCA section 5. The Agency is proposing to expand the categories of activities for which fees are collected and increase the amount of fees required for certain activities under TSCA sections 4, 5 and 6. This proposal lays out the fee categories and payment amounts that the Agency believes are both reasonable and appropriate to begin collecting in fiscal year 2019; they are intended to provide a sustainable source of funds to defray approximately 25 percent of the costs to carry out the activities specified in TSCA section 26(b), as well as 50% or 100% of the costs of risk evaluations requested by manufacturers, depending on the chemical. Because EPA will not begin collecting fees until fiscal year 2019, EPA believes it is appropriate to look to TSCA section 26(b)(4)(F) for the parameters which must be applied for setting fees. TSCA section 26(b)(4)(F) requires EPA, ``beginning with the fiscal year that is 3 years after the date of enactment [June 22, 2016],'' to adjust fees as necessary so they are sufficient to defray approximately 25 percent of the costs to carry out the activities of TSCA sections 4, 5, 6 and 14, other than the costs of manufacturer-requested risk evaluations. Further, the fees shall defray 50% or 100% of the costs of risk evaluations requested by manufacturers, depending on the chemical. EPA acknowledges that fees were initially to be established under the authority of TSCA section 26(b)(4)(B), which provides different parameters, most notably a cap on fees of $25 million. However, given the timing of this fee rule proposal such that fees won't be collected under fiscal year 2019, EPA believes it is more appropriate to set these fees based on the parameters that are required to be in effect by fiscal year 2019. EPA also notes that because the estimated costs for covered activities are under $100 million and costs defrayed under $25 million, the cap on fees found in TSCA 26(b)(4)(B) would have had no bearing on the proposed fees in any case. EPA considered industry comments regarding the fee structure. Several predominant themes emerged through consultation with industry. Many commenters felt that EPA should charge fees that are proportional to EPA costs for undertaking the activities. This was consistent with one the considerations that EPA applied in setting the proposed fees-- equity as determined by proportionality between EPA costs and the fee associated with each activity. EPA notes that the statute does not require such proportionality. In fact, the fee triggers under the law (for example, submission of a section 5 notice) are distinct from EPA activities for which costs can be defrayed by the fees collected. Thus, EPA could, consistent with TSCA, collect fees for section 5 submissions that exceed the cost of processing the section 5 submissions, so long as the fees in the aggregate are not designed to exceed 25% of the costs to EPA of carrying out sections 4, 5, 6 and [[Page 8216]] 14. Nonetheless, none of the fees that EPA is proposing exceed the Agency's costs associated with the activities associated with a given fee. A. Who will be charged fees? As mentioned previously in Unit II.B., EPA has authority to collect fees from manufacturers and processors who: Are required by test rule, test order or enforceable consent agreement to submit information (TSCA section 4); Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA section 5); Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA section 6(b)). Although EPA has authority to collect fees from both manufacturers and processors of chemical substances, EPA is proposing to focus fee collection on manufacturers. EPA is proposing to collect fees from processors only when processors submit a SNUN under section 5 or when a section 4 activity is tied to a SNUN submission by a processor. The Agency feels the effort of trying to identify a representative group of processors for the other three fee-triggering actions would be overly burdensome and expects many processors would be missed. The Agency believes this approach is the simplest and most straightforward way to assess fees for conducting risk evaluations under TSCA section 6 and other TSCA section 4 testing. Furthermore, EPA expects that manufacturers required to pay user fees will have a better sense of the universe of processors and will pass some of the costs on to them. The Agency is seeking public comment on this approach. For certain actions for which a fee will be charged, such as new chemical submissions under section 5, fee payers will self-identify by virtue of the submission they make to the Agency. For others, such as risk evaluations under section 6, EPA plans to look to recent Chemical Data Reporting (CDR) submissions to identify manufacturers (including importers) subject to section 6 fees. The CDR Rule, issued under the authority of TSCA section 8(a), requires chemical substance manufacturers to give EPA information on the chemicals they manufacture domestically or import into the United States. Information is collected every four years; data were most recently collected in 2016, including 2012-2015 production volume information and 2015 manufacturing, processing and use information. The next submission period will be in 2020. EPA acknowledges that CDR data may not contain the entire list of companies subject to a fee, and failure by EPA to identify companies subject to a fee does not remove their obligation to pay. EPA proposes to use CDR data to identify a preliminary list of companies. EPA also seeks comment on whether to adopt a process that would allow time for public input for adding to that preliminary list before finalization. EPA seeks public comment on this approach. The Agency is also interested in comments on using other sources to identify those subject to payment of fees. These sources include, for example, information reported to the Toxics Release Inventory (TRI), and notice of commencement (NOC) submissions under EPA's TSCA New Chemicals Review Program. EPA may also look to information reported to the Agency under the TSCA inventory active/inactive notification rule. Each of these data sources provides information that may be useful in identifying manufacturers and processors of chemical substances who may be required to pay TSCA user fees. The TRI under section 313 of the Emergency Planning and Community Right-to-Know Act, currently covers over 650 chemicals. Facilities that manufacture, process or otherwise use these chemicals in amounts above established levels must submit annual TRI reports on each chemical. Facilities that report to TRI include larger facilities involved in chemical manufacturing. Under section 5 of TSCA, manufacturers are required to submit a NOC to the Agency within 30 days following the start of manufacture of a new chemical substance (i.e., any substance that is not on the TSCA Inventory). Upon receipt of the NOC form, EPA places the substance on the TSCA Inventory. EPA finalized the TSCA inventory active/inactive notification rule in June 2017. The rule requires manufacturers to report to EPA chemical substances on the TSCA Inventory that were in U.S. commerce during the 10-year period prior to the TSCA amendments of June 2016. The rule also requires manufacturers and processors to notify EPA in the future when they intend to re-introduce an ``inactive'' substance on the Inventory into U.S. commerce. The Agency plans to include a limitation in the final regulatory text to ensure a manageable approach for the identification of manufacturers who are subject to a particular fee. EPA welcomes comment on these approaches for identifying those subject to TSCA user fees. B. How did EPA calculate user fees? 1. Background. EPA is presenting for comment its proposed methodology for determining the user fees that will be assessed under amended TSCA. The Act provides EPA authority to establish fees to defray a portion of the costs associated with administering TSCA sections 4, 5 and 6, as well as the costs of collecting, processing, reviewing, and providing access to and protecting from disclosure, as appropriate, information on chemical substances under TSCA section 14. The events that trigger a fee payment however, involve a narrower set of activities under TSCA sections 4, 5 and 6. While the collection of fees is tied to the submission of particular information under sections 4 and 5 or the manufacturing of a particular chemical substance undergoing a risk evaluation under section 6, in general, the use of these fees is not limited to defraying the cost of the action that was the basis for payment of the fee. EPA believes that assigning fees across TSCA sections 4, 5 and 6 is the most equitable and efficient approach for allocating costs to the manufacturers and processors detailed in Unit III.A. Those manufacturers and processors would be expected to bear the burden, and receive benefits, of TSCA reviews conducted by the Agency. The Agency's proposed fee methodology is intended to fully recover the amount specified in the statute per TSCA section 26(b)(4)(F). The estimated annual Agency costs of carrying out TSCA section 4, 5, 6 and 14, without including the costs associated with manufacturer-requested chemical risk evaluations, are approximately $80.2 million. Based on these cost estimates, EPA anticipates collecting approximately $20.05 million in fees each year. In addition, the Agency intends to collect fees from manufacturers to recover a portion of costs incurred by EPA in conducting chemical risk evaluations requested by manufacturers. EPA expects this fee amount will be $1.3 million for per chemical for chemicals on the Work Plan and $2.6 million per chemical for chemicals not on the Work Plan. EPA determined the anticipated costs associated with TSCA sections 4, 5, 6 and 14 activities, including both program costs and indirect costs (see Table 1). For fiscal year 2019 through fiscal year 2021, these costs were estimated to be approximately $80.2 million per year. More detail on how anticipated costs were calculated follows in Unit III.B.2. [[Page 8217]] Table 1--Estimated Annual Costs to EPA [Fiscal Year 2019 through Fiscal Year 2021] ---------------------------------------------------------------------------------------------------------------- Direct program costs Indirect costs Annual costs ---------------------------------------------------------------------------------------------------------------- TSCA Section 4.................................................. $2,765,000 $778,000 $3,543,000 TSCA Section 5.................................................. 22,375,000 6,296,000 28,672,000 TSCA Section 6.................................................. 34,073,000 9,545,000 43,618,000 TSCA Section 14................................................. 3,531,000 814,000 4,345,000 ----------------------------------------------- Total:...................................................... 62,744,000 17,425,000 80,178,000 ---------------------------------------------------------------------------------------------------------------- Notes: Numbers may not add due to rounding The indirect cost rate for Office of Chemical Safety and Pollution Prevention is estimated at 28.14% for the purposes of this analysis. After estimating the annual costs of administering TSCA section 4, 5, 6 and 14, the Agency had to determine how the costs would be allocated over the narrower set of activities under TSCA section 4, 5 and 6, which trigger a fee. The Agency took an approach to determining user fees that parsed the fees based on the type of submission or fee triggering event. This allows allocation of costs more equitably among the submissions and their related costs. 2. Program costs. To determine the program costs for implementing sections 4, 5, 6 and 14 of TSCA, the Agency accounted for the intramural and extramural costs for activities under these sections. Intramural costs are those costs related to the efforts exerted by EPA staff and management in operating the program, collecting and processing information and funds, conducting reviews, and related activities. Extramural costs are those costs related to the acquisition of contractors to conduct activities such as analyzing data, developing IT systems and supporting the TSCA Help Desk. The Agency then added indirect costs to the direct program cost estimates. The Agency used an indirect cost rate of 28.14% to calculate the indirect costs associated will all TSCA section 4, 5, 6 and 14 direct program cost estimates. a. TSCA section 4 program costs. TSCA section 4, Testing of Chemical Substances and Mixtures, gives EPA the authority to require, by rule, order, or enforceable consent agreement (ECA), manufacturers and processors to conduct testing of identified chemical substances or mixtures. EPA estimated TSCA section 4 submission costs based on prior experience with developing test rules and ECAs, reviewing study plans, and reviewing the data received. EPA estimates that, on average, it will undertake work associated with 10 test orders, one test rule and one ECA each year. While EPA expects to work on one test rule and one ECA each year, we expect to initiate each of these activities about every other year. It takes approximately two years to complete the work associated with both of these activities. Costs assume that each TSCA section 4 activity will cover one to 7 chemicals. While testing required by test orders is likely to be completed in under a year, test rules and enforceable consent agreements are likely to take two years to complete. This estimate is based on EPA's prior experience with test rules and ECAs. To estimate the costs of reviewing test data, we assume that on average, data will be submitted to EPA for seven tests on each chemical. The estimated cost to the Agency of each test order is approximately $279,000. Each test rule is estimated to cost approximately $844,000 and each enforceable consent agreement is estimated to cost approximately $652,000. These cost estimates include submission review and are based on projected full-time equivalent (FTE) and extramural support needed for each activity divided by the number of orders, rules and ECAs EPA assumes will be worked on over a three- year period. Several of these activities (rules and ECAs) are expected to span two years, as noted earlier so those estimates are based on the annual estimated costs multiplied by two. The annual cost estimate of administering TSCA section 4 in fiscal year 2019 through fiscal year 2021 is $3,543,000 (Ref. 5: Table 8). b. TSCA section 5 program costs. TSCA section 5, Manufacturing and Processing Notices, requires that manufacturers and processors provide EPA with notice before initiating the manufacture of a new chemical substance or initiating the manufacturing or processing for a significant new use of a chemical substance. EPA is required to review and make determinations on the notices and take risk management action, as needed. Examples of the notices or other information that manufacturers and processors are required to submit under TSCA section 5 are PMNs, significant new use notifications (SNUNs), microbial commercial activity notices (MCANs), and numerous types of exemption notices and applications (e.g., low-volume exemptions [LVEs], test-marketing exemptions [TMEs], low exposure/low release exemptions [LoREXs], TSCA experimental release applications [TERAs], certain new microorganism [Tier II] exemptions, film article exemptions, etc.). EPA's TSCA section 5 efforts under the previous law are well understood through experience that spans several decades. The Agency has historical data on costs, as well as the number of different section 5 submission types sent to the Agency each year. In 1987, the costs for the Agency to process a PMN were approximately up to $15,000 per submission, depending on the amount of detailed analysis necessary; these estimates did not include indirect costs. Recent data on the number of annual submissions is found at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review. (Ref. 6) In calendar year 2016, EPA received 577 PMNs, SNUNs and MCANs, and another 560 exemption notices and applications, most of which were LVEs. The provisions of TSCA, as amended, result in additional TSCA section 5 Agency costs that arise primarily from the requirement to review the intended, known or reasonably foreseen activities associated with the chemical, and the requirement to make an affirmative risk determination, and from development of significant new use rules (SNURs) and orders that result from our analysis and findings under TSCA, as amended. Therefore, the Agency used the cost estimates from prior experience as a starting point and then added estimates for the costs of these additional responsibilities. EPA's cost estimates include the costs of processing, reviewing, and making determinations, and the Agency's costs of taking any regulatory action such as [[Page 8218]] with a SNUR or an order. Costs of reviewing any data that is submitted to EPA as a result of an order is also included. EPA's cost estimates for administering TSCA section 5 also include the costs associated with processing, retaining records, related to a NOC submission. NOC costs also include the cost of registering the chemical with the Chemical Abstracts Service. EPA has lumped the costs associated with NOCs (totaling an estimated $1,700,000 per year) with those of PMNs, MCANs and SNUNs. The average cost of a PMN, MCAN and SNUN is approximately $55,200. This estimate is based on projected FTE and extramural support needed for these actions divided by the number of submissions the Agency assumes will be received each year once fees are in place which is 462. Our estimate of number of submissions is based on submissions received FY 16 reduced by 20% due to the anticipated impact of higher fees on the number of submissions (Ref. 5: Table 9). Costs associated with section 5 exemption notices and applications include processing and reviewing the application, retaining records, and related activities. The average cost of an exemption is $5,600. This estimate is based on projected FTE and extramural support needed for these actions divided by the number of submissions the Agency assumes will be received each year once fees are in place which is 560. Our estimate of number of submissions is based on submissions received in FY 16 (Ref. 5: Table 10). The annual cost estimate of administering TSCA section 5 in fiscal year 2019 through fiscal year 2021 is $28,600,000. Approximately $25,500,000 is attributed to PMNs, SNUNs and MCANs; another approximately $3,149,000 is attributed to section 5 exemptions notices and applications for LVEs, LoREXs, TMEs, TERAs, Tier IIs and film articles. c. TSCA section 6 program costs. TSCA section 6, Prioritization, Risk Evaluation, and Regulation of Chemical Substances and Mixtures, describes EPA's process for assessing and managing chemical safety under TSCA. TSCA section 6 addresses: (a) Prioritizing chemicals for evaluation; (b) evaluating risks from chemicals; and (c) addressing unreasonable risks identified through the risk evaluation. Under TSCA, EPA is now required to undergo a risk-based prioritization process to designate existing chemicals on the TSCA Inventory as either high- priority for risk evaluation or low-priority. For chemicals designated as high-priority substances, EPA must evaluate existing chemicals to determine whether they ``present an unreasonable risk of injury to health or the environment.'' Under the conditions of use for each chemical, the Agency will assess the hazard(s), exposure(s), and the potentially exposed or susceptible subpopulation(s) that EPA determines are relevant. This information will be used to make a final determination as to whether the chemical presents an unreasonable risk under the conditions of use. The first step in the risk evaluation process, as outlined in TSCA, is to issue a scoping document for each chemical substance within six months of its designation in the Federal Register. The scoping document will include information about the chemical substance, such as conditions of use, exposures, including potentially exposed or susceptible subpopulations, and hazards, that the Agency expects to consider in the risk evaluation. TSCA requires that these chemical risk evaluations be completed within three years of initiation, allowing for a 6-month extension. By the end of calendar year 2019, EPA must have at least 20 chemical risk evaluations ongoing at any given time on high-priority chemicals plus industry-requested evaluations. For each risk evaluation that the Agency completes, TSCA requires that EPA begin another. The Agency expects to have between 20 and 30 risk evaluations ongoing in any given year at different stages in the review process. TSCA section 6 cost estimates have been informed by the Agency's experience completing assessments for several TSCA Work Plan Chemicals, including N-methylpyrrolidone, antimony trioxide, methylene chloride, trichloroethylene, and 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- hexamethylcyclopenta[[gamma]]-2-benzopyran (HHCB) and by the Agency's experience addressing risks identified from particular uses of a chemical. TSCA section 6 risk evaluation costs include the cost of information gathering, considering human and environmental hazard, environmental fate, and exposure assessments. Costs also include the use of the ECOTOX knowledge and Health and Environmental Research Online (HERO) databases, among others. Other costs include scoping (including problem formulation, conceptual model and analysis plan), developing and publishing the draft evaluation, conducting and responding to peer review and public comment, and developing the final evaluation, which includes a risk determination. Under TSCA section 6, the Agency also has obligations to take action to address any unreasonable risks identified from a chemical. Cost estimates for risk management activities have been informed, in part, by EPA's recent risk reduction actions on several chemicals, including the use of N-methylpyrrolidone in paint and coating removal and trichloroethylene in both commercial vapor degreasing and aerosol degreasing and for spot cleaning in dry cleaning facilities. Section 6(a) of TSCA provides authority for EPA to ban or restrict the manufacture, processing, distribution in commerce, and commercial use of chemicals, as well as any manner or method of disposal of chemicals. In addition to considering previous experience with TSCA Workplan chemicals described above, EPA also benchmarked risk evaluation costs against cost associated with conducting risk assessments for pesticides under the Pesticide Registration Improvement Act (PRIA). The Agency chose the costs of conducting reviews for new conventional food-use pesticide active ingredients as the most relevant comparison to an existing chemical review under TSCA based on the scope and complexity of the assessments and the data considered in conducting the reviews. EPA estimates the cost of completing a risk assessment and risk management decision for a new conventional food use pesticide active ingredient to be approximately $2,900,000 which includes direct cost estimates provided by the Office of Pesticide Programs and indirect costs at 28.14%. The primary rationale for the increased cost estimate for a risk evaluation under TSCA when compared to a new pesticide review under PRIA are that the scope of an existing chemical assessment under TSCA is expected to be broader in terms of conditions of use and exposure scenarios that must be assessed and uncertainties associated with implementing a new evaluation program. EPA also expects that risk management costs will be higher under TSCA since rulemaking is required to implement any mitigation that is considered appropriate whereas most mitigation for a pesticide can be achieved directly through changes to the product labeling and/or terms and conditions of the registration. The breakdown of costs for an average three-year EPA-initiated chemical risk evaluation is shown in Table 2. [[Page 8219]] Table 2--Estimated Costs (Direct and Indirect) Associated With an Average EPA-Initiated Chemical Risk Evaluation ------------------------------------------------------------------------ Risk evaluation activity Estimated cost ------------------------------------------------------------------------ Risk Evaluation: Data Gathering (i.e., literature $395,000 search)................................................ Risk Evaluation: Databases (e.g., ECOTOX and HERO)...... 147,000 Risk Evaluation: Hazard Assessment...................... 1,008,000 Risk Evaluation: Exposure Assessment.................... 1,038,000 Risk Evaluation: Scoping................................ 235,000 Risk Evaluation: Draft Evaluation....................... 502,000 Risk Evaluation: Peer Review & Responding to Comment.... 230,000 Risk Evaluation: Final Evaluation....................... 329,000 --------------- Total............................................... 3,884,000 ------------------------------------------------------------------------ For purposes of this proposal, EPA is estimating that manufacturer- requested risk evaluations will cost less than EPA-initiated risk evaluations on high-priority substances. Specifically, EPA is estimating the average actual cost of a manufacturer-requested risk evaluation to be $2,600,000. There are a number of factors supporting this cost estimate and the assumption that manufacturer-requested risk evaluations will actually cost less than EPA-initiated risk evaluations. First, as required in the Risk Evaluation rule finalized in June 2017, (40 CFR 702.37) manufacturers requesting a risk evaluation must provide EPA with a list of existing information that would be adequate for EPA to conduct an evaluation. The upfront provision of data by manufacturers would limit the amount of subsequent work that the Agency would need to undertake to evaluate the chemical. Second, EPA believes that manufacturers who choose to submit risk evaluation requests to EPA will likely do so in cases where they believe the chemical is less likely to present an unreasonable risk. At this time, EPA believes that manufacturers are more likely to request risk evaluations on chemicals that are low hazard or low exposure, or are otherwise fairly straightforward to analyze. As such, EPA is estimating that these risk evaluations will be less costly than an average EPA-initiated risk evaluation on a high-priority chemical. While EPA does not yet have experience in receiving these types of requests from manufacturers, or undertaking these risk evaluations, these cost estimates represent EPA's best judgment based on past and current activities and the expectation that manufacturers are more likely to submit low hazard, low exposure chemicals for review. For the first 10 chemical risk evaluations that EPA is currently undergoing, for example, there are significant differences in the level of effort necessary to complete the evaluations, with some being substantially less complicated and therefore less burdensome than others. EPA expects manufacturer-requested risk evaluations to be on the less complicated end of the spectrum. The annual cost estimate of administering TSCA section 6 in fiscal year 2019 through 2021 is $43,618,000. Approximately $32,370,000 is attributed to risk evaluation work on 25 chemical risk evaluations; another approximately $6,584,000 is attributed to risk management efforts; another approximately $2,091,000 is attributed to support from the Office of Research and Development (ORD) for alternative animal testing and methods development and enhancement, and approximately $2,573,000 is attributed to the annual process of designating chemicals as High- or Low-priority substances (Ref. 5: Table 11). d. TSCA section 14 program costs. The June 2016 amendments to TSCA provided EPA with new obligations under section 14, Confidential Information. EPA must now review most chemical identity CBI claims within 90 days and 25 percent of a subset of other types of CBI claims within 90 days. This increased workload, along with the IT infrastructure to support this work was included in EPA's cost estimates for administering section 14. The annual cost estimate of administering TSCA section 14 from fiscal year 2019 through 2021 is $4,346,000. These estimates include FTE and extramural costs of conducting CBI reviews and operating and maintaining the CBI Local Area Network (LAN) (Ref. 5). 3. Indirect costs. Indirect costs are the intramural and extramural costs that are not accounted for in the direct program costs, but are important to capture because of their necessary enabling and supporting nature, and so that our proposed user fees will accomplish full cost recovery up to that provided by law. Indirect costs typically include such cost items as accounting, budgeting, payroll preparation, personnel services, purchasing, centralized data processing, and rent. Indirect costs are disparate and more difficult to track than the other cost categories, because they are typically incurred as part of the normal flow of work (e.g., briefings and decision meetings involving upper management) at many offices across the Agency. EPA accounts for some indirect costs in the costs associated with TSCA sections 4, 5, 6 and 14 by the inclusion of an indirect cost factor. This rate is multiplied by and then added to the program costs. An indirect cost rate is determined annually for all of EPA offices by the Agency's Office of the Controller, according to EPA's indirect cost methodology and as required by Federal Accounting Standards Advisory Board's Statement of Federal Financial Accounting Standards No. 4: Managerial Cost Accounting Standards and Concepts. An indirect cost rate of 28.14% was applied to direct program costs of work conducted by EPA's Office of Chemical Safety and Pollution Prevention, based on FY 2016 data (Ref. 7). Some of the direct program costs included in the TSCA sections 4, 5, 6 and 14 estimates are for work performed in other Agency offices (e.g., the Office of Research and Development and the Office of General Counsel). Appropriate indirect cost rates were applied to those cost estimates (i.e., 25.56% and 8.05%). These indirect rates are based on EPA's existing indirect cost methodology (Ref. 7). Indirect cost rates are calculated each year and therefore subject to change. Indirect costs were included in the program cost estimates in the previous sections. 4. Fee categories. In addition to Agency costs, another piece of information relevant to determining applicable user fees is the type of events that trigger a fee payment (e.g., information submission, exemption notice). Under this proposal, EPA would [[Page 8220]] require payment of fees for most types of fee triggering events under TSCA sections 4, 5 and 6. This includes the requirement to submit information to comply with a test order, test rule, or enforceable consent agreement under TSCA section 4. Payment would also be required for the following TSCA section 5 notices and exemptions: PMNs and consolidated PMNs, SNUNs, MCANs and consolidated MCANs, TMEs, LoREXs, LVEs, Tier II, film article exemptions and TSCA experimental release applications TERAs. Payment would also be required for chemicals undergoing both EPA-initiated and manufacturer-requested risk evaluations under TSCA section 6. See Unit III.D. for a detailed discussion of small business concerns. EPA is proposing three fee categories for TSCA section 4 activities. The proposed fee associated with a test order is $10,000. The proposed fee associated with a test rule is $32,000 and the fee proposed for an enforceable consent agreement is $25,000. EPA expects these fees will be paid by consortia, assuming that multiple companies manufacture the same chemical, and is requesting consortia assign comparatively lower fees for small businesses than for large businesses in the consortia. Consistent with comments previously received, the Agency is proposing to provide flexibility to manufacturers to form consortia to allocate these fees amongst those members involved in each submission activity. Two categories of fees, with different fee amounts, are being proposed for TSCA section 5 submissions. EPA chose to lump activities with similar Agency costs together in order to develop a simple fee structure. The fee being proposed for each PMN, SNUN and MCAN is $16,000. The proposed fee for each LoREX, LVE, TME, Tier II, film article and TERA is $4,700. EPA is proposing to continue the practice of allowing consolidation of PMNs, consolidation of MCANs, and in some cases, consolidation of a synthetic sequence, for up to six closely similar chemical substances with similar use, structure, and probable toxicology at the same time and for the same fee as a single chemical substance. See 48 FR 21734, May 13, 1983. Consolidated PMNs (and MCANs) benefit submitters by reducing the administrative burden of developing multiple section 5 submission forms for manufacture of two or more structurally related new chemical substances that have similar use, exposure, environmental release, and test data. EPA's review process is also better facilitated by reviewing similar substances simultaneously. EPA limits the number of substances that may be included in a consolidated PMN to six. EPA announced a policy that it would accept submission of consolidated notices, subject to the approval of each submission, in the preamble of the May 13, 1983 Federal Register (Ref. 8). When EPA initially accepted consolidations, there was no limit on the number of substances which could be submitted in one consolidation. A consolidation, though less demanding of EPA's resources than the same number of separate submissions of related chemicals, still requires a substantially increased amount of effort over the assessment of a single submission. EPA has decided that it is appropriate to continue to limit the number of substances in a consolidation to six. Persons who intend to submit a consolidated notice should first contact EPA for approval before submission of the notice; through that process, EPA can determine if the criteria for consolidation are met. Substances should be adequately similar chemically and toxicologically; planned uses must should be similar enough for combined review; and intended volumes must should not be excessively different. Consolidations are typically not granted for more than six substances in one notice, nor for substances which are not chemically and toxicologically similar. Novel or category chemicals are more likely to be approved for consolidation if the intended uses and volumes are similar. EPA intends to eliminate the ``intermediate PMN'' fee class. EPA currently charges a reduced fee of $1,000 for the submission of PMN for each chemical intermediate in a synthetic pathway when accompanied by a PMN for the final substance on that pathway, and a full $2,500 user fee for the final substance. The original intent of this reduced fee was to encourage manufacturers to submit these notices together. The Agency however, has not realized advantages in reviewing these notices together; each intermediate takes about the same amount of effort to review as does the ``final'' chemical substance on that pathway. For this reason, the Agency proposes to eliminate the reduced fee for intermediate PMN submissions and will take comment on this approach. EPA is not proposing to assess greater fees for submissions containing CBI claims. At least six commenters opposed fees for such claims, or suggested that the Agency collect only nominal payments under TSCA section 14. While the CBI costs are considered in the fee- defrayable costs, EPA is not proposing to charge an additional fee for submissions and activities that contain CBI. In order to distribute the full costs to be defrayed among the fee payment-triggering events in a way that is proportional to the costs of the work associated with those events, EPA identified different fee categories, based on the section of TSCA under which the event is covered and the effort and burden for EPA to conduct the work associated with the triggering event. EPA identified eight distinct fee categories. The two fee categories under section 5 are further broken out below for transparency. The annual estimated costs for fee categories under TSCA section 4, including both direct and indirect program costs are shown in Table 3. Please note that the costs presented in Tables 3, 4 and 5 do not include costs associated with CBI reviews, alternative testing methods development, risk management for existing chemicals or prioritization of existing chemicals. Costs associated with those activities are part of the overall costs of administering sections 4, 5, 6 and 14 and, as such, are included in the overall cost estimates previously in Table 1. Table 3--TSCA Section 4 Costs * ---------------------------------------------------------------------------------------------------------------- Estimated number of Estimated cost Estimated Fee category ongoing to Agency/ annual cost to actions/year action Agency ---------------------------------------------------------------------------------------------------------------- Test Order...................................................... 10 $279,000 $2,795,000 Test Rule....................................................... 1 844,000 422,000 Enforceable Consent Agreement................................... 1 652,000 326,000 ---------------------------------------------------------------------------------------------------------------- * Numbers may not add due to rounding. [[Page 8221]] The estimated annual costs for fee categories under TSCA section 5, including both direct and indirect program costs are shown in Table 4. Table 4--TSCA Section 5 Costs * ---------------------------------------------------------------------------------------------------------------- Estimated number of Estimated cost Estimated Fee category ongoing to Agency/ annual cost to actions/year action Agency ---------------------------------------------------------------------------------------------------------------- PMN and consolidated PMN, SNUN, MCAN and consolidated MCAN...... 462 $55,200 $25,500,000 LoREX, LVE, TME, Tier II exemption, TERA, Film Article.......... 560 5,600 3,149,000 ---------------------------------------------------------------------------------------------------------------- * Numbers may not add due to rounding. The estimated annual costs for fee categories under TSCA section 6, including both program and indirect costs are shown in Table 5. Table 5--TSCA Section 6 Costs * ---------------------------------------------------------------------------------------------------------------- Estimated number of Estimated cost Estimated Fee category ongoing to Agency/ annual cost to actions/year action Agency ---------------------------------------------------------------------------------------------------------------- EPA-initiated risk evaluation................................... 25 $3,884,000 $32,370,000 Manufacturer-requested risk evaluation: Work Plan chemical...... 2 2,600,000 1,733,000 Manufacturer-requested risk evaluation: Non-Work Plan chemical.. 3 2,600,000 2,600,000 ---------------------------------------------------------------------------------------------------------------- * Numbers may not add due to rounding. 5. Calculating user fees. Almost all industry commenters expressed support for a fair, simple, and efficient fee structure and all industry commenters recommended that fees be assessed based on the level of effort required of EPA as a result of the submission or undertaking the activity for which a fee is charged. The Agency considered these comments in developing this proposal. The Agency is proposing a general fee structure that is generally proportional to the Agency's costs, yet takes into account the numerous comments received from industry regarding the desire to limit costs associated with information submission under TSCA section 4. Two other alternate fee structure proposals are included in this preamble. When providing comments to the Agency on the various options, please recognize that there are tradeoffs between decreasing fees in one area and increasing fees in another. At the end of the day, the fee structure that the Agency finalizes, must result in the collection of funds sufficient to defray ``approximately but not more than 25 percent'' of the costs to the Administrator of carrying out section 4, 5, 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14. Because of the different costs associated with the different fee triggering events, the Agency chose to start by differentiating fees among the 8 categories discussed in Table 6. Fees for each triggering activity were then calculated for each of these separate fee categories using the following mathematical expression: [GRAPHIC] [TIFF OMITTED] TP26FE18.002 Where: cat x = category of similar types of submissions from manufacturers and processors requiring similar effort and burden on the part of EPA. Program Costs = All EPA intramural costs and extramural costs associated with a particular category of similar submission types under TSCA section 4, 5 or 6. 6. Amount of fees. EPA used the formula in Unit III.B.5. to calculate the fees per submission for each fee category. However, the Agency needed to further adjust the fees to ensure that 25% of the costs of administering TSCA sections 4, 5, 6 and 14 would be collected in any given year (i.e., approximately $20.05 million annually in fiscal year 2019 through 2021). Because the Agency includes the costs of administering TSCA section 14, risk management activities under section 6, prioritization of chemicals for evaluation and ORD support for alternative testing and methods development\enhancement in the costs, but can't collect a specific fee for these actions, the Agency calculated fees at 33% of the associated costs for TSCA sections 4, 5 and 6, as a baseline to ensure collecting 25% of costs and then adjusted the fees from there. During the public meeting in August 2016 and the Industry-specific consultation meeting in September 2016, some commenters suggested that the bulk of the Agency's cost recovery should fall under TSCA section 6. About half of the industry commenters explicitly opposed assessment of fees for submission of information under TSCA section 4. Several of these and other commenters were willing to consider fees for TSCA section 4 submissions, but only to account for the Agency's effort to review the data from these submissions and only if the fees were kept to a nominal amount, representing a minimal portion of EPA'S overall cost recovery. Further, commenters requested that the Agency [[Page 8222]] consider impacts of fees on innovation and competitive standing. EPA considered a number of options for setting fee levels taking into account feedback received during the consultation with industry stakeholders. With respect to the section 4 fees, the Agency is proposing to set fee levels for each subcategory at roughly 3.5% of the activity cost. This low fee level relative to program costs was chosen in part to take into account the fact that manufacturers and processors are investing resources already in conducting the testing yet recognizes that the Agency does expend resources issuing orders and reviewing data under this section of the statute (Ref. 5). With respect to the section 5 fees, the Agency is proposing to set two basic fee levels as mentioned above. The Agency is proposing to set fee levels for each notice subcategory at roughly 29% of the activity cost. Exemption category fees were then set at roughly \1/3\ of the PMN amount which accounts for approximately 89% of the cost of the activity (Ref. 5). To make up the difference in funds that would not be collected under TSCA section 4 or 5 based on these proposed fee levels, the Agency proposes to set the risk evaluation fee to be approximately 35% of the costs of those (Ref. 5). Overall, that results in the bulk of the fees expected to be collected under this proposed allocation coming from manufacturers of chemicals subject to EPA-initiated risk evaluations. The Agency considered this approach in part to try to set section 5 fees at levels that would minimize the potential impact on innovation and competitive standing. TSCA states the percentage of costs to be collected for manufacturer-requested risk evaluations. Namely, TSCA specifies that manufacturers be assessed fifty percent of the costs of a risk evaluation for a chemical on EPA's Work Plan and 100 percent of the costs incurred by the Agency to conduct a risk evaluation for a chemical not on the Work Plan. The fee amounts being proposed today are summarized in Table 6. Table 6--Proposed TSCA User Fees ------------------------------------------------------------------------ Proposed fee category Proposed fee ------------------------------------------------------------------------ TSCA Section 4: Test order.......................................... $9,800 Test rule........................................... 29,500 Enforceable consent agreement....................... 22,800 TSCA Section 5: PMN and consolidated PMN, SNUN, MCAN and 16,000 consolidated MCAN.................................. LoREX, LVE, TME *, Tier II exemption, TERA, Film 4,700 Articles............................................... TSCA Section 6: EPA-initiated risk evaluation....................... 1,350,000 Manufacturer-requested risk evaluation on a chemical 1,300,000 included in the Work Plan.......................... Manufacturer-requested risk evaluation on a chemical 2,600,000 not included in the Work Plan...................... ------------------------------------------------------------------------ * EPA is proposing to waive the TME fee for submissions from companies that have graduated from EPA's Sustainable Futures program. The Agency is interested in hearing from stakeholders regarding this approach for setting fees for the different categories of activities. EPA's Sustainable Futures program encourages chemical developers to use the Agency's models and methods to screen new chemicals for potential risk early in the development process, with the goal of producing safer chemicals more reliably and more quickly, saving time and money, and in turn, getting safer chemicals into the market. Companies that graduate from Sustainable Futures can earn expedited review of TSCA section 5 for prescreened new chemical notices. Prescreening chemicals for hazard concerns helps companies anticipate and avoid developing chemicals of concern. As described in the Federal Register Notice announcing Sustainable Futures (Ref. 9), the expedited review is achieved by allowing the graduate's submission to be considered both as a PMN and a TME. The graduate simultaneously submits two separate notices, the PMN, MCAN or SNUN and the TME, as a combined Sustainable Futures submission. The advantage of the simultaneous submission is that the case will be considered a TME and the submitter will be able to manufacture at day 45 instead of having to wait until the PMN 90-day review period ends. This in effect cuts the review time in half. EPA would like to encourage companies to graduate from the Sustainable Futures program and is proposing to waive the TME fee for submissions from graduates that come in with a valid PMN, MCAN or SNUN. In fiscal year 2016, 13 Sustainable Futures graduates accounted for 7.6% of the PMNs, 37.5% of MCANs and 0% of SNUNs submitted to the Agency. The annualized fees estimated to be collected under this proposed approach total approximately $20.05 million in fiscal year 2019 through 2021, with an additional $3.5 million in annualized fees expected from manufacturer-requested chemical risk evaluations during the three-year period. While TSCA section 6(b)(4)(E)(ii) sets minimum requirements on the number of ongoing manufacturer-requested risk evaluations if EPA receives a sufficient number of compliant requests (25% of the number of ongoing EPA-initiated chemical risk evaluations), we do not expect to receive a sufficient number of manufacturer requests over the next three years to meet this threshold. Manufacturers are likely to wait until the initial chemical risk evaluations are completed to see how the process plays out. The Agency estimates receiving a total of five manufacturer requests for chemical risk evaluations during the next three years--two for risk evaluations on Work Plan chemicals and three for risk evaluations on chemicals not included in the Work Plan. In developing this proposal, the Agency considered its experiences in implementing its fee collection program for pesticide registration actions. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) amendments passed by Congress in 2004 created a registration service fee system for applications for specific pesticide registration, amended registration, and associated tolerance actions. Activities conducted as part of the pesticide registration program and those to be conducted as part of the new chemical approval review program are similar in many respects. Both involve applications to the Agency to make a risk determination for a chemical substance prior to its introduction into the marketplace. In each program, the Agency conducts an independent [[Page 8223]] evaluation of potential risks presented by the proposed uses of the chemical based on the best available scientific information and in the event that risks are identified seeks to manage those risks as needed through various mitigation strategies. In conducting this analysis, the Agency recognizes that while there are valuable insights to be gained from its experiences implementing PRIA for the past 13 years that there are also important differences that also need to be understood when applying lessons learned from that program to a fee collection program under TSCA. One difference is that comprehensive data requirements have been established for pesticide registration applications under 40 CFR 158 whereas similar data requirements are not in place for chemical substances under TSCA. Another difference is the time frames allowed for making a determination on a pesticide registration application vs. reviews of chemical substances. The time frames for pesticide registration decisions vary significantly based on the type of application being submitted to the Agency. For a new pesticide active or inert ingredient, the closest relatable set of categories to a new chemical under TSCA, the time frames for a decision range from 8 to 24 months. Under TSCA, the Agency has a shorter time frame, 90 days with possible extension to 180 days, in which to make a decision on most new chemicals. The length of the decision time frames can have an impact on the queuing of actions and resources in that having to conduct a similarly scoped review in a shorter time period would be more resource intensive. In seeking to benchmark the fees being proposed for new chemical activities under TSCA, the Agency compared expected level of effort for a new chemical review to PRIA categories which might be expected to have a similar level of effort. EPA focused on the categories for the registration of new active ingredients in pesticides. The time frames associated with these reviews range from 8 months (new inert ingredient not for use on food) to 24 months (several categories). The fees for these categories range from $11,025 for a new non-food inert ingredient to $627,568 for a new conventional active ingredient for use on food crops. The most analogous PRIA categories to a new chemical review under TSCA based on data and/or the nature of the assessments needed are believed to be: PRIA Category I004- Approval of new non-food use inert ingredient ($11,025 fee and 8-month review period), and PRIA Category B600--New biopesticide active ingredient; non-food use ($19,146 fee and 13-month review period). The fees identified in this proposal for new chemicals fall within the range of these analogous categories. Considering the 90-day review period for a new chemical under TSCA, the Agency also considered PRIA categories with a similar decision time frame. Only six of the 189 PRIA categories have decision time frames of three months. One of these is to repackage an existing end use product as a manufacturing use product with identical uses (a relatively small change to a product label with no data review) while the others are for reviewing a single study protocol, reviewing a rebuttal to an Agency protocol review or to make a preliminary determination on a waiver request for a biopesticide. Each have a fee of $2,530. All of these categories are very limited in terms of data review and the scope of the decision to be made and would not be considered analogous to a new chemical determination under TSCA. C. What other options were considered? In addition to the proposed fee structure, the Agency considered two other methodologies for calculating user fees. Option A involved setting the fees for each fee category at 33% of the estimated costs to the Agency in conducting work associated with that particular activity without further adjustment. In this option, fees for test orders, test rules, and enforceable consent agreements are considerably higher than the fees being proposed today and new chemical notices fees are increased while risk evaluations and new chemical exemptions are lower. The Agency also considered an approach, Option B, in which test orders, test rule and ECA fees were set at 10% of the estimated costs to the Agency but PMN fees were set based on the inflation-adjusted amount of currently existing fees. That resulted in lower PMN, MCAN, and SNUN fees. Exemption fees were set at \1/3\ the amount of the PMN fees. To make up the difference, EPA adjusted the risk evaluation fees resulting in an increase in risk evaluation fees to approximately 43% of the estimated costs to the Agency. See Table 7 for a summary of alternate fees associated with Alternate Options A and B. Table 7--Other Alternative TSCA User Fees Considered ------------------------------------------------------------------------ Alternate fee Alternate fee Alternative fee category ``A'' ``B'' ------------------------------------------------------------------------ TSCA Section 4: Test order.......................... $92,000 $28,000 Test rule........................... 278,000 84,000 Enforceable consent agreement....... 215,000 65,000 TSCA Section 5: PMN and consolidated PMN, SNUN, MCAN and 18,200 10,400 consolidated MCAN, LoREX, LVE.......... TME, Tier II exemption, TERA............ 1,850 3,500 TSCA Section 6: EPA-initiated risk evaluation....... 1,280,000 1,670,000 Manufacturer-requested risk 1,300,0000 1,300,000 evaluation on a chemical included in the Work Plan................... Manufacturer-requested risk 2,600,000 2,600,000 evaluation on a chemical not included in the Work Plan.......... ------------------------------------------------------------------------ The annualized fees estimated to be collected under these alternative approaches are approximately the same as those estimated to be collected under the approach being proposed today. C. How did EPA take into account small business concerns? EPA is proposing reduced fees for small businesses. These reduced fees are summarized in Table 8. [[Page 8224]] Table 8--Proposed TSCA User Fees for Small Businesses ------------------------------------------------------------------------ Proposed small Proposed fee category business fee ------------------------------------------------------------------------ TSCA Section 4: Test order.......................................... $1,950 Test rule........................................... 5,900 ECA................................................. 4,600 TSCA Section 5: PMN and consolidated PMN, SNUN, MCAN and 2,800 consolidated MCAN.................................. LoREX, LVE, TME, Tier II exemption, TERA............ 940 TSCA Section 6: EPA-initiated risk evaluation....................... 270,000 Manufacturer-requested risk evaluation on a chemical 1,300,000 included in the Work Plan.......................... Manufacturer-requested risk evaluation on a chemical 2,600,000 not included in the Work Plan...................... ------------------------------------------------------------------------ EPA set the proposed small business fees at an 80% reduction compared to the base fee for each category. In one case, for PMN and related actions, the proposed small business fee reduction is 82.5%. This slightly higher percentage reduction is due to the concern for the potential impact on small businesses of higher fee levels. The proposed small business fees for each category fee is only triggered when there is one entity subject to the fee, and that entity is a small business or if there is a consortium paying the fee and all members of that consortium are small businesses. By way of comparison, PRIA fees may be reduced for small businesses by a maximum of 75% under certain conditions. EPA is also proposing to revise the size standard used to identify businesses that can qualify as a ``small business concern'' under TSCA for the purposes of fee collection. A regulatory definition for a small business that makes a submission under TSCA section 5 was promulgated in 1988 and is based on the annual sales value of the business's parent company. 40 CFR 700.43 currently states: ``Small business concern means any person whose total annual sales in the person's fiscal year preceding the date of the submission of the applicable section 5 notice, when combined with those of the parent company (if any), are less than $40 million.'' The Agency is proposing several changes to this definition. Consistent with the definition of small manufacturer or importer at 40 CFR 704.3, EPA proposes to increase the current revenue threshold of $40 million using the Producer Price Index (PPI) for Chemicals and Allied Products, as compiled by the U.S. Bureau of Labor Statistics. [Data series WPU06 at http://data.bls.gov/cgi-bin/srgatet.] Using a base year of 1988 and inflating to 2015 dollars results in a value of approximately $91 million (Ref. 10). Pursuant to 13 CFR 121.903(a)(1)(ii), the Agency also proposes to change the time frame over which annual sales values are used when accounting for a business's revenue. Instead of using just one year preceding the date of submission, the Agency is proposing to average annual sales values over the three years preceding the submission. EPA proposes to apply this updated definition--adjusted for inflation and averaging sales revenue over three years--to not only TSCA section 5 submissions, but also to TSCA sections 4 and 6 submissions as well. The Agency is seeking comment on this approach and is specifically interested in comment on whether an employee-based size standard would be more appropriate than a receipts-based size standard and what that employee level should be; whether the size standard, be it receipts- based or employee-based, should vary from industry to industry to reflect differences among the impacted industries; and what other factors and data sources the Agency should consider, besides inflation, when developing the size standard to qualify for reduced fee amounts. Further, with respect to small business size standards, the Agency has recently committed to revisiting the definition of small businesses as it relates to the TSCA section 8(a) data reporting regulations (82 FR 56824). Due to the urgent need for the Agency to promulgate this regulation and expeditiously collect the fees, the Agency believes that upcoming rulemaking will provide a venue for a more expansive consideration of appropriate size standards for industries subject to TSCA and offer the public with further opportunities to comment on the size standard. In addition to considering comments submitted in response to this proposal, the Agency is committed to evaluating the results of the 8(a) rulemaking process and, in the event that the reporting and fee standards differ, to determine if the size standards set through that process should be harmonized with the small business definition for fees. This harmonization could be implemented in a subsequent rulemaking for the next three-year fee cycle (FY22-FY25). D. How would the Agency handle fees from multiple parties? Not every person subject to this rule must individually submit fees to EPA. TSCA section 26(b)(4)(C) allows for payment of fees by consortia of manufacturers and processors. EPA is proposing to allow joint submissions under TSCA section 5 and is permitting the formation of, and payment by, consortia for submissions under TSCA sections 4 and 6. Joint submitters of a TSCA section 5 notice would be required to remit the applicable fee identified in paragraph (b) of this section for each section 5 notice submitted. Only one fee is required for each submission, regardless of the number of joint submitters for that notice. To qualify for the fee identified in paragraph (b)(1) of this section, each joint submitter of a TSCA section 5 notice must qualify as a small business concern under Sec. 700.43. This approach aligns with comments received from industry during the consultation process. Any consortium formed to jointly submit TSCA user fees would be expected to notify EPA of such intent. Once established, it would be up to the consortium to determine how the user fee would be split among the members. EPA strongly encourages consortia to set lower fees for small business concerns; Congress intended small business to be afforded lower fee payments (TSCA 26(b)(4)(A)). If, after 30 days, a consortium is unable to reach agreement on splitting the user fee, the principal sponsor must notify EPA, so EPA can calculate the [[Page 8225]] individual fee for each consortium member. The Agency proposes to divide the total fee by the number of members. Small businesses will be afforded an 80% discount, which the remaining consortium members will be required to cover in equal amounts. EPA requests comment on this default approach. F. What methods of payment would be accepted? The U.S. Department of the Treasury has determined that federal agencies should move away from receiving payments by check, and transition to electronic methods of payment. EPA proposes to accept payment of fees through two different electronic payment options: Pay.gov and Fedwire. Pay.gov is a secure government-wide collection portal that helps federal agencies meet the directives outlined in the Government Paperwork Elimination Act (Pub. L. 105-277) (Ref. 11), primarily by reducing the number of paper transactions and utilizing electronic transaction processing. pay.gov, accessible online at http://www.Pay.gov, currently processes payments for hundreds of federal government agencies. It provides a full suite of services, allowing federal agencies to process collections quickly and easily; it also provides reports that can assist in integrating information into other financial systems. Pay.gov provides customers the ability to electronically complete forms and make payments twenty-four hours a day. Because the application is web-based, customers can access their accounts from any computer with internet access. Fedwire is generally used for foreign payments. With this method of electronic payment, payers authorize a financial institution to initiate an electronic (wire transfer) payment to the Federal Reserve Bank of New York. Credit Gateway, which is operated by a commercial bank, then allows federal agencies to access their money from Fedwire. Credit Gateway processes transactions and settles them at Federal Reserve Banks. EPA proposes that those subject to fees could use any payment method of their choice supported by the Department of the Treasury's Pay.gov electronic payment collection services (or any applicable alternative or successor to Pay.gov developed by Treasury) or Fedwire, as long as EPA's financial tracking systems are able to obtain and process the selected method of payment. Specifically, manufacturers and processors would be expected to create payment accounts in Pay.gov and use one of the electronic payment methods currently supported by Pay.gov (e.g., Automated Clearing House debits (ACH) from bank accounts, credit card payments, debit card payments, PayPal or Dwolla) or use Fedwire to authorize an electronic payment. Because Pay.gov and Fedwire do not accept paper checks as payment, EPA will not accept paper checks as payment for TSCA services. Additional instructions for making payments to EPA using Pay.gov and Fedwire are found at https://www.epa.gov/financial/additional-instructions-making-payments-epa. The Agency requests comment on this approach. G. When would payment of fees be required? There is precedent for advance payments of user fees in several of the Agency's existing user fee programs. For example, EPA's Office of Pesticide Programs and EPA's Office of Air and Radiation fee programs typically require advance payment prior to administering program services involving the review of applications for the various certifications and registrations administered by those programs. This follows the guidance outlined in OMB Circular No. A-25, which states that user charges will ``be collected in advance of, or simultaneously with, the rendering of services.'' (Ref. 3) EPA is proposing to collect lump sum payment of the entire user fee for section 5 notices prior to reviewing each submission or undertaking the activity associated with the fee. EPA is proposing to require fee payment at the time a TSCA section 5 notice (this includes an exemption) is submitted. EPA is proposing to allow fee submitters for test orders, test rules, ECAs and EPA-initiated chemical risk evaluations time to associate with a consortium and work out fee payments within that consortium. Payment for fee categories under TSCA section 4 (i.e., test orders, test rules and ECAs) is due within 60 days of the effective date of the order or rule, or 60 days upon signing of an enforceable consent agreement. For EPA-initiated risk evaluations, full payment is due within 60 days of EPA publishing the final scope of a chemical risk evaluation. EPA believes this provides sufficient time for manufacturers to associate as a consortium, if they so choose, and to decide on the partial fee payments each member of the consortium will be responsible for. Manufacturers will have ample warning that a risk evaluation is underway, well before the final scope is published in the Federal Register. For manufacturer-requested risk evaluations, EPA is proposing to collect a fee when EPA grants the request to conduct the evaluation. Payment will be required within 30 days of EPA providing such notice. EPA is also proposing that user fees will begin to be incurred starting on October 1, 2018. As discussed above, TSCA section 26(b)(4)(F) requires EPA, ``beginning with the fiscal year that is 3 years after the date of enactment [June 22, 2016],'' to adjust fees as necessary so they are sufficient to defray a portion of EPA's costs. Since Congress expected fees to already be in place by October 1, 2018 such that they may need adjusting, EPA believes it is reasonable for all actions for which a fee is proposed to be subject to fees as of October 1, 2018. EPA will not, however, collect any fees until the final rule resulting from this proposal is effective. Instead, EPA intends to record actions that would be expected to trigger payment of fees and once the rule is final send invoices to the affected parties indicating. The invoices would reflect timing for payments and amounts based on the final rule. H. Under what circumstances will EPA refund payments? EPA will continue to refund any fee paid for a section 5 notice whenever EPA determines that the notice or fee was not required. See, e.g., 40 CFR 720.62. This can happen, for example, when the intended use described in the PMN is not actually subject to TSCA jurisdiction or when the substance is already on the Inventory. TSCA section 26(b)(4)(G) permits EPA to refund fees, or a portion of fees, for notices submitted under TSCA section 5 that are later withdrawn and for which the Agency conducts no substantive work unless the Agency determines that the submitter unduly delayed the process. EPA proposes to refund a consistent 75% of the user fee to the submitter if the notice is withdrawn within 10 business days. This percentage is consistent with the approach for refunds for withdrawn actions under PRIA. Beyond ten business days, EPA is likely to have already conducted substantial review work that qualifies as substantive work for which no refund is authorized under TSCA 26(b)(4)(G). Up to three significant milestones of the PMN review process can take place within 10 business days. The Chemical Review/Search Strategy Meeting occurs between Day 8 and 12; the Structure Activity Team Meeting occurs between Day 9 and 13; and Development of Exposure/Release Assessments occurs between Day 10 and 19. EPA feels that tying the refund time period to a certain number of days is a simpler and more efficient [[Page 8226]] approach than tying it to a specific milestone of the review process. EPA does not have authority to, and therefore will not, provide refunds under any other circumstances. I. What are the consequences of failing to pay a fee? Failure to comply with any requirement of a rule promulgated under TSCA is a prohibited act under TSCA section 15 and is subject to penalties under TSCA section 16. When the fee payment requirements are finalized, failure to pay the appropriate fee at the required time would subject each manufacturer and processor who is subject to the fee payment to penalties of as much as the maximum statutory amount per day ($38,114 as of January 2017) until the required fee is paid. Each person subject to fees would be subject to such penalties regardless of whether they intend to pay independently, as a joint submitter or through consortia. Specifically, each member of a consortium, and each joint submitter, is individually responsible for payment of the fee, and subject to penalties for non-payment, until the fee is actually paid. J. Compliance Date EPA is proposing to start collecting fees the day after the final TSCA user fees regulations are published in the Federal Register. Stakeholders were provided notice during public meetings in August of 2016 requesting comment through EPA Docket: EPA-HQ-2016-0401 and indicating that the Agency intended to start collecting new fees for TSCA section 4 and section 6 activities and that fees associated with the submission of notices under TSCA section 5 would increase. EPA believes that we have provided sufficient notice to, and opportunity for, industry to provide comment regarding the user fees. (See Unit II.C. titled, ``Stakeholder Involvement''.) Furthermore, for EPA to sufficiently address the increased workload under TSCA as amended in June 2016, the Agency must start collecting fees as soon as possible for use in defraying some of the costs of activities spelled out in TSCA section 26 paragraph (b)(1). EPA is seeking comment on this approach. K. What other amendments are being proposed? EPA is proposing minor changes to several of its regulations that cross-reference the part 700 fees regulations, specifically parts 720, 723, 725, 790 and 791. Amending the regulatory text in these parts will ensure that existing regulations appropriately reference the regulatory text being proposed. EPA is proposing minor updates for implementing the fee requirements for test marketing exemptions at Sec. 720.38; premanufacture notification regulations at Sec. 720.45(a)(5); instant photographic and peel-apart film articles exemptions at Sec. 723.175; amendments to regulations covering MCANs and exemption requests at Sec. 725.25 and Sec. 725.33; minor amendments at Sec. 790.45 and Sec. 790.59; and a modification to the general provisions for data reimbursement found at Sec. 791.39. IV. Projected Economic Impacts of TSCA User Fees EPA has evaluated the potential costs for manufacturers and processors of chemical substances for this proposed rule. Overall, EPA developed eight fee categories for activities under TSCA sections 4, 5, and 6. TSCA section 4 fee categories include test orders, test rules, and ECAs. TSCA section 5 fee categories include PMNs and consolidated PMNs, SNUNs, MCANs and consolidated MCANs, LoREXs, LVEs, TMEs, Tier II exemptions and TERAs. Finally, TSCA section 6 fee categories include Agency-initiated risk evaluations, manufacturer-requested risk evaluations for Work Plan chemicals, and manufacturer-requested risk evaluations for non-Work Plan chemicals. For the baseline, EPA used a historical average of the 2013 through 2016 submissions for each TSCA section 5 action (Ref. 12) as the estimate of the number of submissions per fee category for the next three years. TSCA section 4 test orders are new under TSCA and the average number of such actions expected per year represents an EPA estimate. For the other TSCA section 4 actions (test rules and ECAs), EPA also estimated the expected number of such actions per year. The amended TSCA regulations specify the number of risk evaluations that EPA must have ongoing over the next three years. EPA uses the mandated number of risk evaluations to estimate the cost of the proposed rule for TSCA section 6 activities. Under the recent amendments to TSCA, EPA assumes that the number of TSCA section 4 activities (test rules and ECAs) would change from the baseline as the Agency seeks additional test data and information on chemical substances, TSCA section 5 activities would decrease as a result of higher fees and the new statutory requirement for affirmative determination, and TSCA section 6 risk evaluations initiated over the next several years would increase before leveling off in accordance with statutory requirements. The Agency expects to have between 20 and 30 risk evaluations ongoing in any given year at different stages in the review process, including manufacturer-requested evaluations. The Agency seeks comment on these assumptions. EPA estimates the total fee collection by multiplying the proposed fees with the number of expected activities under full implementation for each section. For test rules and ECAs, EPA has not promulgated any in the recent past and has estimated the number of activities that EPA will likely need to issue to meet our requirements. EPA based the estimates of the future number of TSCA section 5 submissions on the historical number of submissions for all TSCA section 5 notices and exemptions. EPA further assumes that the number of submissions under each TSCA section 5 fee category will decline by approximately 10% as a result of (a) higher fees on PMNs, MCANs, and SNUNs; (b) new fees for exemption notices; and (c) the requirement that EPA make an affirmative determination on every new chemical. Previously, new chemicals could enter the marketplace unless EPA made a specific determination that regulatory controls were needed. Now, an affirmative safety determination must be made before a new chemical can enter the marketplace and before a significant new use is allowed for an existing chemical. EPA's assumption that there will be a 10% decrease in submissions under TSCA section 5 follows the same assumption made back in 1987 when TSCA section 5 fees were first proposed (Ref. 12). TSCA section 6 risk evaluations are a new activity under the amended TSCA. In the past, EPA developed risk assessments. This risk assessment process has been replaced by risk evaluations and EPA uses manufacturer data for the first 10 chemicals identified for this process to estimate the average number of impacted firms per chemical and proportion of firms impacted that are small businesses. The annualized fees collected from industry for the proposed option (identified as Option C in the Economic Analysis (Ref. 2)) are approximately $20.05 million. This total does not include the fees collected for manufacturer-requested risk evaluations. Total fee collections were calculated by multiplying the estimated number of actions per fee category anticipated each year, by the corresponding proposed fee. For the proposed option, TSCA section 4 fees account for less than one percent of the total fee collection, TSCA section 5 fees for approximately 43 percent, and TSCA section 6 fees for approximately 56 percent. Annual fees collected by EPA [[Page 8227]] are expected to total approximately $20.05 million. Under the proposed option, the total fees collected from industry for a risk evaluation requested by manufactures are estimated to be $1.3 million for chemicals included in the Work Plan and $2.6 million for chemicals not included in the Work Plan. For small businesses, EPA estimates that 18.5 percent of TSCA section 5 submissions will be from small businesses that are eligible to pay discounted fees because they have average annual sales of less than $91 million in the three preceding years. Total annualized fees for TSCA section 5 collected from small businesses are estimated to be $550,000 (Ref. 2). For TSCA sections 4 and 6, discounted fees for eligible small businesses and fees for all other affected firms may differ over the three-year period that was analyzed, since the fee paid by each firm is dependent on the number of affected firms per action. Based on past TSCA section 4 actions and data related to the first ten chemicals identified for risk evaluations under TSCA as amended, EPA estimates annualized fees collected from small businesses for TSCA section 4 and TSCA section 6 to be approximately $37,000 and $2.6 million, respectively. For each of the three years to be covered by this proposed rule, EPA estimates that total fees paid by small businesses will account for about 16 percent of the approximately $20.05 million fees to be collected for TSCA sections 4, 5, and 6 actions. The annualized total industry fee collection for small businesses is estimated to be approximately $3.2 million. For this proposed rule, affected manufacturers (including importers) and processors of chemical substances would be required to pay a specified user fee to be established for actions regulated under TSCA. The fees to be paid by industry would defray the cost for EPA to administer TSCA sections 4, 5, 6, and 14. Absent this proposed regulation, EPA costs to administer these sections of TSCA would be borne by taxpayers through budget appropriations from general revenue. As a result of this proposed rule, 25% of EPA costs to administer TSCA section 4, 5, 6, and 14 and activities paid from general revenue would be transferred via the user fees to industry. Although these user fees may be perceived by industry as direct private costs, from an economic perspective, they are transfer payments rather than real social costs. Therefore, the total social cost of this proposed rule does not include the fees collected from industry by EPA. Rather, it includes the opportunity costs incurred by industry, such as the cost to read and familiarize themselves with the proposed rule, determine their eligibility for paying reduced fees, notify EPA of participation in a consortium, and arrange to submit fee payments. The total social cost of the proposed rule also includes the additional costs to EPA to administer TSCA sections 4, 5, 6, and 14. The total opportunity cost to industry is approximately $58,000 and the additional Agency burden is approximately $1,000, yielding a total social cost of approximately $59,000 for this proposed rule. V. Request for Comments A. Affected Industry EPA is specifically seeking additional information and data that the Agency could consider in developing the final economic analysis. In particular, EPA is seeking data that could facilitate EPA's further evaluation of the potentially affected industry and firms, including data related to potential impacts on those small businesses that would be subject to user fees. B. User Fees Categories EPA seeks comments on all aspects of the fee categories being proposed for manufacturers and processors in Unit III.B.4 and welcomes comments on how the various fees and fee categories discussed could be combined in different ways to achieve an overall fee structure amounting to 25% of the Agency's costs to administer TSCA sections 4, 5, 6 and 14. In addition, the Agency would appreciate specific comments on the decision to not include a fee category for risk management under TSCA section 6(a) and the decision to eliminate the existing intermediate PMN fee category, which currently provides a discount to manufacturers who submit intermediate PMNs at the same time as a final PMN. The Agency will still accept intermediate PMN submissions, but will charge a full PMN fee for each chemical. We recognize there may be minimal efficiencies with intermediate submissions submitted at the same time as a final PMN and are seeking comment on the elimination of this fee category for PMN submissions. The Agency is interested in comments on the fee amounts being proposed today, as well as the alternative fees considered; proposed and alternative fee amounts are shown in Table 9. EPA is also interested in comments on the proposal to waive exemption fees on TMEs submitted at the same time as a PMN, SNUN, or MCAN from a company that has graduated from the Agency's Sustainable Futures program. Table 9--Comparison of Proposed TSCA User Fees and the Alternative Fees Considered ---------------------------------------------------------------------------------------------------------------- Alternate fee Alternate fee Proposed fee category Proposed fee ``A'' ``B'' ---------------------------------------------------------------------------------------------------------------- TSCA Section 4: Test order.................................................. $9,800 $92,000 $28,000 Test rule................................................... 29,500 278,000 84,000 Enforceable consent agreement............................... 22,800 215,000 65,000 TSCA Section 5: PMN and consolidated PMN.................................... 16,000 18,200 10,400 SNUN, MCAN and consolidated MCAN............................ LoREX, LVE, TME, Tier II exemption, TERA.................... 4,700 1,850 3,500 TSCA Section 6: EPA-initiated risk evaluation............................... 1,350,000 1,280,000 1,670,000 Manufacturer-requested risk evaluation on a chemical 1,300,000 1,300,000 1,300,000 included in the Work Plan.................................. Manufacturer-requested risk evaluation on a chemical not 2,600,000 2,600,000 2,600,000 included in the Work Plan.................................. ---------------------------------------------------------------------------------------------------------------- [[Page 8228]] C. Small Business Concerns EPA is proposing several changes to the size standard used to identify businesses that can qualify as a ``small business concern'' for purposes of fees and seeks comment on the proposed approach as discussed in Unit III. The Agency is also interested in comments on the reduced fee amounts being proposed for those businesses that can qualify as a ``small business concern.'' The Agency is seeking comment on this approach and is specifically interested in comment on whether an employee-based size standard would be more appropriate than a receipts-based size standard and what that employee level should be; whether the size standard, be it receipts- based or employee-based, should vary from industry to industry to reflect differences among the impacted industries; and what other factors and data sources the Agency should consider, besides inflation, when developing the size standard to qualify for reduced fee amounts. Further, with respect to small business size standards, the Agency has recently committed to revisiting the definition of small businesses as it relates to the TSCA Section 8(a) data reporting regulations (82 FR 56824). Due to the urgent need for the Agency to promulgate this regulation and expeditiously collect fees, the Agency believes that upcoming rulemaking will provide a venue for a more expansive consideration of appropriate size standards for industries subject to TSCA and offer the public with further opportunities to comment on the size standard. In addition to considering comments submitted in response to this proposal, the Agency is committed to evaluating the results of the 8(a) rulemaking process and, in the event that the reporting and fee standards differ, to determine if the size standards set through that process should be harmonized with the small business definition for fees. This harmonization could be implemented in a subsequent rulemaking for the next three-year fee cycle (FY22-FY25). D. Electronic Payment of Fees The Agency is interested in comments pertaining to the electronic payment of fees. If, for some reason, neither Pay.gov nor Fedwire meets the needs of those required to pay user fees, the Agency would appreciate the identification of other appropriate electronic payment methods to consider. VI. References The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT. 1. 2016. The Frank R. Lautenberg Chemical Safety for the 21st Century Act. June 22, 2016. 2. 2017. EPA. Economic Analysis for the TSCA Section 26(b) Proposed Fees Rule. December 2017. 3. 1993 OMB. Circular No. A-25 Revised. July 8, 1993. 4. 2008. GAO. Federal User Fees: A Design Guide. Report to Congressional Requesters. GAO-08-386SP. May 2008. 5. 2017. EPA. Technical Background Document for TSCA Fees. December 2017. 6. 2017. EPA. Statistics for the New Chemicals Review Program under TSCA. https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/statistics-new-chemicals-review. 7. 2017. EPA. Interagency Agreement and Oil Indirect Cost Rates for FY 2018 and Beyond. September 28, 2017. 8. 1983. EPA. 48 FR 21722, 27134-35. 9. 2002. EPA. 67 FR 238. Sustainable Futures--Voluntary Pilot Project Under the TSCA New Chemicals Program. 10. 2016. Abt Associates. Memorandum: Inflation of Small Business Definition under section 5 of TSCA. August 31, 2016. 11. 1998. Government Paperwork Elimination Act. Public Law 105-277. 12. 1987. EPA. Proposed Fees for Processing Premanufacture Notices, Exemption Applications and Notices, and Significant New Use Notices. 42 FR 12940. 13. 2017. EPA. Information Collection Request for the TSCA Section 26(b) Proposed Reporting Requirements Associated with the Payment of TSCA Fees (EPA ICR No. 2569.01; OMB Control No. 2070-[NEW]). December 2017. VII. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket for this action as required by section 6(a)(3)(E) of Executive Order 12866. EPA prepared an economic analysis of the potential costs and benefits associated with this action (Ref. 2), which is available in the docket and discussed in Unit IV. B. Executive Order 13771: Reducing Regulation and Controlling Regulatory Costs This action is expected to be subject to the requirements for regulatory actions specified in Executive Order 13771 (82 FR 9339, February 3, 2017). Details on the estimated costs of this proposed rule can be found in EPA's analysis (Ref. 2) of the potential costs and benefits associated with this action, which is available in the docket and is summarized in Unit IV. C. Paperwork Reduction Act (PRA) The information collection requirements in this proposed rule have been submitted to OMB for review and approval under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) prepared by EPA has been assigned EPA ICR number 2569.01. You can find a copy of the ICR in the docket for this proposed rule (Ref. 13), and it is briefly summarized here. The information collection activities associated with the proposed rule include familiarization with the regulation, small business discount eligibility determination, informing EPA of participation in consortia, and electronic payment of fees through Pay.gov or Fedwire. Respondents/affected entities: Persons who manufacture, distribute in commerce, use, dispose, process a chemical substance (or any combination of such activities) and are required to submit information to EPA under TSCA sections 4, 5, or 6, or if you manufacture or process a chemical substance that is the subject of a risk evaluation under TSCA section 6(b). Respondent's obligation to respond: Mandatory. Estimated number of respondents: 1,414 respondents. Frequency of response: On occasion to EPA as needed. Total estimated burden: 740 hours (per year). Burden is defined at 5 CFR 1320.3(b). Total estimated cost: $59,540 (per year). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information [[Page 8229]] unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive your ICR-related comments no later than March 28, 2018. EPA will respond to any ICR-related comments with the final rule. D. Regulatory Flexibility Act (RFA) Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities expected to be subject to the requirements of this action are small chemical manufacturers and processors, small petroleum refineries, and small chemical and petroleum wholesalers. There may be some potentially affected firms within other sectors, but not all firms within those sectors will be potentially affected firms. EPA has determined that 84 small businesses may be affected annually by section 4 actions; 190 small businesses may be affected by section 5 actions (164 may pay discounted fees and the remaining 26 would pay the general industry fee); and 24 small business firms may be affected by section 6 actions. As a result, EPA estimates that, of the 298 small businesses paying fees every year, all may have annual cost- revenue impacts less than 1%. EPA continues to be interested in the potential impacts of this proposed rule on small entities that are required to pay user fees and welcomes comments on issues related to such impacts. E. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. As such, the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531- 1538, do not apply to this action. F. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of ``covered regulatory action'' in section 2-202 of Executive Order 13045. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate environmental health risks or safety risks. I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy 1 Supply, Distribution, or Use This action is not a ``significant energy action'' as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use. This action is proposing service fees for TSCA, which will not have a significant effect on the supply, distribution or use of energy. J. National Technology Transfer and Advancement Act (NTTAA) Since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to this action. K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action does not affect the level of protection provided to human health or the environment. When implemented, the user fees collected under this proposed rule will assist the Agency in carrying out various requirements under TSCA, including conducting risk evaluations, risk-based screenings, authorizing testing of chemical substances and mixtures, and evaluating and reviewing manufacturing and processing notices, as required under TSCA sections 4, 5, and 6. Although not directly impacting environmental justice-related concerns, the fees will enable the Agency to better protect human health and the environment, including in low- income and minority communities. List of Subjects 40 CFR Part 700 Chemicals, Environmental protection, Hazardous substances, Reporting and recordkeeping requirements, User fees. 40 CFR Part 720 Chemicals, Environmental protection, Hazardous substances, Imports, Reporting and recordkeeping requirements. 40 CFR Part 723 Chemicals, Environmental protection, Hazardous substances, Phosphate, Reporting and recordkeeping requirements. 40 CFR Part 725 Administrative practice and procedure, Chemicals, Environmental protection, Hazardous substances, Imports, Labeling, Occupational safety and health, Reporting and recordkeeping requirements. 40 CFR Part 790 Administrative practice and procedure, Chemicals, Confidential business information, Environmental protection, Hazardous substances, Reporting and recordkeeping requirements. 40 CFR Part 791 Administrative practice and procedure, Chemicals, Environmental [[Page 8230]] protection, Hazardous substances, Reporting and recordkeeping requirements. Dated: February 7, 2018, E. Scott Pruitt, Administrator. Therefore, EPA proposes to amend 40 CFR parts 700, 720, 723, 725, 790 and 791 as follows: PART 700--[AMENDED] 0 1. The authority citation for part 700 is revised to read as follows: Authority: 15 U.S.C. 2625 and 2665, 44 U.S.C. 3504. 0 2. Section 700.40 is revised to read as follows: Sec. 700.40 Purpose and applicability. (a) Purpose. The purpose of this subpart is to establish and collect fees from manufacturers (including importers) and processors to defray part of EPA's cost of administering the Toxic Substances Control Act (15 U.S.C. 2601-2692), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182). (b) Applicability. This subpart applies to all manufacturers (including importers) and processors who are required to submit information under section 4 of the Act; who submit certain notices and exemption requests to EPA under section 5 of the Act; and who manufacture a chemical substance that is subject to a risk evaluation under TSCA section 6(b)(4) of the Act. (c) After [DATE 1 DAY AFTER PUBLICATION OF THE FINAL RULE IN THE Federal Register], all persons specified in Sec. 700.45 and paragraph (a) of this section must comply with this subpart. 0 3. Section 700.43 is amended by: 0 a. Revising the section heading; 0 c. Revising the introductory text; 0 d. Adding in alphabetical order definitions for ``Consortium'', ``Enforceable consent agreement'', and ``EPA-initiated risk evaluation''; 0 e. Removing the definitions of ``Exemption application'' and ``Intermediate premanufacture notice''; 0 f. Revising the definition of ``Joint submitters''; 0 g. Adding in alphabetical order a definition for ``Manufacturer- requested risk evaluation''; 0 h. Revising the definition of ``Person''; 0 i. Adding in alphabetical order definitions for ``Principal sponsor'' and ``Risk evaluation''; 0 i. Revising the definitions of ``Significant new use notice'' and ``Small business concern''; and 0 k. Adding in alphabetical order definitions for ``Test order'' and ``Test rule''. The revisions and additions read as follows: Sec. 700.43 Definitions applicable to this subpart. Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in Sec. Sec. 704.3, 720.3, 723.175(b), 725.3, and 790.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply: * * * * * Consortium means an association of manufacturers (including importers) and/or processors who have made an agreement to jointly split the cost of applicable user fees. * * * * * Enforceable consent agreement means a consent agreement used by EPA to accomplish testing where a consensus exists among EPA and interested parties (as identified in Sec. 790.22(b)(2)) concerning the need for and scope of testing under section 4 of the Act. EPA-initiated risk evaluation means any risk evaluation conducted pursuant to section 6(b)(4)(C)(i) of the Act. * * * * * Joint submitters mean two or more persons who submit a TSCA section 5 notice together. Manufacturer-requested risk evaluation means any chemical substance risk evaluation conducted at the request of one or more manufacturers of that chemical substance pursuant to section 6(b)(4)(C)(ii) of the Act. * * * * * Person means a manufacturer (including importer) or processor. * * * * * Principal sponsor means a person who assumes primary responsibility for the direction of study, the payment of user fees to EPA, and for oral and written communication with EPA. Risk evaluation means any risk evaluation conducted pursuant to section 6(b) of the Act. * * * * * Significant new use notice or SNUN means any notice submitted to EPA pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of this chapter. Small business concern means any person whose average total annual sales over the person's three fiscal years preceding the date the fee is assessed, when combined with those of the parent company (if any), are less than $91 million. Test order means an order to develop information pursuant to section 4(a) of the Act. Test rule refers to a regulation requiring the development of information pursuant to section 4(a) of the Act. 0 4. Section 700.45 is revised to read as follows: Sec. 700.45 Fee payments. (a) Persons who must pay fees. (1) Manufacturers and/or processors submitting a TSCA section 5 notice to EPA shall remit for each such notice the applicable fee identified in paragraph (b) of this section in accordance with the procedures in paragraphs (d) and (e) of this section. (2) Manufacturers and/or processors of chemical substances and mixtures required to test these chemical substance and mixtures under a TSCA section 4(a) test rule, test order, or enforceable consent agreement shall remit for each such test rule, order, or enforceable consent agreement the applicable fee identified in paragraph (b) of this section in accordance with the procedures in paragraphs (d) and (e) of this section. (3) Manufacturers of chemical substances and mixtures required to test these chemical substance and mixtures under a TSCA section 4(a) test rule, test order, or enforceable consent agreement other than a test rule, test order, or enforceable consent agreement described in paragraph (a)(2) of this section shall remit for each such test rule, order, or enforceable consent agreement the applicable fee identified in paragraph (b) of this section in accordance with the procedures in paragraphs (d) and (e) of this section. (4) Manufacturers of a chemical substance that is subject to a risk evaluation under section 6(b) of the Act, shall remit for each such chemical risk evaluation the applicable fee identified in paragraph (b) of this section in accordance with the procedures in paragraphs (d) and (e) of this section. Manufacturers will be identified through the most current Chemical Data Reporting (CDR) submissions. While EPA will attempt to identify manufacturers through CDR data, failure to identify a manufacturer that is subject to a risk evaluation fee does not remove their obligation to pay the associated fee. (b) Fees for the 2019, 2020 and 2021 fiscal years. Persons shall remit fee payments to EPA as follows: (1) Small business concerns. Small business concerns shall remit fees as follows: [[Page 8231]] (i) Premanufacture notice and consolidated premanufacture notice. Persons shall remit a fee totaling $2,800 for each premanufacture notice (PMN) or consolidated (PMN) submitted in accordance with part 720 of this chapter. (ii) Significant new use notice. Persons shall remit a fee totaling $2,800 for each significant new use notice (SNUN) submitted in accordance with part 721 of this chapter. (iii) Exemption application. Persons shall remit a fee totaling $940 for each of the following exemption requests submitted under section 5 of the Act: (A) Low releases and low exposures exemption or LoREX request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with Sec. 723.50(a)(1)(ii) of this chapter. (B) Low volume exemption or LVE request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with Sec. 723.50(a)(1)(i) of this chapter. (C) Test marketing exemption or TME application submitted to EPA pursuant to section 5 of the Act in accordance with Sec. Sec. 725.300 through 725.355 of this chapter. (D) TSCA Experimental Release Application or TERA application submitted to EPA pursuant to section 5 of the Act for research and development activities involving microorganisms in accordance with Sec. Sec. 725.200 through 725.260 of this chapter. (E) Tier II exemption application submitted to EPA pursuant to section 5 of the Act in accordance with Sec. Sec. 725.428 through 725.455 of this chapter. (iv) Instant photographic film article exemption notice. Persons shall remit a fee totaling $940 for each instant photographic film article exemption notice submitted in accordance with Sec. 723.175 of this chapter. (v) Microbial commercial activity notice and consolidated microbial commercial activity notice. Persons shall remit a fee totaling $2,800 for each microbial commercial activity notice (MCAN) or consolidated MCAN submitted in accordance with Sec. Sec. 725.25 through 725.36 of this chapter. (vi) Persons shall remit a total of twenty percent of the applicable user fee under paragraph (b)(2)(vi), (b)(2)(vii) or (b)(2)(viii) of this section for a test rule, test order, or enforceable consent agreement. (vii) Persons shall remit a total fee of twenty percent of the applicable user fee under paragraphs (b)(2)(ix) of this section for an EPA-initiated risk evaluation. (2) Others. Persons other than small business concerns shall remit fees as follows: (i) PMN and consolidated PMN. Persons shall remit a fee totaling $16,000 for each PMN or consolidated PMN submitted in accordance with part 720 of this chapter. (ii) SNUN. Persons shall remit a fee totaling $16,000 for each significant new use notice submitted in accordance with part 721 of this chapter. (iii) Exemption applications. Persons shall remit a fee totaling $4,700 for each of the following exemption requests, and modifications to previous exemption requests, submitted under section 5 of the Act: (A) Low releases and low exposures exemption or LoREX request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with Sec. 723.50 (a)(1)(ii) of this chapter. (B) Low volume exemption or LVE request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with Sec. 723.50 (a)(1)(i) of this chapter. (C) Test marketing exemption or TME application submitted to EPA pursuant to section 5 of the Act in accordance with Sec. Sec. 725.300 through 725.355 of this chapter, unless the submitting company has graduated from EPA's Sustainable Futures program, in which case this exemption fee is waived. (D) TSCA Experimental Release Application or TERA application submitted to EPA pursuant to section 5 of the Act for research and development activities involving microorganisms in accordance with Sec. Sec. 725.200 through 725.260 of this chapter. (E) Tier II exemption application submitted to EPA pursuant to section 5 of the Act in accordance with Sec. Sec. 725.428 through 725.455 of this chapter. (iv) Instant photographic film article exemption notice. Persons shall remit a fee totaling $4,700 for each exemption notice submitted in accordance with Sec. 723.175 of this chapter. (v) MCAN and consolidated MCAN. Persons shall remit a fee totaling $16,000 for each MCAN or consolidated MCAN submitted in accordance with Sec. Sec. 725.25 through 725.36 of this chapter. (vi) Test rule. Persons shall remit a fee totaling $9,800 for each test rule. (vii) Test order. Persons shall remit a fee totaling $29,500 for each test order. (viii) Enforceable consent agreement. Persons shall remit a fee totaling $22,800 for each enforceable consent agreement. (ix) EPA-initiated chemical risk evaluation. Persons shall remit a fee totaling $1,350,000. (x) Manufacturer-requested risk evaluation of a Work Plan Chemical. Persons shall remit a fee totaling $1,300,000. (xi) Manufacturer-requested risk evaluation of a Non-Work Plan Chemical. Persons shall remit a fee totaling $2,600,000. (c) Fees for 2022 fiscal year and beyond. (1) Fees for the 2022 and later fiscal years will be adjusted on a three-year cycle by multiplying the fees in paragraph (b) by the current PPI index value with a base year of 2019 using the following formula: FA = F x I Where: FA = the inflation-adjusted future year fee amount. F = the user fee specified in paragraph (b) of this section. I = Producer Price Index for Chemicals and Allied Products inflation value with 2019 as a base year. (2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption applications and manufacturer-requested chemical risk evaluation requests apply to submissions received by the Agency on or after October 1 of every three-year fee adjustment cycle beginning in fiscal year 2022 (October 1, 2021). Updated fee amounts also apply to test rules, test orders, enforceable consent agreements and EPA-initiated chemical evaluations that are ``noticed'' on or after October 1 of every three-year fee adjustment cycle, beginning in fiscal 2022. (3) The Agency will initiate industry consultation prior to making fee adjustments. If it is determined that no additional adjustment is necessary beyond for inflation, EPA will provide public notice of the inflation-adjusted fee amounts most likely through posting to the Agency's web page by the beginning of each three-year fee adjustment cycle (i.e., October 1, 2021, October 1, 2024, etc.). If the Agency determines that adjustments beyond inflation are necessary, EPA will provide public notice of that determination and the process to be followed to make those adjustments. (d) No fee required. Persons are exempt from remitting any fee for Tier I exemption submissions under Sec. 725.424 and polymer exemption reports submitted under Sec. 723.250 of this chapter. (e) Multiple parties, including joint submitters and consortia. (1) Joint submitters of a TSCA section 5 notice are required to remit the applicable fee identified in paragraph (b) of this section for each section 5 notice submitted. Only one fee is required for [[Page 8232]] each submission, regardless of the number of joint submitters for that notice. To qualify for the fee identified in paragraph (b)(1) of this section, each joint submitter of a TSCA section 5 notice must qualify as a small business concern under Sec. 700.43 of this chapter. (2) Any consortium formed to split the cost of the applicable user fee under section 4 of the Act is required to remit the appropriate fee identified in paragraph (b) of this section for each test rule, test order, or enforceable consent agreement regardless of the number of manufacturers and/or processors in that consortium. For the consortium to qualify for the fee identified in paragraph (b)(1) of this section, each person in the consortium must qualify as a small business concern under Sec. 700.43 of this chapter. Failure to provide notice or submit fee payment pursuant to this paragraph (e)(2) constitutes a violation by each consortium member. (i) Notification must be provided to EPA that a consortium has formed. The notification must be accomplished within 30 days of the effective date of a test order or test rule under section 4 of the Act or within 30 days of the signing of an enforceable consent agreement under section 4 of the Act. If timely notification has occurred, additional entities may join the consortia after the notification period. (ii) Notification must be rendered in a .pdf file and submitted electronically via the Agency's electronic reporting software (e.g., Central Data Exchange (CDX)). The following information must be included: (A) Full name, address, telephone number and signature of principal sponsor; (B) Name(s) and contact information for each manufacturer and/or processor associating with the consortium. (iii) It is up to the consortium to determine how fees will be split among the persons in the consortium. (iv) Consortia are encouraged to set lower fees for small business concerns participating in the consortium. (v) If a consortium is unable to come to terms on how user fees will be split among the persons in the consortium, the principal sponsor must notify EPA in writing before the user fee is due under paragraph (e)(2) of this section. (vi) If a consortium provides notice to EPA under paragraph (e)(2)(v) of this section, EPA will assess fees to all persons of the consortium as described under paragraph (e)(4) of this section and provide an additional 30 days for those persons to submit fees. (3) Any consortium formed to split the cost of the applicable user fee supporting a risk evaluation under section 6(b) of the Act is required to remit the appropriate fee identified in paragraph (b) of this section for each risk evaluation, regardless of the number of manufacturers in that consortium. For the consortium to qualify for the fee identified in paragraph (b)(1)(vii) of this section, each person in the consortium must qualify as a small business concern under Sec. 700.43 of this chapter. Failure to provide notice or submit fee payment pursuant to this paragraph (e)(3) constitutes a violation by each consortium member. (i) Notification must be provided to EPA that a consortium has formed. The notification must be accomplished within 30 days of the publication of the final scope of a chemical risk evaluation under section 6(b)(4)(D) of the Act or within 30 days of EPA providing notification to a manufacturer that a manufacturer-requested risk evaluation has been granted. (ii) Notification must be rendered in a .pdf file and submitted electronically via the Agency's electronic reporting software (e.g., CDX). The following information must be included: (A) Full name, address, telephone number and signature of principal sponsor; (B) Name(s) and contact information for each manufacturer and/or processor associating with the consortium. (iii) It is up to the consortium to determine how fees will be split among the persons in the consortium. (iv) Consortia are encouraged to set lower fees for small business concerns participating in the consortium. (v) If a consortium is unable to come to terms on how user fees will be split among the persons in the consortium, the principal sponsor must notify EPA in writing before the user fee is due. (vi) If a consortium provides notice to EPA under paragraph (e)(3)(v) of this section, EPA will assess fees to all persons of the consortium as described under paragraph (e)(4) of this section and provide an additional 30 days for those persons to submit fees. (4) If multiple persons are subject to user fees triggered by section 4 or 6(b) of the Act and no consortium is formed, EPA will determine the portion of the total applicable user fee to be remitted by each person subject to the requirement. Each person's share of the applicable user fee specified in paragraph (b) of this section shall be in proportion to the total number of manufacturers and/or processors of the chemical substance, with lower fees for small businesses: [GRAPHIC] [TIFF OMITTED] TP26FE18.003 Where: P s = the portion of the user fee under paragraph (b) of this section that is owed by a person who qualifies as a small business concern under Sec. 700.43 of this chapter. Po = the portion of the user fee owed by a person other than a small business concern. F = the total user fee required under paragraph (b) of this section. Mt = the total number of persons subject to the user fee requirement. Ms = the number of persons subject to the user fee requirement who qualify as a small business concern. (5) If multiple persons are subject to user fees triggered by section 4 or 6(b) of the Act and some inform EPA of their intent to form a consortium while others choose not to associate with the consortium, EPA will determine the portion of the total applicable user fee to be remitted by each person outside the consortium and by the consortium, per paragraph (e)(4) of this section. For purposes of calculating the portion of the total applicable user fee to be remitted by each person outside the consortium, EPA will consider each person within the consortium as ``one'' person. The balance of the applicable user fee remaining is the responsibility of the consortium; EPA will inform consortium of this requisite user fee amount. (f) Remittance procedure. (1) Electronic payment: Each remittance under this section shall be paid electronically in U.S. dollars, using one of the electronic payment methods supported by the Department of the Treasury's Pay.gov or Fedwire online electronic payment service, or any applicable additional or successor online electronic payment service offered by the Department of Treasury. (2) Timing of payment for user fees incurred between October 1, 2018 and [the effective date of this rule will be inserted at the final rule stage]. User fees required by paragraph (b) of this section for which the fee-triggering action or [[Page 8233]] event occurred between October 1, 2018, and [EFFECTIVE DATE OF FINAL RULE] shall be paid in response to invoices EPA will send within 30 days of the effective date of this rule. (3) Timing of payment for user fees incurred after [EFFECTIVE DATE OF FINAL RULE]. User fees required by paragraph (b) of this section for which the fee-triggering action or event occurred after [EFFECTIVE DATE OF FINAL RULE] shall be paid at the following time: (i) Test orders and test rules. The applicable user fee specified in paragraph (b) of this section shall be paid in full not later than 60 days after the effective date of a test rule or test order under section 4 of the Act. (ii) Enforceable consent agreements. The applicable user fee specified in paragraph (b) of this section shall be paid in full not later than 60 days after the signing of an enforceable consent agreement under section 4 of the Act. (iii) Section 5 notice. The applicable user fee specified in paragraph (b) of this section shall be paid in full immediately upon submission of a TSCA section 5 notice. (iv) Risk evaluations. (A) For EPA-initiated risk evaluations, the applicable user fee specified in paragraph (b) of this section shall be paid in full not later than 60 days after EPA publishes the final scope of a chemical risk evaluation under section 6(b)(4)(D) of the Act. (B) For manufacturer-requested risk evaluations under section 6(b)(4)(C)(ii) of the Act, the applicable user fee specified in paragraph (b) of this section shall be paid in full not later than 30 days after EPA provides the submitting manufacture(s) notice that it has granted the request. (4)(i) Persons who submit a TSCA section 5 notice shall place an identifying number and a payment identity number on the front page of each TSCA section 5 notice submitted. The identifying number must include the letters ``TS'' followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a ``Pay.gov'' transaction number or FedWire wire transfer number used to transmit the user fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one TSCA section 5 notice, the person shall include the name of the submitter and a new TS number for each TSCA section 5 notice to which the remittance applies, and the amount of the remittance that applies to each notice. (ii) Persons who are required to submit a letter of intent to conduct testing per Sec. 790.45 of this chapter shall place a payment identity number on the front page of each letter submitted. The identifying number must include the letters ``TS'' followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a ``Pay.gov'' transaction number or FedWire wire transfer number used to transmit the user fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one letter of intent to conduct testing, the person shall include the name of the submitter and a new TS number for each letter of intent to conduct testing to which the remittance applies, and the amount of the remittance that applies to each letter of intent. (iii) Persons who sign an enforceable consent agreement per Sec. 790.60 of this chapter shall place a payment identity number within the contents of the signed agreement. The identifying number must include the letters ``TS'' followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a ``Pay.gov'' transaction number or FedWire wire transfer number used to transmit the user fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one enforceable consent agreement, the party or parties shall include the name of the submitter(s) and a new TS number for each enforceable consent agreement to which the remittance applies, and the amount of the remittance that applies to each enforceable consent agreement. (5)(i) Each person who remits the fee identified in paragraph (b)(1) of this section for a PMN, consolidated PMN, intermediate PMN, or SNUN shall insert a check mark for the statement, ``The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $2,800 in accordance with 40 CFR 700.45(b).'' under ``CERTIFICATION'' on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25). This form is available on EPA's website at https://cdx.epa.gov/SSL/PMN/Outbound/Electronic_PMN_Form_version2.pdf. (ii) Each person who remits the fee identified in paragraph (b)(1) of this section for a LVE, LoREX, TERA, TMEA, or Tier II exemption request under TSCA section 5 shall insert a check mark for the statement, ``The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $940 in accordance with 40 CFR 700.45(b).'' in the exemption application. (iii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption notice under Sec. 723.175 of this chapter shall include the words, ``The company or companies identified in this notice is/are a small business concern under 40 CFR 700.43 and has/have remitted a fee of $940 in accordance with 40 CFR 700.45(b).'' in the certification required in Sec. 723.175(i)(1)(x) of this chapter. (iv) Each person who remits the fee identified in paragraph (b)(1) of this section for a MCAN or consolidated MCAN for a microorganism shall insert a check mark for the statement, ``The company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $2,800 in accordance with 40 CFR 700.45(b).'' in the certification required in Sec. 725.25(b) of this chapter. (6)(i) Each person who remits a fee identified in paragraph (b)(2) of this section for a PMN, consolidated PMN, intermediate PMN, or SNUN shall insert a check mark for the statement, ``The company named in part 1, section A has remitted the fee of $16,000 specified in 40 CFR 700.45(b).'' under ``CERTIFICATION'' on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25). (ii) Each person who remits a fee identified in paragraph (b)(2) of this section for a LVE, LoREX, TERA, TMEA, or Tier II exemption request under TSCA section 5 shall insert a check mark for the statement, ``The company named in part 1, section A has remitted the fee of $4,700 specified in 40 CFR 700.45(b).'' in the exemption application. (iii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption notice under Sec. 723.175 of this chapter shall include the words, ``The company or companies identified in this notice has/have remitted a fee of $4,700 in accordance with 40 CFR 700.45(b).'' in the certification required in Sec. 723.175(i)(1)(x) of this chapter. (iv) Each person who remits the fee identified in paragraph (b)(2) of this section for a MCAN for a microorganism shall insert a check mark for the statement, ``The company named in part 1, section A has remitted the fee of $16,000 in accordance with 40 CFR 700.45(b).'' in the certification required in Sec. 725.25(b) of this chapter. [[Page 8234]] (g) Full fee refunds. EPA will refund, in totality, any fee paid for a section 5 notice whenever the Agency determines: (i) That the chemical substance that is the subject of a PMN, consolidated PMN, exemption request, or exemption notice, is not a new chemical substance as of the date of submission of the notice, (ii) In the case of a SNUN, that the notice was not required, (iii) The notice is incomplete under either Sec. 720.65(c), Sec. 723.50(e)(3) or Sec. 725.33, of this chapter, (iv) That as of the date of submission of the notice: The microorganism that is the subject of a MCAN or consolidated MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use; or (v) When the Agency fails to make a determination on a notice by the end of the applicable notice review period under Sec. 720.75 or Sec. 725.50 of this chapter, unless the Agency determines that the submitter unduly delayed the process, or (vi) When the Agency fails to approve, or deny an exemption request within the applicable period under Sec. 720.38(d), Sec. 723.50(g) or Sec. 725.50(b) of this chapter, unless the Agency determines that the submitter unduly delayed the process. (h) Partial fee refunds. (1) If a TSCA section 5 notice is withdrawn during the first 10 business days after the beginning of the applicable review period under Sec. 720.75(a) of this chapter, the Agency will refund all but 25% of the user fee as soon as practicable. (2) Once withdrawn, any future submission related to the TSCA section 5 notice must be submitted as a new notice. 0 5. Section 700.49 is revised to read as follows: Sec. 700.49 Failure to remit fees. (a) EPA will not consider a TSCA section 5 notice to be complete unless the appropriate certification under Sec. 700.45(e) is included and until the appropriate remittance under Sec. 700.45(b) has been submitted as provided in Sec. 700.45(e). EPA will notify the submitter of a section 5 notice that it is incomplete in accordance with Sec. Sec. 720.65(c) and 725.33(b)(1) of this chapter. (b) Failure to submit the appropriate remittance specified under Sec. 700.45(b) for a test order, test rule, enforceable consent agreement, or EPA-initiated risk evaluation as provided in Sec. 700.45(e) is a violation of TSCA and enforceable under section 15 of the Act. (c) EPA will not initiate a manufacturer-requested risk evaluation that the Agency has otherwise determined to be complete unless the appropriate remittance under Sec. 700.45(b) has been submitted as provided in Sec. 700.45(e). PART 720--[AMENDED] 0 6. The authority citation for part 720 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2613. 0 7. Section 720.38 is amended by adding paragraphs (b)(6) and (f) to read as follows: Sec. 720.38 Exemptions for test marketing. * * * * * (b) * * * (6) A user fee payment identity number, as required in 40 CFR 700.45(e)(3). * * * * * (f) When applying for a test marketing exemption, persons are subject to user fees in accordance with 40 CFR 700.45. 0 8. Section 720.45 is amended by revising paragraph (a)(5) to read as follows: Sec. 720.45 Information that must be included in the notice form. * * * * * (a) * * * (5) If a manufacturer cannot provide all the information specified in paragraphs (a) (1) and (2) of this section because the new chemical substance is manufactured using a reactant having a specific chemical identity claimed as confidential by its supplier, the manufacturer must submit a notice directly to EPA containing all the information known by the manufacturer about the chemical identity of the reported substance and its proprietary reactant. In addition, the manufacturer must ensure that the supplier of the confidential reactant submit a letter of support directly to EPA providing the specific chemical identity of the confidential reactant, including the CAS number, if available, and the appropriate PMN or exemption number, if applicable. The letter of support must reference the manufacturer's name and PMN User Fee Identification Number. The statutory review period will commence upon receipt of both the notice and the letter of support. * * * * * PART 723--[AMENDED] 0 9. The authority citation for part 723 continues to read as follows: Authority: 15 U.S.C. 2604. 0 10. Section 723.175 is amended by adding paragraph (a)(2)(iv) and by revising paragraphs (h)(3)(i)(1)(ii)(C) and (h)(3)(i)(1)(iii), and adding paragraph (h)(3)(i)(1)(xi) to read as follows: Sec. 723.175 Chemical substances used in or for the manufacture or processing of instant photographic and peel-apart film articles. (a) * * * (2) * * * (iv) Remit the applicable user fee specified in Sec. 700.45(b) of this chapter. * * * * * (h) * * * (3) * * * (1) * * * (ii) * * * * * * * * (C) Polymers. For a polymer, the notice must identify monomers and other reactants used in the manufacture of the polymer by chemical name and CAS Registry Number. The notice must indicate the amount of each monomer used (by weight percent of total monomer); the maximum residual of each monomer present in the polymer; and a partial or incomplete structural diagram, if available. The notice must indicate the number average molecular weight of the polymer and characterize the anticipated low molecular weight species. The notice must include this information for each typical average molecular weight composition of the polymer to be manufactured. (iii) Impurities. The notice must identify the impurities that can be reasonably anticipated to be present in the new chemical substance when manufactured under the exemption by name and CAS Registry Number, by class of substances, or by process or source. The notice also must estimate the maximum percent (by weight) of each impurity in the new chemical substance and the percent of unknown impurities present. * * * * * (xi) User fee payment ID number. The manufacturer or processor must include a payment identity number on the front page of the notice. * * * * * PART 725--[AMENDED] 0 11. The authority citation for part 725 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, 2613, and 2625. 0 12. Section 725.25 is amended by adding paragraph (i) to read as follows: Sec. 725.25 General administrative requirements. * * * * * (i) Fees. Persons submitting MCANs and exemption requests to EPA under this part are subject to the applicable [[Page 8235]] user fees and conditions specified in Sec. Sec. 700.40, 700.45(b), and 700.49 of this chapter. 0 13. Section 725.33 is amended by revising paragraphs (a)(9) and (10) to read as follows: Sec. 725.33 Incomplete submissions. (a) * * * (9) The submitter does not remit the fees required by Sec. 700.45(b) of this chapter. (10) The submitter does not include an identifying number and a payment identity number. * * * * * PART 790--[AMENDED] 0 14. The authority citation for part 790 continues to read as follows: Authority: 15 U.S.C. 2603. 0 15. Section 790.45 is amended by adding paragraphs (c)(7) and (g) to read as follows: Sec. 790.45 Submission of letter of intent to conduct testing or exemption application. * * * * * (c) * * * (7) A payment identity number on the front page of the letter, as required in Sec. 700.45(e)(3) of this chapter. * * * * * (g) Manufacturers and processors subject to a test rule described in Sec. 790.40 and required to comply with the requirements of that test rule as provided in Sec. 790.42(a) must remit the applicable user fee specified in Sec. 700.45(b) of this chapter. 0 16. Section 790.59 is amended by adding paragraph (c) to reads as follows: Sec. 790.59 Failure to comply with a test rule. * * * * * (c) Persons who fail to pay the requisite user fee as specified in Sec. 700.45(b) of this chapter will be in violation of the rule. 0 17. Section 790.60 is amended by adding paragraphs (a)(18) and (d) to read as follows: Sec. 790.60 Contents of consent agreements. (a) * * * (18) Payment identity number, as required in Sec. 700.45(e)(3) of this chapter. * * * * * (d) Fees. Manufacturers and/or processors signing the consent agreement are subject to the applicable user fee specified in Sec. 700.45(b) of this chapter. 0 18. Section 790.65 is amended by revising paragraph (b) to read as follows: Sec. 790.65 Failure to comply with a consent agreement. * * * * * (b) The Agency considers failure to comply with any aspect of a consent agreement, including the failure to pay requisite user fees as specified in Sec. 700.45 of this chapter, to be a ``prohibited act'' under section 15 of TSCA, subject to all the provisions of the Act applicable to violations of section 15. Section 15(1) of TSCA makes it unlawful for any person to fail or refuse to comply with any rule or order issued under section 4. Consent agreements adopted pursuant to this part are ``orders issued under section 4'' for purposes of section 15(1) of TSCA. * * * * * PART 791--[AMENDED] 0 19. The authority citation for part 791 continues to read as follows: Authority: 15 U.S.C. 2603 and 2607. 0 20. Section 791.39 is amended by removing paragraph (a)(3) and revising paragraph (b). The revision reads as follows: Sec. 791.39 Fees and expenses. * * * * * (b) Expenses. All expenses of the hearing, including the cost of recording (though not transcribing) the hearing and required traveling and other expenses of the hearing officer and of American Arbitration Association representatives, and the expenses of any witness or the cost of any proofs produced at the direct request of the hearing officer, shall be borne equally by the parties, unless they agree otherwise, or unless the hearing officer, in the award, assesses such expenses or any part thereof against any specified party or parties. * * * * * [FR Doc. 2018-02928 Filed 2-23-18; 8:45 am] BILLING CODE 6560-50-P
![8212 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules
The Proposed Amendment Erie VORTAC (including imports) a chemical
(Lat. 42°01′03″ N, long. 80°17′34″ W) substance that is the subject of a risk
In consideration of the foregoing, the
That airspace extending upward from the evaluation under TSCA section 6(b).
Federal Aviation Administration
surface extending northeast of the Erie This notice of proposed rulemaking
proposes to amend 14 CFR part 71 as International Airport/Tom Ridge Field 4.2-
follows: provides a description of proposed
mile radius from within 4 miles northwest of TSCA fees and fee categories for fiscal
the Erie VORTAC 054° radial to 3.5 miles
PART 71—DESIGNATION OF CLASS A, southeast of the Erie ILS localizer northeast
years 2019, 2020, and 2021, and
B, C, D, AND E AIRSPACE AREAS; AIR course then extending southwest from a explains the methodology by which the
TRAFFIC SERVICE ROUTES; AND point located along the Erie localizer proposed TSCA user fees were
REPORTING POINTS northeast course 9.2 miles NE of lat. determined and would be determined
42°07′30″ N, long. 80°05′36″ W, to the 4.2- for subsequent fiscal years. In proposing
■ 1. The authority citation for part 71 mile radius of the airport. This Class E these new TSCA user fees, the Agency
continues to read as follows: airspace area is effective during the specific also proposes amending long standing
dates and times established in advance by a user fee regulations governing the
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Notice to Airmen. review of premanufacture notices,
1959–1963 Comp., p. 389. Paragraph 6005 Class E Airspace Areas exemption applications and notices, and
Extending Upward From 700 Feet or More significant new use notices. After
§ 71.1 [Amended] Above the Surface of the Earth. implementation of final TSCA user fees
■ 2. The incorporation by reference in * * * * * regulations, certain manufacturers and
14 CFR 71.1 of Federal Aviation processors would be required to pay a
Administration Order 7400.11B, AEA PA E5 Erie, PA [Amended]
prescribed fee for each notice,
Airspace Designations and Reporting Erie International Airport/Tom Ridge Field, exemption application and data set
Points, dated August 3, 2017, and PA
submitted or chemical substance subject
effective September 15, 2017, is (Lat. 42°04′59″ N, long. 80°10′26″ W)
St. Vincent Health Center Heliport, PA to a risk evaluation in order for EPA to
amended as follows: recover certain costs associated with
(Lat. 42°06′43″ N, long. 80°04′51″ W)
Paragraph 5000 Class D Airspace. That airspace extending upward from 700 carrying out certain work under TSCA.
* * * * * feet above the surface within a 6.7-mile With this action, EPA is also proposing
radius of Erie International Airport/Tom standards for determining which
AEA PA D Erie, PA [Amended]
Ridge Field, and within 4.4 miles each side persons qualify as small business
Erie International Airport/Tom Ridge Field, of the 054° bearing from the airport extending concerns and thus would be subject to
PA from the 6.7-mile radius to 14 miles northeast
(Lat. 42°04′59″ N, long. 80°10′26″ W)
lower fee payments.
of the airport and within a 6-mile radius of
Erie VORTAC St. Vincent Health Center Heliport. DATES: Comments must be received on
(Lat. 42°01′03″ N, long. 80°17′34″ W) or before April 27, 2018.
Issued in College Park, Georgia, on
That airspace extending upward from the February 14, 2018. ADDRESSES: Submit your comments,
surface to and including 3,200 feet MSL identified by docket identification (ID)
within a 4.2-mile radius of Erie International Ryan W. Almasy,
Manager, Operations Support Group, Eastern
number EPA–HQ–OPPT–2016–0401, by
Airport/Tom Ridge Field. This Class D one of the following methods:
airspace area is effective during the specific Service Center, Air Traffic Organization.
days and times established in advance by a [FR Doc. 2018–03655 Filed 2–23–18; 8:45 am]
• Federal eRulemaking Portal: http://
Notice to Airmen. The effective days and www.regulations.gov. Follow the online
BILLING CODE 4910–13–P
times will thereafter be continuously instructions for submitting comments.
published in the Chart Supplement. Do not submit electronically any
Paragraph 6002 Class E Surface Area information you consider to be
ENVIRONMENTAL PROTECTION Confidential Business Information (CBI)
Airspace. AGENCY or other information whose disclosure is
* * * * *
40 CFR Parts 700, 720, 723, 725, 790, restricted by statute.
AEA PA E2 Erie, PA [Amended]
and 791 • Mail: Document Control Office
Erie International Airport/Tom Ridge Field, (7407M), Office of Pollution Prevention
PA [EPA–HQ–OPPT–2016–0401; FRL–9974–31] and Toxics (OPPT), Environmental
(Lat. 42°04′59″ N, long. 80°10′26″ W) Protection Agency, 1200 Pennsylvania
RIN 2070–AK27
Erie VORTAC Ave. NW, Washington, DC 20460–0001.
(Lat. 42°01′03″ N, long. 80°17′34″ W)
User Fees for the Administration of the • Hand Delivery: To make special
That airspace extending upward from the Toxic Substances Control Act
surface within a 4.2-mile radius of Erie
arrangements for hand delivery or
International Airport/Tom Ridge Field. This delivery of boxed information, please
AGENCY: Environmental Protection
Class E airspace area is effective during the follow the instructions at http://
Agency (EPA).
specific days and times established in www.epa.gov/dockets/contacts.html.
ACTION: Proposed rule.
advance by a Notice to Airmen. The effective Additional instructions on
days and times will thereafter be commenting or visiting the docket,
continuously published in the Chart SUMMARY: As permissible under section
26(b) of the Toxic Substances Control along with more information about
Supplement.
Act (TSCA or the Act), the dockets generally, is available at http://
daltland on DSKBBV9HB2PROD with PROPOSALS
Paragraph 6004 Class E Airspace Environmental Protection Agency (EPA www.epa.gov/dockets.
Designated as an Extension to a Class D FOR FURTHER INFORMATION CONTACT:
Surface Area.
or the Agency) is proposing to set user
fees applicable to any person required to For technical information contact:
* * * * * submit information to EPA under the Mark Hartman, Immediate Office, Office
AEA PA E4 Erie, PA [Amended] TSCA section 4 or a notice, including an of Pollution Prevention and Toxics,
Erie International Airport/Tom Ridge Field, exemption or other information, to be Environmental Protection Agency, 1200
PA reviewed by the Administrator under Pennsylvania Ave. NW, Washington, DC
(Lat. 42°04′59″ N, long. 80°10′26″ W) TSCA section 5, or who manufactures 20460–0001; telephone number: (202)
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![Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules 8215
the activity supported by the fee. A assurance that existing charges are are intended to provide a sustainable
number of commenters opposed adjusted to reflect unanticipated source of funds to defray approximately
assessment of fees under TSCA section changes in costs, and plans to readjust, 25 percent of the costs to carry out the
4. Others indicated a willingness to as necessary, the fees to account for activities specified in TSCA section
accept nominal fees under TSCA section these changes, as well as inflation. 26(b), as well as 50% or 100% of the
4 or fees solely to account for EPA’s TSCA 26(b)(4)(F) sets the readjustment costs of risk evaluations requested by
effort in reviewing submissions. Many schedule at three year intervals. As manufacturers, depending on the
commenters expressed concern that required in TSCA section 26 and chemical.
higher fees imposed on bringing new discussed in the GAO Guide, parties Because EPA will not begin collecting
chemicals to market (i.e., TSCA section potentially subject to fees or their fees until fiscal year 2019, EPA believes
5 submissions) could create an representatives will be consulted and it is appropriate to look to TSCA section
economic barrier to innovation. Several asked to provide input when the fees are 26(b)(4)(F) for the parameters which
commenters recommended that the bulk reviewed and updated to reflect changes must be applied for setting fees. TSCA
of the fees the rule establishes should be in program costs. section 26(b)(4)(F) requires EPA,
from manufacturers and processors of The Agency is proposing a process by ‘‘beginning with the fiscal year that is 3
chemicals subject to risk evaluation which TSCA user fees would be years after the date of enactment [June
under TSCA section 6. established for fiscal year 2019 through 22, 2016],’’ to adjust fees as necessary so
The Agency also sought comment 2022 and then adjusted for inflation they are sufficient to defray
from industry on lower fees for small every three years, beginning in fiscal approximately 25 percent of the costs to
businesses. Many trade associations year 2022, based on applicable Producer carry out the activities of TSCA sections
reaffirmed the need for lower fees for Price Index (PPI) values available from 4, 5, 6 and 14, other than the costs of
small businesses. All commenters that the U.S. Department of Labor. Fees for manufacturer-requested risk
mentioned small businesses fiscal year 2022 and later would be evaluations. Further, the fees shall
recommended that the TSCA definition calculated by multiplying each fee defray 50% or 100% of the costs of risk
of a small business be updated, though identified for fiscal years 2019 through evaluations requested by manufacturers,
there was diverse opinion on how; 2021 by the most current PPI value depending on the chemical. EPA
recommendations included an inflation- available at the beginning of the three- acknowledges that fees were initially to
adjusted, revenue-based standard and year adjustment period, beginning with be established under the authority of
an employee-based definition. October 1, 2021. EPA would provide TSCA section 26(b)(4)(B), which
EPA considered all of these comments public notice of the inflation-adjusted provides different parameters, most
in the development of the proposed fee amounts most likely through posting notably a cap on fees of $25 million.
rule. EPA welcomes comment from to the Agency’s web page by the However, given the timing of this fee
stakeholders on all aspects of the beginning of each three-year fee rule proposal such that fees won’t be
Agency’s proposed fee structure during adjustment cycle (i.e., October 1, 2021, collected under fiscal year 2019, EPA
the public comment period opened with October 1, 2024, etc.). The Agency may believes it is more appropriate to set
this document. also identify the need to update program these fees based on the parameters that
D. Federal User Fee Design Guidance costs underlying the fee amounts, and/ are required to be in effect by fiscal year
or propose any changes to the fees 2019. EPA also notes that because the
EPA also looked to federal user fee beside adjustment for inflation. The estimated costs for covered activities are
guidance in designing the proposed Agency will initiate industry under $100 million and costs defrayed
TSCA user fees. Office of Management consultation as required under TSCA under $25 million, the cap on fees
and Budget Circular A–25 on User 26(b)(4)(E) in either case and provide found in TSCA 26(b)(4)(B) would have
Charges (Ref. 3) and the GAO User Fees public notice for any fee changes based had no bearing on the proposed fees in
Design Guide (Ref. 4) contain on inflation. EPA expects to undertake any case.
information that is relevant to the notice and comment rulemaking for EPA considered industry comments
administrative processes of setting, more substantial changes to the fees. regarding the fee structure. Several
revising, collecting, and administration EPA seeks comment on this approach predominant themes emerged through
of fees. As EPA discusses its rationale for readjusting fees every three years. consultation with industry. Many
for setting the TSCA fees in the commenters felt that EPA should charge
remainder of this preamble, the Agency III. Detailed Discussion of the Proposed fees that are proportional to EPA costs
will rely on the policies and principles Rule for undertaking the activities. This was
identified in these two federal guidance EPA is proposing to establish and consistent with one the considerations
documents. Circular A–25 explains, for collect fees from manufacturers and that EPA applied in setting the proposed
executive agencies, the scope and type processors of chemical substances fees—equity as determined by
of activities subject to user fee charges pursuant to TSCA section 26(b). As proportionality between EPA costs and
and the basis on which user fees should discussed previously in Unit II.A., EPA the fee associated with each activity.
be set. EPA followed the Circular A–25 currently collects fees for PMNs, certain EPA notes that the statute does not
guidance in identifying the relevant PMN exemption applications and require such proportionality. In fact, the
direct and indirect costs to be recovered notices, and SNUNs submitted under fee triggers under the law (for example,
by user fees including, but not limited TSCA section 5. The Agency is submission of a section 5 notice) are
to, an appropriate share of personnel proposing to expand the categories of distinct from EPA activities for which
daltland on DSKBBV9HB2PROD with PROPOSALS
costs, including salaries and fringe activities for which fees are collected costs can be defrayed by the fees
benefits; management and supervisory and increase the amount of fees required collected. Thus, EPA could, consistent
costs; costs of research, establishment of for certain activities under TSCA with TSCA, collect fees for section 5
standards and regulations; physical sections 4, 5 and 6. This proposal lays submissions that exceed the cost of
overhead; and other indirect costs out the fee categories and payment processing the section 5 submissions, so
including supply costs and travel. amounts that the Agency believes are long as the fees in the aggregate are not
The Agency plans to periodically both reasonable and appropriate to designed to exceed 25% of the costs to
review the user fees to provide begin collecting in fiscal year 2019; they EPA of carrying out sections 4, 5, 6 and
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![Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules 8217
TABLE 1—ESTIMATED ANNUAL COSTS TO EPA
[Fiscal Year 2019 through Fiscal Year 2021]
Direct program Indirect costs Annual costs
costs
TSCA Section 4 ........................................................................................................................... $2,765,000 $778,000 $3,543,000
TSCA Section 5 ........................................................................................................................... 22,375,000 6,296,000 28,672,000
TSCA Section 6 ........................................................................................................................... 34,073,000 9,545,000 43,618,000
TSCA Section 14 ......................................................................................................................... 3,531,000 814,000 4,345,000
Total: ..................................................................................................................................... 62,744,000 17,425,000 80,178,000
Notes: Numbers may not add due to rounding The indirect cost rate for Office of Chemical Safety and Pollution Prevention is estimated at
28.14% for the purposes of this analysis.
After estimating the annual costs of about every other year. It takes TSCA section 5 are PMNs, significant
administering TSCA section 4, 5, 6 and approximately two years to complete new use notifications (SNUNs),
14, the Agency had to determine how the work associated with both of these microbial commercial activity notices
the costs would be allocated over the activities. (MCANs), and numerous types of
narrower set of activities under TSCA Costs assume that each TSCA section exemption notices and applications
section 4, 5 and 6, which trigger a fee. 4 activity will cover one to 7 chemicals. (e.g., low-volume exemptions [LVEs],
The Agency took an approach to While testing required by test orders is test-marketing exemptions [TMEs], low
determining user fees that parsed the likely to be completed in under a year, exposure/low release exemptions
fees based on the type of submission or test rules and enforceable consent [LoREXs], TSCA experimental release
fee triggering event. This allows agreements are likely to take two years applications [TERAs], certain new
allocation of costs more equitably to complete. This estimate is based on microorganism [Tier II] exemptions,
among the submissions and their related EPA’s prior experience with test rules film article exemptions, etc.).
costs. and ECAs. To estimate the costs of EPA’s TSCA section 5 efforts under
2. Program costs. To determine the reviewing test data, we assume that on the previous law are well understood
program costs for implementing sections average, data will be submitted to EPA through experience that spans several
4, 5, 6 and 14 of TSCA, the Agency for seven tests on each chemical. decades. The Agency has historical data
accounted for the intramural and The estimated cost to the Agency of on costs, as well as the number of
extramural costs for activities under each test order is approximately different section 5 submission types
these sections. Intramural costs are $279,000. Each test rule is estimated to sent to the Agency each year. In 1987,
those costs related to the efforts exerted cost approximately $844,000 and each the costs for the Agency to process a
by EPA staff and management in enforceable consent agreement is PMN were approximately up to $15,000
operating the program, collecting and estimated to cost approximately per submission, depending on the
processing information and funds, $652,000. These cost estimates include amount of detailed analysis necessary;
conducting reviews, and related submission review and are based on these estimates did not include indirect
activities. Extramural costs are those projected full-time equivalent (FTE) and costs. Recent data on the number of
costs related to the acquisition of extramural support needed for each annual submissions is found at https://
contractors to conduct activities such as activity divided by the number of www.epa.gov/reviewing-new-chemicals-
analyzing data, developing IT systems orders, rules and ECAs EPA assumes under-toxic-substances-control-act-tsca/
and supporting the TSCA Help Desk. will be worked on over a three-year statistics-new-chemicals-review. (Ref. 6)
The Agency then added indirect costs to period. Several of these activities (rules In calendar year 2016, EPA received 577
the direct program cost estimates. The and ECAs) are expected to span two PMNs, SNUNs and MCANs, and another
Agency used an indirect cost rate of years, as noted earlier so those estimates 560 exemption notices and applications,
28.14% to calculate the indirect costs are based on the annual estimated costs most of which were LVEs.
associated will all TSCA section 4, 5, 6 multiplied by two. The annual cost The provisions of TSCA, as amended,
and 14 direct program cost estimates. estimate of administering TSCA section result in additional TSCA section 5
a. TSCA section 4 program costs. 4 in fiscal year 2019 through fiscal year Agency costs that arise primarily from
TSCA section 4, Testing of Chemical 2021 is $3,543,000 (Ref. 5: Table 8). the requirement to review the intended,
Substances and Mixtures, gives EPA the b. TSCA section 5 program costs. known or reasonably foreseen activities
authority to require, by rule, order, or TSCA section 5, Manufacturing and associated with the chemical, and the
enforceable consent agreement (ECA), Processing Notices, requires that requirement to make an affirmative risk
manufacturers and processors to manufacturers and processors provide determination, and from development of
conduct testing of identified chemical EPA with notice before initiating the significant new use rules (SNURs) and
substances or mixtures. EPA estimated manufacture of a new chemical orders that result from our analysis and
TSCA section 4 submission costs based substance or initiating the findings under TSCA, as amended.
on prior experience with developing test manufacturing or processing for a Therefore, the Agency used the cost
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rules and ECAs, reviewing study plans, significant new use of a chemical estimates from prior experience as a
and reviewing the data received. EPA substance. EPA is required to review starting point and then added estimates
estimates that, on average, it will and make determinations on the notices for the costs of these additional
undertake work associated with 10 test and take risk management action, as responsibilities.
orders, one test rule and one ECA each needed. EPA’s cost estimates include the costs
year. While EPA expects to work on one Examples of the notices or other of processing, reviewing, and making
test rule and one ECA each year, we information that manufacturers and determinations, and the Agency’s costs
expect to initiate each of these activities processors are required to submit under of taking any regulatory action such as
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![8218 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules
with a SNUR or an order. Costs of chemicals designated as high-priority developing the final evaluation, which
reviewing any data that is submitted to substances, EPA must evaluate existing includes a risk determination.
EPA as a result of an order is also chemicals to determine whether they Under TSCA section 6, the Agency
included. EPA’s cost estimates for ‘‘present an unreasonable risk of injury also has obligations to take action to
administering TSCA section 5 also to health or the environment.’’ Under address any unreasonable risks
include the costs associated with the conditions of use for each chemical, identified from a chemical. Cost
processing, retaining records, related to the Agency will assess the hazard(s), estimates for risk management activities
a NOC submission. NOC costs also exposure(s), and the potentially exposed have been informed, in part, by EPA’s
include the cost of registering the or susceptible subpopulation(s) that recent risk reduction actions on several
chemical with the Chemical Abstracts EPA determines are relevant. This chemicals, including the use of N-
Service. EPA has lumped the costs information will be used to make a final methylpyrrolidone in paint and coating
associated with NOCs (totaling an determination as to whether the removal and trichloroethylene in both
estimated $1,700,000 per year) with chemical presents an unreasonable risk commercial vapor degreasing and
those of PMNs, MCANs and SNUNs. under the conditions of use. The first aerosol degreasing and for spot cleaning
The average cost of a PMN, MCAN and step in the risk evaluation process, as in dry cleaning facilities. Section 6(a) of
SNUN is approximately $55,200. This outlined in TSCA, is to issue a scoping TSCA provides authority for EPA to ban
estimate is based on projected FTE and document for each chemical substance or restrict the manufacture, processing,
extramural support needed for these within six months of its designation in distribution in commerce, and
actions divided by the number of the Federal Register. The scoping commercial use of chemicals, as well as
submissions the Agency assumes will be document will include information any manner or method of disposal of
received each year once fees are in place about the chemical substance, such as chemicals.
which is 462. Our estimate of number of conditions of use, exposures, including In addition to considering previous
submissions is based on submissions potentially exposed or susceptible experience with TSCA Workplan
received FY 16 reduced by 20% due to subpopulations, and hazards, that the chemicals described above, EPA also
the anticipated impact of higher fees on Agency expects to consider in the risk benchmarked risk evaluation costs
the number of submissions (Ref. 5: evaluation. TSCA requires that these against cost associated with conducting
Table 9). chemical risk evaluations be completed risk assessments for pesticides under
Costs associated with section 5 within three years of initiation, allowing the Pesticide Registration Improvement
exemption notices and applications for a 6-month extension. By the end of Act (PRIA). The Agency chose the costs
include processing and reviewing the calendar year 2019, EPA must have at of conducting reviews for new
application, retaining records, and least 20 chemical risk evaluations conventional food-use pesticide active
related activities. The average cost of an ongoing at any given time on high- ingredients as the most relevant
exemption is $5,600. This estimate is priority chemicals plus industry- comparison to an existing chemical
based on projected FTE and extramural requested evaluations. For each risk review under TSCA based on the scope
support needed for these actions evaluation that the Agency completes, and complexity of the assessments and
divided by the number of submissions TSCA requires that EPA begin another. the data considered in conducting the
the Agency assumes will be received The Agency expects to have between 20 reviews. EPA estimates the cost of
each year once fees are in place which and 30 risk evaluations ongoing in any completing a risk assessment and risk
is 560. Our estimate of number of given year at different stages in the management decision for a new
submissions is based on submissions review process. conventional food use pesticide active
received in FY 16 (Ref. 5: Table 10). TSCA section 6 cost estimates have ingredient to be approximately
The annual cost estimate of been informed by the Agency’s $2,900,000 which includes direct cost
administering TSCA section 5 in fiscal experience completing assessments for estimates provided by the Office of
year 2019 through fiscal year 2021 is several TSCA Work Plan Chemicals, Pesticide Programs and indirect costs at
$28,600,000. Approximately including N-methylpyrrolidone, 28.14%. The primary rationale for the
$25,500,000 is attributed to PMNs, antimony trioxide, methylene chloride, increased cost estimate for a risk
SNUNs and MCANs; another trichloroethylene, and 1,3,4,6,7,8- evaluation under TSCA when compared
approximately $3,149,000 is attributed Hexahydro-4,6,6,7,8,8- to a new pesticide review under PRIA
to section 5 exemptions notices and hexamethylcyclopenta[g]-2-benzopyran are that the scope of an existing
applications for LVEs, LoREXs, TMEs, (HHCB) and by the Agency’s experience chemical assessment under TSCA is
TERAs, Tier IIs and film articles. addressing risks identified from expected to be broader in terms of
c. TSCA section 6 program costs. particular uses of a chemical. TSCA conditions of use and exposure
TSCA section 6, Prioritization, Risk section 6 risk evaluation costs include scenarios that must be assessed and
Evaluation, and Regulation of Chemical the cost of information gathering, uncertainties associated with
Substances and Mixtures, describes considering human and environmental implementing a new evaluation
EPA’s process for assessing and hazard, environmental fate, and program. EPA also expects that risk
managing chemical safety under TSCA. exposure assessments. Costs also management costs will be higher under
TSCA section 6 addresses: (a) include the use of the ECOTOX TSCA since rulemaking is required to
Prioritizing chemicals for evaluation; (b) knowledge and Health and implement any mitigation that is
evaluating risks from chemicals; and (c) Environmental Research Online (HERO) considered appropriate whereas most
daltland on DSKBBV9HB2PROD with PROPOSALS
addressing unreasonable risks identified databases, among others. Other costs mitigation for a pesticide can be
through the risk evaluation. Under include scoping (including problem achieved directly through changes to the
TSCA, EPA is now required to undergo formulation, conceptual model and product labeling and/or terms and
a risk-based prioritization process to analysis plan), developing and conditions of the registration.
designate existing chemicals on the publishing the draft evaluation, The breakdown of costs for an average
TSCA Inventory as either high-priority conducting and responding to peer three-year EPA-initiated chemical risk
for risk evaluation or low-priority. For review and public comment, and evaluation is shown in Table 2.
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![8224 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules
TABLE 8—PROPOSED TSCA USER FEES FOR SMALL BUSINESSES
Proposed
Proposed 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, MCAN and consolidated MCAN ...................................................................................... 2,800
LoREX, LVE, TME, Tier II exemption, TERA .............................................................................................................................. 940
TSCA Section 6:
EPA-initiated risk evaluation ......................................................................................................................................................... 270,000
Manufacturer-requested risk evaluation on a chemical included in the Work Plan .................................................................... 1,300,000
Manufacturer-requested risk evaluation on a chemical not included in the Work Plan .............................................................. 2,600,000
EPA set the proposed small business Pursuant to 13 CFR 121.903(a)(1)(ii), event that the reporting and fee
fees at an 80% reduction compared to the Agency also proposes to change the standards differ, to determine if the size
the base fee for each category. In one time frame over which annual sales standards set through that process
case, for PMN and related actions, the values are used when accounting for a should be harmonized with the small
proposed small business fee reduction is business’s revenue. Instead of using just business definition for fees. This
82.5%. This slightly higher percentage one year preceding the date of harmonization could be implemented in
reduction is due to the concern for the submission, the Agency is proposing to a subsequent rulemaking for the next
potential impact on small businesses of average annual sales values over the three-year fee cycle (FY22-FY25).
higher fee levels. The proposed small three years preceding the submission.
D. How would the Agency handle fees
business fees for each category fee is EPA proposes to apply this updated
from multiple parties?
only triggered when there is one entity definition—adjusted for inflation and
subject to the fee, and that entity is a averaging sales revenue over three Not every person subject to this rule
small business or if there is a years—to not only TSCA section 5 must individually submit fees to EPA.
consortium paying the fee and all submissions, but also to TSCA sections TSCA section 26(b)(4)(C) allows for
members of that consortium are small 4 and 6 submissions as well. payment of fees by consortia of
businesses. By way of comparison, PRIA The Agency is seeking comment on manufacturers and processors. EPA is
fees may be reduced for small this approach and is specifically proposing to allow joint submissions
businesses by a maximum of 75% under interested in comment on whether an under TSCA section 5 and is permitting
certain conditions. employee-based size standard would be the formation of, and payment by,
EPA is also proposing to revise the more appropriate than a receipts-based consortia for submissions under TSCA
size standard used to identify size standard and what that employee sections 4 and 6. Joint submitters of a
businesses that can qualify as a ‘‘small level should be; whether the size TSCA section 5 notice would be
business concern’’ under TSCA for the standard, be it receipts-based or required to remit the applicable fee
purposes of fee collection. A regulatory employee-based, should vary from identified in paragraph (b) of this
definition for a small business that industry to industry to reflect section for each section 5 notice
makes a submission under TSCA differences among the impacted submitted. Only one fee is required for
section 5 was promulgated in 1988 and industries; and what other factors and each submission, regardless of the
is based on the annual sales value of the data sources the Agency should number of joint submitters for that
business’s parent company. 40 CFR consider, besides inflation, when notice. To qualify for the fee identified
700.43 currently states: ‘‘Small business developing the size standard to qualify in paragraph (b)(1) of this section, each
concern means any person whose total for reduced fee amounts. joint submitter of a TSCA section 5
annual sales in the person’s fiscal year Further, with respect to small notice must qualify as a small business
preceding the date of the submission of business size standards, the Agency has concern under § 700.43. This approach
the applicable section 5 notice, when recently committed to revisiting the aligns with comments received from
combined with those of the parent definition of small businesses as it industry during the consultation
company (if any), are less than $40 relates to the TSCA section 8(a) data process.
million.’’ reporting regulations (82 FR 56824). Due Any consortium formed to jointly
The Agency is proposing several to the urgent need for the Agency to submit TSCA user fees would be
changes to this definition. Consistent promulgate this regulation and expected to notify EPA of such intent.
with the definition of small expeditiously collect the fees, the Once established, it would be up to the
manufacturer or importer at 40 CFR Agency believes that upcoming consortium to determine how the user
704.3, EPA proposes to increase the rulemaking will provide a venue for a fee would be split among the members.
current revenue threshold of $40 more expansive consideration of EPA strongly encourages consortia to set
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million using the Producer Price Index appropriate size standards for industries lower fees for small business concerns;
(PPI) for Chemicals and Allied Products, subject to TSCA and offer the public Congress intended small business to be
as compiled by the U.S. Bureau of Labor with further opportunities to comment afforded lower fee payments (TSCA
Statistics. [Data series WPU06 at http:// on the size standard. In addition to 26(b)(4)(A)).
data.bls.gov/cgi-bin/srgatet.] Using a considering comments submitted in If, after 30 days, a consortium is
base year of 1988 and inflating to 2015 response to this proposal, the Agency is unable to reach agreement on splitting
dollars results in a value of committed to evaluating the results of the user fee, the principal sponsor must
approximately $91 million (Ref. 10). the 8(a) rulemaking process and, in the notify EPA, so EPA can calculate the
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![Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules 8225
individual fee for each consortium (e.g., Automated Clearing House debits conduct the evaluation. Payment will be
member. The Agency proposes to divide (ACH) from bank accounts, credit card required within 30 days of EPA
the total fee by the number of members. payments, debit card payments, PayPal providing such notice.
Small businesses will be afforded an or Dwolla) or use Fedwire to authorize EPA is also proposing that user fees
80% discount, which the remaining an electronic payment. Because Pay.gov will begin to be incurred starting on
consortium members will be required to and Fedwire do not accept paper checks October 1, 2018. As discussed above,
cover in equal amounts. EPA requests as payment, EPA will not accept paper TSCA section 26(b)(4)(F) requires EPA,
comment on this default approach. checks as payment for TSCA services. ‘‘beginning with the fiscal year that is 3
Additional instructions for making years after the date of enactment [June
F. What methods of payment would be 22, 2016],’’ to adjust fees as necessary so
payments to EPA using Pay.gov and
accepted? they are sufficient to defray a portion of
Fedwire are found at https://
The U.S. Department of the Treasury www.epa.gov/financial/additional- EPA’s costs. Since Congress expected
has determined that federal agencies instructions-making-payments-epa. The fees to already be in place by October
should move away from receiving Agency requests comment on this 1, 2018 such that they may need
payments by check, and transition to approach. adjusting, EPA believes it is reasonable
electronic methods of payment. EPA for all actions for which a fee is
proposes to accept payment of fees G. When would payment of fees be proposed to be subject to fees as of
through two different electronic required? October 1, 2018. EPA will not, however,
payment options: Pay.gov and Fedwire. There is precedent for advance collect any fees until the final rule
Pay.gov is a secure government-wide payments of user fees in several of the resulting from this proposal is effective.
collection portal that helps federal Agency’s existing user fee programs. For Instead, EPA intends to record actions
agencies meet the directives outlined in example, EPA’s Office of Pesticide that would be expected to trigger
the Government Paperwork Elimination Programs and EPA’s Office of Air and payment of fees and once the rule is
Act (Pub. L. 105–277) (Ref. 11), Radiation fee programs typically require final send invoices to the affected
primarily by reducing the number of advance payment prior to administering parties indicating. The invoices would
paper transactions and utilizing program services involving the review reflect timing for payments and amounts
electronic transaction processing. of applications for the various based on the final rule.
pay.gov, accessible online at http:// certifications and registrations
www.Pay.gov, currently processes administered by those programs. This H. Under what circumstances will EPA
payments for hundreds of federal follows the guidance outlined in OMB refund payments?
government agencies. It provides a full Circular No. A–25, which states that EPA will continue to refund any fee
suite of services, allowing federal user charges will ‘‘be collected in paid for a section 5 notice whenever
agencies to process collections quickly advance of, or simultaneously with, the EPA determines that the notice or fee
and easily; it also provides reports that rendering of services.’’ (Ref. 3) was not required. See, e.g., 40 CFR
can assist in integrating information into EPA is proposing to collect lump sum 720.62. This can happen, for example,
other financial systems. Pay.gov payment of the entire user fee for when the intended use described in the
provides customers the ability to section 5 notices prior to reviewing each PMN is not actually subject to TSCA
electronically complete forms and make submission or undertaking the activity jurisdiction or when the substance is
payments twenty-four hours a day. associated with the fee. EPA is already on the Inventory.
Because the application is web-based, proposing to require fee payment at the TSCA section 26(b)(4)(G) permits EPA
customers can access their accounts time a TSCA section 5 notice (this to refund fees, or a portion of fees, for
from any computer with internet access. includes an exemption) is submitted. notices submitted under TSCA section 5
Fedwire is generally used for foreign EPA is proposing to allow fee that are later withdrawn and for which
payments. With this method of submitters for test orders, test rules, the Agency conducts no substantive
electronic payment, payers authorize a ECAs and EPA-initiated chemical risk work unless the Agency determines that
financial institution to initiate an evaluations time to associate with a the submitter unduly delayed the
electronic (wire transfer) payment to the consortium and work out fee payments process. EPA proposes to refund a
Federal Reserve Bank of New York. within that consortium. Payment for fee consistent 75% of the user fee to the
Credit Gateway, which is operated by a categories under TSCA section 4 (i.e., submitter if the notice is withdrawn
commercial bank, then allows federal test orders, test rules and ECAs) is due within 10 business days. This
agencies to access their money from within 60 days of the effective date of percentage is consistent with the
Fedwire. Credit Gateway processes the order or rule, or 60 days upon approach for refunds for withdrawn
transactions and settles them at Federal signing of an enforceable consent actions under PRIA. Beyond ten
Reserve Banks. agreement. For EPA-initiated risk business days, EPA is likely to have
EPA proposes that those subject to evaluations, full payment is due within already conducted substantial review
fees could use any payment method of 60 days of EPA publishing the final work that qualifies as substantive work
their choice supported by the scope of a chemical risk evaluation. EPA for which no refund is authorized under
Department of the Treasury’s Pay.gov believes this provides sufficient time for TSCA 26(b)(4)(G). Up to three
electronic payment collection services manufacturers to associate as a significant milestones of the PMN
(or any applicable alternative or consortium, if they so choose, and to review process can take place within 10
successor to Pay.gov developed by decide on the partial fee payments each business days. The Chemical Review/
daltland on DSKBBV9HB2PROD with PROPOSALS
Treasury) or Fedwire, as long as EPA’s member of the consortium will be Search Strategy Meeting occurs between
financial tracking systems are able to responsible for. Manufacturers will have Day 8 and 12; the Structure Activity
obtain and process the selected method ample warning that a risk evaluation is Team Meeting occurs between Day 9
of payment. Specifically, manufacturers underway, well before the final scope is and 13; and Development of Exposure/
and processors would be expected to published in the Federal Register. Release Assessments occurs between
create payment accounts in Pay.gov and For manufacturer-requested risk Day 10 and 19. EPA feels that tying the
use one of the electronic payment evaluations, EPA is proposing to collect refund time period to a certain number
methods currently supported by Pay.gov a fee when EPA grants the request to of days is a simpler and more efficient
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![8228 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules
C. Small Business Concerns referenced in this document. The docket (58 FR 51735, October 4, 1993) and
EPA is proposing several changes to includes these documents and other 13563 (76 FR 3821, January 21, 2011).
the size standard used to identify information considered by EPA, Any changes made in response to
businesses that can qualify as a ‘‘small including documents that are referenced OMB recommendations have been
business concern’’ for purposes of fees within the documents that are included documented in the docket for this action
and seeks comment on the proposed in the docket, even if the referenced as required by section 6(a)(3)(E) of
approach as discussed in Unit III. The document is not physically located in Executive Order 12866. EPA prepared
Agency is also interested in comments the docket. For assistance in locating an economic analysis of the potential
on the reduced fee amounts being these other documents, please consult costs and benefits associated with this
proposed for those businesses that can the technical person listed under FOR action (Ref. 2), which is available in the
qualify as a ‘‘small business concern.’’ FURTHER INFORMATION CONTACT. docket and discussed in Unit IV.
The Agency is seeking comment on 1. 2016. The Frank R. Lautenberg Chemical B. Executive Order 13771: Reducing
this approach and is specifically Safety for the 21st Century Act. June 22, Regulation and Controlling Regulatory
interested in comment on whether an 2016. Costs
employee-based size standard would be 2. 2017. EPA. Economic Analysis for the
more appropriate than a receipts-based TSCA Section 26(b) Proposed Fees Rule. This action is expected to be subject
size standard and what that employee December 2017. to the requirements for regulatory
level should be; whether the size 3. 1993 OMB. Circular No. A–25 Revised. actions specified in Executive Order
July 8, 1993. 13771 (82 FR 9339, February 3, 2017).
standard, be it receipts-based or 4. 2008. GAO. Federal User Fees: A Design
employee-based, should vary from Details on the estimated costs of this
Guide. Report to Congressional proposed rule can be found in EPA’s
industry to industry to reflect Requesters. GAO–08–386SP. May 2008.
differences among the impacted 5. 2017. EPA. Technical Background
analysis (Ref. 2) of the potential costs
industries; and what other factors and Document for TSCA Fees. December and benefits associated with this action,
data sources the Agency should 2017. which is available in the docket and is
consider, besides inflation, when 6. 2017. EPA. Statistics for the New summarized in Unit IV.
developing the size standard to qualify Chemicals Review Program under TSCA.
https://www.epa.gov/reviewing-new-
C. Paperwork Reduction Act (PRA)
for reduced fee amounts.
Further, with respect to small chemicals-under-toxic-substances- The information collection
control-act-tsca/statistics-new- requirements in this proposed rule have
business size standards, the Agency has
chemicals-review. been submitted to OMB for review and
recently committed to revisiting the 7. 2017. EPA. Interagency Agreement and Oil
definition of small businesses as it approval under the PRA, 44 U.S.C. 3501
Indirect Cost Rates for FY 2018 and
relates to the TSCA Section 8(a) data et seq. The Information Collection
Beyond. September 28, 2017.
reporting regulations (82 FR 56824). Due 8. 1983. EPA. 48 FR 21722, 27134–35. Request (ICR) prepared by EPA has been
to the urgent need for the Agency to 9. 2002. EPA. 67 FR 238. Sustainable assigned EPA ICR number 2569.01. You
promulgate this regulation and Futures—Voluntary Pilot Project Under can find a copy of the ICR in the docket
expeditiously collect fees, the Agency the TSCA New Chemicals Program. for this proposed rule (Ref. 13), and it
believes that upcoming rulemaking will 10. 2016. Abt Associates. Memorandum: is briefly summarized here.
provide a venue for a more expansive Inflation of Small Business Definition The information collection activities
under section 5 of TSCA. August 31, associated with the proposed rule
consideration of appropriate size
2016. include familiarization with the
standards for industries subject to TSCA 11. 1998. Government Paperwork
and offer the public with further regulation, small business discount
Elimination Act. Public Law 105–277.
opportunities to comment on the size 12. 1987. EPA. Proposed Fees for Processing
eligibility determination, informing EPA
standard. In addition to considering Premanufacture Notices, Exemption of participation in consortia, and
comments submitted in response to this Applications and Notices, and electronic payment of fees through
proposal, the Agency is committed to Significant New Use Notices. 42 FR Pay.gov or Fedwire.
evaluating the results of the 8(a) 12940. Respondents/affected entities:
rulemaking process and, in the event 13. 2017. EPA. Information Collection Persons who manufacture, distribute in
that the reporting and fee standards Request for the TSCA Section 26(b) commerce, use, dispose, process a
Proposed Reporting Requirements chemical substance (or any combination
differ, to determine if the size standards
Associated with the Payment of TSCA of such activities) and are required to
set through that process should be Fees (EPA ICR No. 2569.01; OMB
harmonized with the small business submit information to EPA under TSCA
Control No. 2070-[NEW]). December
definition for fees. This harmonization 2017.
sections 4, 5, or 6, or if you manufacture
could be implemented in a subsequent or process a chemical substance that is
rulemaking for the next three-year fee VII. Statutory and Executive Order the subject of a risk evaluation under
cycle (FY22–FY25). Reviews TSCA section 6(b).
Respondent’s obligation to respond:
D. Electronic Payment of Fees Additional information about these Mandatory.
The Agency is interested in comments statutes and Executive Orders can be Estimated number of respondents:
pertaining to the electronic payment of found at https://www.epa.gov/laws- 1,414 respondents.
fees. If, for some reason, neither Pay.gov regulations/laws-and-executive-orders. Frequency of response: On occasion to
nor Fedwire meets the needs of those A. Executive Order 12866: Regulatory EPA as needed.
daltland on DSKBBV9HB2PROD with PROPOSALS
required to pay user fees, the Agency Planning and Review and Executive Total estimated burden: 740 hours
would appreciate the identification of Order 13563: Improving Regulation and (per year). Burden is defined at 5 CFR
other appropriate electronic payment Regulatory Review 1320.3(b).
methods to consider. Total estimated cost: $59,540 (per
This action is a significant regulatory year).
VI. References action that was submitted to the Office An agency may not conduct or
The following is a listing of the of Management and Budget (OMB) for sponsor, and a person is not required to
documents that are specifically review under Executive Orders 12866 respond to a collection of information
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![8230 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules
protection, Hazardous substances, ■ k. Adding in alphabetical order Test order means an order to develop
Reporting and recordkeeping definitions for ‘‘Test order’’ and ‘‘Test information pursuant to section 4(a) of
requirements. rule’’. the Act.
Dated: February 7, 2018, The revisions and additions read as Test rule refers to a regulation
follows: requiring the development of
E. Scott Pruitt,
information pursuant to section 4(a) of
Administrator. § 700.43 Definitions applicable to this
subpart. the Act.
Therefore, EPA proposes to amend 40
■ 4. Section 700.45 is revised to read as
CFR parts 700, 720, 723, 725, 790 and Definitions in section 3 of the Act (15
follows:
791 as follows: U.S.C. 2602), as well as definitions
contained in §§ 704.3, 720.3, 723.175(b), § 700.45 Fee payments.
PART 700—[AMENDED] 725.3, and 790.3 of this chapter, apply (a) Persons who must pay fees. (1)
to this subpart unless otherwise Manufacturers and/or processors
■ 1. The authority citation for part 700 specified in this section. In addition, the
is revised to read as follows: submitting a TSCA section 5 notice to
following definitions apply: EPA shall remit for each such notice the
Authority: 15 U.S.C. 2625 and 2665, 44 * * * * * applicable fee identified in paragraph
U.S.C. 3504. Consortium means an association of (b) of this section in accordance with
■ 2. Section 700.40 is revised to read as manufacturers (including importers) the procedures in paragraphs (d) and (e)
follows: and/or processors who have made an of this section.
agreement to jointly split the cost of (2) Manufacturers and/or processors
§ 700.40 Purpose and applicability. applicable user fees. of chemical substances and mixtures
(a) Purpose. The purpose of this * * * * * required to test these chemical
subpart is to establish and collect fees Enforceable consent agreement means substance and mixtures under a TSCA
from manufacturers (including a consent agreement used by EPA to section 4(a) test rule, test order, or
importers) and processors to defray part accomplish testing where a consensus enforceable consent agreement shall
of EPA’s cost of administering the Toxic exists among EPA and interested parties remit for each such test rule, order, or
Substances Control Act (15 U.S.C. 2601– (as identified in § 790.22(b)(2)) enforceable consent agreement the
2692), as amended by the Frank R. concerning the need for and scope of applicable fee identified in paragraph
Lautenberg Chemical Safety for the 21st testing under section 4 of the Act. (b) of this section in accordance with
Century Act (Pub. L. 114–182). EPA-initiated risk evaluation means the procedures in paragraphs (d) and (e)
(b) Applicability. This subpart applies any risk evaluation conducted pursuant of this section.
to all manufacturers (including to section 6(b)(4)(C)(i) of the Act. (3) Manufacturers of chemical
importers) and processors who are * * * * * substances and mixtures required to test
required to submit information under Joint submitters mean two or more these chemical substance and mixtures
section 4 of the Act; who submit certain persons who submit a TSCA section 5 under a TSCA section 4(a) test rule, test
notices and exemption requests to EPA notice together. order, or enforceable consent agreement
under section 5 of the Act; and who Manufacturer-requested risk other than a test rule, test order, or
manufacture a chemical substance that evaluation means any chemical enforceable consent agreement
is subject to a risk evaluation under substance risk evaluation conducted at described in paragraph (a)(2) of this
TSCA section 6(b)(4) of the Act. the request of one or more section shall remit for each such test
(c) After [DATE 1 DAY AFTER manufacturers of that chemical rule, order, or enforceable consent
PUBLICATION OF THE FINAL RULE substance pursuant to section agreement the applicable fee identified
IN THE Federal Register], all persons 6(b)(4)(C)(ii) of the Act. in paragraph (b) of this section in
specified in § 700.45 and paragraph (a) * * * * * accordance with the procedures in
of this section must comply with this Person means a manufacturer paragraphs (d) and (e) of this section.
subpart. (including importer) or processor. (4) Manufacturers of a chemical
■ 3. Section 700.43 is amended by: * * * * * substance that is subject to a risk
■ a. Revising the section heading; Principal sponsor means a person evaluation under section 6(b) of the Act,
■ c. Revising the introductory text; who assumes primary responsibility for shall remit for each such chemical risk
■ d. Adding in alphabetical order the direction of study, the payment of evaluation the applicable fee identified
definitions for ‘‘Consortium’’, user fees to EPA, and for oral and in paragraph (b) of this section in
‘‘Enforceable consent agreement’’, and written communication with EPA. accordance with the procedures in
‘‘EPA-initiated risk evaluation’’; Risk evaluation means any risk paragraphs (d) and (e) of this section.
■ e. Removing the definitions of evaluation conducted pursuant to Manufacturers will be identified
‘‘Exemption application’’ and section 6(b) of the Act. through the most current Chemical Data
‘‘Intermediate premanufacture notice’’; * * * * * Reporting (CDR) submissions. While
■ f. Revising the definition of ‘‘Joint Significant new use notice or SNUN EPA will attempt to identify
submitters’’; means any notice submitted to EPA manufacturers through CDR data, failure
■ g. Adding in alphabetical order a pursuant to section 5(a)(1)(B) of the Act to identify a manufacturer that is subject
definition for ‘‘Manufacturer-requested in accordance with part 721 of this to a risk evaluation fee does not remove
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risk evaluation’’; chapter. their obligation to pay the associated
■ h. Revising the definition of ‘‘Person’’; Small business concern means any fee.
■ i. Adding in alphabetical order person whose average total annual sales (b) Fees for the 2019, 2020 and 2021
definitions for ‘‘Principal sponsor’’ and over the person’s three fiscal years fiscal years. Persons shall remit fee
‘‘Risk evaluation’’; preceding the date the fee is assessed, payments to EPA as follows:
■ i. Revising the definitions of when combined with those of the parent (1) Small business concerns. Small
‘‘Significant new use notice’’ and company (if any), are less than $91 business concerns shall remit fees as
‘‘Small business concern’’; and million. follows:
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event occurred between October 1, (ii) Persons who are required to mark for the statement, ‘‘The company
2018, and [EFFECTIVE DATE OF FINAL submit a letter of intent to conduct named in part 1, section A is a small
RULE] shall be paid in response to testing per § 790.45 of this chapter shall business concern under 40 CFR 700.43
invoices EPA will send within 30 days place a payment identity number on the and has remitted a fee of $940 in
of the effective date of this rule. front page of each letter submitted. The accordance with 40 CFR 700.45(b).’’ in
(3) Timing of payment for user fees identifying number must include the the exemption application.
incurred after [EFFECTIVE DATE OF letters ‘‘TS’’ followed by a combination (iii) Each person who remits the fee
FINAL RULE]. User fees required by of 6 numbers (letters may be substituted identified in paragraph (b)(1) of this
paragraph (b) of this section for which for some numbers). The payment section for an exemption notice under
the fee-triggering action or event identity number may be a ‘‘Pay.gov’’ § 723.175 of this chapter shall include
occurred after [EFFECTIVE DATE OF transaction number or FedWire wire the words, ‘‘The company or companies
FINAL RULE] shall be paid at the transfer number used to transmit the identified in this notice is/are a small
following time: user fee. The same TS number and the business concern under 40 CFR 700.43
(i) Test orders and test rules. The submitter’s name must appear on the and has/have remitted a fee of $940 in
applicable user fee specified in corresponding fee remittance under this accordance with 40 CFR 700.45(b).’’ in
paragraph (b) of this section shall be section. If a remittance applies to more the certification required in
paid in full not later than 60 days after than one letter of intent to conduct § 723.175(i)(1)(x) of this chapter.
the effective date of a test rule or test testing, the person shall include the (iv) Each person who remits the fee
order under section 4 of the Act. name of the submitter and a new TS identified in paragraph (b)(1) of this
(ii) Enforceable consent agreements. number for each letter of intent to section for a MCAN or consolidated
The applicable user fee specified in conduct testing to which the remittance MCAN for a microorganism shall insert
paragraph (b) of this section shall be applies, and the amount of the a check mark for the statement, ‘‘The
remittance that applies to each letter of company named in part 1, section A is
paid in full not later than 60 days after
intent. a small business concern under 40 CFR
the signing of an enforceable consent
(iii) Persons who sign an enforceable 700.43 and has remitted a fee of $2,800
agreement under section 4 of the Act.
consent agreement per § 790.60 of this in accordance with 40 CFR 700.45(b).’’
(iii) Section 5 notice. The applicable
chapter shall place a payment identity in the certification required in
user fee specified in paragraph (b) of
number within the contents of the § 725.25(b) of this chapter.
this section shall be paid in full (6)(i) Each person who remits a fee
signed agreement. The identifying
immediately upon submission of a identified in paragraph (b)(2) of this
number must include the letters ‘‘TS’’
TSCA section 5 notice. section for a PMN, consolidated PMN,
followed by a combination of 6 numbers
(iv) Risk evaluations. (A) For EPA- intermediate PMN, or SNUN shall insert
(letters may be substituted for some
initiated risk evaluations, the applicable a check mark for the statement, ‘‘The
numbers). The payment identity number
user fee specified in paragraph (b) of may be a ‘‘Pay.gov’’ transaction number company named in part 1, section A has
this section shall be paid in full not later or FedWire wire transfer number used remitted the fee of $16,000 specified in
than 60 days after EPA publishes the to transmit the user fee. The same TS 40 CFR 700.45(b).’’ under
final scope of a chemical risk evaluation number and the submitter’s name must ‘‘CERTIFICATION’’ on page 2 of the
under section 6(b)(4)(D) of the Act. appear on the corresponding fee Premanufacture Notice for New
(B) For manufacturer-requested risk remittance under this section. If a Chemical Substances (EPA Form 7710–
evaluations under section 6(b)(4)(C)(ii) remittance applies to more than one 25).
of the Act, the applicable user fee enforceable consent agreement, the (ii) Each person who remits a fee
specified in paragraph (b) of this section party or parties shall include the name identified in paragraph (b)(2) of this
shall be paid in full not later than 30 of the submitter(s) and a new TS section for a LVE, LoREX, TERA, TMEA,
days after EPA provides the submitting number for each enforceable consent or Tier II exemption request under
manufacture(s) notice that it has granted agreement to which the remittance TSCA section 5 shall insert a check
the request. applies, and the amount of the mark for the statement, ‘‘The company
(4)(i) Persons who submit a TSCA remittance that applies to each named in part 1, section A has remitted
section 5 notice shall place an enforceable consent agreement. the fee of $4,700 specified in 40 CFR
identifying number and a payment (5)(i) Each person who remits the fee 700.45(b).’’ in the exemption
identity number on the front page of identified in paragraph (b)(1) of this application.
each TSCA section 5 notice submitted. section for a PMN, consolidated PMN, (iii) Each person who remits the fee
The identifying number must include intermediate PMN, or SNUN shall insert identified in paragraph (b)(2) of this
the letters ‘‘TS’’ followed by a a check mark for the statement, ‘‘The section for an exemption notice under
combination of 6 numbers (letters may company named in part 1, section A is § 723.175 of this chapter shall include
be substituted for some numbers). The a small business concern under 40 CFR the words, ‘‘The company or companies
payment identity number may be a 700.43 and has remitted a fee of $2,800 identified in this notice has/have
‘‘Pay.gov’’ transaction number or in accordance with 40 CFR 700.45(b).’’ remitted a fee of $4,700 in accordance
FedWire wire transfer number used to under ‘‘CERTIFICATION’’ on page 2 of with 40 CFR 700.45(b).’’ in the
transmit the user fee. The same TS the Premanufacture Notice for New certification required in
number and the submitter’s name must Chemical Substances (EPA Form 7710– § 723.175(i)(1)(x) of this chapter.
appear on the corresponding fee 25). This form is available on EPA’s (iv) Each person who remits the fee
daltland on DSKBBV9HB2PROD with PROPOSALS
remittance under this section. If a website at https://cdx.epa.gov/SSL/ identified in paragraph (b)(2) of this
remittance applies to more than one PMN/Outbound/Electronic_PMN_Form_ section for a MCAN for a microorganism
TSCA section 5 notice, the person shall version2.pdf. shall insert a check mark for the
include the name of the submitter and (ii) Each person who remits the fee statement, ‘‘The company named in part
a new TS number for each TSCA section identified in paragraph (b)(1) of this 1, section A has remitted the fee of
5 notice to which the remittance section for a LVE, LoREX, TERA, TMEA, $16,000 in accordance with 40 CFR
applies, and the amount of the or Tier II exemption request under 700.45(b).’’ in the certification required
remittance that applies to each notice. TSCA section 5 shall insert a check in § 725.25(b) of this chapter.
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![8234 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules
(g) Full fee refunds. EPA will refund, that the Agency has otherwise (h)(3)(i)(1)(iii), and adding paragraph
in totality, any fee paid for a section 5 determined to be complete unless the (h)(3)(i)(1)(xi) to read as follows:
notice whenever the Agency appropriate remittance under
determines: § 700.45(b) has been submitted as § 723.175 Chemical substances used in or
for the manufacture or processing of
(i) That the chemical substance that is provided in § 700.45(e). instant photographic and peel-apart film
the subject of a PMN, consolidated articles.
PMN, exemption request, or exemption PART 720—[AMENDED]
(a) * * *
notice, is not a new chemical substance ■ 6. The authority citation for part 720 (2) * * *
as of the date of submission of the continues to read as follows: (iv) Remit the applicable user fee
notice, specified in § 700.45(b) of this chapter.
(ii) In the case of a SNUN, that the Authority: 15 U.S.C. 2604, 2607, and 2613.
notice was not required, ■ 7. Section 720.38 is amended by * * * * *
(iii) The notice is incomplete under (h) * * *
adding paragraphs (b)(6) and (f) to read
(3) * * *
either § 720.65(c), § 723.50(e)(3) or as follows: (1) * * *
§ 725.33, of this chapter, (ii) * * *
(iv) That as of the date of submission § 720.38 Exemptions for test marketing.
of the notice: The microorganism that is * * * * * * * * * *
the subject of a MCAN or consolidated (b) * * * (C) Polymers. For a polymer, the
MCAN is not a new microorganism; nor (6) A user fee payment identity notice must identify monomers and
is the use involving the microorganism number, as required in 40 CFR other reactants used in the manufacture
a significant new use; or 700.45(e)(3). of the polymer by chemical name and
(v) When the Agency fails to make a * * * * * CAS Registry Number. The notice must
determination on a notice by the end of (f) When applying for a test marketing indicate the amount of each monomer
the applicable notice review period exemption, persons are subject to user used (by weight percent of total
under § 720.75 or § 725.50 of this fees in accordance with 40 CFR 700.45. monomer); the maximum residual of
chapter, unless the Agency determines ■ 8. Section 720.45 is amended by each monomer present in the polymer;
that the submitter unduly delayed the revising paragraph (a)(5) to read as and a partial or incomplete structural
process, or follows: diagram, if available. The notice must
(vi) When the Agency fails to approve, indicate the number average molecular
§ 720.45 Information that must be included weight of the polymer and characterize
or deny an exemption request within in the notice form.
the applicable period under § 720.38(d), the anticipated low molecular weight
§ 723.50(g) or § 725.50(b) of this chapter, * * * * * species. The notice must include this
(a) * * * information for each typical average
unless the Agency determines that the (5) If a manufacturer cannot provide
submitter unduly delayed the process. molecular weight composition of the
all the information specified in polymer to be manufactured.
(h) Partial fee refunds. (1) If a TSCA paragraphs (a) (1) and (2) of this section
section 5 notice is withdrawn during the (iii) Impurities. The notice must
because the new chemical substance is identify the impurities that can be
first 10 business days after the manufactured using a reactant having a
beginning of the applicable review reasonably anticipated to be present in
specific chemical identity claimed as the new chemical substance when
period under § 720.75(a) of this chapter, confidential by its supplier, the
the Agency will refund all but 25% of manufactured under the exemption by
manufacturer must submit a notice name and CAS Registry Number, by
the user fee as soon as practicable. directly to EPA containing all the
(2) Once withdrawn, any future class of substances, or by process or
information known by the manufacturer source. The notice also must estimate
submission related to the TSCA section
about the chemical identity of the the maximum percent (by weight) of
5 notice must be submitted as a new
reported substance and its proprietary each impurity in the new chemical
notice.
reactant. In addition, the manufacturer substance and the percent of unknown
■ 5. Section 700.49 is revised to read as
must ensure that the supplier of the impurities present.
follows:
confidential reactant submit a letter of * * * * *
§ 700.49 Failure to remit fees. support directly to EPA providing the (xi) User fee payment ID number. The
(a) EPA will not consider a TSCA specific chemical identity of the manufacturer or processor must include
section 5 notice to be complete unless confidential reactant, including the CAS a payment identity number on the front
the appropriate certification under number, if available, and the page of the notice.
§ 700.45(e) is included and until the appropriate PMN or exemption number,
if applicable. The letter of support must * * * * *
appropriate remittance under
§ 700.45(b) has been submitted as reference the manufacturer’s name and PART 725—[AMENDED]
provided in § 700.45(e). EPA will notify PMN User Fee Identification Number.
the submitter of a section 5 notice that The statutory review period will ■ 11. The authority citation for part 725
it is incomplete in accordance with commence upon receipt of both the continues to read as follows:
§§ 720.65(c) and 725.33(b)(1) of this notice and the letter of support. Authority: 15 U.S.C. 2604, 2607, 2613, and
chapter. * * * * * 2625.
(b) Failure to submit the appropriate ■ 12. Section 725.25 is amended by
daltland on DSKBBV9HB2PROD with PROPOSALS
remittance specified under § 700.45(b) PART 723—[AMENDED]
adding paragraph (i) to read as follows:
for a test order, test rule, enforceable ■ 9. The authority citation for part 723
consent agreement, or EPA-initiated risk continues to read as follows: § 725.25 General administrative
evaluation as provided in § 700.45(e) is requirements.
a violation of TSCA and enforceable Authority: 15 U.S.C. 2604. * * * * *
under section 15 of the Act. ■ 10. Section 723.175 is amended by (i) Fees. Persons submitting MCANs
(c) EPA will not initiate a adding paragraph (a)(2)(iv) and by and exemption requests to EPA under
manufacturer-requested risk evaluation revising paragraphs (h)(3)(i)(1)(ii)(C) and this part are subject to the applicable
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![Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Proposed Rules 8235
user fees and conditions specified in § 790.65 Failure to comply with a consent SUMMARY: EPA issued a proposed rule in
§§ 700.40, 700.45(b), and 700.49 of this agreement. the Federal Register of February 8,
chapter. * * * * * 2018, proposing to amend the
■ 13. Section 725.33 is amended by (b) The Agency considers failure to significant new use rule (SNUR) under
revising paragraphs (a)(9) and (10) to comply with any aspect of a consent section 5(a)(2) of the Toxic Substances
read as follows: agreement, including the failure to pay Control Act (TSCA) for oxazolidine,
requisite user fees as specified in 3,3′-methylenebis[5-methyl-, which was
§ 725.33 Incomplete submissions. § 700.45 of this chapter, to be a the subject of a premanufacture notice
(a) * * * ‘‘prohibited act’’ under section 15 of (PMN) and a significant new use notice
(9) The submitter does not remit the TSCA, subject to all the provisions of (SNUN). This document extends the
fees required by § 700.45(b) of this the Act applicable to violations of comment period for 17 days and
chapter. section 15. Section 15(1) of TSCA makes provides notice that EPA has added two
(10) The submitter does not include it unlawful for any person to fail or documents to the docket.
an identifying number and a payment refuse to comply with any rule or order DATES: The comment period for the
identity number. issued under section 4. Consent proposed rule published February 8,
* * * * * agreements adopted pursuant to this 2018 (83 FR 5598) is extended. This
part are ‘‘orders issued under section 4’’ document extends the comment period
PART 790—[AMENDED] for purposes of section 15(1) of TSCA. for 17 days, from February 23, 2018, to
* * * * * March 12, 2018. Comments, identified
■ 14. The authority citation for part 790 by docket identification (ID) number
continues to read as follows: PART 791—[AMENDED] EPA–HQ–OPPT–2011–0941, must be
Authority: 15 U.S.C. 2603. received on or before March 12, 2018.
■ 19. The authority citation for part 791 ADDRESSES: Follow the detailed
■ 15. Section 790.45 is amended by continues to read as follows: instructions provided under ADDRESSES
adding paragraphs (c)(7) and (g) to read Authority: 15 U.S.C. 2603 and 2607. in the Federal Register document of
as follows: February 8, 2018 (83 FR 5598) (FRL–
■ 20. Section 791.39 is amended by
§ 790.45 Submission of letter of intent to removing paragraph (a)(3) and revising 9973–02).
conduct testing or exemption application. paragraph (b). FOR FURTHER INFORMATION CONTACT:
* * * * * The revision reads as follows: For technical information contact:
(c) * * * Kenneth Moss, Chemical Control
§ 791.39 Fees and expenses. Division, Office of Pollution Prevention
(7) A payment identity number on the
* * * * * and Toxics, Environmental Protection
front page of the letter, as required in
(b) Expenses. All expenses of the Agency, 1200 Pennsylvania Ave. NW,
§ 700.45(e)(3) of this chapter.
hearing, including the cost of recording Washington, DC 20460–0001; telephone
* * * * * (though not transcribing) the hearing number: (202) 564–9232; email address:
(g) Manufacturers and processors and required traveling and other moss.kenneth@epa.gov.
subject to a test rule described in expenses of the hearing officer and of For general information contact: The
§ 790.40 and required to comply with American Arbitration Association TSCA-Hotline, ABVI-Goodwill, 422
the requirements of that test rule as representatives, and the expenses of any South Clinton Ave., Rochester, NY
provided in § 790.42(a) must remit the witness or the cost of any proofs 14620; telephone number: (202) 554–
applicable user fee specified in produced at the direct request of the 1404; email address: TSCA-Hotline@
§ 700.45(b) of this chapter. hearing officer, shall be borne equally epa.gov.
■ 16. Section 790.59 is amended by by the parties, unless they agree SUPPLEMENTARY INFORMATION: This
adding paragraph (c) to reads as follows: otherwise, or unless the hearing officer, document extends the public comment
§ 790.59 Failure to comply with a test rule.
in the award, assesses such expenses or period established in the Federal
any part thereof against any specified Register document of February 8, 2018
* * * * * party or parties. (83 FR 5598) (FRL–9973–02), which
(c) Persons who fail to pay the
* * * * * proposed amendments to the SNUR for
requisite user fee as specified in [FR Doc. 2018–02928 Filed 2–23–18; 8:45 am] the chemical substance in 40 CFR
§ 700.45(b) of this chapter will be in
BILLING CODE 6560–50–P 721.10461. EPA has added two
violation of the rule.
documents to the docket: the redacted
■ 17. Section 790.60 is amended by
(to mask information claimed as
adding paragraphs (a)(18) and (d) to ENVIRONMENTAL PROTECTION confidential business information)
read as follows: AGENCY Significant New Use Notice for
§ 790.60 Contents of consent agreements. oxazolidine, 3,3′-methylenebis[5-
40 CFR Part 721 methyl-,; and a revised redacted version
(a) * * *
[EPA–HQ–OPPT–2011–0941; FRL–9974–60] of the Structure Activity Team report. In
(18) Payment identity number, as order to give all interested persons the
required in § 700.45(e)(3) of this RIN 2070–AB27 opportunity to comment fully, EPA is
chapter. hereby extending the comment period,
daltland on DSKBBV9HB2PROD with PROPOSALS
* * * * * Modification of Significant New Use of which was set to end on February 23,
(d) Fees. Manufacturers and/or a Certain Chemical Substance; 2018, to March 12, 2018.
processors signing the consent Extension of Comment Period To submit comments, or access the
agreement are subject to the applicable AGENCY: Environmental Protection docket, please follow the detailed
user fee specified in § 700.45(b) of this Agency (EPA). instructions provided under ADDRESSES
chapter. in the Federal Register document of
ACTION: Proposed rule; extension of
■ 18. Section 790.65 is amended by February 8, 2018. If you have questions,
comment period.
revising paragraph (b) to read as follows: consult the technical person listed
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Document Created: 2018-02-24 01:00:22
Document Modified: 2018-02-24 01:00:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before April 27, 2018. | |
| 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) | |
| FR Citation | 83 FR 8212 | |
| RIN Number | 2070-AK27 | |
| CFR Citation | 40
CFR
700 40 CFR 720 40 CFR 723 40 CFR 725 40 CFR 790 40 CFR 791 | |
| CFR Associated | Chemicals; Environmental Protection; Hazardous Substances; Reporting and Recordkeeping Requirements; User Fees; Imports; Phosphate; Administrative Practice and Procedure; Labeling; Occupational Safety and Health and Confidential Business Information |
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