57612 Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Rules and Regulations 
premarket approval, have been 
approved under OMB control number 0910–0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910–0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910–0485. 
List of Subjects in 21 CFR Part 874 
Medical devices. 
Therefore, under the Federal Food, 
Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows: 
PART 874—EAR, NOSE, AND THROAT 
DEVICES 
■1. The authority citation for part 874 
continues to read as follows: 
Authority: 21 U.S.C. 351, 360, 360c, 360e, 
360j, 360l, 371. 
■2. Add § 874.3325 to subpart D to read 
as follows: 
§ 874.3325 Self-fitting air-conduction 
hearing aid. 
(a) Identification. A self-fitting air- 
conduction hearing aid is a wearable 
sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. 
(b) Classification. Class II (special 
controls). The special controls for this device are: 
(1) Clinical data must evaluate the 
effectiveness of the self-fitting strategy. 
(2) Electroacoustic parameters, 
including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested. 
(3) Performance data must 
demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. 
(4) Software verification, validation, 
and hazard analysis must be performed. 
(5) If the device incorporates wireless 
technology: 
(i) Performance testing must validate 
safety of exposure to non-ionizing radiation; 
(ii) Performance data must validate 
wireless technology functions; and 
(iii) Labeling must specify 
instructions, warnings, and information relating to wireless technology and human exposure to non-ionizing radiation. 
(6) Usability testing must demonstrate 
that users can correctly use the device as intended under anticipated conditions of use. 
(7) Patient labeling must include the 
following: 
(i) Information on how a patient can 
self-identify as a candidate for the device; 
(ii) Information about when to seek 
professional help; 
(iii) A warning about using hearing 
protection in loud environments; 
(iv) A warning about staying alert to 
sounds around the user of the device; 
(v) Technical information about the 
device, including information about EMC; and 
(vi) Information on how to correctly 
use and maintain the device. 
Dated: October 23, 2019. 
Lowell J. Schiller, 
Principal Associate Commissioner for Policy. 
[FR Doc. 2019–23464 Filed 10–25–19; 8:45 am] 
BILLING CODE 4164–01–P 
ENVIRONMENTAL PROTECTION 
AGENCY 
40 CFR Parts 9 and 721 
[EPA–HQ–OPPT–2017–0560; FRL–10000– 
69] 
RIN 2070–AB27 
Significant New Use Rules on Certain 
Chemical Substances (17–4) 
AGENCY : Environmental Protection 
Agency (EPA). 
ACTION : Final rule. 
SUMMARY : EPA is issuing significant new 
use rules (SNURs) under the Toxic Substances Control Act (TSCA) for eight chemical substances which are the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these eight chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination. 
DATES : This rule is effective on 
December 27, 2019. For purposes of judicial review, this rule shall be 
promulgated at 1 p.m. (e.s.t.) on November 12, 2019. 
FOR FURTHER INFORMATION CONTACT : For 
technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone 
number: (202) 564–9232; email address: moss.kenneth@epa.gov. 
For general information contact: The 
TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@epa.gov. 
SUPPLEMENTARY INFORMATION : 
I. General Information 
A. Does this action apply to me? 
You may be potentially affected by 
this action if you manufacture, process, 
or use the chemical substances contained in this rule. The following list of North American Industrial 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: 
•Manufacturers or processors of one 
or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. 
This action may also affect certain 
entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA. Importers of chemicals subject to these SNURs must certify compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after November 27, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. 
B. How can I access the docket? 
The docket includes information 
considered by the Agency in developing 
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the proposed and final rules. The docket 
for this action, identified by docket identification (ID) number EPA–HQ– OPPT–2017–0560, is available at http:// 
www.regulations.gov or at the Office of 
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/ DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. 
II. Background A. What action is the Agency taking? 
EPA is finalizing these SNURs under 
TSCA section 5(a)(2) for eight 
substances which were the subject of PMNs. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. 
In the Federal Register of August 27, 
2018 (83 FR 43606) (FRL–9982–78), EPA proposed a SNUR for 10 chemical substances in 40 CFR part 721 subpart E. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents for the direct final 
SNUR of August 27, 2018 (83 FR 43527) (FRL–9982–77), which is referenced in the proposed SNUR. The direct final rule was withdrawn in the Federal Register of October 26, 2018 (83 FR 
54032) (9985–56). Note that the SNUR for PMN P–16–455 was erroneously included as proposed 40 CFR 721.11121 and will not be finalized, because it was already codified as 40 CFR 721.11017. In addition, the SNUR for PMN P–16– 503 was erroneously included as proposed 40 CFR 721.11122 and will not be finalized, because it is already codified as 40 CFR 721.11018. 
B. What is the Agency’s authority for 
taking this action? 
TSCA section 5(a)(2) (15 U.S.C. 
2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ‘‘significant new use.’’ EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III. C. Applicability of General Provisions 
General provisions for SNURs appear 
in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA’s findings. 
III. Significant New Use Determination 
When the Agency issues an Order 
under TSCA section 5(e), section 5(f)(4) 
requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the Order or publish a statement describing the reasons for not initiating the rulemaking. TSCA section 5(a)(2) states that EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: 
•The projected volume of 
manufacturing and processing of a chemical substance. 
•The extent to which a use changes 
the type or form of exposure of human beings or the environment to a chemical substance. 
•The extent to which a use increases 
the magnitude and duration of exposure of human beings or the environment to a chemical substance. •The reasonably anticipated manner 
and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. 
In determining what would constitute 
a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four TSCA section 5(a)(2) factors listed in this unit. 
IV. Public Comments on Proposed Rule 
and EPA Responses 
EPA received public comments from 
four entities on the proposed rule. The Agency’s responses are described in a separate Response to Public Comments document contained in the public docket for this rule, EPA–HQ–OPPT– 2017–0560. In addition, EPA is withdrawing the proposed SNURs for the substances described in PMN P–16– 455 and P–16–503 because they were previously regulated under final SNURs at 40 CFR 721.11017 and 721.11018, respectively. Furthermore, the response to comments will describe changes to the proposed SNURs for PMN P–16– 342, P16–406 and P16–407 to include an exemption from SNUR requirements when these PMN substances have been fully reacted (cured). This makes the SNURs consistent with the same exemption contained in the underlying TSCA section 5 Orders for those substances. 
V. Substances Subject to This Rule 
EPA is establishing significant new 
use and recordkeeping requirements for 
eight chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the original direct final rule (83 FR 43527; August 27, 2018) (FRL–9982–77), EPA provides the following information for each chemical substance: 
•PMN number. 
•Chemical name (generic name, if 
the specific name is claimed as CBI). 
•Chemical Abstracts Service (CAS) 
Registry number (if assigned for non- confidential chemical identities). 
•Basis for the TSCA section 5(e) 
Order. 
•Potentially Useful Information. This 
is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR. 
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•CFR citation assigned in the 
regulatory text section of this rule. 
The regulatory text section of each 
rule specifies the activities designated 
as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on 
manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use. 
These final rules include eight PMN 
substances that are subject to Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). 
Where EPA determined that the PMN 
substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below the New Chemical Exposure Limit (NCEL). The comprehensive NCELs provisions in TSCA section 5(e) Orders include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order. 
VI. Rationale and Objectives of the Rule A. Rationale 
During review of the PMNs submitted 
for the chemical substances that are subject to these SNURs, EPA concluded 
that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard. 
B. Objectives 
EPA is issuing these SNURs because 
the Agency wants: 
•To identify as significant new uses 
any manufacturing, processing, use, 
distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). 
•To receive notice of any person’s 
intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins. 
•To have an opportunity to review 
and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. 
•To be able to either determine that 
the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs. 
Issuance of a SNUR for a chemical 
substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/ index.html. 
VII. Applicability of the Significant 
New Use Designation 
To establish a significant new use, 
EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the 
TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing. 
When chemical substances identified 
in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of six of the eight chemical substances subject to this rule have been claimed as confidential. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing. 
Furthermore, EPA designated August 
27, 2018 (the date of public release of the original direct final and proposed rules) as the cutoff date for determining 
whether the new use is ongoing. The objective of EPA’s approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule. 
In the unlikely event that a person 
began commercial manufacture or processing of the chemical substances for a significant new use identified as of August 27, 2018, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. 
VIII. Development and Submission of 
Information 
EPA recognizes that TSCA section 5 
does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, Order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN. 
In the absence of a rule, Order, or 
consent agreement under TSCA section 
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4 covering the chemical substance, 
persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable (40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing, under 40 CFR part 721, subpart E. In Unit IV. of the original direct final rule (83 FR 43527; August 27, 2018) (FRL–9982–77), lists potentially useful information that will be useful to EPA’s evaluation. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance. EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing on vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). 
In some of the TSCA section 5(e) 
Orders for the chemical substances regulated under this rule, EPA has established production volume limits. These limits cannot be exceeded unless the PMN submitter submits the results of specified tests. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing. 
Any request by EPA for the triggered 
and pended testing described in the Orders was made based on EPA’s consideration of available screening- level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of 
available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. 
The potentially useful information 
identified in Unit IV. of the original direct final rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test 
data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should provide detailed information on the following: 
•Human exposure and 
environmental release that may result from the significant new use of the chemical substances. 
•Information on risks posed by the 
chemical substances compared to risks posed by potential substitutes. 
IX. Procedural Determinations 
By this rule, EPA is establishing 
certain significant new uses which have 
been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1). 
Under these procedures a 
manufacturer or processor may request EPA to determine whether a proposed 
use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the 
chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant 
new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step. 
If EPA determines that the use 
identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. 
X. SNUN Submissions 
According to 40 CFR 721.1(c), persons 
submitting a SNUN must comply with 
the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E–PMN software is available electronically at http://www.epa.gov/opptintr/newchems. 
XI. Economic Analysis 
EPA has evaluated the potential costs 
of establishing SNUN requirements for 
potential manufacturers and processors of the chemical substances subject to this rule. EPA’s complete economic analysis is available in the docket under docket ID number EPA–HQ–OPPT– 2017–0560. 
XII. Statutory and Executive Order 
Reviews 
Additional information about these 
statutes and Executive Orders can be found at https://www.epa.gov/laws- regulations-and-executive-orders. 
A. Executive Order 12866: Regulatory 
Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review 
This action establishes SNURs for 
several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). 
B. Paperwork Reduction Act (PRA) 
According to the PRA (44 U.S.C. 3501 
et seq.), an agency may not conduct or 
sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR 
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part 9, and included on the related 
collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB’s implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ‘‘good cause’’ under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment. 
The information collection activities 
in this action have already been approved by OMB pursuant to the PRA under OMB control number 2070–0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. 
Send any comments about the 
accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including using automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 
20460–0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. 
C. Regulatory Flexibility Act (RFA) 
Pursuant to RFA section 605(b) (5 
U.S.C. 601 et seq.), the Agency hereby 
certifies that promulgation of this SNUR 
will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a ‘‘significant new use.’’ Because these uses are ‘‘new,’’ based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the 
future must first notify EPA by submitting a SNUN. EPA’s experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential 
economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) 
(FRL–5597–1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration. 
D. Unfunded Mandates Reform Act 
(UMRA) 
Based on EPA’s experience with 
proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). 
E. Executive Order 13132: Federalism 
This action will not have a substantial 
direct effect on 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). 
F. Executive Order 13175: Consultation 
and Coordination With Indian Tribal Governments 
This action does not have Tribal 
implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action. 
G. Executive Order 13045: Protection of 
Children From Environmental Health Risks and Safety Risks 
This action is not subject to Executive 
Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. 
H. Executive Order 13211: Actions 
Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 
This action is not subject to Executive 
Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. 
I. National Technology Transfer and 
Advancement Act (NTTAA) 
In addition, 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. 
J. Executive Order 12898: Federal 
Actions To Address Environmental Justice in Minority Populations and Low-Income Populations 
This action does not entail special 
considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994). 
XIII. Congressional Review Act (CRA) 
Pursuant to the CRA (5 U.S.C. 801 et 
seq.), EPA will submit a report 
containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not 
a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). 
List of Subjects 40 CFR Part 9 
Environmental protection, Reporting 
and recordkeeping requirements. 
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40 CFR Part 721 
Environmental protection, Chemicals, 
Hazardous substances, Reporting and 
recordkeeping requirements. 
Dated: October 15, 2019. 
Tala Henry, 
Deputy Director, Office of Pollution 
Prevention and Toxics. 
Therefore, 40 CFR parts 9 and 721 are 
amended as follows: 
PART 9—[AMENDED] 
■1. The authority citation for part 9 
continues to read as follows: 
Authority: 7 U.S.C. 135 et seq., 136–136y; 
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 
1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 
300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 6901–6992k, 7401–7671q, 7542, 9601–9657, 11023, 11048. 
■2. In § 9.1, add the following sections 
in numerical order under the 
undesignated center heading ‘‘Significant New Uses of Chemical Substances’’ to read as follows: 
§ 9.1 OMB approvals under the Paperwork 
Reduction Act. 
* * * * * 
40 CFR citation OMB control No. 
*****  
Significant New Uses of Chemical 
Substances 
*****  
721.11116 2070–0012 721.11117 2070–0012 721.11118 2070–0012 721.11119 2070–0012 721.11120 2070–0012 721.11123 2070–0012 
*****  
* * * * * 
PART 721—[AMENDED] 
■3. The authority citation for part 721 
continues to read as follows: 
Authority: 15 U.S.C. 2604, 2607, and 
2625(c). 
■4. Add §§ 721.11116 through 
721.11123 to subpart E to read as 
follows: 
Subpart E—Significant New Uses for 
Specific Chemical Substances 
* * * * * Sec. 
721.11116 Substituted carbocycle, N-[[[4- 
[[(4-substituted carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (generic). 
721.11117 Aliphatic polyester (generic). 721.11118 Modified acrylic polymer 
(generic). 
721.11119 Functionalized polyimide and 
functionalized polyamide (generic). 
721.11120 Siloxanes and Silicones, di-Me, 
3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-nonafluorohexyl. 
721.11121–721.11122 [Reserved] 721.11123 Carboxylic acids, C6-18 and C8- 
15-di-, polymers with diethylene glycol, glycerol, oleic acid, phthalic, acid and sorbitol. 
* * * * * 
§ 721.11116 Substituted carbocycle, N-[[[4- 
[[(4-substituted carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (generic). 
(a) Chemical substance and 
significant new uses subject to reporting. 
(1) The chemical substance identified generically as substituted carbocycle, N- [[[4-[[(4-substituted carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4- methyl- (PMN P–13–307) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. 
(2) The significant new uses are: 
(i) Protection in the workplace. 
Requirements as specified in 
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g. enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10 or maintain workplace airborne concentrations), (a)(6) (particulate (including solids or liquid droplets)), (b) (concentrations set at 1.0%) and (c). 
(A) As an alternative to the respirator 
requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 4 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order. 
(B) [Reserved] 
(ii) Hazard communication. 
Requirements as specified in§ 721.72(a), 
(b), (c), (d), (e)(concentration set at 1.0%), (f), (g)(1)(iv), (viii), (ix), (g)(2)(ii), (iii), (iv) (use respiratory protection or maintain workplace airborne concentrations below an 8-hour timeweighted average of 4 mg/m
3), 
(g)(2)(v), (g)(4)(i), (ii) and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. 
(iii) Industrial, commercial, and 
consumer activities. Requirements as specified in § 721.80(f), (k) and (q). 
(iv) Release to water. Requirements as 
specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 30 ppb. 
(b) Specific requirements. The 
provisions of subpart A of this part apply to this section except as modified by this paragraph (b). 
(1) Recordkeeping. Recordkeeping 
requirements as specified in § 721.125(a) through (i) and (k). 
(2) Limitations or revocation of 
certain notification requirements. The provisions of § 721.185 apply to this section. 
(3) Determining whether a specific use 
is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 
§ 721.11117 Aliphatic polyester (generic). 
(a) Chemical substance and 
significant new uses subject to reporting. (1) The chemical substances identified generically as aliphatic polyester (PMNs P–16–316 and P–16–317) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. 
(2) The significant new uses are: 
(i) Industrial, commercial, and 
consumer activities. Requirements as 
specified in § 721.80(k). It is a significant new use to manufacture the chemical substances with less than the confidential average molecular weight identified in the Order for the chemical substances and containing greater than the confidential percentage of molecular weight species less than 500 daltons identified in the Order for the chemical substances. 
(ii) [Reserved] 
(b) Specific requirements. The 
provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b). 
(1) Recordkeeping. Recordkeeping 
requirements as specified in § 721.125(a) through (c) and (i) are 
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applicable to manufacturers and 
processors of these substances. 
(2) Limitations or revocation of 
certain notification requirements. The provisions of § 721.185 apply to this section. 
(3) Determining whether a specific use 
is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 
§ 721.11118 Modified acrylic polymer 
(generic). 
(a) Chemical substance and 
significant new uses subject to reporting. 
(1) The chemical substance identified generically as modified acrylic polymer (PMN P–16–342) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the chemical substance after they have been completely reacted (cured). 
(2) The significant new uses are: 
(i) Hazard communication. 
Requirements as specified in 
§ 721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. 
(ii) Industrial, commercial, and 
consumer activities. Requirements as specified in § 721.80(f). It is a significant new use for any use other than as a dispersant for deflocculation of pigments in industrial paints and coatings. It is a significant new use for any use in the paint/coating formulation at concentration greater than 1.0% by weight or volume. It is a significant new use for any use of the substance that would allow inhalation exposure to the substance by vapor, dust, mist or aerosols at concentrations greater than 1.0% by weight or volume. 
(b) Specific requirements. The 
provisions of subpart A of this part apply to this section except as modified by this paragraph (b). 
(1) Recordkeeping. Recordkeeping 
requirements as specified in § 721.125(a), (b), (c), (f), (g), (h), and (i) are applicable to manufacturers and processors of this substance. 
(2) Limitations or revocation of 
certain notification requirements. The provisions of § 721.185 apply to this section. 
§ 721.11119 Functionalized polyimide and 
functionalized polyamide (generic). 
(a) Chemical substance and 
significant new uses subject to reporting. 
(1) The chemical substances identified generically as functionalized polyimide (PMN P–16–406) and functionalized 
polyamide (PMN P–16–407) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the chemical substances after they have been completely reacted (cured). 
(2) The significant new uses are: 
(i) Industrial, commercial, and 
consumer activities. Requirements as 
specified in § 721.80(k), (y)(1) and (2). It is a significant new use to use the substances other than for the specific uses identified in the Order. It is a significant new use to use any manufacturing process that results in inhalation exposure to the substances. 
(ii) [Reserved] 
(b) Specific requirements. The 
provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b). 
(1) Recordkeeping. Recordkeeping 
requirements as specified in § 721.125(a) through (c) and (i) are applicable to manufacturers and processors of these substances. 
(2) Limitations or revocation of 
certain notification requirements. The provisions of § 721.185 apply to this section. 
§ 721.11120 Siloxanes and Silicones, di- 
Me, 3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-nonafluorohexyl. 
(a) Chemical substance and 
significant new uses subject to reporting. 
(1) The chemical substance identified as siloxanes and silicones, di-Me, 3- hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6- nonafluorohexyl (CAS: 1610862–54–8) (PMN P–16–413) is subject to reporting 
under this section for the significant new uses described in paragraph (a)(2) of this section. 
(2) The significant new uses are: 
(i) Industrial, commercial, and 
consumer activities. Requirements are 
described in § 721.80(f) and (p)(40,000 kilograms and 151,300 kilograms). It is a significant new use to process or use the chemical substance in a manner that results in inhalation exposure to spray, mist or aerosol. 
(ii) Release to water. Requirements as 
specified in § 721.90(a)(1), (b)(1), and (c)(1). 
(b) Specific requirements. The 
provisions of subpart A of this part apply to this section except as modified by this paragraph (b). 
(1) Recordkeeping. Recordkeeping 
requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. 
(2) Limitations or revocation of 
certain notification requirements. The provisions of § 721.185 apply to this section. 
§ 721.11121–721,11122 [Reserved] 
§ 721.11123 Carboxylic acids, C6-18 and 
C8-15-di-, polymers with diethylene glycol, glycerol, oleic acid, phthalic, acid and sorbitol. 
(a) Chemical substance and 
significant new uses subject to reporting. 
(1) The chemical substance identified as carboxylic acids, C6-18 and C8-15-di-, polymers with diethylene glycol, glycerol, oleic acid, phthalic, acid and sorbitol (CAS No. 1877295–51–6) (PMN P–16–570) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured). 
(2) The significant new uses are: 
(i) Protection in the workplace. 
Requirements as specified in 
§ 721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), (a)(3), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), (b)(concentrations set at 1.0%) and (c). 
(ii) Hazard communication. 
Requirements as specified in § 721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (g)(4)(iii) and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. 
(iii) Industrial, commercial, and 
consumer activities. Requirements as specified in § 721.80(q). It is a significant new use to use the substance other than as an aromatic polyester polyol for manufacturing rigid foam. It is a significant new use to manufacture the substance with residual phthalate greater than 0.1% by weight. It is a significant new use to modify the manufacturing, processing or use activities of the PMN substance to result in the generation of a vapor, mist or aerosol. 
(iv) Release to water. Requirements as 
specified in § 721.90(a)(1), (b)(1), and (c)(1). 
(b) Specific requirements. The 
provisions of subpart A of this part apply to this section except as modified by this paragraph (b). 
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(1) Recordkeeping. Recordkeeping 
requirements as specified in 
§ 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this substance. 
(2) Limitations or revocation of 
certain notification requirements. The provisions of § 721.185 apply to this section. 
(3) Determining whether a specific use 
is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 
[FR Doc. 2019–23389 Filed 10–25–19; 8:45 am] 
BILLING CODE 6560–50–P 
ENVIRONMENTAL PROTECTION AGENCY 
40 CFR Part 180 
[EPA–HQ–OPP–2019–0062; FRL–9999–56] 
Mandipropamid; Pesticide Tolerances 
AGENCY : Environmental Protection 
Agency (EPA). 
ACTION : Final rule. 
SUMMARY : This regulation establishes 
tolerances for residues of 
mandipropamid in or on cacao, dried bean. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). 
DATES : This regulation is effective 
October 28, 2019. Objections and requests for hearings must be received on or before December 27, 2019 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the 
SUPPLEMENTARY INFORMATION ). 
ADDRESSES : The docket for this action, 
identified by docket identification (ID) number EPA–HQ–OPP–2019–0062, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. 
FOR FURTHER INFORMATION CONTACT : 
Michael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. 
SUPPLEMENTARY INFORMATION : 
I. General Information 
A. Does this action apply to me? 
You may be potentially affected by 
this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial 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: 
•Crop production (NAICS code 111). 
•Animal production (NAICS code 
112). 
•Food manufacturing (NAICS code 
311). 
•Pesticide manufacturing (NAICS 
code 32532). 
B. How can I get electronic access to 
other related information? 
You may access a frequently updated 
electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/text- idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_ 02.tpl. 
C. How can I file an objection or hearing request? 
Under FFDCA section 408(g), 21 
U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2019–0062 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before December 27, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). 
In addition to filing an objection or 
hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2019–0062, 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 CBI or other information whose disclosure is restricted by statute. 
•Mail: OPP Docket, Environmental 
Protection Agency Docket Center (EPA/ DC), (28221T), 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. 
II. Summary of Petitioned-For Tolerance 
In the Federal Register of June 7, 2019 
(84 FR 26630) (FRL–9993–93), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9F8733) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.637 be amended by establishing tolerances for residues of the fungicide mandipropamid in or on cocoa bean at 0.05 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing. 
Based upon review of the data 
supporting the petition, EPA is establishing the tolerance at 0.06 ppm in or on cacao, dried bean. The reason for this change is explained in Unit IV.C. 
III. Aggregate Risk Assessment and 
Determination of Safety 
Section 408(b)(2)(A)(i) of FFDCA 
allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes 
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