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DEPARTMENT OF JUSTICE Legal Authority necessary to avoid an imminent hazard Section 201 of the CSA, 21 U.S.C. 811, to the public safety, the Administrator is Drug Enforcement Administration provides the Attorney General with the required to consider three of the eight authority to temporarily place a factors set forth in 21 U.S.C. 811(c): The 21 CFR Part 1308 substance in schedule I of the CSA for substance’s history and current pattern two years without regard to the of abuse; the scope, duration and [Docket No. DEA–631] requirements of 21 U.S.C. 811(b), if he significance of abuse; and what, if any, finds that such action is necessary to risk there is to the public health. 21 Schedules of Controlled Substances: avoid an imminent hazard to the public U.S.C. 811(h)(3). Consideration of these Temporary Placement of Isotonitazene safety. 21 U.S.C. 811(h)(1). In addition, factors includes actual abuse, diversion in Schedule I if proceedings to control a substance are from legitimate channels, and initiated under 21 U.S.C. 811(a)(1) while clandestine importation, manufacture, AGENCY: Drug Enforcement the substance is temporarily controlled or distribution. 21 U.S.C. 811(h)(3). Administration, Department of Justice. under section 811(h), the Attorney A substance meeting the statutory ACTION: Proposed amendment; notice of General may extend the temporary requirements for temporary scheduling intent. scheduling for up to one year. 21 U.S.C. may only be placed in schedule I. 21 811(h)(2). U.S.C. 811(h)(1). Substances in schedule SUMMARY: The Acting Administrator of Where the necessary findings are I are those that have a high potential for the Drug Enforcement Administration is made, a substance may be temporarily abuse, no currently accepted medical issuing this notice of intent to publish scheduled if it is not listed in any other use in treatment in the United States, a temporary order to schedule N,N- schedule under section 202 of the CSA, and a lack of accepted safety for use diethyl-2-(2-(4 isopropoxybenzyl)-5- 21 U.S.C. 812, or if there is no under medical supervision. 21 U.S.C. nitro-1H-benzimidazol-1-yl)ethan-1- exemption or approval in effect for the 812(b)(1). amine (commonly known as substance under section 505 of the Isotonitazene isotonitazene), including its isomers, Federal Food, Drug, and Cosmetic Act esters, ethers, salts, and salts of isomers, The availability of synthetic opioids (FDCA), 21 U.S.C. 355. 21 U.S.C. in the illicit drug market continues to esters, and ethers whenever the 811(h)(1); 21 CFR part 1308. The existence of such isomers, esters, ethers, pose an imminent hazard to the public Attorney General has delegated safety. Adverse health effects associated and salts is possible, in schedule I of the scheduling authority under 21 U.S.C. Controlled Substances Act. When it is with the abuse of synthetic opioids and 811 to the Administrator of DEA the continued evolution and increased issued, the temporary scheduling order (Administrator). 28 CFR 0.100. will impose the regulatory controls and popularity of these substances have been a serious concern in recent years. administrative, civil, and criminal Background As the United States continues to sanctions applicable to schedule I Section 201(h)(4) of the CSA, 21 experience an unprecedented epidemic controlled substances on persons who U.S.C. 811(h)(4), requires the of opioid misuse and abuse, the handle (manufacture, distribute, reverse Administrator to notify the Secretary of presence of new synthetic opioids with distribute, import, export, engage in the Department of Health and Human no approved medical use exacerbates research, conduct instructional Services (HHS) of his intention to the epidemic. The trafficking and abuse activities or chemical analysis, or temporarily place a substance in of new synthetic opioids are deadly new possess), or propose to handle 2 schedule I of the CSA. The Acting trends. isotonitazene. Administrator transmitted notice of his The identification of isotonitazene in intent to place isotonitazene in schedule DATES: June 18, 2020. the illicit drug market has been reported I on a temporary basis to the Assistant in Canada, Estonia, Germany, Latvia, FOR FURTHER INFORMATION CONTACT: Secretary for Health of HHS (Assistant Sweden, and the United States (see Scott A. Brinks, Regulatory Drafting and Secretary) by letter dated March 2, 2020. Factor 4 below). Data obtained from Policy Support Section, Diversion The Assistant Secretary responded to preclinical pharmacology studies show Control Division, Drug Enforcement this notice by letter dated March 31, that isotonitazene has the Administration; Mailing Address: 8701 2020, and advised that based on a pharmacological profile similar to that Morrissette Drive, Springfield, Virginia review by the Food and Drug of the potent synthetic opioid 22152; Telephone: (571) 362–3261. Administration (FDA), there are etonitazene, a schedule I controlled SUPPLEMENTARY INFORMATION: This currently no investigational new drug substance. Because of the document is issued pursuant to the applications (INDs) or approved new pharmacological similarities of temporary scheduling provisions of 21 drug applications (NDAs) for isotonitazene to etonitazene, the use of U.S.C. 811(h). The Drug Enforcement isotonitazene. The Assistant Secretary isotonitazene presents a high risk of Administration (DEA) intends to issue a also stated that HHS had no objection to abuse and may negatively affect users temporary scheduling order (in the form the temporary placement of and communities. The abuse of of a temporary amendment) to add isotonitazene in schedule I of the CSA. isotonitazene has been associated with isotonitazene to schedule I under the Isotonitazene is not currently listed in at least 19 fatalities in the United States Controlled Substances Act (CSA).1 The any schedule under the CSA, and no (see Factor 5 below). The positive temporary scheduling order will be exemptions or approvals are in effect for identification of this substance in post- published in the Federal Register on or isotonitazene under section 505 of the mortem cases is a serious concern for after July 20, 2020. FDCA, 21 U.S.C. 355. public safety. Thus, isotonitazene poses To find that placing a substance an imminent hazard to public safety. 1 Though DEA has used the term ‘‘final order’’ temporarily in schedule I of the CSA is Available data and information for with respect to temporary scheduling orders in the isotonitazene, as summarized below, past, this notice of intent adheres to the statutory 2 The Secretary of HHS has delegated to the language of 21 U.S.C. 811(h), which refers to a Assistant Secretary for Health of HHS the authority indicates that this substance has a high ‘‘temporary scheduling order.’’ No substantive to make domestic drug scheduling potential for abuse, no currently change is intended. recommendations. 58 FR 35460, July 1, 1993. accepted medical use in treatment in the

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United States, and a lack of accepted 2019 and January 2020, four member (2); and U–47700, a schedule I safety for use under medical states (Estonia, Latvia, Germany, and substance (1). The average concentration supervision. DEA’s three-factor analysis Sweden) have reported 24 isotonitazene of isotonitazene in these biological is available in its entirety under cases involving 109.6 g of powder (22 samples (blood) was 2.2 ± 2.1 ‘‘Supporting and Related Material’’ of cases) and 4.5 g of liquid (two cases). nanogram/milliliter (ng/ml) (range 0.4 to the public docket for this action at Isotonitazene has been encountered by 9.5 ng/ml). Isotonitazene was detected www.regulations.gov under Docket US law enforcement primarily in as the only opioid in 50 percent (n = 9) Number DEA–631. powder form. In March 2020, Canada of the specimens for these decedents. law enforcement also encountered DEA is aware of another postmortem Factor 4. History and Current Pattern of isotonitazene in tablet form as a white case in Pennsylvania where Abuse triangular tablet with ‘M’ logo on one isotonitazene was identified in a The chemical syntheses of side and ‘8’ logo on the other side and biological sample. In total, isotonitazene isotonitazene (a benzimidazole as a blue tablet in Dilaudid counterfeit has been positively identified in 19 derivative) and other benzimidazole pills. Identification of isotonitazene in postmortem cases. derivatives (including schedule I counterfeit pills is deeply concerning Law enforcement data indicate that substances such as synthetic opioids because the identity, purity, and isotonitazene has appeared in the etonitazene and clonitazene) were first quantity of isotonitazene in this United States’ illicit drug market. reported in the scientific literature in formulation are uncertain, thus According to the National Forensic 1957. Isotonitazene is not an approved presenting additional safety concerns Laboratory Information System pharmaceutical product and is not for unsuspecting users. (NFLIS) 5 database, which collects drug approved for medical use anywhere in In the United States, isotonitazene has identification results from drug cases the world. As discussed in the been identified as a single substance or submitted to and analyzed by Federal, background section, the Assistant in combination with other substances. State and local forensic laboratories, Secretary stated in a March 31, 2020 In April 2019, the United States there have been eight encounters of letter to DEA that there are no INDs or Customs and Border Protection (CBP) isotonitazene in the United States FDA-approved NDAs for isotonitazene seized 1.6 grams of isotonitazene in (queried March 5, 2020). These eight in the United States. Hence, DEA notes California. In addition, Wisconsin State encounters were in 2019 and in two there is no legitimate channel for Crime Laboratories identified states, Tennessee (7) and California (1). isotonitazene as a marketed drug isotonitazene mixed with heroin and One of these encounters consisted of 1.6 product. bromazolam, a nonscheduled grams of isotonitazene seized by the Since 2014, numerous synthetic benzodiazepine, in seized powder. CBP in California in April 2019. opioids structurally related to fentanyl Further, isotonitazene was identified in The population likely to abuse and several opioids from other a substance obtained from the scene of isotonitazene appears to be the same as structural classes have begun to emerge a death investigation case in Iowa. those abusing prescription opioid in the illicit drug market as evidenced Evidence suggests that individuals are analgesics, heroin, tramadol, fentanyl, by the identification of these drugs in using isotonitazene as a replacement to and other synthetic opioid substances. forensic drug exhibits and toxicology heroin or other opioids, either This is evidenced by the types of other samples. Beginning in April 2019, knowingly or unknowingly. drugs co-identified in isotonitazene fatal isotonitazene emerged on the illicit overdose cases. Because abusers of synthetic drug market in the United Factor 5. Scope, Duration, and isotonitazene are likely to obtain it States as evidenced by its identification Significance of Abuse through unregulated sources, the in drug seizures and in biological Isotonitazene, similar to etonitazene identity, purity, and quantity are samples collected and submitted to (schedule I), has been described as a uncertain and inconsistent, thus posing National Medical Services (NMS) potent synthetic opioid and evidence significant adverse health risks to the Laboratory 3 in August 2019. In August suggests it is being abused for its end user. The misuse and abuse of 2019, isotonitazene was first reported in opioidergic effects (see Factor 6). The opioids have been demonstrated and are a drug case in Belgium and toxicology abuse of isotonitazene, similar to other well characterized. According to the casework in Canada (toxicological synthetic opioids, has resulted in most recent data from the National sample was collected in March 2019). In adverse health effects. Isotonitazene has Survey on Drug Use and Health the United States, the Center for been positively identified in 18 death (NSDUH),6 as of 2018, an estimated 10.3 Forensic Science Research and investigation cases spanning between Education (under the novel August 2019 and January 2020. These 5 NFLIS represents an important resource in psychoactive substances discovery reports were from four states—Illinois monitoring illicit drug trafficking, including the (9), Indiana (7), Minnesota (1), and diversion of legally manufactured pharmaceuticals program) first reported isotonitazene in into illegal markets. NFLIS-Drug is a comprehensive November 2019. Wisconsin (1). Most (n = 12) of the information system that includes data from forensic According to a report by the European decedents were male. The ages ranged laboratories that handle the nation’s drug analysis Monitoring Center for Drugs and Drug from 24 to 66 years old with an average cases. NFLIS-Drug participation rate, defined as the percentage of the national drug caseload 4 age of 41. Other substances identified in addiction and Europol, between April represented by laboratories that have joined NFLIS, postmortem blood specimens obtained is currently 98.5 percent. NFLIS includes drug 3 NMS Labs, in collaboration with the Center for from these decedents include etizolam chemistry results from completed analyses only. Forensic Science Research and Education at the (6); flualprazolam, a nonscheduled While NFLIS data is not direct evidence of abuse, Fredric Rieders Family Foundation and the benzodiazepine (7); fentanyl (6); heroin it can lead to an inference that a drug has been Organized Crime Drug Enforcement Task Force at diverted and abused. See 76 FR 77330, 77332, Dec. the U.S. Department of Justice, has received funding (3); tramadol, a schedule IV substance 12, 2011. NFLIS data was queried on March 5, 2020. from the Centers for Disease Control and Prevention 6 The National Survey on Drug Use and Health to develop systems for the early identification and diethyl-2-[[4-(1-methylethoxy)phenyl]methyl]-5- (NSDUH), formerly known as the National notification of novel psychoactive substances in the nitro-1H-benzimidazole-1-ethanamine Household Survey on Drug Abuse (NHSDA), is drug supply within the United States. (isotonitazene). In accordance with Article 5b of conducted annually by HHS’ Substance Abuse and 4 European Monitoring Centre for Drugs and Drug Regulation (EC) No. 1920/2006 (as amended), Mental Health Services Administration (SAMHSA). Addiction and Europol (2020), EMCDDA initial Publications Office of the European Union, It is the primary source of estimates of the report on the new psychoactive substance N,N- Luxembourg. prevalence and incidence of nonmedical use of

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million people aged 12 years or older can induce dose-dependent respiratory chemical analysis, possession, and had misused opioids in the past year, depression. abuse of isotonitazene pose an including 9.9 million prescription pain As with any mu-opioid receptor imminent hazard to the public safety. reliever misusers and 808,000 heroin agonist, the potential health and safety DEA is not aware of any currently users. In 2018, an estimated 2.0 million risks for users are high. The public accepted medical uses for isotonitazene people had an opioid use disorder health risks attendant to the abuse of in the United States. A substance which included 1.7 million people with heroin and other mu-opioid receptor meeting the statutory requirements for a prescription pain reliever use disorder agonists are well established and have temporary scheduling, found in 21 and 0.5 million people with heroin use resulted in large numbers of drug U.S.C. 811(h)(1), may only be placed in disorder. This population abusing treatment admissions, emergency schedule I. Substances in schedule I are opioids is likely to be at risk of abusing department visits, and fatal overdoses. those that have a high potential for isotonitazene. Individuals who initiate According to the Centers for Disease abuse, no currently accepted medical (i.e., use a drug for the first time) use of Control and Prevention (CDC), opioids, use in treatment in the United States, isotonitazene are likely to be at risk of mainly synthetic opioids other than and a lack of accepted safety for use developing substance use disorder, methadone, are predominantly under medical supervision. Available overdose, and death similar to that of responsible for drug overdose deaths in data and information for isotonitazene other opioid analgesics (e.g., fentanyl, recent years. A CDC report shows that indicate that this substance has a high morphine, etc.). Law enforcement and from 2013 to 2018,7 opioid-related potential for abuse, no currently toxicology reports demonstrate that overdose deaths in the United States accepted medical use in treatment in the isotonitazene is being illicitly increased from 25,052 to 46,802. Of the United States, and a lack of accepted distributed and abused. drug overdose death data for 2018, safety for use under medical opioids were involved in about 69.5 supervision. As required by 21 U.S.C. Factor 6. What, if Any, Risk There Is to percent of all drug-involved overdose 811(h)(4), the Acting Administrator, the Public Health deaths. through a letter dated March 2, 2020, notified the Assistant Secretary for The increase in opioid overdose Isotonitazene has been co-identified with other substances in 18 postmortem Health of DEA’s intention to temporarily deaths in the United States has been place isotonitazene in schedule I. exacerbated recently by the availability cases and DEA is aware of an additional of potent synthetic opioids in the illicit death case that occurred in January 2020 Conclusion drug market. Data obtained from pre- involving isotonitazene in the United States. These deaths associated with This notice of intent provides the 30- clinical studies demonstrate that day notice pursuant to 21 U.S.C. isotonitazene exhibits a isotonitazene occurred in five states- Illinois (9), Indiana (7), Minnesota (1), 811(h)(1) of DEA’s intent to issue a pharmacological profile similar to that temporary scheduling order. In of etonitazene and other mu-opioid Pennsylvania (1), and Wisconsin (1). Information gathered from case histories accordance with 21 U.S.C. 811(h)(1) and receptor agonists. In an in vivo (in mice) (3), the Acting Administrator considered study, isotonitazene was 500 times more and autopsy findings shows that isotonitazene use is similar to that of available data and information, herein potent than morphine as an analgesic in set forth the grounds for his a tail-flick assay. The tail-flick assay is classic opioid agonists. Evidence obtained from reported cases of death determination that it is necessary to useful in evaluating antinociceptive temporarily schedule isotonitazene in effect. Data from in vitro studies showed scenes suggests that isotonitazene, similar to heroin, can be used schedule I of the CSA, and finds that that isotonitazene activated the mu- 8 placement of this substance in schedule opioid receptor and acted as a mu- intravenously. The introduction of potent synthetic I of the CSA is necessary in order to opioid receptor agonist. Isotonitazene, opioids such as isotonitazene into the avoid an imminent hazard to the public similar to hydromorphone and fentanyl, illicit market is a portal to problematic safety. activated the mu-opioid receptor and The temporary placement of opioid use for those seeking these acted as an agonist via interaction at the isotonitazene in schedule I of the CSA powerful opioids. As documented by a mu-opioid receptor with b-arrestin-2, a will take effect pursuant to a temporary published toxicology report, poly- regulatory protein, in a live cell-based scheduling order, which will not be substance abuse remains common in receptor assay. Naloxone, an opioid issued before July 20, 2020. Because the fatalities associated with the abuse of receptor antagonist, blocked Acting Administrator hereby finds that isotonitazene.9 isotonitazene’s activation of the mu- it is necessary to temporarily place opioid receptor. Substances that act as Finding of Necessity of Schedule I isotonitazene in schedule I to avoid an an agonist at the mu-opioid receptors Placement To Avoid Imminent Hazard imminent hazard to the public safety, have a high potential for addiction and to Public Safety the temporary order scheduling this In accordance with 21 U.S.C. substance will be effective on the date pharmaceutical drugs, illicit drugs, alcohol, and 811(h)(3), based on the available data the order is published in the Federal tobacco use in the United States. The survey is Register, and will be in effect for a and information summarized above, the based on a nationally representative sample of the period of two years, with a possible uncontrolled manufacture, distribution, civilian, non-institutionalized population 12 years extension of one additional year, of age and older. The survey excludes homeless reverse distribution, importation, pending completion of the regular people who do not use shelters, active military exportation, conduct of research and personnel, and residents of institutional group (permanent) scheduling process. 21 quarters such as jails and hospitals. The NSDUH U.S.C. 811(h)(1) and (2). It is the provides yearly national and state level estimates of 7 CDC—National Center for Health Statistics drug abuse, and includes prevalence estimates by (NCHS), National Vital Statistics System, Mortality. intention of the Acting Administrator to lifetime (i.e., ever used), past year, and past month NCHS Data Brief, Number 356, January 2020. issue a temporary scheduling order as abuse or dependence. The 2018 NSDUH annual 8 Krotulski AJ, Papsun DM, Kacinko SL, and soon as possible after the expiration of report is available at https://www.samhsa.gov/data/ Logan BK (2020). Isotonitazene Quantitation and 30 days from the date of publication of sites/default/files/cbhsq-reports/ Metabolite Discovery in Authentic Forensic NSDUHNationalFindingsReport2018/ Casework. Journal of Analytical Toxicology. [Epub this document. Upon publication of the NSDUHNationalFindingsReport2018.pdf (last ahead of print]. temporary order, isotonitazene will then accessed April 9, 2020). 9 Id. be subject to the CSA’s schedule I

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regulatory controls and administrative, Attorney General to follow rulemaking jobs; the environment; public health or civil, and criminal sanctions applicable procedures for other kinds of scheduling safety; or State, local, or tribal to the manufacture, distribution, reverse actions, see 21 U.S.C. 811(a), it is governments or communities; (2) create distribution, importation, exportation, noteworthy that, in 21 U.S.C. 811(h), a serious inconsistency or otherwise research, conduct of instructional Congress authorized the issuance of interfere with an action taken or activities and chemical analysis, and temporary scheduling actions by order planned by another agency; (3) possession. rather than by rule. materially alter the budgetary impact of The CSA sets forth specific criteria for In the alternative, even assuming that entitlements, grants, user fees, or loan scheduling a drug or other substance. this notice of intent might be subject to programs, or the rights and obligations Regular scheduling actions in section 553 of the APA, the Acting of recipients thereof; or (4) raise novel accordance with 21 U.S.C. 811(a) are Administrator finds that there is good subject to formal rulemaking procedures cause to forgo the notice-and-comment legal or policy issues arising out of legal done ‘‘on the record after opportunity requirements of section 553, as any mandates, the President’s priorities, or for a hearing’’ conducted pursuant to further delays in the process for the principles set forth in the Executive the provisions of 5 U.S.C. 556 and 557. issuance of temporary scheduling orders Order. Because this is not a rulemaking 21 U.S.C. 811. The regular scheduling would be impracticable and contrary to action, this is not a significant process of formal rulemaking affords the public interest in view of the regulatory action as defined in Section interested parties with appropriate manifest urgency to avoid an imminent 3(f) of Executive Order 12866. In process and the government with any hazard to the public safety. addition, this action does not meet the additional relevant information needed Although DEA believes this notice of definition of an Executive Order 13771 to make a determination. Final intent to issue a temporary scheduling regulatory action, and the repeal and decisions that conclude the regular order is not subject to the notice-and- cost offset requirements of Executive scheduling process of formal comment requirements of section 553 of Order 13771 have not been triggered. rulemaking are subject to judicial the APA, DEA notes that in accordance This action will not have substantial review. 21 U.S.C. 877. Temporary with 21 U.S.C. 811(h)(4), the Acting direct effects on the States, on the Administrator took into consideration scheduling orders are not subject to relationship between the national comments submitted by the Assistant judicial review. 21 U.S.C. 811(h)(6). government and the States, or on the Secretary in response to the notice that Regulatory Analyses DEA transmitted to the Assistant distribution of power and 21 U.S.C. 811(h) provides for a Secretary pursuant to such subsection. responsibilities among the various temporary scheduling action where Further, DEA believes that this levels of government. Therefore, in such action is necessary to avoid an temporary scheduling action is not a accordance with Executive Order 13132 imminent hazard to the public safety. ‘‘rule’’ as defined by 5 U.S.C. 601(2), (Federalism), it is determined that this As provided in this subsection, the and, accordingly, is not subject to the action does not have sufficient Attorney General may, by order, requirements of the Regulatory federalism implications to warrant the schedule a substance in schedule I on a Flexibility Act. The requirements for the preparation of a Federalism Assessment. temporary basis. Such an order may not preparation of an initial regulatory List of Subjects in 21 CFR Part 1308 be issued before the expiration of 30 flexibility analysis in 5 U.S.C. 603(a) are days from: (1) The publication of a not applicable where, as here, DEA is Administrative practice and notice in the Federal Register of the not required by section 553 of the APA procedure, Drug traffic control, intention to issue such order and the or any other law to publish a general Reporting and recordkeeping grounds upon which such order is to be notice of proposed rulemaking. requirements. issued, and (2) the date that notice of In accordance with the principles of the proposed temporary scheduling Executive Orders 12866, 13563, and For the reasons set out above, DEA order is transmitted to the Assistant 13771, this action is not a significant proposes to amend 21 CFR part 1308 as Secretary of HHS. 21 U.S.C. 811(h)(1). regulatory action. Executive Order follows: Inasmuch as 21 U.S.C. 811(h) directs 12866 directs agencies to assess all costs that temporary scheduling actions be and benefits of available regulatory PART 1308—SCHEDULES OF issued by order and sets forth the alternatives and, if regulation is CONTROLLED SUBSTANCES procedures by which such orders are to necessary, to select regulatory be issued, including the requirement of approaches that maximize net benefits ■ 1. The authority citation for part 1308 a publication in the Federal Register of (including potential economic, continues to read as follows: a notice of intent, the notice-and- environmental, public health, and safety comment requirements of section 553 of effects; distributive impacts; and Authority: 21 U.S.C. 811, 812, 871(b), the Administrative Procedure Act equity). Executive Order 13563 is 956(b), unless otherwise noted. (APA), 5 U.S.C. 553, do not apply to this supplemental to and reaffirms the ■ 2. In § 1308.11, add paragraph (h)(48) Notice of Intent. The APA expressly principles, structures, and definitions to read as follows: differentiates between an order and a governing regulatory review as rule, as it defines an ‘‘order’’ to mean a established in Executive Order 12866. § 1308.11 Schedule I ‘‘final disposition, whether affirmative, Executive Order 12866 classifies a * * * * * negative, injunctive, or declaratory in ‘‘significant regulatory action,’’ form, of an agency in a matter other requiring review by the Office of (h) * * * than rule making.’’ 5 U.S.C. 551(6) Management and Budget (OMB), as any (emphasis added). The specific language regulatory action that is likely to result (48) N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H- chosen by Congress indicates an in a rule that may: (1) Have an annual benzimidazol-1-yl)ethan-1- intention for DEA to proceed through effect on the economy of $100 million amine, its isomers, esters, the issuance of an order instead of or more or adversely affect in a material ethers, salts and salts of iso- proceeding by rulemaking. Given that way the economy; a sector of the mers, esters and ethers (Other Congress specifically requires the economy; productivity; competition; name: Isotonitazene) ...... 9614

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* * * * * discussion of all points you wish to particular source is capable of meeting make. The EPA will generally not by the application of control technology Timothy J. Shea, consider comments or comment that is reasonably available considering Acting Administrator. contents located outside of the primary technological and economic feasibility.1 [FR Doc. 2020–12304 Filed 6–17–20; 8:45 am] submission (i.e., on the web, cloud, or The CTGs usually identify a particular BILLING CODE 4410–09–P other file sharing system). For control level which EPA recommends as additional submission methods, please being RACT. States are required to contact the person identified in the FOR address RACT for the source categories ENVIRONMENTAL PROTECTION FURTHER INFORMATION CONTACT section. covered by CTGs through adoption of AGENCY For the full EPA public comment policy, rules as part of the SIP. information about CBI or multimedia On October 5, 2006 (71 FR 58745), 40 CFR Part 52 submissions, and general guidance on EPA issued four new CTGs: Industrial [EPA–R01–OAR–2020–0048; FRL–10010– making effective comments, please visit Cleaning Solvents; Offset Lithographic 93–Region 1] https://www.epa.gov/dockets/ Printing and Letterpress Printing; commenting-epa-dockets. Publicly Flexible Package Printing; and Flat Air Plan Approval; Rhode Island; available docket materials are available Wood Paneling Coatings, and applicable Reasonably Available Control at https://www.regulations.gov or at the areas were required to address them by Technology for the 2008 and 2015 U.S. Environmental Protection Agency, October 5, 2007. On October 9, 2007 (72 Ozone Standards EPA Region 1 Regional Office, Air and FR 57215), EPA issued three more CTGs: Paper, Film, and Foil Coatings; AGENCY: Environmental Protection Radiation Division, 5 Post Office Large Appliance Coatings; and Metal Agency (EPA). Square—Suite 100, Boston, MA. EPA Furniture Coatings, and applicable areas ACTION: Proposed rule. requests that if at all possible, you contact the contact listed in the FOR were required to address them by SUMMARY: The Environmental Protection FURTHER INFORMATION CONTACT section to October 9, 2008. On October 7, 2008 (73 Agency (EPA) is proposing approval of schedule your inspection. The Regional FR 58841), EPA issued an additional a State Implementation Plan (SIP) Office’s official hours of business are four CTGs: Miscellaneous Metal and revision submitted by the State of Rhode Monday through Friday, 8:30 a.m. to Plastic Parts Coatings; Fiberglass Boat Island. The SIP revision consists of a 4:30 p.m., excluding legal holidays and Manufacturing Materials; Miscellaneous demonstration that Rhode Island meets facility closures due to COVID–19. Industrial Adhesives; and Automobile and Light-Duty Truck Assembly the requirements of reasonably available FOR FURTHER INFORMATION CONTACT: Coatings. Applicable areas were control technology (RACT) for the two David L. Mackintosh, Air Quality required to address these CTGs by precursors for ground-level ozone, Branch, U.S. Environmental Protection October 7, 2009. Lastly, on Oct 27, 2016 oxides of nitrogen (NOX) and volatile Agency, EPA Region 1, 5 Post Office (81 FR 74798), EPA issued a new CTG organic compounds (VOCs), set forth by Square—Suite 100, (Mail Code 05–2), for the Oil and Natural Gas Industry, the Clean Air Act (CAA or Act) with Boston, MA 02109–3912, tel. 617–918– and applicable areas were required to respect to the 2008 and 2015 ozone 1584, email [email protected]. National Ambient Air Quality Standards address it by October 27, 2018. SUPPLEMENTARY INFORMATION: On March 27, 2008 (73 FR 16436), (NAAQSs or standards). Additionally, Throughout this document whenever we are proposing approval of specific EPA revised the health-based NAAQS ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean for ozone to 0.075 parts per million regulations that implement the RACT EPA. requirements by limiting air emissions (ppm), averaged over an 8-hour of NO and VOC pollutants from Table of Contents timeframe. EPA determined that the X revised 8-hour standard would be more sources within the State. This action is I. Background being taken in accordance with the protective of human health, especially II. Summary of Rhode Island’s SIP Revision with regard to children and adults who Clean Air Act. III. EPA’s Evaluation of the Submittal are active outdoors and individuals with DATES: A. NOX RACT for Major Sources Written comments must be a pre-existing respiratory disease such received on or before July 20, 2020. B. Non-CTG VOC RACT for Major Sources C. CTG VOC RACT as asthma. ADDRESSES: Submit your comments, IV. Proposed Action On March 6, 2015 (80 FR 12264), EPA identified by Docket ID No. EPA–R01– V. Incorporation by Reference published a final rule outlining the OAR–2020–0048 at https:// VI. Statutory and Executive Order Reviews obligations for areas in nonattainment www.regulations.gov, or via email to I. Background with the 2008 ozone standard, as well [email protected]. For as obligations for areas in the OTR. This comments submitted at Regulations.gov, Rhode Island is part of the Ozone rule, referred to as the ‘‘2008 Ozone follow the online instructions for Transport Region (OTR) under Section Implementation Rule,’’ contains a submitting comments. Once submitted, 184(a) of the CAA. Sections 182(b)(2), description of EPA’s expectations for comments cannot be edited or removed 182(f) and 184 of the CAA require states states with RACT obligations, and from Regulations.gov. For either manner with ozone nonattainment areas that are required states in the OTR to certify of submission, the EPA may publish any classified as moderate or above, as well RACT requirements by July 20, 2014. comment received to its public docket. as areas in the OTR, to submit a SIP The 2008 Ozone Implementation Rule Do not submit electronically any revision requiring the implementation gives states several options for meeting information you consider to be of VOC RACT for sources covered by a RACT requirements for the 2008 ozone Confidential Business Information (CBI) control techniques guideline (CTG) and or other information whose disclosure is for all major sources of VOC and NOX. 1 See Memorandum from Roger Strelow, Assistant restricted by statute. Multimedia A CTG is a document issued by EPA Administrator for Air and Waste Management, U.S. submissions (audio, video, etc.) must be which establishes a ‘‘presumptive EPA, to Regional Administrators, U.S. EPA, ‘‘Guidance for Determining Acceptability of SIP accompanied by a written comment. norm’’ for RACT for a specific VOC Regulations in Non-Attainment Areas’’ (Dec. 9, The written comment is considered the source category. RACT is defined as the 1976); see also 44 FR 53761, 53762 (September 17, official comment and should include lowest emission limitation that a 1979).

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