The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”), 1 Public Law 94-163 (42 U.S.C. 6291-6317) authorizes DOE to regulate the energy efficiency of a number of consumer products and industrial equipment types. Title III, Part B  2 of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles. Title III, Part C  3 of EPCA established the Energy Conservation Program for Certain Industrial Equipment. Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures.

The Federal testing requirements consist of test procedures that manufacturers of covered products and equipment must use as the basis for: (1) Certifying to DOE that their products or equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s); 42 U.S.C. 6316(a)), and (2) making representations about the efficiency of those products or equipment (42 U.S.C. 6293(c); 42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the products or equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s); 42 U.S.C.6316 (a))

Under 42 U.S.C. 6293 and 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered products and equipment. EPCA requires that test procedures must be reasonably designed to produce test results that reflect energy efficiency, energy use or estimated annual operating cost of a covered product or covered equipment during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct (42 U.S.C. 6293(b)(3); 42 U.S.C. 6314(a)(2)). DOE's regulations provide that upon receipt of a petition, DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 430.27(a)(1) and 10 CFR 431.401(f)(2). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures.

In addition to the full waiver (“decision and order”) described above, the waiver process permits parties submitting a petition for waiver to also file an application for interim waiver from the applicable test procedure requirements. 10 CFR 430.27(a) and 10 CFR 431.401(a). The current regulations specify that, if administratively feasible, DOE will notify the applicant in writing of the disposition of a petition for interim waiver within 30 business days of receipt of the application. The Assistant Secretary will grant an interim waiver if it appears likely that the petition for waiver will be granted, and/or the Assistant Secretary determines that it would be desirable for public policy reasons to grant immediate relief pending a determination of the petition for waiver. 10 CFR 430.27(e)(2) and 10 CFR 430.401(e)(2). Notice of DOE's determination on the petition for interim waiver will also be published in the Federal Register . 10 CFR 430.27(e)(1) and 10 CFR 431.401(e)(1). Within one year of issuance of an interim waiver, DOE will either: (i) Publish in the Federal Register a determination on the petition for waiver; or (ii) publish in the Federal Register a new or amended test procedure that addresses the issues presented in the waiver. 10 CFR 430.27(h)(1) and 10 CFR 431.401(h)(2). When DOE amends the test procedure to address the issues presented in a waiver, the waiver will automatically terminate on the date on which use of that test procedure is required to demonstrate compliance. 10 CFR 430.27(h)(2) and 10 CFR 431.401(h)(2).

In this proposed rule, DOE is proposing amendments to its regulations that would reduce manufacturers' burden associated with the interim waiver application process, provide them with greater certainty, and speed the availability of innovative product options to consumers. DOE's proposal responds to stakeholder concerns regarding lengthy waiting times following submission of interim waiver and waiver applications, and the burden that lengthy processing time imposes on manufacturers, who are unable to sell their products or equipment absent an interim waiver or waiver from DOE. 4 This burden may be especially pronounced for manufacturers of seasonal appliances, such as room air conditioners, in cases where interim waiver delays cause a product to miss the applicable seasonal sale window.

Specifically, this proposal is intended to address delays in DOE's current process for considering requests for interim waivers and waivers from the DOE test method, which in turn can result in significant delays for manufacturers in bringing new and innovative products to market. DOE has in the past incurred delays by not responding to petitions in a timely manner, and this delay has imposed negative consequences for manufacturers who cannot bring their products to market absent a waiver from the Department that allows them to test their products and certify them as compliant with DOE energy conservation standards. Additional information on the length and cost to manufacturers of the delays is described in Section III. DOE's proposal would ensure that manufacturers would need to wait only a maximum of 30 business days before selling products under an approved interim waiver. If the petition for waiver ultimately requires the use of a different test method than that granted under the interim waiver, manufacturers would have an additional grace period of 180 days to begin using the test method required by the waiver.

DOE regulations currently require the Department to notify an applicant in writing of the disposition of a petition for interim waiver within 30 business days of receipt of the application “[i]f administratively feasible.” 10 CFR 430.27(e)(1) and 10 CFR 431.401(e)(1). DOE proposes in this notice to amend 10 CFR 430.27(e)(1) and 10 CFR 431.401(e)(1) to require the Department to issue decisions on interim waiver applications within 30 business days, removing the language “[i]f administratively feasible.” Under the proposal, an application for interim waiver would be deemed granted, thereby permitting use of the alternate test procedure suggested by the applicant in its application, if DOE fails to notify the applicant in writing of the disposition of an application within 30 business days of receipt of the application. DOE's decision on the interim waiver request will not depend on DOE's view of the sufficiency of the associated petition for waiver, because DOE can work with the petitioner to gather any additional information or conduct any additional analysis deemed necessary to reach a decision on the petition while the manufacturer is able to sell the product or equipment at issue under the interim waiver. DOE's regulations specify that DOE may grant an interim waiver if DOE determines that it would be desirable for public policy reasons to grant immediate relief pending a determination of the

This notice of intent contained in this document is issued pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to issue a temporary scheduling order (in the form of a temporary amendment) placing N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I of the Controlled Substances Act (CSA). 1 The temporary scheduling order will be published in the Federal Register on or after May 31, 2019.

Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b), if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance permanently are initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily controlled under section 811(h), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance in schedule I of the CSA. 2 The Acting Administrator transmitted notice of his intent to place N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter dated March 9, 2018. The Acting Assistant Secretary responded to this notice of intent by letter dated March 27, 2018, and advised that based on a review by the Food and Drug Administration (FDA), there were currently no approved new drug applications or active investigational new drug applications for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP. The Acting Assistant Secretary also stated that the HHS had no objection to the temporary placement of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I of the CSA. N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP under section 505 of the FDCA, 21 U.S.C. 355.

In order to find that placing a substance temporarily in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).

Recently, novel synthetic cathinones that mimic the biological effects of substances with stimulant-like effects have emerged on the illicit drug market. These novel cathinones, also known as designer drugs, are structurally similar to several drugs of abuse such as schedule I synthetic cathinones ( e.g., methcathinone, mephedrone, methylone, pentylone, and 3,4-methylenedioxypyrovalerone (MDPV)). The illicit use of synthetic cathinones has continued throughout the United States, resulting in severe adverse effects, overdoses, and deaths. Indeed, hospital reports, scientific publications and/or law enforcement reports demonstrate that these types of substances are being abused for their psychoactive properties and they cause harm ( see DEA 3-Factor Analysis). Recreational effects reported by abusers of synthetic cathinones include euphoria, sense of well-being, increased sociability, energy, empathy, increased alertness, improved concentration, and focus. Adverse effects such as tachycardia, hypertension, rhabdomyolysis, hyponatremia, seizures, and altered mental status (paranoia, hallucinations, and delusions) have also been reported from the abuse of synthetic cathinones. Consequently, there are documented reports of emergency room admissions and deaths associated with the abuse of synthetic cathinone substances. With many generations of synthetic cathinones having been encountered since 2009, the abuse of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP is impacting or will negatively impact communities.

Law enforcement data indicate that N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP have appeared in the United States' illicit drug market ( see DEA 3-Factor Analysis). Law enforcement encounters include those reported to the National Forensic Laboratory Information System (NFLIS), a DEA sponsored program that systematically collects drug identification results and associated information from drug cases analyzed by Federal, State, and local forensic laboratories. From January 2012 to September 24, 2018, NFLIS registered 1,131 drug exhibits pertaining to the trafficking, distribution and abuse of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP. These exhibits had a net weight of approximately 18.7 kilograms and were encountered in powder, crystal, rock, resin, capsule, and tablet forms.

As observed by the DEA and by the United States Customs and Border Protection (CBP), synthetic cathinones originate from foreign sources, such as China. Bulk powder substances are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. Encounters of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP have occurred by the CBP ( see DEA 3-Factor Analysis).

N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP have no accepted medical use in the United States. N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP have been seized by law enforcement in the United States. The misuse of α-PHP, 4-MEAP, MPHP, and PV8 has been reported to result in adverse effects in humans in the United States. Although no overdose information is currently available for N -ethylhexedrone and 4-chloro-α-PVP, law enforcement seizures of these two substances and their pharmacological similarity to currently controlled schedule I synthetic cathinones ( e.g., methcathinone, mephedrone, methylone, pentylone, MDPV) suggest that these two synthetic cathinones are likely to produce adverse effects similar to those produced by other synthetic cathinones.

N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are synthetic cathinones that have pharmacological effects similar to schedule I synthetic cathinone substances such as methcathinone, mephedrone, methylone, pentylone, and MDPV and schedule II stimulants such as methamphetamine and cocaine. The misuse of α-PHP, 4-MEAP, MPHP, and PV8 has been associated with one or more overdoses with some requiring emergency medical intervention in the United States. With no approved medical use and limited safety or toxicological information, N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP have emerged on the designer drug market, and the abuse or trafficking of these substances for their psychoactive properties is concerning.

N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are synthetic cathinones that have been identified in the United States' illicit drug market. Evidence indicates that these substances are being substituted for schedule I synthetic cathinones. Products containing synthetic cathinones have been falsely marketed as “research chemicals,” “jewelry cleaner,” “stain remover,” “plant food or fertilizer,” “insect repellants,” or “bath salts.” They have been sold at smoke shops, head shops, convenience stores, adult bookstores, and gas stations. They can also be purchased on the internet. These substances are commonly encountered in the form of powders, crystals, tablets, and capsules. Other encountered forms include resin, rock, liquid, and deposits on plant matter. Law enforcement has encountered N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in powder, crystal, resin, rock, capsule, or tablet forms. The packages of these commercial products usually contain the warning “not for human consumption,” most likely in an effort to circumvent statutory restrictions for these substances.

N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are likely to be abused in the same manner as schedule I synthetic cathinones such as methcathinone, mephedrone, methylone, pentylone, and MDPV. Information from published scientific studies indicate that the most common routes of administration for synthetic cathinones are nasal insufflation by snorting the powder and ingestion by swallowing capsules or tablets. The powder can also be injected or swallowed. Other methods of intake include rectal administration, ingestion by “bombing” (wrapping a dose of powder in a paper wrap and swallowing) and intramuscular injection.

Based upon the information collected from case reports, medical journals, and scientific publications including survey data, the main users of synthetic cathinones are youths and young adults. Given that N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are newly emerging synthetic cathinones, it is likely that these substances will be used by the same population. This is consistent with data collected from the use of schedule I synthetic cathinones ( e.g., mephedrone, methylone, pentylone, MDPV). According to Monitoring the Future (MTF) survey data, 3 the 2017 annual prevalence rate of synthetic cathinone use was 0.6% for high school seniors and 0.3% for young adults (19-30 years). However, there was an 18 percentage point increase in the perceived risk of trying “bath salts” in young adults (aged 19-26 years).

N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are likely to have duration of effects similar to those of schedule I synthetic cathinones because of their structural and pharmacological similarities. Users report (drug surveys, scientific and medical literature, etc. ) that the effects of synthetic cathinones occur a few minutes to 15 minutes after administration, depending on the synthetic cathinone and the route of administration (oral, insufflation, intravenous, etc. ), and can last up to three hours.

Evidence indicated that N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are ingested with other substances. This is likely to either heighten the effects or ameliorate the come-down effects of the synthetic cathinones. Co-ingestions can be from the ingestion of multiple products separately or a single product that is composed of multiple substances ( e.g., one tablet containing N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, 4-chloro-α-PVP and other illicit substances). Indeed, law enforcement routinely encounters synthetic cathinone mixtures. Substances found in combination with N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-α-PVP are: Other synthetic cathinones ( e.g., MDPV, 4-chloromethcathinone, N -ethylpentylone, α-PVP), common cutting agents ( e.g., caffeine), or other recreational substances ( e.g., methamphetamine, fentanyl, fentanyl analogues, carfentanil, benzodiazepines ( e.g., alprazolam), heroin, cocaine, synthetic cannabinoids, fluoroamphetamine, MDMA). Multiple drug use and potential co-ingestions are confirmed by forensic analysis of seized and purchased synthetic cathinone products.

Since 2009, the popularity of synthetic cathinones and their associated products has continued, as evidenced by law enforcement seizures, public health information, and media reports. As one synthetic cathinone is controlled, another unscheduled synthetic cathinone appears in the recreational drug market. N -Ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are synthetic cathinones that have been identified in the United States' illicit drug market ( see DEA 3-Factor Analysis for a full discussion).

Law enforcement data indicate that N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are being abused in the United States as recreational drugs. While law enforcement data are not direct evidence of abuse, the data can infer that a drug has been diverted and abused. 4 Forensic laboratories have confirmed the presence of these substances in drug exhibits received from state, local, and federal law enforcement agencies. From January 2012 to September 24, 2018, there were 1,131 exhibits reported to NFLIS databases (federal, state, and local forensic laboratories) pertaining to the trafficking, distribution and abuse of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP. These exhibits had a net weight of approximately 18.7 kilograms. These data also indicated that the abuse of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP is widespread and has been encountered in many states since 2012 in the United States.

The following information details data obtained from the NFLIS database (queried on September 24, 2018), including dates of first encounter, exhibits/reports, and locations.

N-ethylhexedrone: NFLIS—233 reports, first encountered in August 2016, locations include: Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wyoming.

α-PHP: NFLIS—395 reports, first encountered in May 2014, locations include: Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, and Wyoming.

4-MEAP: NFLIS—105 reports, first encountered in August 2013, locations include: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, and Texas.

MPHP: NFLIS—71 reports, first encountered in June 2012, locations include: California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Maine, Minnesota, Missouri, Nebraska, Nevada, New Jersey, Ohio, Pennsylvania, and Texas.

PV8: NFLIS—166 reports, first encountered in December 2013, locations include: Arizona, Connecticut, District of Columbia, Florida, Georgia, Idaho, Indiana, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and Wisconsin.

4-Chloro-α-PVP: NFLIS—160 reports, first encountered in December 2015, locations include: California, District of Columbia, Louisiana, Maryland, Arizona, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington.

Additionally, encounters/seizures of these substances have occurred by the CBP at United States ports of entry. As observed by the DEA and CBP, synthetic cathinones originate from foreign sources, such as China. Bulk powder substances are smuggled via common carrier into the United States and find their way to clandestine designer drug product manufacturing operations located in residential neighborhoods, garages, warehouses, and other similar destinations throughout the country. From 2014 to 2017, CBP encountered 73 shipments of products containing N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, or 4-chloro-α-PVP. Additional evidence indicates that some of these synthetic cathinones have been seized abroad. N -Ethylhexedrone and 4-chloro-α-PVP have been identified in seized materials in China and Poland, respectively. These data demonstrate that these substances are being trafficked and abused in the United States and abroad.

Concerns over the abuse of synthetic cathinone substances have led to the control of many synthetic cathinones. The DEA controlled 13 synthetic cathinones: methylone, mephedrone, MDPV, 4-methyl- N -ethylcathinone (4-MEC), 4-methyl- alpha -pyrrolidinopropiophenone (4-MePPP), alpha -pyrrolidinopentiophenone (α-PVP), butylone (1-(1,3-benzodioxol-5- yl)-2-(methylamino)butan-1-one), pentedrone (2-(methylamino)-1-phenylpentan-1-one), pentylone, 4-fluoro- N -methylcathinone (4-FMC), 3-fluoro- N -methylcathinone (3-FMC), naphyrone (1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one), and alpha -pyrrolidinobutiophenone (α-PBP) from 2011 to 2014 (October 21, 2011; 76 FR 65371 and March 7, 2014; 79 FR 12938). Recently, the DEA controlled another synthetic cathinone, N -ethylpentylone (August, 31, 2018; 83 FR 44474), as a schedule I substance.

Available evidence on the overall public health risks associated with the use of synthetic cathinones suggests that N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP can cause acute health problems leading to emergency department (ED) admissions, violent behaviors causing harm to self or others, or death. Acute adverse effects of synthetic cathinone substances are those typical of sympathomimetic agents ( e.g., cocaine, methamphetamine, amphetamine) and include among other effects tachycardia, headache, palpitations, agitation, anxiety, mydriasis, tremor, fever or sweating, and hypertension. Other effects, with possible public health risk implications, that have been reported from the use of synthetic cathinone substances include psychological effects such as psychosis, paranoia, hallucinations, and agitation.

α-PHP, 4-MEAP, MPHP, and PV8 have been associated with the overdoses or deaths of individuals. There have been documented reports of ED admissions or deaths associated with the abuse of α-PHP, 4-MEAP, MPHP, and PV8. Individuals under the influence of 4-MEAP and MPHP have acted violently or unpredictably causing harm, or even death, to themselves or others. Adverse effects associated with α-PHP, 4-MEAP, MPHP, and PV8 abuse included vomiting, agitation, paranoia, hypertension, unconsciousness, tachycardia, seizures, cardiac arrest, rhabdomyolysis, or death. No overdose information is currently available for N -ethylhexedrone and 4-chloro-α-PVP, but the pharmacological similarity of these substances to other currently controlled schedule I synthetic cathinones ( e.g., methcathinone, mephedrone, methylone, pentylone, MDPV) suggests that these substances can also pose an imminent hazard to public safety.

It remains highly likely that additional cases of adverse health effects involving α-PHP, 4-MEAP, MPHP, and PV8 in the United States may have occurred and will continue to be under-reported as these substances, as well as N -ethylhexedrone and 4-chloro-α-PVP, are not part of standard panels for biological specimens. The pharmacological data for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP alone or combined with documented case reports, if any, demonstrate that the potential for fatal and non-fatal overdoses exists for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP; thus, these substances pose an imminent hazard to the public health and safety.

As found with other synthetic cathinone substances, products containing synthetic cathinones often do not bear labeling information regarding the ingredients or the health risks and potential hazards associated with these products. The limited knowledge about product content and its purity, as well as lack of information about its effects, pose additional risks for significant adverse health effects to the users.

Based on pharmacological data or documented case reports of overdose fatalities, the misuse and abuse of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP leads to the same qualitative public health risks as schedule I and II substances such as cathinone, methcathinone, mephedrone, methylone, pentylone, MDPV, methamphetamine, cocaine, and MDMA. α-PHP, MPHP, and PV8 have been associated with fatalities. As the data demonstrates, the potential for fatal and non-fatal overdoses exists for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP; thus, N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP pose an imminent hazard to the public safety.

N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP are being encountered on the illicit drug market in the United States and have no accepted medical use in the United States. Regardless, these products continue to be easily available and abused by diverse populations.

In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and/or abuse of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP, resulting from the lack of control of these substances, pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP indicate that these synthetic cathinones have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Acting Administrator, through a letter dated March 9, 2018, notified the Acting Assistant Secretary of the DEA's intention to temporarily place N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I.

This notice of intent provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h), of the DEA's intent to issue a temporary scheduling order. In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Acting Administrator considered available data and information, herein set forth the grounds for his determination to temporarily schedule N -ethylhexedrone; alpha-pyrrolidinohexanophenone (trivial name: α-PHP); 4-methyl-alpha-ethylaminopentiophenone (trivial name: 4-MEAP); 4′-methyl-alpha-pyrrolidinohexiophenone (trivial name: MPHP); alpha-pyrrolidinoheptaphenone (trivial name: PV8); and 4-chloro-alpha-pyrrolidinovalerophenone (trivial name: 4-chloro-α-PVP) in schedule I of the CSA, and finds that placement of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I of the CSA on a temporary basis is necessary to avoid an imminent hazard to the public safety.

The temporary placement of N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I of the CSA will take effect pursuant to a temporary scheduling order, which will not be issued before May 31, 2019. Because the Acting Administrator hereby finds that it is necessary to temporarily place N - ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP in schedule I to avoid an imminent hazard to the public safety, the temporary order scheduling these substances will be effective on the date that the order is published in the Federal Register and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). It is the intention of the Acting Administrator to issue a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this notice. Upon publication of the temporary order, N -ethylhexedrone, α-PHP, 4-MEAP, MPHP, PV8, and 4-chloro-α-PVP will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession of a schedule I controlled substance.

The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary of HHS. 21 U.S.C. 811(h)(1).

Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order (as distinct from a rule) and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, which are applicable to rulemaking, do not apply to this notice of intent. The APA expressly differentiates between an order and a rule, as it defines an “order” to mean a “final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making.” 5 U.S.C. 551(6) (emphasis added). The specific language chosen by Congress indicates an intention for the DEA to proceed through the issuance of an order instead of proceeding by rulemaking. Given that Congress specifically requires the Attorney General to follow rulemaking procedures for other kinds of scheduling actions, see section 201(a) of the CSA, 21 U.S.C. 811(a), it is noteworthy that, in section 201(h), Congress authorized the issuance of temporary scheduling actions by order rather than by rule.

In the alternative, even assuming that this notice of intent might be subject to section 553 of the APA, the Acting Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.

Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Acting Administrator took into consideration comments submitted by the Assistant Secretary in response to the notice that DEA transmitted to the Assistant Secretary pursuant to section 811(h)(4).

Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.

Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget.

This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism), it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

For the reasons set out above, the DEA proposes to amend 21 CFR part 1308 as follows:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Illinois program effective June 1, 1982. You can find background information on the Illinois program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Illinois program in the June 1, 1982, Federal Register (47 FR 23858). You can also find later actions concerning the Illinois program and program amendments at 30 CFR 913.10, 913.15, and 913.17.

By letter dated December 5, 2018 (Administrative Record No. IL-5100), Illinois sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq. ) at its own initiative. By email dated December 11, 2018, Illinois requested that OSMRE's review be put on hold until they could resubmit the proposed amendment due to editorial changes requested by the Illinois Joint Committee on Administrative Rules. Illinois resubmitted the proposed amendment to OSMRE on February 20, 2019. OSMRE will use this date for its review. Below is a summary of the changes proposed by Illinois. The full text of the program amendment is available for you to read at the locations listed above under ADDRESSES .

Illinois proposes to revise the Illinois Surface Coal Mining Land Conservation and Reclamation Act (225 ILCS 720), Section 1.06, “Scope of the Act,” by adding language allowing coal extraction as an incidental part of a government-financed project. The language added is nearly identical to that found in Section 528 of SMCRA (30 U.S.C. 1278).

Illinois also proposes to revise the following Parts of Title 62 of the Illinois Administrative Code:

Illinois proposes to revise its regulation at section 1701 Appendix A, amending a number of its definitions, including those for “ownership,” “control,” and “violations,” to conform with the Federal definitions at 30 CFR 701.5 and 707.5.

Illinois proposes adding a new section 1703 to allow the extraction of coal as an incidental part of a government-financed construction project, which incorporates language identical to the Federal regulations at 30 CFR part 707.

Illinois proposes to amend section 1773.15, “Review of Permit Applications” to comport with changes made to the Federal regulations at 30 CFR 773.12. These changes preclude the Department from considering violations upstream of the permit applicant by removing “person who owns or controls the applicant” from this section.

Illinois also proposes to amend section 1773.25, “Standards for Challenging Ownership or Control Links and the Status Violations,” to update a subsection reference.

Illinois proposes to amend section 1774.13, “Permit Revisions,” to provide further clarification as to which reclamation plan land use changes require a significant revision for a permit application. Illinois proposes to remove the requirement for a significant revision for land use changes involving greater than five percent of the total permit acreage after finding the five percent limitation to be unduly restrictive and burdensome. Instead, the Department will consider changes in the reclamation plan for post-mining land use in determining whether a significant revision to the permit must be obtained. These changes are proposed in order to make the Illinois rules as effective as the Federal regulations at 30 CFR 774.13.

Illinois proposes adding a new section 1778.9, “Certifying and Updating Existing Permit Application Information,” which incorporates language identical to the Federal regulations at 30 CFR 778.9.

Illinois proposes to amend section 1778.13, “Identification of Interests,” to comport with changes made to the Federal regulations at 30 CFR 778.11 and 778.12.

Illinois proposes to amend section 1778.14, “Violation Information,” to comport with changes made to the Federal regulations at 30 CFR 778.14.

Illinois proposes to amend section 1778.15, “Right of Entry Information,” to add language found in the Federal regulations at 30 CFR 778.13 related to property interest information to the existing right of entry language in this section, which corresponds to 30 CFR 778.15, so that all property related rules are located in one section.

Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether the amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the State program.

If you submit written comments, they should be specific, confined to issues pertinent to the proposed regulations, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence decisions on the final program will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.

We cannot ensure that comments received after the close of the comment period (see DATES ) or sent to an address other than those listed (see ADDRESSES ) will be included in the docket for this rulemaking and considered.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., CST on May 16, 2019. If you are disabled and need reasonable accommodations to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT . We will arrange the location and time of the hearing with those persons requesting the hearing. If no one requests an opportunity to speak, we will not hold a hearing.

To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak and others present in the audience who wish to speak, have been heard.

If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under FOR FURTHER INFORMATION CONTACT . All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES . We will make a written summary of each meeting a part of the administrative record.

Pursuant to Office of Management and Budget (OMB) Guidance and dated October 12, 1993, the approval of state program amendments is exempted from OMB review under Executive Order 12866.

When a State submits a program amendment to OSMRE for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the Federal Register indicating receipt of the proposed amendment, its text or a summary of its terms, and an opportunity for public comment. We conclude our review of the proposed amendment after the close of the public comment period and determine whether the amendment should be approved, approved in part, or not approved. At that time, we will also make the determinations and certifications required by the various laws and executive orders governing the rulemaking process and include them in the final rule.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Kentucky program effective May 18, 1982. You can find additional background information on the Kentucky program, including the Secretary's findings, the disposition of comments, and conditions of approval in the May 18, 1982, Federal Register , (47 FR 21434). You can also find later actions concerning Kentucky's program and program amendments at 30 CFR 917.11, 917.12, 917.13, 917.15, 917.16, and 917.17.

By letter dated February 6, 2018, Kentucky sent OSMRE an amendment to its program under SMCRA (30 U.S.C. 1201 et seq. ), that includes changes to statutory provisions of the Kentucky Revised Statutes (KRS) and changes to its Kentucky Administrative Regulations (KAR) (Administrative Record No. KY-259-49). On March 20, 2018, and July 26, 2018, Kentucky sent OSMRE clarifying information in the form of marked-up regulations that identify the additions and deletions that were made to the existing regulatory provisions (Administrative Record Nos. KY-259-1 through 48 and KY-259-50).

The General Assembly of the Commonwealth of Kentucky enacted statutory changes through House bill 234 on March 27, 2017, and the changes became effective on June 29, 2017. The statutory changes involved removing Kentucky's requirement to permit the area overlying underground mine works or “shadow area.” The changes are codified at Chapter 350, Surface Coal Mining, sections 350.055 and 350.060 of the Kentucky Revised Statutes (KRS). Due to the requirements of the bill, the Kentucky Department for Natural Resources was required to promulgate administrative regulations to define necessary terms and provide information on how underground permitting would be addressed moving forward. The administrative regulations were promulgated to incorporate these new requirements at Title 405 KAR, Energy and Environment Cabinet, Department for Natural Resources . On January 1, 2018, the Kentucky Legislative Research Commission approved the revisions to the administrative regulations, which address the revised statutory requirements mentioned above as well as revisions that address preliminary applications and forms. The revised statutory provisions of 350 KRS and new and revised administrative regulations of 405 KAR are described below:

A. Statutory Revisions—Changes at KRS 350, Surface Coal Mining .

1. KRS 350.055, Publication of Notice of Intention to Mine by Permit Applicant, Notification of Various Local Government Bodies by Cabinet . Kentucky seeks to revise its statutory provision at KRS 350, section 1(3)(b), by requiring that a public notice of the filing of an application include, but not be limited to, the location, ownership, and boundaries of the permitted area, rather than the boundaries of the mining site, as previously provided.

2. KRS 350.060, Permit Requirement, Contents of Application, Fee, Bond, Administrative Regulations, Successive Renewal, Auger Mining of Previously Mined Area, Exempt Operations. Kentucky seeks to revise its statutory provision at KRS 350.060, section (12), by removing the requirement that all the areas overlying underground workings be permitted.

B. Regulatory Revisions—Changes at KAR 405, Energy and Environment Cabinet, Department for Natural Resources. Kentucky seeks to revise its administrative regulatory provisions that address the statutory changes noted above by revising the definition of “permit area”; adding the definition of “shadow area”; revising other sections affected by the permit area definition change; and addressing underground mining requirements that relate to permit revisions, right of entry, application requirements, criteria for approval, bonding requirements, active acre/acreage fees, cost recovery, permanent abandonment of operations, and temporary cessation of operations. Kentucky seeks to revise other administrative regulations not affected by the statutory provisions. These revisions involve preliminary permit applications and updates to standard forms. The following sections of 405 KAR are revised:

1. 7:001, Definitions for 405 KAR Chapter 7. Kentucky seeks to revise its administrative regulations at 7:001, Definitions for 405 KAR Chapter 7, General Provisions, by revising the definition of permit area and adding the definition of shadow area as follows:

a. Definition of Permit Area: The definition of “ permit area ” at Section 1.(61) is being changed from:

b. Definition of Shadow Area: The definition of “ shadow area” is added to the list of definitions at subsection (74). A shadow area is defined as the surface area overlying underground mine works and surface areas associated with auger and in situ mining.

2. Other Regulations that Include the Definitions of Permit Area and Shadow Area: Kentucky seeks to revise the following administrative regulations at 405 KAR that include the revised definition of permit area and/or the new definition of shadow area as defined by 405 KAR 7:001:

○ 8:001, Definitions for 405 KAR Chapter 8, (Permits). Section 1, Definitions, subsection (82) for permit area and subsection (109) for shadow area;

○ 10:001, Definitions for 405 KAR Chapter 10, (Bond and Insurance Requirements). Section 1, Definitions, subsection (37) for permit area;

○ 12:001, Definitions for 405 KAR Chapter 12, (Inspection and Enforcement) Section 1, Definitions, subsection (20) for permit area; and

○ 16:001, Definitions for 405 KAR Chapter 16, (Performance Standards for Surface Mining Activities), Section 1, Definitions, subsection (77) for permit area and (99) for shadow area.

○ 18:001, Definitions for 405 KAR Chapter 18, (Performance Standards for Underground Mining Activities), Section 1, Definitions, subsection (80) for permit area and (101) for shadow area,

○ 20:001, Definitions for 405 KAR Chapter 20, (Special Performance Standards), Section 1, Definitions, subsection (52) for permit area and (66) for shadow area.

3. Revised Regulations that Involve the Permit Area and Shadow Area: Kentucky seeks to revise the following administrative regulation sections at 405 KAR that apply to the permit area as well as the shadow area by adding shadow area to many provisions that previously only mentioned the permit area, since the shadow area is no longer included within the definition of permit area.

○ 7:001, Definitions for 405 KAR Chapter 7 (General Provisions);

○ 7:095, Assessment of civil penalties ;

○ 8:001, Definitions for 405 KAR Chapter 8 (Permits, underground coal mining permits, and permits for special categories of mining;

○ 8:010, General provisions for permits ;

○ 8:040, Underground coal mining permits ;

○ 16:001, Definitions for 405 KAR Chapter 16 (Performance Standards for Surface Mining Activities);

○ 16:110, Surface and groundwater monitoring ;

○ 18:010, General provisions (Chapter 18: Performance Standards for Underground Mining Activities (definitions, general provisions, casing and sealing of underground openings, general hydrologic requirements, and surface and groundwater monitoring);

○ 18:040, Casing and sealing of underground openings ;

○ 18:060, General hydrologic requirements ;

○ 18:110, Surface and groundwater monitoring ;

○ 18:260, Other facilities ; and

○ 20:080, In situ processing

The revised regulations at the sections noted above add the word shadow area within many subsections of the regulations. They involve subject areas, including, but not limited to: Other definitions, permit applications, maps and drawings, protection of the hydrologic balance; prohibited mining areas; general requirements for baseline geologic and hydrologic information, surface and groundwater monitoring, fish and wildlife information, land use information, the mine reclamation plan, and utility installations.

4. Underground Mining Regulations. Kentucky seeks to revise or add the following provisions that pertain to underground mining operations.

a. 8:010, General provisions for permits. Kentucky seeks to revise Section 2, General Requirements, subsection (2)(a) by adding that the provisions of this section also apply to underground only operations, in addition to surface coal mining and reclamation operations. Kentucky seeks to revise Section 20, Permit Revisions, by adding subsection (3)(g), which requires that extensions of the underground mining area that are not incidental boundary revisions and do not include planned subsidence or other new proposed disturbances shall be considered minor permit revisions.

b. 8:040, Underground coal mining permits. Kentucky seeks to revise Section 4, Right of Entry and Right to Mine, subsection (3) to add that nothing in the regulation shall be construed to authorize the cabinet to require right of entry for shadow areas. Kentucky seeks to revise Section 25, MRP; Existing Structures, subsection (1)(d) by deleting a part of the regulation. The regulation requires the application include a description of each existing structure proposed to be used in connection with or to facilitate the surface coal mining and reclamation operation. Part of the description includes a showing, including relevant monitoring data or other evidence, of whether the structure meets the performance standards of 405 KAR Chapters 16 through 20. It also requires that if the structure does not meet those performance standards, the application should provide a showing of whether the structure meets the interim performance standards of 405 KAR Chapter 3. With this change, Kentucky is removing the requirement to provide a showing of whether the structure meets the interim performance standards.

c. 8:050, Permits for special categories of mining. This regulation establishes permit requirements for special categories, which include mining on prime farmland, augering, in situ processes, off-site coal preparation plants, mountaintop removal mining, and mining on steep slopes. Kentucky seeks to add Section 9, Underground Only Permits, to this regulation. The regulation applies to an underground only operation that does not have a surface disturbance and includes provisions that involve application requirements, criteria for approval, and bonding requirements.

d. 10:001, Definitions for 405 KAR Chapter 10. This regulation defines certain essential terms used in Chapter 10, Bond and Insurance Requirements. Kentucky seeks to revise Section 1, Definitions, subsection (d) by deleting the statement that an active area does not include the acreage of a permit that is permitted and bonded for underground acreage only.

e. 20:090, Underground only permits. Kentucky seeks to add this new regulation to its program. This chapter sets forth certain performance standards for underground only permits. It provisions address cost recovery, permanent abandonment of operations, and temporary cessation of operations.

5. Other Regulatory Changes.

a. Section 8:010, General Provisions. Kentucky seeks to revise Section 4, Preliminary Requirements, subsections (1) and (2), by revising the regulations to no longer require a preliminary application for a permit, but provide the option to submit a preliminary application. Section 5, General Format and Content of Applications, subsection (c) of this section is revised to remove the Preliminary Application form from the list of forms required to be submitted with a permit application. Section 26, Incorporation by Reference, Subsections (a), (d), and (k) of this section are revised to reflect 2017 updates to the following documents: Preliminary Application; Technical Information for a Mining Permit; and Application for Renewal of a Mining Permit. In addition, the following form is added: Application for a Coal Marketing Deferment, dated August 2017.

Minor changes such as edits, renumbered paragraphs, and changes in reference citations are also included.

The full text of the program amendment is available for you to read at the locations listed above under ADDRESSES or at www.regulations.gov .

Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether the amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of Kentucky's State program.

If you submit written or electronic comments on the proposed rule during the 30-day comment period, they should be specific, confined to issues pertinent to the proposed regulations, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence decisions on the final regulations will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.

We cannot ensure that comments received after the close of the comment period (see DATES ) or sent to an address other than those listed (see ADDRESSES ) will be included in the docket for this.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., e.s.t. on May 16, 2019. If you are disabled and need reasonable accommodations to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT . We will arrange the location and time of the hearing with those persons requesting the hearing. If no one requests an opportunity to speak, we will not hold a hearing.

To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak, and others present in the audience who wish to speak, have been heard.

If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under FOR FURTHER INFORMATION CONTACT . All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES . We will make a written summary of each meeting a part of the administrative record.

Pursuant to Office of Management and Budget (OMB) Guidance dated October 12, 1993, the approval of State program amendments is exempted from OMB review under Executive Order 12866.

When a State submits a program amendment to OSMRE for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the Federal Register indicating receipt of the proposed amendment, its text or a summary of its terms, and an opportunity for public comment. We will conclude our review of the proposed amendment after the close of the public comment period and determine whether the amendment should be approved, approved in part, or not approved. At that time, we will also make the determinations and certifications required by the various laws and executive orders governing the rulemaking process and include them in the final rule.

I. Background on the Missouri Program II. Description of the Proposed Amendment III. Public Comment Procedures IV. Procedural Determinations I. Background on the Missouri Program

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Missouri program effective November 21, 1980. You can find background information on the Missouri program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Missouri program in the November 21, 1980, Federal Register (47 FR 77027). You can also find later actions concerning the Missouri program and program amendments at 30 CFR 925.10, 925.12, 925.15, and 925.16.

By letter dated February 8, 2019 (Administrative Record No. MO-684), Missouri sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq. ) at its own initiative. Below is a summary of the changes proposed by Missouri. The full text of the program amendment is available for you to read at the locations listed above under ADDRESSES .

Missouri proposes to amend the following sections of the Missouri Coal Mining Regulations to incorporate by reference to corresponding Federal regulations:

Missouri proposes to rescind the following sections of the Missouri Coal Mining Regulations as they have been incorporated in the aforementioned proposed amended sections:

Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether the amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the State program.

If you submit written comments, they should be specific, confined to issues pertinent to the proposed regulations, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence decisions on the final program will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.

We cannot ensure that comments received after the close of the comment period (see DATES ) or sent to an address other than those listed (see ADDRESSES ) will be included in the docket for this rulemaking and considered.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., CST on May 16, 2019. If you are disabled and need reasonable accommodations to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT . We will arrange the location and time of the hearing with those persons requesting the hearing. If no one requests an opportunity to speak, we will not hold a hearing.

To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak and others present in the audience who wish to speak, have been heard.

If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under FOR FURTHER INFORMATION CONTACT . All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES . We will make a written summary of each meeting a part of the administrative record.

Pursuant to Office of Management and Budget (OMB) Guidance and dated October 12, 1993, the approval of State program amendments is exempted from OMB review under Executive Order 12866.

When a State submits a program amendment to OSMRE for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the Federal Register indicating receipt of the proposed amendment, its text or a summary of its terms, and an opportunity for public comment. We conclude our review of the proposed amendment after the close of the public comment period and determine whether the amendment should be approved, approved in part, or not approved. At that time, we will also make the determinations and certifications required by the various laws and executive orders governing the rulemaking process and include them in the final rule.

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Pennsylvania program effective July 31, 1982. You can find additional background information on the Pennsylvania program, including the Secretary's findings, the disposition of comments, and conditions of approval in the July 30, 1982, Federal Register , (47 FR 33050). You can also find later actions concerning Pennsylvania's program and program amendments at 30 CFR 938.11, 938.12, 938.13, 938.15, and 938.16.

By letter dated August 9, 2018, Pennsylvania sent us rationale it believes supports its request that a program amendment OSMRE required on November 7, 1997, at 30 CFR 938.16(rrr), which involves hydrologic balance protections and siltation structures, be removed (Administrative Record No. PA 903.00). See 62 FR 60172. The Federal regulations at 30 CFR parts 816 and 817 (Permanent Program Performance Standards for surface mining and underground mining respectively) include requirements for protection of the hydrologic balance within the permit and adjacent areas and to prevent material damage to the hydrologic balance outside the permit area during mining and reclamation activities. The standards address ground-water quality and surface water protections and include the requirement that additional contributions of suspended solids sediment to streamflow or runoff outside the permit area be prevented to the extent possible. One of the mechanisms used to address this requirement is the construction of siltation structures, which include sedimentation ponds. These ponds are designed, constructed and maintained to provide adequate sediment storage volume and adequate detention time to allow the effluent from the ponds to meet State and Federal effluent limitations.

In 1996, through a program amendment request, Pennsylvania proposed requiring that sedimentation ponds be maintained until the disturbed area is stabilized and revegetated and removal is approved by the Department of Environmental Protection (herein referred to as the “Department”). The regulation also added that ponds may not be removed sooner than two years after the last augmented seeding, unless the Department finds that the disturbed area has been sufficiently revegetated and stabilized. The regulations at 30 CFR 816.46(b)(5), Hydrologic balance: Siltation structures, general requirements (applicable to surface mining) and 817.46(b)(5), (applicable to underground mining), specifically prohibit the removal of siltation structures ( e.g., sedimentation ponds) sooner than two years after the last augmented seeding. Therefore OSMRE imposed a requirement at 938.16(rrr) that Pennsylvania submit a program amendment to 25 Pennsylvania Code (Pa Code) subsections 87.108(c), Hydrologic balance: sedimentation ponds (applicable to surface coal mining), 89.24(c), Performance Standards: Sedimentation ponds (applicable to underground coal mining), and 90.108(c), Hydrologic balance: sedimentation ponds (applicable to coal refuse disposal sites), or otherwise amend its program to require, without exception, that sedimentation ponds not be removed sooner than two years after the last augmented seeding.

Pennsylvania states that it included language requiring the two-year limitation in 1995 when it submitted the regulation to the Pennsylvania Environmental Quality Board (EQB) for review and approval, but the EQB revised the proposed regulation and added an exception to allow removal of the siltation structures sooner than the two-year time frame. The EQB provided an exception to the two-year limitation and allowed removal when the Department determines that the reclaimed area has been sufficiently revegetated and stabilized. Pennsylvania states the basis for the EQB allowing a lesser period of time was that a properly managed site will normally be revegetated and stabilized within one year and as few as eight months when ideal conditions exist.

With this request, Pennsylvania provides rationale it contends supports its position that the required amendment be removed. Pennsylvania presents the following four reasons why the required amendment should be removed.

1. The Federal regulations and Pennsylvania regulations require the approval by the regulatory authority before siltation structures can be removed. Pennsylvania reasons that its regulations at §§ 87.108(c), 89.24(c), and 90.108(c) require the regulatory authority to approve the removal of the ponds as required by Federal regulation.

2. Pennsylvania's approved program requires the use of the Best Technology Currently Available (BTCA) to prevent erosion and sedimentation and that vegetation can serve as BTCA. Pennsylvania refers to the Federal regulation at § 816.46(b)(1), which requires additional contributions of suspended sediment to streamflow or runoff outside the permit area be prevented to the extent possible using the BTCA. Pennsylvania points out that the Federal requirement at 816.46(b)(2) that existed in 1986 required all surface drainage from the disturbed area be passed through a siltation structure before leaving the permit area, but the regulation was suspended on December 22, 1986, due to a 1985 court order. See the November 20, 1986, Federal Register (51 FR 41952, 51957). The regulation was suspended due to litigation that resulted in the determination that the preamble to the regulations failed to provide a sufficient rationale for requiring siltation structures in every instance. In re Permanent Surface Mining Reclamation Litigation, 620 F. Supp. 1519, 1568 (1985). Pennsylvania states the result of the suspension is that the regulation at 816.46(b)(1) is now the governing regulation. Pennsylvania asserts the regulation only requires the use of BTCA, when possible, and that vegetation serves as the BTCA where successful vegetation has served to meet the sedimentation control requirements. The vegetation is intended to assure drainage meets effluent limits and does not contribute suspended solids to the streamflow.

Regarding surface mines and coal refuse disposal facilities, Pennsylvania states its approved program at §§ 87.108(i) and 90.108(j), respectively, requires the implementation of BTCA upon reclamation of the sedimentation ponds, which is consistent with § 816.46(b)(1). Pennsylvania points to the regulations at these sections, which provide when a sedimentation pond is to be removed, the affected land shall be regraded and revegetated in accordance with §§ 87.147 and 90.151, Revegetation: general requirements, (applicable to surface mining and coal refuse disposal sites respectively). Pennsylvania specifically references subsections (c) and (d) of §§ 87.147 and 90.151, which require that revegetation provide a quick germinating, fast-growing, vegetative cover capable of stabilizing the soil surface from erosion; be completed in compliance with the reclamation plan as approved by Pennsylvania in the permit; and be carried out in a manner that encourages a prompt vegetative cover and recovery of productivity levels compatible with the approved postmining land use.

Regarding underground mining, Pennsylvania refers to the general revegetation requirements in § 89.86, Performance Standards: Revegetation which provide for implementation of BTCA for the reclamation of stormwater controls. It notes that this section is applicable to all reclamation, including the reclamation of stormwater controls. Pennsylvania also notes the specific requirements in subsections (c) and (d), which address seeding, planting, mulching, and other soil stabilizing practices.

Pennsylvania asserts at least two states (Ohio and Montana) have amended their programs and received OSMRE approval to allow removal of sedimentation ponds sooner than two years after last augmented seeding if replaced by BTCA and, in these cases, the BTCA includes sediment control measures, in the form of vegetation. See the November 15, 1994, Federal Register (59 FR 58778) and the May 11, 1990, Federal Register (55 FR 19727), respectively.

3. Based on Pennsylvania's experience, revegetation is often established in less than two years. Further, Pennsylvania adds that because siltation structures pose reclamation liability, and in some cases a potential public safety hazard, they should be removed as soon as they are no longer necessary, which is often less than two years.

4. There is no statutory prohibition to Pennsylvania's approach.

In conclusion, Pennsylvania asserts that its program is no less effective than the Federal program for all the reasons mentioned above and requests the required amendment be removed.

The full text of the justification to remove the required amendment is available for you to read at the locations listed above under ADDRESSES or at www.regulations.gov.

Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether the justification is sufficient to remove the required amendment at 30 CFR 938.16(rrr). If we approve the request, we will remove the provision at 938.16(rrr).

If you submit written or electronic comments on the request during the 30-day comment period, they should be specific, confined to issues pertinent to the request, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence our decision will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.

We cannot ensure that comments received after the close of the comment period (see DATES ) or sent to an address other than those listed (see ADDRESSES ) will be included in the docket for this rulemaking and considered.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

If you wish to speak at the public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT by 4:00 p.m., e.s.t. on May 16, 2019. If you are disabled and need reasonable accommodations to attend a public hearing, contact the person listed under FOR FURTHER INFORMATION CONTACT . We will arrange the location and time of the hearing with those persons requesting the hearing. If no one requests an opportunity to speak, we will not hold a hearing.

To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak, and others present in the audience who wish to speak, have been heard.

If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under FOR FURTHER INFORMATION CONTACT . All such meetings are open to the public and, if possible, we will post notices of meetings at the locations listed under ADDRESSES . We will make a written summary of each meeting a part of the administrative record.

Pursuant to Office of Management and Budget (OMB) Guidance dated October 12, 1993, the approval of State program amendments is exempted from OMB review under Executive Order 12866.

When a State submits a program amendment to OSMRE for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the Federal Register indicating receipt of the proposed amendment, its text or a summary of its terms, and an opportunity for public comment. We will conclude our review of the request for removal of the required amendment after the close of the public comment period and determine whether the amendment should be removed.

The Defense Health Agency (DHA), the agency of the Department of Defense responsible for administration of the TRICARE Program, has as its primary mission the support and delivery of an integrated, affordable, and high quality health service to all DoD beneficiaries and in doing so, is a responsible steward of taxpayer dollars. In recent years, fraud and abuse has been inhibiting DHA's mission. One example involves compound drugs. In fiscal year 2004, DoD paid about $5 million for compound drugs. Ten years later in fiscal year 2014, the amount paid had risen over 10,000% exceeding $514 million, and for fiscal year 2015, the cost exceeded $1.3 billion in expenditures just for compound drugs. Significantly, compounded drugs make up only 0.5 percent of the total number of prescriptions provided through TRICARE, but in 2015 accounted for more than 20 percent of TRICARE's total pharmacy expenditures. The astronomical increase in expenditures related to compound drugs was almost solely due to fraud and abuse, resulting in many investigations and prosecutions by the Department of Justice (DOJ). However, because DOJ is responsible for the prosecution of all fraud and abuse in all Federal healthcare programs, including Medicare, TRICARE, and the Federal Employees Health Benefits Program and does not have unlimited resources, DOJ must prioritize cases and is unable to prosecute a large portion of those entities who commit fraud and abuse in the TRICARE Program. Therefore, the Department of Defense, acting through the DHA, seeks to implement its authority under section 1128A(m) of the Social Security Act (42 U.S.C. 1320a-7a(m)) to initiate administrative proceedings to impose civil monetary penalties against those who commit fraud and abuse in the TRICARE Program. Because CMPs may be imposed in addition to criminal proceedings, we believe that the establishment of a CMP Program within the DoD will serve a complementary function to the criminal justice process and provide additional deterrence to fraudulent actions against the Federal TRICARE Program and the recovery of funds lost to fraud and abuse. The purpose of this proposed rule utilizing CMP authority is to ensure the integrity of TRICARE and make the government whole for funds lost to fraud and abuse, which is necessary to the delivery of an integrated, affordable, and high quality health service for all DoD beneficiaries.

This proposed rule would reduce Defense Health Program requirements by $74 million from FY 2020-FY 2024. The savings estimates were based on recent history of TRICARE fraud and abuse audits and investigations that, for a variety of reasons, did not result in criminal or civil actions by the Department of Justice under other legal authorities. The saving estimates were based on the estimate of 50 cases per year with an average penalty of $600,000 per case and a collection rate of 60%. Additionally, the estimated recovery amount subtracts out appeal costs, full-time equivalent costs, and administrative costs.

The proposed rule along with additional proposed legislation allows the funds collected to be credited to appropriations available for expenses of the affected DoD health care program. Based on the results of the HHS civil money penalty program, the expectation is that funds recovered will more than pay for the activities associated with investigating abuses and administering the civil money penalty program, producing savings for DoD.

Because CMPs may be imposed in addition to criminal proceedings, we believe that the benefit of the establishment of a CMP Program within the DoD will serve a complementary function to the criminal justice process and provide additional deterrence to fraudulent actions against the Federal TRICARE Program and the recovery of funds lost to fraud and abuse. We believe the recovery of funds lost to fraud and abuse will make the government whole and will help ensure the continued delivery of an integrated, affordable, and high quality health service for all DoD beneficiaries.

The specific legal authority authorizing the Department of Defense, to establish a program to impose CMPs in the TRICARE Program is provided in section 1128A(m) of the Social Security Act [42 U.S.C. 1320a-7a(m)]. This provision of law authorizes Federal Departments other than HHS with jurisdiction over a Federal health care program (as defined in section 1128B(f)) of the Social Security Act), to impose CMPs as enumerated in section 1128A of the Social Security Act. Some of the CMPs enumerated in section 1128A of the Social Security Act limit the applicability to conduct only involving Medicare and Medicaid; therefore, this proposed rule would implement all CMP authorities under section 1128A that are not specifically limited to Medicare, Medicaid, or other HHS-exclusive authority.

We propose to establish Civil Monetary Penalties (CMP) regulations at 32 CFR part 200 to implement authority provided to the Department of Defense under section 1128A of the Social Security Act, as amended. The proposed rule closely follows the organization and substance of HHS's CMP regulations. We propose to follow HHS's process and procedure for imposing CMPs, as well as HHS's methodology for calculating the amount of penalties and assessments. Additionally, for ease of interpretation and transparency, we have adopted HHS's numerical structure for this proposed regulation. Accordingly, the numerical provisions of the proposed 32 CFR part 200 directly correspond to HHS's numerical provisions at 42 CFR part 1003. Following this organizational construct and HHS rules and procedures, the proposed rule addresses such matters as: Liability for penalties and assessments, determinations regarding the amount of penalties and assessments, CMPs and assessments for false and fraudulent claims and other similar misconduct, penalties and assessments for unlawful kickbacks, CMPs and assessments for contracting organization misconduct, procedures for the imposition of CMPs and assessments, judicial review, time limitations for CMPs and assessments, statistical sampling, and appeals.

For over 25 years, the HHS Office of Inspector General (OIG) has exercised the authority to impose CMPs, assessments, and exclusions in furtherance of its mission to protect the Federal health care programs and their beneficiaries from fraud and abuse. As those programs have changed over the last two decades, HHS-OIG has received new fraud-fighting CMP authorities in response. Section 231 of HIPAA expanded the reach of CMPs to include federal health programs other than those funded by HHS. In 1977, Congress first mandated the exclusion of physicians and other practitioners convicted of program-related crimes from participation in Medicare and Medicaid through the Medicare-Medicaid Anti-Fraud and Abuse Amendments, Public Law 95-142 (now codified at section 1128 of the Social Security Act (the SSA)). This was followed in 1981 with Congress enacting the Civil Monetary Penalties Law (CMPL), Public Law 97-35, section 1128A of the SSA, 42 U.S.C. 1320a-7a, to further address health care fraud and abuse. The CMPL authorized the Secretary to impose penalties and assessments on a person, as defined in 42 CFR part 1003, who defrauded Medicare or Medicaid or engaged in certain other wrongful conduct. The CMPL also authorized the Secretary of Health and Human Services to exclude persons from Medicare and all State health care programs (including Medicaid). Congress later expanded the CMPL and the scope of exclusion to apply to all Federal health care programs. The Secretary of HHS delegated the CMPL's authorities to HHS-OIG. 53 FR 12993 (April 20, 1988). Since 1981, Congress has created various other CMP authorities covering numerous types of fraud and abuse. These new authorities were also delegated by the Secretary to HHS-OIG and were added to part 1003.

In 1996, Section 231 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) expanded the reach of certain CMPs to include Federal health programs other than HHS, including specific CMPs that may be implemented to prevent fraud and abuse against programs such as TRICARE. The CMPL authorizes the Department or agency head to impose CMPs, assessments, and program exclusions against individuals and entities who submit false or fraudulent, or otherwise improper claims for payment under Federal healthcare programs administered by that Department of agency. HHS has an active, robust process in place to seek CMPs. Additionally, in September 2016, HHS substantially increased the amount of the penalty it may collect for each act of fraud and abuse. The Office of Personnel Management (OPM) also actively seeks civil monetary penalties under the Federal Employees Health Benefits (FEHB) Program. Subsequent to HIPAA, Congress expanded CMP authorities to reach additional conduct, such as: (1) Failure to grant an OIG timely access to records, upon reasonable request; (2) ordering or prescribing while excluded when the excluded person knows or should know that the item or service may be paid for by a Federal health care program; (3) making false statements, omissions, or misrepresentations in an enrollment or similar bid or application to participate in a Federal health care program; (4) failure to report and return an overpayment that is known to the person; and (5) making or using a false record or statement that is material to a false or fraudulent claim. Most recently, in the Bipartisan Budget Act of 2018, Congress doubled the maximum amount of penalties and assessments under section 1128A.

As noted above, section 1128A(m) of the SSA authorizes the applicable Department head to impose civil monetary penalties (CMPs), assessments, and program exclusions against individuals and entities who submit false or fraudulent, or otherwise improper claims for payment. To date, DoD has not implemented its authority under this law, but proposes to now do so. The Defense Health Agency will utilize this authority and create the regulatory framework in this proposed rule to initiate a program to impose civil monetary penalties against those who commit fraud or abuse against the TRICARE program. The DHA will utilize the authority in section 1128A of the SSA to impose civil monetary penalties and assessments, but, unlike the HHS CMP Program, TRICARE will not utilize authority to impose program exclusions as part of its CMP program. Rather, program exclusions in the TRICARE program will remain under TRICARE's established authority and process at 32 CFR 199.9(f). In order to integrate this proposed rule into TRICARE's exclusion process under 32 CFR 199.9(f), we propose to amend 32 CFR 199.9(f)(1)(ii) by adding a sentence at the end of the provision stating: “A final determination of an imposition of a civil monetary penalty under 32 CFR part 200 shall constitute an administrative determination of fraud and abuse.” We believe that this amendment will clarify that a final determination of an imposition of a CMP, implicating conduct under 32 CFR part 200, may subject the respondent of the CMP to exclusion as authorized under 32 CFR 199.9(f)(1)(ii).

Section 1128A(m) of the SSA provides the Secretary of Defense with CMP authority over claims involving the TRICARE Program. This proposed rule reflects a delegation of authority from the Secretary of Defense to the DHA Director to impose CMPs and assessments against any person who has violated one or more provisions of CMPL as applicable to the TRICARE Program. We propose that the authority at 32 CFR 200.150 will include all powers to impose and compromise civil monetary penalties and assessments under section 1128A of the Social Security Act.

We propose that the following prohibited acts under section 1128A(a) [42 U.S.C. 1320a-7a(a)] be subject to the imposition of civil monetary penalties in the TRICARE Program. These prohibitions include (but are not limited to) any person (including an organization, agency, or other entity, but excluding a beneficiary, as defined in subsection (i)(5) of this section) that—

• knowingly presents or causes to be presented to an officer, employee, or agent of the United States, or of any department or agency thereof, or of any State agency a claim that—

○ Is for a medical or other item or service that the person knows or should know was not provided as claimed, including any person who engages in a pattern or practice of presenting or causing to be presented a claim for an item or service that is based on a code that the person knows or should know will result in a greater payment to the person than the code the person knows or should know is applicable to the item or service actually provided [1320a-7a(a) (1)(A)];

○ Is for a medical or other item or service and the person knows or should know the claim is false or fraudulent [1320a-7a(a)(1)(B)];

○ Is presented for a physician service by a person who knows or should know that the individual who furnished the service—(i) was not licensed as a physician, (ii) was licensed as a physician, but such license had been obtained through a misrepresentation of material fact (including cheating on an examination required for licensing), or (iii) represented to the patient at the time the service was furnished that the physician was certified in a medical specialty by a medical specialty board when the individual was not so certified [1320a-7a(a)(1)(C)];

○ Is for a medical or other item or service furnished during a period in which the person was excluded from the TRICARE program under 32 CFR 199.9(f) or other Federal health care program (as defined in section 1128B(f) of the Social Security Act) under which the claim was made pursuant to Federal law [1320a-7a(a)(1)(D)];

○ Is for a pattern of medical or other items or services that the person knows or should know are not medically necessary [1320a-7a(a)(1)(E)].

• arranges or contracts (by employment or otherwise) with an individual or entity that the person knows or should know is excluded from participation in a Federal health care program (as defined in section 1320a-7b(f) of this title), for the provision of items or services for which payment may be made under such a program; [1320a-7a(a)(6)].

• commits an act described in paragraph (1) or (2) of section 1320a-7b(b) of title 42; [1320a-7a(a)(7)].

• knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim for payment for items and services furnished under a Federal health care program; [1320a-7a(a)(8)].

• fails to grant timely access, upon reasonable request (as defined by the Secretary in regulations), to the Office of Inspector General (OIG), for the purpose of audits, investigations, evaluations, or other statutory functions of the OIG; [1320a-7a(a)(9)].

• orders or prescribes a medical or other item or service during a period in which the person was excluded from a Federal health care program (as so defined), in the case where the person knows or should know that a claim for such medical or other item or service will be made under such a program [1320a-7a(a)(8)]; ( Note: There are two section 1320a-7a(a)(8) provisions enacted into the statute).

• knowingly makes or causes to be made any false statement, omission, or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider of services or a supplier under a Federal health care program (as so defined) [1320a-7a(a)(9)]; ( Note: There are two section 1320a-7a(a)(9) provisions enacted into the statute).

• knows of an overpayment (as defined in paragraph (4) of section 1128J(d) [42 U.S.C. 1320a-7k(d)]) and does not report and return the overpayment in accordance with such section [1320a-7a(a)(10)].

DHA will coordinate with the Department of Justice (DOJ) and Defense Criminal Investigative Organizations (DCIOs) in resolving all CMP matters. Allegations of fraud will be referred promptly for investigation to the appropriate DCIO consistent with the requirements of Department of Defense Instruction 5505.02. In cases where DOJ or the appropriate DCIO does not participate the case will be governed by either DHA's or HHS's CMPL authorities depending on whether the relevant claims are primarily TRICARE Claims or Medicare Claims. In cases involving mixed Medicare and TRICARE Claims, DHA will seek to resolve only those cases which consist of primarily TRICARE claims. Medicare will take the lead role in resolving cases which consist of primarily Medicare claims. Administrators from both HHS and the DHA will coordinate in resolving cases with mixed TRICARE and Medicare claims. If claims implicated by CMPL are primarily TRICARE claims, those claims will be governed by DHA's applicable CMP authorities. In some cases, disclosing parties may request release under the False Claims Act (FCA), and in other cases, DOJ may choose to participate in the disposition of the matters. DOJ determines the approach in cases in which it is involved. If DOJ participates, the matter will be resolved as DOJ determines is appropriate consistent with its resolution of FCA cases.

In order to ensure full compliance with the authority delegated to the Secretary of Defense in section 1128A(m), DoD proposes to impose penalties and assessments in the amount not to exceed the maximum adjusted civil penalty amounts prescribed in 32 CFR part 269. DoD proposes to follow annually updated penalty amounts, as adjusted in accordance with the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-140), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. L. 114-74); and the Bipartisan Budget Act of 2018.

The time period and effect of exclusion will follow TRICARE's established exclusion process at 32 CFR 199.9(f). A person who has been excluded from the TRICARE Program may apply for reinstatement at the end of the period of exclusion. The process for reinstatement will be in accordance with the pertinent provisions of 32 CFR 199.9(h). Unlike HHS's CMP process, whereby HHS imposes penalties, assessments and exclusions, DHA will not exercise authority over exclusions in the TRICARE Program as part of the CMP implementation. Exclusion actions under the TRICARE Program will continue to be governed under the established process at 32 CFR 199.9(f). Appeals of exclusions will be in accordance with the established process at 32 CFR 199.10 and will not be part of the proposed CMP appeals process.

Additionally, as part of this proposed rule we are proposing an amendment to 32 CFR 199.9(f)(1)(ii) that would clarify that a final determination of an imposition of a civil monetary penalty under 32 CFR part 200 would be considered an administrative determination of fraud and abuse. By clarifying that a final determination of an imposition of a civil monetary penalty is an administrative determination of fraud and abuse, it will allow the TRICARE program an additional, appropriate basis for exclusion under the existing exclusion process at § 199.9(f). Therefore, once a final determination has been made to impose a CMP, the claim will be referred for consideration of exclusion pursuant to 32 CFR 199.9(f), under the normal TRICARE process where there has been a determination of fraud and abuse.

Where sufficient evidence supports the imposition of a CMP, the DHA may serve a notice of proposed determination on the respondent, in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure detailing the basis and remedy sought. This proposed rule at 32 CFR 200.1500 mirrors the requirements of 42 CFR 1003.1500, but eliminates the requirement in 42 CFR 1003.1500(a)(7) involving a termination of a Medicare Provider Agreement pursuant to 1866(b)(2)(C) of the SSA, because the provision governing Medicare Provider Agreements is not applicable to the TRICARE Program.

For clarity, to improve transparency in DHA's decision-making processes, and for consistency with HHS's CMP process, we propose to use the very same factors in determining the amount of penalties and assessments for violations as HHS uses codified at 42 CFR 1003.140. As codified in the proposed regulation at 32 CFR 200.140, the primary factors for determining the amount of penalties and assessments for violations that we will consider are: (1) The nature and circumstances of the violation, (2) the degree of culpability of the person, (3) the history of prior offenses, (4) other wrongful conduct, and (5) other matters as justice may require.

In accordance with the authority delegated to the Secretary of Defense, the imposition of CMPs in the TRICARE Program will be subject to a six year statute of limitations.

The proposed regulation at § 200.1580 provides that a statistical sampling study, if based upon an appropriate sampling and computed by valid statistical methods, shall constitute prima facie evidence of the number and amount of claims or requests for payment. The use of statistical sampling will allow DHA to impose penalties and assessments based upon an extrapolated number and amount of claims. Additionally, statistical sampling will allow DHA to recover the extrapolated amount of overpaid funds through administrative recoupment.

Administrative review of the imposition of a civil monetary penalty under the TRICARE Program will be before an Administrative Law Judge (ALJ). We propose entering into an arrangement with the HHS Departmental Appeals Board (DAB), pursuant to an interagency agreement between DoD and HHS for the DAB to hear TRICARE CMP appeals. However, as an alternative, DHA continues to evaluate possibly utilizing ALJ's currently assigned to the Department of Defense, and invites public comments on this alternative as well as the DAB proposal included in the text of the proposed rule.

The proposed appeals process would involve appeals of civil monetary penalties and assessments but not include appeals of exclusions, which will be governed by the established process at 32 CFR 199.9(f). We believe that DAB ALJs, would be good candidates to preside over TRICARE CMP appeals. DAB ALJs currently hear CMP appeals for the Medicare Program pursuant to HHS regulations at 42 CFR part 1005, which provide for a direct appeal to the DAB for CMPs assessed by Medicare. During the appeals process, the DHA will have exclusive authority to settle any issues or case without consent of the ALJ. If the imposition of the CMP is successful on appeal, the determination of the CMP by the Secretary of Defense will become final. Once a determination by the Secretary has become final, collection of any penalty and assessment will be the responsibility of DHA. A penalty or an assessment imposed under this program may be compromised by the DHA and may be recovered in a civil action brought in the United States district court for the district where the claim was presented or where the respondent resides.

Although we continue to evaluate the use of DoD ALJs, we believe that utilization of DAB ALJs and HHS's long established appeals process will be the most efficient means to adjudicate appeals under the TRICARE Program. The HHS appeals process would not add any additional process or burden to those in the industry who might be impacted by CMP law, because those entities implicated by the CMP law under TRICARE are for the most part the same entities that are already subject to the same civil monetary penalties law under Medicare. Additionally, we believe the adoption of HHS appeals regulations will assist the seamless adjudication of TRICARE Appeals by HHS ALJs with familiarity and experience working with the Medicare Appeals regulations.

We are proposing the adoption of a 120 day deadline, extending the 60 day deadline established in 42 CFR 1005.20(c) for the ALJ to issue a decision following the close of the record. We are also proposing extending the 60 day deadline established in 42 CFR 1005.21(i) for the Board to issue a decision following the close of the record. After consultation with the HHS DAB, the DAB has requested that in order to ensure adequate resources necessary to properly adjudicate CMP Appeals, including complex statistical sampling cases, that the deadline to issue a decision be extended from 60 days to 120 days for the ALJ and the Board to issue a decision following the close of the record. We believe that the requested extension to 120 days for the issuance of an ALJ and Board decision provides appellants with appropriate due process. Accordingly, pursuant to the DAB recommendation we propose the deadline for decision by the ALJ in 42 CFR 1005.20(c) and the decision by the Board § 1005.21(i) to be 120 days from the date the record is closed.

Therefore, with the exception of regulations involving exclusions and the extension of deadlines for the ALJ and Board to issue a decision, in part for purposes of uniformity with Medicare, we propose that the regulations at 42 CFR part 1005, §§ 1005.1 through 1005.23, be adopted in full to the extent applicable to appeals of civil momentary penalties and assessments in the TRICARE Civil Monetary Penalty Program. These appeals regulations are codified in this proposed regulation under 32 CFR 200.2001 through 200.2023.

This is being issued as proposed rule to implement authority provided to the Secretary of Defense in section 1128A(m) of the SSA. DoD invites public comments on this proposed rule and is committed to considering all comments and issuing a final rule as soon as practicable.

E.O. 13771 seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis in OMB Circular A-4 and Office of Information and Regulatory Affairs guidance on implementing E.O. 13771, this proposed rule does not involve regulatory costs subject to E.O. 13771.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this rule is not a significant regulatory action. The rule does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders.

This is not an economically significant rule because it does not reach that economic threshold of $100 million or more. This proposed rule is designed to implement statutory provisions, authorizing the Department of Defense to impose CMPs. The vast majority of providers and Federal health care programs would be minimally impacted, if at all, by these proposed revisions. Accordingly, the aggregate economic effect of these regulations would be significantly less than $100 million.

Under the Congressional Review Act, a major rule may not take effect until at least 60 days after submission to Congress of a report regarding the rule. A major rule is one that would have an annual effect on the economy of $100 million or more; or a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. This final rule is not a major rule, because it does not reach the economic threshold or have other impacts as required under the Congressional Review Act.

The RFA and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most providers are considered small entities by having revenues of $5 million to $25 million or less in any one year. For purposes of the RFA, most physicians and suppliers are considered small entities. The aggregate effect of implementing a CMP Program within the TRICARE Program would be minimal. In summary, we have concluded that this proposed rule should not have a significant impact on the operations of a substantial number of small providers and that a regulatory flexibility analysis is not required for this rulemaking. Therefore, this proposed rule is not subject to the requirements of the RFA.

Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 104-4, also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditures in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $140 million. As indicated above, these proposed rules implement statutory authority to impose CMPs on claims submitted to the TRICARE Program is a similar manner as implemented by the Department of Health and Human Services in the Medicare Program. It has been determined that there are no significant costs associated with the proposed implementation of a CMP Program to impose CMPs on claims submitted to the TRICARE Program that would impose any mandates on State, local, or tribal governments or the private sector that would result in an expenditure of $140 million or more (adjusted for inflation) in any given year and that a full analysis under the Unfunded Mandates Reform Act is not necessary.

This rulemaking does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. chapter 35).

This proposed rule has been examined for its impact under E.O. 13132, and it does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national Government and the States, or on the distribution of powers and responsibilities among the various levels of Government. Therefore, consultation with State and local officials is not required.

For the reasons stated in the preamble, the Department of Defense proposes to amend 32 CFR subchapter M as set forth below:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

On March 12, 2019, the Seattle Seafair Organization notified the Coast Guard that it will be moving its annual Air Show Performance location due to the Interstate 90 Floating Bridge construction project for the Sound Transit Light Rail and subsequent light rail operations. In order to avoid closing the Interstate 90 Floating Bridge on Lake Washington during the Air Show Performance which would be required under the current safety zone regulations, the Seattle Seafair Organization has moved Air Show Performance location south of the Interstate 90 Floating Bridge.

The northern boundary of the proposed safety zone would encompass the navigable waters of Lake Washington approximately 1,700 yards south of the existing safety zone's northern boundary to the southern Interstate 90 floating bridge. The proposed safety zone location would then overlap the existing safety zone location south of the Interstate 90 Bridge to southern boundary line, a line perpendicular to the Bailey Peninsula to Mercer Island. The southern boundary would then be extended 1,100 yards further south past the existing boundary line.

The Air Show Performance poses several dangers to the public, including low-flying high-speed aircraft, excessive noise, and potential objects falling from aircraft. The Captain of the Port Puget Sound (COTP) has determined that potential hazards associated with the Air Show Performance would be a safety concern for anyone near the Air Show Performance.

The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters near the new Air Show Performance location immediately before, during, and after the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).

The COTP is proposing to amend the current safety zone location by moving it south in conjunction with the new Air Show Performance location. The safety zone would cover all navigable waters of Lake Washington south of the Interstate 90 Floating Bridge and north of Bailey Peninsula. No vessel or person would be permitted to enter or remain in the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time of day the safety zone. Vessel traffic would be able to safely transit around the safety zone which would impact a small designated area of Lake Washington during the Air Show Performance.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves amending a safety zone by moving the regulated area south of the Interstate 90 Bridge and north of Bailey Peninsula. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit https://www.regulations.gov/privacyNotice.

Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

This proposed rule is organized as follows:

Aluminum naturally occurs in surface waters, but under certain environmental conditions, it can be converted to toxic forms that can be toxic to aquatic life. Anthropogenic activities such as bauxite mining, alumina refining, production of aluminum products, and manufacturing processes can contribute aluminum to surface waters. 1 In addition, alum (potassium aluminum sulfate), used in clarification processes in drinking water and wastewater processes, can contribute to levels of aluminum in surface waters. Lastly, certain activities, such as wastewater discharges, stormwater runoff, mining, or agriculture can influence a waterbody's pH, dissolved organic carbon (DOC), or total hardness and, therefore, the toxicity of aluminum in that waterbody.

Entities such as industrial facilities, stormwater management districts, or publicly owned treatment works (POTWs) that discharge pollutants to fresh waters of the United States under the State of Oregon's jurisdiction could be indirectly affected by this rulemaking, because federal WQS promulgated by the EPA would be applicable WQS for the State for CWA purposes. These WQS are the minimum standards which must be used in CWA regulatory programs, such as National Pollutant Discharge Elimination System (NPDES) permitting  2 and identifying impaired waters under CWA section 303(d). Citizens concerned with water quality in Oregon could also be interested in this rulemaking. Categories and entities that could potentially be affected include the following:

This table is not intended to be exhaustive, but rather provides a guide for readers to identify entities that could potentially be affected by this action. Any parties or entities who depend upon or contribute to the water quality of Oregon's waters could be affected by this proposed rule. To determine whether your facility or activities could be affected by this action, you should carefully examine this proposed rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS for their waters subject to the CWA. CWA section 303(c)(2)(A)  3 provides that WQS shall consist of designated uses of the waters and water quality criteria based on those uses. The EPA's regulations at 40 CFR 131.11(a)(1) provide that “[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use [and] [f]or waters with multiple use designations, the criteria shall support the most sensitive use.” In addition, 40 CFR 131.10(b) provides that “[i]n designating uses of a water body and the appropriate criteria for those uses, the [s]tate shall take into consideration the water quality standards of downstream waters and shall ensure that its water quality standards provide for the attainment and maintenance of the water quality standards of downstream waters.”

States are required to review applicable WQS at least once every three years and, if appropriate, revise or adopt new WQS (CWA section 303(c)(1)  4 and 40 CFR 131.20). Any new or revised WQS must be submitted to the EPA for review and approval or disapproval (CWA section 303(c)(2)(A) and (c)(3)  5 and 40 CFR 131.20 and 131.21). If the EPA disapproves a state's new or revised WQS, the CWA provides the state 90 days to adopt a revised WQS that meets CWA requirements, and if it fails to do so, the Agency shall promptly propose and then within 90 days promulgate such WQS unless the Agency approves a state replacement WQS first (CWA section 303(c)(3) and (c)(4)  6 ).

Under CWA section 304(a), the EPA periodically publishes criteria recommendations for states to consider when adopting water quality criteria for particular pollutants to meet the CWA section 101(a)(2) goals. Where the EPA has published recommended criteria, states should establish numeric water quality criteria based on the Agency's CWA section 304(a) recommended criteria, CWA section 304(a) recommended criteria modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)). In all cases criteria must be sufficient to protect the designated use and be based on sound scientific rationale (40 CFR 131.11(a)(1)).

On July 8, 2004, Oregon submitted 89 revised aquatic life criteria for 25 pollutants to the EPA for review under CWA section 303(c) including acute and chronic criteria for aluminum. Many of Oregon's revised criteria were the same as the EPA's national recommended CWA section 304(a) aquatic life criteria at the time. Oregon subsequently submitted revised WQS to the EPA for CWA section 303(c) review on April 23, 2007. The EPA did not take CWA section 303(c) action to approve or disapprove within the statutorily mandated timeline (CWA 303(c)(3)). On May 29, 2008, the U.S. District Court for the District of Oregon entered a consent decree setting deadlines for the EPA to take action under section 303(c) of the CWA on Oregon's July 8, 2004, submission of aquatic life criteria ( Northwest Environmental Advocates v. U.S. EPA, No. 06-479-HA (D. Or. 2006)). On November 27, 2012, the District Court issued an extension of the applicable deadlines for the EPA's CWA section 303(c) action and amended the decree to require the Agency to act by January 31, 2013, on Oregon's July 8, 2004, submission of aquatic life criteria, as amended by subsequent submissions by Oregon dated April 23, 2007, and July 21, 2011.

The EPA initially considered approving Oregon's aluminum criteria. Prior to taking a final action on the aquatic life criteria, however, the EPA requested formal consultation with the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (USFWS) on its proposed approval of the State's criteria, consistent with section 7(a)(2) of the Endangered Species Act (ESA). The EPA initiated this consultation on January 14, 2008, by submitting a biological evaluation to NMFS and USFWS, which contained an analysis of the potential effects of the Agency's proposed approval of Oregon's criteria, including criteria for aluminum, on threatened and endangered species in Oregon.

Before receiving a biological opinion from NMFS or USFWS, the EPA realized that the Agency's initial understanding that Oregon's criteria were entirely equivalent to the Agency's 1988 CWA section 304(a) recommended criteria was incorrect. While the EPA's 1988 CWA section 304(a) recommended aluminum criteria “apply at pH values of 6.5-9.0,” the Agency later identified a footnote to Oregon's revised aluminum criteria table specifying that Oregon's aluminum criteria applied “to waters with pH values less than 6.6 and hardness values less than 12 mg/L (as CaCO 3 ).” The State had not supplied a scientific rationale to justify the application of the criteria to pH values less than 6.6 and hardness values less than 12 mg/L. As a result, the EPA prepared to disapprove the aluminum criteria. The EPA sent a letter to NMFS and USFWS identifying this change. USFWS had already completed and transmitted its biological opinion to the EPA by that point and the Agency was therefore unable to withdraw the consultation request for aluminum. USFWS biological opinion (provided to the EPA on July 31, 2012) found that the Agency's proposed approval of Oregon's aquatic life criteria (which at the time of the consultation, was based on the application of the aluminum criteria to waters with pH 6.5-9.0) would not jeopardize the continued existence of listed species or result in the destruction or adverse modification of designated critical habitat under USFWS jurisdiction.

NMFS had not yet transmitted its analysis to the EPA at that time, so the Agency sent a letter to NMFS withdrawing its request for consultation on Oregon's acute and chronic aluminum criteria. NMFS acknowledged the EPA's request to withdraw the aluminum criteria from consultation in the biological opinion; however, NMFS did not modify the document to exclude the acute and chronic aluminum criteria. On August 14, 2012, NMFS concluded in its biological opinion that seven of Oregon's revised freshwater criteria would jeopardize the continued existence of endangered species in Oregon for which NMFS was responsible, including acute and chronic aluminum (applied to waters with pH 6.5-9.0). 7 NMFS acknowledged the EPA's request to withdraw the aluminum criteria from consultation and indicated that it would await a further request from the EPA regarding the EPA's future actions on Oregon's aluminum criteria.

On January 31, 2013, the EPA disapproved several of the State's revised aquatic life criteria under CWA section 303(c). The EPA disapproved the State's aluminum criteria because the State had not supplied a scientific rationale for the conditions under which the criteria would apply. On April 20, 2015, the EPA was sued for failing to promptly prepare and publish replacement criteria for seven of the aquatic life criteria disapproved in its January 31, 2013 action ( Northwest Environmental Advocates v. U.S. EPA, 3:15-cv-00663-BR (D. Or. 2015)). This lawsuit was resolved in a consent decree entered by the District Court on June 9, 2016 which established deadlines for the EPA to address the disapproved aquatic life criteria by either approving replacement criteria submitted by Oregon or by proposing and promulgating federal criteria. The State and the EPA have addressed the disapprovals for five of the criteria subject to the consent decree, 8 but the State has not yet addressed the EPA's 2013 disapproval of its freshwater criteria for acute and chronic aluminum (the sixth and seventh of the disapproved criteria). For the freshwater aluminum criteria, the consent decree originally established deadlines for the EPA to propose federal criteria by December 15, 2017, and to take final action on the proposal by September 28, 2018. On December 5, 2017, the District Court granted an extension of the applicable deadlines for the EPA's proposal and final action. At that time, the consent decree required the EPA to propose federal criteria for the State by March 15, 2018, and to take final action on the proposal by March 27, 2019. On March 1, 2018, the District Court again granted an extension of the consent decree deadlines for the EPA's proposed and final actions. The consent decree required that by March 15, 2019, the EPA will either approve aluminum criteria submitted by Oregon or the EPA will sign a notice of federal rulemaking proposing aluminum criteria for Oregon. The consent decree includes a force majeure clause relating to “circumstances outside the reasonable control of EPA [that] could delay compliance with the deadlines specified in this Consent Decree. Such circumstances include . . . a government shutdown.” Due to the 35-day government shutdown that occurred between December 22, 2018, and January 25, 2019, the deadline for signing a rule proposal is April 19, 2019. As a result, the EPA is proposing freshwater acute and chronic criteria for aluminum in Oregon in this rule in accordance with CWA section 303(c)(3) and (c)(4) requirements, and consistent with the schedule established in the consent decree. The consent decree also requires that by March 27, 2020, the EPA will either approve aluminum criteria submitted by Oregon or sign a notice of final rulemaking.

The proposed aluminum criteria for Oregon are based on the EPA's 2018 final CWA section 304(a) national recommended freshwater aquatic life criteria for aluminum (Final Aquatic Life Ambient Water Quality Criteria for Aluminum 2018, EPA 822-R-18-001, as cited in 83 FR 65663), which were developed consistent with the EPA's Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses (referred to as the “Aquatic Life Guidelines”). 9 These criteria apply to fresh waters and account for water chemistry characteristics that affect aluminum bioavailability and toxicity. The final 2018 CWA section 304(a) national recommended freshwater aquatic life criteria for aluminum replaced the previous CWA section 304(a) national recommended freshwater aquatic life criteria for aluminum which were issued in 1988. 10 While the earlier criteria were in place at the time that EPA disapproved the State's aluminum criteria, the EPA has since updated its CWA 304(a) national recommended criteria and is proposing criteria for Oregon consistent with the new recommendations.

Under the Agency's CWA section 304(a) authority, the EPA develops recommended criteria and methodologies to protect aquatic life and human health for specific pollutants and pollutant parameters. These recommended criteria and methodologies are subject to public comment as well as scientific expert review before the EPA releases them as formal Agency recommendations for states to consider when developing and adopting water quality criteria. The EPA derives criteria for the protection of aquatic life consistent with its Aquatic Life Guidelines. The EPA's Aquatic Life Guidelines describe an objective way to estimate the highest concentration of a substance in water that will not present a significant risk to the aquatic organisms in the water. If a CWA section 304(a) recommendation exists, states may use it as a basis for their WQS or, alternatively, can use a modified version that reflects site-specific conditions, or another scientifically defensible method. 40 CFR 131.11(b).

Numeric criteria derived consistent with the EPA's Aquatic Life Guidelines are expressed as short-term (acute) and long-term (chronic) values. The combination of a criterion maximum concentration (CMC), a one-hour average value, and a criterion continuous concentration (CCC), typically specified as a four-day average value, protects aquatic life from acute and chronic toxicity, respectively. Neither value is to be exceeded more than once in three years. The EPA selected the CMC's one-hour averaging period because high concentrations of certain pollutants can cause death in one to three hours, and selected the CCC's four-day averaging period to prevent increased adverse effects on sensitive life stages. The EPA based its maximum exceedance frequency recommendation of once every three years on the ability of aquatic ecosystems to recover from the exceedances. An exceedance occurs when the average concentration over the duration of the averaging period is above the CCC or the CMC.

The Aquatic Life Guidelines recommend having toxicity test data from a minimum of eight taxa of aquatic organisms to derive criteria. These taxa are intended to be representative of a wide spectrum of aquatic life, and act as surrogates for untested species. Therefore, the specific test organisms do not need to be present in the water(s) where the criteria will apply. However, a state may develop site-specific criteria using species residing at a local site. In developing site-specific criteria, the EPA recommends that the state maintain similar broad taxonomic representation in calculating the site-specific criteria to ensure protection of the most sensitive species at the site and so the state can demonstrate that the species included in the derivation of the EPA's national criteria recommendation is not present/does not serve as a surrogate for other species at the site.

In December 2018, the EPA published in the Federal Register (83 FR 65663) CWA section 304(a) national recommended freshwater aquatic life criteria for aluminum (referred to in this notice as “final 2018 recommended national criteria”). The published final 2018 recommended national criteria represent the latest scientific knowledge and understanding of the interaction between water chemistry and aluminum toxicity and is a scientifically defensible method upon which the EPA is basing this CWA action. 11 The final 2018 recommended national criteria are based upon Multiple Linear Regression (MLR) models for fish and invertebrate species that use pH, DOC, and total hardness to quantify the effects of these water chemistry parameters on the bioavailability and resultant toxicity of aluminum to aquatic organisms. The MLR models are then used to normalize the available toxicity data to accurately reflect the effects of the water chemistry (pH, DOC, total hardness) on the toxicity of aluminum to tested species. These normalized toxicity test data are then used in a criteria calculator to generate criteria for specific water chemistry conditions, the water-chemistry-condition-specific CMC and CCC outputs.

The final 2018 recommended national aluminum criteria are expressed as total recoverable metal concentrations. The EPA notes that while the criteria values for metals are typically expressed as dissolved metal concentrations, the current EPA-approved CWA Test Methods  12 for aluminum in natural waters and waste waters measure total recoverable aluminum. The use of total recoverable aluminum may be considered conservative because it includes monomeric (both organic and inorganic) forms, polymeric and colloidal forms, as well as particulate forms and aluminum sorbed to clays. However, toxicity data comparing toxicity of aluminum using total recoverable aluminum and dissolved aluminum demonstrated that toxic effects increased with increasing concentrations of total recoverable aluminum even though the concentration of dissolved aluminum was relatively constant. If aluminum criteria were based on dissolved concentrations, toxicity would likely be underestimated, as colloidal forms and hydroxide precipitates of the metal that can dissolve under natural conditions and become biologically available would not be measured. The criteria document contains more discussion of the studies that informed the choice to use total recoverable aluminum as the basis for the final 2018 recommended national criteria.

The numeric outputs of the final 2018 recommended national criteria models for a given set of conditions will depend on the specific pH, DOC, and total hardness entered into the models. The model outputs (CMC and CCC) for a given set of input conditions are numeric values that would be protective for that set of input conditions. Users of the models can determine outputs in two ways: (1) Use the look-up tables provided in the criteria document to find the numeric aluminum CMC and CCC most closely corresponding to the local conditions for pH, DOC, and total hardness or (2) use the provided Aluminum Criteria Calculator V.2.0 to enter the pH, DOC, and total hardness conditions at a specific site to calculate the numeric aluminum CMC and CCC corresponding to the local input conditions.

As with all scientific analyses, there are potential uncertainties in the aluminum criteria approaches to quantifying the toxic effects of aluminum to aquatic life in the environment, particularly when the input parameters fall outside the bounds of the toxicity data underlying the MLR model that supports the criteria calculator. Section 5 of the EPA's final 2018 recommended national criteria document contains more detailed information regarding these uncertainties and the ways the EPA has addressed these uncertainties in developing the criteria document and calculator to ensure the criteria values are protective of applicable aquatic life designated uses. In the case of Oregon waters, an estimated 99% of the State's waters fall within the bounds of the model, and criteria values generated by the calculator are expected be protective of applicable aquatic life designated uses. 13 In situations where water chemistry for a particular water falls outside the bounds of the model and the results are more uncertain, the State should use its discretion and risk management judgment to determine if additional toxicity data should be generated to further validate toxicity predictions or if it should develop new or modified models for site specific criteria for such locations.

In order to calculate numeric water quality criteria that will protect the aquatic life designated uses of a site over the full range of ambient conditions and toxicity, multiple model outputs will need to be reconciled. The following section describes options for reconciling model outputs.

To protect aquatic life in Oregon's fresh waters, the EPA proposes aluminum criteria for Oregon that incorporate by reference the calculation of CMC and CCC freshwater aluminum criteria values for a site using the final 2018 recommended national criteria. That means that the proposed CMC and CCC freshwater aluminum criteria values for a site shall be calculated using the 2018 Aluminum Criteria Calculator V.2.0 ( Aluminum Criteria Calculator V.2.0.xlsx ) or a calculator in R  14 or other software package using the same 1985 Guidelines calculation approach and underlying model equations as in the Aluminum Criteria Calculator V.2.0.xlsx as established in the final 2018 recommended national criteria. Consistent with the final 2018 recommended national criteria, the EPA proposes to express the CMC as a one-hour average total recoverable aluminum concentration (in µg/L) and the CCC as a four-day average total recoverable aluminum concentration (in µg/L), and that the CMC and CCC are not to be exceeded more than once every three years.

The EPA concludes that its final 2018 recommended national criteria represent the latest scientific knowledge on aluminum speciation, bioavailability, and toxicity, and provides predictable and repeatable outcomes. Consistent with the Aquatic Life Guidelines, the final 2018 recommended national criteria protect aquatic life for acute effects (mortality and immobility) as well as chronic effects (growth, reproduction, and survival) at a level of 20% chronic Effects Concentration (EC20) for the 95th percentile of sensitive genera. The final 2018 recommended national criteria are based on a range of toxicological data including data on Oregon threatened and endangered species or their closest taxonomic surrogates. The models on which the criteria are based are therefore appropriate for deriving CMC and CCC values that will protect aquatic life in Oregon. The EPA recommends that commenters consult the docket for the final 2018 recommended national criteria document for information on the science underlying that recommendation [Docket: EPA-HQ-OW-2017-0260].

The EPA requests comment on the proposal to promulgate aluminum criteria for freshwaters in Oregon based on the final 2018 recommended national criteria. The EPA also requests comment on any alternative scientifically defensible criteria calculation methods or models that differ from the final 2018 recommended national criteria. The EPA may consider modifications to the criteria the EPA is proposing for Oregon if warranted based on, among other things, public input, tribal consultation, new data, or evaluations of listed species completed during ESA consultation, or the results of ESA consultation. The docket for this rule contains more information on possible considerations.

The EPA's proposed rule provides that the criteria calculator, which incorporates pH, DOC, and total hardness as input parameters, be used to calculate protective acute and chronic aluminum criteria values for a site as set forth in the final 2018 recommended national criteria. These calculated criteria values would protect aquatic life under the full range of ambient conditions found at each site, including conditions when aluminum is most toxic given the spatial and temporal variability of the water chemistry at the site. Characterization of the parameters that affect the bioavailability, and associated toxicity, of aluminum is the primary feature to determine protectiveness of aquatic life at a site at any given time. Oregon will need to use ambient water chemistry data ( i.e., pH, DOC, total hardness) as inputs to the model in order to determine protective aluminum criteria values for specific sites, unless the State develops default values to be used in implementation. Oregon has the discretion to select the appropriate method to reconcile model outputs and calculate the final criteria values for each circumstance as long as the resulting calculated criteria values shall protect aquatic life throughout the site and throughout the range of spatial and temporal variability, including when aluminum is most toxic. The EPA strongly recommends that the State develop implementation materials to outline its approach.

The EPA suggests three methods that the State could use to reconcile model outputs and calculate criteria values that will result in protection of aquatic life at a site. Alternatively, the State may use its own alternate methods to reconcile outputs to generate protective criteria values. The appropriate method for each circumstance will depend primarily on data availability.

With method one, users identify protective criteria values by selecting one or more individual model outputs based upon spatially and temporally representative site-specific measured values for model inputs. Method one can be used where input datasets are complete and inputs are measured frequently enough to statistically represent changes in the toxicity of aluminum, including conditions under which aluminum is most toxic. In this case, the criteria values are determined by selecting one or more individual outputs that will be protective of aquatic life under the full range of ambient conditions, including conditions of high aluminum toxicity. Method one could be used to also establish criteria values to apply on a seasonal basis where the data are sufficient.

When using method two, users calculate protective criteria values from the lowest 10th percentile of the distribution of individual model outputs, based upon spatially and temporally representative site-specific measured model input values. While the 10th percentile of outputs should be protective in a majority of cases, certain circumstances may warrant use of a more stringent model output ( e.g., consideration of listed species). Sufficient data to characterize the appropriate distribution of model outputs are necessary to derive a protective percentile so that the site is protected under conditions of high aluminum toxicity.

In method three, users select the lowest model outputs (the lowest CMC and the lowest CCC) calculated from spatially and temporally representative input datasets that capture the most toxic conditions at a site as the criteria values. Method three should be used where ten or fewer individual model outputs are available.

The EPA solicits comments on these methods and any other scientifically defensible methods that could be used to select criteria values to protect aquatic life by reconciling model outputs, as well as whether the Agency should promulgate any or all of these suggested methods for Oregon as part of this rulemaking.

Additionally, the EPA solicits comment on promulgating ecoregional default criteria values for aluminum in the final rule to ensure protection of the designated use when available data are insufficient to characterize a site.

The EPA calculated ecoregional default aluminum criteria values from measured pH and measured or estimated DOC and total hardness based on existing concentrations of these variables in waters within each of Oregon's Level III Ecoregions. 15 These defaults are provided in Table 1 below.

To calculate ecoregional default criteria values, the EPA relied on publicly available data (U.S. Geological Survey (USGS) National Water Information System (NWIS); Oregon DEQ)  16 collected in accordance with quality assurance procedures established by each collecting entity. From 2001-2015, a total of 19,274 samples across all Level III Ecoregions in Oregon provided adequate data to calculate corresponding acute and chronic criteria magnitudes. Adequate data to calculate criteria magnitudes included samples with paired measurements of pH, DOC, and total hardness, where available (1,689 samples). When paired measurements of pH, DOC, and total hardness were not available, the EPA paired empirical pH measurements with DOC and/or total hardness data estimated from measured Total Organic Carbon (TOC) and specific conductivity, respectively (17,585 samples). The EPA used DOC and total hardness estimates to expand available data and better represent the potential distribution of criteria magnitudes across Level III Ecoregions in Oregon. The calculation of the default criteria values presented here incorporates the EPA's effort to closely follow Oregon DEQ's approach to developing default DOC input values for Oregon's copper aquatic life criteria rule. More information on the data sources and transformations is available in the docket for this proposal. The EPA then calculated the 10th percentile CMC and CCC for each ecoregion from the distributions of model outputs. The EPA selected the 10th percentile as a statistic that represents a lower bound of spatially and temporally variable conditions that will be protective in the majority of cases.

The EPA solicits comments on the Agency's use of the 10th percentile of the ecoregional model output distributions of the measured and transformed data to derive ecoregional default aluminum criteria values. The EPA also solicits comment on whether a different percentile of the model output distribution should be used, or if combined ecoregional (georegional) distributions of outputs should be used instead of the Level III ecoregional distributions to derive the defaults. Additional information on the inputs used to derive outputs and how the ecoregional default criteria values were selected using percentiles of the model output distribution is provided in the document entitled “Analysis of the Protectiveness of Default Ecoregional Aluminum Criteria Values” which can be found in the docket. The EPA solicits comment on alternative methods to developing default ecoregional criteria values, as presented in the Analysis of the Protectiveness of Default Ecoregional Aluminum Criteria Values. The EPA solicits comment on the inclusion of such default criteria values in the final rule. The EPA also solicits comment on whether there are alternative approaches to ensure that protective model outcomes can be identified for all waterbodies using the proposed criteria, and to ease implementation.

In addition to soliciting comment on including default ecoregional criteria, the EPA also solicits comment on whether the Agency should include default DOC input values in the final rule. Among the input parameters, ambient data are least likely to be available for DOC. DOC influences aluminum toxicity unidirectionally. Higher levels of DOC provide more mitigation of aluminum toxicity. For water bodies for which sufficient pH and total hardness data are available, but DOC data are not available, the EPA solicits comment on whether to promulgate in the final rule the default DOC input values provided in Table 2. If the EPA were to promulgate both the default ecoregional aluminum criteria values provided in Table 1 and the default DOC input values in Table 2, in addition to the EPA's the calculation of CMC and CCC freshwater aluminum criteria values for a site using the final 2018 recommended national criteria, the State could choose to use the default ecoregional aluminum criteria values or use the default DOC input values in Table 2 and calculate criteria. The default DOC input values could be used in combination with measured data for pH and total hardness to calculate aluminum criteria outputs that are more specific to site conditions than the ecoregional default criteria values provided in Table 1. The EPA derived the default DOC input values as the 15th or 20th percentile of the distribution of data from a compilation of high quality data available for Oregon's georegions (aggregated ecoregions with similar water quality characteristics), compiled by Oregon DEQ and the US Geological Survey (see the “Analysis of the Protectiveness of Default Dissolved Organic Carbon Options,” which can be found in the docket.) The calculation of the default DOC input values presented in this preamble reflects the EPA's effort to closely follow Oregon DEQ's approach to developing default DOC input values for Oregon's copper aquatic life criteria rule. The EPA selected the 15th or 20th percentiles as low-end percentile of georegional DOC concentrations as a statistic that represents a lower bound of spatially and temporally variable conditions that will be protective in the majority of cases. The use of default DOC input values would ensure protection of the designated use when site-specific ambient DOC inputs are unavailable. Additional information on the derivation of the default DOC input values is provided in the Analysis of the Protectiveness of Default Dissolved Organic Carbon Options, which can be found in the docket.

The EPA solicits comments on the Agency's use of the 15th and 20th percentiles of the georegional distributions of the available US Geological Survey and Oregon DEQ DOC data to derive default DOC input values for calculating aluminum outputs when DOC data are unavailable. More information on the data and input analysis is available in the Analysis of the Protectiveness of Default Dissolved Organic Carbon Options. The EPA solicits comment on alternative methods to developing default DOC input values, as presented in the Analysis of the Protectiveness of Default Dissolved Organic Carbon Options. The EPA also solicits comments on using default DOC input values based on a different percentile, such as the 5th or 25th percentile of the distribution (or another protective percentile within that range), as well as using default DOC values for ecoregions rather than georegions.

The EPA is not considering the development of default input values for pH and total hardness because the relationship between these parameters and aluminum toxicity is not unidirectional, which means that a given percentile of pH and total hardness may be conservative in some circumstances but not others (see the EPA's final 2018 recommended national criteria document for more information). Also, data for these parameters are more likely to be available (Analysis of the Protectiveness of Default Dissolved Organic Carbon Options). Given the complex nature of aluminum toxicity and how it dynamically varies with water chemistry (especially with pH and total hardness), it is not possible to calculate a universally protective set of water chemistry conditions in cases where the water chemistry is unknown. For example, total hardness at low pH tends to increase criteria magnitudes whereas total hardness at high pH tends to reduce criteria magnitudes. That relationship is also dependent on DOC concentration (see final 2018 recommended national criteria document for further details). Therefore, measured pH and total hardness data are essential to calculate reliable aluminum criteria.

This proposal, if finalized, would likely be the first occasion that a state or authorized tribe would have aluminum criteria based on the final 2018 recommended national criteria. The EPA understands that states have certain flexibility under 40 CFR part 131 with how they implement water quality standards such as these aluminum criteria. The EPA is recommending possible approaches below for the State's consideration and for public comment. The State may choose to use these recommendations or to implement the final aluminum criteria in other ways that are consistent with 40 CFR part 131.

For NPDES permitting, monitoring and assessment, and total maximum daily load (TMDL) development purposes, the State can use different methods to process model outputs in order to generate criteria values for a specific site, as discussed in section III.B. Because of this flexibility, the State should ensure public transparency and predictable, repeatable outcomes. When Oregon calculates aluminum criteria values, the EPA recommends that the State make each site's ambient water chemistry data, including the inputs used in the aluminum criteria value calculations, resultant criteria values, and the geographic extent of the site, publicly available on the State's website.

Where a NPDES permitted discharge is present, the EPA recommends that Oregon ensure that sufficiently representative ambient pH, DOC, and total hardness data are collected to have confidence that conditions in the water body are being adequately captured both upstream of and downstream from the point of discharge. The State should use the criteria calculated values that will be protective at the most toxic conditions to develop water quality-based effluent limits (WQBELs). Input parameter values outside the empirical ranges of the MLR models (as identified in sections 2.7.1 and 5.3.6 of the final 2018 recommended national criteria document) may indicate other potential toxicity issues at a site. When input parameters fall outside those stated ranges, the EPA makes the following recommendations that the State could implement for the protection of designated uses. NPDES permit conditions could include: (1) Additional monitoring approaches such as Whole Effluent Toxicity (WET) testing or biological monitoring; and (2) increased frequency of input parameter and aluminum concentration monitoring. Once criteria values protective of the most toxic conditions are calculated, critical low flows for the purposes of dilution of the pollutant concentration in effluent, combined with critical effluent concentrations of the pollutant, may be used to establish whether there is reasonable potential for the discharge to cause or contribute to an excursion above the applicable criteria and therefore, a need to establish WQBELs, per the EPA's NPDES Permit Writers' Manual. 17 Critical low flows and mixing zones for NPDES permitting purposes are further discussed in Section IV.

In addition, for transparency the EPA recommends that Oregon describe in its NPDES permit fact sheets or statements of basis how the criteria values were calculated, including the input data or summary of input data and source of data. The EPA also recommends that the fact sheets or statements of basis include descriptions of how the criteria values were used to determine whether there is reasonable potential for the discharge to cause or contribute to an excursion above the criteria (“reasonable potential”) and if so, how they were used to derive WQBELs. Similarly, for TMDLs, the EPA recommends that Oregon describe in the TMDL document how the criteria values were calculated and used to determine TMDL targets. In the assessment and impaired waters listing context, the EPA recommends that Oregon describe how it calculated criteria values and the process used to make water quality attainment decisions in the assessment methodology for the Integrated Report. 18

The water quality conditions that determine the bioavailability and toxicity of metals, including aluminum, are unique to each site and can vary widely in both space and time, changing with biological activity, flow, geology, human activities, watershed landscape, and other features of the water body. It is important that the State capture the spatial and temporal variability at sites, and consider establishment of site boundaries carefully. As mentioned above in Section III. B., Oregon should ensure that sufficiently representative data are collected for the model's input parameters (pH, DOC, and total hardness) to have confidence that the most toxic conditions are adequately characterized. To accomplish this, Oregon may evaluate the input parameter data and resultant criteria values that are calculated over time for different flows and seasons through the use of appropriate analytical methods, such as a Monte Carlo  19 simulation or another analytical tool. Also, when defining a site to which to apply criteria for aluminum, the EPA recommends that Oregon consider that metals are generally persistent, so calculating a criterion value using input parameter values from a location at or near the discharge point could result in a criterion value that is not protective of areas that are outside of that location. For example, if downstream waters have different pH conditions that might increase aluminum toxicity downstream from the facility, the permit should account for that. The EPA also recommends that Oregon consider that as the size of a site increases, the spatial and temporal variability is likely to increase; thus, more water samples may be required to adequately characterize the entire site.

Substantial changes in a site's ambient input parameter concentrations will likely affect aluminum toxicity and the relevant criteria values for aluminum at that site. In addition, as a robust, site-specific dataset is developed with regular monitoring, criteria values can be updated to more accurately reflect site conditions. Therefore, the EPA recommends that Oregon revisit each water body's aluminum criteria values periodically (for example, with each CWA section 303(d) listing cycle or WQS triennial review) and re-run the models when changes in water chemistry are evident or suspected at a site and as additional monitoring data become available. This will ensure that the criteria values accurately reflect the toxicity of aluminum and maintain protective values.

The State may use multiple methods to calculate site-specific criteria values in order to implement the criteria for CWA purposes. For example, the State could use Method one, after collecting sufficiently representative model input data for all parameters, as well as corresponding ambient aluminum measurements as described in section III.B, to determine whether the paired aluminum measurements exceed the calculated model output magnitude more than once in three years for assessment purposes. Alternatively, the State could use the output dataset to select a single CMC and a single CCC that are sufficiently protective at the most toxic conditions for the purposes of permitting an aluminum discharge or establishing a TMDL. In contrast, using Methods two or three, the State could calculate a single numeric expression of the criteria that would be the basis for all monitoring, assessment, TMDL, and NPDES permitting purposes.

The Agency is proposing that the final EPA regulatory text incorporate one EPA document by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the EPA's Final Aquatic Life Ambient Water Quality Criteria for Aluminum 2018 (EPA 822-R-18-001), discussed in Section III.A of this preamble. Incorporating this document by reference will allow the State to access all of the underlying information and data the EPA used to develop the final 2018 recommended national criteria. With access to this information, the State will have the flexibility to create its own version of the calculator built upon the underlying peer-reviewed model. The EPA has made, and will continue to make, this document generally available electronically through www.regulations.gov at the docket associated with this rulemaking and at https://www.epa.gov/wqc/aquatic-life-criteria-aluminum.

To ensure that the proposed criteria are applied appropriately to protect Oregon's aquatic life uses, the EPA recommends Oregon use critical low flow values consistent with longstanding EPA guidance  20 when calculating the available dilution for the purposes of determining the need for and establishing WQBELs in NPDES permits. Dilution is one of the primary mechanisms by which the concentrations of contaminants in effluent discharges are reduced following their introduction into a receiving water. During a low flow event, there is less water available for dilution, resulting in higher instream pollutant concentrations. If criteria are implemented using inappropriate critical low flow values ( i.e., values that are too high), the resulting ambient concentrations could exceed criteria values when low flows occur. 21

The EPA notes that in ambient settings, critical low flow conditions used for NPDES permit limit derivation purposes may not always correspond with conditions of highest aluminum bioavailability and toxicity. The EPA's NPDES Permit Writers' Manual describes the importance of characterizing effluent and receiving water critical conditions, because if a discharge is controlled so that it does not cause water quality criteria to be exceeded in the receiving water under critical conditions, then water quality criteria should be attained under all other conditions. 22 The State's implementation procedures should clearly define how the State will consider critical conditions related to critical low flows and the greatest aluminum bioavailability and toxicity to ensure that reasonable potential is assessed and, if needed, appropriate permit limits are established that fully protect aquatic life uses under the full range of ambient conditions.

The EPA's March 1991 Technical Support Document for Water Quality-based Toxics Control recommends two methods for calculating acceptable critical low flow values: The traditional hydrologically-based method developed by the USGS and a biologically based method developed by the EPA. 23 The hydrologically-based critical low flow value is determined statistically, using probability and extreme values, while the biologically-based critical low flow is determined empirically using the specific duration and frequency associated with the criterion. For the acute and chronic aluminum criteria, the EPA recommends the following critical low flow values, except where modeling demonstrates that the most significant critical conditions occur at other than low flow:

Using the hydrologically-based method, the 1Q10 represents the lowest one-day average flow event expected to occur once every ten years, on average, and the 7Q10 represents the lowest seven-consecutive-day average flow event expected to occur once every ten years, on average. Using the biologically-based method, 1B3 represents the lowest one-day average flow event expected to occur once every three years, on average, and 4B3 represents the lowest four-consecutive-day average flow event expected to occur once every three years, on average. 24 The EPA seeks comment on whether the Agency should promulgate these acute and chronic critical low flow values in the final rule or should promulgate alternative critical low flow values.

The criteria in this proposed rule, once finalized, must be attained at the point of discharge unless Oregon authorizes a mixing zone. Where Oregon authorizes a mixing zone, the criteria would apply at the locations allowed by the mixing zone ( i.e., the CMC would apply at the defined boundary of the acute mixing zone and the CCC would apply at the defined boundary of the chronic mixing zone). 25

The EPA's final 2018 recommended national criteria for aluminum represent the best available science. The EPA proposes to promulgate acute and chronic aquatic life aluminum criteria for Oregon based on the EPA's final 2018 recommended national criteria. The EPA is proposing these criteria pursuant to CWA section 303(c)(4)(A), as described in Section II.A of this document, and in compliance with the consent decree described in Section II.B of this document. Section 7(a)(2) of the ESA requires that each Federal Agency ensure that any action authorized, funded, or carried out by such Agency is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. The EPA has initiated ESA consultation on this proposed action and will continue to work closely with NMFS and USFWS to ensure that any acute and chronic aluminum criteria that the Agency finalizes are not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat in Oregon. The EPA will continue ESA consultation with NMFS and USFWS while the Agency develops final aluminum criteria for Oregon that are consistent with the requirements of ESA section 7(a)(2), as well as with the EPA's Aquatic Life Guidelines.

Under the CWA, Congress gave states and authorized tribes primary responsibility for developing and adopting WQS for their navigable waters (CWA section 303(a)-(c)). Although the EPA is proposing aluminum aquatic life criteria for Oregon's fresh waters to remedy the Agency's 2013 disapproval of Oregon's 2004 criteria, Oregon continues to have the option to adopt and submit to the Agency acute and chronic aluminum criteria for the State's fresh waters consistent with CWA section 303(c) and the Agency's implementing regulation at 40 CFR part 131. The EPA encourages Oregon to expeditiously adopt protective aluminum aquatic life criteria. Consistent with CWA section 303(c)(4), if Oregon adopts and submits aluminum aquatic life criteria, and the EPA approves such criteria before finalizing this proposed rule, the Agency would not proceed with the promulgation for those waters and/or pollutants for which the Agency approves Oregon's criteria. Under those circumstances, federal promulgation would no longer be necessary to meet the requirements of the Act.

If the EPA finalizes this proposed rule, and Oregon subsequently adopts and submits aluminum aquatic life criteria, the Agency would approve the State's criteria if those criteria meet the requirements of section 303(c) of the CWA and the Agency's implementing regulation at 40 CFR part 131. If the EPA's federally-promulgated criteria are more stringent than the State's criteria, the EPA's federally-promulgated criteria are and will be the applicable water quality standard for purposes of the CWA until the Agency withdraws those federally-promulgated standards. The EPA would expeditiously undertake such a rulemaking to withdraw the federal criteria if and when Oregon adopts, and the Agency approves corresponding criteria that meet the requirements of section 303(c) of the CWA and the EPA's implementing regulation at 40 CFR part 131. After the EPA's withdrawal of federally promulgated criteria, the State's EPA-approved criteria would become the applicable criteria for CWA purposes. If the State's adopted criteria are as stringent or more stringent than the federally-promulgated criteria, then the State's criteria would become the CWA applicable WQS upon the EPA's approval (40 CFR 131.21(c)).

The federal WQS regulation at 40 CFR part 131 provides several tools that Oregon has available to use at its discretion when implementing or deciding how to implement these aquatic life criteria, once finalized. Among other things, the EPA's WQS regulation: (1) Specifies how states and authorized tribes establish, modify, or remove designated uses (40 CFR 131.10); (2) specifies the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions (40 CFR 131.11); (3) authorizes and provides regulatory guidelines for states and authorized tribes to adopt WQS variances that provide time to achieve the applicable WQS (40 CFR 131.14); and (4) allows states and authorized tribes to authorize the use of compliance schedules in NPDES permits to meet WQBELs derived from the applicable WQS (40 CFR 131.15). Each of these approaches are discussed in more detail in the next sections. Whichever approach a state pursues, however, all NPDES permits would need to comply with the EPA's regulations at 40 CFR 122.44(d)(1)(i).

The EPA's proposed aluminum criteria apply to fresh waters in Oregon where the protection of fish and aquatic life is a designated use (see Oregon Administrative Rules at 340-041-8033, Table 30). The federal regulation at 40 CFR 131.10 provides regulatory requirements for establishing, modifying, and removing designated uses. If Oregon removes designated uses such that no fish or aquatic life uses apply to any particular water body affected by this rule and adopts the highest attainable use, 26 the State must also adopt criteria to protect the newly designated highest attainable use consistent with 40 CFR 131.11. It is possible that criteria other than the federally promulgated criteria would protect the highest attainable use. If the EPA finds removal or modification of the designated use and the adoption of the highest attainable use and criteria to protect that use to be consistent with CWA section 303(c) and the implementing regulation at 40 CFR part 131, the Agency would approve the revised WQS. The EPA would then undertake a rulemaking to withdraw the corresponding federal WQS for the relevant water(s).

Oregon's WQS provide sufficient authority to apply WQS variances when implementing federally promulgated criteria for aluminum, as long as such WQS variances are adopted consistent with 40 CFR 131.14 and submitted to the EPA for review under CWA section 303(c). Federal regulations at 40 CFR 131.3(o) define a WQS variance as a time-limited designated use and criterion, for a specific pollutant or water quality parameter, that reflects the highest attainable condition during the term of the WQS variance. WQS variances adopted in accordance with 40 CFR 131.14 (including a public hearing consistent with 40 CFR 25.5) provide a flexible but defined pathway for states and authorized tribes to comply with NPDES permitting requirements, while providing dischargers with the time they need to meet a WQS that is not immediately attainable but may be in the future. When adopting a WQS variance, states and authorized tribes specify the interim requirements of the WQS variance by identifying a quantitative expression that reflects the highest attainable condition (HAC) during the term of the WQS variance, establishing the term of the WQS variance, and describing the pollutant control activities expected to occur over the specified term of the WQS variance. WQS variances provide a legal avenue by which NPDES permit limits can be written to comply with the WQS variance rather than the underlying WQS for the term of the WQS variance. If dischargers are still unable to meet the WQBELs derived from the applicable WQS once a WQS variance term is complete, the regulation allows the State to adopt a subsequent WQS variance if it is adopted consistent with 40 CFR 131.14. The EPA is proposing a criterion that applies to use designations that Oregon has already established. Oregon's WQS regulations currently include the authority to use WQS variances when implementing criteria, as long as such WQS variances are adopted consistent with 40 CFR 131.14. Oregon may use the EPA-approved WQS variance procedures when adopting such WQS variances.

The EPA's regulations at 40 CFR 122.47 and 40 CFR 131.15 address how permitting authorities can use permit compliance schedules in NPDES permits if dischargers need additional time to undertake actions like facility upgrades or operation changes to meet their WQBELs based on the applicable WQS. The EPA's regulation at 40 CFR 122.47 allows permitting authorities to include compliance schedules in their NPDES permits, when appropriate and where authorized by the state, in order to provide a discharger with additional time to meet its WQBELs implementing applicable WQS. The EPA's regulation at 40 CFR 131.15 requires that states that intend to allow the use of NPDES permit compliance schedules adopt specific provisions authorizing their use and obtain EPA approval under CWA section 303(c) to ensure that a decision to allow permit compliance schedules is transparent and allows for public input (80 FR 51022, August 21, 2015). Oregon already has an EPA-approved provision authorizing the use of permit compliance schedules (see OAR 340-041-0061), consistent with 40 CFR 131.15. That State provision is not affected by this rule. Oregon is authorized to grant permit compliance schedules, as appropriate, based on the federal criteria, as long as such permit compliance schedules are consistent with the EPA's permitting regulation at 40 CFR 122.47.

The proposed criteria would serve as a basis for development of new or revised NPDES permit limits in Oregon for regulated dischargers found to have reasonable potential to cause or contribute to an excursion of the proposed aluminum criteria. However, the EPA cannot anticipate how Oregon would chose to calculate criteria values based on the proposed criteria and what impact they would have on dischargers. Oregon also has NPDES permitting authority, and retains discretion in implementing standards. While Oregon may choose to incorporate the ecoregional default criteria values (from Table 1) directly into certain permits, it has other options available to it as well as discussed in section III.C. For example, the State can calculate criteria values using ambient data. Furthermore, if the State calculates criteria values using ambient data in the model, the State can choose its own method of reconciling multiple outputs. Despite this discretion, if Oregon determines that a permit is necessary, such permit would need to comply with the EPA's regulations at 40 CFR 122.44(d)(1)(i). Still, to best inform the public of the potential impacts of this proposed rule, the EPA made some assumptions to evaluate the potential costs associated with State implementation of the EPA's proposed criteria. The EPA chose to evaluate the expected costs associated with State implementation of the Agency's proposed aluminum criteria based on available information. This analysis is documented in Economic Analysis for the Proposed Rule: Aquatic Life Criteria for Aluminum in Oregon, which can be found in the record for this rulemaking. The EPA seeks public comment on all aspects of the economic analysis including, but not limited to, its assumptions relating to the baseline criteria, affected entities, implementation, and compliance costs.

For the economic analysis, the EPA assumed that in the baseline, Oregon fully implements existing water quality criteria ( i.e., “baseline criteria”) and then estimated the incremental impacts for compliance with the aluminum criteria in this proposed rule. As Oregon has not promulgated numeric aquatic life criteria for aluminum, the “baseline criteria” for aluminum are assumed to be the State's narrative criteria. Because the baseline criteria are narrative, and because few data on aluminum NPDES discharges and assessments are available, there is uncertainty regarding how to numerically express the baseline criteria. The EPA therefore, assumed that the narrative criteria are fully implemented, and in the absence of information to the contrary, the EPA had to make assumptions based on the available data to determine how to attribute costs to comply with the numeric aluminum criteria in this proposed rule. For point source costs, the EPA assumed any NPDES-permitted facility that discharges aluminum and is found to have reasonable potential would be subject to effluent limits and would incur compliance costs if it chose to continue operating. The types of affected facilities include industrial facilities, drinking water treatment plants, and publicly owned treatment works (POTWs) discharging sanitary wastewater to surface waters ( i.e., point sources). For nonpoint sources, those that contribute aluminum loadings to waters that would be considered impaired for aluminum under the proposed criteria may incur incremental costs for additional best management practices (BMPs). It is possible that the narrative criteria are not being fully implemented; in that case, some of the impacts and costs assumed to be attributed to this proposal in this analysis would actually be baseline costs, and thus the costs here would be overestimated.

To evaluate potential costs to NPDES-permitted facilities and the potential for impaired waters, the EPA used the ecoregional default criteria values, calculated from the 10th percentile of the distribution of individual MLR-based calculated criteria outputs for each of Oregon's nine Level III ecoregions, as provided in Table 1. EPA is not proposing these default values as a component of Oregon's aluminum criteria, but is soliciting comment on whether EPA should include them in Oregon's final criteria. For the purposes of this economic analysis, the EPA refers to the ecoregional default criteria values as the “economic analysis criteria.” The economic analysis criteria are likely different from and possibly lower (more stringent) than the actual site-specific criteria that Oregon would calculate using ambient data from each water body and therefore, may be conservative cost estimates. As described earlier in this proposed rule, the EPA recommends that Oregon collect sufficiently representative ambient data to calculate the most accurate and protective aluminum criteria values.

The EPA identified one point source facility, a major discharger, with sufficient data for evaluation  27 of reasonable potential and therefore potentially be affected by the rule. The EPA also identified one minor facility with aluminum effluent limits, however, aluminum effluent data are not available in ICIS-NPDES for the EPA to readily evaluate this facility. The EPA did not include facilities covered by general permits in its analysis because none of the general permits reviewed include specific effluent limits or monitoring requirements for aluminum. Because of the lack of data for aluminum in point source discharges in the State, along with the potential incremental impairments described below, the EPA took additional steps to identify potential costs for point source dischargers that utilize aluminum in their operations. These steps focused on facilities in specific industries that could be affected by the rule: Aluminum anodizing facilities, drinking water treatment plants, and wastewater treatment facilities. For these facilities, the EPA considered both additional controls and product substitution. This analysis supplements the standard analysis that uses data from specific facilities in Oregon to determine potential point source costs based on reasonable potential to cause or contribute to an exceedance of a WQS. See the Economic Analysis for more details.

For the one NPDES-permitted facility with available data, the EPA evaluated the reasonable potential to exceed the economic analysis criteria. There was no reasonable potential to exceed the economic analysis criteria and therefore no basis for estimating projected effluent limitations based on reasonable potential analysis.

For the supplemental point source analysis, the EPA evaluated potential costs to three types of facilities that would incur costs under the proposed rule if they were found to have reasonable potential and were therefore subject to effluent limits. First, several aluminum anodizing facilities discharge to local publicly owned treatment works (POTWs). The proposed criteria could result in the POTWs establishing local (pretreatment) limits for these aluminum anodizers. The EPA identified two options for potential treatment upgrades that may be required (countercurrent cascade rinsing and countercurrent cascade rinsing plus chemical precipitation/flocculation). The EPA developed cost estimates for each of those. Second, drinking water treatment plants often use alum in treatment processes as a coagulant, and discharge filter backwash that may contain aluminum. The proposed criteria may result in the State's drinking water systems needing to reduce aluminum concentrations in their wastewater discharges. For this analysis, the EPA assumed that all water treatment plants in Oregon that discharge directly to surface waters currently use alum as a coagulant and estimated costs to the plants if they were to reduce their wastewater discharges of aluminum and divert the aluminum to sludge disposal. If these assumptions are incorrect, the costs estimated here would be either an overestimate or an underestimate. Third, wastewater treatment facilities often use chemical precipitation followed by filtration to remove phosphorus from the wastewater prior to discharge. The EPA examined the wastewater treatment facilities in the State that have permit limits for total phosphorus and therefore may use alum for phosphorus removal. The EPA assumed that these facilities would substitute ferrous coagulants for the aluminum coagulants, and estimated costs for that change.

If waters were to be identified as impaired when applying the economic analysis criteria, resulting in the need for TMDL development, there could be some costs to nonpoint sources of aluminum. Using available ambient monitoring data, the EPA compared total recoverable aluminum concentrations to the economic analysis criteria, and identified waterbodies that are potentially impaired. There are 826 samples across 260 stations. Note that the EPA was not able to identify BMPs for aluminum and therefore cannot make an estimate of potential nonpoint source costs associated with these discharges.

The NPDES-permitted facility for which monitoring data are available does not have reasonable potential to exceed the economic analysis criteria. Therefore, there are no data indicating that point source dischargers will incur annual costs to comply with the proposed rule.

For the supplemental point source analysis, the EPA made both a low-end and a high-end estimate for the costs to the State's 12 aluminum anodizers, based on two different technology upgrade options. Without information to know which option each facility would choose if they had to upgrade, the EPA estimated that if all 12 facilities upgraded to countercurrent cascade rinsing technology, the total annual cost would be $51,600 (at a 3% discount rate over the 20-year life of the capital equipment). On the high end, the EPA estimated that if all 12 facilities upgraded to countercurrent cascade rinsing technology plus chemical precipitation and settling, the total annual cost would be $5.77 million (at a 3% discount rate over the 20-year life of the capital equipment). For the 57 drinking water treatment plants assumed to use alum as a coagulant, the EPA estimated the annual costs for chemical and sludge disposal at $1.35 million (no additional capital equipment). For the four wastewater treatment facilities currently using alum as a coagulant, the EPA found that if they were to switch to a ferrous coagulant, they would realize $0.64 million in annual cost savings. Although the analysis would suggest potential cost savings, the EPA assumes that, in absence of the proposed rule, the facilities would already be using the lowest cost treatment. Therefore, the EPA estimated that the rule would result in no change in cost for these facilities. Because these estimates are based on assumed need for control strategies simply based on the projected presence of aluminum in various operations, with no specific knowledge of actual levels in any waste stream, these costs are highly speculative.

Based on available monitoring data and the economic analysis criteria, water quality may be impaired for 53 stations. Without additional information about how Oregon might categorize water bodies for the purpose of defining reaches impaired for aluminum, the EPA assumed that the 53 stations represent an upper bound on the number of incremental TMDLs. It may be possible to combine TMDLs for common water bodies ( i.e., if the State decides to combine development of TMDLs for a class of waters with impairments for similar causes) and reduce development costs, though the EPA has no way to know in advance whether the State will do this, or for how many waters. If there is water quality impairment under the economic analysis criteria, there could be costs for TMDL development. The EPA (2001) reports that the average cost to develop a TMDL for a single source of impairment ranges from $27,000 to $29,000 (in 2000 dollars) or $37,000 to $40,000 when updated to 2017 dollars. 28 TMDL development costs are one-time costs that the EPA assumed would be uniformly spread out over several years ( e.g., a 10-year time period). Spread uniformly over a 10-year period, the annual average costs for TMDL development would range from $196,000 to $212,000 for the development of 53 TMDLs.

Combining the potential costs for point source compliance from the supplemental point source analysis with the incremental cost of TMDL development, the total cost annualized at a 3% discount rate would range from $1.6 million to $7.3 million for the first 10 years. The cost would be slightly less in subsequent years after the TMDL development is complete. 29 The fully annualized costs of the rule  30 are $1.5 million to $7.2 million at a 3% discount rate; results at the, 7% discount rate are included in the Economic Analysis for the Proposed Rule: Aquatic Life Criteria for Aluminum in Oregon, but are quite similar.

Note that, while this analysis is based on the best publicly available data and Oregon's current practices regarding water quality impairments, it may not fully reflect the impact of the proposed criteria to nonpoint sources and implementing authorities. If additional monitoring data were available, or if ODEQ increases its monitoring of ambient conditions in future assessment periods, additional impairments may be identified under the baseline criteria and/or final criteria. Conversely, there may be fewer waters identified as impaired for aluminum after Oregon has fully implemented activities to address sources of existing impairments for other contaminants ( e.g., metals in stormwater runoff from urban, industrial, or mining areas).

The total costs presented in the Economic Analysis for the Proposed Rule: Aquatic Life Criteria for Aluminum in Oregon are a product of a series of assumptions and subsequent analyses that are intended to be both conservative and as comprehensive as possible. This proposed rule includes several safeguards inherent in both how aluminum criteria would be calculated for a given water body in practice, and in the implementation of WQS, in general. Permitting procedures such as reasonable potential analysis and TMDL development procedures ensure that entities that are significant contributors and have the capability of load reduction are properly identified and their impacts are accurately quantified. Furthermore, WQS allow for consideration of natural conditions, anthropogenic impacts that cannot be remedied, and social and economic impacts of additional controls through discharger-specific WQS variances and designated use modifications. In short, there are systems in place to evaluate tradeoffs that are central to any benefit-cost analysis. However, these tradeoffs cannot be evaluated without a comprehensive set of WQS that address all important water quality parameters. This and other analyses have demonstrated that aluminum is among the important water quality parameters with respect to supporting aquatic life designated uses. Numeric aluminum criteria can help facilitate the consideration of tradeoffs between control costs and the value of market and non-market use, and non-use benefits.

As determined by the Office of Management and Budget (OMB), this action is a significant regulatory action and was submitted to OMB for review. Any changes made during OMB's review have been documented in the docket. The EPA evaluated the potential costs to NPDES dischargers associated with State implementation of the Agency's proposed criteria. This analysis, Economic Analysis for the Proposed Rule: Aquatic Life Criteria for Aluminum in Oregon, is summarized in section VIII of the preamble and is available in the docket.

This action is expected to be an Executive Order 13771 regulatory action. Details on the estimated costs of this proposed rule can be found in the EPA's analysis of the potential costs and benefits associated with this action.

This action does not impose an information collection burden under the Paperwork Reduction Act. While actions to implement these WQS could entail additional paperwork burden, this action does not directly contain any information collection, reporting, or record-keeping requirements.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act. This action will not impose any requirements on small entities. The EPA-promulgated WQS are implemented through various water quality control programs including the NPDES program, which limits discharges to navigable waters except in compliance with a NPDES permit. CWA section 301(b)(1)(C)  31 and the EPA's implementing regulations at 40 CFR 122.44(d)(1) and 122.44(d)(1)(A) provide that all NPDES permits shall include any limits on discharges that are necessary to meet applicable WQS. Thus, under the CWA, the EPA's promulgation of WQS establishes WQS that the State implements through the NPDES permit process. While the State has discretion in developing discharge limits, as needed to meet the WQS, those limits, per regulations at 40 CFR 122.44(d)(1)(i), “must control all pollutants or pollutant parameters (either conventional, nonconventional, or toxic pollutants) which the Director determines are or may be discharged at a level that will cause, have the reasonable potential to cause, or contribute to an excursion above any [s]tate water quality standard, including [s]tate narrative criteria for water quality.” As a result of this action, the State of Oregon will need to ensure that permits it issues include any limitations on discharges necessary to comply with the WQS established in the final rule. In doing so, the State will have a number of choices associated with permit writing. While Oregon's implementation of the rule may ultimately result in new or revised permit conditions for some dischargers, including small entities, the EPA's action, by itself, does not impose any of these requirements on small entities; that is, these requirements are not self-implementing.

This action contains no federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for state, local, or tribal governments or the private sector. As these water quality criteria are not self-implementing, the EPA's action imposes no enforceable duty on any state, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 or 205 of the UMRA. This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that could significantly or uniquely affect small governments.

Under the technical requirements of Executive Order 13132, the EPA has determined that this proposed rule may not have federalism implications but believes that the consultation requirements of the Executive Order have been satisfied in any event. On several occasions over the course of September 2017 through February 2019, the EPA discussed with the Oregon Department of Environmental Quality the Agency's development of the federal rulemaking and clarified early in the process that if and when the State decided to develop and establish its own aluminum standards, the EPA would instead assist the State in its process. During these discussions, the EPA explained the scientific basis for the proposed criteria; the external peer review process and the comments the Agency received on the revised CWA section 304(a) criteria recommendation on which the proposed criteria are based; the Agency's consideration of those comments and responses; possible alternatives for criteria, including default criteria and input values; and the overall timing of the federal rulemaking effort. The EPA took these discussions with the State into account during the drafting of this proposed rule. The EPA considered the State's initial feedback in making the Agency's decision to propose the criteria as drafted and solicit comment on the default criteria values and default DOC input values as described in Section B. Proposed Acute and Chronic Aluminum Criteria for Oregon's fresh waters of this proposed rulemaking.

The EPA specifically solicits comments on this proposed action from State and local officials.

This action does not have tribal implications as specified in Executive Order 13175. This proposed rule does not impose substantial direct compliance costs on federally recognized tribal governments, nor does it substantially affect the relationship between the federal government and tribes, or the distribution of power and responsibilities between the federal government and tribes. Thus, Executive Order 13175 does not apply to this action.

Many tribes in the Pacific Northwest hold reserved rights to take fish for subsistence, ceremonial, religious, and commercial purposes. The EPA developed the criteria in this proposed rule to protect aquatic life in Oregon from the effects of exposure to harmful levels of aluminum. Protecting the health of fish in Oregon will, therefore, support tribal reserved fishing rights, including treaty-reserved rights, where such rights apply in waters under State jurisdiction.

Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, the Agency consulted with tribal officials during the development of this action. The EPA has sent a letter to tribal leaders in Oregon offering to consult on the proposed aluminum criteria in this rule. The EPA will hold a conference call with tribal water quality technical contacts and tribal officials to explain the Agency's proposed action and timeline approximately two weeks after the proposal is published and the comment period is initiated. The EPA will continue to communicate with the tribes prior to its final action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the Agency has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

This proposed rulemaking does not involve technical standards.

The human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The criteria in this proposed rule, once finalized, will support the health and abundance of aquatic life in Oregon, and will therefore benefit all communities that rely on Oregon's ecosystems.

For the reasons set forth in the preamble, the EPA proposes to amend 40 CFR part 131 as follows:

Background

Improvement of regulations is a continuous focus for the Department of Transportation (DOT) and MARAD. For that reason, DOT/MARAD regularly and deliberately review their rules in accordance with DOT's 1979 Regulatory Policies and Procedures (44 FR 11034), Executive Order (E.O.) 12866, E.O. 13563, and section 610 of the Regulatory Flexibility Act. That process is summarized in Appendix D of DOT's semi-annual regulatory agenda ( e.g., 81 FR 94784). In E.O. 13771 and E.O. 13777, President Trump directed agencies to further scrutinize their regulations. Comments received will inform the review described in this notice and supplement MARAD's periodic regulatory review and its activities under E.O. 13771 and E.O. 13777. This request for comments is narrowly focused on improving and modernizing MARAD's program administration.

Accordingly, MARAD has identified its regulations at 46 CFR part 355 governing requirements for evidencing United States citizenship for consideration consistent with the President's direction. This notice seeks to solicit comments to ensure that MARAD's programs remain effective, modern, and the least burdensome to the public. As part of our review, MARAD is issuing this notice to engage the public and the broad spectrum of stakeholders that may be affected. Information received will be used to evaluate the issues and determine whether to propose a change in how corporations evidence their citizenship.

Citizenship eligibility criteria and documentation requirements may affect stakeholders who participate, directly or indirectly, in MARAD programs and activities, including ship managers and agents of MARAD-owned ships (herein collectively referred to as “Vessel Operators”) which may be used by the Department of Defense (DOD) in support of certain DOD-controlled activities. For example, Vessel Operators are required by regulation to be at least majority owned and controlled by United States citizens at each tier of ownership.

MARAD is interested in learning how it could reduce or remove regulatory burdens on the public. Accordingly, commenters may want to focus on the following: (1) Recognition of modern business forms in addition to corporations ( e.g., limited liability companies and limited partnerships) and modern securities ownership practices ( e.g., street name securities); (2) aligning with current best business practices; (3) reducing the cost of compliance; and (4) revising the corporate citizenship affidavit.

We are interested in information on how any changes to 46 CFR part 355 could impact small businesses, either positively or negatively. In describing a burden placed on your organization by our regulations or potential changes to the regulations, direct experience and quantifiable data are more useful than anecdotal descriptions. If the commenter believes that there is a less burdensome alternative, the commenter should describe that alternative in verifiable detail.

Under this notice, MARAD is not soliciting petitions for rulemaking.

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Please note that even after the comment period has closed, MARAD will continue to file relevant information in the Docket as it becomes available.

Go to the docket online at http://www.regulations.gov., keyword search MARAD-2019-0069 or visit us in person at the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

Background

Improvement of regulations is a continuous focus for the Department of Transportation (DOT) and MARAD. For that reason, DOT/MARAD regularly and deliberately review their rules in accordance with DOT's 1979 Regulatory Policies and Procedures (44 FR 11034), Executive Order (E.O.) 12866, E.O. 13563, and section 610 of the Regulatory Flexibility Act. That process is summarized in Appendix D of DOT's semi-annual regulatory agenda ( e.g., 81 FR 94784). In E.O. 13771 and E.O. 13777, President Trump directed agencies to further scrutinize their regulations. Comments received will inform the review described in this notice and supplement MARAD's periodic regulatory review and its activities under E.O. 13771 and E.O. 13777. This request for comments is narrowly focused on improving and modernizing MARAD's program administration.

Accordingly, MARAD has identified its AFA regulations governing citizenship procedures for consideration consistent with the President's direction. This notice seeks to solicit comments to ensure that the program remains effective, modern, and the least burdensome to the public. As part of our review, MARAD is issuing this notice to engage the public and the broad spectrum of stakeholders that may be affected. Information received will be used to evaluate the issues and determine whether to propose a change in acceptable statements of citizenship.

MARAD is interested in learning how it could reduce or remove regulatory burdens on the public. Accordingly, commenters may want to focus on the following: (1) Whether there are less burdensome methods to evidence corporate citizenship annually; (2) how those alternatives may be applied to improve MARAD program administration consistent with E.O. 13771; and (3) how program participants will benefit from a revision of our AFA regulations.

We are interested in information on how any changes to these regulations could impact small businesses, either positively or negatively. In describing a burden placed on your organization by our regulations or potential changes to the regulations, direct experience and quantifiable data are more useful than anecdotal descriptions. If the commenter believes that there is a less burdensome alternative, the commenter should describe that alternative in verifiable detail.

Under this notice, MARAD is not soliciting petitions for rulemaking.

Please submit your comments, including the attachments, following the instructions provided under the above heading entitled ADDRESSES . Be advised that it may take a few hours or even days for your comment to be reflected on the docket. In addition, your comments must be written in English. We encourage you to provide concise comments and you may attach additional documents as necessary. There is no limit on the length of the attachments.

Please note that even after the comment period has closed, MARAD will continue to file relevant information in the Docket as it becomes available.

Go to the docket online at http://www.regulations.gov., keyword search MARAD-2019-0070 or visit us in person at the Docket Management Facility (see ADDRESSES for hours of operation). We recommend that you periodically check the Docket for new submissions and supporting material.

Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.

If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.

In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to www.regulations.gov, as described in the system of records notice, DOT/ALL-14 FDMS, accessible through www.dot.gov/privacy. To facilitate comment tracking and response, we encourage commenters to provide their name, or the name of their organization; however, submission of names is completely optional. Whether or not commenters identify themselves, all timely comments will be fully considered. If you wish to provide comments containing proprietary or confidential information, please contact the agency for alternate submission instructions.

Background

This rule proposes specifications, which are the combined suite of commercial and recreational catch levels established for one or more fishing years, for Illex squid. Section 302(g)(1)(B) of the Magnuson-Stevens Fishery Conservation and Management Act states that the Scientific and Statistical Committee (SSC) for each regional fishery management council shall provide its Council ongoing scientific advice for fishery management decisions, including recommendations for acceptable biological catch (ABC), preventing overfishing, ensuring maximum sustainable yield, and achieving rebuilding targets. The ABC is a level of catch that accounts for the scientific uncertainty in the estimate of the stock's defined overfishing level (OFL).

The regulations implementing the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan (FMP) require the Mid-Atlantic Fishery Management Council's Atlantic Mackerel, Squid, and Butterfish Monitoring Committee to develop specification recommendations for each species based upon the ABC advice of the Council's SSC. The FMP regulations also require the specification of annual catch limits (ACL) and accountability measure (AM) provisions for butterfish. Both squid species are exempt from the ACL/AM requirements because they have a life cycle of less than one year. In addition, the regulations require the specification of domestic annual harvest (DAH), domestic annual processing (DAP), total allowable level of foreign fishing (TALFF), joint venture processing (JVP), commercial and recreational annual catch targets (ACT), the butterfish mortality cap in the longfin squid fishery, and initial optimum yield (IOY) for both squid species.

On March 1, 2018 (83 FR 8764), we published a final rule in the Federal Register implementing Illex and longfin squid and butterfish specifications for 2018 and projected specifications for fishing years 2019 and 2020. Since then, the Council's SSC met on May 8, 2018, to reevaluate the 2019 specifications based upon the latest information. At that meeting, the SSC concluded that no adjustments to these specifications were warranted. However, the SSC met again on September 18, 2018, at the request of the Council to reevaluate its Illex squid specification recommendation and consider increasing the 2019 Illex landing limit given the fishery had fully harvested available quotas in both the 2017 and 2018 fishing years. The SSC reiterated its observation that landings up to 26,000 mt have not caused harm to the Illex stock. It concluded that raising the Illex squid ABC to 26,000 mt for 2019 and maybe 2020 would not likely result in a greater than 40 percent chance of overfishing this stock. On October 3, 2018, the Council adopted the updated SSC recommendations for a 26,000-mt Illex squid ABC in 2019 and 2020, but did not recommend any changes to the previously approved 2019 specifications for longfin squid and butterfish. The Council submitted its recommendations, as summarized below, along with the required analyses, for initial agency review on February 11, 2019. NMFS must review the Council's recommendations for compliance with the FMP and applicable law, and conduct notice-and-comment rulemaking to propose and implement the final specifications.

This action does not consider revisions to existing specifications for Atlantic mackerel. On August 13, 2018, the Council approved Framework Adjustment 13 to the FMP. This action includes a rebuilding program for Atlantic mackerel and annual specifications for 2019-2021. We will publish a separate proposed rule in the Federal Register to solicit public input on the specifications for the Atlantic mackerel fishery. Until new specifications are implemented, the existing Atlantic mackerel, longfin squid, and butterfish specifications, as described below, will continue pursuant to 50 CFR 648.22(d)(1).

This action maintains the existing longfin squid ABC of 23,400 mt for 2019, as implemented on March 1, 2018 (83 FR 8764). The background for this ABC is discussed in the proposed rule to implement the 2018-2020 squid and butterfish specifications (December 13, 2017; 82 FR 58583) and is not repeated here. The IOY, DAH, and DAP are calculated by deducting an estimated discard rate (2.0 percent) from the ABC. This results in a 2019 IOY, DAH, and DAP of 22,932 mt (Table 1). This action also maintains the existing allocation of longfin squid DAH among trimesters according to percentages specified in the FMP (Table 2). The Council will review these specifications during its annual specifications process following annual data updates each spring, and may change its recommendation for 2020 if new information is available.

This action also maintains the previously approved 2019 butterfish specifications outlined in Table 3, as implemented on March 1, 2018 (83 FR 8764). The background for these specifications is discussed in the proposed rule to implement the 2018-2020 squid and butterfish specifications (December 13, 2017; 82 FR 58583) and is not repeated here. In summary, the 2019 butterfish specifications are based on long-term recruitment estimates and include a 7.5 percent management uncertainty buffer and an estimated discard rate of 2.4 percent. These specifications maintain the existing butterfish mortality cap in the longfin squid fishery (3,884 mt) and the existing allocation of the butterfish mortality cap among longfin squid trimesters (Table 4).

Consistent with the Council's recommendation summarized above, NMFS proposes to increase the 2019 Illex ABC from 24,000 mt to 26,000 mt. The Council recommended that the ABC be reduced by the status quo discard rate of 4.52 percent, which results in a 2019 IOY, DAH, and DAP of 24,825 mt (Table 5), an increase of 8 percent compared to 2018 levels (22,915 mt). The Council will review this decision during its annual specifications process following annual data updates each spring, and may change its recommendations for 2020 if new information is available.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Atlantic Mackerel, Squid, and Butterfish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

This action is exempt from review under E.O. 12866. This proposed rule is not expected to be an Executive Order 13771 regulatory action because this proposed rule is exempt from E.O. 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The purpose, context, and statutory basis for this action is described above and not repeated here. Business entities affected by this action include vessels that are issued limited access longfin squid, Illex squid, and butterfish permits. Although vessels issued open access incidental catch permits for these species are also potentially affected by this action, because these vessels land only small amounts of squid and butterfish and this action would not revise the amount of squid and butterfish that these vessels can land, these entities would not be affected by this proposed rule.

Any entity with combined annual fishery landing receipts less than $11 million is considered a small entity based on standards published in the Federal Register (80 FR 81194, December 29, 2015). In 2017, 63 separate vessels were issued limited access Illex squid permits in 2017. These vessels were owned by 51 entities, 45 of which earned less than $11 million in revenue and were small business entities that would be affected by this action. Average revenues for these entities was $2.0 million in 2017.

The previously approved longfin squid and butterfish commercial landing limits would not be changed by this proposed action, while the commercial Illex squid landing limit would be increased by 8 percent (1,910 mt). Fishing revenue and, therefore, economic impacts of yearly Illex squid specifications depend upon species availability, which may change yearly. For example, the Illex squid fishery landed 14.7 million lb in 2016 for a value of $7.2 million, yet landed over 49.6 million lb in 2017 for a value of just over $22 million. The proposed 1,910-mt increase in the 2019 Illex squid landing limit would increase fishing revenue by nearly $1.9 million compared to the 2018 landing limit if the fishery lands all available quota. If the fishery fully harvests the proposed 2019 commercial landing limit, it could generate approximately $25 million in fishing revenue based on 2016 prices. In determining the significance of the economic impacts of the proposed action, we considered the following two criteria outlined in applicable National Marine Fisheries Service guidance: Disproportionality and profitability. The proposed measures would not place a substantial number of small entities at a significant competitive disadvantage to large entities; all entities affected by this action would be equally affected. Accordingly, there are no distributional economic effects from this action between small and large entities. Proposed measures would not reduce fishing opportunities based on recent squid and butterfish landings, change any entity's access to these resources, or impose any costs to affected entities. Therefore, this action would not reduce revenues or profit for affected entities compared to recent levels. Based on the above justification, the proposed action is not expected to have a significant economic impact on a substantial number of small entities.