Source: https://www.deadiversion.usdoj.gov/fed_regs/rules/2019/fr0913.htm
Timestamp: 2019-12-09 18:00:20
Document Index: 243734286

Matched Legal Cases: ['art 1309', 'art 1310', 'art 1313', 'art 1310', '§1310', '§1310', 'arts 1309', '§1310', '§1310', 'arts 1309']

RESOURCES > Federal Register Notices > Rules - 2019 > Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals
[Pages 48314-48321]
[FR Doc No: 2019-19787]
SUMMARY: The Drug Enforcement Administration (DEA) is proposing the control of N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4-amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) (hereinafter referred to as 4-anilinopiperidine), including its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act (CSA).
Benzylfentanyl and 4-anilinopiperidine are used in, and are important to, the illicit manufacture of the schedule II controlled substance fentanyl. If finalized, this action would subject handlers of benzylfentanyl and 4-anilinopiperidine to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of benzylfentanyl or 4-anilinopiperidine. As such, all transactions of chemical mixtures containing benzylfentanyl or 4-anilinopiperidine will be regulated at any concentration and will be subject to control under the CSA.
DATES: Comments must be submitted electronically or postmarked on or before November 12, 2019. Commenters should be aware that the electronic Federal Docket Management System will not accept any comments after 11:59 p.m. Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-497" on all electronic and written correspondence, including any attachments.
Paper comments: Paper comments that duplicate electronic submissions are not necessary. Should you wish to mail a paper comment, in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the DEA for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.
The DEA is extremely concerned with the increase in the illicit manufacture and distribution of fentanyl. Fentanyl is a synthetic opioid and was first synthesized in Belgium in the late 1950's. Fentanyl is controlled in schedule II of the CSA due to its high potential for abuse and dependence, and accepted medical use in treatment in the United States. Fentanyl was introduced
into medical practice and is approved for medical practitioners in the United States to prescribe lawfully for anesthesia and analgesia. Due to its pharmacological effects, fentanyl can serve as a substitute for heroin, oxycodone, and other opioids in opioid dependent individuals.
\3\ Scholl L., Seth P., Kariisa M., Wilson N., Baldwin G. Drug and Opioid-Involved Overdose Deaths-- United States, 2013-2017. MMWR Morb Mortal Wkly Rep 2019;67:1419-1427.
Fentanyl is not a naturally occurring substance. As such, the manufacture of fentanyl requires it to be produced through synthetic organic chemistry. Synthetic organic chemistry is the process in which a new organic molecule is created through a series of chemical reactions, which involve precursor chemicals. In the early 2000's, a synthetic process, commonly known as the Siegfried method, was utilized to manufacture fentanyl in several domestic and foreign clandestine laboratories. 72 FR 20039. At that time, DEA had determined that two primary synthesis routes (i.e., the Janssen method and the Siegfried method) were being used to produce fentanyl clandestinely, although it believed the Janssen synthesis route to be difficult to perform and beyond the rudimentary skills of most clandestine laboratory operators. The Siegfried synthetic route involves two important intermediates, N-phenethyl-4-piperidone (NPP) and 4-anilino-N-phenethylpiperidine (ANPP). The DEA controlled NPP on April 23, 2007 as a list I chemical through an interim rule (72 FR 20039), which was finalized on July 25, 2008. 73 FR 43355. ANPP was controlled as a schedule II immediate precursor to fentanyl on August 30, 2010. 75 FR 37295.
In 2017, the United Nations Commission on Narcotic Drugs placed NPP and ANPP in Table I of the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (1988 Convention) in response to the international reintroduction of fentanyl on the illicit drug market. As such, member states of the United Nations were required to regulate these precursor chemicals at the national level. In addition, the People's Republic of China regulated NPP and ANPP on February 1, 2018.
Recent law enforcement information indicates that illicit manufacturers of fentanyl may utilize synthetic routes other than the Siegfried method in response to regulations placed on NPP and ANPP. The Janssen method, previously thought to be beyond the skills of most clandestine laboratory operators, is now used with the precursor chemical benzylfentanyl, and other synthetic routes use the precursor chemical 4-anilinopiperidine. The DEA is not aware of any legitimate uses of benzylfentanyl or 4-anilinopiperidine other than in the synthesis of fentanyl.
The original published synthetic pathway to fentanyl, known as the Janssen method, does not involve NPP or ANPP as a chemical precursor. This synthetic pathway involves the important precursors, benzylfentanyl and norfentanyl. Benzylfentanyl is converted to N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl), the immediate precursor in this synthetic pathway, in one chemical reaction. Norfentanyl is then subjected to one simple chemical reaction to complete the synthesis of fentanyl. Norfentanyl is the subject of a Notice of Proposed Rulemaking for control as a schedule II immediate precursor of fentanyl, published elsewhere in this issue of the Federal Register.
According to DEA forensic laboratory data, the Janssen method was confirmed as the synthetic route used in 94% of 85 fentanyl drug exhibits that were evaluated to determine the synthetic route. These exhibits were seized in 2018. In addition, the number of law enforcement encounters of benzylfentanyl has increased in 2017 and 2018, which coincides with the international control that placed of NPP and ANPP in Table I of the 1988 Convention in 2017.
According to NFLIS, there was one identification of benzylfentanyl in 2016; however, benzylfentanyl was identified in 195 reports in 2017 and 237 reports in 2018. Since the DEA is not aware of any legitimate uses of benzylfentanyl other than potentially in the synthesis of fentanyl, it is believed that these law enforcement encounters indicate a change in the synthetic route to the Janssen method by some clandestine manufacturers in efforts to evade chemical regulations on NPP and ANPP.
The DEA has determined that benzylfentanyl is commercially available from both domestic and foreign chemical suppliers. The DEA is aware of at least five domestic suppliers and three foreign suppliers in China, two suppliers in Canada, and one supplier in the United Kingdom. Benzylfentanyl is attractive to illicit manufacturers due to the lack of chemical regulations on this substance, it is readily available from chemical suppliers, and it can be converted to the immediate precursor, norfentanyl, in a one-step chemical reaction.
In addition to the Janssen and Siegfried methods, clandestine manufacturers are using other methods to synthesize fentanyl. 4-Anilinopiperidine can serve as an alternative precursor chemical to NPP in the synthesis of ANPP, albeit through a different synthetic process. 4-Anilinopiperidine has been marketed as a replacement to ANPP as a precursor chemical used in the illicit manufacture of fentanyl by foreign chemical suppliers. This is believed to be in response to international controls placed on NPP and ANPP. Although marketed as a replacement for ANPP, DEA understands that 4-anilinopiperidine is not a direct replacement for ANPP in the synthesis of fentanyl. The DEA is not aware of any legitimate uses of 4-anilinopiperidine other than potentially in the synthesis of fentanyl. In contrast to NPP, where two chemical reaction steps are required to synthesize ANPP, 4-anilinopiperidine can be converted to ANPP in a one-step chemical reaction. The resulting ANPP can then be used as the immediate precursor chemical in the illicit manufacture of the schedule II controlled substance, fentanyl. ANPP is controlled in schedule II of the CSA as of August 30, 2010 for this reason. 75 FR 37295 (June 29, 2010).
4-Anilinopiperidine has been imported and identified in law enforcement seizures in the United States. In addition to domestic encounters, the DEA is aware of international encounters of 4-anilinopiperidine beginning as early as July 2018. The International Narcotics Control Board of the United Nations reported 32 international transactions of 4-anilinopiperidine through the International Operations on Novel Psychoactive Substances Communication System IONICS \5\ reporting system. These identifications, totaling approximately 30 kg, were reported by Mexico as the destination country. In addition, 4-anilinopiperidine was identified at a clandestine laboratory located in Mexico, which was involved in the illicit manufacture of fentanyl.
These recent law enforcement encounters of 4-anilinopiperidine coincide with the placement of NPP and ANPP in Table I of the 1988 Convention, and the February 1, 2018 regulation of NPP and ANPP in the People's Republic of China. The international encounters of 4-anilinopiperidine at ports of entry in Mexico indicate a change in illicit fentanyl manufacturing methods in efforts to evade international controls on NPP and ANPP.
The DEA determined that 4-anilinopiperidine is commercially available from both domestic and foreign chemical suppliers. The DEA has identified 38 domestic suppliers and 28 foreign suppliers of 4-anilinopiperidine from Canada (3), China (11), Germany (3), Hong Kong (1), India (1), Latvia (1), Lithuania (1), Switzerland (2), and the United Kingdom (5). 4-Anilinopiperidine is attractive to illicit manufacturers due to the lack of chemical controls on this substance, it is readily available from chemical suppliers, and it can easily be converted to the schedule II immediate precursor, ANPP, which can subsequently be converted to fentanyl.
The CSA, specifically 21 U.S.C. 802(34), 21 U.S.C. 802(35), and its implementing regulations at 21 CFR 1310.02(c), provide the Attorney General with the authority to specify, by regulation, additional precursor or essential chemicals as "listed chemicals" if they are used in the manufacture of controlled substances in violation of the CSA. Recent law enforcement encounters indicate benzylfentanyl and 4-anilinopiperidine are being used in the illicit manufacture of the schedule II controlled substance fentanyl. This proposed rule would regulate benzylfentanyl and 4-anilinopiperidine as list I chemicals because the DEA finds that benzylfentanyl and 4-anilinopiperidine are used in the manufacture of the controlled substance fentanyl, and are important to the manufacture of the controlled substance fentanyl because they cannot be replaced by other chemicals in their respective synthetic pathways in the manufacture of fentanyl.
This proposed rulemaking, if finalized, would specify that chemical mixtures containing benzylfentanyl or 4-anilinopiperidine would not be exempt from regulatory requirements at any concentration, unless an application for exemption of a chemical mixture is submitted by a benzylfentanyl or 4-anilinopiperidine manufacturer and the application is reviewed and accepted by the DEA under 21 CFR 1310.13 (Exemption by Application Process). The control of chemical mixtures containing any amount of benzylfentanyl or 4-anilinopiperidine is necessary to prevent the illicit extraction, isolation, and use of benzylfentanyl or 4-anilinopiperidine to manufacture fentanyl. This proposed rule would modify the Table of Concentration Limits in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of benzylfentanyl or 4-anilinopiperidine are subject to the CSA chemical control provisions.
The DEA has implemented an application process to exempt mixtures from the requirements of the CSA and its implementing regulations. 21 CFR 1310.13. Under the application process, manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption. Exemption status can be granted if the DEA determines that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical cannot be readily recovered (i.e., it meets the conditions in 21 U.S.C. 802(39)(A)(vi)).
If this rule is finalized as proposed, benzylfentanyl and 4-anilinopiperidine will be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. Upon publication of a final rule, persons potentially handling benzylfentanyl or 4-anilinopiperidine, including regulated chemical mixtures containing benzylfentanyl or 4-anilinopiperidine, will be required to comply with list I chemical regulations, including the following:
1. Registration. Any person who manufactures, distributes, imports, or exports benzylfentanyl or 4-anilinopiperidine, or proposes to engage in the manufacture, distribution, importation, or exportation of benzylfentanyl or 4-anilinopiperidine, must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309.
The DEA recognizes that it is not possible for persons who are subject to
the registration requirements to immediately complete and submit an application for registration, and for the DEA to immediately issue registrations for those activities. Therefore, to allow any continued legitimate commerce in benzylfentanyl and 4-anilinopiperidine, the DEA is proposing to establish in 21 CFR 1310.09, a temporary exemption from the registration requirement for persons desiring to engage in activities with benzylfentanyl or 4-anilinopiperidine, provided that the DEA receives a properly completed application for registration or application for exemption of a chemical mixture under 21 CFR 1310.13 on or before 30 days after publication of a final rule implementing regulations regarding benzylfentanyl and 4-anilinopiperidine. The temporary exemption for such persons will remain in effect until the DEA takes final action on their application for registration or application for exemption of a chemical mixture.
The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would become effective on the effective date of the final rule. This is necessary because a delay in regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.
2. Records and Reports. Every DEA registrant would be required to maintain records and submit reports with respect to benzylfentanyl and 4-anilinopiperidine pursuant to 21 U.S.C. 830 and in accordance with 21 CFR part 1310. Pursuant to 21 CFR 1310.04, a record must be kept for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.
Each regulated bulk manufacturer of a listed chemical will be required to submit manufacturing, inventory, and use data on an annual basis. 21 CFR 1310.05(d). Existing standard industry reports containing the required information are acceptable, provided the information is separate or readily retrievable from the report.
3. Importation and Exportation. All importation and exportation of benzylfentanyl or 4-anilinopiperidine would need to be done in compliance with 21 U.S.C. 957, 958, and 971 and in accordance with 21 CFR part 1313.
4. Security. All applicants and registrants would be required to provide effective controls against theft and diversion of list I chemicals in accordance with 21 CFR 1309.71-1309.73.
As part of this proposed rulemaking, the DEA is soliciting information on any possible legitimate uses of benzylfentanyl and 4-anilinopiperidine unrelated to fentanyl production (including industrial uses) in order to assess the potential commercial impact of controlling benzylfentanyl and 4-anilinopiperidine. The DEA has searched information in the public domain for legitimate uses of these two chemicals, and has not documented a legitimate commercial use for benzylfentanyl or 4-anilinopiperidine other than as intermediary chemicals in the production of fentanyl. The DEA seeks, however, to document any unpublicized use(s) and other proprietary use(s) of benzylfentanyl and 4-anilinopiperidine that are not in the public domain. Therefore, the DEA is soliciting comment on the uses of benzylfentanyl and 4-anilinopiperidine in the legitimate marketplace.
The DEA is soliciting input from all potentially affected parties regarding: (1) The types of legitimate industries using benzylfentanyl and 4-anilinopiperidine; (2) the legitimate uses of benzylfentanyl and 4-anilinopiperidine, if any; (3) the size of the domestic market for benzylfentanyl and 4-anilinopiperidine; (4) the number of manufacturers of benzylfentanyl and 4-anilinopiperidine; (5) the number of distributors of benzylfentanyl and 4-anilinopiperidine; (6) the level of import and export of benzylfentanyl and 4-anilinopiperidine; (7) the potential burden these proposed regulatory controls of benzylfentanyl and 4-anilinopiperidine may have on any legitimate commercial activities; (8) the potential number of individuals/firms that may be adversely affected by these proposed regulatory controls (particularly with respect to the impact on small businesses); and (9) any other information on the manner of manufacturing, distribution, consumption, storage, disposal, and uses of benzylfentanyl and 4-anilinopiperidine by industry and others. The DEA invites all interested parties to provide any information on any legitimate uses of benzylfentanyl and 4-anilinopiperidine in industry, commerce, academia, research and development, or other applications. The DEA seeks both quantitative and qualitative data.
This proposed rule was developed in accordance with the principles of Executive Orders 12866, 13563, and 13771. Executive Order 12866 directs 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; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. Executive Order 12866 classifies a "significant regulatory action," requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector 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 the Executive Order. The DEA has determined that this proposed rule is not a "significant regulatory action" under Executive Order 12866, section 3(f).
If finalized as proposed, benzylfentanyl and 4-anilinopiperidine will be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. Benzylfentanyl and 4-anilinopiperidine are used in, and are important to, the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years.
The DEA has searched information in the public domain for any legitimate uses of these two chemicals, and has not documented a use for benzylfentanyl or 4-anilinopiperidine other than as intermediary chemicals in the production of fentanyl. Based on the review of import and quota information for NPP, ANPP, and fentanyl, The DEA believes the vast majority of, if not all, legitimate pharmaceutical fentanyl is produced via a synthetic route involving NPP and ANPP as intermediaries, not benzylfentanyl (and norfentanyl) or 4-anilinopiperidine. The quantities of NPP and ANPP indicated in import and quota documents generally correspond with the quantities of legitimate pharmaceutical fentanyl produced in the U.S. Therefore, the DEA concludes the vast majority of, if not all, benzylfentanyl or 4-anilinopiperidine is used for the manufacturing of illicit fentanyl.
The DEA cannot rule out the possibility that minimal quantities of benzylfentanyl or 4-anilinopiperidine are used for the manufacturing of legitimate pharmaceutical fentanyl. However, if there are any quantities of benzylfentanyl or 4-anilinopiperidine used for the manufacturing of legitimate pharmaceutical fentanyl, the quantities are believed to be small and economically insignificant. The DEA welcomes any public comment on these quantities and their economic significance.
The DEA evaluated the costs and benefits of this proposed action. Costs
The DEA believes the market for benzylfentanyl or 4-anilinopiperidine for the legitimate manufacturing of pharmaceutical fentanyl is minimal. As stated above, the only use for benzylfentanyl and 4-anilinopiperidine of which the DEA is aware is as intermediaries for the manufacturing of fentanyl. Any manufacturer, distributor, importer, or exporter of benzylfentanyl or 4-anilinopiperidine for the production of legitimate pharmaceutical fentanyl, if they exist at all, would incur costs if this proposed rule were finalized. The primary costs associated with this proposed rule would be the annual registration fees for scheduled drugs or list I chemicals ($3,047 for manufacturers and $1,523 for distributors, importers, and exporters). However, any manufacturer that uses benzylfentanyl or 4-anilinopiperidine for legitimate pharmaceutical fentanyl production would already be registered with the DEA and have all security and other handling processes in place because of the controls already in place on fentanyl, resulting in minimal cost to those entities. While different forms of handling the scheduled substance versus the list I chemical (distribution of fentanyl vs exporting benzylfentanyl), could require a separate registration for the different handling of the substances, if an entity is already registered to handle, manufacture, import, or export a scheduled substance, the entity would not need an additional registration for the list I chemical, provided it is handling the list I chemical in the same manner that it is registered for with the scheduled substance, or as a coincident activity permitted by Sec. 1309.21. Even with the possibility of these additional registrations, the DEA believes that the cost will be minimal.
The DEA has identified 38 domestic suppliers of benzylfentanyl, 4-anilinopiperidine, or both. Only one is registered to handle list I chemicals, the remaining 37 are not registered with the DEA to handle list I chemicals. It is difficult to estimate how much benzylfentanyl and 4-anilinopiperidine is distributed by these suppliers. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the review of import and quota information for NPP, ANPP, and fentanyl, where the quantities of NPP and ANPP imported and manufactured generally correspond with the quantities of fentanyl produced, the DEA believes any quantity of sales from these distributors for legitimate pharmaceutical fentanyl manufacturing is minimal. If this proposed rule is finalized, suppliers for the legitimate use of benzylfentanyl or 4-anilinopiperidine are expected to choose the least-cost option, and stop selling the minimal quantities, if any, of benzylfentanyl or 4-anilinopiperidine, rather than incur the registration cost. Because the DEA believes the quantities of benzylfentanyl or 4-anilinopiperidine supplied for the legitimate manufacturing of pharmaceutical fentanyl are minimal, the DEA estimates that the cost of foregone sales is minimal; and thus, the cost of this proposed rule is minimal. The DEA welcomes any public comment regarding this estimate.
This analysis excludes consideration of any economic impact to those businesses that facilitate the manufacturing and distribution of benzylfentanyl or 4-anilinopiperidine for the production of manufacturing illicit fentanyl. As a law enforcement organization and as a matter of principle, the DEA believes considering the economic utility of facilitating the manufacture of illicit fentanyl would be improper.
Controlling benzylfentanyl and 4-anilinopiperidine is expected to prevent, curtail, and limit the unlawful manufacture and distribution of the controlled substance, fentanyl. As list I chemicals, handling of benzylfentanyl
and 4-anilinopiperidine would require registration with the DEA and various controls and monitoring as required by the CSA. This proposed rule is also expected to assist preventing the possible theft or diversion of benzylfentanyl and 4-anilinopiperidine from any legitimate firms. The DEA also believes control is necessary to prevent unscrupulous chemists from synthesizing benzylfentanyl and 4-anilinopiperidine and selling it (as an unregulated material) through the internet and other channels, to individuals who may wish to acquire unregulated intermediary chemicals for the purpose of manufacturing illicit fentanyl.
In summary, the DEA conducted a qualitative analysis of costs and benefits. The DEA believes this proposed action, if finalized, will minimize the diversion of benzylfentanyl and 4-anilinopiperidine. The DEA believes the market for benzylfentanyl and 4-anilinopiperidine for the legitimate manufacturing of pharmaceutical fentanyl is minimal. Therefore, any potential cost as a result of this regulation is minimal.
This proposed rule does not have tribal implications warranting the application of Executive Order 13175. This proposed rule does not have substantial direct effects 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.
The Acting Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. As discussed above, if finalized as proposed, benzylfentanyl and 4-anilinopiperidine will be subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. Benzylfentanyl and 4-anilinopiperidine are used in, and are important to, the illicit manufacture of the schedule II controlled substance fentanyl. The distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of thousands of fentanyl-related overdoses in the United States in recent years. The DEA has not identified any legitimate industrial use for benzylfentanyl and 4-anilinopiperidine, other than their role as intermediary chemicals in the production of fentanyl. However, the DEA believes the vast majority, if not all, of legitimate pharmaceutical fentanyl is produced via a synthetic route involving NPP and ANPP as intermediaries, not benzylfentanyl (and norfentanyl) or 4-anilinopiperidine. The review of import and quota information for fentanyl, ANPP, and NPP supports this belief. Therefore, the DEA believes the vast majority, if not all, of benzylfentanyl or 4-anilinopiperidine is used for the illicit manufacturing of fentanyl. The primary costs associated with this proposed rule are the annual registration fees ($3,047 for manufacturers and $1,523 for distributors, importers, and exporters). Additionally, any manufacturer that uses benzylfentanyl or 4-anilinopiperidine for legitimate pharmaceutical fentanyl production would already be registered with the DEA and have all security and other handling processes in place, resulting in minimal cost.The DEA has identified 38 domestic suppliers of benzylfentanyl, 4-anilinopiperidine, or both, 37 of which are not registered with the DEA to handle list I chemicals. All 37 non-registered domestic suppliers are affected, of which 35 (94.5%, based on Small Business Administration size standard for chemical distributors and Statistics of U.S. Business data) are estimated to be small entities. It is impossible to know how much benzylfentanyl or 4-anilinopiperidine is distributed by these suppliers. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the review of import and quota information for NPP, ANPP, and fentanyl, where the quantities of NPP and ANPP imported and manufactured generally correspond with the quantities of fentanyl produced, the DEA believes any quantity of sales from these distributors for legitimate pharmaceutical fentanyl manufacturing is minimal. Therefore, the DEA estimates the cost of this rule on any affected small entity is minimal. The DEA welcomes any public comment regarding this estimate. Based on these factors, the DEA projects that this rule, if promulgated, will not result in a significant economic impact on a substantial number of small entities.
This proposed action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This proposed action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
For the reasons set out above, the DEA proposes to amend 21 CFR part 1310 as follows:
(33) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4–AP), its amides, its carbamates, and its salts 8335
c. Add new paragraphs (g)(1)(vii) and (ix). The additions read as follows:
(vii) N-(1-benzylpiperidin-4-yl)-Nphenylpropionamide (benzylfentanyl) and its salts
(o)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to obtain a registration to manufacture, distribute, import, or export regulated N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and its salts, including regulated chemical mixtures pursuant to §1310.12, is temporarily exempted from the registration requirement, provided that the DEA receives a proper application for registration or application for exemption for a chemical mixture containing benzylfentanyl pursuant to §1310.13 on or before 30 days after the publication of a rule finalizing this action. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.
(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and its salts whose application for exemption is subsequently denied by the DEA must obtain a registration with the DEA. A temporary exemption from the registration requirement will also be provided for those persons whose application for exemption is denied, provided that the DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until the DEA takes final action on their registration application.
(p)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to obtain a registration to manufacture, distribute, import, or export regulated N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine, 4-AP) and its amides, its carbamates, and its salts, including regulated chemical mixtures pursuant to §1310.12, is temporarily exempted from the registration requirement, provided that the DEA receives a proper application for registration or application for exemption for a chemical mixture containing 4-anilinopiperidine pursuant to §1310.13 on or before 30 days after the publication of a rule finalizing this action. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.
(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) and its amides, its carbamates, and its salts whose application for exemption is subsequently denied by the DEA must obtain a registration with the DEA. A temporary exemption from the registration requirement will also be provided for those persons whose application for exemption is denied, provided that the DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until the DEA takes final action on their registration application.
5. In Sec. 1310.12, the Table of Concentration Limits in paragraph (c) is amended by adding entries for N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) in alphabetical order to read as follows:
DEA Chemical
N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl), including its salts. 8334 Not exempt at any concentration. Chemical mixtures containing any amount of benzylfentanyl are not exempt.
N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4–AP), including its amides, its carbamates, and its salts. 8335 Not exempt at any concentration. Chemical mixtures containing any amount of 4-anilinopiperidine are not exempt.
[FR Doc. 2019-19787 Filed 9-12-19; 8:45 am]