This final rule designates the following chemicals as list I chemicals and subjects them to the regulatory requirements applicable to list I chemicals:
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The Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) implementing regulations give the Attorney General, as delegated to the Administrator of DEA, the authority to specify, by regulation, a chemical as a “list I chemical.” [ ] This term refers to a chemical that is used in manufacturing a controlled substance in violation of subchapter I (Control and Enforcement) of the CSA and is important to the manufacture of the controlled substance.[ ] The current list of all list I chemicals is available in 21 CFR .02(a).
In addition, the United States is a Party to the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances ( Convention), December 20, , U.N.T.S. 95. Under Article 12 of the Convention, when the United States receives notification that a chemical has been added to Table I or Table II (tables annexed to such Convention), the United States must take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion, including measures related to international trade.
In a letter dated May 23, , the Secretary-General of the United Nations, in accordance with Article 12, paragraph 6 of the Convention, informed the United States Secretary of State that the Commission on Narcotic Drugs (CND) voted to place the chemicals 3,4-MDP-2-P methyl glycidate (PMK glycidate) (and all stereoisomers), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) (and all stereoisomers), and alpha -phenylacetoacetamide (APAA) (and all optical isomers) in Table I of the Convention (CND Decisions 62/10, 62/11, and 62/12, respectively) at its 62nd Session on March 19, .
On December 21, , DEA published a notice of proposed rulemaking (NPRM) [85 FR ] to designate 3,4-MDP-2-P methyl glycidate (PMK glycidate), including its optical and geometric isomers; 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), including its salts, optical and geometric isomers, and salts of isomers; and alpha -phenylacetoacetamide (APAA), including its optical isomers, as list I chemicals under the CSA.[ ]
PMK glycidate, PMK glycidic acid, and APAA are close chemical relatives of controlled list I precursor 3,4 methylenedioxyphenyl-2-propanone (3,4-MDP-2-P), and have been made specifically to circumvent existing precursor controls. DEA has not identified any known legitimate uses for these chemicals, other than possible research purposes. The first two substances, PMK glycidate and PMK glycidic acid, are closely related in chemical structure to precursors of 3,4-methylenedioxymethamphetamine (MDMA) (schedule I) and other “ecstasy”-type substances in schedule I. APAA is a precursor of schedule II controlled substances amphetamine and methamphetamine.
All three chemicals are used for the illicit manufacture of two precursors listed in Table I of the Convention (3,4-MDP-2-P and 1-phenyl-2-propanone (P-2-P)). For years, countries have reported to the International Narcotics Control Board (INCB) the illicit trafficking and use of these chemicals in manufacturing controlled substances, with increasing frequency and amounts reported in and .[ ]
In response to the December 21, , NPRM, DEA received one anonymous comment expressing general opposition to the “war on drugs” and to the addition of more substances to the list and under CSA control. DEA considers the general comment about the war on drugs to be outside the scope of this rulemaking.
Regarding the general opposition to listing more substances, DEA notes that it proposed to designate and add these three specific chemicals to the list as they met the statutory and regulatory definition of a list I chemical, and DEA is using its legal authority to so designate these chemicals as list I chemicals.
Therefore, for the reasons discussed in the NPRM, and reiterated in the above background section, the Acting Administrator of DEA finds that PMK glycidate, PMK glycidic acid, and APAA are used in the manufacture of controlled substances in violation of the CSA, and are important to the manufacture of these controlled substances. Therefore, the Acting Administrator designates PMK glycidate, PMK glycidic acid, and APAA as list I chemicals.
Pursuant to this final rulemaking, chemical mixtures containing any of these three chemicals are subject to regulatory requirements at any concentration unless a manufacturer submits to DEA an application for exemption of a chemical mixture, DEA accepts the application for filing, and DEA exempts the chemical mixture in accordance with 21 CFR .13 (Exemption of chemical mixtures; application). Since even a small amount of these three chemicals can potentially yield a significant amount of controlled substances, DEA believes that regulation of chemical mixtures containing any amount of these three chemicals is necessary to prevent their illicit extraction, isolation, and use. This rule modifies the “Table of Concentration Limits” in 21 CFR .12(c) to reflect the fact that chemical mixtures containing any amount of these three chemicals are subject to CSA chemical control provisions, including 21 CFR parts , , , and .
DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations.[ ] Manufacturers may submit an ( printed page ) application for exemption for those mixtures that do not meet the category criteria set forth in 21 CFR .12(d) for an automatic exemption. DEA may grant an exemption of a chemical mixture if the Administrator 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 the listed chemical or chemicals contained in the chemical mixture cannot be readily recovered ( i.e., the chemical mixture meets the conditions set forth in 21 U.S.C. 802(39)(A)(vi) and 21 CFR .13(a)(1)-(2)).
The designation of these three chemicals as list I chemicals subjects handlers (manufacturers, distributors, importers, and exporters) and proposed handlers to all of the regulatory controls and administrative, civil, and criminal actions applicable to the manufacture, distribution, importation, and exportation of a list I chemical. Upon the effective date of this final rulemaking, persons potentially handling these three chemicals, including regulated chemical mixtures containing any of these three chemicals, are required to comply with the following list I chemical regulations:
1. Registration. Any person who handles (manufactures, distributes, imports, or exports), or proposes to engage in such handling of any of these three chemicals must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part . DEA regulations require separate registrations for manufacturing, distributing, importing, and exporting of any of these three chemicals.[ ] Further, a separate registration is required for each principal place of business at one general physical location where list I chemicals are manufactured, distributed, imported, or exported by a person.[ ]
DEA notes that under the CSA, a “warehouseman” is not required to register and may lawfully possess a list I chemical, if the possession of the chemical is in the usual course of business or employment.[ ] Under DEA implementing regulations, the warehouse in question must receive the list I chemical from a DEA registrant, and shall only distribute the list I chemical back to the DEA registrant and registered location from which it was received.[ ] A warehouse that distributes list I chemicals to persons other than the registrant and registered location from which they were obtained is conducting distribution activities and is required to register as such.
Upon the effective date of this final rulemaking, any person manufacturing, distributing, importing, or exporting any of these three chemicals will become subject to the registration requirement under the CSA. DEA recognizes, however, that it is not possible for persons subject to the registration requirement to immediately complete and submit an application for registration and for DEA to immediately issue registrations for those activities. Therefore, to allow continued legitimate commerce in these three chemicals, DEA is establishing in 21 CFR .09 a temporary exemption from the registration requirement for persons desiring to engage in activities with any of these three chemicals, provided that DEA receives a properly completed application for registration or application for exemption of chemical mixtures on or before June 9, . The temporary exemption for such persons will remain in effect until 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, will become effective on the effective date of the final rule. Therefore, all transactions of these three chemicals and chemical mixtures containing any of these three chemicals will be regulated while an application for registration or exemption is pending. This is necessary because failing to regulate these transactions could result in increased diversion of chemicals desirable to drug traffickers.
Additionally, the temporary exemption does not suspend applicable federal criminal laws relating to these three chemicals, nor does it supersede State or local laws or regulations. All handlers of any of these three chemicals must comply with applicable State and local requirements in addition to the CSA regulatory controls.
2. Records and Reports. Every DEA registrant must maintain records and submit reports to DEA with respect to these three chemicals pursuant to 21 U.S.C. 830(a) and (b)(1) and (2) and in accordance with 21 CFR .04 and .05. Pursuant to 21 CFR .04(a), a record must be made and maintained 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 must submit to DEA manufacturing, inventory, and use data on an annual basis.[ ] Existing standard industry reports containing the required information are acceptable, provided the information is separate or readily retrievable from the report.
The CSA and its implementing regulations require that each regulated person must report to DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of subchapter I of the CSA or 21 CFR part . In addition, regulated persons must report any proposed regulated transaction with a person whose description or other identifying characteristics DEA has previously furnished to the regulated person, any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person, and any in-transit loss in which the regulated person is the supplier.[ ]
3. Importation and Exportation. All importation and exportation of these three chemicals must be done in compliance with 21 U.S.C. 957, 958, and 971 and in accordance with 21 CFR part .
4. Security. All applicants and registrants must provide effective controls against theft and diversion in accordance with 21 CFR .71-.73.
5. Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR .02(c). The CSA allows for administrative inspections of these controlled premises as provided in 21 CFR part , subpart A. 21 U.S.C. 880(b). ( printed page )
6. Liability. Any activity involving these three chemicals not authorized by, or in violation of, the CSA is unlawful, and may subject the person to administrative, civil, and/or criminal action.
This rule was developed in accordance with the principles of Executive Orders (E.O.) and . E.O. 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). E.O. is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. .
E.O. 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 E.O. DEA has determined that this rule is not a “significant regulatory action” under E.O. , section 3(f).
As finalized, PMK glycidate, PMK glycidic acid, and APAA are 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. The first two chemicals, PMK glycidate and PMK glycidic acid, are closely related in chemical structure to precursors of MDMA and other “ecstasy”-type substances, as discussed in the above background section. APAA is a precursor of amphetamine and methamphetamine. All three chemicals are highly suitable for the illicit manufacture of precursors listed in Table I of the Convention (3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) and 1-phenyl-2-propanone (P-2-P)). As noted earlier, incidents of illicit manufacture and tracking of these three chemicals have been reported for many years to the INCB, with an increase in the frequency and amounts reported in and .
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In making its assessment pursuant to Article 12, paragraph 4 of the Convention, the CND found that there was no known legitimate manufacture of and trade in any of the three chemicals and that their use was limited, in small amounts, to research, development, laboratory, and analytical purposes. DEA also searched information in the public domain for legitimate uses of these three chemicals, and likewise, did not identify any known legitimate use for any of these chemicals, other than possibly for research purposes. DEA evaluated the costs and benefits of this action.
DEA cannot rule out the possibility that minimal quantities of PMK glycidate, PMK glycidic, or APAA are used for the manufacturing of legitimate pharmaceutical substances. However, DEA did not receive any public comments to that effect in response to the NPRM.
As stated above, the only use for PMK glycidate and PMK glycidic acid is as intermediaries for the manufacturing of MDMA and other “ecstasy”-type substances. Similarly, the only use for APAA is as a precursor for amphetamine and methamphetamine. Any manufacturer, distributor, importer, or exporter of any of these three chemicals for legitimate pharmaceutical commerce, if they exist at all, will incur costs if they are not already registered for handling List I chemicals. The primary costs associated with this rule are the annual registration fees ($3,047 for manufacturers and $1,523 for distributors, importers, and exporters). Moreover, any manufacturer that uses any of these three chemicals for legitimate pharmaceutical purposes is likely to already be registered with DEA and have all security and other handling processes in place, resulting in minimal cost.
DEA has identified ten domestic suppliers of one or more of these chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these suppliers are not currently registered with DEA to handle list I chemicals. The amount of these three chemicals distributed by these suppliers is unknown. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the discussion above, DEA believes any quantity of sales from these distributors for legitimate pharmaceutical purposes is minimal. As finalized, suppliers for the legitimate use of PMK glycidate, PMK glycidic acid, and APAA are expected to choose the least-cost option, which in many cases may lead them to stop selling the minimal quantities, if any, of PMK glycidate, PMK glycidic acid, and APAA, rather than incur the registration cost. Therefore, DEA estimates that the cost of foregone sales is minimal; and thus, the cost of this rule is minimal.
This analysis excludes consideration of any economic impact to those businesses that facilitate the manufacturing and distribution of PMK glycidate, PMK glycidic acid, or APAA for the illicit production of amphetamine, methamphetamine, MDMA, or other “ecstasy”-type substances.
Controlling PMK glycidate, PMK glycidic acid, and APAA is expected to prevent, curtail, and limit the unlawful manufacture and distribution of amphetamine, methamphetamine, and MDMA and other “ecstasy”-type substances. This action is also expected to assist in the prevention of possible theft or diversion of PMK glycidate, PMK glycidic acid, and APAA from any legitimate firms. DEA also believes control is necessary to prevent unscrupulous chemists from synthesizing PMK glycidate, PMK glycidic acid, and APAA and selling them (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 amphetamine, methamphetamine, or MDMA or other “ecstasy”-type substances.
In summary, DEA conducted a qualitative analysis of costs and benefits. DEA believes this action will minimize the diversion of PMK glycidate, PMK glycidic acid, and APAA. DEA believes the legitimate market for PMK glycidate, PMK glycidic acid, and APAA for legitimate pharmaceutical purposes is minimal. Thus, any potential cost resulting from this regulation is minimal.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard ( printed page ) for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of E.O. . The rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of E.O. . It 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 RFA,[ ] has reviewed this 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, PMK glycidate, PMK glycidic acid, and APAA will now become subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, and exportation of list I chemicals. PMK glycidate and PMK glycidic acid are closely related in chemical structure to precursors of MDMA and other “ecstasy”-type substances. APAA is a precursor of amphetamine and methamphetamine. All three chemicals are highly suitable for the illicit manufacture of precursors listed in Table I of the Convention (3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) and 1-phenyl-2-propanone (P-2-P)). DEA has not identified any legitimate industrial use for PMK glycidate, PMK glycidic acid, or APAA, other than as intermediary chemicals in the production of amphetamine, methamphetamine, and MDMA or other “ecstasy”-type substances. Therefore, DEA believes the vast majority, if not all, of PMK glycidate, PMK glycidic acid, and APAA is used for the illicit manufacturing of amphetamine, methamphetamine, and MDMA or other “ecstasy”-type substances. The primary costs associated with this rule are the annual registration fees ($3,047 for manufacturers and $1,523 for distributors, importers, and exporters), but only if they are not already registered to handle any list I chemicals.
DEA has identified ten domestic suppliers of one or more of the chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these suppliers are currently not registered with DEA to handle list I chemicals. All nine non-registered domestic suppliers are affected, and all nine (94.5 percent, based on Small Business Administration size standard for chemical distributors and Statistics of U.S. Businesses data) are estimated to be small entities. The quantity of these three chemicals distributed by these suppliers is unknown. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the discussion above, DEA believes any quantity of sales from these distributors for legitimate pharmaceutical purposes is minimal. DEA did not receive any comments to the contrary in response to the NPRM. DEA estimates that this rule will not have a significant economic impact on a substantial number of small entities.
In accordance with the UMRA, 2 U.S.C. et seq., DEA has determined and certifies that this rule will not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under the UMRA.
The action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. -. This action will 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.
This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.
Accordingly, for the reasons set forth in the preamble, DEA amends 21 CFR part as follows:
1. The authority citation for part continues to read as follows:
2. In § .02, add paragraphs (a)(34) through (36) to read as follows:
3. In § .04:
a. Redesignate paragraphs (g)(1)(vii) through (xiii) as paragraphs (g)(1)(x) through (xvi), respectively;
b. Redesignate paragraphs (g)(1)(i) through (vi) as paragraphs (g)(1)(ii) through (vii), respectively; and
c. Add new paragraphs (g)(1)(i), (viii), and (ix).
The additions read as follows:
4. In § .09, add paragraph (q) to read as follows:
5. In § .12, in paragraph (c), add in alphanumerical order entries for 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha -phenylacetoacetamide (APAA) in the table “Table of Concentration Limits” to read as follows:
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