Source: https://www.federalregister.gov/articles/2010/07/07/2010-16388/removal-of-thresholds-for-the-list-i-chemicals-pseudoephedrine-and-phenylpropanolamine
Timestamp: 2015-05-24 17:20:12
Document Index: 266688594

Matched Legal Cases: ['§ 716', '§ 721', 'art 1314', 'art 1310', '§ 1310', '§ 1300', 'art 1314', '§ 1310', '§ 1300', '§ 1310', '§ 1300', '§ 1310']

Federal Register | Removal of Thresholds for the List I Chemicals Pseudoephedrine and Phenylpropanolamine
Publication Date: Wednesday, July 07, 2010
-38922 (8 pages)
Document Number: 2010-16388
Shorter URL: https://federalregister.gov/a/2010-16388 Related Topics
Removal of Thresholds for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine 4 actions from November 20th, 2007 to August 6th, 2010
Combat Methamphetamine Epidemic Act of 2005 Back to Top
Further, the CMEA requires that importers, exporters, and persons involved in international transactions of all listed chemicals, including ephedrine, pseudoephedrine, and phenylpropanolamine, provide DEA with information regarding the transferee (i.e., the downstream customer), of the chemical, as well as information regarding the quantity of the chemical to be transferred. Importers, exporters, and persons involved in international transactions are further required to provide DEA with a return declaration regarding each import, export, or international transaction after the transaction is completed (CMEA § 716, 21 U.S.C. 971(d) and (g), as amended). In a separate rulemaking, “Implementation of the Combat Methamphetamine Epidemic Act of 2005; Notice of Transfers Following Importation or Exportation” [Docket No. DEA-292, RIN 1117-AB06] (72 FR 17401, April 9, 2007; Temporary Stay of Certain Provisions 72 FR 28601, May 22, 2007), DEA promulgated regulations implementing these provisions (21 CFR 1313.16, 1313.17, 1313.26, 1313.27, 1313.32, 1313.35).
Finally, the CMEA requires that the notice of importation (DEA Form 486) for ephedrine, pseudoephedrine, and phenylpropanolamine “shall include all information known to the importer on the chain of distribution of such chemical from the manufacturer to the importer.” (CMEA § 721, 21 U.S.C. 971(h) as amended). In a separate rulemaking, “Information on Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and Phenylpropanolamine” [Docket No. DEA-295, RIN 1117-AB07] (73 FR 16793, March 31, 2008), DEA proposed regulations to implement this provision.
Licit Use Back to Top
Discussion of the NPRM Back to Top
Thresholds Back to Top
CMEA mandates that DEA establish the total annual need for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured or imported each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks (21 U.S.C. 826). These requirements apply equally to products containing these three List I chemicals as they do to the List I chemicals themselves. To limit the supply of the chemicals to the amount needed to meet the national need, CMEA requires DEA to establish import and production quotas for all three chemicals. DEA published regulations implementing procedures for import and production quotas for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on July 10, 2007 (72 FR 37439; Final Rule 73 FR 73549, December 3, 2008). DEA established the 2008 assessment of annual national needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on December 26, 2007 (72 FR 73361) and has established the assessment of annual national needs every year thereafter.
Comments Regarding Removal of Thresholds for Pseudoephedrine and Phenylpropanolamine Back to Top
Regulated Transactions Back to Top
In removing a drug or group of drugs from exemption * * * the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption—
Evaluation of Statutory Factors for Removal of Exemption From the Definition of “Regulated Transaction” Back to Top
In 1989, DEA control of chemicals was initiated with passage of the Chemical Diversion and Trafficking Act of 1988 (CDTA) (Subtitle A of Title VI of 100). This law placed recordkeeping and reporting requirements on a wide variety of precursors and essential chemicals used in every aspect of clandestine drug manufacture, including bulk powder ephedrine, pseudoephedrine, and phenylpropanolamine. In response to the regulations, traffickers moved to the illicit use of single-entity ephedrine OTC tablets as an unregulated source of precursor material for the production of methamphetamine.
In the early 1990s, a number of well-publicized seizures of rogue businesses (and prosecutions of their owners) began to impact the tablet manufacturing industry, and a loophole allowing the sale of single-entity ephedrine products was closed in late 1993 with the passage of the Domestic Chemical Diversion Control Act of 1993 (DCDCA) (103).
Current Seizures Back to Top
Illicit Uses Back to Top
While the vast majority of clandestine laboratories seized have used tableted pseudoephedrine and ephedrine products, gel caps and liquid dosage form products can easily serve as the source of precursor material for the production of methamphetamine. DEA scientific studies show that liquid, gel cap, and combination products are easily used as the source of precursor material and the pseudoephedrine/ephedrine from these products can be easily extracted with appropriate reagents/solvents. These reagents/solvents are all readily available at hardware and auto parts stores in the United States.
Comments Regarding Clarification of Regulated Transactions Back to Top
Therefore, based on the above discussion, the Administrator of the Drug Enforcement Administration, under the authority delegated by the Attorney General, finds, after considering the factors specified in 21 U.S.C. 814(b), that drug products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine are being diverted for the illicit production of controlled substances, namely methamphetamine and amphetamine. As DEA has discussed, these products have a demonstrated history over the past 20 years of diversion for illicit purposes. These List I chemicals are diverted regardless of formulation—liquid, nonliquid, gel capsule—and regardless of dosage strength. Accordingly, the Administrator of the Drug Enforcement Administration removes drug products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine from exemption from the definition of “regulated transaction” under 21 U.S.C. 802(39)(a)(iv). As such, unless otherwise exempted, such materials are subject to the chemical regulatory control provisions of the CSA. DEA is adding a new section 1310.14 that removes these drugs from the exemption. The CSA has specifically exempted retail transactions involving scheduled listed chemical products from the definition of regulated transaction (21 U.S.C. 802(39)(a)(v)) and established a separate set of regulations, 21 CFR part 1314, that control those retail transactions (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006).
Overview of Information Collection 1117-0023 Back to Top
* DEA assumes 10 percent of all imports will not be transferred in the first 30 days and will necessitate submission of a subsequent return declaration.
0.283 hour (17 minutes)
2,941 hours.
0.166 hour (10 minutes)
1,730 hours.
0.333 hour (20 minutes)
422.6 hours.
Form 486 (import return declaration) *
Form 486A (import) *
0.4 hour (24 minutes)
Form 486A (import return declaration)*
88 hours.
2.8 hours.
1.2 hours.
5,844.6 hours.
For the reasons set forth above, 21 CFR part 1310 is amended as follows:
2.Section 1310.04 is amended by revising paragraphs (f)(1)(i) table and (ii), (g)(1)(i) through (vii), and adding paragraphs (g)(1)(viii) and (ix) to read as follows: § 1310.04 Maintenance of records.
(ii) For List I chemicals that are contained in scheduled listed chemical products as defined in § 1300.02(b)(34)(i) of this chapter, the thresholds established in paragraph (g) of this section apply only to non-retail distribution, import, and export. Sales of these products at retail are subject to the requirements of part 1314 of this chapter.
3.Section 1310.10 is amended by revising paragraph (a) introductory text to read as follows: § 1310.10 Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.
(a) The Administrator may remove from exemption under § 1300.02(b)(28)(i)(D) of this chapter any drug or group of drugs that the Administrator finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance. In removing a drug or group of drugs from the exemption the Administrator shall consider:
4.Section 1310.14 is added to read as follows: § 1310.14 Removal of exemption from definition of regulated transaction.
The Administrator finds that the following drugs or groups of drugs are being diverted to obtain a listed chemical for use in the illicit production of a controlled substance and removes the drugs or groups of drugs from exemption under § 1300.02(b)(28)(i)(D) of this chapter pursuant to the criteria listed in § 1310.10 of this part: