Department of Justice, Drug Enforcement Administration: Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products
GAO-07-116R: Oct 10, 2006
- Full Report:
GAO reviewed the Department of Justice Drug Enforcement Administration's (DEA) new rule on self-certification of regulated sellers of scheduled listed chemical products. GAO found that (1) the rule implements the provisions of the Combat Methamphetamine Epidemic Act of 2005 and establishes daily and 30-day limits on the sales of scheduled listed chemical products to individuals and recordkeeping requirements for most sales; and (2) the DEA complied with the applicable requirements in promulgating the rule.
Department of Justice, Drug Enforcement Administration: Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products, GAO-07-116R, October 10, 2006
Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Justice, Drug Enforcement Administration (DEA), entitled Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products (RIN: 1117-AB05). We received the rule on
The interim final rule implements the provisions of the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which establishes new requirements for retail sales of over-the-counter (nonprescription) products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The three chemicals can be used to manufacture methamphetamine illegally. The rule establishes daily and 30-day limits on the sales of scheduled listed chemical products to individuals and requires recordkeeping for most sales.
Enclosed is our assessment of the DEA's compliance with the procedural steps required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review indicates that DEA complied with the applicable requirements.
If you have any questions about this report, please contact James W. Vickers, Assistant General Counsel, at (202) 512-8210. The official responsible for GAO evaluation work relating to the subject matter of the rule is Norman Rabkin, Managing Director, Homeland Security and Justice. Mr. Rabkin can be reached at (202) 512-8777.
Kathleen E. Wannisky
Managing Associate General Counsel
ANALYSIS UNDER 5 U.S.C. sect. 801(a)(1)(B)(i)-(iv) OF A MAJOR RULE
ISSUED BY THE
DEPARTMENT OF JUSTICE,
DRUG ENFORCEMENT ADMINISTRATION
"RETAIL SALES OF SCHEDULED LISTED CHEMICAL PRODUCTS;
SELF-CERTIFICATION OF REGULATED SELLERS OF
SCHEDULED LISTED CHEMICAL PRODUCTS"
(i) Cost-benefit analysis
DEA performed a cost-benefit analysis but cannot estimate the cost impact accurately because it is difficult to predict how sales of the listed products will be impacted and how many outlets may stop selling the items. If the value of the existing market is $500 million, the additional costs, including transaction costs would be considerably lower than $100 million. If the value of the market is $1.5 billion, the cost could exceed $100 million.
(ii) Agency actions relevant to the Regulatory Flexibility Act, 5 U.S.C. sections 603-605, 607, and 609
Since the interim final rule was not preceded by a notice of proposed rulemaking, the provisions of the Regulatory Flexibility Act do not apply. However, DEA has reviewed the impacts of the rule and found that it will not have a substantial economic impact on a substantial number of small entities.
(iii) Agency actions relevant to sections 202-205 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. sections 1532-1535
The interim final rule does not contain either an intergovernmental or private sector mandate, as defined in title II, of more than $118 million in any one year.
(iv) Other relevant information or requirements under acts and executive orders
Administrative Procedure Act, 5 U.S.C. sections 551 et seq.
DEA has found good cause to forego the notice and comment requirements of 5 U.S.C. 553. CMEA requires that the sellers self-certify by
Paperwork Reduction Act, 44 U.S.C. sections 3501-3520
The interim final rule contains information collections that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. DEA has submitted the required information to OMB for its review, including the estimated annual burden of 4,548,500 hours.
Statutory authorization for the rule
The interim final rule is promulgated under the authority found at 21 U.S.C. 802, 830, 842, 871(b), 875, and 877.
Executive Order No. 12866
The interim final rule was reviewed by OMB and found to be an economically significant regulatory action under the order.
Executive Order No. 13132 (Federalism)
DEA states that the interim final rule does not have sufficient federalism implications to warrant the preparation of a federalism impact analysis.