[Federal Register Volume 67, Number 43 (Tuesday, March 5, 2002)]
[Notices]
[Pages 9993-9994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-5226]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Performance Construction, Inc.; Denial of Application

    On or about December 6, 2000, the Deputy Assistant Administrator, 
Office of Diversion Control, Drug Enforcement Administration (DEA), 
issued an Order to Show Cause (OTSC) by certified mail to Performance 
Construction, Inc. (Performance), located in Lakeland, Florida, 
notifying it of an opportunity to show cause as to why the DEA should 
not deny its application, dated June 30, 2000, for a DEA Certificate of 
Registration as a manufacturer of List I chemicals and deny any request 
to modify its application to distribute List I chemicals, pursuant to 
21 U.S.C. 823(h), as being inconsistent with the public interest. The 
order also notified Performance that, should no request for hearing be 
filed within 30 days, the right to a hearing would be waived.
    The OTSC was received December 11, 2000, as indicated by the signed 
postal receipt. Since that time, no further response has been received 
from the applicant nor any person purporting to represent the 
applicant. Therefore, the Administrator of the DEA, finding that (1) 
thirty days having passed since receipt of the Order to Show Cause, and 
(2) no request for a hearing having been received, concludes that 
Performance is deemed to have waived its right to a hearing. After 
considering relevant material from the investigative file in this 
matter, the Administrator now enters his final order without a hearing 
pursuant to 21 CFR 1301.43(d) and (e) and 1301.46.
    The Administrator finds that during a pre-registration inspection 
of Performance's premises on October 5, 2000, DEA investigators spoke 
with the president/owner of Performance, who stated that Performance 
was a general contractor, not engaged in the business of manufacturing, 
handling, or distribution of listed chemicals, nor did it have any 
knowledge or experience in this field. He further stated that 
Performance did not wish to manufacture listed chemicals, but proposed 
to be registered in order to make a one-time distribution of the List I 
chemical GBL to an individual also not engaged in the business of 
handling listed chemicals, purportedly for the purpose of stripping 
paint from a boat.
    The Administrator notes that GBL (gamma-butrolactone) has use as an 
industrial solvent. GBL is also a known precursor chemical, however, 
and is readily synthesized into the Schedule I controlled substance 
GHB. Schedule I controlled substances have no known medical uses, and 
are highly subject to abuse. 21 U.S.C. 812(b).
    DEA investigators contacted numerous marine manufacturers and boat 
refinishers in south Florida; however none were aware of the use of GBL 
in the marine industry or for the proposed use in vessel paint 
stripping. In fact, none of those contacted by DEA had even heard of 
GBL.
    The Administrator further notes that a long-standing DEA policy 
prohibits the granting of registrations that are essentially ``shelf 
registrations,'' that is, registrations for which there is no intent to 
use. The granting of a registration for a one-time distribution of a 
chemical that is otherwise widely available from DEA registrants 
throughout the United States would be inconsistent with this long-
standing DEA policy.
    Pursuant to 21 U.S.C. 823(h), the Administrator may deny an 
application for a DEA Certificate of Registration if he determines that 
granting the registration would be inconsistent with the pubic 
interest. Section 823(h) requires the following factors be considered:
    (1) Maintenance by the applicant of effective controls against 
diversion of listed chemicals into other than legitimate channels;
    (2) Compliance by the applicant with applicable Federal, State, and 
local law;
    (3) Any prior conviction record of the applicant under Federal or 
State laws related to controlled substances or to chemicals controlled 
under Federal or State law;
    (4) Any past experience of the applicant in the manufacture and 
distribution of chemicals; and
    (5) Such other factors as are relevant to and consistent with the 
public health and safety.
    Like the public interest analysis for practitioners and pharmacies 
pursuant to subsection (f) of section 823, these factors are to be 
considered in the disjunctive; the Administrator may rely on any one or 
combination of factors and may give each factor the weight he deems 
appropriate in determining whether a registration should be revoked or 
an application for registration be denied. See, e.g. Energy Outlet, 64 
FR 14,269 (1999). See also Henry J. Schwartz, Jr., M.D., 54 FR 16,422 
(1989).
    The Administrator finds that factors one and four are relevant to 
this case. The president/owner of Performance freely admitted his firm 
is a general contractor, and has no experience in handling listed 
chemicals. He further states he did not wish to manufacture the 
chemical, but only to make a one-time distribution pursuant to the 
request of a customer. There is no evidence concerning what measures, 
if any, Performance would take to prevent the diversion of the List I 
chemical. The DEA investigation showed Performance's proposed use of 
the chemical is not consistent with industry practice. The 
Administrator finds the public interest is not served by granting a DEA 
registration for a one-time distribution of a List I chemical to an 
entity with no experience in handling listed chemicals; having no 
intent to enter into the business of handling listed chemicals; for an 
alleged purpose inconsistent with industry practice; and where there is 
no evidence of controls to prevent the diversion of the chemical to the 
illicit manufacture of a Schedule I controlled substance.
    Furthermore, granting this application would violate the long-
standing DEA policy against ``shelf registrations.''
    Therefore, for the above-stated reasons, the Administrator 
concludes that it woudl be inconsistent with the public interest to 
grant the application of Performance.
    Accordingly, the Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him

[[Page 9994]]

by 21 U.S.C. 823 adn 28 CFR 0.100(b) and 0.104, hereby orders that the 
application for a DEA Certificate of Registration submitted by 
Performance Construction, Inc., as a manufacturer and/or distributor, 
be denied. This order is effective April 14, 2002.

    Dated: February 22, 2002.
Asa Hutchinson,
Administrator.

Certificate of Service

    This is to certify that the undersigned, on February 25, 2002, 
placed a copy of the Final Order referenced in the enclosed letter in 
the interoffice mail addressed to Wayne Patrick, Esq., Office of Chief 
Counsel, Drug Enforcement Administration, Washington, DC 20537; and 
caused a copy to be mailed, postage prepaid, registered return receipt 
to Mr. Daniel V. Heleski, Performance Construction, Inc., 308 West 
Highland Drive, Lakeland, Florida 33813.

Karen C. Grant.

[FR Doc. 02-5226 Filed 3-4-02; 8:45 am]
BILLING CODE 4410-09-M