[Federal Register: November 6, 2003 (Volume 68, Number 215)]
[Rules and Regulations]
[Page 62735-62738]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no03-7]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-176F]
RIN 1117-AA47
Sale by Federal Departments or Agencies of Chemicals Which Could
Be Used in the Illicit Manufacture of Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration is finalizing the Notice
of Proposed Rulemaking (NPRM) published in the Federal Register on May
8, 2003 (68 FR 24689). That NPRM proposed to conform DEA regulations to
provisions of the National Defense Authorization Act which provides
that a Federal department or agency may not sell from its stocks any
chemical which could be used in the manufacture of a controlled
substance unless the Administrator of DEA certifies in writing that
there is no reasonable cause to believe that such a sale would result
in the illegal manufacture of a controlled substance. This final rule
codifies current practice established pursuant to statutory authority
by which Federal agencies provide DEA with the opportunity to ensure
that the sale of chemicals by them will not result in the illegal
manufacture of controlled substances.
EFFECTIVE DATE: December 8, 2003.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
[[Page 62736]]
Administration, Washington, DC 20537, Telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background
Section 520 of the National Defense Authorization Act (Pub. L. 104-
201) amended the Controlled Substances Act (CSA) to prohibit a Federal
department or agency from selling from its stocks any chemical which,
as determined by the Administrator of the Drug Enforcement
Administration (DEA), could be used in the manufacture of a controlled
substance. However, the CSA as amended permits sales of such chemicals
if the Administrator of DEA certifies in writing to the head of the
selling Federal department or agency that there is no reasonable cause
to believe that the sale of the chemical would result in the illegal
manufacture of a controlled substance (21 U.S.C. 890).
On May 8, 2003, DEA published a Notice in the Federal Register
proposing to conform its regulations to the provisions of the National
Defense Authorization Act (68 FR 24689). The rule proposed requiring
Federal departments or agencies to notify DEA of the names of
prospective bidders and end-users prior to the sale of chemicals which
could be used in the manufacture of controlled substances. This
notification will allow DEA to identify whether there is reasonable
cause to believe that the sale of a specific chemical to a specific
bidder or end-user would result in the illegal manufacture of a
controlled substance. DEA will work with Federal departments and
agencies to determine which chemicals could be used in the illicit
manufacture of a controlled substance.
Comments Received Regarding the May 8, 2003 Notice of Proposed
Rulemaking
DEA received no written comments regarding the Notice of Proposed
Rulemaking published on May 8, 2003. Accordingly, this Notice of
Proposed Rulemaking is being finalized here without change.
Chemicals Affected by These Implementing Regulations
As stated in the NPRM, these implementing regulations affect any
chemical which DEA determines could be used in the illicit manufacture
of a controlled substance. Chemicals that can be used in the
manufacture of a controlled substance include, but are not limited to,
all List I and List II chemicals as provided in 21 CFR 1310.02.
Further, any chemicals mentioned in the DEA ``Special Surveillance List
of Chemicals, Products, Materials and Equipment Used in the Clandestine
Production of Controlled Substances or Listed Chemicals' published, and
updated from time to time, in the Federal Register (64 FR 25910, May
13, 1999; corrected at 64 FR 50541, Sept. 17, 1999) are affected by
these regulations. Finally, any chemical which is neither a listed
chemical nor is listed in the special surveillance list but which could
be used in the illicit manufacture of a controlled substance is
affected by these implementing regulations. Such chemicals could
include, but are not limited to, those chemicals used in the direct
illegal manufacture of a controlled substance, those chemicals used as
cutting agents, and those chemicals used to process the controlled
substance into a dosage form. DEA STRONGLY recommends that ANY Federal
department or agency considering the sale of any chemical from its
stocks contact DEA to determine whether such chemical could be used in
the illicit manufacture of a controlled substance as far in advance of
the sale of such chemical as possible.
Requirements of This Final Rule
By this final rule, a Federal department or agency is required to
notify the Administrator of DEA in writing at least fifteen calendar
days in advance of a proposed sale of chemicals covered by the Act.
(DEA strongly encourages Federal departments or agencies to notify it
further in advance if possible.) Written notification must be submitted
on official agency letterhead to the Drug Enforcement Administration,
Office of Diversion Control, Domestic Chemical Control Unit (ODID)
Washington, DC 20537 and include: (1) The name and amount of the
chemical to be sold; (2) the name and address of the prospective
bidder(s); (3) the name and address of the potential end-user(s), in
cases where a sale is being brokered; (4) point(s) of contact for the
prospective bidder and end-user; and (5) the end use of the chemical.
Within fifteen calendar days from the date the written notification
is received, DEA will respond in writing to the Federal department or
agency certifying that there is, or is not, reasonable cause to believe
that the sale of the specific chemical to the specific bidder and end-
user would result in the illegal manufacture of a controlled substance.
The certification that there is no reasonable cause to believe that the
sale of the specific chemical to the specific bidder and end-user would
result in the illegal manufacture of a controlled substance will apply
to future sales to the same prospective bidder and end-user for the
same chemical for one calendar year unless DEA notifies the agency to
the contrary in writing.
Factors Considered in Certifying a Bidder or End-User
In determining whether there is reasonable cause to believe that
the sale of a specific chemical to a specific bidder or end-user would
result in the illegal manufacture of a controlled substance, the
Administrator will consider the following factors: (1) The prospective
bidder's and end-user's past experience in the maintenance of effective
controls against diversion of particular chemicals into other than
legitimate medical, scientific, and industrial channels; (2) the
prospective bidder's and end-user's compliance with applicable Federal,
state and local law; (3) the prior conviction record of the prospective
bidder and end-user relating to controlled substances or to chemicals
controlled under Federal or state laws; and (4) such other factors as
may be relevant to and consistent with the public health and safety.
Recourse Available to a Bidder or End-User if DEA Refuses To Certify a
Prospective Bidder or End-User or Withdraws an Existing Certification
If the Administrator determines there is reasonable cause to
believe the sale of a specific chemical to a specific bidder or end-
user would result in the illegal manufacture of a controlled substance
and refuses to certify a prospective bidder or end-user, DEA will
notify both the Federal department or agency and the prospective bidder
and end-user in writing. The written notice to the prospective bidder
and end-user will contain a statement of the legal and factual basis
for certifying that there is reasonable cause to believe the sale of
the specific chemical to that specific person would result in the
illegal manufacture of a controlled substance. The prospective bidder
and end-user may, within thirty calendar days of notification, submit
written comments or objections to the Administrator, providing reasons
and supporting documentation to contest the decision. The Administrator
will take the written comments or objections under consideration and
will either (1) provide a written statement that affirms the original
decision is final and that provides reasons why the written comments or
objections are overruled or are not considered; or (2) confirm the
written response and certify the transaction, thereby reversing the
original decision.
[[Page 62737]]
If the Administrator determines that there is reasonable cause to
believe that an existing certification must be withdrawn, DEA will
notify both the Federal department or agency and the specific bidder
and end-user in writing. The written notice to the specific bidder and
end-user will contain a statement of the legal and factual basis for
certifying that there is reasonable cause to believe the certification
must be withdrawn. The bidder and end-user may, within thirty calendar
days of notification, submit written comments or objections to the
Administrator, providing reasons and supporting documentation to
contest the decision. The Administrator will take the written comments
or objections under consideration and will either (1) provide a written
statement that affirms the original decision is final and that provides
reasons why the written comments or objections are overruled or are not
considered; or (2) confirm the written response and reinstate a
certification, thereby reversing the original decision.
Regulatory Certifications
Regulatory Flexibility Act
The Acting Deputy Administrator hereby certifies that this
rulemaking has been drafted in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by
approving it certifies that this regulation will not have a significant
economic impact on a substantial number of small entities. This final
rule only affects Federal departments or agencies which plan to sell
from their stocks chemicals which could be used in the manufacture of a
controlled substance. The rule provides DEA with advance notice of the
sale and the opportunity to prevent sales of chemicals which could
result in the illicit manufacture of controlled substances.
Executive Order 12866
The Acting Deputy Administrator further certifies that this
rulemaking has been drafted in accordance with the principles in
Executive Order 12866, Section 1(b). DEA has determined that this is
not a significant regulatory action. Therefore, this action has not
been reviewed by the Office of Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million or more in any one year, and will not significantly or uniquely
affect small governments. Therefore, no actions were deemed necessary
under the provisions of the Unfunded Mandates Reform Act of 1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100 million or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
List of Subjects in 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
0
For the reasons set out above, 21 CFR part 1310 is amended as follows:
PART 1310--[AMENDED]
0
1. The authority citation for part 1310 is amended to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 890.
0
2. Part 1310 is amended by adding Sec. 1310.21 to read as follows:
Sec. 1310.21 Sale by Federal departments or agencies of chemicals
which could be used to manufacture controlled substances.
(a) A Federal department or agency may not sell from the stocks of
the department or agency any chemical which, as determined by the
Administrator of the Drug Enforcement Administration, could be used in
the manufacture of a controlled substance, unless the Administrator
certifies in writing to the head of the department or agency that there
is no reasonable cause to believe that the sale of the specific
chemical to a specific person would result in the illegal manufacture
of a controlled substance. For purposes of this requirement, reasonable
cause to believe means that the Administration has knowledge of facts
which would cause a reasonable person to reasonably conclude that a
chemical would be diverted to the illegal manufacture of a controlled
substance.
(b) A Federal department or agency must request certification by
submitting a written request to the Administrator, Drug Enforcement
Administration, Washington, DC 20537, Attention: Domestic Chemical
Control Unit (ODID). A request for certification may be transmitted
directly to the Drug Enforcement Administration, Domestic Chemical
Control Unit through electronic facsimile media. A request for
certification must be submitted no later than fifteen calendar days
before the proposed sale is to take place. In order to facilitate the
sale of chemicals from Federal departments' or agencies' stocks,
Federal departments or agencies may wish to submit requests as far in
advance of the fifteen calendar days as possible. The written
notification of the proposed sale must include:
(1) The name and amount of the chemical to be sold;
(2) The name and address of the prospective bidder;
(3) The name and address of the prospective end-user, in cases
where a sale is being brokered;
(4) Point(s) of contact for the prospective bidder and, where
appropriate, prospective end-user; and
(5) The end use of the chemical.
(c) Within fifteen calendar days of receipt of a request for
certification, the Administrator will certify in writing to the head of
the Federal department or agency that there is, or is not, reasonable
cause to believe that the sale of the specific chemical to the specific
bidder and end-user would result in the illegal manufacture of a
controlled substance. In making this determination, the following
factors must be considered:
(1) Past experience of the prospective bidder or end-user in the
maintenance of effective controls against diversion of listed chemicals
into other than legitimate medical, scientific, and industrial
channels;
(2) Compliance of the prospective bidder or end-user with
applicable Federal, state and local law;
(3) Prior conviction record of the prospective bidder or end-user
relating to listed chemicals or controlled substances under Federal or
state laws; and
[[Page 62738]]
(4) Such other factors as may be relevant to and consistent with
the public health and safety.
(d) If the Administrator certifies to the head of a Federal
department or agency that there is no reasonable cause to believe that
the sale of a specific chemical to a prospective bidder and end-user
will result in the illegal manufacture of a controlled substance, that
certification will be effective for one year from the date of issuance
with respect to further sales of the same chemical to the same
prospective bidder and end-user, unless the Administrator notifies the
head of the Federal department or agency in writing that the
certification is withdrawn. If the certification is withdrawn, DEA will
also provide written notice to the bidder and end-user, which will
contain a statement of the legal and factual basis for this
determination.
(e) If the Administrator determines there is reasonable cause to
believe the sale of the specific chemical to a specific bidder and end-
user would result in the illegal manufacture of a controlled substance,
DEA will provide written notice to the head of a Federal department or
agency refusing to certify the proposed sale under the authority of 21
U.S.C. 890. DEA also will provide, within fifteen calendar days of
receiving a request for certification from a Federal department or
agency, the same written notice to the prospective bidder and end-user,
and this notice also will contain a statement of the legal and factual
basis for the refusal of certification. The prospective bidder and end-
user may, within thirty calendar days of receipt of notification of the
refusal, submit written comments or written objections to the
Administrator's refusal. At the same time, the prospective bidder and
end-user also may provide supporting documentation to contest the
Administrator's refusal. If such written comments or written objections
raise issues regarding any finding of fact or conclusion of law upon
which the refusal is based, the Administrator will reconsider the
refusal of the proposed sale in light of the written comments or
written objections filed. Thereafter, within a reasonable time, the
Administrator will withdraw or affirm the original refusal of
certification as he determines appropriate. The Administrator will
provide written reasons for any affirmation of the original refusal.
Such affirmation of the original refusal will constitute a final
decision for purposes of judicial review under 21 U.S.C. 877.
(f) If the Administrator determines there is reasonable cause to
believe that an existing certification should be withdrawn, DEA will
provide written notice to the head of a Federal department or agency of
such withdrawal under the authority of 21 U.S.C. 890. DEA also will
provide, within fifteen calendar days of withdrawal of an existing
certification, the same written notice to the bidder and end-user, and
this notice also will contain a statement of the legal and factual
basis for the withdrawal. The bidder and end-user may, within thirty
calendar days of receipt of notification of the withdrawal of the
existing certification, submit written comments or written objections
to the Administrator's withdrawal. At the same time, the bidder and
end-user also may provide supporting documentation to contest the
Administrator's withdrawal. If such written comments or written
objections raise issues regarding any finding of fact or conclusion of
law upon which the withdrawal of the existing certification is based,
the Administrator will reconsider the withdrawal of the existing
certification in light of the written comments or written objections
filed. Thereafter, within a reasonable time, the Administrator will
withdraw or affirm the original withdrawal of the existing
certification as he determines appropriate. The Administrator will
provide written reasons for any affirmation of the original withdrawal
of the existing certification. Such affirmation of the original
withdrawal of the existing certification will constitute a final
decision for purposes of judicial review under 21 U.S.C. 877.
Dated: October 28, 2003.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 03-27889 Filed 11-5-03; 8:45 am]
BILLING CODE 4410-09-P