[Federal Register: May 8, 2003 (Volume 68, Number 89)]
[Proposed Rules]
[Page 24689-24692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08my03-21]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-176P]
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: Notice of proposed rulemaking.
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SUMMARY: DEA is proposing to conform its regulations to provisions of
the National Defense Authorization Act. This Act 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
[[Page 24690]]
reasonable cause to believe that such a sale would result in the
illegal manufacture of a controlled substance. This rulemaking 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.
DATES: Written comments must be submitted on or before July 7, 2003.
ADDRESSES: Comments should be submitted to the Deputy Administrator,
Drug Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Telephone: (202) 307-7297.
SUPPLEMENTARY INFORMATION:
What Does the National Defense Authorization Act Require Federal
Agencies To Do Before They May Sell Certain Chemicals?
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 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).
Why Is DEA Taking This Action?
Since enactment of the National Defense Authorization Act in July
1996, DEA has worked with Federal departments and agencies to ensure
compliance. Now, DEA plans to codify in its regulations the current
practice that has been established pursuant to this statutory authority
and the experience that DEA has gained from implementing these
provisions.
How Does This Regulation Impact Federal Departments or Agencies?
This rule simply requires that the Federal department or agency
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. To date, DEA
has been contacted by only one Federal department or agency conducting
sales of chemicals falling under the provisions of the Act, the
Department of Defense (DOD). DEA has received the names of
approximately fifty bidders and end-users from DOD and found, in every
case, that there was 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. Therefore, DEA
has certified each bidder and end-user whose name has been submitted by
DOD to DEA.
What Chemicals Are Affected By These Implementing Regulations?
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.
What Do These Implementing Regulations Require?
DEA is proposing that a Federal department or agency notify the
Administrator of DEA in writing at least 15 calendar days in advance of
a proposed sale of chemicals covered by the Act. However, DEA strongly
encourages Federal departments or agencies to notify it further in
advance if possible.
By this rule, DEA is proposing that the written notification 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 15 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.
What Factors Will DEA Consider 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 state
and local law; (3) the prior conviction record of the prospective
bidder and end-user relating to controlled substances or to chemicals
[[Page 24691]]
controlled under Federal or state laws; and (4) such other factors as
may be relevant to and consistent with the public health and safety.
What Recourse Is 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.
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 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. The 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 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
rulemaking 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, Exports, Imports, Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR Part 1310 is proposed to be
amended as follows:
PART 1310--[AMENDED]
1. The authority citation for Part 1310 is proposed to be revised
to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 890.
2. Part 1310 is proposed to be 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 15 calendar days before
the proposed sale is to take place. In order to facilitate the sale of
chemicals from
[[Page 24692]]
Federal departments' or agencies' stocks, Federal departments or
agencies may wish to submit requests as far in advance of the 15
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 15 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 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
(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: April 25, 2003.
John B. Brown III,
Acting Administrator.
[FR Doc. 03-11393 Filed 5-7-03; 8:45 am]
BILLING CODE 4410-09-P