[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Rules and Regulations]
[Page 17401-17409]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-11]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300 and 1313
[Docket No. DEA-292I]
RIN 1117-AB06
Implementation of the Combat Methamphetamine Epidemic Act of
2005; Notice of Transfers Following Importation or Exportation
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim Final Rule with Request for Comment.
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SUMMARY: This regulation implements section 716 of the Combat
Methamphetamine Epidemic Act (CMEA) of 2005 (21 U.S.C. 971 as amended),
which was enacted on March 9, 2006. DEA is amending its regulations to
require additional reporting for import, export, and international
transactions involving all List I and List II chemicals. This rule
implements section 716 of the CMEA which extends current reporting
requirements for importations, exportations, and international
transactions involving List I and List II chemicals.
DATES: This rule is effective May 9, 2007. Written comments must be
postmarked, and electronic comments must be sent, on or before May 9,
2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-292'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/ODL. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria,
VA 22301. Comments may be directly sent to DEA electronically by
sending an electronic message to dea.diversion.policy@usdoj.gov.
[[Page 17402]]
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided on that
site. An electronic copy of this document is also available at the
http://www.regulations.gov Web site. DEA will accept attachments to
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel
file formats only. DEA will not accept any file formats other than
those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537 at (202) 307-7297.
SUPPLEMENTARY INFORMATION:
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control
Act of 1970, often referred to as the Controlled Substances Act (CSA)
and Controlled Substances Import and Export Act (21 U.S.C. 801 et
seq.), as amended. DEA publishes the implementing regulations for this
statute in Title 21 of the Code of Federal Regulations (CFR), Parts
1300 to end. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for legitimate medical
purposes and to deter the diversion of controlled substances to illegal
purposes. The CSA mandates that DEA establish a closed system of
control for manufacturing, distributing, and dispensing controlled
substances. Any person who manufactures, distributes, dispenses,
imports, exports, or conducts research or chemical analysis with
controlled substances must register with DEA (unless exempt) and comply
with the applicable requirements for the activity. The CSA as amended
also requires DEA to regulate the manufacture and distribution of
chemicals that may be used to manufacture controlled substances. Listed
chemicals that are classified as List I chemicals are important to the
manufacture of controlled substances. Those classified as List II
chemicals may be used to manufacture controlled substances.
On March 9, 2006, the President signed the CMEA of 2005, which is
Title VII of the USA PATRIOT Improvement and Reauthorization Act of
2005 (Pub. L. 109-177). DEA is promulgating this rule as an interim
final rule rather than a proposed rule because the changes being made
merely codify statutory provisions. Much of the statute is self-
implementing; the changes discussed in this rule became effective on
March 9, 2006. An agency may find good cause to exempt a rule from
certain provisions of the Administrative Procedure Act (APA) (5 U.S.C.
553), including Notice of Proposed Rulemaking and the opportunity for
public comment, if it is determined to be unnecessary, impracticable,
or contrary to the public interest. The requirements of the CMEA of
2005 included in this rulemaking were set out in such detail as to be
self-implementing. Therefore the changes in this rulemaking provide
conforming amendments to make the language of the regulations
consistent with that of the law. DEA has no authority to revise the
changes and is simply implementing, and making its regulations conform
to, the statute.
Combat Methamphetamine Epidemic Act of 2005
The portion of the CMEA being implemented in this rulemaking
addresses the importation, exportation, and international transactions
of all List I and List II chemicals. Section 716 of the CMEA (21 U.S.C.
971 as amended) closes a loophole in the current regulatory system for
imports, exports, and international transactions of listed chemicals
used in the illicit manufacture of controlled substances. Prior to
enactment of the CMEA, a company that wanted to import or export any
List I or List II chemical was required to either: (1) Notify the
Department of Justice 15 days in advance of the import or export; or
(2) be a company that previously imported or exported a listed chemical
and that was proposing to import from or export the chemicals to a
customer with whom the company had previously dealt. (See 21 U.S.C.
971(a), (b))
A problem can arise, however, when the sale that the importer or
exporter originally planned falls through. When this happens, the
importer or exporter must quickly find a new buyer for the chemicals on
what is called the ``spot market''--a wholesale market. Sellers are
often under presure to find a buyer in a short amount of time, meaning
that they may be tempted to entertain bids from companies without a
strong record of preventing diversion. More importantly, DEA is not
made aware of, and has no opportunity to review, such transactions in
advance in order to suspend them if there is a danger of diversion to
the clandestine manufacture of a controlled substance.
Section 716 of the CMEA extends the current reporting
requirements--as well as the current exemption for regular importers
and regular customers--to post-import and post-export transactions of
List I and List II chemicals. Importers, exporters, brokers, and
traders are now required to notify DEA, before the transaction is to
take place, of certain information regarding their downstream
customers. If the person to whom the chemical is being transferred is
not a regular customer, the importer, exporter, broker, or trader must
notify DEA no later than 15 days before the transaction is to take
place; upon receipt, DEA will have 15 days to review the notification.
Specifically, the United States importer or exporter must provide the
name and address of each person to whom the listed chemicals will be
transferred, and the name and quantity of the listed chemicals to be
transferred, including package information. This person is referred to
as the ``transferee'' of the United States importer or exporter. The
spot market reporting requirements also apply, to a limited extent, to
United States brokers and traders that arrange international
transactions (i.e., transactions between customers in two foreign
countries).
For a United States exporter, the transferee is the foreign
importer. Thus, this aspect of the new requirement does not represent a
change for United States exporters, who have previously notified DEA of
information on their purchasers. For a United States broker or trader,
the transferee is the foreign customer purchasing the listed chemicals.
Again, this requirement is not a change for brokers and traders, who
have previously notified DEA of information on their purchasers.
The requirement is, however, a change for United States importers.
For a United States importer, the ``transferee'' is the person to whom
the importer transfers the listed chemicals--the downstream customer.
Until the CMEA, importers were required to provide information
regarding their suppliers, but not regarding the parties purchasing the
chemicals in the United States. Under the CMEA, importers will have to
list both the foreign supplier and each United States customer for the
imported chemical.
The provision of customer information by the importer provides DEA
with an opportunity to evaluate the transaction. DEA will have 15 days
from the time the customer information is submitted to review the
transaction and determine whether it may be diverted to the clandestine
manufacture of a controlled substance. If DEA determines that the
transaction does not pose an unacceptable risk of diversion, DEA will
take no action. The importer will thus be granted regular importer
status for transactions involving the specific chemical to be imported
to the specific
[[Page 17403]]
customer. The transferee--the downstream customer--will be granted
regular customer status for imports of the specified chemical by the
specified importer. DEA must review each import transaction based not
only on the chemical to be imported, but also on the transferee to whom
the chemical will be transferred.
If, after submission of the initial DEA Form 486, Import/Export
Declaration, the importer, exporter, broker, or trader will not be
transferring the listed chemical to the person initially named on the
DEA Form 486, or if the importer or exporter will be transferring a
greater quantity than originally indicated on the DEA Form 486, then
the importer, exporter, broker, or trader must file an amended DEA Form
486 reporting the change. This is a new requirement for both United
States importers and exporters, as well as brokers and traders. This
amendment must provide the name of the new prospective customer and/or
the greater quantity of the listed chemical to be transferred. The
requirement to notify DEA of a change in the transferee or an increase
in the quantity of the chemical to be transferred applies to amended
DEA Forms 486 in the same manner that it applies to original
submissions.
Thus, if an importer, exporter, broker, or trader is required to
file an initial advance notice with DEA 15 days before the transaction
is to take place, and the originally planned sale falls through, the
importer, exporter, broker, or trader is required to file a second
advance notice with DEA, identifying the new proposed purchaser. DEA
will again have 15 days to review the new transaction and determine
whether it may be diverted to the clandestine manufacture of a
controlled substance. In the case of a transaction reported by a broker
or trader, DEA cannot suspend the transaction, but could alert
authorities in the foreign country involved in the transaction of the
risk of diversion. In addition, even if an importer or exporter did not
have to file an initial notification--either because he is a regular
importer selling to a regular customer, or an exporter selling to a
regular customer--if the newly arranged spot market sale is to a new
customer (i.e., not a ``regular customer''), the importer or exporter
must file an advance notice 15 days prior to transferring the chemical
to the new customer. As is the case under existing law, a suspension
can be appealed through an administrative hearing. (See 21 U.S.C.
971(c)(2))
If, however, the new proposed purchaser qualifies as a ``regular
customer'' under existing law, the importer or exporter is not required
to file a second advance notice 15 days prior to the transfer of the
listed chemical. Rather, notice must be filed on or before the date of
the transfer. Note that the second notice may occur after importation
or exportation. (Brokers and traders are required to report all
regulated international transactions.)
If DEA determines that a listed chemical shipment handled by a
regular importer or a regular customer (including a regular customer
who is substituted for the original customer listed on the original
advance notification) may be diverted to the clandestine manufacture of
a controlled substance, DEA may disqualify the regular importer or
regular customer status of such importer or customer and may suspend
the shipment. If the importer or customer (including a new proposed
customer) is not a regular importer or customer, then DEA may suspend
the shipment, since there would be no regular importer or regular
customer status to disqualify. The procedures are set forth in the new
regulatory text at 21 CFR 1313.16(d). Similarly, in the case of an
export of a listed chemical that may be diverted to the clandestine
manufacture of a controlled substance, DEA may disqualify the regular
customer status of the transferee and suspend the shipment. See 21 CFR
1313.26(d).
Finally, within 30 days after the importation, exportation, or
international transaction is completed, the importer, exporter, broker,
or trader must send DEA a return declaration containing information
regarding the transaction, including the name of the transferee, date
the import or export and any subsequent transfer occurred, the name of
the chemical transferred, the actual quantity transferred, the
container, and any other information that DEA may specify. This is a
new requirement for United States importers, exporters, brokers, and
traders. For importers, a single return declaration may include the
information for both the importation and distribution. If the importer
has not distributed all chemicals imported by the end of the initial
30-day period, the importer must file supplemental return declarations
no later than 30 days from the date of any further distribution, until
the distribution or other disposition of all chemicals imported under
the import notification or any update are accounted for. In addition,
if an importer, exporter, broker, or trader files a DEA Form 486, but
the transfer covered fails to take place (e.g., the import or export is
canceled prior to shipment), the person must file an amended DEA Form
486 to notify DEA of the cancellation. These additional filings will
ensure that DEA has an accurate record of importations, exportations,
and international transactions.
Summary of Changes Made by This Interim Final Rule
The table below provides a comparison of the previous requirements
regarding imports, exports, and international transactions with the new
requirements of the CMEA:
Table 1.--Comparison of Previous and New Requirements
------------------------------------------------------------------------
Requirement Previous rule New rule
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Notify DEA prior to import/ Yes................... Yes.
export/international
transactions.
Identify source of imports/ Yes................... Yes.
international transactions.
Identify transferees of exports/ Yes................... Yes.
international transactions.
Identify transferees (downstream No.................... Yes.
customers) of imports.
Notify DEA of change in No.................... Yes.
transferees of exports and
international transactions
prior to transaction.
Notify DEA of change in No.................... Yes.
transferees (downstream
customers) of imports prior to
transaction.
Notify DEA of increase in No.................... Yes.
chemical quantity transferred
for exports and international
transactions prior to
transaction.
Notify DEA of increase in No.................... Yes.
chemical quantity transferred
for import transactions prior
to transaction.
File return declaration when No.................... Yes.
imports/exports and
international transactions are
distributed.
File subsequent return No.................... Yes.
declaration if entire quantity
of import not distributed
within 30 days of importation.
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[[Page 17404]]
Specific Changes Made by This Interim Final Rule
In this interim final rule, DEA is incorporating the provisions of
section 716 of the CMEA into Title 21 of the Code of Federal
Regulations. Specific changes are discussed below.
Certain definitions relating to listed chemicals in section 1300.02
are being revised or amended. The definition of ``established business
relationship'' is being revised to remove language regarding foreign
customers; this definition is now a general definition relating to any
business relationship, either import or export. Further, parts of this
definition are moved to new Section 1313.05, requirements of an
established business relationship. The definition of ``established
record as an importer'' is being revised by moving certain information
into new Section 1313.08. Finally, the definition of ``regular
customer'' is being revised to update the cross reference.
As noted previously, Section 1313.05 is added to specify
requirements of an established business relationship. Information in
this section was previously found in the definition of ``established
business relationship.''
As noted previously, Section 1313.08 is added to specify
requirements for establishing a record as an importer. Information in
this section was previously found in the definition of ``established
record as an importer.'' Section 1313.15(a) is being amended to update
the cross reference accordingly.
Section 1313.12, requirement of authorization to import, is amended
by revising paragraph (c) to add the requirement that, to qualify for a
waiver of the 15 day advance notice, not only does the importer have to
be known to DEA as a regular importer, but also that the customer must
meet the requirements in Section 1313.05 to be regarded as a regular
customer. The effect of this new requirement is that, effective May 9,
2007, all persons previously granted regular importer status will be
required to provide advance notification of imports with information
regarding transferees, even for customers that they did business with
in the past. This advance notification will provide DEA the opportunity
to review and approve the customer as a regular customer (see the new
definition in Section 1300.02 and the requirements in new Section
1313.05). If the 15-day notification period elapses without DEA taking
action, then that importer is granted regular importer status for all
imports of that particular chemical intended for the specified
customer.
Section 1313.13, contents of import declaration, is amended by
requiring the importer to provide information regarding the person or
persons to whom the importer intends to transfer the chemical.
Section 1313.16 is added to specify requirements regarding
transfers after importation, Section 1313.26 is added to specify
requirements regarding transfers after exportation, and Section 1313.32
is amended to specify requirements for brokers and traders regarding
international transactions. These requirements specify what the U.S.
importer, the U.S. exporter, or the U.S. broker or trader must do if an
originally planned sale falls through and the importer or exporter
arranges a subsequent spot market sale, as explained earlier in the
preamble. For brokers and traders, the situation is somewhat more
complicated because the broker or trader does not control the sale. If
a transaction is not completed, the broker or trader could be asked to
find another buyer for the chemical or the broker or trader may not be
involved in arranging the subsequent sale. If the broker or trader
arranges a subsequent sale to replace the previously arranged
transaction, this transaction is a new transaction and must be reported
as such; a return declaration must be filed when the transaction is
completed.
Sections 1313.17(a), 1313.27(a), and 1313.35(a) are added to
specify the requirement that within 30 days of the completion of a
transaction, the importer, exporter, broker, or trader must send DEA a
return declaration containing information regarding the transaction,
including the name of the transferee, date the import, export, or
international transaction and any subsequent transfer occurred, the
name of the chemical transferred, the actual quantity transferred, the
container, and any other information that DEA may specify.
Sections 1313.17(b), 1313.27(b), and 1313.35(b) are added to
specify the requirement that if an importation, exportation, or
international transaction reported on a DEA Form 486 fails to be
completed, the importer, exporter, broker, or trader must file an
amendment to the Form 486 to notify DEA.
Revision of DEA Form 486: Import/Export Declaration for Precursor and
Essential Chemicals
To comply with the changes made to the Controlled Substances Act by
the Combat Methamphetamine Epidemic Act of 2005, DEA is revising the
existing DEA Form 486, Import/Export Declaration. DEA notes that this
form has not been revised or amended since its inception in 1989. Thus,
this form has not kept pace with subsequent legislation including the
Domestic Chemical Diversion Control Act of 1993, the Comprehensive
Methamphetamine Control Act of 1996, and the Methamphetamine Anti-
Proliferation Act of 2000. Therefore, some of the changes DEA is making
to this form are not directly related to the CMEA. However, these
changes are necessary for ease of use and clarity of the form.
Changes being made include the following:
Changing the title of the form to: ``Import/Export
Declaration for List I and List II Chemicals'' to more accurately
characterize the use of the form.
Adding a check box for ``international transaction'' in
addition to existing fields for ``import'' and ``export.''
Adding fields for DEA registration number and company
identifier, if applicable.
Adding a field for the foreign permit number, if
applicable.
Adding check boxes for the type of submission of the form:
``original,'' ``amended,'' and ``withdrawn.''
Adding fields for the actual date and quantity imported.
Adding fields for reporting by importers of the person to
whom the listed chemical will be transferred, the downstream customer,
per requirements of the CMEA.
Adding fields regarding return declaration by importers
and exporters.
Removing the certification by the Customs District
Director; this certification is now the responsibility of the importer
or exporter as part of the return declaration.
Eliminating a number of fields, including: gross weight of
chemicals imported/exported; intermediate carriers; address of
intermediate consignees.
Reorganizing layout for clarity.
Implementation of This Rule
Effective May 9, 2007, all United States importers and exporters of
List I and List II chemicals must use the revised DEA Form 486 to
notify DEA of their imports and exports. This revised form will be
available on the Diversion Control Program Web site, http://www.deadiversion.usdoj.gov
.
Effective May 9, 2007, all persons previously granted regular
importer status will no longer hold that status. Every import of a List
I and List II chemical must be reported to DEA not later than 15 days
prior to the proposed importation. This report must include
[[Page 17405]]
the name of the person to whom the chemical is proposed to be
transferred and the amount of the chemical proposed to be transferred.
DEA will evaluate each proposed importation based not only on the
chemical to be imported but on the transferee information supplied by
the importer as well. This process will allow for the establishment of
regular customer status by transferees of United States importers, and
for establishment of regular importer status by importers importing a
specific listed chemical intended for sale to a specific customer.
Effective May 9, 2007, all persons importing and exporting List I
and List II chemicals must provide the above discussed return
declarations to DEA.
Note Regarding Importation of the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine
This rulemaking addresses all List I and List II chemicals. While
ephedrine, pseudoephedrine, and phenylpropanolamine are List I
chemicals and are covered by these regulations, other provisions of
section 721 of the CMEA require the reporting of certain information
regarding the foreign chain of distribution of these three List I
chemicals. Other provisions of the CMEA require that these three List I
chemicals be imported only if there is a medical, scientific, or other
legitimate purpose for these chemicals. DEA is addressing these
provisions in a separate rulemaking. Persons importing ephedrine,
pseudoephedrine, and phenylpropanolamine are required to comply with
the provisions of this rule until such time as the rulemaking regarding
provision of information about the foreign chain of distribution is
promulgated. At that time, persons importing these three List I
chemicals will then be subject to those additional requirements.
Further, since the CMEA requires that these three List I chemicals
be imported only if there is a medical, scientific, or other legitimate
purpose for these chemicals, DEA must establish import quotas for
ephedrine, pseudoephedrine, and phenylpropanolamine. DEA is addressing
these provisions in separate rulemakings.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
The Administrative Procedure Act (APA) generally requires agencies
to publish a notice of proposed rulemaking and allow for a period of
public comment prior to implementing new rules. The APA also provides,
however, that agencies can be excepted from these requirements when
``the agency for good cause finds (and incorporates the finding and a
brief statement of reasons therefor in the rules issued) that notice
and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest.'' (5 U.S.C. 553(b)(B).
DEA has concluded that ``good cause'' exists to promulgate this
rule as an interim final rule rather than a proposed rule because the
mandates of the CMEA were set forth in such detail as to be self-
implementing. The changes announced in this interim final rule render
DEA's regulations consistent with the new provisions of the CMEA. Since
DEA is without authority to revise this rule based on public comments,
DEA finds that notice and opportunity for comment are unnecessary and
impracticable under the APA (5 U.S.C. 553(b)(B)).
DEA is cognizant of the fact that exceptions to the APA's notice
and comment procedures are to be ``narrowly construed and only
reluctantly countenanced.'' American Federation of Government Employees
v. Block, 655 F2d 1153, 1156 (D.C. Cir. 1981) (quoting New Jersey
Department of Environmental Protection v. EPA, 626 F2d 1038, 1045 (D.C.
Cir. 1980)). Based on the detailed requirements set forth in the CMEA
which give no discretion in their implementation, however, DEA finds
that the invocation of the ``good cause'' exception, and the issuance
of this rule as an interim final rule, is justified.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (RFA) (5
U.S.C. 605(b)). The RFA applies to rules that are subject to notice and
comment. Because this rule is simply codifying statutory provisions,
DEA has determined, as explained above, that public notice and comment
are not necessary. Consequently, the RFA does not apply.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has
been drafted in accordance with the principles in Executive Order 12866
Sec. 1(b). It has been determined that this is ``a significant
regulatory action.'' Therefore, this action has been reviewed by the
Office of Management and Budget (OMB). As discussed above, this action
is codifying statutory provisions and involves no agency discretion.
This statutory change imposes minimal costs on United States importers,
exporters, brokers, and traders; they simply have to file a form with
DEA in advance of spot market transactions. They must also provide a
return declaration after the import or export has occurred.
Paperwork Reduction Act
As discussed previously, the DEA is revising an information
collection by revising the information collected on DEA Form 486:
Import/Export Declaration for List I and List II Chemicals [OMB
information collection 1117-0023]. Those changes have been discussed
above, and are necessary for DEA to implement the provisions of the
CMEA of 2005.
The Department of Justice, DEA, has submitted the following
information collection request to the OMB for review and clearance in
accordance with review procedures of the Paperwork Reduction Act of
1995. The information collection is published to obtain comments from
the public and affected agencies.
All comments and suggestions, or questions regarding additional
information, to include obtaining a copy of the information collection
instrument with instructions, should be directed to Mark W. Caverly,
Chief, Liaison and Policy Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537.
Written comments and suggestions from the public and affected
agencies concerning the collection of information are encouraged. Your
comments on the information collection-related aspects of this rule
should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Overview of this information collection:
[[Page 17406]]
(1) Type of Information Collection: revision of an existing
collection.
(2) Title of the Form/Collection: Import/Export Declaration for
List I and List II Chemicals.
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection:
Form Number: DEA Form 486.
Office of Diversion Control, Drug Enforcement Administration, U.S.
Department of Justice.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract:
Primary: business or other for-profit.
Other: none.
Abstract: Persons importing, exporting, and conducting
international transactions with List I and List II chemicals must
notify DEA of those transactions in advance of their occurrence,
including information regarding the person(s) to whom the chemical will
be transferred and the quantity to be transferred. For importations,
persons must also provide return declarations, confirming the date of
the importation and transfer, and the amounts of the chemical
transferred. This information is used to prevent shipments not intended
for legitimate purposes.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond:
----------------------------------------------------------------------------------------------------------------
Number of Number of Average time per
respondents responses response Total hours
----------------------------------------------------------------------------------------------------------------
Form 486 (export)............... 225 7,917 0.2 hour 1,583.4 hours.
(12 minutes)
Form 486 (export return 225 7,917 0.08 hour 659.75 hours.
declaration). (5 minutes)
Form 486 (import)............... 216 2,278 0.25 hour 569.5 hours.
(15 minutes)
Form 486 (import return 216 2,506 0.08 hour 208.8 hours.
declaration)*. (5 minutes)
Form 486 (international 9 111 0.2 hour 22.2 hours.
transaction). (12 minutes)
Form 486 (international 9 111 0.08 hour 9.25 hours.
transaction return declaration). (5 minutes)
Quarterly reports for imports of 110 440 0.5 hour 220 hours.
acetone, 2-butanone, and (30 minutes)
toluene.
-------------------------------------------------------------------------------
Total....................... 225 .............. .................... 3,272.9 hours.
----------------------------------------------------------------------------------------------------------------
* DEA assumes 10% of all imports will not be transferred in the first thirty days and will necessitate
submission of a subsequent return declaration.
(6) An estimate of the total public burden (in hours) associated
with the collection: DEA estimates that this collection will take
3,272.9 hours annually.
If additional information is required, contact: Lynn Bryant,
Department Clearance Officer, Information Management and Security
Staff, Justice Management Division, Department of Justice, Patrick
Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530.
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
$118,000,000 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.
Congressional Review Act
This rule is not a major rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Congressional
Review Act). This rule will not result in an annual effect on the
economy of $100,000,000 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
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1313
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
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For the reasons set out above, 21 CFR parts 1300 and 1313 are amended
as follows:
PART 1300--DEFINITIONS
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1. The authority citation for part 1300 continues to read as follows:
Authority: 21 U.S.C. 802, 871(b), 951, 958(f).
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2. Section 1300.02 is amended by revising paragraphs (b)(12), (b)(13),
and (b)(25) to read as follows:
Sec. 1300.02 Definitions related to listed chemicals.
* * * * *
(b) * * *
(12) The term established business relationship means the regulated
person has imported or exported a listed chemical at least once within
the past six months, or twice within the past twelve months from or to
a foreign manufacturer, distributor, or end user of the chemical that
has an established business with a fixed street address. A person or
business that functions as a broker or intermediary is not a customer
for purposes of this definition.
[[Page 17407]]
(13) The term established record as an importer means that the
regulated person has imported a listed chemical at least once within
the past six months, or twice within the past twelve months from a
foreign supplier.
* * * * *
(25) The term regular customer means a person with whom the
regulated person has an established business relationship for a
specified listed chemical or chemicals that has been reported to the
Administration subject to the criteria established in part 1313 of this
chapter.
* * * * *
PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II
CHEMICALS
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3. The authority citation for part 1313 continues to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
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4. The heading of part 1313 is revised to read as set forth above.
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5. Section 1313.05 is added to read as follows:
Sec. 1313.05 Requirements for an established business relationship.
To document that an importer or exporter has an established
business relationship with a customer, the importer or exporter must
provide the Administrator with the following information in accordance
with the waiver of 15-day advance notice requirements of Sec. 1313.15
or Sec. 1313.24:
(a) The name and street address of the chemical importer or
exporter and of each regular customer;
(b) The telephone number, contact person, and where available, the
facsimile number for the chemical importer or exporter and for each
regular customer;
(c) The nature of the regular customer's business (i.e., importer,
exporter, distributor, manufacturer, etc.), and if known, the use to
which the listed chemical or chemicals will be applied;
(d) The duration of the business relationship;
(e) The frequency and number of transactions occurring during the
preceding 12-month period;
(f) The amounts and the listed chemical or chemicals involved in
regulated transactions between the chemical importer or exporter and
regular customer;
(g) The method of delivery (direct shipment or through a broker or
forwarding agent); and
(h) Other information that the chemical importer or exporter
considers relevant for determining whether a customer is a regular
customer.
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6. Section 1313.08 is added to read as follows:
Sec. 1313.08 Requirements for establishing a record as an importer.
To establish a record as an importer, the regulated person must
provide the Administrator with the following information in accordance
with the waiver of the 15-day advance notice requirements of Sec.
1313.15:
(a) The name, DEA registration number (where applicable), street
address, telephone number, and, where available, the facsimile number
of the regulated person and of each foreign supplier; and
(b) The frequency and number of transactions occurring during the
preceding 12 month period.
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7. Section 1313.12 is amended by revising paragraph (c) to read as
follows:
Sec. 1313.12 Requirement of authorization to import.
* * * * *
(c) The 15-day advance notification requirement for listed chemical
imports may be waived for the following:
(1) Any importation that meets both of the following requirements:
(i) The regulated person has satisfied the requirements for
reporting to the Administration as a regular importer of the listed
chemicals.
(ii) The importer intends to transfer the listed chemicals to a
person who is a regular customer for the chemical, as defined in Sec.
1300.02 of this chapter.
(2) A specific listed chemical, as set forth in paragraph (f) of
this section, for which the Administrator determines that advance
notification is not necessary for effective chemical diversion control.
* * * * *
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8. Section 1313.13 is amended by revising paragraph (c)(4) and adding
paragraph (c)(5) to read as follows:
Sec. 1313.13 Contents of import declaration.
* * * * *
(c) * * *
(4) The name, address, telephone number, telex number, and, where
available, the facsimile number of the consigner in the foreign country
of exportation; and
(5) The name, address, telephone number, and where available, the
facsimile number of the person or persons to whom the importer intends
to transfer the listed chemical and the quantity to be transferred to
each transferee.
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9. Section 1313.15 is amended by revising paragraph (a) to read as
follows:
Sec. 1313.15 Waiver of 15-day advance notice for regular importers.
(a) Each regulated person seeking designation as a ``regular
importer'' shall provide, by certified mail return receipt requested,
to the Administration such information as is required under Sec.
1313.08 documenting their status as a regular importer.
* * * * *
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10. Section 1313.16 is added to read as follows:
Sec. 1313.16 Transfers following importation.
(a) In the case of a notice under Sec. 1313.12(a) submitted by a
regulated person, if the transferee identified in the notice is not a
regular customer, the importer may not transfer the listed chemical
until after the expiration of the 15-day period beginning on the date
on which the notice is submitted to the Administration.
(b) After a notice under Sec. 1313.12(a) or (d) is submitted to
the Administration, if circumstances change and the importer will not
be transferring the listed chemical to the transferee identified in the
notice, or will be transferring a greater quantity of the chemical than
specified in the notice, the importer must update the notice to
identify the most recent prospective transferee or the most recent
quantity or both (as the case may be) and may not transfer the listed
chemical until after the expiration of the 15-day period beginning on
the date on which the update is submitted to the Administration, except
that the 15-day restriction does not apply if the prospective
transferee identified in the update is a regular customer. The
preceding sentence applies with respect to changing circumstances
regarding a transferee or quantity identified in an update to the same
extent and in the same manner as the sentence applies with respect to
changing circumstances regarding a transferee or quantity identified in
the original notice under Sec. 1313.12(a) or (d).
(c) In the case of a transfer of a listed chemical that is subject
to a 15-day restriction, the transferee involved shall, upon the
expiration of the 15-day period, be considered to qualify as a regular
customer, unless the Administration otherwise notifies the importer
involved in writing.
(d) With respect to a transfer of a listed chemical with which a
notice or update referred to in Sec. 1313.12(a) or (d) is concerned:
(1) The Administration--
(i) May, in accordance with the same procedures as apply under
Sec. Sec. 1313.51 through 1313.57, order the suspension
[[Page 17408]]
of the transfer of the listed chemical by the importer involved, except
for a transfer to a regular customer, on the ground that the chemical
may be diverted to the clandestine manufacture of a controlled
substance (without regard to the form of the chemical that may be
diverted, including the diversion of a finished drug product to be
manufactured from bulk chemicals to be transferred), subject to the
Administration ordering the suspension before the expiration of the 15-
day period with respect to the importation (in any case in which such a
period applies); and
(ii) May, for purposes of this paragraph (d), disqualify a regular
customer on that ground.
(2) From and after the time when the Administration provides
written notice of the order under paragraph (d)(1)(i) of this section
(including a statement of the legal and factual basis for the order) to
the importer, the importer may not carry out the transfer.
(e) For purposes of this section:
(1) The term transfer, with respect to a listed chemical, includes
the sale of the chemical.
(2) The term transferee means a person to whom an importer
transfers a listed chemical.
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11. Section 1313.17 is added to read as follows:
Sec. 1313.17 Return declaration or amendment to Form 486 for imports.
(a) Within 30 days after a transaction is completed, the importer
must send to the Administration a return declaration containing
particulars of the transaction, including the date, quantity, chemical,
container, name of transferees, and any other information as the
Administration may specify. A single return declaration may include the
particulars of both the importation and distribution. If the importer
has not distributed all chemicals imported by the end of the initial
30-day period, the importer must file supplemental return declarations
no later than 30 days from the date of any further distribution, until
the distribution or other disposition of all chemicals imported under
the import notification or any update are accounted for.
(b) If an importation for which a Form 486 has been filed fails to
take place, the importer must file an amended Form 486 notifying the
Administration that the importation did not occur.
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12. Section 1313.26 is added to read as follows:
Sec. 1313.26 Transfers following exportation.
(a) In the case of a notice under Sec. 1313.21(a) submitted by a
regulated person, if the transferee identified in the notice, i.e., the
foreign importer, is not a regular customer, the regulated person may
not transfer the listed chemical until after the expiration of the 15-
day period beginning on the date on which the notice is submitted to
the Administration.
(b) After a notice under Sec. 1313.21(a) is submitted to the
Administration, if circumstances change and the exporter will not be
transferring the listed chemical to the transferee identified in the
notice, or will be transferring a greater quantity of the chemical than
specified in the notice, the exporter must update the notice to
identify the most recent prospective transferee or the most recent
quantity or both (as the case may be) and may not transfer the listed
chemical until after the expiration of the 15-day period beginning on
the date on which the update is submitted to the Administration, except
that the 15-day restriction does not apply if the prospective
transferee identified in the update is a regular customer. The
preceding sentence applies with respect to changing circumstances
regarding a transferee or quantity identified in an update to the same
extent and in the same manner as the sentence applies with respect to
changing circumstances regarding a transferee or quantity identified in
the original notice under paragraph (a) of this section.
(c) In the case of a transfer of a listed chemical that is subject
to a 15-day restriction, the transferee involved shall, upon the
expiration of the 15-day period, be considered to qualify as a regular
customer, unless the Administration otherwise notifies the exporter
involved in writing.
(d) With respect to a transfer of a listed chemical with which a
notice or update referred to in Sec. 1313.21(a) is concerned:
(1) The Administration--
(i) May, in accordance with the same procedures as apply under
Sec. Sec. 1313.51 through 1313.57, order the suspension of the
transfer of the listed chemical by the exporter involved, except for a
transfer to a regular customer, on the ground that the chemical may be
diverted to the clandestine manufacture of a controlled substance
(without regard to the form of the chemical that may be diverted,
including the diversion of a finished drug product to be manufactured
from bulk chemicals to be transferred), subject to the Administration
ordering the suspension before the expiration of the 15-day period with
respect to the exportation (in any case in which such a period
applies); and
(ii) May, for purposes of this paragraph (d), disqualify a regular
customer on that ground.
(2) From and after the time when the Administration provides
written notice of the order under paragraph (d)(1)(i) of this section
(including a statement of the legal and factual basis for the order) to
the exporter, the exporter may not carry out the transfer.
(e) For purposes of this section:
(1) The term transfer, with respect to a listed chemical, includes
the sale of the chemical.
(2) The term transferee means a person to whom an exporter
transfers a listed chemical.
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13. Section 1313.27 is added to read as follows:
Sec. 1313.27 Return declaration or amendment to Form 486 for exports.
(a) Within 30 days after a transaction is completed, the exporter
must send to the Administration a return declaration containing
particulars of the transaction, including the date, quantity, chemical,
container, name of transferees, and any other information as the
Administration may specify.
(b) If an exportation for which a Form 486 has been filed fails to
take place, the exporter must file an amended Form 486 notifying the
Administration that the exportation did not occur.
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14. Section 1313.32 is amended by adding paragraphs (d) and (e) to read
as follows:
Sec. 1313.32 Requirement of authorization for international
transactions.
* * * * *
(d) After a notice under paragraph (a) of this section is submitted
to the Administration, if circumstances change and the broker or trader
will not be transferring the listed chemical to the transferee
identified in the notice, or will be transferring a greater quantity of
the chemical than specified in the notice, the broker or trader must
update the notice to identify the most recent prospective transferee or
the most recent quantity or both (as the case may be). The preceding
sentence applies with respect to changing circumstances regarding a
transferee or quantity identified in an update to the same extent and
in the same manner as the sentence applies with respect to changing
circumstances regarding a transferee or quantity identified in the
original notice under paragraph (a) of this section.
(e) For purposes of this section:
(1) The term transfer, with respect to a listed chemical, includes
the sale of the chemical.
[[Page 17409]]
(2) The term transferee means a person to whom an exporter
transfers a listed chemical.
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15. Section 1313.35 is added to read as follows:
Sec. 1313.35 Return declaration or amendment to Form 486 for
international transactions.
(a) Within 30 days after a transaction is completed, the broker or
trader must send to the Administration a return declaration containing
particulars of the transaction, including the date, quantity, chemical,
container, name of transferees, and any other information as the
Administration may specify.
(b) If a transaction for which a Form 486 has been filed fails to
take place, the broker or trader must file an amended Form 486
notifying the Administration that the transaction did not occur.
Dated: March 30, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 07-1718 Filed 4-6-07; 8:45 am]
BILLING CODE 4410-09-P