[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Rules and Regulations]
[Pages 17401-17409]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1718]


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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 <a href="/cdn-cgi/l/email-protection#5b3f3e3a753f322d3e2928323435752b34373238221b2e283f3431753c342d"><span class="__cf_email__" data-cfemail="b8dcddd996dcd1ceddcacbd1d7d696c8d7d4d1dbc1f8cdcbdcd7d296dfd7ce">[email protected]</span></a>.

[[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
------------------------------------------------------------------------
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:
    <bullet> 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.
    <bullet> Adding a check box for ``international transaction'' in 
addition to existing fields for ``import'' and ``export.''
    <bullet> Adding fields for DEA registration number and company 
identifier, if applicable.
    <bullet> Adding a field for the foreign permit number, if 
applicable.
    <bullet> Adding check boxes for the type of submission of the form: 
``original,'' ``amended,'' and ``withdrawn.''
    <bullet> Adding fields for the actual date and quantity imported.
    <bullet> 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.
    <bullet> Adding fields regarding return declaration by importers 
and exporters.
    <bullet> 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.
    <bullet> Eliminating a number of fields, including: gross weight of 
chemicals imported/exported; intermediate carriers; address of 
intermediate consignees.
    <bullet> 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.

0
For the reasons set out above, 21 CFR parts 1300 and 1313 are amended 
as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

    Authority: 21 U.S.C. 802, 871(b), 951, 958(f).


0
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

0
3. The authority citation for part 1313 continues to read as follows:

    Authority: 21 U.S.C. 802, 830, 871(b), 971.


0
4. The heading of part 1313 is revised to read as set forth above.


0
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.

0
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.

0
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.
* * * * *

0
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.

0
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.
* * * * *

0
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.

0
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.

0
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.

0
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.

0
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.

0
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


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