[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Proposed Rules]
[Pages 16793-16797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6357]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1313

[Docket No. DEA-295P]
RIN 1117-AB07


Information on Foreign Chain of Distribution for Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which 
was enacted on March 9, 2006, requires DEA to collect from importers of 
ephedrine, pseudoephedrine, and phenylpropanolamine all information 
known to the importer on the foreign chain of distribution of the 
chemical from the manufacturer to the importer. DEA is proposing to 
amend its regulations to incorporate the requirement for this 
information into the import declaration.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before May 30, 2008.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-295'' 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, 8701 Morrissette Drive, Springfield, VA 
22152. Comments may be directly sent to DEA electronically by sending 
an electronic message to: [email protected]. 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

[[Page 16794]]

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.
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. If you wish 
to inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

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 the Controlled Substances Import and Export Act (21 U.S.C. 801-
971), as amended. DEA publishes the implementing regulations for these 
statutes in title 21 of the Code of Federal Regulations (CFR), parts 
1300 to 1399. These regulations are designed to ensure that there is a 
sufficient supply of controlled substances for legitimate medical, 
scientific, research, and industrial 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, distribution, import, and export of chemicals 
that may be used to manufacture controlled substances illegally. 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 Combat Methamphetamine 
Epidemic Act of 2005 (CMEA), which is title VII of the USA PATRIOT 
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). The 
changes proposed here are needed to implement the statutory provisions. 
The statute is self-implementing; the provisions related to information 
to be collected at the importation of ephedrine, pseudoephedrine, and 
phenylpropanolamine became effective on March 9, 2006. The changes 
proposed in this rulemaking provide conforming amendments to make the 
language of the regulations consistent with that of the statute. DEA 
must implement the statute and is simply conforming its regulations to, 
and implementing, the statute.

Import Declaration Requirements

    Under existing DEA regulations (21 CFR part 1313), importers of 
listed chemicals are required to provide DEA with advance notification 
of imports unless the importer has met the requirements as a regular 
importer of the listed chemical; for regular importers, the 
notification must be filed by the date of importation. In the 
importation declaration (DEA Form 486), the importer must provide 
information on the chemical (name, size and weight of the container, 
number of containers, total weight of chemical), importation (date, 
foreign port of shipment, United States port of entry) and the foreign 
supplier (name, address, contact information).
    CMEA imposes several new requirements on imports of listed 
chemicals. CMEA amended 21 U.S.C. 971, ``Notification, suspension of 
shipment, and penalties with respect to importation and exportation of 
listed chemicals'', to require DEA to collect information regarding 
persons to whom the United States importer, exporter, broker, or trader 
transfers the listed chemical, actual quantities shipped, and the date 
the shipment occurred. If the person to whom the listed chemical is to 
be transferred is not a regular customer of the United States importer 
or exporter, then the importer or exporter must notify DEA no later 
than 15 days before the transaction is to take place. Further, if the 
person to whom the chemical is to be transferred changes subsequent to 
initial notification of DEA, or if the amount of the chemical to be 
transferred increases, the importer or exporter shall update the notice 
to DEA 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 DEA, except 
that such 15-day restriction does not apply if the prospective 
transferee identified in the update is a regular customer. These 
changes apply to all listed chemicals. On April 9, 2007, DEA published 
an Interim Final Rule with Request for Comment codifying these 
provisions (72 FR 17401). Subsequently, due to requests from the 
regulated industry, DEA temporarily stayed certain provisions of that 
rule (72 FR 28601, May 22, 2007). That Interim Final Rule became 
effective June 8, 2007.
    CMEA added a new paragraph (h) to 21 U.S.C. 971 that applies 
specifically to the importation of ephedrine, pseudoephedrine, and 
phenylpropanolamine. In paragraph (h)(1), the Act states that the 
import declaration ``shall include all information known to the 
importer on the chain of distribution of such chemical from the 
manufacturer to the importer.'' Paragraphs 971(h)(2) and (3) state that 
the Attorney General may ask foreign manufacturers and distributors

[[Page 16795]]

to provide information known to them on distribution of the chemical, 
including sales. If the foreign manufacturer or distributor refuses to 
cooperate, the Attorney General may issue an order prohibiting the 
importation of the three chemicals if the foreign manufacturer or 
distributor is part of the chain of distribution. Not later than 60 
days prior to issuing the order, the Attorney General must publish in 
the Federal Register a notice of intent to issue the order. Imports 
handled by the foreign distributor may not be restricted during the 60-
day period. In the Conference Report (H.R. 109-333), Congress stated 
that the ``provision will assist U.S. law enforcement agencies to 
better track where meth precursors come from, and how they get to the 
U.S. At present, very little information exists about the international 
`chain of distribution' for these chemicals, hindering effective 
controls.''
    DEA is proposing to add a new paragraph (d) to 21 CFR 1313.13, 
Contents of import declaration, to state that importers of ephedrine, 
pseudoephedrine, and phenylpropanolamine must provide information known 
to them on the chain of distribution from the manufacturer to the 
importer. DEA is also proposing to add a new 21 CFR 1313.42 to cover 
the provisions of paragraphs (h)(2) and (3) on orders to prohibit 
imports from foreign manufacturers and distributors who refuse to 
cooperate with requests for information.

Revision of DEA Form 486: Import/Export Declaration for List I and List 
II Chemicals

    To comply with the changes made to the Controlled Substances Act by 
the Combat Methamphetamine Epidemic Act of 2005, DEA is proposing to 
establish a new DEA Form 486A to be used by persons importing 
ephedrine, pseudoephedrine, or phenylpropanolamine, or drug products 
containing ephedrine, pseudoephedrine, or phenylpropanolamine. This new 
form responds to the requirement regarding the foreign chain of 
distribution discussed above, as well as to requirements implemented 
regarding import quotas for ephedrine, pseudoephedrine, and 
phenylpropanolamine. In a separate rulemaking, ``Import and Production 
Quotas for Certain List I Chemicals'' [Docket No. DEA-293, RIN 1117-
AB08] (72 FR 37439, July 10, 2007), DEA implemented the import quota 
provisions of CMEA. Importers of ephedrine, pseudoephedrine, and 
phenylpropanolamine will be required to provide information about their 
individual import quota on the DEA Form 486A so that DEA may determine 
whether the importer has enough quota remaining to import the quantity 
requested.
    Thus, in addition to the fields currently present on the DEA Form 
486, the DEA Form 486A contains the following fields:
     Name and address of foreign distributor (if applicable).
     Import quota, including: quota for current year; quota 
used to date for current year; and, amount of quota remaining.
    Once the new DEA Form 486A is implemented, DEA will make both the 
DEA Form 486 and the DEA Form 486A fully interactive forms. That is, 
these forms would be able to be completed and submitted electronically. 
Currently, forms can be completed electronically, but must be printed 
and sent to DEA via facsimile. DEA notes that the availability of a 
fully interactive form has been long sought by the regulated industry.

Implementation of this Rule

    Effective 30 days after publication of a Final Rule implementing 
these regulations in the Federal Register, all United States importers 
of the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine would be required to use the new DEA Form 486A 
``Importation of the List I Chemicals Ephedrine, Pseudoephedrine, and 
Phenylpropanolamine'' to notify DEA of their imports.

Regulatory Certifications

Regulatory Flexibility Act

    The Acting Administrator hereby certifies that this rulemaking has 
been drafted in accordance with the provisions of the Regulatory 
Flexibility Act (5 U.S.C. 601-612). This rule is necessary to comply 
with statutory mandates which require that notices of importation for 
imports of the List I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine provide to DEA all information known to the 
importer on the foreign chain of distribution of the chemical. As noted 
above, changes to the forms also respond to provisions regarding import 
quotas, requiring that importers note on the form the amount of quota 
issued and available for each chemical. Without these changes, DEA will 
be unable to comply with statutory mandates and will not be able to 
fully administer the system of import and production quotas mandated 
for ephedrine, pseudoephedrine, and phenylpropanolamine.
    DEA notes that the statute requires importers to provide only 
information that is known to them; the burden associated with providing 
names on the foreign chain of distribution will be minimal. This rule 
does not impose any new costs. DEA notes that, prior to this rule, 
importers of ephedrine, pseudoephedrine, and phenylpropanolamine were 
required to complete a DEA Form 486 to import these List I chemicals. 
Only the information on the form has changed. Therefore, this rule will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12866

    The Acting Administrator further certifies that this rulemaking has 
been drafted in accordance with the principles in Executive Order 12866 
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. As discussed above, this action is codifying 
statutory provisions and involves no agency discretion. This statutory 
change imposes minimal costs on importers; they simply have to file a 
form with DEA in advance of transactions that includes information that 
is known to them. They are not required to conduct research to obtain 
information. DEA notes that the requirement to complete the form is 
already present in DEA regulations. This rule merely requires that 
importers of these three List I chemicals provide information known to 
them regarding the foreign chain of distribution of the chemicals.

Paperwork Reduction Act

    DEA is proposing to revise an existing information collection by 
establishing a new form for the reporting of imports of the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 
Specifically, DEA is creating new DEA Form 486A, ``Import Declaration 
for Ephedrine, Pseudoephedrine, and Phenylpropanolamine''. This form 
permits the reporting of any information known to the United States 
importer regarding the foreign chain of distribution of the List I 
chemical(s).
    Specifically, DEA estimates that 30 respondents will import 
ephedrine, pseudoephedrine, and phenylpropanolamine annually. These 
persons will conduct 350 individual importations, necessitating the 
submission of 350 forms. Because of the additional information required 
on the DEA Form 486A, DEA estimates that this form will take 20 minutes 
to

[[Page 16796]]

complete, as opposed to the DEA Form 486, which DEA estimates takes 15 
minutes to complete. DEA notes here that the completion of the DEA Form 
486A will be in lieu of the currently-required completion of the DEA 
Form 486. Therefore, while the number of responses remains constant, 
the hour burden increases due to the greater time associated with the 
DEA Form 486A. The net increase for this collection is 13 hours 
annually.
    The Department of Justice, Drug Enforcement Administration, has 
submitted the following information collection request to the Office of 
Management and Budget (OMB) for review and clearance in accordance with 
review procedures of the Paperwork Reduction Act of 1995. The proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    All comments, suggestions, or questions regarding additional 
information, to include obtaining a copy of the proposed 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 Information Collection 1117-0023

    (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 and DEA Form 486A. 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. Persons must also 
provide return declarations, confirming the date of the importation and 
transfer, and the amounts of the chemical transferred. For the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
importers must report all information known to them on the chain of 
distribution of the chemical from the manufacturer to the importer. 
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       Total  (in
                                          respondents      responses            response              hours)
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Form 486 (export).....................             239           7,997  0.2 hour (12 minutes)...        1,599.4
Form 486 (Export Return Declaration)..             239           7,997  0.08 hour (5 minutes)...          666.4
Form 486 (import).....................             230            2000  0.25 hour (15 minutes)..          500
Form 486 (import return                            230            2200  0.08 hour (5 minutes)...          183.3
 declaration)\*\.
Form 486A (import)....................              30             350  0.33 hour (20 minutes)..          116.7
Form 486A (import return                            30             385  0.08 hour (5 minutes)...           32.1
 declaration)\*\.
Form 486 (international transaction)..               9             111  0.2 hour (12 minutes)...           22.2
Form 486 (international transaction                  9             111  0.08 hour (5 minutes)...            9.25
 return declaration.
Quarterly reports for imports of                   110             440  0.5 hour (30 minutes)...          220
 acetone, 2-butanone, and toluene.
                                       -------------------------------------------------------------------------
    Total.............................             239  ..............  ........................        3,349.35
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* 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 3,350 
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 
$120,000,000 or more

[[Page 16797]]

(adjusted for inflation) 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 section 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 in 21 CFR Part 1313

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Reporting and recordkeeping requirements.

    For the reasons set out above, 21 CFR part 1313 is proposed to be 
amended as follows:

PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II 
CHEMICALS

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

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

    2. Section 1313.13 is amended by adding paragraph (d) to read as 
follows:


Sec.  1313.13  Contents of import declaration.

* * * * *
    (d) Any regulated person importing ephedrine, pseudoephedrine, or 
phenylpropanolamine must submit, on the import declaration, all 
information known to the importer on the chain of distribution of the 
chemical from the manufacturer to the importer. Ephedrine, 
pseudoephedrine, or phenylpropanolamine include each of the salts, 
optical isomers, and salts of optical isomers of the chemical.
    3. Section 1313.42 is added to read as follows:


Sec.  1313.42  Prohibition of shipments from certain foreign sources.

    (a) If the Administrator determines that a foreign manufacturer or 
distributor of ephedrine, pseudoephedrine, or phenylpropanolamine has 
refused to cooperate with a request by the Administrator for 
information known to the manufacturer or distributor on the 
distribution of the chemical, including sales, the Administrator may 
issue an order prohibiting the importation of the chemical in any case 
where the manufacturer or distributor is part of the chain of 
distribution.
    (b) Not later than 60 days prior to issuing the order to prohibit 
importation, the Administrator shall publish in the Federal Register a 
notice of intent to issue the order. During the 60 day period, imports 
from the foreign manufacturer or distributor may not be restricted 
under this section.

    Dated: March 14, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-6357 Filed 3-28-08; 8:45 am]
BILLING CODE 4410-09-P