[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Proposed Rules]
[Page 16793-16797]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr08-28]
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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: dea.diversion.policy@usdoj.gov. 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:
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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.
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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