Federal
Register Notices > Rules - 200 8
- Information on Foreign Chain of Distribution for
Ephedrine, Pseudoephedrine, and Phenylpropanolamine
FR Doc E8-6357[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]
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.
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:
|
Number of respondents
|
Number of responses
|
Average time per response
|
Total (in hours)
|
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 declaration)\*\.
|
230
|
2200
|
0.08 hour (5 minutes)
|
183.3
|
Form 486A (import)
|
30
|
350
|
0.33 hour (20 minutes)
|
116.7
|
Form 486A (import return declaration)\*\.
|
30
|
385
|
0.08 hour (5 minutes)
|
32.1
|
Form 486 (international transaction)
|
9
|
111
|
0.2 hour (12 minutes)
|
22.2
|
Form 486 (international transaction return declaration
|
9
|
111
|
0.08 hour (5 minutes)
|
9.25
|
Quarterly reports for imports of acetone, 2-butanone, and
toluene
|
110
|
440
|
0.5 hour (30 minutes)
|
220
|
Total
|
239
|
.............
|
.............
|
3,349.35
|
* 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]
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