[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Rules and Regulations]
[Pages 10168-10172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4716]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1313
[Docket No. DEA-295F]
RIN 1117-AB07
Information on Foreign Chain of Distribution for Ephedrine,
Pseudoephedrine, and Phenylpropanolamine
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is finalizing,
without change, the Notice of Proposed Rulemaking published in the
Federal Register on March 31, 2008 (73 FR 16793). The Combat
Methamphetamine Epidemic Act of 2005 (CMEA) 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.
This rule amends DEA regulations to incorporate the requirement for
this information.
DATES: Effective Dates: This Final Rule is effective May 4, 2010.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152,
Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background and 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 (CSIEA) (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 made by this rule are needed to implement the statutory
provisions. This Final Rule amends the language of the regulations to
be consistent with that of the statute.
Import/Export 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 U.S. 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 U.S. 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
[[Page 10169]]
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.
Imports of Ephedrine, Pseudoephedrine, and Phenylpropanolamine
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 (h)(3) state
that the Attorney General may ask foreign manufacturers and
distributors 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.''
In its Notice of Proposed Rulemaking proposing implementation of
the provisions of 21 U.S.C. 971(h) (73 FR 16793, March 31, 2008), DEA
proposed 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 also proposed to add a new 21 CFR 1313.42 to cover the
provisions of paragraphs (h)(2) and (h)(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 CSA by CMEA, DEA proposed 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; 73 FR 73549, December 3, 2008), 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 was proposed to contain 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.
Comments Received
DEA received two comments in response to the Notice of Proposed
Rulemaking. Commenters included one member of the public who indicated
he was a health care provider and one chemical manufacturer. The
commenters generally supported the rulemaking, but had a variety of
comments regarding certain aspects of the proposed rule. The comments,
and DEA's responses, are discussed below.
Safety of medication manufactured overseas: One commenter stated
that he supported the rule because he believed that improving drug
safety can save lives. The commenter also asserted that ``this rule has
the potential to improve safety of the industry even further by putting
the burden of finding the foreign chain of distribution on the
importer.'' The commenter emphasized his concern with the safety of
medications manufactured in foreign countries and asserted that the
Food and Drug Administration (FDA) does not have adequate resources to
regulate overseas manufacturing facilities, and believed this rule
could be beneficial in that regard. The commenter believed that the
reporting of information about where a drug comes from is of interest
not only to the importer, but to all parties concerned, including
practitioners who prescribe those medications to their patients. The
commenter believed that it is useful to know that medications came from
``trustworthy'' facilities, and that such a requirement would be a
``small price to pay'' for protecting lives.
DEA Response: DEA appreciates the commenter's support. Regarding
the safety of medications manufactured in foreign countries, DEA does
not have jurisdiction regarding foreign manufacture of ephedrine,
pseudoephedrine, phenylpropanolamine, or drug products containing those
three List I chemicals. DEA also emphasizes that information regarding
the foreign chain of distribution will be made known by the importer to
DEA, but that information will not be made known to the general public.
Distributions to countries other than the United States: The second
commenter, a chemical manufacturer, asked whether it was DEA's intent
to collect information about the foreign manufacturer's use of
distribution centers for shipments to any destination in the world, or
only collect information on the use of distributors for shipment to the
United States.
DEA Response: DEA is only requiring collection of the information
on the use of distributors for shipment to the U.S. The CSA and its
implementing regulations address importation of listed chemicals only
in regard to the United States, not in regard to foreign countries (21
U.S.C. 951(a)(1)). Thus, any requirements DEA imposes regarding
importation of listed chemicals relate to the U.S.
Source of distribution data: The second commenter also asked DEA to
clarify in the Final Rule the information required to be included on
the DEA Form 486, stating: ``* * * if distribution
[[Page 10170]]
data is obtained from a central location should the importer include
that information in the existing foreign consignor field (field 2b), or
does the manufacturing site information from which the direct export
occurs suffice if DEA could obtain distribution data from the contact
information being provided in a timely manner?''
DEA Response: If a foreign exporter exports a listed chemical from
a particular location to the U.S., but the information regarding all
exports from the foreign country to the U.S. is aggregated at a central
location, the U.S. importer should provide information on the DEA Form
486 regarding the actual export location, not the location at which the
information is aggregated. DEA emphasizes that this requirement is not
a change from existing requirements or policies.
Quota information on Import Declarations: The commenter also
requested that DEA delay implementation of the requirements regarding
foreign chain of distribution until calendar year 2009. The commenter
believed this would be beneficial to the regulated industry as that
industry had already made significant changes to its processes to
comply with other requirements of CMEA. The commenter believed that
delaying the effective date of the rule until calendar year 2009 would
ensure that both importers and DEA have established timely quota
processes that will not interfere with compliance to the proposed rule.
DEA Response: DEA acknowledges that the regulated industry has
worked to adapt its business process to the statutory requirements
imposed by CMEA. The information sought by the new DEA Form 486A
regarding foreign chain of distribution should not pose a significant
additional burden to importer registrants. Further, the information
required pertaining to import quotas is necessary to fully implement
the quota provisions of CMEA and should already be maintained by
importers. However, to ensure that industry has adequate time in which
to begin to use the new form, DEA is making this rule effective May 4,
2010. DEA believes industry will have adequate time to begin to submit
the DEA Form 486A based on this effective date.
Implementation of This Rule
Thus, to comply with the provisions of CMEA codified at 21 U.S.C.
971(h), this Final Rule adds a new paragraph (d) to 21 CFR 1313.13,
Contents of import declaration, and states that importers of ephedrine,
pseudoephedrine, and phenylpropanolamine must provide information known
to them on the chain of distribution from the manufacturer to the
importer. This rule adds a new 21 CFR 1313.42 to cover the provisions
of paragraphs (h)(2) and (h)(3) on orders to prohibit imports from
foreign manufacturers and distributors who refuse to cooperate with
requests for information.
Effective May 4, 2010, all U.S. importers of the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine will 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 of those three List I chemicals.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy 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 Deputy 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
This Final Rule revises 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 establishing a new DEA Form 486A, ``Import
Declaration for Ephedrine, Pseudoephedrine, and Phenylpropanolamine''.
This form permits the reporting of any information known to the U.S.
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 and 385 import return declarations. Because of
the additional information required on the DEA Form 486A, DEA estimates
that this form will take 24 minutes to complete, as opposed to the DEA
Form 486, which DEA estimates takes 20 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 24 hours annually.
DEA solicited comments regarding the Paperwork Reduction Act
aspects of the Notice of Proposed Rulemaking and received no comments.
Therefore, DEA is finalizing the Paperwork Reduction Act aspects of
this rule without change.
[[Page 10171]]
The Department of Justice, Drug Enforcement Administration, has
submitted the following information collection request to the Office of
Management and Budget for review and clearance in accordance with
review procedures of the Paperwork Reduction Act of 1995.
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, 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 Total
respondents responses Average time per response (hours)
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Form 486 (export)......................... 193 10,327 0.283 hour (17 minutes)..... 2,926
Form 486 (Export Return Declaration)...... 193 10,327 0.166 hour (10 minutes)..... 1721.2
Form 486 (import)......................... 120 1,268 0.333 hour (20 minutes)..... 422.6
Form 486 (import return declaration) *.... 120 1,395 0.2 hour (12 minutes)....... 279
Form 486A (import)........................ 30 350 0.4 hour (24 minutes)....... 140
Form 486A (import return declaration) *... 30 385 0.2 hour (12 minutes)....... 77
Form 486 (international transaction)...... 14 14 0.2 hour (12 minutes)....... 2.8
Form 486 (international transaction return 14 14 0.08 hour (5 minutes)....... 1.2
declaration).
Quarterly reports for imports of acetone, 110 440 0.5 hour (30 minutes)....... 220
2-butanone, and toluene.
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Total..................................... 193 ........... ............................ 5,789.8
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* DEA assumes 10% of all imports will not be transferred in the first 30 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 5,790
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 (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.
Dated: February 25, 2010.
Michele M. Leonhart,
Deputy Administrator.
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For the reasons set out above, 21 CFR part 1313 is amended as follows:
PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II
CHEMICALS
0
1. The authority citation for part 1313 continues to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
0
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.
[[Page 10172]]
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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.
[FR Doc. 2010-4716 Filed 3-4-10; 8:45 am]
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