[Federal Register: September 11, 2003 (Volume 68, Number 176)]
[Proposed Rules]
[Page 53529-53532]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11se03-21]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
[[Page 53529]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-192P]
RIN 1117-AA56
Exemption From Import/Export Requirements for Personal Medical
Use
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Controlled Substances Import and Export Act (CSI&EA)
authorizes the Drug Enforcement Administration (DEA) to accommodate
travelers who have a legitimate medical need for controlled substances
during their journey. The CSI&EA allows DEA to issue a regulation
exempting travelers from application of the CSI&EA requirements
regarding importation and exportation of controlled substances. Such a
regulation has existed since the CSI&EA came into effect in 1971.
However, in recent years, Congress became aware that this regulation
was being exploited by some individuals as a means of bringing
controlled substances into the United States for illicit use. For this
reason, Congress amended the CSI&EA in 1998 to place additional
restrictions on the importation of controlled substances for personal
use.
In this document, DEA is proposing to amend its regulations to
expressly incorporate the restrictions on personal use importation
imposed by Congress in 1998 and to expand upon those restrictions to
curtail diversion that has continued even after the 1998 congressional
amendment. Specifically, DEA is proposing to limit to 50 dosage units
the total amount of controlled substances that a United States resident
may bring into the United States for legitimate personal medical use
when returning from travel abroad.
DATES: Comments must be postmarked by November 10, 2003.
ADDRESSES: Comments should be submitted to the Deputy Administrator,
Drug Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
What Does This Rule Accomplish and by What Authority Is It Being
Issued?
Background
The CSI&EA (21 U.S.C. 951 et seq.) prohibits the importation of
controlled substances into the United States, and the exportation of
controlled substances from the United States, except as authorized by
the Act. 21 U.S.C. 952, 953, 957, 960. In general, only persons who are
registered with DEA to import or export controlled substances may do
so. Id. In addition, depending on the schedule of the controlled
substance being imported or exported, the CSI&EA requires the
appropriate permit, notification, or declaration, as specified in the
DEA regulations. Id.; 21 CFR 1312.11-1312.30. These requirements are
necessary and appropriate to ensure that international shipments of
controlled substances are limited to that which is necessary to meet
the medical, scientific, and other legitimate needs of the country of
destination and to prevent diversion of dangerous drugs into illicit
channels. In addition, these requirements are necessary to meet United
States obligations to control drugs of abuse in accordance with
international treaties to which the United States is a party, including
the Single Convention on Narcotic Drugs, 1961 (Single Convention), and
the Convention on Psychotropic Substances, 1971 (Psychotropic
Convention).
The CSI&EA makes a limited allowance, however, for travelers
entering and departing the United States who have a legitimate medical
need for controlled substances during their journey. As set forth in 21
U.S.C. 956, the Administrator of DEA \1\ may, by regulation, exempt an
individual traveler from application of the CSI&EA requirements
regarding importation and exportation of controlled substances where
such traveler possesses a controlled substance (except a substance in
Schedule I) for the traveler's personal medical use, provided the
controlled substance was obtained lawfully and the traveler makes the
appropriate declaration or notification to the United States Customs
Service, as specified in the DEA regulation. Such regulation has been
in place since the CSI&EA was enacted in 1970. The regulation currently
appears in 21 CFR 1301.26.
---------------------------------------------------------------------------
\1\ The Attorney General has delegated to the Administrator of
DEA functions vested in the Attorney General by the CSA. 28 CFR
0.100.
---------------------------------------------------------------------------
The allowance for personal use importation and exportation is
consistent with United States treaty obligations. Article 4(a) of the
Psychotropic Convention states: ``In respect of psychotropic substances
other than those in Schedule I, the Parties may permit * * * the
carrying by international travellers of small quantities of
preparations for personal use; each Party shall be entitled, however,
to satisfy itself that these preparations have been lawfully
obtained.''
The Official Commentary to the Psychotropic Convention explains the
purpose and meaning of article 4(a): ``Paragraph (a) applies only to
small quantities needed for personal use, i.e., to such quantities as
the traveller may require during his journey or voyage and until he is
able to provide himself with the medicine in question in the country of
destination.''
It bears emphasis that 21 U.S.C. 956 does not require DEA to permit
any minimum amount of controlled substances to be imported or exported
for personal medical use. Rather, consistent with article 4(a) of the
Psychotropic Convention, Congress gave DEA permissive authority to
issue a regulation allowing personal use importation/exportation under
such conditions as DEA finds are necessary to prevent diversion of
controlled substances into illicit channels and which are consistent
with Congressional intent.
Another critical factor is that transporting controlled substances
across international borders entails a
[[Page 53530]]
heightened risk of diversion. Because of this inherent risk of
diversion, United States drug control laws and international drug
control treaties have, for most of the past century, placed paramount
focus on international shipments of drugs of abuse. For example, the
CSI&EA has, in general, always prohibited the commercial importation
into the United States of controlled substances manufactured abroad,
except where domestic production is inadequate to supply the legitimate
medical, scientific, research, and industrial needs of the United
States. In this manner, drug control authorities in the United States
can maintain oversight over the handling of controlled substances from
the point of manufacture to the point of dispensing to the ultimate
user. Such complete oversight is essential to preventing diversion of
controlled substances. This is precisely why Congress made the ``
`closed' system of drug distribution'' the hallmark of the CSA.\2\
---------------------------------------------------------------------------
\2\ See House Report No. 91-1444, 1970 U.S.C.C.A.N. 4566-4572.
``The [CSA] provides for control by the Justice Department of
problems related to drug abuse through registration of
manufacturers, wholesalers, retailers, and all others in the
legitimate distribution chain, and makes transactions outside the
legitimate distribution chain illegal.'' Id.
---------------------------------------------------------------------------
The allowance of importation and exportation of controlled
substances for personal medical use (first established by Congress in
1970 and codified in 21 U.S.C. 956) was meant to strike a balance
between the significant risk of diversion associated with the carrying
of controlled substances across international borders and the desire to
accommodate the legitimate medical needs of travelers during their
actual travel between countries. Stated alternatively, the allowance
was meant to accommodate those who have an unavoidable legitimate
medical need to import (or export) controlled substances as a result of
their travel. The allowance was not meant to encourage United States
residents to travel abroad to obtain their controlled substances for
use in this country. To encourage such obtaining of controlled
substances abroad would be to diminish the closed system of drug
distribution intended by Congress under the CSA.
Why Congress Amended the Law in 1998
In 1998, Congress became concerned that 21 U.S.C. 956 and the DEA
regulation implementing this provision were being misused by
individuals--particularly United States residents--whose true intent
was to divert controlled substances obtained abroad for illicit use in
the United States (rather than to import controlled substances for
legitimate personal medical use). Due to this concern, Congress amended
21 U.S.C. 956 to limit to 50 dosage units the amount of a controlled
substance that a United States resident may bring into the country
through an international land border for personal medical use without a
prescription. This amendment was contained in a bill entitled the
``Controlled Substances Trafficking Prohibition Act'' (Pub. L. 105-
357), which was enacted November 10, 1998.
The sponsor of the bill in the House of Representatives,
Representative Chabot of Ohio, explained the purpose of the amendment
as follows:
This important initiative [the amendment to 21 U.S.C. 956] will
close a loophole in Federal law that allows dangerous drugs,
particularly drugs used in connection with date rape, to be legally
imported into the United States.
Federal, State and local law enforcement agencies have raised
serious concerns about the trafficking of controlled substances from
Mexico. Right now uppers, downers, hallucinogens and date rape drugs
similar to Rohypnol may be easily obtained from so-called health
care providers or pharmacists in Mexico with no documentation of
medical need whatsoever.
According to DEA, these drugs are frequently resold illegally in
the United States. This situation is especially dangerous because
these powerful drugs may be used in connection with date rapes.
While Rohypnol, the most well-known date rape drug, has been banned
in the U.S., it is still being used to rape young women, and many
other dangerous controlled substances have taken its place. Jane
Maxwell, director of the Texas Commission on Alcohol and Drug Abuse,
says that this loophole continues to allow date rape drugs to cross
the border.
For example, the drug Rivotril is everywhere, according to
Maxwell, and is now being used by juveniles, just as Rohypnol has
been used. A 1996 study documented the controlled substance drug
trafficking problems along the U.S.-Mexico border. The study found
that in just one year at the Laredo border crossing over 60,000 drug
products were brought into the U.S. by more than 24,000 people. All
of the top 15 drug products, which represented 94 percent of the
total quantity of declared drugs, were controlled substances. These
dangerous drugs, classified as prescription tranquilizers,
stimulants and narcotic analgesics, are potentially addictive and
subject to abuse. Specifically, Valium was declared by 70 percent of
the people, with the average person bringing in 237 tablets.
Rohypnol was brought in by 43 percent of those who declared their
prescription medication. Over a full year that means that over 4
million doses of Valium and almost 1.5 million doses of Rohypnol
were brought in at one single border crossing.
The median age for those who declared Valium and Rohypnol is 24
and 26 years old respectively. The large quantity of dangerous drugs
passing through a single border crossing underscores the seriousness
of the problem. The quantity and types of pills discovered also back
up DEA's view that these drugs are being used for illegal purposes.
While this problem is most notable in communities along the
U.S.-Mexico border, it impacts communities well outside the
Southwest. The study in Laredo found that residents from 39 States
crossed the border and returned to the United States with a variety
of drug products.
Around the country, prescription drug abuse is a growing
problem, especially among our youth. The purity and low price of
prescription drug pills makes them an attractive alternative to
traditional street drugs. At a recent Subcommittee on Crime hearing
on date rape drugs, experts testified that GHB, Rohypnol and other
date rape drugs are rapidly becoming the drug of choice in various
communities and among the different types of users, particularly
among teenagers.
Mr. Speaker, this legislation will help close the loophole which
allows these dangerous drugs into our communities.
144 Cong. Rec. H 6903-01, H6904 (August 3, 1998).
Will the Proposed Rule Eliminate Any of the Current Requirements for
Personal Use Importation?
The proposed rule will expand upon, but not eliminate, the
requirements currently in effect as a result of Congress's 1998
amendment to 21 U.S.C. 956. The current requirements are as follows:
Under 21 CFR 1301.26, any individual may enter or depart the U.S.
with a controlled substance listed in Schedule II, III, IV, or V, which
he/she has lawfully obtained for his/her personal medical use, or for
administration to an animal accompanying him/her, provided that the
following conditions are met:
(a) The controlled substance is in the original container in
which it was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate
official of the U.S. Customs Service stating:
(1) That the controlled substance is possessed for his/her
personal use, or for an animal accompanying him/her; and
(2) The trade or chemical name and the symbol designating the
schedule of the controlled substance if it appears on the container
label, or, if such name does not appear on the label, the name and
address of the pharmacy or practitioner who dispensed the substance
and the prescription number, if any; and
(c) The importation of the controlled substance for personal
medical use is authorized or permitted under other Federal laws and
state law.
[[Page 53531]]
21 CFR 1301.26.
The 1998 amendments to the CSI&EA made by Congress added
restrictions that are in addition to the foregoing requirements in the
DEA regulations. These amendments are contained in 21 U.S.C. 956(a)(2).
This subsection provides that, where a United States resident is
returning to this country through a land border (i.e., returning by
land from Mexico or Canada), and such person seeks to bring into the
country a controlled substance obtained abroad for personal medical use
(not obtained pursuant to a prescription issued by a DEA registrant),
such person may bring in no more than 50 dosage units of the controlled
substance.
The rule proposed here would specify that the 50-dosage-unit limit
mandated by Congress under 956(a)(2) applies to the combined total of
all controlled substances that the returning traveler seeks to import
for personal medical use (rather than up to 50 dosage units of each of
a variety of controlled substances). [A dosage unit is considered by
DEA to be the basic unit used to quantify the amount to be taken in
normal usage (i.e., tablet, capsule, milliliter, or teaspoon).] This
limitation applies whether or not the controlled substances were
obtained using a prescription issued by a DEA-registered practitioner.
The rule, as proposed here, would also be applied to all United
States residents who return to the United States at any location and by
any means (not just travelers returning to the United States through a
land border with Canada or Mexico). The United States Customs Service
has advised DEA that it would be beneficial to have the rule written in
a manner that is applied uniformly at all United States border
checkpoints.
Does the 50-Dosage-Unit Limit Mean That a Returning Traveler May Bring
Into the United States Up to 50 Dosage Units of Controlled Substances
``No Questions Asked''?
Many persons appear to be under the mistaken impression that
Congress's 1998 amendment to 21 U.S.C. 956 was intended to allow United
States residents to travel to Mexico or Canada, purchase controlled
substances, then return to the United States with up to 50 dosage units
``no questions asked.'' It is DEA's intention, through this
publication, to end any such misconceptions. In 1998 Congress placed a
limit of 50 dosage units on the amount of a controlled substance that
may be imported by United States residents entering from Mexico or
Canada; Congress did not eliminate any of the existing requirements
established by DEA in its regulation governing personal use importation
(21 CFR 1301.26). It remains true that all persons who wish to import
controlled substances for personal medical use may do so only for
legitimate personal medical use and must satisfy all of the
requirements in 21 CFR 1301.26. The requirements found in Sec. 1301.26
are necessary to ensure that the drugs possessed by the traveler will
actually be used by the traveler for legitimate personal medical use;
Congress had no intention of eliminating these appropriate safeguards
against diversion.
In all instances, if there is evidence that the traveler is
attempting to bring into the United States controlled substances (in
any amount) for other than legitimate personal medical use, the
importation does not comport with either the statute (21 U.S.C. 956) or
the DEA regulation (21 CFR 1301.26) and must be disallowed. The Customs
official should, of course, take into account all facts and
circumstances of a particular case in determining whether the traveler
is attempting to bring in controlled substances for legitimate personal
medical use or attempting to do so in order to divert the drugs for
illicit use. Though neither dispositive nor exhaustive, the following
factors may, depending on the circumstances, be indicative of
diversion: (i) The same traveler has made repeated attempts over a
short period of time to import controlled substances for claimed
personal medical use; (ii) the traveler is carrying a variety of
different controlled substances that are either contraindicated or in a
combination that is commonly used by drug abusers.
Does the 50-Dosage-Unit Limit Apply to Foreign Travelers?
By its express terms, Congress's 1998 amendment, which imposed the
50-dosage-unit limit, applies only to United States residents; it does
not apply to foreign travelers entering the United States. Likewise,
the DEA regulation proposed here will apply only to United States
residents.
Having made this distinction, it must be emphasized that all
travelers--United States residents or non-United States residents--may
only import (or export) controlled substances for legitimate personal
medical use and must comply fully with all of the current provisions of
21 CFR 1301.26.
How Does the Combined 50-Dosage-Unit Limit Contained in the Proposed
Rule Comport With Congress's 1998 Amendment to the CSI&EA?
On its face, the 1998 amendment to the CSI&EA (contained in 21
U.S.C. 956(a)(2)) does not mandate that United States residents be
allowed to bring into the United States 50 dosage units of each of a
variety of controlled substances purchased abroad. Rather, 50 dosage
units is the maximum amount of a controlled substance that DEA may
permit, through regulation, to be imported for personal medical use
without a prescription. As explained above, Congress in 1998 was
responding to the exploitation of the personal use allowance by persons
seeking to divert controlled substances. Congress recognized that DEA
would continue to monitor the situation and, if necessary, modify its
regulation to impose tighter controls. As Senator Leahy stated during
consideration of the bill:
Such abuses have increased dramatically in recent years, and
there is a need to address this problem now. [The 1998 amendment]
does this by limiting the personal use exemption in certain
circumstances to 50 dosage units. But this is only a stopgap
measure. What constitutes ``personal use'' is a complicated issue
that will turn on a number of circumstances, including the nature of
the controlled substance and the medical needs of the individual. It
is the sort of issue that should be addressed not through single-
standard legislation but through measured regulations passed by an
agency with the expertise in this matter. For this reason, * * * I
[will] direct the Department of Justice to study the problems at our
borders and to pass regulations that are more finely tuned to
address those problems.
144 Cong. Rec. S 12680-04, 12681 (October 20, 1998).
Indeed, recently obtained information indicates that the misuse of
the personal use importation allowance persists even after the 1998
amendment by Congress. Thus, revising the DEA regulations such that the
50-dosage-unit limit enacted by Congress applies to the combined total
of all controlled substances in the traveler's possession is a
necessary and appropriate step to further curtail the misuse of the
personal use importation exception. DEA will continue to monitor the
situation to determine whether future revisions to the regulation are
needed to maintain adequate safeguards against diversion.
What Is the Meaning of ``Lawfully Obtained'' In the Context of Personal
Use Importation?
Both the statute (21 U.S.C. 956) and the DEA regulation (21 CFR
1301.26) allow personal use importation only
[[Page 53532]]
where the controlled substances was ``lawfully obtained'' by the
traveler abroad. In harmony with international drug control treaties,
many countries, including Canada and Mexico, have laws that govern the
prescribing and dispensing of controlled substances. For example, as is
the case in the United States, Canadian law allows pharmacies to
dispense controlled substances only pursuant to a prescription issued
by a practitioner licensed to prescribe controlled substances in the
province in which the controlled substance is dispensed.
The traveler seeking to import into the United States controlled
substances obtained abroad for personal medical use may only do so if
the controlled substances were dispensed in full compliance with the
laws of the country in which they were obtained. It is the duty of the
individual seeking to import a controlled substance for personal
medical use pursuant to 21 U.S.C. 956(a) and DEA's regulation to know
and comply with the laws of the jurisdiction in which the controlled
substance was dispensed. Additionally, compliance with the CSI&EA and
DEA's regulation does not excuse noncompliance with other Federal laws
and state laws that may regulate the importation of controlled
substances.
Regulatory Certifications
Regulatory Flexibility Act
The Administrator hereby certifies that this rulemaking has been
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), and by approving it certifies that this regulation will not
have a significant economic impact on a substantial number of small
entities. This proposed regulation affects only individual travelers
and personal use quantities of controlled substances. Small businesses
are subject to other DEA regulations for the importation and
exportation of controlled substances, including registration,
recordkeeping, reporting and security requirements. Businesses would
not be using the personal use importation exemption to bring controlled
substances into the United States. In fact, this rule could help small
businesses as United States residents will purchase controlled
substances from United States pharmacies rather than traveling outside
the United States to make such purchases.
Executive Order 12866
The Administrator further certifies that this rulemaking has been
drafted in accordance with the principles of Executive Order 12866,
section 1(b). This action has been determined to be a significant
regulatory action. Therefore, this regulation has been reviewed by the
Office of Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988.
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 regulation will not result in the expenditure by State, local,
and tribal governments in the aggregate, or by the private sector, of
$100 million or more in any one year, and would not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100 million or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation or on the ability of U.S.-based companies to compete with
foreign-based companies in domestic and export markets.
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
For the reasons set out above, 21 CFR Part 1301 is proposed to be
amended as follows:
PART 1301--[AMENDED]
1. The authority citation for 21 CFR Part 1301 is proposed to be
amended to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 951,
952, 953, 956, 957.
2. Section 1301.26 is proposed to be revised to read as follows:
Sec. 1301.26 Exemptions from import or export requirements for
personal medical use.
Any individual who has in his/her possession a controlled substance
listed in schedules II, III, IV, or V, which he/she has lawfully
obtained for his/her personal medical use, or for administration to an
animal accompanying him/her, may enter or depart the United States with
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C.
952-955), provided the following conditions are met:
(a) The controlled substance is in the original container in which
it was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate official
of the U.S. Customs Service stating:
(1) That the controlled substance is possessed for his/her personal
use, or for an animal accompanying him/her; and
(2) The trade or chemical name and the symbol designating the
schedule of the controlled substance if it appears on the container
label, or, if such name does not appear on the label, the name and
address of the pharmacy or practitioner who dispensed the substance and
the prescription number.
(c) In addition to (and not in lieu of) the foregoing requirements
of this section, a United States resident may import into the United
States no more than 50 dosage units combined of all such controlled
substances in the individual's possession.
Dated: September 4, 2003.
Karen P. Tandy,
Administrator.
[FR Doc. 03-23169 Filed 9-10-03; 8:45 am]
BILLING CODE 4410-09-P