[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Notices]
[Pages 14269-14273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7123]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 98-1]
Jacqueline Lee Pierson Energy Outlet; Denial of Application
On July 31, 1997, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA) issued an
Order to Show Cause to two businesses with the same address in
Westminster, Colorado, The New Connection, and Jacqueline Lee Pierson,
Energy Outlet, notifying them of an opportunity to show cause as to why
DEA should not deny their applications for registration as a retail
distributor of list I chemicals pursuant to 21 U.S.C. 823(h), for
reason that the registration would be inconsistent with the public
interest.
Both The New Connection and Energy Outlet (Respondent) filed a
request for a hearing on the issues raised by the Order to Show Cause,
and the matters were docketed before Administrative Law Judge Gail A.
Randall. On October 21, 1997, Judge Randall issued a Memorandum and
Order consolidating the proceedings regarding The New Connection and
Respondent, for hearing purposes only and a hearing was held in Denver,
Colorado on February 11 and 12, 1998. At the hearing, all parties
called witnesses to testify and introduced documentary evidence. After,
the hearing, all parties submitted proposed findings of fact,
conclusions of law and argument. On September 30, 1998, Judge Randall
issued her Opinion and Recommended Ruling, recommending that
Respondent's application for registration be denied. On October 20,
1998, Respondent filed exceptions to Judge Randall's Opinion and
Recommended Ruling, and on November 5, 1998, Judge Randall transmitted
the record of these proceedings to the then-Acting Deputy
Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues his final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts, in full, the Opinion and Recommended
Ruling of the Administrative Law Judge. His adoption is in no manner
diminished by any recitation of facts, issues and conclusions herein,
of any failure to mention a matter of fact or law.
The Deputy Administrator finds that ephedrine is a List I chemical
that has legitimate uses, but it can also be used to manufacture
methamphetamine, a Schedule II controlled substance. Methamphetamine is
a very potent central nervous system stimulant and its abuse is a
growing problem in the United States. Ephedrine extracted from over-
the-counter ephedrine products is often used in the illicit manufacture
of methamphetamine.
In an effort to curb the use of licit chemicals in the illicit
manufacture of controlled substances, Congress amended the Controlled
Substances Act in 1988 with the passage of the Chemical Diversion and
Trafficking Act (CDTA). Pub. L. 100-690, 102 Stat. 4181 (1988). The
CDTA required that records and reports be made of certain transactions
involving various chemicals. However, products containing ephedrine
were exempt from the recordkeeping and reporting requirements because
they were approved for marketing under the Federal Food, Drug, and
Cosmetic Act. The CDTA also made it illegal to distribute a listed
chemical ``knowing, or having reasonable cause to believe, that the
listed chemical will be used to manufacture a controlled substance. . .
.'' See 21 U.S.C. 841(d)(2). This provision applied to the distribution
of all listed chemicals including ephedrine products.
In 1979, Jacqueline Pierson began working as a salesperson for MFC
Enterprises which operated a chain of four stores called the
Connection. Michael F. Carles was the president of MFC Enterprises. In
1990, Ms. Pierson began working at the Connection store located at 7115
North Federal Boulevard in Westminster, Colorado. According to Ms.
Pierson, in 1991 and 1992 almost 100% of the store's sales were of
ephedrine products; the store was primarily engaged in small sales; and
she did not receive compensation based on her sales.
DEA began an investigation of the Connection stores, after
receiving information that they were receiving large quantities of
ephedrine from an east coast distributor. On July 31, 1991, an
undercover DEA agent purchased 10,000 ephedrine tablets from Ms.
Pierson at the North Federal Connection store without giving any reason
for the purchase.
In February 1992, DEA personnel, acting in their official capacity,
went to the North Federal Connection store and advised Ms. Pierson of
the recordkeeping and reporting requirements imposed by the CDTA. They
also advised Ms. Pierson that ephedrine is often used in the illicit
manufacture of methamphetamine and that if she suspected that someone
was purchasing ephedrine for that purpose, she should contact DEA.
The undercover agent returned to the North Federal Connection store
on August 28, 1992, and purchased 30,000 ephedrine tablets. On this
occasion, the undercover agent handed Ms. Pierson a handwritten formula
for the manufacture of methamphetamine entitled ``Synthesis for Meth''
and asked her whether the ephedrine tablets he was purchasing would
work in the formula. Ms. Pierson indicated that they would.
A second undercover agent made visits to the North Federal
Connection store. On June 19, 1992, this undercover agent attempted to
buy 20 1,000-count bottles of ephedrine at one of the other Connection
stores. An employee at that store sold the undercover agent 10 bottles
and told him that he could buy the other 20 bottles at the North
Federal Connection store. At the North Federal Connection store the
undercover agent met Ms. Pierson and told her that on his next visit he
wanted to purchase 75 1,000-count bottles of ephedrine. Ms. Pierson
indicated that she would need two days advance notice in order to have
that amount available and she would have to talk to her boss about the
[[Page 14270]]
sale. The undercover agent then bought the 10 1,000-count bottles of
ephedrine for $250.00.
The next visit by the second undercover agent to the North Federal
Connection store was on August 20, 1992. He purchased 50,000 ephedrine
tablets for $750.00. According to the undercover agent, he indicated to
Ms. Pierson that he was concerned with making repeated visits to the
store because he did not want the police to figure out that he was
buying the ephedrine to make ``meth.'' He further indicated that he was
buying the ephedrine for a motorcycle gang, and Ms. Pierson asked him
not to tell them where he was buying the tablets. Then at Ms. Pierson's
request, the undercover agent helped her remove the labels from the
bottles that indicated the store's name and address.
On September 15, 1992, the second undercover agent went to the
North Federal Connection store, however Ms. Pierson was not at the
store that day. He returned to the store on September 17, 1992. The
undercover agent did not purchase any ephedrine on this occasion, but
he did discuss with Ms. Pierson the possibility of purchasing 100,000
tablets of ephedrine and told her that it would be used to manufacture
methamphetamine. Ms. Pierson indicated that she could sell the
undercover agent 50,000 tablets at the North Federal Connection store;
that he could buy another 50,000 at a different Connection store; that
he should return the following day to make the purchase; and that it
would cost a total of $1,500.
On September 18, 1992, the undercover agent returned to the North
Connection Store with only $900.00. He explained to Ms. Pierson that he
had already spent $600.00 on hydriodic acid to be used by the
motorcycle gang to manufacture methamphetamine. The undercover agent
then purchased 60,000 tablets of ephedrine. Ms. Pierson again expressed
concern about the removal of the store labels and told the undercover
agent that she would put the bottles of ephedrine in black plastic bags
so the neighboring businesses would not be suspicious.
As a result of the investigation, the corporate officers and
employees of the Connection stores, including Ms. Pierson, were
indicted in the United States District Court for the District of
Colorado and charged with violations of 21 U.S.C. 841(d)(2), 846 and 18
U.S.C. 2. On January 20, 1993, a search warrant was executed at the
North Federal Connection store and Ms. Pierson was arrested. At the
time of her arrest, Ms. Pierson indicated that Michael Carles had died
in approximately October 1992. She also acknowledged that she knew why
the undercover agents were purportedly obtaining the ephedrine.
Initially, Ms. Pierson agreed to plead guilty to some of the
charges against her and to testify on behalf of the Government at the
trial of the other employees. During her pretrial debriefing, Ms.
Pierson again acknowledged that she understood that the undercover
purchases of ephedrine were intended to be used in the illegal
manufacture of controlled substances. However, Ms. Pierson subsequently
filed a motion to withdraw her guilty pleas and disclosed that she
suffered from various mental and emotional disorders. it was also
disclosed in her motion that Ms. Pierson was dominated and intimidated
by Michael Carles who physically abused her and threatened her with
extreme harm. In addition the motion stated that Ms. Pierson ``did not
want to sell large quantities of ephedrine to [the] undercover
government agents but did so because Michael Carles insisted she do so
and informed her that she was not doing anything wrong.''
The Government did not oppose Ms. Pierson's motion indicating that
the indictment against Ms. Pierson's co-defendants had been dismissed
and that had Ms. Pierson also gone to trial, her case would have
similarly been dismissed. Therefore, the criminal charges against Ms.
Pierson were ultimately dismissed.
Recognizing, among other things that the use of over-the-counter
ephedrine products in the illegal manufacture of methamphetamine was
increasing, Congress passed the Domestic Chemical Diversion Control Act
of 1993 (DCDCA). Pub. L. 103-200, 107 Stat. 2333 (1993). The DCDCA
removed the exemption from recordkeeping and reporting requirements for
single entity ephedrine products. In addition, the DCDCA also
established a registration system for certain handlers of List I
chemicals, including retail distributors. DEA temporarily exempted from
registration anyone who submitted an application by November 13, 1995,
until such time as DEA either approves or denies the application. See
21 CFR 1310.09 (1996).
According to Ms. Pierson, she assumed ownership of the North
Federal Connection Store after Michael Carles died in October 1992. Ms.
Pierson submitted an application dated August 10, 1995, for
registration for the New Connection located at 7115 North Federal
Boulevard, Westminster, Colorado, as a retail distributor of ephedrine,
pseudoephedrine and phenylpropanolamine. It was determined during the
course of the hearing in this matter that a retail distributor does not
need to be registered with DEA to distribute pseudoephedrine and
phenylpropanolamine. Therefore the only chemical relevant to the
application in this proceeding is ephedrine.
In February 1996, DEA personnel conducted a preregistration
inspection of the New Connection. One of the investigators who
conducted this inspection testified at the hearing in this matter that
the security system at The New Connection was suitable for registration
purposes and that the store's records appeared to be in order. During
the inspection, DEA personnel discussed the relevant requirements with
Ms. Pierson and two other employees in the back room of the store. One
of the employees left the discussion on two to three occasions to
conduct business transactions in the front of the store. As the DEA
investigator was leaving the store he noticed three sales records that
had been left on the counter that contained only the names of the
customers and no other information. When questioned, Ms. Pierson and
the employee indicated that these were repeat customers and the
remaining information would be filled in when the store was not so
busy. The investigator was unable to say at the hearing what substances
were sold during the three transactions, and Ms. Pierson indicated that
the forms were used for both ephedrine and pseudoephedrine sales.
On March 12, 1996, Ms. Pierson submitted an application for
registration as a retail distributor of ephedrine for Respondent, the
Energy Outlet, also located at 7115 North Federal Boulevard,
Westminster, Colorado. During a telephone conversation with the DEA
investigator, Ms. Pierson indicated that she simply was trying to
effectuate a name change and thought that she had to submit another
application. According to the investigator, because it was the same
location as the New Connection which had just been inspected the month
before, no additional preregistration inspection was conducted. Ms.
Pierson testified that she is not operating two businesses at the North
Federal location and only wants a DEA registration for the Energy
Outlet.
At the hearing in this matter Ms. Pierson testified that she
reported every large transaction to Michael Carles who told her that he
would make the proper reports. She stated that she was afraid of
Michael Carles because he abused and threatened her and he told her
that if she did not make the sales, he would find someone who would.
Ms. Pierson
[[Page 14271]]
testified that ``in an effort to improve her self-esteem, as part of
her efforts to separate herself from Michael Carles' control,'' she
took a ``life skills'' course.
Ms. Pierson further testified that the undercover agents used the
word ``meth'' and at that time she did not know what ``meth'' meant.
However, she also stated that she suspected that the 1992 purchases
were being used to manufacture controlled substances. With respect to
the removal of the labels, Ms. Pierson testified that this was done at
Michael Carles' request and also because she was afraid of motorcycle
gangs and she did not want them to know where the ephedrine came from.
Ms. Pierson testified that currently ephedrine accounts for 60-75%
of her sales at Respondent and she has not made any large sales since
she took over the store from Michael Carles. It is her current policy
to sell no more than two 250-count bottles to any customer in a week.
At the time of the hearing, Ms. Pierson was still suffering from
panic attacks and severe anxiety. However, she testified that her
condition did not interfere with her ability to operate her business.
The Government contends that granting Respondent's application for
registration would be inconsistent with the public interest due to Ms.
Pierson's sales of ephedrine in 1991 and 1992 to the undercover agents
when she had reason to believe that the ephedrine would be used to
illegally manufacture a controlled substance and due to Respondent's
failure to keep complete and accurate records of the three sales
transactions that occurred during DEA's preregistration inspection in
February 1996. Respondent contends however that the Government has
failed to establish that issuance of a DEA registration to Respondent
would be inconsistent with the public interest. Respondent argues that
Ms. Pierson should not be punished for activities that occurred in 1991
and 1992 while the store was under different ownership and that
Respondent has been operating in a legal manner since Ms. Pierson
became its owner. Further, Respondent contends that how the business is
currently being run is more relevant than what occurred in 1991 and
1992. Pursuant to 21 U.S.C. 823(h), the Deputy Administrator may deny
an application for a DEA Certificate of Registration, if he determines
that granting the registration would be inconsistent with the public
interest. Section 832(h) requires that the following factors be
considered in determining the public interest:
(1) Maintenance by the applicant of effective controls against
diversion of listed chemicals into other than legitimate channels;
(2) Compliance by the applicant with applicable Federal, State, and
local law;
(3) Any prior conviction record for the applicant under Federal or
State laws relating to controlled substances or to chemicals controlled
under Federal or State law;
(4) Any past experience of the applicant in the manufacture and
distribution of chemicals; and
(5) Such other factors as are relevant to and consistent with the
public health and safety.
In passing the DCDCA, Congress intended to create a registration
system parallel to that in place for controlled substances:
This registration system is precisely patterned after the system
which has been successfully applied to legitimate controlled
substances for over 20 years. It will enable DEA to prevent a firm
from distributing these covered chemicals if it can be shown that
registration of the firm is contrary to the public interest.
139 Cong. Rec. E2341 (daily ed. Oct. 5, 1993) (statement of Rep.
Stupak). Therefore, consistent with this congressional intent, these
factors are to be considered in the disjunctive; the Deputy
Administrator may properly rely on any one or a combination of these
factors, and give each factor the weight he deems appropriate in
determining whether an application should be denied. See Henry J.
Schwarz, Jr., M.D., 54 FR 16,422 (1989).
As a preliminary matter, DEA has consistently held that a retail
store operates under the control of its owners, stockholders, or other
employees, and therefore the conduct of these individuals is relevant
in evaluating the fitness of an applicant or registrant for
registration. See, e.g., Rick's Pharmacy, 62 FR 42,595 (1997); Big T
Pharmacy, Inc., 47 FR 51,830 (1982). Since Ms. Pierson is the owner of
Respondent, her conduct is relevant in determining whether or not to
grant Respondent's application for registration.
Regarding factor one, the preregistration inspection that was
conducted in February 1996 revealed that Respondent's security system
was suitable for registration and its records appeared to be in order.
While this preregistration inspection was conducted based upon the
application filed by Ms. Pierson for The New Connection, it is clear
that the application that is the subject of this proceeding was filed
by Ms. Pierson merely to change the name of the business from The New
Connection to the Energy Outlet. Therefore, it is reasonable to
consider the findings of the February 1996 preregistration inspection
in evaluating Energy Outlet's application for registration.
As to factor two, the Deputy Administrator finds that based upon
the law in place at the time of the undercover transactions in 1991 and
1992, Ms. Pierson was not required to maintain records of these
transactions. However, Ms. Pierson clearly violated 21 U.S.C. 841(d)(2)
by distributing ephedrine to the undercover agents knowing or having
reasonable cause to believe that the ephedrine would be used to
manufacture methamphetamine. On August 28, 1992, Ms. Pierson sold
30,000 ephedrine tablets to the first undercover agent even though he
handed her a formula for the manufacture of methamphetamine entitled
``Syntheses for Meth,'' and asked her whether the tablets would work in
the formula. The second undercover agent purchased 50,000 ephedrine
tablets from Ms. Pierson on August 20, 1992. During this visit, the
undercover agent indicated that he was concerned with making repeated
visits to the store because he did not want the police to figure out
that he was buying ephedrine for the manufacture of ``meth.'' It was
also on this occasion that Ms. Pierson requested that the labels with
the store's name and address be removed from the bottles. Finally, Ms.
Pierson sold the undercover agent 60,000 ephedrine tablets on September
18, 1992, even after the undercover agent stated that he had earlier
purchased $600.00 worth of hydriodic acid to be used by a motorcycle
gang to make ``meth.'' On this occasion, not only did Ms. Pierson
express concerns regarding the bottles' labels, but she also stated
that she would put the bottles of ephedrine in black plastic bags so
the neighboring businesses would not be suspicious.
At the hearing, Ms. Pierson testified that she did not understand
what the agents meant by ``meth.'' However, the Deputy Administrator
finds Ms. Pierson's contention beyond belief. First, DEA personnel
specifically discussed with her in February 1992 that ephedrine is used
in the illegal manufacture of methamphetamine. Also, at the time the
second undercover agent was discussing that the ephedrine was to be
used to manufacture ``meth,'' he was also stating that he was concerned
that the police would figure out why he was purchasing the ephedrine.
Clearly, Ms. Pierson knew or had reasonable cause to believe that the
ephedrine she distributed to the undercover agents was going to be used
[[Page 14272]]
in the illegal manufacture of methamphetamine.
The Government contends that Respondent failed to fully record
three sales transactions that occurred during the February 1996
preregistration inspection in violation of 21 U.S.C. 830 and 21 CFR
1310.06. However, the Deputy Administrator agrees with Judge Randall
that the Government has failed to prove by a preponderance of the
evidence that a violation occurred. Pursuant to 21 CFR 1310.03, records
must be made of regulated transactions. But, there is no evidence that
the transactions in question were in fact regulated transactions. The
investigator did not determine what substances were sold during these
transactions. Therefore, the Deputy Administrator cannot find that a
record was even required to be made of transactions.
But even assuming that these were regulated transactions requiring
a record, there is no requirement that a record of a transaction must
be made simultaneously with the transaction. Ms. Pierson and her
employee indicated that these were repeat customers and the records
would be completed when the store was not as busy. Consequently, the
Deputy Administrator finds that the record does not establish that
there was a violation of the recordkeeping requirements in February
1996.
Regarding factor three, there is no evidence that an owner,
shareholder or employee of Respondent has been convicted of any crimes
relating to controlled substances of listed chemicals.
As to Respondent's experience in distributing chemicals, Ms.
Pierson has been involved in the distribution of chemicals since
approximately 1986. As discussed previously, in 1991 and 1992, Ms.
Pierson distributed large quantities of ephedrine tablets knowing or
having reasonable cause to believe that they would be used for illegal
purposes. However, the record also indicates that since Ms. Pierson
became the owner of Respondent in approximately October 1992, there
have been no allegations of improper distributions. According to Ms.
Pierson, her current policy is to sell no more than two 250-count
bottles to any customer in a week.
Regarding factor five, Judge Randall expressed concern regarding
Ms. Pierson's ability to responsibly handle ephedrine in the future.
Ms. Pierson testified that her behavior in 1991 and 1992 was a result
of her fear of Michael Carles. As Judge Randall stated, ``Jacqueline
Pierson's previous vulnerability to intimidation and coercion is
significant, particularly in light of the serious problem with
methamphetamine abuse and the dangerous nature of the illicit market.''
Judge Randall noted that ``the record contains no basis for assurances
that, in the future, Ms. Pierson would not be equally intimidated by an
abusive customer into engaging in similar conduct.'' The Deputy
Administrator finds it particularly troubling that at the time of the
hearing Ms. Pierson suffered from panic attacks and severe anxiety and
there is no evidence in the record regarding her ongoing treatment for
these disorders. However, there is no evidence in the record of any
improper conduct by Ms. Pierson since 1992, and as Judge Randall noted,
``this passage of time is also significant, for it adds credence to Ms.
Pierson's assertions that her mental and emotional difficulties do not
interfere with her ability to manage the Respondent business.''
Judge Randall concluded that Respondent's registration would be
inconsistent with the public interest in light of Ms. Pierson's 1992
distributions of ephedrine knowing or having reasonable cause to
believe that it would be used in the illicit manufacture of a
controlled substance and her susceptibility to intimidation ``that is
not rebutted by evidence in the record, except by the passage of time
without any further documented incidents.'' Judge Randall further found
that Ms. Pierson has failed to present adequate assurances ``that she
has developed the needed self-esteem to withstand potential customer
abuses from the customer base her products attract.'' Accordingly,
Judge Randall recommended that the application of Energy Outlet be
denied.
In its exceptions to Judge Randall's Opinion and Recommended
Ruling, Respondent argues that Judge Randall unfairly interjected a new
issue, Ms. Pierson's lack of self-esteem, into the proceedings.
However, as stated in Judge Randall's opinion ``[t]he issue in this
case is whether or not the record as a whole establishes by a
preponderance of the evidence that the DEA should deny the application,
dated March 12, 1996, for a DEA Certificate of Registration as a retail
distributor of the List I chemical ephedrine, of the Energy Outlet,
pursuant to 21 U.S.C. 823(h), because to grant such application would
be inconsistent with the public interest.'' In light of Ms. Pierson's
behavior in 1991 and 1992, the Government clearly established a prima
facie case for denial of Respondent's application for registration. In
determining whether Respondent's application should be granted or
denied, the Deputy Administrator must look at all of the evidence
presented. During the course of these proceedings, Respondent raised
the issue of Ms. Pierson's susceptibility to intimidation and her lack
of self-esteem in explaining her behavior in 1991 and 1992. In
evaluating whether Respondent can responsibly handle the listed
chemical ephedrine in the future, it is reasonable to consider whether
the same susceptibility to intimidation and lack of self-esteem still
exists.
The Deputy Administrator concludes that Respondent's registration
with DEA would be inconsistent with the public interest. Although there
have been no allegations of any wrongdoing since 1992, Ms. Pierson's
behavior in 1991 and 1992 was unconscionable. She clearly sold
ephedrine to the undercover agents knowing or having reasonable cause
to believe that it would be used to illegally manufacture
methamphetamine. In attempting to explain her behavior, Ms. Pierson
testified that she was intimidated by the previous owner of the store,
and lacked the self-esteem to withstand his intimidation. The Deputy
Administrator is extremely troubled by this explanation.
In a previous DEA case involving a practitioner registered with DEA
to handle controlled substances, the practitioner also attributed his
improper conduct to intimidation by another. James B. Rivers, D.M.D.,
53 FR 20,382 (1988). In revoking the practitioner's DEA registration,
the then-Administrator concluded that:
Respondent does not appreciate the enormous responsibility which
accompanies DEA registration. Registrants under the Controlled
Substances Act are required to prevent the diversion of controlled
substances into the illicit market. Respondent's conduct reflects a
failure to take adequate action to protect the public health and
safety. Respondent has failed to provide any satisfactory assurances
that a situation such as the one he alleges occurred with the
individual is unlikely to recur. Id.
Similarly, those registered to distribute List I chemicals must
prevent the diversion of the chemicals to the illegal manufacture of
controlled substances. Here, the Deputy Administrator is not convinced
that Ms. Pierson could withstand intimidation in the future by an
individual seeking to purchase ephedrine for illegal purposes. Other
than Ms. Pierson's statement that she took a ``self-help class,'' there
is no evidence in the record regarding any treatment that she has
received. In fact, Ms. Pierson still suffers from panic attacks and
anxiety. The Deputy Administrator recognizes that there have been no
allegations of wrongdoing by Ms. Pierson since 1992, however this
[[Page 14273]]
is outweighed by the lack of adequate assurances that Ms. Pierson has
the needed self-esteem to withstand being intimidated to sell ephedrine
for illegal purposes in the future.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the
application for registration as a retail distributor of ephedrine,
submitted by Jacqueline Lee Pierson, d/b/a Energy Outlet, be, and it
hereby is, denied. This order is effective April 23, 1999.
Dated: March 17, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-7123 Filed 3-23-99; 8:45 am]
BILLING CODE 4410-09-M
