Mr. Checkout North Texas; Admonition of Registrant, 4418-4422 [2010-1634]
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Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[LLOR912000–L63100000.DD0000]
Notice of Reestablishment of the
Secure Rural Schools Resource
Advisory Committees
AGENCY:
Bureau of Land Management,
Interior.
ACTION: Notice.
SUMMARY: This notice is published in
accordance with Section 9(a)(2) of the
Federal Advisory Committee Act of
1972. Notice is hereby given that the
Secretary of the Interior (Secretary) has
reestablished the Bureau of Land
Management’s Secure Rural Schools
Resource Advisory Committees.
FOR FURTHER INFORMATION CONTACT:
Allison Sandoval, Legislative Affairs
and Correspondence (600), Bureau of
Land Management, 1620 L Street, NW.,
MS–LS–401, Washington, DC 20036,
telephone (202) 912–7434.
SUPPLEMENTARY INFORMATION: The
purpose of the Committees is to provide
recommendations to the Secretary for
project funding, as required by the
Secure Rural Schools and Community
Self-Determination Act of 2000, Public
Law 106–393, as amended by Public
Law 110–343, Title VI (2008).
Certification Statement
I hereby certify that the
reestablishment of the Secure Rural
Schools Resource Advisory Committees
is necessary and in the public interest
in connection with the Secretary of the
Interior’s responsibilities to manage the
lands, resources, and facilities
administered by the Bureau of Land
Management.
Dated: January 21, 2010.
Ken Salazar,
Secretary of the Interior.
[FR Doc. 2010–1624 Filed 1–26–10; 8:45 am]
BILLING CODE 4310–33–P
INTERNATIONAL TRADE
COMMISSION
srobinson on DSKHWCL6B1PROD with NOTICES
[Investigation No. 337–TA–677]
In the Matter of: Certain Course
Management System Software
Products; Notice of Commission
Determination Not To Review an Initial
Determination Terminating the
Investigation on the Basis of a
Settlement Agreement
AGENCY: U.S. International Trade
Commission.
ACTION: Notice.
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16:22 Jan 26, 2010
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SUMMARY: Notice is hereby given that
the U.S. International Trade
Commission has determined not to
review an initial determination (‘‘ID’’)
(Order No. 6) terminating the
investigation of the basis of a settlement
agreement.
FOR FURTHER INFORMATION CONTACT:
James A. Worth, Office of the General
Counsel, U.S. International Trade
Commission, 500 E Street, SW.,
Washington, DC 20436, telephone (202)
205–3065. Copies of non-confidential
documents filed in connection with this
investigation are or will be available for
inspection during official business
hours (8:45 a.m. to 5:15 p.m.) in the
Office of the Secretary, U.S.
International Trade Commission, 500 E
Street, SW., Washington, DC 20436,
telephone (202) 205–2000. General
information concerning the Commission
may also be obtained by accessing its
Internet server (https://www.usitc.gov).
The public record for this investigation
may be viewed on the Commission’s
electronic docket (EDIS) at https://
edis.usitc.gov. Hearing-impaired
persons are advised that information on
this matter can be obtained by
contacting the Commission’s TDD
terminal on (202) 205–1810.
SUPPLEMENTARY INFORMATION: This
investigation was instituted on June 9,
2009, based upon a complaint filed on
behalf of Blackboard Inc. of Washington,
DC (‘‘Blackboard’’) on April 17, 2009,
and supplemented on May 6 and May
14, 2009. 74 FR 27345 (June 9, 2009).
The complaint alleged violations of
section 337 of the Tariff Act of 1930 (19
U.S.C. 1337) in the importation into the
United States, the sale for importation,
and the sale within the United States
after importation of certain course
management system software products
that infringe certain claims of United
States Patent No. 6,988,138. The notice
of investigation named Desire2Learn,
Inc. of Ontario, Canada (‘‘D2L’’) as
respondent.
On December 17, 2009, Blackboard
and D2L filed a joint motion pursuant
to Commission Rule 210.21(b) to
terminate the investigation based upon
a settlement agreement. On December
24, 2009, the Commission investigative
attorney filed a response in support of
the motion. On December 28, 2009, the
ALJ issued Order No. 6, granting the
motion. No petitions for review were
filed.
The Commission has determined not
to review the subject ID.
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of section 210.42(h) of the
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Commission’s Rules of Practice and
Procedure (19 CFR 210.42(h)).
By order of the Commission.
Issued: January 21, 2010.
Marilyn R. Abbott,
Secretary to the Commission.
[FR Doc. 2010–1489 Filed 1–26–10; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 07–47]
Mr. Checkout North Texas; Admonition
of Registrant
On August 14, 2007, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA or ‘‘the
Government’’), issued an Order to Show
Cause to Mr. Checkout North Texas
(Respondent), of Grand Prairie, Texas.
The Order to Show Cause proposed the
revocation of Respondent’s DEA
Certificate of Registration as a
distributor of list I chemicals on the
ground that its continued registration
was ‘‘inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(h).’’ Show Cause Order at 1.
The Show Cause Order specifically
alleged that Respondent was
distributing certain list I chemical
products containing pseudoephedrine
and ephedrine, which are precursor
chemicals used in the illicit
manufacture of methamphetamine, a
schedule II controlled substance, to
convenience stores and truck stops, and
that these stores traditionally sell only
very small quantities of nonprescriptions drugs. Id. at 2. The Order
further alleged that the specific list I
chemical products Respondent
distributes ‘‘are rarely found in any
retail store serving the traditional
therapeutic market,’’ and have ‘‘a history
of being diverted into the illicit
production of methamphetamine.’’ Id.
The Order thus alleged that Respondent
‘‘continues to be primarily involved in
the list I chemical business and is
continuing to sell these products with
high diversion potential to retailers who
have minimal expectation of sales of
products of these kinds.’’ Id. at 3.
Finally, the Order alleged that
Respondent ‘‘has been involved in the
distribution of listed chemical products
out of an unregistered location in
violation of the registration
requirements of 21 U.S.C. 822.’’ Id. at 2.
On September 17, 2007, Respondent
timely requested a hearing on the
allegations and the matter was placed
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on the docket of the Agency’s
Administrative Law Judges (ALJ).
Thereafter, on February 5, 2008, a
hearing was held in Dallas, Texas. ALJ
Ex. 2; ALJ at 4. At the hearing, both
parties called witnesses to testify and
introduced documentary evidence. After
the hearing, both parties filed briefs.
On June 10, 2009, the ALJ issued her
recommended decision (ALJ). Therein,
the ALJ concluded that the Government
had failed to show that Respondent’s
continued registration is inconsistent
with the public interest. ALJ at 36. As
to the first factor—the maintenance of
effective controls against diversion—the
ALJ noted that, during an inspection in
April 2006, Respondent’s owner, Mr.
Thomas Naulty, told an Agency
Diversion Investigator (DI) ‘‘that he had
stored and distributed some listed
chemical products from another storage
facility’’; however, when the DI advised
Mr. Naulty that such distribution
constituted a violation of DEA
regulations, he ‘‘took corrective action
by moving the listed chemical products
to the approved storage facility and
inform[ed the DI] of this later that same
day.’’ Id. at 26.
Because the record contained ‘‘no
evidence of inadequate recordkeeping’’
or ‘‘evidence that the Respondent sold
controlled substances 1 over the
regulatory threshold amounts,’’ the ALJ
concluded that ‘‘Mr. Naulty’s immediate
response’’ to the DI’s notification that
Respondent was violating the
regulations ‘‘demonstrates the
Respondent’s commitment to
compliance.’’ Id. at 27. The ALJ thus
concluded that this factor supports
Respondent’s continued registration. Id.
As to the second and fourth factors—
Respondent’s compliance with
applicable laws and its past experience
in the distribution of listed chemicals—
the ALJ again noted that Mr. Naulty had
taken prompt corrective action upon
being told that Respondent was
violating DEA regulations by
distributing from the unregistered
location. Id. The ALJ also found
significant that ‘‘Respondent’s owners
personally deliver the listed chemical
products to its customers’’ and ‘‘require
their listed chemical customers to
comply with the sales limits of the
[Combat Methamphetamine Epidemic
Act].’’ Id. at 27–28. Based on
‘‘Respondent’s sincere commitment to
compliance over a 10 year time period,’’
the ALJ concluded that the evidence
‘‘heavily weighs in favor of continuing
1 The Respondent’s registration does not entitle
him to distribute controlled substances, but rather
only listed chemicals. I presume that the ALJ meant
the latter.
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Respondent’s DEA registration.’’ Id. at
28.
As to factor three—Respondent’s
record of convictions under Federal or
State laws relating to controlled
substances or listed chemicals—the ALJ
observed that the record contained no
evidence of such convictions by either
Mr. Naulty or his son, Mr. Anthony
Naulty, owner of Mr. Checkout & Son,
a subsidiary of Respondent. Id. at 5, 28.
The ALJ also noted that the record
contained no evidence that any of
‘‘Respondent’s customers had been
convicted of a crime related to the
handling of listed chemical products or
methamphetamine.’’ Id. at 28.
Finally, as to factor five—other factors
that are relevant to and consistent with
the public health and safety—the ALJ
noted that ‘‘[i]n the past, the DEA has
revoked the registrations of listed
chemical product distributors because it
found the listed chemical products had
been sold in quantities that exceeded
the amount that could be expected to be
sold to customers with legitimate need
for such products.’’ Id. (citations
omitted). The ALJ then reasoned that
‘‘[i]mplicit in this issue * * * is the
necessity for the Government to
establish an expected monthly sales
amount—the quantity consistent with
‘legitimate demand’— that can be
compared against the Respondent’s
actual sales.’’ Id. at 29 (citation omitted).
While noting that in past cases, ‘‘the
Government attempted to establish this
baseline by entering the declarations of
its expert witness, Jonathan Robbin,’’ the
ALJ observed that ‘‘[m]ore recently
* * * the validity of Mr. Robbin’s
methodology and the applicability of
the underlying data he uses have been
sharply called into question,’’ and that I
‘‘ha[ve] declined to rely on [his] figures
in reaching her decisions.’’ Id. at 29–30
(citing Novelty Distributors, Inc., 73 FR
52589, 52693–95 (2008); Gregg & Son
Distributors, 74 FR 17517, 17519–20
(2009); Sunny Wholesale, Inc., 73 FR
57655, 57658–59 (2008)).
Accordingly, although Respondent
did not challenge the statistical
evidence contained in the affidavit
which the Government entered into
evidence, the ALJ concluded that she
could not ‘‘simply close [her] eyes to the
reduced credibility of Mr. Robbins
methods and analysis.’’ Id. at 30–31.
Based on the decisions cited above, as
well as because ‘‘Mr. Robbin’s analysis
was clearly not tailored to this
Respondent,’’ the ALJ concluded that
the Government had not ‘‘established by
a preponderance of the evidence that
these figures accurately represent[ed]
the average dollar amount of expected
sales.’’ Id. at 31.
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The ALJ further noted that the
Government did not establish
Respondent’s own average monthly sale,
per customer, of listed chemical
products. Id. Because there was no
‘‘baseline average sales figure to
compare’’ Respondent’s sales to, the ALJ
concluded that the Government had
failed to prove by a preponderance of
the evidence that ‘‘this Respondent sold
listed chemical products in such
excessive quantities’’ as to support the
inference that the products were being
diverted into the illicit manufacture of
methamphetamine. Id. at 33.
The ALJ also noted that the evidence
showed that ‘‘at one time, the
Respondent distributed a rose in a glass
container,’’ and that ‘‘[c]redible evidence
establishes that the packaging of this
product is sometimes used as drug
paraphernalia.’’ Id. The ALJ further
remarked that ‘‘the record contains no
evidence that the roses sold by the
Respondent were ever sold at retail in
conjunction with other products that
would lead the seller of the roses to
believe this product would be used as
drug paraphernalia,’’ that ‘‘there are no
regulations or other guidance provided
by DEA * * * to indicate that the
Respondent was on notice of the
potential misuse of this product,’’ and
that ‘‘there is no evidence that
Respondent had any actual knowledge
of such potential misuse of the product.’’
Id. at 33. The ALJ thus found that ‘‘the
evidence relevant to the fifth factor does
not lead to the conclusion that this
Respondent’s DEA registration should
be revoked.’’ Id. at 33–34.
Having found that ‘‘the Government
has failed to prove by a preponderance
of the evidence that the Respondent
engaged in excessive sales or created a
serious risk of diversion,’’ the ALJ
ultimately found that ‘‘the evidence in
this case supports a conclusion that the
continued registration of the
Respondent would not be inconsistent
with the public interest.’’ Id. at 36.
Accordingly, she recommended that
‘‘the Respondent’s DEA registration
should be continued and its renewal
application should be granted without
restrictions.’’ Id.
Neither party filed exceptions to the
ALJ’s Decision. On July 29, 2009, the
ALJ forwarded the matter to me for final
agency action.
Having reviewed the record in its
entirety, I adopt the ALJ’s conclusion
that the Government did not prove by a
preponderance of the evidence that
Respondent engaged in sales in excess
of legitimate demand or otherwise has
failed to maintain effective controls
against diversion. I also agree with the
ALJ’s conclusion that Respondent
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violated Federal law by distributing
from an unregistered location, but that
because Respondent immediately
discontinued this practice upon
learning that it was a violation, this
conduct does not warrant the revocation
of its registration. Finally, I agree with
the ALJ’s conclusion that the
Government has not established that
Respondent violated the drug
paraphernalia statute (21 U.S.C. 863)
when it sold glass roses. I therefore also
adopt her conclusion that Respondent’s
continued registration is not
inconsistent with the public interest.
However, based on Respondent’s
conduct in distributing from an
unregistered location, I conclude that it
should be admonished. I make the
following findings of fact.
Findings
Respondent, which is owned by Mr.
Thomas Naulty as a sole proprietorship,
is a wholesale distributor of various
products including non-prescription
drug products, as well as sunglasses,
ball caps, candies, batteries, condoms
‘‘and whatever you can find around the
checkout area of a convenience store.’’
Tr. 105–06. Among the non-prescription
drugs distributed by Respondent are
products which contain the list I
chemicals pseudoephedrine and
ephedrine. GX 29. Respondent
distributes list I chemical products to
convenience stores, gas stations, and
similar establishments in the Dallas,
Texas metropolitan area. Id. at 63; GX
31.
Both pseudoephedrine and ephedrine
have FDA-approved therapeutic uses.
Ephedrine is lawfully marketed under
the Food, Drug and Cosmetic Act for
over-the-counter use as a bronchodilator
to treat asthma, and pseudoephedrine is
lawfully marketed for over-the-counter
use as a decongestant. See GX 15, at 3–
4. Both substances are, however,
regulated as list I chemicals under the
Controlled Substances Act because they
are precursor chemicals which are
easily extracted from over-the-counter
drug products and frequently diverted
into the illicit manufacture of
methamphetamine, a schedule II
controlled substance. See 21 U.S.C.
802(34); id. 812(c); 21 CFR 1308.12(d).
See also GX 15, at 8.
Respondent has held a DEA
registration to distribute list I chemicals
since November 1997. GX 1. While the
expiration date of its most recent
registration certificate is January 31,
2007, on January 5, 2007, Respondent
submitted a renewal application. GX 1;
Tr. 65. Accordingly, I find that
Respondent’s registration has remained
in effect pending the issuance of this
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Decision and Final Order.2 See 5 U.S.C.
558(c).
Mr. Anthony Naulty is Thomas
Naulty’s son. Id. at 4. Anthony Naulty
is the owner of Mr. Checkout & Sons,
which, pursuant to a partnership
agreement executed in October 2005
and still in effect on the date of the
hearing, was a subsidiary of
Respondent. Id. at 112; RX 12. Under
the agreement, Thomas Naulty handles
the responsibilities of maintaining
inventory and setting distribution
schedules for Respondent and Mr.
Checkout & Sons; Anthony Naulty
manages sales, physical distribution,
and the accounts receivable for both
businesses. RX 12. Anthony Naulty
planned to take over Respondent upon
Thomas Naulty’s retirement and so
applied for his own registration. Tr. 48.
Sometime in 2007, Anthony Naulty was
served with an Order to Show Cause
which proposed the denial of his
application; he then withdrew his
application. Id. at 55. However, the
record does not disclose the basis of the
Agency’s decision to deny the
application.
The 2006 Inspection
In April 2006, two DEA Diversion
Investigators (DIs) visited Respondent to
conduct a cyclic investigation.3 Id. at
61. The DIs went to Respondent’s
registered location, which is Mr.
Naulty’s residence in Grand Prairie,
Texas, and reviewed its recordkeeping,
security, and business practices. Id. at
61–62. The DIs determined, however,
that Respondent stores its listed
chemical products in a unit of a storage
facility located at 3150 East Pioneer
Parkway, Arlington, Texas, some five or
six miles from its registered location.4
Id. at 61–62, 102, 111–12.
The DIs also determined that
Respondent was storing listed chemicals
in a second storage unit located in
McKinney, Texas, which is an estimated
2 Respondent also holds a State of Texas permit
as a Wholesale Distributor of Drugs. GX 30; RX 11;
see also Tr. 105–06.
3 DEA Investigators had previously inspected
Respondent prior to granting its initial registration,
as well as in 2001. Tr. 37–38, 89–90, 93.
4 At the hearing, an Agency Diversion Investigator
(DI) testified that under DEA regulations, the use of
such a storage facility is permissible and expected
for small, independent registrants like Respondent.
Id. at 90. Apparently, the DI had not read any of
the Agency decisions which have held that the use
of public storage units to store listed chemicals does
not provide an acceptable level of security. See
Stephen J. Heldman, 72 FR 4032, 4034 (2007);
Sujak Distributors, 71 FR 50102, 50104 (2006).
The ALJ credited the DI’s testimony ‘‘that,
pursuant to DEA regulations, the Respondent is
required to move the listed chemical products to
the registered location before distributing them.’’
ALJ at 10; see also Tr. 62, 83, 90; see also 21 CFR
1309.23(b)(1).
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40 miles from Respondent’s registered
location. Id. at 62–64. According to Mr.
Naulty, his son was distributing listed
chemicals from this storage unit. Id. at
116. However, upon being informed by
the DIs that this was a violation of DEA
regulations (because the products were
not being returned to the registered
location prior to being distributed),
Respondent immediately ceased doing
so. Id. at 63 & 116; see also 21 CFR
1309.23(b)(1).
The DIs also determined that
Respondent distributed Max Brand, a
pseudoephedrine product, as well as
seven ephedrine products including
Mini-Thin, Twin Tabs, Mini-Two Way,
and Rapid Action. Tr. 74; GX 25. The DI
testified that none of the eight products
were available at chain pharmacies or
supermarkets, which are considered to
be the ‘‘traditional’’ market where
consumers purchase over-the-counter
drugs containing list I chemicals to treat
cough, cold, and asthma.5 Tr. 75.
Moreover, other evidence in the record
shows that at least two of the products
distributed by Respondent (Max Brand
and Mini-Two Way) have been found in
numerous seizures conducted by law
enforcement.6 See GXs 2 & 3.
During the inspection, Mr. Naulty
provided the DIs with Respondent’s
5 According to a Diversion Investigator, DEA
considers the ‘‘traditional’’ market for cough, asthma
and cold remedies containing list I chemicals to
include large chain grocery stores, nationally
recognized pharmacy chains, larger convenience
stores (e.g., 7–11), and large retail stores (e.g., WalMart). GX 16, at 5. It considers the ‘‘non-traditional,’’
or ‘‘gray,’’ market for these products to include
smaller-chain and non-chain convenience stores
and other smaller retail establishments ‘‘where
consumers would not normally purchase over the
counter medications.’’ Id. at 6. Such ‘‘nontraditional’’ outlets typically carry listed chemical
products in higher strengths and packaged in
bottles or blister packs in larger quantities. Id.
Convenience store sales of such products are a
major source of the ephedrine and pseudoephedrine
used in the illicit manufacture of
methamphetamine. Tr. 19; GX 16, at 8–9.
According to a DEA Special Agent,
methamphetamine traffickers use people who
engage in a practice known as ‘‘smurfing.’’ GX 16,
at 6; Tr. 18. This practice involves going to multiple
stores and buying the maximum number of
packages possible of ephedrine and/or
pseudoephedrine at each store. Tr. 18. Smurfers
typically avoid larger retail stores such as ‘‘Target
or Wal-Mart,’’ because such chains have lossprevention personnel dedicated to detecting
shoplifting and suspicious buying practices. Id. at
18–19. As a result, smurfers target convenience
stores and gas stations, which generally lack these
security practices; these stores have thus become a
large and consistent source of precursor chemicals
for the illicit manufacturers of methamphetamine.
Id. at 19.
6 At the time of the hearing in February 2008,
Respondent carried one pseudoephedrine product
and two ephedrine products, Mini-Thin and
BronchEase. Tr. 103–05. The ALJ found that
Thomas Naulty ‘‘credibly testified the Respondent
would cease handling the pseudoephedrine
product’’ in mid-2008. ALJ at 7; see also Tr. 104.
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customer list for list I chemical
products; the list contained contact
information for 49 businesses and was
comprised of convenience stores, small
markets, and gas stations. Tr. 93–94; GX
31. Thomas Naulty indicated that
Respondent made deliveries to
customers approximately once every
two weeks. Tr. 84, 122. According to
Thomas Naulty’s testimony, his
customers generally buy three to four
dozen packages of list I chemical
products at a time. Id. at 122. Mr. Naulty
further indicated that, of those stores
that sell both ephedrine and
pseudoephedrine products, ‘‘one
[product] outsells the other, so they buy
minimally and averagely’’ such that if a
customer purchased four dozen of one
type of product, it would purchase only
one dozen of the other type. Id. at 122–
23.
During the inspection, Thomas Naulty
told the DI that list I chemical product
sales constituted approximately 20
percent of his overall dollar sales. Id. at
88. Moreover, at the hearing, Thomas
Naulty testified that list I chemical
products constituted approximately 23
percent of his total dollar sales and thus
represented the inventory item which
generated the largest sales volume. Id. at
104, 118–20.
During the inspection, the DI
reviewed Respondent’s purchase and
sales invoices for the seven months
prior to April 10, 2006. Id. at 84. To
show some of Respondent’s purchases
and sales of list I chemical products, the
Government entered into evidence two
purchase invoices from December 2005,
one sales invoice from March 2006, and
one sales invoice from April 2006. See
GXs 32 & 33. However, the DI only
made copies of the two sales invoices
which were entered into evidence. Tr.
84–85.
One of the sales invoices shows that
a customer purchased 120 bottles of 36count Max Brand pseudoephedrine (60mg. strength) for $288 as well as twelve
48-count blister packs of Mini Thin
ephedrine for $36. GX 33, at 2; see also
Tr. 74–76, 78–80. In testimony, the DI
asserted that, from the invoices he had
reviewed, while some stores might
receive a delivery of half a case (72
bottles); no store received a full case
(144 bottles). Id. at 85.
The DIs did not, however, prepare a
compilation of the sales invoices they
reviewed. Nor did the Government
produce any other evidence to show
what Respondent’s average monthly sale
of list I products was to its various
customers.7
7 The Government also introduced into evidence
a declaration prepared by an expert in statistical
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Moreover, the Government apparently
did not conduct an audit of
Respondent’s handling of list I products
and produced no evidence showing that
Respondent had violated any provisions
of the CSA or Agency regulations or that
its recordkeeping was inadequate. At
the conclusion of the inspection, the DIs
informed Thomas Naulty that they had
found no violations of DEA regulations.8
Id. at 98–99.
After the inspection, one of the DIs
conducted customer verifications at the
two stores whose sales invoices he had
copied. Id. at 87. The customers verified
that they had purchased and received
the quantities listed in the invoices. Id.
At the time of the hearing,
Respondent distributed list I chemical
products to twenty-four customers, all
of whom had self-certified as required
by the Combat Methamphetamine
Epidemic Act (‘‘CMEA’’). Id. at 127–28;
RX 7. Respondent also required that its
customers enter into a written
stipulation that they cannot purchase
only list I chemical products. Tr. 129.
At its own expense, Respondent
provided its list I chemical product
customers with logbooks outlining the
sales restrictions of the CMEA. Id. at
105. Thomas Naulty further indicated
his belief that Respondent’s customers
were satisfying the statutory
requirements for the logbook. Id. at 129–
30. As the ALJ further found, there is
‘‘no evidence that any of the stores that
purchase listed chemical products from
the Respondent have failed to abide by
the self-certification requirements, the
behind-the-counter placement
analysis of ‘‘demographic, economic, geographic,
survey and sales data.’’ GX 25 (affidavit of Jonathan
Robbin, President of Ricercar, Inc). Therein, the
Government’s Expert opined that ‘‘the expected sale
of ephedrine (Hcl) tablets in a convenience store
ranges between $0 and $25, with an average of
$12.58,’’ and that ‘‘[a] monthly retail sale * * * of
$60 of ephedrine (Hcl) tablets would be expected
to occur about once in a million times in random
sampling.’’ Id. at 7–8.
In her discussion of this evidence, the ALJ noted
that in several cases, the Expert’s ‘‘methodology and
the applicability of the underlying data he uses
have been sharply called into question,’’ and that
more recently, I had ‘‘declined to rely on [Robbin’s]
figures in reaching her decisions.’’ ALJ at 30 (citing
Novelty Distributors, Inc., 73 FR 52689, 52693–95
(2008)). For this reason, as well as because the
Expert ‘‘analysis was clearly not tailored to this
Respondent,’’ the ALJ declined ‘‘to rely on his
figures.’’ Id. at 31.
As the Expert’s affidavit indicates that he used
the same methodology which I found wanting in
Novelty, I am again compelled to reject this
evidence as not probative of either the average
expected sales levels of these products to meet
legitimate demand at convenience stores, or of the
probability of various sales levels occurring in
normal commerce. I therefore do not make any
findings regarding these issues.
8 Of course, the DIs had found a violation because
Respondent had distributed products through the
McKinney, Texas storage unit.
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
4421
requirements, the regulated transaction
limits, or any other provisions of the
CMEA or the Texas methamphetamine
precursor legislation.’’ ALJ at 7.
At the hearing, the Government also
pointed to a sales invoice, which
showed that on April 3, 2006,
Respondent sold 72 glass roses to a store
in Arlington, Texas. GX 33, at 2.
Government Counsel then asked the DI
if he knew ‘‘what a glass rose is?’’ Tr. 79.
The DI replied: ‘‘Not particularly. I’ve
heard it’s also used in clan[destine
methamphetamine] labs.’’ Id. However,
the DI did not know what this item is
specifically used for. Id. Moreover, on
cross-examination, the Government did
not ask Mr. Naulty any questions
regarding his sales of glass roses.
The record contains no evidence that
Respondent or Thomas or Anthony
Naulty has been convicted of a State or
Federal crime related to the use or
distribution of controlled substances or
listed chemical products. See also ALJ
at 9. Similarly, the record contains no
evidence that any of Respondent’s
customers or individuals related to
those businesses has been convicted of
a crime involving the manufacture,
distribution or use of
methamphetamine. See also id. Finally,
the record contains no evidence that any
of the listed chemical products actually
distributed by Respondent has been
discovered in a methamphetamine
laboratory. See also id.
Finally, the ALJ found that Thomas
Naulty ‘‘credibly testified that he is
committed to handling listed chemical
products in a manner that would
prevent them from being diverted into
illegitimate channels.’’ ALJ at 19 (citing
Tr. 106). She also found that he
‘‘credibly testified that his company
‘will continue to follow the DEA rules
and regulations as we have in the past.
Whatever compliance is necessary, we
will do.’’’ Id. (citing Tr. 107–08).
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that a
registration to distribute a list I chemical
‘‘may be suspended or revoked * * *
upon a finding that the registrant * * *
has committed such acts as would
render [its] registration under section
823 of this title inconsistent with the
public interest as determined under
such section.’’ 21 U.S.C. 824(a)(4).
Moreover, under section 303(h), ‘‘[t]he
Attorney General shall register an
applicant to distribute a list I chemical
unless the Attorney General determines
that registration of the applicant is
inconsistent with the public interest.’’
Id. § 823(h). In making the public
interest determination, Congress
E:\FR\FM\27JAN1.SGM
27JAN1
4422
Federal Register / Vol. 75, No. 17 / Wednesday, January 27, 2010 / Notices
directed that the following factors be
considered:
srobinson on DSKHWCL6B1PROD with NOTICES
(1) maintenance by the [registrant] of
effective controls against diversion of listed
chemicals into other than legitimate
channels;
(2) compliance by the [registrant] with
applicable Federal, State, and local law;
(3) any prior conviction record of the
[registrant] under Federal or State laws
relating to controlled substances or to
chemicals controlled under Federal or State
law;
(4) any past experience of the [registrant]
in the manufacture and distribution of
chemicals; and
(5) such other factors as are relevant to and
consistent with the public health and safety.
Id.
‘‘These factors are considered in the
disjunctive.’’ Gregg & Son Distributors,
74 FR at 17520; see also Joy’s Ideas, 70
FR 33195, 33197 (2005). I may rely on
any one or a combination of factors, and
I may give each factor the weight I deem
appropriate in determining whether to
revoke an existing registration or to
deny an application for renewal of a
registration. Gregg & Son, 74 FR at
17520; Jacqueline Lee Pierson Energy
Outlet, 64 FR 14269, 14271 (1999).
Moreover, I am not required to make
findings as to all of the factors. Volkman
v. DEA, 567 F.3d 215, 222 (6th Cir.
2009); Morall v. DEA, 412 F.3d 165,
173–74 (D.C. Cir. 2005).
The Government bears the burden of
proof. 21 CFR 1309.54. Having
considered all of the factors, I conclude
that while the Government has proved
a single violation of Federal law, the
evidence does not support the
conclusion that Respondent’s continued
registration is inconsistent with the
public interest.
During the hearing, the Government
appeared to raise three principal
allegations: (1) That Respondent was
selling excessive quantities of listed
chemical products to non-traditional
retailers, (2) that Respondent sold an
item which is used as drug
paraphernalia, and (3) that Respondent
distributed products directly from a
storage facility which was located forty
miles from its registered location
without first returning them to its
registered location. The first two
allegations require no more than token
discussion because they fail for lack of
substantial evidence. While the third
allegation was proved, Respondent
quickly corrected the violation.
As for the first allegation, having
previously found that the Government
Expert’s methodology is unreliable and
it being apparent that the expert’s
affidavit relies on the same
methodology, once again I conclude that
VerDate Nov<24>2008
16:22 Jan 26, 2010
Jkt 220001
his findings as to both the monthly
expected sales range and the statistical
improbability of certain sales levels of
listed chemical products in legitimate
commerce at convenience stores are not
supported by substantial evidence. See
Novelty Distributors, 73 FR at 52693–94;
see also CBS Wholesale Distributors, 74
FR 36746, 36748 (2009); Gregg & Son,
74 FR at 17520. While this provides
reason alone to find the allegation
unproven, the deficiency in the
Government’s case is compounded by
its failure to show what Respondent’s
average monthly sales were to its
various customers. The allegation is
therefore rejected.
The Government also failed to prove
that Respondent violated Federal law by
selling drug paraphernalia. See 21
U.S.C. 863. While I have now held in
several cases that glass roses constitute
drug paraphernalia, see, e.g., Gregg &
Son, 74 FR at 17521, the Supreme Court
has held that the statute imposes a
scienter requirement. See Posters ‘N’
Things, Ltd. v. United States, 511 U.S.
513, 524 (1994). (‘‘It is sufficient that the
defendant be aware that customers in
general are likely to use the
merchandise with drugs. Therefore, the
Government must establish that the
defendant knew that the items at issue
are likely to be used with illegal drugs.’’)
(citing United States v. United States
Gypsum Co., 438 U.S. 422, 444 (1978)
(‘‘knowledge of ‘probable consequences’
sufficient for conviction’’)).
The Government produced absolutely
no evidence that Mr. Naulty was aware
that the glass roses’ likely use is as drug
paraphernalia. Nor did it even pose this
obvious question to Mr. Naulty when it
cross-examined him. The allegation
therefore also fails for lack of substantial
evidence.
The only allegation that was proved
was that Respondent distributed list I
chemical products directly from a
storage facility which was not a
registered location (and which was
located approximately forty miles from
its registered location). Under Federal
law, ‘‘[a] separate registration is required
for each principal place of business at
one general physical location where List
I chemicals are distributed * * * by a
person.’’ 21 CFR 1309.23(a). However, a
registration is not required for ‘‘[a]
warehouse where List I chemicals are
stored by or on behalf of a registered
person, unless such chemicals are
distributed directly from such
warehouse to locations other than the
registered location from which the
chemicals were originally delivered.’’ Id.
§ 1309.23(b)(1).
Respondent did not dispute that it
distributed list I chemicals from its
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
McKinney storage unit without first
returning them to its registered location.
In doing so, Respondent violated
Federal law. 21 U.S.C. 843(a)(9) (‘‘It
shall be unlawful for any person
knowingly or intentionally * * * to
distribute * * * a list I chemical
without registration required by this
subchapter[.]’’). However, the
Government did not establish the extent
of the violations and Mr. Naulty
immediately ceased doing so upon
being told by the DIs that this was a
violation. The Government’s evidence
therefore does not establish that
Respondent’s continued registration is
inconsistent with the public interest.
Respondent’s violation does, however,
warrant an admonition, which shall be
made a part of Respondent’s record.9
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(h) and 824(a), as well
as 28 CFR 0.100(b) and 0.104, I hereby
order that Mr. Checkout North Texas,
be, and it hereby is, admonished. I
further order that the application of Mr.
Checkout North Texas for renewal of its
DEA Certificate of Registration be, and
it hereby is, granted. This order is
effective immediately.
Dated: January 18, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010–1634 Filed 1–26–10; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Antitrust Division
Notice Pursuant to The National
Cooperative Research and Production
Act of 1993—Cooperative Research
Group on Clean Diesel V
Notice is hereby given that, on
December 10, 2009, pursuant to Section
9 As found above, Respondent is currently using
a rental storage unit to store list I products. In
several cases, DEA has held that the use of such
units does not provide adequate security. More
specifically, I have noted a number of ‘‘security
concerns which are raised by these facilities
including the inadequacy of their construction, the
lack of alarm systems, the lack of 24 hour on-site
monitoring, the ability of unauthorized persons to
gain access to the facility and the storage units, and
the fact that the tenant does not control what other
tenants the landlord rents to.’’ Novelty Distributors,
73 FR at 52698; see also Heldman, 72 FR at 4034;
Sujak Distributors, 71 FR at 50104.
While it seems unlikely that Respondent’s storage
unit provides adequate security, the Government
did not raise this as an issue at any time in this
proceeding. Consistent with the Due Process Clause
and Administrative Procedure Act, because
Respondent has had no opportunity to contest
whether his storage unit provides adequate security,
I do not consider the issue. See CBS Wholesale, 74
FR at 36749–50.
E:\FR\FM\27JAN1.SGM
27JAN1
Agencies
[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Notices]
[Pages 4418-4422]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1634]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 07-47]
Mr. Checkout North Texas; Admonition of Registrant
On August 14, 2007, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA or ``the
Government''), issued an Order to Show Cause to Mr. Checkout North
Texas (Respondent), of Grand Prairie, Texas. The Order to Show Cause
proposed the revocation of Respondent's DEA Certificate of Registration
as a distributor of list I chemicals on the ground that its continued
registration was ``inconsistent with the public interest, as that term
is used in 21 U.S.C. 823(h).'' Show Cause Order at 1.
The Show Cause Order specifically alleged that Respondent was
distributing certain list I chemical products containing
pseudoephedrine and ephedrine, which are precursor chemicals used in
the illicit manufacture of methamphetamine, a schedule II controlled
substance, to convenience stores and truck stops, and that these stores
traditionally sell only very small quantities of non-prescriptions
drugs. Id. at 2. The Order further alleged that the specific list I
chemical products Respondent distributes ``are rarely found in any
retail store serving the traditional therapeutic market,'' and have ``a
history of being diverted into the illicit production of
methamphetamine.'' Id. The Order thus alleged that Respondent
``continues to be primarily involved in the list I chemical business
and is continuing to sell these products with high diversion potential
to retailers who have minimal expectation of sales of products of these
kinds.'' Id. at 3. Finally, the Order alleged that Respondent ``has
been involved in the distribution of listed chemical products out of an
unregistered location in violation of the registration requirements of
21 U.S.C. 822.'' Id. at 2.
On September 17, 2007, Respondent timely requested a hearing on the
allegations and the matter was placed
[[Page 4419]]
on the docket of the Agency's Administrative Law Judges (ALJ).
Thereafter, on February 5, 2008, a hearing was held in Dallas, Texas.
ALJ Ex. 2; ALJ at 4. At the hearing, both parties called witnesses to
testify and introduced documentary evidence. After the hearing, both
parties filed briefs.
On June 10, 2009, the ALJ issued her recommended decision (ALJ).
Therein, the ALJ concluded that the Government had failed to show that
Respondent's continued registration is inconsistent with the public
interest. ALJ at 36. As to the first factor--the maintenance of
effective controls against diversion--the ALJ noted that, during an
inspection in April 2006, Respondent's owner, Mr. Thomas Naulty, told
an Agency Diversion Investigator (DI) ``that he had stored and
distributed some listed chemical products from another storage
facility''; however, when the DI advised Mr. Naulty that such
distribution constituted a violation of DEA regulations, he ``took
corrective action by moving the listed chemical products to the
approved storage facility and inform[ed the DI] of this later that same
day.'' Id. at 26.
Because the record contained ``no evidence of inadequate
recordkeeping'' or ``evidence that the Respondent sold controlled
substances \1\ over the regulatory threshold amounts,'' the ALJ
concluded that ``Mr. Naulty's immediate response'' to the DI's
notification that Respondent was violating the regulations
``demonstrates the Respondent's commitment to compliance.'' Id. at 27.
The ALJ thus concluded that this factor supports Respondent's continued
registration. Id.
---------------------------------------------------------------------------
\1\ The Respondent's registration does not entitle him to
distribute controlled substances, but rather only listed chemicals.
I presume that the ALJ meant the latter.
---------------------------------------------------------------------------
As to the second and fourth factors--Respondent's compliance with
applicable laws and its past experience in the distribution of listed
chemicals--the ALJ again noted that Mr. Naulty had taken prompt
corrective action upon being told that Respondent was violating DEA
regulations by distributing from the unregistered location. Id. The ALJ
also found significant that ``Respondent's owners personally deliver
the listed chemical products to its customers'' and ``require their
listed chemical customers to comply with the sales limits of the
[Combat Methamphetamine Epidemic Act].'' Id. at 27-28. Based on
``Respondent's sincere commitment to compliance over a 10 year time
period,'' the ALJ concluded that the evidence ``heavily weighs in favor
of continuing Respondent's DEA registration.'' Id. at 28.
As to factor three--Respondent's record of convictions under
Federal or State laws relating to controlled substances or listed
chemicals--the ALJ observed that the record contained no evidence of
such convictions by either Mr. Naulty or his son, Mr. Anthony Naulty,
owner of Mr. Checkout & Son, a subsidiary of Respondent. Id. at 5, 28.
The ALJ also noted that the record contained no evidence that any of
``Respondent's customers had been convicted of a crime related to the
handling of listed chemical products or methamphetamine.'' Id. at 28.
Finally, as to factor five--other factors that are relevant to and
consistent with the public health and safety--the ALJ noted that ``[i]n
the past, the DEA has revoked the registrations of listed chemical
product distributors because it found the listed chemical products had
been sold in quantities that exceeded the amount that could be expected
to be sold to customers with legitimate need for such products.'' Id.
(citations omitted). The ALJ then reasoned that ``[i]mplicit in this
issue * * * is the necessity for the Government to establish an
expected monthly sales amount--the quantity consistent with `legitimate
demand'-- that can be compared against the Respondent's actual sales.''
Id. at 29 (citation omitted). While noting that in past cases, ``the
Government attempted to establish this baseline by entering the
declarations of its expert witness, Jonathan Robbin,'' the ALJ observed
that ``[m]ore recently * * * the validity of Mr. Robbin's methodology
and the applicability of the underlying data he uses have been sharply
called into question,'' and that I ``ha[ve] declined to rely on [his]
figures in reaching her decisions.'' Id. at 29-30 (citing Novelty
Distributors, Inc., 73 FR 52589, 52693-95 (2008); Gregg & Son
Distributors, 74 FR 17517, 17519-20 (2009); Sunny Wholesale, Inc., 73
FR 57655, 57658-59 (2008)).
Accordingly, although Respondent did not challenge the statistical
evidence contained in the affidavit which the Government entered into
evidence, the ALJ concluded that she could not ``simply close [her]
eyes to the reduced credibility of Mr. Robbins methods and analysis.''
Id. at 30-31. Based on the decisions cited above, as well as because
``Mr. Robbin's analysis was clearly not tailored to this Respondent,''
the ALJ concluded that the Government had not ``established by a
preponderance of the evidence that these figures accurately
represent[ed] the average dollar amount of expected sales.'' Id. at 31.
The ALJ further noted that the Government did not establish
Respondent's own average monthly sale, per customer, of listed chemical
products. Id. Because there was no ``baseline average sales figure to
compare'' Respondent's sales to, the ALJ concluded that the Government
had failed to prove by a preponderance of the evidence that ``this
Respondent sold listed chemical products in such excessive quantities''
as to support the inference that the products were being diverted into
the illicit manufacture of methamphetamine. Id. at 33.
The ALJ also noted that the evidence showed that ``at one time, the
Respondent distributed a rose in a glass container,'' and that
``[c]redible evidence establishes that the packaging of this product is
sometimes used as drug paraphernalia.'' Id. The ALJ further remarked
that ``the record contains no evidence that the roses sold by the
Respondent were ever sold at retail in conjunction with other products
that would lead the seller of the roses to believe this product would
be used as drug paraphernalia,'' that ``there are no regulations or
other guidance provided by DEA * * * to indicate that the Respondent
was on notice of the potential misuse of this product,'' and that
``there is no evidence that Respondent had any actual knowledge of such
potential misuse of the product.'' Id. at 33. The ALJ thus found that
``the evidence relevant to the fifth factor does not lead to the
conclusion that this Respondent's DEA registration should be revoked.''
Id. at 33-34.
Having found that ``the Government has failed to prove by a
preponderance of the evidence that the Respondent engaged in excessive
sales or created a serious risk of diversion,'' the ALJ ultimately
found that ``the evidence in this case supports a conclusion that the
continued registration of the Respondent would not be inconsistent with
the public interest.'' Id. at 36. Accordingly, she recommended that
``the Respondent's DEA registration should be continued and its renewal
application should be granted without restrictions.'' Id.
Neither party filed exceptions to the ALJ's Decision. On July 29,
2009, the ALJ forwarded the matter to me for final agency action.
Having reviewed the record in its entirety, I adopt the ALJ's
conclusion that the Government did not prove by a preponderance of the
evidence that Respondent engaged in sales in excess of legitimate
demand or otherwise has failed to maintain effective controls against
diversion. I also agree with the ALJ's conclusion that Respondent
[[Page 4420]]
violated Federal law by distributing from an unregistered location, but
that because Respondent immediately discontinued this practice upon
learning that it was a violation, this conduct does not warrant the
revocation of its registration. Finally, I agree with the ALJ's
conclusion that the Government has not established that Respondent
violated the drug paraphernalia statute (21 U.S.C. 863) when it sold
glass roses. I therefore also adopt her conclusion that Respondent's
continued registration is not inconsistent with the public interest.
However, based on Respondent's conduct in distributing from an
unregistered location, I conclude that it should be admonished. I make
the following findings of fact.
Findings
Respondent, which is owned by Mr. Thomas Naulty as a sole
proprietorship, is a wholesale distributor of various products
including non-prescription drug products, as well as sunglasses, ball
caps, candies, batteries, condoms ``and whatever you can find around
the checkout area of a convenience store.'' Tr. 105-06. Among the non-
prescription drugs distributed by Respondent are products which contain
the list I chemicals pseudoephedrine and ephedrine. GX 29. Respondent
distributes list I chemical products to convenience stores, gas
stations, and similar establishments in the Dallas, Texas metropolitan
area. Id. at 63; GX 31.
Both pseudoephedrine and ephedrine have FDA-approved therapeutic
uses. Ephedrine is lawfully marketed under the Food, Drug and Cosmetic
Act for over-the-counter use as a bronchodilator to treat asthma, and
pseudoephedrine is lawfully marketed for over-the-counter use as a
decongestant. See GX 15, at 3-4. Both substances are, however,
regulated as list I chemicals under the Controlled Substances Act
because they are precursor chemicals which are easily extracted from
over-the-counter drug products and frequently diverted into the illicit
manufacture of methamphetamine, a schedule II controlled substance. See
21 U.S.C. 802(34); id. 812(c); 21 CFR 1308.12(d). See also GX 15, at 8.
Respondent has held a DEA registration to distribute list I
chemicals since November 1997. GX 1. While the expiration date of its
most recent registration certificate is January 31, 2007, on January 5,
2007, Respondent submitted a renewal application. GX 1; Tr. 65.
Accordingly, I find that Respondent's registration has remained in
effect pending the issuance of this Decision and Final Order.\2\ See 5
U.S.C. 558(c).
---------------------------------------------------------------------------
\2\ Respondent also holds a State of Texas permit as a Wholesale
Distributor of Drugs. GX 30; RX 11; see also Tr. 105-06.
---------------------------------------------------------------------------
Mr. Anthony Naulty is Thomas Naulty's son. Id. at 4. Anthony Naulty
is the owner of Mr. Checkout & Sons, which, pursuant to a partnership
agreement executed in October 2005 and still in effect on the date of
the hearing, was a subsidiary of Respondent. Id. at 112; RX 12. Under
the agreement, Thomas Naulty handles the responsibilities of
maintaining inventory and setting distribution schedules for Respondent
and Mr. Checkout & Sons; Anthony Naulty manages sales, physical
distribution, and the accounts receivable for both businesses. RX 12.
Anthony Naulty planned to take over Respondent upon Thomas Naulty's
retirement and so applied for his own registration. Tr. 48. Sometime in
2007, Anthony Naulty was served with an Order to Show Cause which
proposed the denial of his application; he then withdrew his
application. Id. at 55. However, the record does not disclose the basis
of the Agency's decision to deny the application.
The 2006 Inspection
In April 2006, two DEA Diversion Investigators (DIs) visited
Respondent to conduct a cyclic investigation.\3\ Id. at 61. The DIs
went to Respondent's registered location, which is Mr. Naulty's
residence in Grand Prairie, Texas, and reviewed its recordkeeping,
security, and business practices. Id. at 61-62. The DIs determined,
however, that Respondent stores its listed chemical products in a unit
of a storage facility located at 3150 East Pioneer Parkway, Arlington,
Texas, some five or six miles from its registered location.\4\ Id. at
61-62, 102, 111-12.
---------------------------------------------------------------------------
\3\ DEA Investigators had previously inspected Respondent prior
to granting its initial registration, as well as in 2001. Tr. 37-38,
89-90, 93.
\4\ At the hearing, an Agency Diversion Investigator (DI)
testified that under DEA regulations, the use of such a storage
facility is permissible and expected for small, independent
registrants like Respondent. Id. at 90. Apparently, the DI had not
read any of the Agency decisions which have held that the use of
public storage units to store listed chemicals does not provide an
acceptable level of security. See Stephen J. Heldman, 72 FR 4032,
4034 (2007); Sujak Distributors, 71 FR 50102, 50104 (2006).
The ALJ credited the DI's testimony ``that, pursuant to DEA
regulations, the Respondent is required to move the listed chemical
products to the registered location before distributing them.'' ALJ
at 10; see also Tr. 62, 83, 90; see also 21 CFR 1309.23(b)(1).
---------------------------------------------------------------------------
The DIs also determined that Respondent was storing listed
chemicals in a second storage unit located in McKinney, Texas, which is
an estimated 40 miles from Respondent's registered location. Id. at 62-
64. According to Mr. Naulty, his son was distributing listed chemicals
from this storage unit. Id. at 116. However, upon being informed by the
DIs that this was a violation of DEA regulations (because the products
were not being returned to the registered location prior to being
distributed), Respondent immediately ceased doing so. Id. at 63 & 116;
see also 21 CFR 1309.23(b)(1).
The DIs also determined that Respondent distributed Max Brand, a
pseudoephedrine product, as well as seven ephedrine products including
Mini-Thin, Twin Tabs, Mini-Two Way, and Rapid Action. Tr. 74; GX 25.
The DI testified that none of the eight products were available at
chain pharmacies or supermarkets, which are considered to be the
``traditional'' market where consumers purchase over-the-counter drugs
containing list I chemicals to treat cough, cold, and asthma.\5\ Tr.
75. Moreover, other evidence in the record shows that at least two of
the products distributed by Respondent (Max Brand and Mini-Two Way)
have been found in numerous seizures conducted by law enforcement.\6\
See GXs 2 & 3.
---------------------------------------------------------------------------
\5\ According to a Diversion Investigator, DEA considers the
``traditional'' market for cough, asthma and cold remedies
containing list I chemicals to include large chain grocery stores,
nationally recognized pharmacy chains, larger convenience stores
(e.g., 7-11), and large retail stores (e.g., Wal-Mart). GX 16, at 5.
It considers the ``non-traditional,'' or ``gray,'' market for these
products to include smaller-chain and non-chain convenience stores
and other smaller retail establishments ``where consumers would not
normally purchase over the counter medications.'' Id. at 6. Such
``non-traditional'' outlets typically carry listed chemical products
in higher strengths and packaged in bottles or blister packs in
larger quantities. Id. Convenience store sales of such products are
a major source of the ephedrine and pseudoephedrine used in the
illicit manufacture of methamphetamine. Tr. 19; GX 16, at 8-9.
According to a DEA Special Agent, methamphetamine traffickers
use people who engage in a practice known as ``smurfing.'' GX 16, at
6; Tr. 18. This practice involves going to multiple stores and
buying the maximum number of packages possible of ephedrine and/or
pseudoephedrine at each store. Tr. 18. Smurfers typically avoid
larger retail stores such as ``Target or Wal-Mart,'' because such
chains have loss-prevention personnel dedicated to detecting
shoplifting and suspicious buying practices. Id. at 18-19. As a
result, smurfers target convenience stores and gas stations, which
generally lack these security practices; these stores have thus
become a large and consistent source of precursor chemicals for the
illicit manufacturers of methamphetamine. Id. at 19.
\6\ At the time of the hearing in February 2008, Respondent
carried one pseudoephedrine product and two ephedrine products,
Mini-Thin and BronchEase. Tr. 103-05. The ALJ found that Thomas
Naulty ``credibly testified the Respondent would cease handling the
pseudoephedrine product'' in mid-2008. ALJ at 7; see also Tr. 104.
---------------------------------------------------------------------------
During the inspection, Mr. Naulty provided the DIs with
Respondent's
[[Page 4421]]
customer list for list I chemical products; the list contained contact
information for 49 businesses and was comprised of convenience stores,
small markets, and gas stations. Tr. 93-94; GX 31. Thomas Naulty
indicated that Respondent made deliveries to customers approximately
once every two weeks. Tr. 84, 122. According to Thomas Naulty's
testimony, his customers generally buy three to four dozen packages of
list I chemical products at a time. Id. at 122. Mr. Naulty further
indicated that, of those stores that sell both ephedrine and
pseudoephedrine products, ``one [product] outsells the other, so they
buy minimally and averagely'' such that if a customer purchased four
dozen of one type of product, it would purchase only one dozen of the
other type. Id. at 122-23.
During the inspection, Thomas Naulty told the DI that list I
chemical product sales constituted approximately 20 percent of his
overall dollar sales. Id. at 88. Moreover, at the hearing, Thomas
Naulty testified that list I chemical products constituted
approximately 23 percent of his total dollar sales and thus represented
the inventory item which generated the largest sales volume. Id. at
104, 118-20.
During the inspection, the DI reviewed Respondent's purchase and
sales invoices for the seven months prior to April 10, 2006. Id. at 84.
To show some of Respondent's purchases and sales of list I chemical
products, the Government entered into evidence two purchase invoices
from December 2005, one sales invoice from March 2006, and one sales
invoice from April 2006. See GXs 32 & 33. However, the DI only made
copies of the two sales invoices which were entered into evidence. Tr.
84-85.
One of the sales invoices shows that a customer purchased 120
bottles of 36-count Max Brand pseudoephedrine (60-mg. strength) for
$288 as well as twelve 48-count blister packs of Mini Thin ephedrine
for $36. GX 33, at 2; see also Tr. 74-76, 78-80. In testimony, the DI
asserted that, from the invoices he had reviewed, while some stores
might receive a delivery of half a case (72 bottles); no store received
a full case (144 bottles). Id. at 85.
The DIs did not, however, prepare a compilation of the sales
invoices they reviewed. Nor did the Government produce any other
evidence to show what Respondent's average monthly sale of list I
products was to its various customers.\7\
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\7\ The Government also introduced into evidence a declaration
prepared by an expert in statistical analysis of ``demographic,
economic, geographic, survey and sales data.'' GX 25 (affidavit of
Jonathan Robbin, President of Ricercar, Inc). Therein, the
Government's Expert opined that ``the expected sale of ephedrine
(Hcl) tablets in a convenience store ranges between $0 and $25, with
an average of $12.58,'' and that ``[a] monthly retail sale * * * of
$60 of ephedrine (Hcl) tablets would be expected to occur about once
in a million times in random sampling.'' Id. at 7-8.
In her discussion of this evidence, the ALJ noted that in
several cases, the Expert's ``methodology and the applicability of
the underlying data he uses have been sharply called into
question,'' and that more recently, I had ``declined to rely on
[Robbin's] figures in reaching her decisions.'' ALJ at 30 (citing
Novelty Distributors, Inc., 73 FR 52689, 52693-95 (2008)). For this
reason, as well as because the Expert ``analysis was clearly not
tailored to this Respondent,'' the ALJ declined ``to rely on his
figures.'' Id. at 31.
As the Expert's affidavit indicates that he used the same
methodology which I found wanting in Novelty, I am again compelled
to reject this evidence as not probative of either the average
expected sales levels of these products to meet legitimate demand at
convenience stores, or of the probability of various sales levels
occurring in normal commerce. I therefore do not make any findings
regarding these issues.
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Moreover, the Government apparently did not conduct an audit of
Respondent's handling of list I products and produced no evidence
showing that Respondent had violated any provisions of the CSA or
Agency regulations or that its recordkeeping was inadequate. At the
conclusion of the inspection, the DIs informed Thomas Naulty that they
had found no violations of DEA regulations.\8\ Id. at 98-99.
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\8\ Of course, the DIs had found a violation because Respondent
had distributed products through the McKinney, Texas storage unit.
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After the inspection, one of the DIs conducted customer
verifications at the two stores whose sales invoices he had copied. Id.
at 87. The customers verified that they had purchased and received the
quantities listed in the invoices. Id.
At the time of the hearing, Respondent distributed list I chemical
products to twenty-four customers, all of whom had self-certified as
required by the Combat Methamphetamine Epidemic Act (``CMEA''). Id. at
127-28; RX 7. Respondent also required that its customers enter into a
written stipulation that they cannot purchase only list I chemical
products. Tr. 129.
At its own expense, Respondent provided its list I chemical product
customers with logbooks outlining the sales restrictions of the CMEA.
Id. at 105. Thomas Naulty further indicated his belief that
Respondent's customers were satisfying the statutory requirements for
the logbook. Id. at 129-30. As the ALJ further found, there is ``no
evidence that any of the stores that purchase listed chemical products
from the Respondent have failed to abide by the self-certification
requirements, the behind-the-counter placement requirements, the
regulated transaction limits, or any other provisions of the CMEA or
the Texas methamphetamine precursor legislation.'' ALJ at 7.
At the hearing, the Government also pointed to a sales invoice,
which showed that on April 3, 2006, Respondent sold 72 glass roses to a
store in Arlington, Texas. GX 33, at 2. Government Counsel then asked
the DI if he knew ``what a glass rose is?'' Tr. 79. The DI replied:
``Not particularly. I've heard it's also used in clan[destine
methamphetamine] labs.'' Id. However, the DI did not know what this
item is specifically used for. Id. Moreover, on cross-examination, the
Government did not ask Mr. Naulty any questions regarding his sales of
glass roses.
The record contains no evidence that Respondent or Thomas or
Anthony Naulty has been convicted of a State or Federal crime related
to the use or distribution of controlled substances or listed chemical
products. See also ALJ at 9. Similarly, the record contains no evidence
that any of Respondent's customers or individuals related to those
businesses has been convicted of a crime involving the manufacture,
distribution or use of methamphetamine. See also id. Finally, the
record contains no evidence that any of the listed chemical products
actually distributed by Respondent has been discovered in a
methamphetamine laboratory. See also id.
Finally, the ALJ found that Thomas Naulty ``credibly testified that
he is committed to handling listed chemical products in a manner that
would prevent them from being diverted into illegitimate channels.''
ALJ at 19 (citing Tr. 106). She also found that he ``credibly testified
that his company `will continue to follow the DEA rules and regulations
as we have in the past. Whatever compliance is necessary, we will
do.''' Id. (citing Tr. 107-08).
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to distribute a list I chemical ``may be suspended or
revoked * * * upon a finding that the registrant * * * has committed
such acts as would render [its] registration under section 823 of this
title inconsistent with the public interest as determined under such
section.'' 21 U.S.C. 824(a)(4). Moreover, under section 303(h), ``[t]he
Attorney General shall register an applicant to distribute a list I
chemical unless the Attorney General determines that registration of
the applicant is inconsistent with the public interest.'' Id. Sec.
823(h). In making the public interest determination, Congress
[[Page 4422]]
directed that the following factors be considered:
(1) maintenance by the [registrant] of effective controls
against diversion of listed chemicals into other than legitimate
channels;
(2) compliance by the [registrant] with applicable Federal,
State, and local law;
(3) any prior conviction record of the [registrant] under
Federal or State laws relating to controlled substances or to
chemicals controlled under Federal or State law;
(4) any past experience of the [registrant] in the manufacture
and distribution of chemicals; and
(5) such other factors as are relevant to and consistent with
the public health and safety.
Id.
``These factors are considered in the disjunctive.'' Gregg & Son
Distributors, 74 FR at 17520; see also Joy's Ideas, 70 FR 33195, 33197
(2005). I may rely on any one or a combination of factors, and I may
give each factor the weight I deem appropriate in determining whether
to revoke an existing registration or to deny an application for
renewal of a registration. Gregg & Son, 74 FR at 17520; Jacqueline Lee
Pierson Energy Outlet, 64 FR 14269, 14271 (1999). Moreover, I am not
required to make findings as to all of the factors. Volkman v. DEA, 567
F.3d 215, 222 (6th Cir. 2009); Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005).
The Government bears the burden of proof. 21 CFR 1309.54. Having
considered all of the factors, I conclude that while the Government has
proved a single violation of Federal law, the evidence does not support
the conclusion that Respondent's continued registration is inconsistent
with the public interest.
During the hearing, the Government appeared to raise three
principal allegations: (1) That Respondent was selling excessive
quantities of listed chemical products to non-traditional retailers,
(2) that Respondent sold an item which is used as drug paraphernalia,
and (3) that Respondent distributed products directly from a storage
facility which was located forty miles from its registered location
without first returning them to its registered location. The first two
allegations require no more than token discussion because they fail for
lack of substantial evidence. While the third allegation was proved,
Respondent quickly corrected the violation.
As for the first allegation, having previously found that the
Government Expert's methodology is unreliable and it being apparent
that the expert's affidavit relies on the same methodology, once again
I conclude that his findings as to both the monthly expected sales
range and the statistical improbability of certain sales levels of
listed chemical products in legitimate commerce at convenience stores
are not supported by substantial evidence. See Novelty Distributors, 73
FR at 52693-94; see also CBS Wholesale Distributors, 74 FR 36746, 36748
(2009); Gregg & Son, 74 FR at 17520. While this provides reason alone
to find the allegation unproven, the deficiency in the Government's
case is compounded by its failure to show what Respondent's average
monthly sales were to its various customers. The allegation is
therefore rejected.
The Government also failed to prove that Respondent violated
Federal law by selling drug paraphernalia. See 21 U.S.C. 863. While I
have now held in several cases that glass roses constitute drug
paraphernalia, see, e.g., Gregg & Son, 74 FR at 17521, the Supreme
Court has held that the statute imposes a scienter requirement. See
Posters `N' Things, Ltd. v. United States, 511 U.S. 513, 524 (1994).
(``It is sufficient that the defendant be aware that customers in
general are likely to use the merchandise with drugs. Therefore, the
Government must establish that the defendant knew that the items at
issue are likely to be used with illegal drugs.'') (citing United
States v. United States Gypsum Co., 438 U.S. 422, 444 (1978)
(``knowledge of `probable consequences' sufficient for conviction'')).
The Government produced absolutely no evidence that Mr. Naulty was
aware that the glass roses' likely use is as drug paraphernalia. Nor
did it even pose this obvious question to Mr. Naulty when it cross-
examined him. The allegation therefore also fails for lack of
substantial evidence.
The only allegation that was proved was that Respondent distributed
list I chemical products directly from a storage facility which was not
a registered location (and which was located approximately forty miles
from its registered location). Under Federal law, ``[a] separate
registration is required for each principal place of business at one
general physical location where List I chemicals are distributed * * *
by a person.'' 21 CFR 1309.23(a). However, a registration is not
required for ``[a] warehouse where List I chemicals are stored by or on
behalf of a registered person, unless such chemicals are distributed
directly from such warehouse to locations other than the registered
location from which the chemicals were originally delivered.'' Id.
Sec. 1309.23(b)(1).
Respondent did not dispute that it distributed list I chemicals
from its McKinney storage unit without first returning them to its
registered location. In doing so, Respondent violated Federal law. 21
U.S.C. 843(a)(9) (``It shall be unlawful for any person knowingly or
intentionally * * * to distribute * * * a list I chemical without
registration required by this subchapter[.]''). However, the Government
did not establish the extent of the violations and Mr. Naulty
immediately ceased doing so upon being told by the DIs that this was a
violation. The Government's evidence therefore does not establish that
Respondent's continued registration is inconsistent with the public
interest. Respondent's violation does, however, warrant an admonition,
which shall be made a part of Respondent's record.\9\
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\9\ As found above, Respondent is currently using a rental
storage unit to store list I products. In several cases, DEA has
held that the use of such units does not provide adequate security.
More specifically, I have noted a number of ``security concerns
which are raised by these facilities including the inadequacy of
their construction, the lack of alarm systems, the lack of 24 hour
on-site monitoring, the ability of unauthorized persons to gain
access to the facility and the storage units, and the fact that the
tenant does not control what other tenants the landlord rents to.''
Novelty Distributors, 73 FR at 52698; see also Heldman, 72 FR at
4034; Sujak Distributors, 71 FR at 50104.
While it seems unlikely that Respondent's storage unit provides
adequate security, the Government did not raise this as an issue at
any time in this proceeding. Consistent with the Due Process Clause
and Administrative Procedure Act, because Respondent has had no
opportunity to contest whether his storage unit provides adequate
security, I do not consider the issue. See CBS Wholesale, 74 FR at
36749-50.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(h) and
824(a), as well as 28 CFR 0.100(b) and 0.104, I hereby order that Mr.
Checkout North Texas, be, and it hereby is, admonished. I further order
that the application of Mr. Checkout North Texas for renewal of its DEA
Certificate of Registration be, and it hereby is, granted. This order
is effective immediately.
Dated: January 18, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-1634 Filed 1-26-10; 8:45 am]
BILLING CODE 4410-09-P