Sunny Wholesale, Inc.; Revocation of Registration and Denial of Application, 57655-57668 [E8-23395]
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[FR Doc. E8–23399 Filed 10–2–08; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket Nos. 05–13 and 05–45]
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Sunny Wholesale, Inc.; Revocation of
Registration and Denial of Application
On August 24, 2005, I, the Deputy
Administrator of the Drug Enforcement
Administration, issued an Order to
Show Cause and Immediate Suspension
of Registration to Sunny Wholesale, Inc.
(Respondent), of Forest Park, Georgia.
ALJ Ex. 6. The Order immediately
suspended Respondent’s DEA
Certificate of Registration, No.
004550SLY, which authorizes it to
distribute the list I chemicals ephedrine
and pseudoephedrine, on the ground
that it was selling ‘‘excessive amounts’’
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of these chemicals to convenience
stores, id. at 6, which are the ‘‘primary
source’’ for the diversion of these
chemicals into the illicit manufacture of
methamphetamine, a schedule II
controlled substance.1 Id. at 4.
More specifically, the Show Cause
Order alleged that in July 2005, DEA
Diversion Investigators (DIs) learned
that records seized from various north
Georgia convenience stores which were
‘‘suspected of illegally distributing
listed chemical precursors,’’ had
‘‘indicated that [Respondent] had been
distributing 60 count bottles of’’ Max
Brand pseudoephedrine, a product
which has been repeatedly found at
illicit methamphetamine labs ‘‘in full
case and double case lots.’’ Id. at 6. The
Show Cause Order alleged that ‘‘law
enforcement officials [in Tennessee and
Georgia] have observed that an
overwhelming proportion of precursors
found at illicit methamphetamine sites
has involved non-traditional brands
sold through convenience stores,’’ id. at
4, that DEA had retained an expert in
retail marketing and statistics who had
concluded that sales of
pseudoephedrine products at
convenience stores in Tennessee and
Georgia ‘‘averaged between $15.00 and
$60.00 per month’’ per store and that
sales of combination ephedrine
products were even lower, Id. at 5, and
that ‘‘[c]onvenience store purchases of
case quantities of high count/high
strength pseudoephedrine products [are]
consistent with diversion of the
products into the illicit manufacture of
methamphetamine.’’ Id. at 6. The Show
Cause Order further alleged that
Respondent had continued selling large
amounts of pseudoephedrine ‘‘to
convenience stores and gas stations,’’
notwithstanding that it had been ‘‘put
on notice of the potential illegal
character of its activities with the
issuance of the original Order to Show
Cause’’ which was served in October
2004. Id. ‘‘[B]ecause of the substantial
likelihood that [Respondent would]
continue to divert listed chemical
products,’’ I thus concluded that
Respondent’s ‘‘continued registration,
during the pendency of these
proceedings, would constitute an
1 On October 20, 2004, the Deputy Assistant
Administrator issued the initial Order to Show
Cause to Respondent; the Order proposed the
revocation of its registration at its Forest Park
location and the denial of its pending application
for a registration at its Decatur, Georgia location.
ALJ Ex. 1. Each of the allegations of the initial Show
Cause Order was repeated verbatim in the
subsequent Order to Show Cause and Immediate
Suspension of Registration. On November 19, 2004,
Respondent, through its counsel, requested a
hearing on the allegations of the first Show Cause
Order. ALJ Ex. 2.
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57655
immediate danger to the public health
and safety.’’ Id. at 7.2
In addition to the above, the Show
Cause Order alleged that during a July
2001 inspection, DEA DIs audited
Respondent’s handling of listed
chemical products and determined that
it had ‘‘various overages and shortages,
including an unexplained shortage of
approximately 10,000 bottles of Max
Brand, and (another non-traditional
brand) Heads Up 60 count bottles.’’ Id.
at 5. The Show Cause Order alleged that
while inventorying Respondent’s listed
chemical products, it had ‘‘no
traditional brand * * * products but
only ‘grey market’ brands of
pseudoephedrine and combination
ephedrine products’’ which are not sold
at drug stores or supermarkets, but ‘‘are
typically only sold in locations where
goods of these types are not expected to
be sold, such as liquor stores, head
shops, gas stations, and other small
retail stores.’’ Id.
The Show Cause Order further alleged
that following the inspection, DEA DIs
conducted verifications of Respondent’s
customers; the DIs allegedly found that
some of the locations were ‘‘nonexistent,’’ some were residences, and
others included such establishments as
‘‘liquor stores, gift shops, a Blimpie
restaurant * * * and a magazine store.’’
Id. Relatedly, the Order alleged that in
seeking a registration for its Decatur
location, Respondent provided a list of
its proposed list I chemical customers
which included ‘‘liquor stores, a lotto
store, a clothing store, a newsstand, and
another distributor.’’ Id. at 3.
The Show Cause Order also alleged
that Respondent would not maintain
proper security of listed chemical
products at its new proposed location
because while its owner, Mr. Shaukat
Sayani, had represented that his
customers would place their orders ‘‘in
person’’ and that Respondent would
deliver the products by van, the DIs had
previously determined that Respondent
did not conduct business in this
‘‘manner at [its] Forest Park’’ location.
Id. The Show Cause Order further
alleged that Respondent ‘‘intended to
co-mingle listed chemical products with
2 The Order also alleged that in July 2005, DEA
DIs discovered that Respondent ‘‘was also selling
one-ounce bottles of liquid iodine to several
convenience stores,’’ another chemical used in the
illicit manufacture of methamphetamine. Show
Cause Order at 6. The Order further alleged that
‘‘[i]odine * * * has miniscule sales for use as an
antiseptic, even in pharmacies,’’ that ‘‘[t]he
likelihood of sales of iodine to customers in
convenience stores approaches zero,’’ and that
while Respondent ‘‘sold between 48 and as many
as 240 bottles of iodine to individual convenience
stores,’’ it ‘‘never reported these transactions * * *
as extraordinary sales or suspicious transactions.’’
Id.
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non-regulated products on the
warehouse floor,’’ that it ‘‘had no
procedure in place to detect theft or loss
at the warehouse,’’ that its ‘‘proposed
method of sales recordkeeping * * *
was inadequate to comply with 21 CFR
1310.06,’’ and that it had no means of
‘‘compar[ing] sales between its two
* * * locations in order to determine if
excessive or suspicious transactions
were being encountered.’’ Id. Relatedly,
the Show Cause Order alleged that
warehouse security at the Forest Park
location was inadequate. Id. at 5.
On September 13, 2005, Respondent
requested a hearing on the allegations of
the Order to Show Cause and Immediate
Suspension and moved to consolidate
the two proceedings. ALJ Ex. 7. While
the hearing on the original Show Cause
Order had been scheduled to begin on
September 20, 2005, Respondent’s
counsel sought a continuance to obtain
additional time to prepare. Accordingly,
the ALJ ordered that the original hearing
be cancelled. On December 14, 2005, the
ALJ conducted a pre-hearing conference
and set the hearing for March 21, 2006.
ALJ Decision (ALJ) at 2–3.
Thereafter, on February 27, 2006,
Respondent’s counsel filed an
emergency motion for a continuance.
The ALJ granted the motion and
subsequently rescheduled the hearing to
begin on August 15, 2006. Id. at 3.
A hearing was held on August 15
through 18, 2006, at which both parties
called witnesses to testify and submitted
documentary evidence. At the hearing,
Respondent also submitted a motion for
summary judgment. Id. (citing RX 26).
Following the hearing, both parties
submitted briefs containing their
proposed findings of fact, conclusions of
law, and argument.
On May 4, 2007, the ALJ ordered the
parties to file a joint status report
regarding Respondent’s Forest Park
registration. On June 11, 2007, the
parties filed the report; the report stated
that ‘‘it is the position of the agency and
Respondent that [it] currently has a
pending application for renewal of its
currently suspended registration.’’ Joint
Status Report at 2.
On August 17, 2007, the ALJ issued
her recommended decision. In her
decision, the ALJ concluded that
Respondent did not maintain effective
controls against diversion because it did
not ‘‘verify the legitimacy of its
customers,’’ sold ‘‘suspiciously high
quantities of iodine products to some
customers’’ even though its owner ‘‘was
repeatedly made aware of iodine’s role
as a methamphetamine precursor,’’ had
‘‘inadequate inventory procedures [and]
poor recordkeeping,’’ and failed ‘‘to
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report suspicious transactions.’’ Id. at
29–30.
The ALJ also concluded that
Respondent was not in compliance with
federal law because it ‘‘could not
account for large quantities of missing
bottles of product,’’ and ‘‘did not keep
adequate records’’ of its sales which
‘‘hindered [its] ability to ascertain
whether a customer had purchased an
amount above the regulated threshold.’’
Id. at 31. The ALJ further found that
‘‘Respondent has distributed large, case
quantities of pseudoephedrine and
ephedrine products,’’ as well as ‘‘large
amounts of 2% iodine,’’ and that ‘‘even
[its] witness concurred that some of [its]
sales were in excess of what would be
expected.’’ Id. at 32–33. Finally, the ALJ
noted that ‘‘[m]any of the ‘businesses’ to
which Respondent sold list I chemical
products operated within the * * *
non-traditional market for such
products,’’ that sales to the nontraditional market create an
‘‘unacceptable risk of diversion,’’ and
that ‘‘[s]ome of [Respondent’s
customers] did not even appear to be
tangentially related to the legitimate sale
of pseudoephedrine and ephedrine
products.’’ Id. at 34.
The ALJ did note that Respondent had
improved its security and had
‘‘conduct[ed] some investigations into
some of its customers’ business
identities.’’ Id. at 34. The ALJ
concluded, however, that Respondent’s
‘‘cooperation is dwarfed by the
significant risk of diversion posed [by
its] continued sales of listed chemical
products to [non-traditional] customers
without adequate sales records or
customer verification,’’ and that it ‘‘has
not provided sufficient evidence * * *
that its future conduct would change to
the degree necessary to eliminate the
threat to the public interest.’’ Id. at 35.
The ALJ further rejected Respondent’s
arguments that the Government was
denying it equal protection of the laws
under the Due Process Clause of the
Fifth Amendment. More specifically,
Respondent argued that it was being
held ‘‘ ‘to a different standard than [the
Government’s] published rules
dictate,’ ’’ id. (quoting Resp. Br. at 16),
that the Agency had not ‘‘put
Respondent on notice as to what
specific action would be a violation [of
its] rules and regulations,’’ id. (quoting
Resp. Br. at 17), and that ‘‘the agency
[was] ‘exercising uncontrolled
discretion.’ ’’ Id. (quoting Resp. Br. at
20).
Finally, the ALJ rejected Respondent’s
contention that it was entitled to
judgment as a matter of law because its
sales did not exceed the 1,000 gram
monthly threshold (which triggers
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various reporting and recordkeeping)
requirements. Id. at 37. Citing several
DEA decisions, the ALJ explained that
‘‘Respondent need not exceed the
Government’s threshold of allowed sales
in order to [be deemed to have] act[ed]
in a manner inconsistent with the
public interest.’’ Id. (citations omitted).3
While the ALJ did not make an
express finding that Respondent’s
continued registration is inconsistent
with the public interest, such a finding
is implicit in her recommended
sanction that Respondent’s registration
at its Forest Park location should be
revoked and its pending application for
a registration at its Decatur location
should be denied. ALJ at 38. Thereafter,
both parties filed exceptions to the ALJ’s
decision.
The Government’s exception noted
that while it concurred with the ALJ’s
recommendation, it was ‘‘not apparent
whether the ALJ actually made a finding
that Respondent’s continued registration
would not be in the public interest.’’
Gov. Exceptions at 1. The Government
thus requested that I ‘‘make a finding
that Respondent’s continued registration
and pending application for registration
are not in the public interest as that
term is used’’ in the applicable
provisions of the Controlled Substances
Act. Id.
The Government also took exception
to three of the ALJ’s factual findings
(FOFs 52, 57, 58), pertaining to the
testimony of the Government’s expert
on the expected sale range of listed
chemical products at convenience stores
and other non-traditional retailers of
these products. Id. at 2. More
specifically, the Government took
exception to the ALJ’s findings that
Respondent’s expert had credibly
testified that the Government’s expert
had made several ‘‘flawed assumptions’’
including ‘‘that everybody sells
everything in’’ the product category, and
that as a result, ‘‘the average
convenience store might sell $173.25 of
list I chemical products per month,’’
and that ‘‘this number [is] more credible
than the $82 value’’ given by the
Government’s expert.4 ALJ at 23–24;
Gov. Exceptions at 2.
Because ‘‘Respondent sold in excess
of both experts’ figures,’’ the
Government declined to ‘‘opine’’ as to
3 The ALJ also noted that there was no evidence
that supported Respondent’s contention that it is
being discriminated against because its owner ‘‘is
a legal alien who is attempting to operate a business
in this country in accordance with its laws.’’ ALJ
at 37 (quoting Res. Br. 24).
4 The ALJ noted, however, that ‘‘even using this
larger number * * *. Respondent repeatedly sold
list I chemical products in excess of $173.25 per
month.’’ ALJ at 24.
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whose expert’s sales figures were
‘‘exactly correct’’ or whether ‘‘there is a
more precise figure somewhere between
their numbers.’’ Gov. Exceptions at 2–3.
The Government nonetheless urged that
I not adopt the ALJ’s finding because
Respondent’s expert’s ‘‘analysis of this
case was not in detail, but quite
limited,’’ and the expert ‘‘did not
perform his own independent analysis
of the data, but only compared end data
from two different parts of [the
Government expert’s] report.’’ Id. at 3.
In its exceptions, Respondent also
noted that the ALJ had not made a
finding as to whether its continued
registration would be in the public
interest and argued that ‘‘no such ruling
would be appropriate in this matter.’’
Resp. Exceptions at 2. More specifically,
Respondent contends that it has
‘‘complied with every request that was
given to it by the DEA, repeatedly
requested of DEA what they wanted it
to do and was willing to do anything the
DEA wanted.’’ Id. at 3. It further
contends that the Show Cause Orders
were based on Respondent’s exceeding
sales levels, but that the Government’s
evidence on the expected sales was ‘‘not
credible,’’ and that therefore, the
Government has not carried its burden
of showing that its registration would be
inconsistent with the public interest. Id.
at 4.
Respondent also takes exception to
the ALJ’s finding that it has ‘‘inadequate
inventory procedures.’’ Id. at 4 (citing
ALJ at 30). More specifically,
Respondent contends that ‘‘there is no
requirement under any of the DEA rules
to have an inventory system, and [that
it] is once again being asked to comply
with something that is not in the DEA
rules.’’ Id. at 5. Respondent thus
contends that it is ‘‘being held to [a]
previously unspecified and unpublished
* * * guideline[ ],’’ and that in doing
so, the Agency is violating its
constitutional rights to due process and
equal protection. Id. at 5. Finally,
Respondent contends that the ALJ
‘‘ignore[d] the substantial remedial
actions that [it] had taken to correct
problems of which the DEA had notified
it.’’ Id.
Thereafter, the record was forwarded
to me for final agency action. Having
considered the record as a whole, as
well as the exceptions of both parties, I
adopt the ALJ findings of fact except as
expressly noted herein. I further
conclude that the Government has made
out a prima facie case that Respondent’s
registration would be inconsistent with
the public interest and that Respondent
has failed to present sufficient evidence
to establish that it will maintain
effective controls against diversion in
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the future. I also reject Respondent’s
constitutional claims and its motion for
judgment as a matter of law. I therefore
also adopt the ALJ’s recommended
sanction that Respondent’s Forest Park
registration be revoked and its
applications for renewal of the latter
registration and for a registration at its
Decatur location be denied. I make the
following findings.
Findings
Respondent is a corporation which
engages in the wholesale distribution of
assorted products to gas stations,
convenience stores, dollar stores, beauty
stores, and other establishments. Tr.
701. Respondent is owned by Mr. Sunny
Sayani, id., and operates two
warehouses which are located in Forest
Park and Decatur, Georgia. Id. at 702.
According to the record, Respondent
operates ‘‘a cash and carry’’ business in
which its customers come to the
warehouse to purchase the products
they need. RX 25a, Tr. 731.5
Respondent currently holds DEA
Certificate of Registration, # 004550SLY,
which authorizes it to distribute the list
I chemicals ephedrine and
pseudoephedrine out of its Forest Park
warehouse. Tr. 245; GX 1. While
Respondent’s registration expired on
February 28, 2005, it filed a renewal
application and paid the requisite fee at
some point in January 2005. See Joint
Status Report at 1–2. Accordingly,
Respondent has a registration, albeit one
that has been suspended, at its Forest
Park location.
Methamphetamine and the Market for
List I Chemicals
Both pseudoephedrine and ephedrine
have therapeutic uses and are lawfully
marketed as non-prescription (OTC)
drug products under the Federal Food,
Drug and Cosmetic Act. GX 15, at 3.
Pseudoephedrine is approved for
marketing as a decongestant; ephedrine
(in combination with guaifenesin) is
approved for marketing as a
bronchodilator.6 Id. at 4. Both
pseudoephedrine and ephedrine are,
however, regulated as list I chemicals
under the Controlled Substances Act
because they are precursor chemicals
that are easily extracted from OTC
products and used in the illicit
manufacture of methamphetamine, a
5 Respondent’s owner testified that it delivers, but
that the customer must ‘‘buy more than $1000’’ to
justify the expenses of paying for the driver,
gasoline and the truck. Tr. 731.
6 In July 2005, the Food and Drug Administration
issued a notice of proposed rulemaking which
proposes to remove combination ephedrine/
guaifenesin products from the OTC monograph on
the ground that these drugs are not safe and
effective for OTC use. 70 FR 40232 (2005).
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schedule II controlled substance. See 21
U.S.C. 802(34); 21 CFR 1308.12(d); GX
15, at 8 (noting that ‘‘the production of
methamphetamine from ephedrine or
pseudoephedrine can be accomplished
via a simple one step reaction and can
be accomplished with little or no
chemistry expertise’’).
Methamphetamine is a highly
addictive and abused central-nervous
system stimulant. GX 15, at 9.
Methamphetamine abuse has destroyed
numerous lives and families and
ravaged communities. Id.; see also
Rick’s Picks, L.L.C., 72 FR 18275, 18276
(2007). Moreover, because of the toxic
nature of the chemicals used to make
the drug, its illicit manufacture causes
serious environmental harms. Id.; GX
14, at 10.
A DEA Special Agent from the Atlanta
Field Division testified regarding the
rapid growth of illicit manufacturing of
methamphetamine during his tenure in
Atlanta. Tr. 29. According to the S/A’s
testimony, over ‘‘a short period of time’’
the number of meth. lab seizures by
DEA and local law enforcement had
‘‘multiplied by ten times.’’ Id. Other
evidence showed that between 1999 and
2004, the number of seizures in the
State of Georgia had increased from 34
to 229.7 See GXs 9 & 35.
The Special Agent, who had debriefed
over 200 individuals involved in the
illicit manufacture of
methamphetamine, Tr. 39, also testified
that convenience stores, gas stations,
and other small retailers were the
primary source of the ephedrine and
pseudoephedrine which was used by
‘‘mom-and-pop’’ meth. labs. Id. at 56 &
59. The Agent further testified that
meth. cooks use individuals known as
‘‘runners’’ who would travel to different
stores and purchase small amounts each
day to avoid detection. Id. at 62.
Moreover, runners generally avoided
larger retailers such as chain stores
because these establishments have ‘‘too
much security’’ and ‘‘too much video
surveillance,’’ id. at 56, and have ‘‘been
very militant on * * * limit[ing] sales’’
of the drugs. Id. at 102; see also id. at
100.
The S/A also testified that in some
instances, meth. cooks recruited
multiple persons to go to smaller stores
and buy the maximum amount of
product the store would sell them. Id. at
63. Moreover, in some instances, either
the owner or an employee of a smaller
7 Between 1999 and 2004, the States adjacent to
Georgia also experienced large increases in the
number of meth. lab seizures. In Alabama, the
number of seizures increased from 27 to 369; in
Tennessee, the number increased from 106 to 1251;
and in South Carolina, the number increased from
5 to 153. See GXs 9 & 35.
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store would sell a case quantity of a
listed chemical product to a person
affiliated with a lab. Id.
The Government also established that
the overwhelming majority of commerce
in non-prescription drug products
occurs in drug stores, supermarkets,
large discount merchandisers and
electronic shopping/mail order houses.
GX 25. According to the declaration of
Jonathan Robbin,8 who has testified in
numerous DEA and federal court
proceedings as an expert witness on the
market for list I chemical products
containing pseudoephedrine and
ephedrine, ‘‘over 97% of all sales of
non-prescription drug products occur in
drug stores and pharmacies,
supermarkets, large discount
merchandisers and electronic shopping
and mail order houses.’’ Id. at 4; see also
GX 24, at 3.9 According to Mr. Robbin,
these retailers ‘‘constitute the traditional
marketplace where [nonprescription
drugs for coughs, cold, nasal congestion,
and asthma] are purchased by ordinary
consumers.’’ GX 25, at 4.
Mr. Robbin has further concluded that
sales of non-prescription drugs at
convenience stores ‘‘account for only
2.2% of the overall sales of all
convenience stores that handle the
line.’’ Id. Moreover, only 4.87% of
convenience store shoppers purchase a
non-prescription drug product, GX 24,
at 5; and only 4.59% of these shoppers
purchase a pseudoephedrine
product.10 Id. at 4. Mr. Robbin thus
concluded that .21% of convenience
store shoppers purchased a
pseudoephedrine product. Id. at 5. In
another document, Mr. Robbin
explained that by extrapolating data
from the 1997 U.S. Economic Census
data and information obtained from
surveys of the National Association of
Convenience Stores, he had estimated
that during 2005, ‘‘[t]he expected
average monthly convenience store sales
of nonprescription drug products
containing pseudoephedrine (hcl) in
Georgia were * * * $82.’’ GX 26 at 2.11
Respondent called as an expert
witness, Dr. Danny N. Bellenger. Dr.
Bellenger holds a PhD in Business
Administration and is a Professor and
Marketing Research Fellow at the
Robinson College of Business at Georgia
State University. RX 31, at 2. Dr.
Bellenger previously served as chairman
of the Department of Marketing at
Robinson, and was the Dean of the
College of Business at Auburn
University. Id.
Dr. Bellenger disputed Mr. Robbin’s
figures for the expected monthly sales
range of pseudoephedrine at
convenience stores. Dr. Bellenger
testified that he did not agree with the
conclusions of Mr. Robbin’s reports and
that reports did not ‘‘agree with each
other.’’ Tr. 521. More specifically, Dr.
Bellenger noted that one of Mr. Robbin’s
reports stated that ‘‘two in 1,000 * * *
convenience store shoppers would be
expected to buy Sudafed,’’ but in
another report, Mr. Robbin had stated
‘‘that there’s 120,000 purchasers or
customers [who] come into a
convenience store.’’ Id. at 523; see also
GX 25, at 11 (stating that ‘‘[t]he average
annual number of shoppers in a
convenience store (excluding gasoline
purchases) is about 120,000’’).12
Dr. Bellenger explained that if two out
of a 1,000 customers purchased
pseudoephedrine and a convenience
store has 120,000 customers, at least 240
of these persons would buy the product
over the course of a year or ‘‘twenty per
month for an average convenience
store.’’ Tr. 523. Dr. Bellenger testified
that multiplying this number ‘‘times the
average retail price of * * * Sudafed’’
gives an ‘‘estimate of about $170 * * *
based on the numbers that are in the
reports.’’ Id.
Dr. Bellenger subsequently testified
that he determined the average price of
Sudafed by ‘‘looking at the wholesale
prices and assuming a markup,’’ and
that he ‘‘also looked in Kroger to see
what it cost, but [the price] would vary
a lot * * * by store.’’ Id. at 662–63.
However, Dr. Bellenger did not ‘‘recall
the actual figure’’ he used for the retail
price. Id. at 663. Nor did he explain
what source he used for the wholesale
price figure, or what price he used.
Dr. Bellenger also testified that he
confirmed his estimate by multiplying
the percentage of convenience store
shoppers who purchase
pseudoephedrine (.0027) times the
average annual merchandise sales of
convenience stores ($770,000). Dividing
this figure by twelve results in a
monthly sales figure of $173.25, which
is ‘‘a similar number’’ to the sales figure
obtained in the first method. Id. at
524.13
Dr. Bellenger further testified that Mr.
Robbin’s methodology was based on
several assumptions which he
contended ‘‘are not consistent with
reality.’’ Id. at 527. More specifically, he
contended that one of Mr. Robbin’s
assumptions was that ‘‘all retailers
[including] convenience stores carry a
full line of all’’ non-prescription
medicinal products that are reported in
the Economic Census’s merchandise
line, and that this is ‘‘not consistent
with the common practice’’ because ‘‘a
convenience store * * * carries a much
narrower line of most products.’’ Id. at
526; see also id. at 583, 664. According
to Dr. Bellenger, ‘‘when the
conveniences stores sell less than a full
line and the supermarkets and
drugstores sell the full line, * * * it
distorts the numbers,’’ by ‘‘caus[ing] the
estimate for Sudafed for the
convenience store to be lower than it
actually should be.’’ Id. at 664.14
While the ALJ credited Dr. Bellenger’s
testimony that the monthly expected
sales figure of pseudoephedrine
products at convenience stores was
$173.25, see ALJ at 24, I decline to
adopt this finding. While Dr. Bellenger’s
testimony that approximately 240
8 Mr. Robbin holds degrees from Harvard College
and Columbia University and is an expert in
multivariate statistical analysis and the processing
of economic census and population data. See GX
25, at 1–2. He also founded Claritas, Inc., a
company which is now the largest producer and
seller of census-based consumer marketing
information products, systems and services. Id. at
1.
9 According to this report, convenience stores
selling gasoline account for 1.75% of the nonprescription drug market; convenience stores that
do not sell gasoline account for .95% of the market.
GX 24, at 3. All other establishments combined
account for only .21%. Id.
10 While the text accompanying table 3 uses the
figure of 5.59% as the percentage of nonprescription drug buyers who purchase
pseudoephedrine at convenience stores, the
previous table makes clear that the actual percent
is 4.59%. Compare GX 24, at 5, with id. at 4.
11 Mr. Robbin noted that data from the 2002
Economic Census for Florida (a neighboring State)
indicated that the expected sales were 21% lower
than the data from the 1997 Economic Census
suggested. GX 26, at 1–2. Mr. Robbin thus stated
that ‘‘using the same factor as encountered in
Florida would produce an updated estimate of
$65.’’ Id. at 2.
12 With respect to the number of convenience
store shoppers who would purchase Sudafed, Dr.
Bellenger testified that ‘‘[t]he numbers which I’ve
computed actually says its 2.7 [out of 1,000], but
* * * that’s a relatively minor difference.’’ Tr. 523.
Dr. Bellenger testified that he used ‘‘the data that
was in [Mr. Robbin’s] report, and [did] exactly the
computations [Mr. Robbin] did * * * and came out
with * * * 2.7 customers in 1,000.’’ Id. at 581. In
his testimony, Dr. Bellenger did not specifically
identify which figures he used, and as explained
above, it appears that one of Mr. Robbins’ reports
contains a transcription error. See supra n. 10.
13 Notably, Dr. Bellenger used the figure which
appears to be based on a transcription error in one
of Mr. Robbin’s reports. If, however, the .0021 (or
2.1 shoppers out of 1,000) figure is used, see GX 24,
at 5; the average monthly sale is $134.75.
14 Dr. Bellenger also testified that one of Mr.
Robbin’s reports assumed that all stores were
‘‘expected to sell the same amount,’’ and that this
requires the assumption that the stores are ‘‘all the
same size’’ and ignores the stores’ locations. Tr.
529. As Dr. Bellenger further testified, ‘‘[i]f you’ve
got a very large store attached to a gasoline station
selling on the interstate, the mix of products is not
going to be the same as a small rural store.’’ Id. at
530. I note, however, that in one of the reports, Mr.
Robbin estimated a sales range which was based on
‘‘differences in sales occurring as a consequence of
store size, location, hours, advertising expenditures
and management practices.’’ GX 25, at 7. This
would appear to address Dr. Bellenger’s testimony
on this point.
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persons would purchase
pseudoephedrine at a convenience store
over the course of a year calls into
question the validity of the
Government’s figure, he did not
establish the source of the wholesale
price information (and the price) that he
relied upon or the amount of markup he
used. As for his testimony regarding
pricing at Kroger, he did not testify as
to what that price was, what size
package it was, and stated that the price
would vary a lot by store. Finally, while
Dr. Bellenger ‘‘confirmed’’ his estimate
by multiplying the percentage of
convenience store shoppers who
purchase pseudoephedrine by the
average store’s sales volume, this
methodology seems to require a major
assumption in its own right—that the
average amount spent by a customer in
purchasing pseudoephedrine is the
same as the average purchase of those
convenience store customers who buy
other products.
Accordingly, I conclude that neither
the Government’s nor Respondent’s
evidence reliably establishes the
monthly expected sales range.15 For
purposes of this case, I assume without
deciding that Dr. Bellenger’s figures are
accurate.
Dr. Bellenger also testified regarding
several other matters. With respect to
the size of a retailer’s purchases, Dr.
Bellenger testified that buying a case
quantity may be a legitimate business
decision ‘‘to invest in more inventory so
as to lower [its labor] cost of taking
inventory and processing order forms.’’
Tr. 549. According to Dr. Bellenger:
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The simple fact that someone, in * * *
their business model, decides to order in
large quantities is not necessarily suspicious
in and of itself. What would be suspicious to
me is if someone repeatedly ordered in large
quantities. So I would think that looking for
repeated large quantity orders by the same
store or a combination of products which go
into the production and ordering in large
quantities * * * of a group of products
which are involved in the manufacture of
some illicit substance would be important for
determining suspicious orders.
Id. at 549–50.
Amplifying this testimony, Dr.
Bellenger added that to purchase a case
quantity (144 bottles) is ‘‘one of two
things. It’s a conscious business
decision where a store owner has
decided it’s more efficient to order in
large quantities, put it in the stockroom,
and make fewer orders, and have less
labor involved.’’ Id. at 570. Dr. Bellenger
than allowed that ‘‘maybe there’s some
nefarious practice involved here,’’ but
15 Accordingly,
I agree with the Government’s
exception and decline to adopt the ALJ’s finding.
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that if this was so, ‘‘you would see
repeat purchases of large
quantities.’’ 16 Id. at 570–71.
The ALJ also credited Dr. Bellenger’s
testimony that in reviewing the various
exhibits, he noted that while ‘‘some of
[Respondent’s customers] were buying
by case lot,’’ he did not find a pattern
of the customers ‘‘buying [ten] 144s.’’
Tr. 571 (cited at ALJ at 25).
Respondent’s own evidence shows,
however, that there were multiple
instances in which Respondent sold
case quantities that suggest that the
sales were for an illicit purpose. See RX
12.
For example, during the year 2004,
Respondent sold cases (144 bottles) of
Max Brand Pseudo to the Coastal Food
Mart of Rockmart, Georgia, on eight
occasions: January 21, February 2,
March 4, April 19, June 3, July 14,
August 2, and September 5.17 Id. at 52,
82, 86, 91, 93, 97, 99. On crossexamination, Dr. Bellenger
acknowledged that the store was
‘‘probably * * * buying in excess of
what would be expected,’’ that ‘‘a case
over a six-month period is rational,’’ but
this store’s purchases ‘‘would raise [his]
suspicions.’’ Tr. 619–20. Moreover,
when asked whether this store’s retail
sales would be ‘‘many standard
distributions beyond’’ the $175 figure he
calculated for average monthly sales, Dr.
Bellenger answered: ‘‘Right.’’ Id. at 620.
Dr. Bellenger also acknowledged that it
would not be logical for a store to ‘‘order
additional inventory on a regular basis
unless they were selling it.’’ Id. at 642.
On re-direct, Dr. Bellenger opined that
‘‘it would be highly unlikely in the
normal course of business’’ for an entity
like Sunny Wholesale to detect these
transactions. Id. at 646. According to Dr.
Bellenger, ‘‘you’ve got to be looking real,
real, real close’’ to find these
transactions ‘‘given the scope of
[Respondent’s] business,’’ and the fact
that the product category was ‘‘less than
two percent of the total business and
these instances would account for a
fraction of that.’’ Id. at 647.
16 Dr. Bellenger added that he was not ‘‘sure how
much of this is stuff is required to make the illicit
drugs in question,’’ and that he was ‘‘not sure if 144
[bottles] will make enough to matter or not.’’ Id. at
571. The Government’s evidence showed, however,
that Georgia and the adjacent States had
experienced a proliferation in smaller
methamphetamine labs which typically produced a
quarter to a half ounce. Id. at 35. The evidence also
showed that ‘‘even unskilled persons can obtain a
50–70% yield of methamphetamine.’’ GX 15, at 8.
Contrary to Dr. Bellenger’s understanding, four
sixty-count bottles of 60 mg. pseudoephedrine
would provide enough material for even an
unskilled person to manufacture a quarter ounce of
the drug; 144 bottles would provide enough
material to make nine ounces.
17 Each case sold for $1006.56.
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The Coastal Food Mart was not,
however, the only store to which
Respondent repeatedly sold large
quantities of pseudoephedrine. During
the same year, it sold a case quantity to
Chitra Inc.’s Quick Stop of Rome,
Georgia, on eight separate dates: January
4, April 8, June 14, July 5, August 2,
August 20, September 14, and October
11. See RX 12, at 80, 91, 94, 95, 97, 98,
100, & 101. It sold a case to the Phillips
66 Mart of Hapeville on eight occasions:
January 5, February 5, March 22, April
1, May 5, June 3, August 17, and
September 12. See id. at 80, 84, 88, 89,
92, 93, 98 & 99.
It sold a case to the R & S Grocery of
Columbus on nine dates: January 21,
February 2, March 2, April 1, May 5,
June 21, July 7, August 30, and
September 29. See id. at 82, 86, 89, 92,
95, 96, 98, & 100. It sold a case to the
Stop In of Bremen on nine occasions:
January 5, February 3, March 2, April 1,
May 5, June 1, July 27, August 20, and
September 14. See id. at 52, 80, 83, 86,
89, 92, 93, 98, 100.
Moreover, the record shows that there
were instances in which Respondent
sold to two customers who used the
same address. For example, Respondent
sold case quantities to the P & K Mini
Mart, with an address of 461 Columbia
Drive, Carrollton, on January 6,
February 10, March 4, April 8, and May
5. See id. at 53, 81, 84, 86, 89. Yet it also
sold a case to a customer it listed as the
‘‘Quick Stop/Tushar/BP’’ with the same
461 Columbia Drive, Carrollton address,
on February 2, March 4, April 8,18 May
5, July 22, and August 1. See id. at 54,
83, 86, 91, 96, 97. Moreover,
Respondent sold a case to the DJ Food
Mart, with an address of 15582 HWY 27,
Trion, on January 6, February 10, March
4, April 8, May 5, and June 15. See id.
at 54, 81, 85, 87, 90, 94. It also sold a
case to a customer it listed as ‘‘BJ’s Food
Market # 1’’ with the address of 15582
HWY 27 North, Trion, on February 10,
March 4, April 8, May 5, June 4, July 27,
July 22, August 18, and September 5.
See id. at 54, 84, 87, 90, 93, 96, 98, 99.
Relatedly, Dr. Bellenger testified that
‘‘unusual orders become very
challenging if there’s a relatively small
number of * * * those orders * * *
given the large numbers of people [a
business is] dealing with.’’ Id. at 556.
Dr. Bellenger acknowledged, however,
that ‘‘you could create a computer
program which would create an
exceptions report.’’ Id. at 648. Dr.
Bellenger nonetheless maintained that it
would be difficult to track these
18 The record indicates that on this date,
Respondent sold 96 bottles for a total sale of
$671.04. RX 12, at 91.
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purchases and that finding a high
volume purchase ‘‘in the normal course
of business would be an accident.’’ Id.
at 647.
I reject Dr. Bellenger’s testimony
regarding the difficulty of detecting
excessive purchases. As noted below,
during an earlier meeting with DEA
investigators, Mr. Sayani stated that ‘‘a
typical sale’’ of listed] chemicals ‘‘was
two to three boxes,’’ with each ‘‘box
contain[ing] twelve bottles of 60-count
tablets.’’ Id. at 331. Notably, during this
meeting, the DI specifically told Mr.
Sayani that an order of ‘‘ten boxes [or
120 bottles] would be suspicious,’’ and
that if a customer ‘‘requested cases
quantities’’ or 144 bottles, ‘‘he was to
notify DEA.’’ Id. at 336.
Moreover, Respondent’s records show
that many of these customers were not
trying to hide the size of their purchases
by purchasing smaller quantities on
different dates. Rather, they were openly
ordering case quantities, see RX 12, at
79–101; and as found above, several of
these customers did so with disturbing
frequency. Finally, even crediting Dr.
Bellenger’s testimony that in some
instances, a convenience store owner
could make a legitimate business
decision to purchase a case quantity, it
does not require that much effort to call
up a customer’s account history to
determine how frequently the customer
was purchasing the products.
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Respondent’s History as a Registrant
In September 1999, Respondent
applied for a DEA registration to handle
list I chemicals at its Forest Park
warehouse. Tr. 703. Prior to being
granted the registration, DEA DIs
conducted a pre-registration inspection.
Id.; see also id. at 323. During the
inspection, a DI provided Mr. Sayani
with a copy of the DEA Chemical
Handler’s Manual and a document
which listed the thresholds for
pseudoephedrine and ephedrine (which
trigger additional reporting and
recordkeeping obligations). Id. at 726–
27. Moreover, Mr. Sayani told the DI
that ‘‘he would deliver [the listed
chemical products] to his customers.’’
Id. at 323.19 Shortly after the inspection,
Respondent obtained a registration for
this location.
On January 31, 2001, Respondent
applied for a registration to handle
pseudoephedrine, ephedrine, and
phenylpropanolamine, at its Decatur
warehouse. GX 2. Accordingly, on
March 31, 2001, DEA DIs went to
19 Mr. Sayani made the same representation
during the pre-registration investigation of
Respondent’s application for the Decatur location.
Tr. 323.
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Respondent’s Decatur facility to conduct
a pre-registration inspection. Tr. 246.
During the inspection, the DIs met with
Mr. Sayani and provided him with
another copy of the Chemical Handler’s
Manual, as well as notices stating that
drug products containing
phenylpropanolamine were being used
by drug traffickers to manufacture
amphetamine, GX 5, and combination
ephedrine and pseudoephedrine were
being used to by traffickers to
manufacture amphetamine and
methamphetamine. GX 6, Tr. 249. The
DIs also provided Mr. Sayani with
notices pertaining to recordkeeping and
reporting of theft and losses of listed
chemical products. Tr. 249.
The DI had previously requested that
Mr. Sayani provide her with lists of his
suppliers, the products he intended to
carry, and his proposed customers. Id.
246–47. On the list of suppliers and
products, Mr. Sayani indicated that he
intended to sell products distributed by
Compare Generics of Hauppauge, New
York, including Max Brand and Heads
Up, two brands of products which ‘‘are
notoriously popular [with]
methamphetamine traffickers.’’ 20 GX
34, at 11; GX 27.
During the inspection, the DIs
reviewed the Chemical Handler’s
Manual with Mr. Sayani, placing special
emphasis on its provisions pertinent to
record keeping, security, the need to
know his customers, and requiring proof
of identity from his customers. Tr. 321.
The DIs also discussed with Mr. Sayani
the listed chemical thresholds and the
requirement to report suspicious orders.
Id. Mr. Sayani again represented that the
listed chemical products ‘‘would be
delivered just like they were at his
Forest Park location.’’ Id. at 323. The DI
observed, however, that Respondent did
not ‘‘deliver most of the time’’ as ‘‘[t]he
majority of the time the customers were
coming’’ to the warehouse. Id. at 324.21
Based on Mr. Sayani’s list of proposed
customers, one of the DIs checked to see
if DEA’s computer system held
information regarding the customers. Id.
at 255. The DI also visited several of the
customers’ addresses to verify whether
there was a business at the location. Id.
Moreover, the DIs’ supervisor decided
that before sending the report on the
Decatur application to DEA
Headquarters, the DIs needed to inspect
Respondent’s practices at its Forest Park
warehouse because the location had
‘‘never been audited.’’ Id. at 370.
Accordingly, on June 30, 2001, several
DIs went to the Forest Park warehouse
and conducted an inspection. Id. at 255.
Upon their arrival, the DIs met with
Mr. Sayani and asked him to provide
them with an inventory and a list of the
listed chemical products Respondent
distributed. Id. at 256. One of the DIs
also asked him for a list of his customers
and suppliers and provided him with
another copy of the Chemical Handler’s
Manual and several DEA notices. Id.
During the inspection, the DIs observed
that Respondent’s list I products were
co-mingled with other products in the
warehouse and were not stored in a
secure area.22
The DIs then proceeded to conduct an
audit of Respondent’s handling of list I
products for the period January 1, 2001,
through the close of business on June
30, 2001. GX 31. The DIs selected eleven
non-traditional products to audit; with
the assistance of Mr. Sayani, they
counted the actual number on hand of
each of the selected products. Tr. 264 &
275; GX 30.23 Because Mr. Sayani did
not have a previous inventory of the
products,24 id. at 260, the DIs assigned
an opening value of zero for each of the
products. Id. at 377; GX 31. Assigning
an opening value of zero for a product
should result in an overage if, in fact,
there was any of the product on hand on
the beginning date of the audit and the
distributor is keeping (and provides)
complete records of its purchases and
distributions.25 Tr. 269 & 377.
To complete the audit, the DIs
requested that Mr. Sayani provide them
with his purchase invoices and sales
invoices. Id. at 266. The sales invoices
did not, however, clearly indicate the
package size (e.g., whether it was a six
count packet or 60 count bottle). Id. at
20 On its product list, Respondent also indicated
that he would be distributing four products from
BDI Marketing, Inc., another firm whose products
have been found at numerous illicit
methamphetamine labs. GX 4. However, according
to the DI, none of these products contained a list
I chemical. Tr. 250.
Respondent also listed three other suppliers; the
listed chemical products he listed under these
suppliers were nationally recognized brands such
as Tylenol, Advil, Nyquil, Contac, and Vicks 44.
See GX 27.
21 The DI also obtained information that
Respondent had a single employee who was ‘‘his
delivery guy.’’ Tr. 324. The position was vacant for
some unspecified period of time. Id. at 324–25.
22 At some point between 2002 and 2005,
Respondent built a cage at its Forest Park
warehouse in which it stored its list I chemical
products and installed several security cameras. RX
25a. The cage had a separate cash register and
window at which the products were paid for and
delivered to the customer. Id.
23 The DIs provided Mr. Sayani with a copy of the
count. Tr. 362.
24 At the hearing, a DI testified that DEA’s
regulations do not require that a list I chemical
distributor keep an inventory. Id. at 261.
25 Assigning an opening value of zero will also
result in an undercount of a shortage if any product
had actually been on hand on the opening date of
the audit.
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267. The DI therefore contacted Mr.
Sayani and requested additional
information. Id. at 266–67. While Mr.
Sayani then provided his sales tracking
reports, even these were sometimes
lacking the necessary information. Id. at
267.
The audit found that there were
shortages with respect to six of the
eleven products.26 See GX 31. Most
significantly, Respondent was short
7640 sixty-count bottles of Heads Up
and 3656 sixty-count bottles of Max
Brand. Id. Moreover, Respondent was
short 284 sixty-count bottles of Mini 2Way Action. Id. Respondent was also
short 180 six-count packets of Max
Brand, 154 six-count packets of Mini 2Way Action, and 262 packets of Max
Brand Pseudo (24-count). Id.
Regarding the audit, Mr. Sayani
testified that upon being served with the
Show Cause Order, which had alleged
that he was short approximately 10,000
bottles of Max Brand and Heads Up, he
checked his July 2001 inventory and
had 2069 bottles on hand and did not
‘‘know where this 10,000 figure came
from.’’ Tr. 715. Mr. Sayani further
testified that because 10,000 bottles is a
large amount, he ‘‘would know where
[it] is going.’’ Id. at 716.
The ALJ did not make ‘‘precise
findings’’ on the amount of the
shortages. ALJ Dec. 30 at n.6. I do.
Notably, Mr. Sayani’s testimony that
he had 2069 bottles on hand according
to his July 2001 inventory is consistent
with the total amount of product that he
and the DIs physically counted.27
Moreover, the DIs found that the largest
shortage was in the Heads Up 60-count
bottles, yet none of this product was on
hand when the physical count was on
hand. See GX 31. The audit of this
product was thus based entirely on
Respondent’s records of its purchases
and distributions; if the amount was
incorrect, Respondent could have
produced his records to show that.
Moreover, for each of the audited
products, the amount of the shortages
(11,296 60-count bottles of Max Brand
and Heads Up) was determined based
on the discrepancy between the amount
of these products which Respondent
26 As the DI explained, the audit was conducted
by adding Respondent’s purchases to the opening
inventory figure and comparing that figure with the
total of the ending inventory plus the amounts
which Respondent distributed to its customers. Tr.
268, GX 31.
27 Mr. Sayani did not state which products were
included in his 2069 figure. According to GX 31,
the physical count found 1584 Max Brand (60
count) bottles, 36 Mini 2-Way (48-count) and 428
(60-count) bottles, and 18 Mini Twins (60 count
bottles). These products would total 2066 bottles. I
further note the testimony that Mr. Sayani agreed
with the results of the inventory. Tr. 266.
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23:33 Oct 02, 2008
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obtained from his suppliers during the
audit period and the sum of the amount
it had on hand on June 30 and the
amount its sales records showed it had
distributed during the audit period. Mr.
Sayani’s assertion aside, he offered no
credible evidence that gives me reason
to reject the audit’s finding.
Accordingly, I adopt as findings, the
audit results as listed in GX 31.
As found above, during the visit, the
DIs also discussed with Mr. Sayani the
size of a normal monthly sale to a single
store of non-traditional products. Id. at
330. Mr. Sayani told the DIs that ‘‘[a]
typical sale was two to three boxes,’’
with each ‘‘box contain[ing] twelve
bottles of 60-count tablets.’’ Id. at 331.
As found above, however, Respondent
frequently sold listed chemical products
in far larger quantities and did so
notwithstanding that the DIs had
informed him that sales of case
quantities were suspicious and should
be reported to DEA. See RX 12; Tr. 336.
Following the inspection, several DIs
were assigned to conduct customer
verifications.28 ALJ at 15–17. The
verifications serve several purposes
including determining whether the
customer actually exists, the nature of
its business and whether it is legitimate,
and whether the customer has a
business relationship with the
distributor. Tr. 139, 145, 187, 202, 355–
56. As the ALJ found, the verifications
produced ‘‘mixed results.’’ ALJ at 15.
One DI, who was assigned twelve
verifications, found that several of the
businesses were convenience stores, gas
stations, and a liquor store. Tr. 142–45.
Moreover, upon visiting the addresses of
three of the customers, two of which
were listed as businesses (Pamela’s
Unique Clothing and Reliance
Wholesale Supply), and one which was
listed as an individual (M.S.), the DI
found that they were residences and
that there were no signs of businesses.
Tr. 142 & 144. The DI further found that
the R.S. Corporation was a Blimpie
restaurant, id. at 142, and that Artistic
Sales was a gift shop which did not sell
list I chemicals. Id. at 143.
Another DI testified that when she
and her partner went looking for
Ashley’s Boutique, they could neither
find the store nor the address that Mr.
Sayani had given for it. Id. at 202–03,
233. The DIs further found that the
Atlanta Cleaners Plus ‘‘was closed
down.’’ Id. at 203. While the DIs found
that the Matierra Mexicana #3 was a
28 According to the record, Mr. Sayani provided
two separate customer lists. One was a list which
Mr. Sayani represented as being his actual Forest
Park warehouse list I customers; the other was a list
of his potential list I customers for his Decatur
warehouse. Tr. 373–74.
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supermarket, the store did not purchase
items from Respondent. Id. at 203–04.
Moreover, one of the establishments was
a liquor and check cashing store. Id. at
204.
Another customer (BDI Inc.) was a
Shell gas station whose manager stated
that while he had purchased products
from Respondent nine months earlier,
he no longer did so. Id. at 205.
Moreover, the manager told the DIs that
Respondent ‘‘did not deliver’’ and that
‘‘he had to drive to [Respondent’s]
facility to pick up his products.’’ Id.
Finally, the DIs determined that another
customer (Golden Dealers) ‘‘was a house
that was located in a cul-de-sac’’ and
there was no store on the premises. Id.
at 206.
Following the customer verifications,
one of the DIs and her supervisor met
with Mr. Sayani and his attorney Henry
D. Frantz, Esq., to discuss their concerns
that some of Respondent’s customers
were not legitimate. Id. at 254. More
specifically, the DI told Mr. Sayani that
the DI had ‘‘found numerous suspect
customers that normally would not be
selling these type of products.’’ Id. at
372. The DI also expressed her concern
that some of Respondent’s customers
were engaged in wholesale distribution
out of their homes and were therefore
required to be registered under 21
U.S.C. § 823(h), but were not. Id. at 259.
Upon being informed by the DIs that
‘‘some of the customers were
suspicious,’’ Mr. Sayani stated that he
had ‘‘provided * * * a list of the
customers he thought * * * would
purchase from him, whether it was list
I chemicals or other products that he
handled.’’ Id. at 254. At the meeting, the
DIs also provided Mr. Sayani and his
attorney with a list of 147 customers
who they deemed suspicious and
instructed him to investigate them. Id. at
687.
Several weeks thereafter,
Respondent’s attorney wrote a letter to
the DIs reporting that 119 of the
customers owned either a convenience
store or grocery. RX 8, at 1.
Respondent’s attorney further reported
that 14 of the customers had ‘‘never
purchased a list I’’ product and that
three of them ‘‘have a DEA license.’’ Id.
As for the remaining suspicious
customers, the letter stated that
Respondent could not contact eight of
the customers and that three of them
were jobbers who had purchased small
amounts. Id.
Respondent’s attorney further wrote
that it ‘‘had tightened up * * * his
business with regard to checking out the
customer on all sales pertaining to list
I chemicals.’’ Id. More specifically, the
letter stated Respondent ‘‘currently asks
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for a tax identification number, business
license[,] as well as a DEA permit if the
customer does not have a store.’’ Id. at
2.29
At the hearing, Mr. Sayani testified
that he did not go to a new customer’s
store to verify whether it was legitimate
‘‘because at the time of opening the
account, we get enough proof from them
that they’re legitimate * * * or that
they’re who they say’’ they are. Tr. 768.
Mr. Sayani acknowledged, however,
that anyone who applied for a state or
local tax identification number would
be issued one. Id. at 769.
At the hearing, Mr. Sayani further
testified that upon being served with the
Show Cause Order, which referred to
Max Brand and Heads Up as nontraditional products, he stopped selling
the products. Id. at 714. As found above,
the first Show Cause Order was dated
October 20, 2004, and served on
Respondent no later than November 19,
2004, when his counsel requested a
hearing.
Contrary to Mr. Sayani’s testimony,
Respondent’s ‘‘Sales Tracking Report’’
indicates that it repeatedly sold Max
Brand after the first Show Cause Order
was served and frequently did so in
large quantities. Moreover, there is
evidence that it made multiple large
sales to several stores.
For example, on November 30, 2004,
it sold $504 of Max Brand 2–Way to the
Lucky Star of Brookfield, Georgia. RX
12, at 67. This was followed by two
December 12, 2004 sales, each totaling
$1509.84, to the Dixie Stop of Twion
and the Modern Kwik Shop of
Summerville, id. at 101, and a December
19, 2004 sale of $504 to Jay
Swaminarayan, Inc., of Tifton, Georgia.
Id. at 74. On February 13, 2005, it sold
an additional $861.12 of the products to
both the Dixie Stop and the Modern
Kwik Shop.30 Id. at 104.
On both November 29, 2004, and
January 3, 2005, it sold $1006.56 of the
products to ABJ Ashburn, Inc., of
Ashburn. Id. at 106 & 101. Respondent
made further sales of the products to
this store on January 27, February 17,
and February 25, when it sold $430.56
worth on each date, and on both March
20 and April 2, when it sold $861.12 of
the products to this store. Id. at 101–2,
105–6.
Moreover, on January 8, 2005, it sold
$861.12 of Max Brand pseudoephedrine
to Priya Nidhi, Inc., of Calhoun,
29 The letter also stated that Respondent would
‘‘cross-check * * * all customers purchasing list I
items between’’ its two warehouses, and that it was
maintaining ‘‘an updated inventory.’’ RX 8, at 2.
30 Respondent had also sold $1509.84 of the
products to the Modern Kwik Stop on November
14, 2004. RX 12, at 53.
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Georgia. Id. at 53. Notably, it has
previously sold this establishment
$1006.56 on October 15, 2004. Id. at 52.
On February 5, 2005, it made two
separate sales of the products (one
totaling $504, the other totaling $430.56)
to the West Gray BP of Gray, Georgia, id.
at 78 & 112; on February 18, 2005, it
sold $504 of the product to the Razk,
Inc., Marathon of Douglasville. Id. at 64.
And on February 20, 2005, it made two
separate sales (one worth $504, and one
worth $430.56 of the products) to
Krishna Corp. of Huntsville, Alabama.
Id. at 72 & 107.
On January 13, February 6, March 1,
and April 1, 2005, it sold $430.56 worth
of the products to the Texaco 10 Opelika
of Phenix City, Alabama; on January 13,
it also sold an additional $576 of the
products to this store. Id. at 102, 104–
06, 113. Moreover, on both February 20
and April 2, it sold $861.12 of the
products to USA Trading Inc., of
Pheonex (sic) City, Alabama. Id. at 102
& 104. It also sold $861.12 of the
products to Thakurs Fuel, Inc., of
Pinehurst, Georgia, on each of these
dates: February 25, March 20, and April
8, 2005. Id. at 103, 105 & 109.
The evidence further shows numerous
other instances in which Respondent
sold large quantities of Max Brand as
late as April 2005. Id. at 110–12. More
specifically, on April 3, 2005,
Respondent sold $861.12 of the product
to each of the following stores: Amin
Enterprises, Inc. of Lithonia, the Coastal
Food Mart of Rockmart, and the Hill
Top Gas Station of Bremen. Id. at 110–
11. Moreover, on April 6, it sold $861.12
worth of the products to Wendel’s JKF,
Inc., Discount Tobacco #2, and Discount
Tobacco; all three stores were located in
Americus, Georgia.31 Id. at 111. Finally,
between April 10 and 16, 2005, it sold
$504 worth of the products to eleven
establishments (the DM Cotton Patch of
Richland, DM Shopper Stop # 334 of
Cusetta, OM Traders #271, DM Shopper
Stops #s 442 and 451, all of Cataula;
KDC Inv. and RDSP, both of Columbus;
Hyaat Groceries of Covington; Jai
Bhrahmani, Inc., of Buchanan;
Gainesville BP of Gainesville; all in
Georgia, and Prem, Inc., of Alexander
City, Alabama. Id. at 111–12.
The ALJ specifically found—based on
Mr. Sayani’s testimony—that
‘‘Respondent stopped selling Heads Up
and Max Brand products because they
were identified as ‘non-traditional’
items by the DEA in the October 2004
Order to Show Cause.’’ ALJ at 21. To the
extent this finding implies that Mr.
31 The address of Discount Tobacco # 2 is listed
as 137 N. Lee St; the address of Discount Tobacco
is listed as 107 South Lee St. RX 12, at 111.
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Sayani stopped selling the products
shortly after service of the Order, it is
inconsistent with the evidence which
shows that for approximately five
months after the Order was served,
Respondent continued to sell these
products. Indeed, Mr. Sayani’s
testimony begs the question of why, if
the products were identified in the
Show Cause Order, it took five months
to stop selling them.
The Government also produced
evidence showing that Respondent had
distributed iodine tincture to several of
its customers. See GX 46, at 1, 2, 3, 15,
& 16. Moreover, Respondent’s evidence
shows that it distributed 2,852 (1 oz.)
units of this product to a single store
between June 8, 2003, and November 6,
2004. RX 16, at 5.
Regarding the allegation that
Respondent sold excessive quantities of
iodine to convenience stores, the
Government offered anecdotal evidence
in the form of a DI’s testimony that she
had visited more than 100 convenience
stores in both the course of her official
duties and as a consumer and had never
been able to find tincture of iodine. Tr.
396. But in contrast to the extensive
evidence the Government introduced
regarding the expected sales range of
pseudoephedrine and ephedrine at
convenience stores, it produced no such
evidence with respect to iodine tincture.
The Government also introduced into
evidence several documents indicating
that iodine was used in manufacturing
methamphetamine. The first of these
was a blue notice, which was reprinted
in the Chemical Handler’s Manual, a
copy of which was provided to Mr.
Sayani at both the pre-registration
inspection and the schedule regulatory
inspection. Tr. 307. The notice stated
that ‘‘iodine became a federally
regulated List II chemical on 10/3/96,’’
and that it was being provided to
‘‘[m]ake you aware that iodine is being
used to clandestinely produce
methamphetamine.’’ GX 36a.
The Government also introduced into
evidence an ‘‘Information Brief’’
published by the National Drug
Intelligence Center entitled: Iodine in
Methamphetamine Production. GX 36B;
Tr. 308. The document stated that
‘‘[s]mall-scale methamphetamine
producers who are unable to obtain
iodine crystals occasionally produce
them from iodine tincture by mixing
iodine tincture with hydrogen
peroxide.’’ GX 36B, at 2. This document
further explained that ‘‘[t]his is a timeconsuming process that yields a very
small amount of iodine crystals in
relation to the amount of tincture and
hydrogen peroxide use,’’ and also noted
that ‘‘[i]odine tincture is not regulated
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by law.’’ Id. Putting aside the statement
that iodine tincture was not regulated,
the Government produced no evidence
that this document was ever provided to
Mr. Sayani.
To counter the Government,
Respondent introduced a copy of a
Notice of Proposed Rulemaking (NPRM)
in which the Agency proposed ‘‘the
control of chemical mixtures containing
greater than 2.2 percent iodine.’’ DEA,
Changes in the Regulation of Iodine
Crystals and Chemical Mixtures
Containing Over 2.2 Percent Iodine, 71
FR 46144, 46145 (Aug. 11, 2006); RX 28.
The NPRM expressly stated that
‘‘[i]odine two percent tincture and
solution U.S.P. are sold at a wide variety
of retail outlets and have household
application as antiseptic and
antimicrobial products. These products
will not become regulated under the
proposed regulation.’’ 71 FR at 46146.
The NPRM further noted that ‘‘[w]hile
the regulatory controls placed on iodine
apply to iodine crystals, they have not
pertained to iodine tinctures (which are
considered chemical mixtures).’’ Id.
(emphasis added).
In discussing the rationale for the
proposed rule, the NPRM further
explained that because ‘‘seven percent
iodine tincture and solutions are the
predominant iodine-containing
chemical mixtures diverted by
traffickers * * * these chemical
mixtures should be subject to CSA
chemical regulatory controls.’’ Id. at
46149. The NPRM then noted that
‘‘[t]wo percent iodine tincture and
solutions are also diverted, but DEA has
not documented the frequent diversion
of these materials at clandestine
laboratories. Therefore, DEA does not
intend to regulate the two percent
iodine tincture or solution at this time.’’
Id.
Respondent also called as a witness a
sales representative for the company
which supplied him with iodine
tincture. The sales rep. testified that he
had sold Respondent iodine tincture
with an iodine concentration of only
one to two percent, Tr. 437–38, and
there is no evidence refuting this. See
RX 11a & b. The sales rep. further
testified that it was his understanding
that a DEA registration was not required
to sell these products, and that while he
had been selling the products for eight
to nine years, he had ‘‘no idea’’ that
iodine tincture was being diverted into
the illicit manufacture of
methamphetamine. Tr. 439 & 442.
Discussion
Section 304(a) of the Controlled
Substances Act provides that a
registration to distribute a list I chemical
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‘‘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.’’
21 U.S.C. 823(h). In making the public
interest determination, Congress
directed that the following factors be
considered:
(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 of 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.
Id. § 823(h).
‘‘These factors are considered in the
disjunctive.’’ Joy’s Ideas, 70 FR 33195,
33197 (2005). I may rely on any one or
a combination of factors, and may give
each factor the weight I deem
appropriate in determining whether a
registration should be revoked or an
application for a registration should be
denied. See, e.g., David M. Starr, 71 FR
39367, 39368 (2006); Energy Outlet, 64
FR 14269 (1999). Moreover, I am ‘‘not
required to make findings as to all of the
factors.’’ Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); Morall v. DEA, 412
F.3d 165, 173–74 (D.C. Cir. 2005).
While I reject the Government’s
allegations based on Respondent’s sales
of iodine tincture, I nonetheless
conclude that the evidence under
factors one, four, and five make out as
prima facie case that Respondent’s
continued registration would be
‘‘inconsistent with the public interest.’’
21 U.S.C. 823(h). Moreover, while I
acknowledge that Respondent has
improved its physical security, it has
otherwise failed to demonstrate that it
has adequate procedures in place to
protect the public from the diversion of
listed chemical products. Finally, I find
especially disturbing Respondent’s
conduct in continuing to sell large
quantities of listed chemical products
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even after the service of the initial Show
Cause Order.
Finally, I reject Respondent’s
argument that revoking his registration
would violate its constitutional right to
due process because it has not sold
listed chemicals ‘‘in excess of the
quantities authorized in the published
rules * * * of the DEA.’’ Resp. Prop.
Findings at 16. I also find unavailing his
claim—based on the ALJ’s finding that
his inventory procedures were
inadequate—that it ‘‘is once again being
asked to comply with something that is
not in the DEA rules,’’ and that this is
another violation of its right to due
process. Resp. Exceptions at 6.
Accordingly, Respondent’s Forest Park
registration will be revoked; its pending
renewal application for its Forest Park
facility and its application for a
registration at its Decatur facility will
also be denied.
Factor One—Maintenance of Effective
Controls Against Diversion
Under DEA precedent and
regulations, this factor encompasses a
variety of considerations and is not
limited to whether the registrant
maintains adequate physical security of
listed chemical products. ALJ at 29–30.
A DEA regulation requires the
consideration of the adequacy of a
registrant’s ‘‘systems for monitoring the
receipt, distribution, and disposition of
List I chemicals in its operations.’’ 21
CFR 1309.71(b)(8). Relatedly, a
registrant must exercise a high degree of
care in monitoring its customer’s
purchases. Rick’s Picks, 72 FR 18275,
18278 (2007), John J. Fotinopoulos, 72
FR 24602, 24605 (2007), D & S Sales, 71
FR 37607, 37610 (2006); Joy’s Ideas, 70
FR 33195, 33197–98 (2005).
It is undisputed that Respondent
upgraded its physical security by
building storage cages, installing video
cameras, and assigning a person to
distribute the products from the cage.
This, however, is only one part of a
registrant’s obligation to maintain
effective controls against diversion.
Here, the record shows that
Respondent’s procedures for verifying
the legitimacy of its listed chemical
customers were wholly inadequate to
prevent diversion. Moreover, those
procedures remain so. While following
the meeting in which agency
investigators notified Respondent of
their concerns regarding the legitimacy
of its customers, Respondent’s counsel
stated that it had ‘‘tightened up’’ its
procedures and was requiring that its
customers produce a tax identification
number and business license, RX 8, at
1–2 2, these documents can be easily
obtained by anyone. While Mr. Sayani
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testified that this provided ‘‘enough
proof’’ that his customers were
‘‘legitimate,’’ he did not have an
employee personally visit a new
customer to determine whether it was a
legitimate business with a need for
listed chemical products.
Moreover, Respondent generally
operated as a ‘‘cash and carry’’ business
and only delivered if a customer
ordered at least $ 1,000 worth of the
items and requested that it do so. Thus,
a customer could be obtaining listed
chemical products from multiple
sources and Respondent would have no
knowledge of this. See Holloway
Distributing, 72 FR 42118, 42124 (2007)
(noting a registrant’s obligation to
determine whether a customer is
receiving listed chemical products from
other suppliers).
As the results of the customer
verifications demonstrate, Respondent
was indifferent to its obligation to
determine whether a potential list I
customer had a legitimate need for the
products. Moreover, Mr. Sayani’s
testimony indicates that Respondent did
not change its practices. Indeed,
Respondent’s practices are
fundamentally inconsistent with its
obligations as a registrant, and are a
prescription for wide-spread diversion.
Id., see also D & S Sales, 71 FR at 37610.
Respondent’s unwillingness to reform
them provides reason alone to conclude
that it does not—and will not—maintain
effective controls against diversion and
that its registration would be
‘‘inconsistent with the public interest.’’
21 U.S.C. 823(h).
Buttressing this finding is the
evidence pertaining to the audit. As
found above, the audit, which covered
a six-month period, found that
Respondent had massive shortages of
several listed chemical products
including 7640 sixty-count bottles of
Head Up, 3656 sixty-count bottles of
Max Brand, and 284 sixty-count bottles
of Mini 2-Way Action.32 See GX 31. In
total, Respondent was short 11,580
sixty-count bottles of pseudoephedrine
and combination ephedrine products, or
nearly 695,000 dosage units. This was
so notwithstanding that the DIs used 0
as the opening inventory for each of the
products (the consequence of this is that
if any product had, in fact, been on
hand on the opening date of the audit,
the audit would result in an undercount
of the shortage), and that the time
period was of limited duration.
Based on the ALJ’s finding that its
‘‘lack of an inventory system, alone,
provides persuasive weight against
32 Respondent also had substantial shortages of
three other products. GX 31.
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Respondent’s continued registration,’’
ALJ at 30 n.6, Respondent argues that
‘‘there is no requirement under any of
the DEA rules to have an inventory
system, and [that it] is * * * being
asked to comply with something that is
not in the DEA rules.’’ Resp. Exceptions
at 6. Respondent contends that it is
‘‘being held to * * * unpublished DEA
guidelines,’’ and that this is ‘‘a violation
of due process * * * and equal
protection guarantees.’’ Id.
Respondent is correct that there is no
regulation which explicitly requires that
it maintain an inventory system.
However, in enacting section 303(h),
Congress made plain that in
determining the public interest, the
Attorney General was to consider the
applicant’s (and in a revocation/
suspension proceeding, the registrant’s)
‘‘maintenance * * * of effective
controls against diversion of listed
chemicals into other than legitimate
channels.’’ 21 U.S.C. 823(h).
Moreover, in 1995, DEA promulgated
21 CFR 1309.71(a), which directed that
‘‘[a]ll applicants and registrants shall
provide effective controls and
procedures to guard against theft and
diversion of List I chemicals.’’ This
regulation, which remains in effect,
further explained that ‘‘[i]n evaluating
the effectiveness of security controls
and procedures, the Administrator shall
consider * * * [t]he adequacy of the
registrant’s or applicant’s systems for
monitoring the receipt, distribution, and
disposition of List I chemicals in its
operations.’’ 21 CFR 1309.71(b)(8).
Federal law further requires that a
registrant report ‘‘any regulated
transaction involving an extraordinary
quantity of a listed chemical,’’ 21 U.S.C.
830(b)(1)(A), and a ‘‘regulated
transaction’’ is based on ‘‘the
quantitative threshold or the cumulative
amount for multiple transactions within
a calendar month.’’ 21 CFR 1310.04(f).
Federal law also requires a distributor to
report to this Agency ‘‘any unusual or
excessive loss or disappearance of a
listed chemical under the control of the
regulated person.’’ 21 U.S.C.
830(b)(1)(C). Accordingly, to satisfy 21
CFR 1309.71(b)(8), a registrant’s
recordkeeping must be sufficient so as
to enable it to comply with its reporting
obligations under Federal law.33 See
Fotinopoulos, 72 FR at 24605.
33 Typically, this requires no more than
maintaining the records that a registrant keeps in
the normal course of business. See, e.g. , DEA,
Implementation of the Domestic Chemical
Diversion Control Act of 1993, 60 FR 32447, 32451
(1995) (noting ‘‘that most of the information
required by the regulations is already maintained in
general business records for all transactions’’).
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Here, Respondent has no satisfactory
explanation as to the disposition of
approximately 11,580 sixty-count
bottles or 695,000 dosage units of listed
chemical products. Whether the
shortages are due to poor recordkeeping,
theft, or some other reason, the
magnitude of these shortages provides a
further reason to conclude that
Respondent does not maintain effective
controls against diversion and that its
continued registration would be
‘‘inconsistent with the public interest.’’
21 U.S.C. 823(h).
Factor Four—Respondent’s Past
Experience in Distributing Listed
Chemicals
Under this factor, the ALJ further
concluded that Respondent made
‘‘excessive sales of both list one
chemical products and iodine’’ that
‘‘pose a risk to the public interest.’’ ALJ
at 32. While the ALJ found the
testimony of Respondent’s expert ‘‘more
persuasive’’ than the Government’s
evidence on the expected sales level of
list I chemical products, as she further
explained, even the Respondent’s expert
witness ‘‘concurred that some of the
[sales of] Respondent’s List I chemical
products * * * were in excess of what
would be expected.’’ Id. at 33. While I
adopt the ALJ’s conclusions with
respect to list I chemicals, I reject them
with respect to iodine.
With respect to its distributions of
iodine, the ALJ found that ‘‘Respondent
has knowingly distributed large
amounts of 2% iodine, another
methamphetamine precursor.’’ ALJ at
32. In support of her conclusion, the
ALJ relied on the testimony of
Respondent’s expert that there were
‘‘five instances where the quantity [of
iodine] purchased might be suspiciously
high,’’ Tr. 571, as well as on Mr.
Sayani’s testimony that he was aware
that one of his customers was
purchasing hundreds of bottles but that
he thought the customer was
distributing to other small retailers. Id.
at 744; see also ALJ at 32.
The Government’s own evidence
establishes, however, that the 2% iodine
product which Respondent sold ‘‘is not
regulated by law,’’ GX 36B at 2, and the
NPRM which announced the Agency’s
intent to regulated iodine tinctures
containing more than 2.2 percent iodine
noted that 2% iodine tincture products
‘‘are sold at a wide variety of retail
outlets and have household application
as antiseptic and antimicrobial
products.’’ 71 FR 46146. The same
NPRM also explained that the ‘‘frequent
diversion’’ of two percent iodine
tincture at clandestine laboratories ‘‘has
not [been] documented.’’ Id. at 46149.
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Furthermore, DEA’s regulations
provide that two conditions must be met
for a chemical mixture to be exempted
from regulation. 21 CFR 1310.13(a).
First, ‘‘[t]he mixture [must be]
formulated in such a way that it cannot
be easily used in the illicit production
of a controlled substance.’’ Id.
§ 1310.13(a). Second, ‘‘[t]he listed
chemical or chemicals contained in the
chemical mixture cannot be readily
recovered.’’ Id. § 1310.13(b). Given the
criteria for exempting a chemical
mixture from regulation, neither the ALJ
nor the Government explained why
large sales of 2% iodine tincture are, by
themselves, enough to give rise to a
reasonable belief that the chemical
contained therein is likely to be
diverted.
Here, there is no evidence that
Respondent sold these products with
knowledge that they would be diverted
for use in the illicit manufacture of
methamphetamine, and in any event,
the Government’s allegation that
Respondent was selling excessive
amounts of iodine tincture is not
supported by substantial evidence. The
Government’s evidence is limited to the
testimony of a diversion investigator
that she had visited 100 convenience
stores and had never found iodine
tincture. Yet the Agency’s NPRM noted
that these products, which have several
legitimate uses, are sold at ‘‘a wide
variety of retail outlets.’’ 71 FR at 46146.
More importantly, even assuming that
the investigator was specifically looking
for iodine tincture at the convenience
stores she visited, the testimony
amounts to nothing more than anecdotal
evidence. As such, it does not
conclusively establish the extent to
which these products are sold at
convenience stores and the statistical
improbability that Respondent’s sales of
these products were to meet legitimate
demand. Indeed, the evidence stands in
contrast to the quantum of the evidence
the Government introduced regarding
the expected sales levels of list I
chemical products at convenience
stores.34 Accordingly, I conclude that
Respondent’s sales of iodine do not
support a finding that its continued
registration is inconsistent with the
public interest.
On the other hand, Respondent’s sales
of list I chemical products clearly were
excessive and support a finding that its
continued registration is inconsistent
with the public interest. Even assuming
that the monthly expected sales figure of
34 Because 2% iodine tincture is not regulated,
the Government’s allegation that it engaged in
regulated transactions which it failed to report as
suspicious transactions is also rejected.
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$173 for pseudoephedrine given by
Respondent’s expert is accurate, and
that some stores might make a legitimate
business decision to purchase a case
quantity to reduce their costs, the
evidence shows that Respondent
repeatedly sold case quantities to
multiple customers including the
Coastal Food Mart, Chitra Inc.’s Quick
Stop, the Phillips 66 Mart, the R & S
Grocery, and the Stop In.
The evidence also shows that
Respondent sold case quantities to two
customers which gave the same address.
For example, between January 6 and
August 1, 2004, Respondent sold a total
of eleven cases to the P & K Mini Mart
and the Quick Stop/Tushar/BP, both of
which used the same address. Moreover,
between January 6 and September 5,
2004, it sold a total of fifteen cases to
the DJ Food Mart and BJ Food Market
#1, which gave their respective
addresses as 15582 HWY 27 and 15582
HWY 27 North in Trion, Georgia.
With respect to the Coastal Food Mart,
which purchased eight cases between
January 21 and September 5, 2004, even
Respondent’s expert acknowledged that
this store’s purchases were many times
the expected norm. Tr. 619–20. And as
found above, several of Respondent’s
customers purchased even larger
amounts of list I chemical products than
did the Coastal Food Mart. As
Respondent’s expert allowed with
respect to those customers who were
repeatedly purchasing large quantities,
‘‘maybe there’s some nefarious practice
involved here’’ and the customers are
‘‘doing something that * * * they
shouldn’t be doing.’’ Id. 570.35
Respondent raises two arguments in
response to the allegations that it sold
excessive quantities of list I chemical
products. First, it argues that given the
nature and size of its business, it would
be ‘‘almost impossible to find’’ the
excessive sales. Resp. Prop. Findings at
15.
Second, it argues that is ‘‘has not sold
any restricted item in excess of the
quantities authorized in the published
rules and regulations * * * which show
the threshold quantities of restricted
items the wholesalers * * * are allowed
to sell without * * * putting their DEA
license at risk.’’ Id. at 16. Relatedly,
Respondent raises again a due process
argument that ‘‘[i]f the Government is
proceeding on any basis other than
35 As DEA has found in numerous other cases,
where there is a pattern of distributions which are
so large as to be statistically improbable to meet
legitimate demand, a finding that the products have
been diverted is warranted. See Holloway
Distributing, 72 FR at 42125; T. Young Associates,
Inc., 71 FR 60567, 60572 (2006); D & S Sales, 71
FR at 37611; Joy’s Ideas, 70 FR at 33198.
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Fmt 4703
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57665
Respondent having exceeded the sale
quantity thresholds which the
Government has specifically published
(such as ‘not in the public interest’),
then the Government is proceeding
under a rule or statute which is void for
vagueness as it does not put Respondent
on notice as to what specific action
would be violative of [its] rules and
regulations.’’ Id. at 17–18.
As for the argument that it would be
nearly impossible to detect excessive
purchases, Respondent’s expert
acknowledged that a computer program
could be written to detect such
purchases. Tr. 648. Nor would it require
more than minimal effort to call up a
customer’s account to determine the
frequency and amounts of its purchases
before selling additional amounts of the
products to it.
Also unavailing is Respondent’s
contention that because it did not sell
more than the threshold quantities, its
registration cannot be revoked. Contrary
to Respondent’s understanding, selling
under threshold amounts does not
relieve a registrant from its obligation to
taking necessary measures ‘‘to
determine the ultimate disposition of
[its] products.’’ Rick’s Picks, 72 FR at
18278. The thresholds simply trigger
additional recordkeeping and reporting
requirements. As I explained in Rick’s
Picks:
Congress’s imposition of recordkeeping
and reporting requirements for regulated
transactions does not mean that one can
engage in below-threshold transactions
without any further obligation to determine
whether the products are likely to be
diverted. Indeed, DEA has found that
products which have been distributed to nontraditional retailers in sub-threshold
transactions are routinely diverted. Contrary
to Respondent’s view, the threshold
provisions pertaining to regulated
transactions do not create a safe harbor
which allows a registrant to sell list I
chemicals without any further duty to
investigate how the products are being used.
Id. Cf. United States v. Kim, 449 F.3d
933, 944 (9th Cir. 2006) (‘‘[T]he
recording and reporting statutes
establish no safe harbor from
prosecution under [21 U.S.C.]
841(c)(2).’’). I therefore reject
Respondent’s contention (as raised in
both its Exceptions and Motion for
Judgment as a Matter of Law) that this
proceeding should be dismissed because
it did not sell in excess of the
thresholds.
Finally, there is no merit to
Respondent’s related contention that it
has been denied fair ‘‘notice as to what
specific action would be violative of
[DEA’s] rules and regulations.’’ Resp.
Prop. Findings at 18. Contrary to
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Respondent’s view, the standards,
which it was expected to conform to,
were identifiable ‘‘with ascertainable
certainty’’ by reviewing DEA’s public
pronouncements. Trinity Broadcasting,
Inc., v. FCC, 211 F.3d 618, 628 (D.C. Cir.
2000).
In section 304(a), Congress made clear
that a registration is subject to
revocation where a registrant ‘‘has
committed such acts as would render
his registration * * * inconsistent with
the public interest as determined
under’’ under section 303. 21 U.S.C.
824(a)(4). And in section 303(h),
Congress clearly provided that one of
the criteria for determining the public
interest is whether a registrant
maintains ‘‘effective controls against
diversion of listed chemicals into other
than legitimate channels.’’ Id.
§ 823(h)(1). The statute itself thus
provides fair warning to a registrant that
is must not sell to diverters.
Moreover, in several decisions which
pre-dated nearly all of the listed
chemical distributions discussed above,
this Agency made clear that selling in
quantities that greatly exceed legitimate
demand for these products supports a
finding of diversion and that such
conduct can be the basis for the
revocation of a registration. See, e.g.,
Branex, Inc., 69 FR 8682, 8690–94
(2004) 36 (revoking registration noting
that distributor’s sales of
pseudoephedrine to convenience stores
greatly exceeded the expected sales
range at such stores and supported a
finding that the pseudoephedrine was
likely diverted); MDI Pharmaceuticals,
68 FR 4233, 4238 (2003) (revoking
registration on ground that ‘‘firm
distributed large quantities of
pseudoephedrine tablets to smoke shops
and * * * convenience stores in
quantities that apparently exceeded
legitimate demand for these products’’);
Ace Wholesale & Trading Co., 67 FR
12574, 12576 (2002) (revoking
registration on grounds that registrant
‘‘was distributing large quantities of
pseudoephedrine to [a convenience
store] and other establishments that
appeared far in excess of legitimate
demand’’).37 In these decisions, all of
36 The Branex decision was published in the
Federal Register on February 25, 2004, before
Respondent made many of the case quantity
distributions.
37 In addition, in publications such as the
Chemical Handler’s Manual, DEA explained that
‘‘[i]t is fundamental for sound operations that
handlers take reasonable measures to identify their
customers, understand the normal and expected
transactions typically conducted by those
customers, and, consequently, identify those
transactions conducted by their customers that are
suspicious in nature.’’Chemical Handler’s Manual
15 (2002).
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23:33 Oct 02, 2008
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which were also published on the
Agency’s Web site as well as in the
Federal Register, DEA provided fair
warning that Respondent’s conduct in
selling large quantities of listed
chemicals could result in the revocation
of its registration.
Respondent’s argument rings hollow
for another reason. In the first Show
Cause Order, Respondent was put on
notice that ‘‘Max Brand products have
been found on numerous occasions in
situations related to the illicit
manufacture of methamphetamine,’’
Show Cause Order I, at 3; that the
monthly expected sales range of
pseudoephedrine products at
convenience stores in Georgia ‘‘averaged
between $15 and $60,’’ id. at 4; and that
its sales of listed chemical products
were ‘‘wildly inconsistent with the
expectation of sales’’ by convenience
stores. Id. at 5. Mr. Sayani even testified
under oath that at the ‘‘end of 2004,
starting of 2005,’’ and after receiving the
Show Cause Order, he had stopped
selling Max Brand products. Tr. 713.
Respondent’s records establish,
however, that it continued to sell the
products for months past the date when
Mr. Sayani claimed it had stopped; it
also shows numerous instances in
which Respondent sold half-case
quantities or larger for several months
thereafter.38 I thus reject Respondent’s
contention that it lacked fair warning
that its excessive sales could be grounds
for the revocation of its registration.
Accordingly, while Respondent was
authorized to distribute list I chemicals
for approximately six years, its
experience is characterized by its
frequent disregard of its obligation to
protect against the diversion of these
products. This conclusion provides an
additional basis, which is sufficient by
itself, to find that Respondent’s
The Chemical Handler’s Manual also sets forth
numerous criteria for recognizing suspicious
transactions including ‘‘resell[ing] to nontraditional outlets for regulated OTC products, e.g.,
hair salons, head shops, drug paraphernalia stores,
liquor stores, record stores, video shops, auto parts
stores,’’ and ‘‘resell[ing] large volumes into the
‘independent convenience store’ market.’’ Id. at 42.
The manual also listed as relevant criterion ‘‘[a]ny
customer who asks for large bottle sizes, 60 count
or higher,’’ or ‘‘buy[s] only the largest size
available.’’ Id.
38 Relatedly, Mr. Sayani told the DI during one of
the 2001 inspections that ‘‘a typical sale’’ would be
two to three boxes containing 12 bottles; in the
same conversation, the DI told Mr. Sayani that a
sale of a case quantity would be suspicious. Tr.
330–31. Many of Respondent’s sales were well in
excess of a typical sale. Respondent thus not only
ignored the DI’s instruction, it also ignored its own
understanding of the market. Moreover, at the
various visits, Respondent was provided with a
copy of several notices which explained that
pseudoephedrine and combination ephedrine were
being diverted into the illicit manufacture of
methamphetamine.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
continued registration is ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
823(h).
Factor Five—Such Other Factors as Are
Relevant to and Consistent With Public
Health and Safety
As found above, the illicit
manufacture and abuse of
methamphetamine have had pernicious
effects on families and communities
throughout the nation.39 Cutting off the
supply sources of methamphetamine
traffickers is of critical importance in
protecting the public from the
devastation wreaked by this drug.
While listed chemical products
containing both ephedrine and
pseudoephedrine have legitimate
medical uses, DEA orders have
established that convenience stores, gasstations, and other small retailers,
constitute the non-traditional retail
market for legitimate consumers of
products containing these chemicals.
See, e.g., Tri-County Bait Distributors,
71 FR 52160, 52161–62 (2006); D & S
Sales, 71 FR at 37609; Branex, Inc., 69
FR 8682, 8690–92 (2004). DEA has
further found that there is a substantial
risk of diversion of list I chemicals into
the illicit manufacture of
methamphetamine when these products
are sold by non-traditional retailers. See,
e.g., Joy’s Ideas, 70 FR at 33199 (finding
that the risk of diversion was ‘‘real’’ and
‘‘substantial’’); Jay Enterprises, Inc., 70
FR 24620, 24621 (2005) (noting
‘‘heightened risk of diversion’’ if
application to distribute to nontraditional retailers was granted). For
this reason, DEA has repeatedly revoked
the registrations and denied an
application for registration when a
registrant distributes (or an applicant
proposes to distribute) listed chemicals
to non-traditional retailers and other
evidence (such as excessive sales,
inadequate diversion controls, previous
violations/criminal convictions or a lack
of adequate experience) confirm that the
registrant/applicant is unlikely to
responsibly handle the products. See
Rick’s Picks, 72 FR at 18278–80; John J.
Fotinopoulos, 72 FR at 24605–07; TriCounty Bait Distributors, 71 FR at
52163–64; D & S Sales, 71 FR at 37610–
12; Joy’s Ideas, 70 FR at 33197–99;
Xtreme Enterprises, 67 FR 76195,
76197–98 (2002).
The record here likewise establishes a
substantial nexus between the sale of
non-traditional list I chemicals products
and the diversion of these products into
the illicit manufacture of
39 As found above, methamphetamine trafficking
has increased substantially in Georgia and the
adjacent States.
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Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
methamphetamine. According to the
testimony of a DEA Special Agent, who
had debriefed more than 200
individuals involved in the illicit
manufacture of methamphetamine,
convenience stores, gas stations and
other small retailers were the primary
and preferred source of
pseudoephedrine and ephedrine that
was used by smaller meth. labs. Tr. 56
& 59; see also TNT Distributors, 70 FR
12729, 12730 (2005) (noting Special
Agent’s testimony that ‘‘80 to 90 percent
of ephedrine and pseudoephedrine
being used [in Tennessee] to
manufacture methamphetamine was
being obtained from convenience
stores’’).
The record establishes that
Respondent’s list I customer base was
comprised primarily of the same type of
establishments. More specifically,
Respondent’s list I customers included
gas stations, convenience stores, dollar
stores, liquor stores, beauty stores, gift
shops, and some customers (such as
those located at private residences)
whose business was not even clear. As
the ALJ observed ‘‘[s]ome of these
businesses did not even appear to be
tangentially related to the legitimate sale
of pseudoephedrine and ephedrine
products.’’ ALJ at 34. As the ALJ further
noted, notwithstanding the substantial
risk of diversion present when
distributing to these establishments, as
well as the testimony that nontraditional retailers were the primary
supply source for illicit meth. cooks,
Respondent offered no evidence that it
‘‘would cease dealing with’’ these
establishments. Id.
Moreover, while Respondent disputed
the amount of monthly sales of
pseudoephedrine at convenience stores
to meet legitimate demand, it did not
challenge the Government’s evidence
that sales of non-prescription drugs
account for only a small percentage of
the total sales of convenience stores that
handle the products. Nor did it offer any
evidence to refute the Government’s
evidence that only a small number
(approximately two in one thousand) of
convenience store customers purchase a
pseudoephedrine product. And even
using the monthly expected sales figures
put forth by its expert, as found above,
Respondent repeatedly sold to multiple
non-traditional retailers quantities of list
I chemical products that greatly
exceeded legitimate demand for these
products.
Having concluded that the
Government made out its prima facie
case, the ALJ then turned to assessing
whether Respondent had produced
sufficient evidence that it would protect
the public interest from the diversion of
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23:33 Oct 02, 2008
Jkt 217001
the products. Id. at 34. As the ALJ
noted, Respondent did improve its
physical security. Id. The ALJ also noted
that Respondent had conducted ‘‘some
investigations into some of its
customer’s business identities.’’ Id. Yet
at the hearing, Mr. Sayani testified that
he did not go to a new customer’s store
to verify whether it was a legitimate
business and that a new customer’s
presentation of a tax identification
number and business license provided
sufficient proof of the customer’s bona
fides. Tr. 768–69. Mr. Sayani offered no
testimony that Respondent was willing
to change this practice.40
The ALJ nonetheless concluded that
Respondent ‘‘does demonstrate a
willingness to comply with DEA
directions’’ because it did not handle
list I chemical products at its Decatur
location while its application was
pending and at its Forest Park location
after that registration was suspended.
ALJ at 34–35. The ALJ also reasoned
that Respondent ‘‘stopped selling nontraditional listed chemical products in
2004, after the DEA served its first Order
to Show Cause.’’ Id. at 35.
Both the handling of a list I chemical
product at an unregistered location and
the distribution of a list I product out of
a location with a suspended registration
would, however, constitute felony
offenses under Federal law. See 21
U.S.C. 841(f)(1); id. § 843(a)(9); id.
§ 844(a). Even if Respondent’s
compliance with these provisions is
probative of its willingness to cooperate
(a debatable proposition given that its
non-compliance would expose it to
substantial criminal penalties), the
remaining basis for the ALJ’s conclusion
is not supported by the record.
As found above, Respondent
continued selling non-traditional
products—and made numerous large
quantity transactions—well into April
2005, approximately five to six months
after service of the first Show Cause
Order. Indeed, Mr. Sayani’s testimony
regarding when Respondent stopped
selling the products is clearly refuted by
the documentary evidence. The weight
of the evidence thus does not support
the ALJ’s conclusion that Respondent is
willing to comply with DEA’s direction.
In any event, notwithstanding her
finding, the ALJ concluded that
40 There was also evidence that on one occasion,
Respondent’s attorney reported an incident
involving an individual who, in attempting to
purchase products, admitted to Mr. Sayani that he
did not have a store, and then showed Mr. Sayani
a van full of products which he had purchased from
a competitor of Respondent. RX 29. While the letter
provided information regarding the practices of
Respondent’s competition, it did not report the
name of the individual or give the license plate
number (or a description) of the van. See id.
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57667
Respondent’s ‘‘cooperation is dwarfed
by the significant risk of diversion
posed to the public by * * *
Respondent’s continued sales of listed
chemical products to [non-traditional
retailers] without adequate sales records
or customer verification.’’ ALJ at 35.
While Respondent contends that the
ALJ ‘‘ignore[d] the substantial remedial
actions that [it] had taken to correct
[the] problems of which’’ it was
notified, Resp. Exceptions at 6, the ALJ
considered them and properly
concluded that they only partially
addressed the problems identified by
the Agency. See ALJ at 35 (noting that
Respondent has ‘‘not provided sufficient
evidence to convince [the Agency] that
its future conduct would change to the
degree necessary to eliminate the threat
to the public interest’’).
In short, Respondent offered no
evidence of its willingness to change its
practices for determining whether its
customers are legitimate. It offered no
evidence that it has in place systems to
accurately account for the products it
handles and to properly identify those
customers who are purchasing excessive
quantities.
Likewise, it has offered no credible
evidence that it is willing to change its
practices to limit its sales of these
products. Its claim that it stopped
selling the products shortly after service
of the first Show Cause Order, is
contradicted by the documentary
evidence. Moreover, its argument that
the thresholds establish the ‘‘quantities
of restricted items the wholesalers
* * * are allowed to sell without * * *
putting their DEA license at risk, [and]
are what both the Government and the
public are bound to abide by,’’ Resp.
Prop. Findings at 16—a theme which is
repeated throughout its brief—makes
plain its view that it can continue to sell
up to the thresholds with no obligation
to limit its distributions to those
establishments at which there is only
limited consumer demand for these
products for their lawful use. Because
this view is fundamentally inconsistent
with a distributor’s obligation under the
CSA, I conclude that Respondent’s
registration ‘‘is inconsistent with the
public interest.’’ 21 U.S.C. 823(h).41
41 Respondent also contends that ‘‘the
Government had no reasonable justification in
summarily proceeding to seize his products and
summarily revoke his license without affording him
a due process right to a hearing.’’ Id. at 20.
Respondent ignores, however, that section 304(d) of
the CSA expressly authorizes the suspension of
‘‘any registration simultaneously with the
institution of proceedings under this section, in
cases where he finds that there is an imminent
danger to the public health and safety.’’ 21 U.S.C.
824(d).
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Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(h) & 824(a), as well as
28 CFR 0.100(b) & 0.104, I order that
DEA Certificate of Registration,
040450SLY, issued to Sunny Wholesale,
Inc., 120 Forest Parkway, Forest Park,
Georgia, be, and it hereby is, revoked,
and that its application to renew this
registration be, and it hereby is, denied.
I further order that Sunny Wholesale,
Inc.’s, application for a DEA Certificate
Registration at 2935 N. Decatur Road,
Suite C, Decatur, Georgia, be, and it
hereby is, denied. These orders are
effective November 3, 2008.
Dated: September 26, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–23395 Filed 10–2–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Office of the Secretary
Submission for OMB Review:
Comment Request
September 26, 2008.
mstockstill on PROD1PC66 with NOTICES
The Department of Labor (DOL)
hereby announces the submission of the
following public information collection
request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. chapter 35).
A copy of this ICR, with applicable
supporting documentation; including
among other things a description of the
likely respondents, proposed frequency
Respondent does not argue that the statute is
unconstitutional. Nor could it, as the Supreme
Court has repeatedly upheld the use of postdeprivation process in emergency situations. See,
e.g., Gilbert v. Homar, 520 U.S. 924 (1997).
Moreover, in this case, the evidence of
Respondent’s continued large sales of listed
chemical products, even after being served with the
first Show Cause Order, supports the finding that
Respondent’s continued registration during the
pendency of the proceeding posed an imminent
danger to public health and safety. Respondent
could also have sought review of the suspension in
a ‘‘court of competent jurisdiction.’’ 21 U.S.C.
824(d).
Finally, Respondent asserts that ‘‘the effect of the
DEA’s arbitrary actions [in its] case [is] to
discriminate against him because he is a legal
alien’’ in violation of his right to equal protection
of the laws. Resp. Prop. Findings at 25. Respondent
does not, however, contend that the Agency is
intentionally discriminating against its owner, see
Hernandez v. New York, 500 U.S. 352, 359–60
(1991), a requirement for stating a claim under the
Equal Protection Clause, and in any event, it has
produced no evidence to support its claim.
Respondent is just one of many list I chemical
distributors whose registrations have been revoked
for committing acts inconsistent with the public
interest.
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23:33 Oct 02, 2008
Jkt 217001
of response, and estimated total burden
may be obtained from the RegInfo.gov
Web site at https://www.reginfo.gov/
public/do/PRAMain or by contacting
Amy Hobby on 202–693–4553 (this is
not a toll-free number)/email:
DOL_PRA_PUBLIC@dol.gov.
Interested parties are encouraged to
send comments to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for the
Employment Standards Administration
(ESA), Office of Management and
Budget, Room 10235, Washington, DC
20503, Telephone: 202–395–7316 / Fax:
202–395–6974 (these are not toll-free
numbers), E-mail:
OIRA_submission@omb.eop.gov within
30 days from the date of this publication
in the Federal Register. In order to
ensure the appropriate consideration,
comments should reference the OMB
Control Number (see below).
The OMB is particularly interested in
comments which:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Agency: Employment Standards
Administration.
Type of Review: Extension without
change of an existing OMB Control
Number.
Title of Collection: Requirements of a
Bona Fide Thrift or Savings Plan (29
CFR Part 547) and Requirements of a
Bona Fide Profit-Sharing Plan or Trust
(29 CFR Part 549).
OMB Control Number: 1215–0119.
Affected Public: Businesses or other
for-profits, Farms, Not-for-profit
institutions.
Total Estimated Number of
Respondents: 844,000.
Total Estimated Annual Burden
Hours: 352.
Total Estimated Annual Costs Burden:
$0.
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Frm 00081
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Sfmt 4703
Description: This information
collection applies to employers claiming
the overtime exemption available under
section 7(e)(3)(b) of the Fair Labor
Standards Act. Specifically, in
calculating an employee’s regular rate of
pay, an employer need not include
contributions made to a bona fide thrift
or savings plan or a bona fide profitsharing plan or trust—as defined in 29
CFR Parts 547 and 549. Employers are
required to communicate, or make
available to the employees, the terms of
the bona fide thrift or savings plan and
bona fide profit-sharing plan or trust,
and retain certain records. For
additional information, see related
notice published at 73 FR 39725 on July
10, 2008.
Darrin A. King,
Departmental Clearance Officer.
[FR Doc. E8–23101 Filed 10–2–08; 8:45 am]
BILLING CODE 4510–27–P
DEPARTMENT OF LABOR
Employment and Training
Administration
[TA–W–62,583; TA–W–62,583A]
PeopLoungers, Inc., Nettleton, MS, and
PeopLoungers, Inc., Mantachie, MS;
Amended Certification Regarding
Eligibility To Apply for Worker
Adjustment Assistance and Alternative
Trade Adjustment Assistance
In accordance with Section 223 of the
Trade Act of 1974 (19 U.S.C. 2273), and
Section 246 of the Trade Act of 1974 (26
U.S.C. 2813), as amended, the
Department of Labor issued a
Certification of Eligibility to Apply for
Worker Adjustment Assistance and
Alternative Trade Adjustment
Assistance on April 2, 2008, applicable
to workers of PeopLoungers, Inc.,
Nettleton, Mississippi. The notice was
published in the Federal Register on
April 17, 2008 (73 FR 20954).
At the request of a company official,
the Department reviewed the
certification for workers of the subject
firm. The workers are engaged in the
production of furniture.
New information provided by the
company official shows that after the
worker group was certified eligible to
apply for adjustment assistance, the
subject firm relocated remaining
workers and production from Nettleton,
Mississippi to Mantachie, Mississippi.
Based on this finding, the Department
is amending the certification to include
workers separated from the Mantachie,
Mississippi location of PeopLoungers,
Inc.
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Agencies
[Federal Register Volume 73, Number 193 (Friday, October 3, 2008)]
[Notices]
[Pages 57655-57668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23395]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket Nos. 05-13 and 05-45]
Sunny Wholesale, Inc.; Revocation of Registration and Denial of
Application
On August 24, 2005, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Sunny Wholesale, Inc. (Respondent), of
Forest Park, Georgia. ALJ Ex. 6. The Order immediately suspended
Respondent's DEA Certificate of Registration, No. 004550SLY, which
authorizes it to distribute the list I chemicals ephedrine and
pseudoephedrine, on the ground that it was selling ``excessive
amounts'' of these chemicals to convenience stores, id. at 6, which are
the ``primary source'' for the diversion of these chemicals into the
illicit manufacture of methamphetamine, a schedule II controlled
substance.\1\ Id. at 4.
---------------------------------------------------------------------------
\1\ On October 20, 2004, the Deputy Assistant Administrator
issued the initial Order to Show Cause to Respondent; the Order
proposed the revocation of its registration at its Forest Park
location and the denial of its pending application for a
registration at its Decatur, Georgia location. ALJ Ex. 1. Each of
the allegations of the initial Show Cause Order was repeated
verbatim in the subsequent Order to Show Cause and Immediate
Suspension of Registration. On November 19, 2004, Respondent,
through its counsel, requested a hearing on the allegations of the
first Show Cause Order. ALJ Ex. 2.
---------------------------------------------------------------------------
More specifically, the Show Cause Order alleged that in July 2005,
DEA Diversion Investigators (DIs) learned that records seized from
various north Georgia convenience stores which were ``suspected of
illegally distributing listed chemical precursors,'' had ``indicated
that [Respondent] had been distributing 60 count bottles of'' Max Brand
pseudoephedrine, a product which has been repeatedly found at illicit
methamphetamine labs ``in full case and double case lots.'' Id. at 6.
The Show Cause Order alleged that ``law enforcement officials [in
Tennessee and Georgia] have observed that an overwhelming proportion of
precursors found at illicit methamphetamine sites has involved non-
traditional brands sold through convenience stores,'' id. at 4, that
DEA had retained an expert in retail marketing and statistics who had
concluded that sales of pseudoephedrine products at convenience stores
in Tennessee and Georgia ``averaged between $15.00 and $60.00 per
month'' per store and that sales of combination ephedrine products were
even lower, Id. at 5, and that ``[c]onvenience store purchases of case
quantities of high count/high strength pseudoephedrine products [are]
consistent with diversion of the products into the illicit manufacture
of methamphetamine.'' Id. at 6. The Show Cause Order further alleged
that Respondent had continued selling large amounts of pseudoephedrine
``to convenience stores and gas stations,'' notwithstanding that it had
been ``put on notice of the potential illegal character of its
activities with the issuance of the original Order to Show Cause''
which was served in October 2004. Id. ``[B]ecause of the substantial
likelihood that [Respondent would] continue to divert listed chemical
products,'' I thus concluded that Respondent's ``continued
registration, during the pendency of these proceedings, would
constitute an immediate danger to the public health and safety.'' Id.
at 7.\2\
---------------------------------------------------------------------------
\2\ The Order also alleged that in July 2005, DEA DIs discovered
that Respondent ``was also selling one-ounce bottles of liquid
iodine to several convenience stores,'' another chemical used in the
illicit manufacture of methamphetamine. Show Cause Order at 6. The
Order further alleged that ``[i]odine * * * has miniscule sales for
use as an antiseptic, even in pharmacies,'' that ``[t]he likelihood
of sales of iodine to customers in convenience stores approaches
zero,'' and that while Respondent ``sold between 48 and as many as
240 bottles of iodine to individual convenience stores,'' it ``never
reported these transactions * * * as extraordinary sales or
suspicious transactions.'' Id.
---------------------------------------------------------------------------
In addition to the above, the Show Cause Order alleged that during
a July 2001 inspection, DEA DIs audited Respondent's handling of listed
chemical products and determined that it had ``various overages and
shortages, including an unexplained shortage of approximately 10,000
bottles of Max Brand, and (another non-traditional brand) Heads Up 60
count bottles.'' Id. at 5. The Show Cause Order alleged that while
inventorying Respondent's listed chemical products, it had ``no
traditional brand * * * products but only `grey market' brands of
pseudoephedrine and combination ephedrine products'' which are not sold
at drug stores or supermarkets, but ``are typically only sold in
locations where goods of these types are not expected to be sold, such
as liquor stores, head shops, gas stations, and other small retail
stores.'' Id.
The Show Cause Order further alleged that following the inspection,
DEA DIs conducted verifications of Respondent's customers; the DIs
allegedly found that some of the locations were ``non-existent,'' some
were residences, and others included such establishments as ``liquor
stores, gift shops, a Blimpie restaurant * * * and a magazine store.''
Id. Relatedly, the Order alleged that in seeking a registration for its
Decatur location, Respondent provided a list of its proposed list I
chemical customers which included ``liquor stores, a lotto store, a
clothing store, a newsstand, and another distributor.'' Id. at 3.
The Show Cause Order also alleged that Respondent would not
maintain proper security of listed chemical products at its new
proposed location because while its owner, Mr. Shaukat Sayani, had
represented that his customers would place their orders ``in person''
and that Respondent would deliver the products by van, the DIs had
previously determined that Respondent did not conduct business in this
``manner at [its] Forest Park'' location. Id. The Show Cause Order
further alleged that Respondent ``intended to co-mingle listed chemical
products with
[[Page 57656]]
non-regulated products on the warehouse floor,'' that it ``had no
procedure in place to detect theft or loss at the warehouse,'' that its
``proposed method of sales recordkeeping * * * was inadequate to comply
with 21 CFR 1310.06,'' and that it had no means of ``compar[ing] sales
between its two * * * locations in order to determine if excessive or
suspicious transactions were being encountered.'' Id. Relatedly, the
Show Cause Order alleged that warehouse security at the Forest Park
location was inadequate. Id. at 5.
On September 13, 2005, Respondent requested a hearing on the
allegations of the Order to Show Cause and Immediate Suspension and
moved to consolidate the two proceedings. ALJ Ex. 7. While the hearing
on the original Show Cause Order had been scheduled to begin on
September 20, 2005, Respondent's counsel sought a continuance to obtain
additional time to prepare. Accordingly, the ALJ ordered that the
original hearing be cancelled. On December 14, 2005, the ALJ conducted
a pre-hearing conference and set the hearing for March 21, 2006. ALJ
Decision (ALJ) at 2-3.
Thereafter, on February 27, 2006, Respondent's counsel filed an
emergency motion for a continuance. The ALJ granted the motion and
subsequently rescheduled the hearing to begin on August 15, 2006. Id.
at 3.
A hearing was held on August 15 through 18, 2006, at which both
parties called witnesses to testify and submitted documentary evidence.
At the hearing, Respondent also submitted a motion for summary
judgment. Id. (citing RX 26). Following the hearing, both parties
submitted briefs containing their proposed findings of fact,
conclusions of law, and argument.
On May 4, 2007, the ALJ ordered the parties to file a joint status
report regarding Respondent's Forest Park registration. On June 11,
2007, the parties filed the report; the report stated that ``it is the
position of the agency and Respondent that [it] currently has a pending
application for renewal of its currently suspended registration.''
Joint Status Report at 2.
On August 17, 2007, the ALJ issued her recommended decision. In her
decision, the ALJ concluded that Respondent did not maintain effective
controls against diversion because it did not ``verify the legitimacy
of its customers,'' sold ``suspiciously high quantities of iodine
products to some customers'' even though its owner ``was repeatedly
made aware of iodine's role as a methamphetamine precursor,'' had
``inadequate inventory procedures [and] poor recordkeeping,'' and
failed ``to report suspicious transactions.'' Id. at 29-30.
The ALJ also concluded that Respondent was not in compliance with
federal law because it ``could not account for large quantities of
missing bottles of product,'' and ``did not keep adequate records'' of
its sales which ``hindered [its] ability to ascertain whether a
customer had purchased an amount above the regulated threshold.'' Id.
at 31. The ALJ further found that ``Respondent has distributed large,
case quantities of pseudoephedrine and ephedrine products,'' as well as
``large amounts of 2% iodine,'' and that ``even [its] witness concurred
that some of [its] sales were in excess of what would be expected.''
Id. at 32-33. Finally, the ALJ noted that ``[m]any of the `businesses'
to which Respondent sold list I chemical products operated within the *
* * non-traditional market for such products,'' that sales to the non-
traditional market create an ``unacceptable risk of diversion,'' and
that ``[s]ome of [Respondent's customers] did not even appear to be
tangentially related to the legitimate sale of pseudoephedrine and
ephedrine products.'' Id. at 34.
The ALJ did note that Respondent had improved its security and had
``conduct[ed] some investigations into some of its customers' business
identities.'' Id. at 34. The ALJ concluded, however, that Respondent's
``cooperation is dwarfed by the significant risk of diversion posed [by
its] continued sales of listed chemical products to [non-traditional]
customers without adequate sales records or customer verification,''
and that it ``has not provided sufficient evidence * * * that its
future conduct would change to the degree necessary to eliminate the
threat to the public interest.'' Id. at 35.
The ALJ further rejected Respondent's arguments that the Government
was denying it equal protection of the laws under the Due Process
Clause of the Fifth Amendment. More specifically, Respondent argued
that it was being held `` `to a different standard than [the
Government's] published rules dictate,' '' id. (quoting Resp. Br. at
16), that the Agency had not ``put Respondent on notice as to what
specific action would be a violation [of its] rules and regulations,''
id. (quoting Resp. Br. at 17), and that ``the agency [was] `exercising
uncontrolled discretion.' '' Id. (quoting Resp. Br. at 20).
Finally, the ALJ rejected Respondent's contention that it was
entitled to judgment as a matter of law because its sales did not
exceed the 1,000 gram monthly threshold (which triggers various
reporting and recordkeeping) requirements. Id. at 37. Citing several
DEA decisions, the ALJ explained that ``Respondent need not exceed the
Government's threshold of allowed sales in order to [be deemed to have]
act[ed] in a manner inconsistent with the public interest.'' Id.
(citations omitted).\3\
---------------------------------------------------------------------------
\3\ The ALJ also noted that there was no evidence that supported
Respondent's contention that it is being discriminated against
because its owner ``is a legal alien who is attempting to operate a
business in this country in accordance with its laws.'' ALJ at 37
(quoting Res. Br. 24).
---------------------------------------------------------------------------
While the ALJ did not make an express finding that Respondent's
continued registration is inconsistent with the public interest, such a
finding is implicit in her recommended sanction that Respondent's
registration at its Forest Park location should be revoked and its
pending application for a registration at its Decatur location should
be denied. ALJ at 38. Thereafter, both parties filed exceptions to the
ALJ's decision.
The Government's exception noted that while it concurred with the
ALJ's recommendation, it was ``not apparent whether the ALJ actually
made a finding that Respondent's continued registration would not be in
the public interest.'' Gov. Exceptions at 1. The Government thus
requested that I ``make a finding that Respondent's continued
registration and pending application for registration are not in the
public interest as that term is used'' in the applicable provisions of
the Controlled Substances Act. Id.
The Government also took exception to three of the ALJ's factual
findings (FOFs 52, 57, 58), pertaining to the testimony of the
Government's expert on the expected sale range of listed chemical
products at convenience stores and other non-traditional retailers of
these products. Id. at 2. More specifically, the Government took
exception to the ALJ's findings that Respondent's expert had credibly
testified that the Government's expert had made several ``flawed
assumptions'' including ``that everybody sells everything in'' the
product category, and that as a result, ``the average convenience store
might sell $173.25 of list I chemical products per month,'' and that
``this number [is] more credible than the $82 value'' given by the
Government's expert.\4\ ALJ at 23-24; Gov. Exceptions at 2.
---------------------------------------------------------------------------
\4\ The ALJ noted, however, that ``even using this larger number
* * *. Respondent repeatedly sold list I chemical products in excess
of $173.25 per month.'' ALJ at 24.
---------------------------------------------------------------------------
Because ``Respondent sold in excess of both experts' figures,'' the
Government declined to ``opine'' as to
[[Page 57657]]
whose expert's sales figures were ``exactly correct'' or whether
``there is a more precise figure somewhere between their numbers.''
Gov. Exceptions at 2-3. The Government nonetheless urged that I not
adopt the ALJ's finding because Respondent's expert's ``analysis of
this case was not in detail, but quite limited,'' and the expert ``did
not perform his own independent analysis of the data, but only compared
end data from two different parts of [the Government expert's]
report.'' Id. at 3.
In its exceptions, Respondent also noted that the ALJ had not made
a finding as to whether its continued registration would be in the
public interest and argued that ``no such ruling would be appropriate
in this matter.'' Resp. Exceptions at 2. More specifically, Respondent
contends that it has ``complied with every request that was given to it
by the DEA, repeatedly requested of DEA what they wanted it to do and
was willing to do anything the DEA wanted.'' Id. at 3. It further
contends that the Show Cause Orders were based on Respondent's
exceeding sales levels, but that the Government's evidence on the
expected sales was ``not credible,'' and that therefore, the Government
has not carried its burden of showing that its registration would be
inconsistent with the public interest. Id. at 4.
Respondent also takes exception to the ALJ's finding that it has
``inadequate inventory procedures.'' Id. at 4 (citing ALJ at 30). More
specifically, Respondent contends that ``there is no requirement under
any of the DEA rules to have an inventory system, and [that it] is once
again being asked to comply with something that is not in the DEA
rules.'' Id. at 5. Respondent thus contends that it is ``being held to
[a] previously unspecified and unpublished * * * guideline[ ],'' and
that in doing so, the Agency is violating its constitutional rights to
due process and equal protection. Id. at 5. Finally, Respondent
contends that the ALJ ``ignore[d] the substantial remedial actions that
[it] had taken to correct problems of which the DEA had notified it.''
Id.
Thereafter, the record was forwarded to me for final agency action.
Having considered the record as a whole, as well as the exceptions of
both parties, I adopt the ALJ findings of fact except as expressly
noted herein. I further conclude that the Government has made out a
prima facie case that Respondent's registration would be inconsistent
with the public interest and that Respondent has failed to present
sufficient evidence to establish that it will maintain effective
controls against diversion in the future. I also reject Respondent's
constitutional claims and its motion for judgment as a matter of law. I
therefore also adopt the ALJ's recommended sanction that Respondent's
Forest Park registration be revoked and its applications for renewal of
the latter registration and for a registration at its Decatur location
be denied. I make the following findings.
Findings
Respondent is a corporation which engages in the wholesale
distribution of assorted products to gas stations, convenience stores,
dollar stores, beauty stores, and other establishments. Tr. 701.
Respondent is owned by Mr. Sunny Sayani, id., and operates two
warehouses which are located in Forest Park and Decatur, Georgia. Id.
at 702. According to the record, Respondent operates ``a cash and
carry'' business in which its customers come to the warehouse to
purchase the products they need. RX 25a, Tr. 731.\5\
---------------------------------------------------------------------------
\5\ Respondent's owner testified that it delivers, but that the
customer must ``buy more than $1000'' to justify the expenses of
paying for the driver, gasoline and the truck. Tr. 731.
---------------------------------------------------------------------------
Respondent currently holds DEA Certificate of Registration,
004550SLY, which authorizes it to distribute the list I
chemicals ephedrine and pseudoephedrine out of its Forest Park
warehouse. Tr. 245; GX 1. While Respondent's registration expired on
February 28, 2005, it filed a renewal application and paid the
requisite fee at some point in January 2005. See Joint Status Report at
1-2. Accordingly, Respondent has a registration, albeit one that has
been suspended, at its Forest Park location.
Methamphetamine and the Market for List I Chemicals
Both pseudoephedrine and ephedrine have therapeutic uses and are
lawfully marketed as non-prescription (OTC) drug products under the
Federal Food, Drug and Cosmetic Act. GX 15, at 3. Pseudoephedrine is
approved for marketing as a decongestant; ephedrine (in combination
with guaifenesin) is approved for marketing as a bronchodilator.\6\ Id.
at 4. Both pseudoephedrine and ephedrine are, however, regulated as
list I chemicals under the Controlled Substances Act because they are
precursor chemicals that are easily extracted from OTC products and
used in the illicit manufacture of methamphetamine, a schedule II
controlled substance. See 21 U.S.C. 802(34); 21 CFR 1308.12(d); GX 15,
at 8 (noting that ``the production of methamphetamine from ephedrine or
pseudoephedrine can be accomplished via a simple one step reaction and
can be accomplished with little or no chemistry expertise'').
---------------------------------------------------------------------------
\6\ In July 2005, the Food and Drug Administration issued a
notice of proposed rulemaking which proposes to remove combination
ephedrine/guaifenesin products from the OTC monograph on the ground
that these drugs are not safe and effective for OTC use. 70 FR 40232
(2005).
---------------------------------------------------------------------------
Methamphetamine is a highly addictive and abused central-nervous
system stimulant. GX 15, at 9. Methamphetamine abuse has destroyed
numerous lives and families and ravaged communities. Id.; see also
Rick's Picks, L.L.C., 72 FR 18275, 18276 (2007). Moreover, because of
the toxic nature of the chemicals used to make the drug, its illicit
manufacture causes serious environmental harms. Id.; GX 14, at 10.
A DEA Special Agent from the Atlanta Field Division testified
regarding the rapid growth of illicit manufacturing of methamphetamine
during his tenure in Atlanta. Tr. 29. According to the S/A's testimony,
over ``a short period of time'' the number of meth. lab seizures by DEA
and local law enforcement had ``multiplied by ten times.'' Id. Other
evidence showed that between 1999 and 2004, the number of seizures in
the State of Georgia had increased from 34 to 229.\7\ See GXs 9 & 35.
---------------------------------------------------------------------------
\7\ Between 1999 and 2004, the States adjacent to Georgia also
experienced large increases in the number of meth. lab seizures. In
Alabama, the number of seizures increased from 27 to 369; in
Tennessee, the number increased from 106 to 1251; and in South
Carolina, the number increased from 5 to 153. See GXs 9 & 35.
---------------------------------------------------------------------------
The Special Agent, who had debriefed over 200 individuals involved
in the illicit manufacture of methamphetamine, Tr. 39, also testified
that convenience stores, gas stations, and other small retailers were
the primary source of the ephedrine and pseudoephedrine which was used
by ``mom-and-pop'' meth. labs. Id. at 56 & 59. The Agent further
testified that meth. cooks use individuals known as ``runners'' who
would travel to different stores and purchase small amounts each day to
avoid detection. Id. at 62. Moreover, runners generally avoided larger
retailers such as chain stores because these establishments have ``too
much security'' and ``too much video surveillance,'' id. at 56, and
have ``been very militant on * * * limit[ing] sales'' of the drugs. Id.
at 102; see also id. at 100.
The S/A also testified that in some instances, meth. cooks
recruited multiple persons to go to smaller stores and buy the maximum
amount of product the store would sell them. Id. at 63. Moreover, in
some instances, either the owner or an employee of a smaller
[[Page 57658]]
store would sell a case quantity of a listed chemical product to a
person affiliated with a lab. Id.
The Government also established that the overwhelming majority of
commerce in non-prescription drug products occurs in drug stores,
supermarkets, large discount merchandisers and electronic shopping/mail
order houses. GX 25. According to the declaration of Jonathan
Robbin,\8\ who has testified in numerous DEA and federal court
proceedings as an expert witness on the market for list I chemical
products containing pseudoephedrine and ephedrine, ``over 97% of all
sales of non-prescription drug products occur in drug stores and
pharmacies, supermarkets, large discount merchandisers and electronic
shopping and mail order houses.'' Id. at 4; see also GX 24, at 3.\9\
According to Mr. Robbin, these retailers ``constitute the traditional
marketplace where [nonprescription drugs for coughs, cold, nasal
congestion, and asthma] are purchased by ordinary consumers.'' GX 25,
at 4.
---------------------------------------------------------------------------
\8\ Mr. Robbin holds degrees from Harvard College and Columbia
University and is an expert in multivariate statistical analysis and
the processing of economic census and population data. See GX 25, at
1-2. He also founded Claritas, Inc., a company which is now the
largest producer and seller of census-based consumer marketing
information products, systems and services. Id. at 1.
\9\ According to this report, convenience stores selling
gasoline account for 1.75% of the non-prescription drug market;
convenience stores that do not sell gasoline account for .95% of the
market. GX 24, at 3. All other establishments combined account for
only .21%. Id.
---------------------------------------------------------------------------
Mr. Robbin has further concluded that sales of non-prescription
drugs at convenience stores ``account for only 2.2% of the overall
sales of all convenience stores that handle the line.'' Id. Moreover,
only 4.87% of convenience store shoppers purchase a non-prescription
drug product, GX 24, at 5; and only 4.59% of these shoppers purchase a
pseudoephedrine product.\10\ Id. at 4. Mr. Robbin thus concluded that
.21% of convenience store shoppers purchased a pseudoephedrine product.
Id. at 5. In another document, Mr. Robbin explained that by
extrapolating data from the 1997 U.S. Economic Census data and
information obtained from surveys of the National Association of
Convenience Stores, he had estimated that during 2005, ``[t]he expected
average monthly convenience store sales of nonprescription drug
products containing pseudoephedrine (hcl) in Georgia were * * * $82.''
GX 26 at 2.\11\
---------------------------------------------------------------------------
\10\ While the text accompanying table 3 uses the figure of
5.59% as the percentage of non-prescription drug buyers who purchase
pseudoephedrine at convenience stores, the previous table makes
clear that the actual percent is 4.59%. Compare GX 24, at 5, with
id. at 4.
\11\ Mr. Robbin noted that data from the 2002 Economic Census
for Florida (a neighboring State) indicated that the expected sales
were 21% lower than the data from the 1997 Economic Census
suggested. GX 26, at 1-2. Mr. Robbin thus stated that ``using the
same factor as encountered in Florida would produce an updated
estimate of $65.'' Id. at 2.
---------------------------------------------------------------------------
Respondent called as an expert witness, Dr. Danny N. Bellenger. Dr.
Bellenger holds a PhD in Business Administration and is a Professor and
Marketing Research Fellow at the Robinson College of Business at
Georgia State University. RX 31, at 2. Dr. Bellenger previously served
as chairman of the Department of Marketing at Robinson, and was the
Dean of the College of Business at Auburn University. Id.
Dr. Bellenger disputed Mr. Robbin's figures for the expected
monthly sales range of pseudoephedrine at convenience stores. Dr.
Bellenger testified that he did not agree with the conclusions of Mr.
Robbin's reports and that reports did not ``agree with each other.''
Tr. 521. More specifically, Dr. Bellenger noted that one of Mr.
Robbin's reports stated that ``two in 1,000 * * * convenience store
shoppers would be expected to buy Sudafed,'' but in another report, Mr.
Robbin had stated ``that there's 120,000 purchasers or customers [who]
come into a convenience store.'' Id. at 523; see also GX 25, at 11
(stating that ``[t]he average annual number of shoppers in a
convenience store (excluding gasoline purchases) is about
120,000'').\12\
---------------------------------------------------------------------------
\12\ With respect to the number of convenience store shoppers
who would purchase Sudafed, Dr. Bellenger testified that ``[t]he
numbers which I've computed actually says its 2.7 [out of 1,000],
but * * * that's a relatively minor difference.'' Tr. 523. Dr.
Bellenger testified that he used ``the data that was in [Mr.
Robbin's] report, and [did] exactly the computations [Mr. Robbin]
did * * * and came out with * * * 2.7 customers in 1,000.'' Id. at
581. In his testimony, Dr. Bellenger did not specifically identify
which figures he used, and as explained above, it appears that one
of Mr. Robbins' reports contains a transcription error. See supra n.
10.
---------------------------------------------------------------------------
Dr. Bellenger explained that if two out of a 1,000 customers
purchased pseudoephedrine and a convenience store has 120,000
customers, at least 240 of these persons would buy the product over the
course of a year or ``twenty per month for an average convenience
store.'' Tr. 523. Dr. Bellenger testified that multiplying this number
``times the average retail price of * * * Sudafed'' gives an ``estimate
of about $170 * * * based on the numbers that are in the reports.'' Id.
Dr. Bellenger subsequently testified that he determined the average
price of Sudafed by ``looking at the wholesale prices and assuming a
markup,'' and that he ``also looked in Kroger to see what it cost, but
[the price] would vary a lot * * * by store.'' Id. at 662-63. However,
Dr. Bellenger did not ``recall the actual figure'' he used for the
retail price. Id. at 663. Nor did he explain what source he used for
the wholesale price figure, or what price he used.
Dr. Bellenger also testified that he confirmed his estimate by
multiplying the percentage of convenience store shoppers who purchase
pseudoephedrine (.0027) times the average annual merchandise sales of
convenience stores ($770,000). Dividing this figure by twelve results
in a monthly sales figure of $173.25, which is ``a similar number'' to
the sales figure obtained in the first method. Id. at 524.\13\
---------------------------------------------------------------------------
\13\ Notably, Dr. Bellenger used the figure which appears to be
based on a transcription error in one of Mr. Robbin's reports. If,
however, the .0021 (or 2.1 shoppers out of 1,000) figure is used,
see GX 24, at 5; the average monthly sale is $134.75.
---------------------------------------------------------------------------
Dr. Bellenger further testified that Mr. Robbin's methodology was
based on several assumptions which he contended ``are not consistent
with reality.'' Id. at 527. More specifically, he contended that one of
Mr. Robbin's assumptions was that ``all retailers [including]
convenience stores carry a full line of all'' non-prescription
medicinal products that are reported in the Economic Census's
merchandise line, and that this is ``not consistent with the common
practice'' because ``a convenience store * * * carries a much narrower
line of most products.'' Id. at 526; see also id. at 583, 664.
According to Dr. Bellenger, ``when the conveniences stores sell less
than a full line and the supermarkets and drugstores sell the full
line, * * * it distorts the numbers,'' by ``caus[ing] the estimate for
Sudafed for the convenience store to be lower than it actually should
be.'' Id. at 664.\14\
---------------------------------------------------------------------------
\14\ Dr. Bellenger also testified that one of Mr. Robbin's
reports assumed that all stores were ``expected to sell the same
amount,'' and that this requires the assumption that the stores are
``all the same size'' and ignores the stores' locations. Tr. 529. As
Dr. Bellenger further testified, ``[i]f you've got a very large
store attached to a gasoline station selling on the interstate, the
mix of products is not going to be the same as a small rural
store.'' Id. at 530. I note, however, that in one of the reports,
Mr. Robbin estimated a sales range which was based on ``differences
in sales occurring as a consequence of store size, location, hours,
advertising expenditures and management practices.'' GX 25, at 7.
This would appear to address Dr. Bellenger's testimony on this
point.
---------------------------------------------------------------------------
While the ALJ credited Dr. Bellenger's testimony that the monthly
expected sales figure of pseudoephedrine products at convenience stores
was $173.25, see ALJ at 24, I decline to adopt this finding. While Dr.
Bellenger's testimony that approximately 240
[[Page 57659]]
persons would purchase pseudoephedrine at a convenience store over the
course of a year calls into question the validity of the Government's
figure, he did not establish the source of the wholesale price
information (and the price) that he relied upon or the amount of markup
he used. As for his testimony regarding pricing at Kroger, he did not
testify as to what that price was, what size package it was, and stated
that the price would vary a lot by store. Finally, while Dr. Bellenger
``confirmed'' his estimate by multiplying the percentage of convenience
store shoppers who purchase pseudoephedrine by the average store's
sales volume, this methodology seems to require a major assumption in
its own right--that the average amount spent by a customer in
purchasing pseudoephedrine is the same as the average purchase of those
convenience store customers who buy other products.
Accordingly, I conclude that neither the Government's nor
Respondent's evidence reliably establishes the monthly expected sales
range.\15\ For purposes of this case, I assume without deciding that
Dr. Bellenger's figures are accurate.
---------------------------------------------------------------------------
\15\ Accordingly, I agree with the Government's exception and
decline to adopt the ALJ's finding.
---------------------------------------------------------------------------
Dr. Bellenger also testified regarding several other matters. With
respect to the size of a retailer's purchases, Dr. Bellenger testified
that buying a case quantity may be a legitimate business decision ``to
invest in more inventory so as to lower [its labor] cost of taking
inventory and processing order forms.'' Tr. 549. According to Dr.
Bellenger:
The simple fact that someone, in * * * their business model,
decides to order in large quantities is not necessarily suspicious
in and of itself. What would be suspicious to me is if someone
repeatedly ordered in large quantities. So I would think that
looking for repeated large quantity orders by the same store or a
combination of products which go into the production and ordering in
large quantities * * * of a group of products which are involved in
the manufacture of some illicit substance would be important for
determining suspicious orders.
Id. at 549-50.
Amplifying this testimony, Dr. Bellenger added that to purchase a
case quantity (144 bottles) is ``one of two things. It's a conscious
business decision where a store owner has decided it's more efficient
to order in large quantities, put it in the stockroom, and make fewer
orders, and have less labor involved.'' Id. at 570. Dr. Bellenger than
allowed that ``maybe there's some nefarious practice involved here,''
but that if this was so, ``you would see repeat purchases of large
quantities.'' \16\ Id. at 570-71.
---------------------------------------------------------------------------
\16\ Dr. Bellenger added that he was not ``sure how much of this
is stuff is required to make the illicit drugs in question,'' and
that he was ``not sure if 144 [bottles] will make enough to matter
or not.'' Id. at 571. The Government's evidence showed, however,
that Georgia and the adjacent States had experienced a proliferation
in smaller methamphetamine labs which typically produced a quarter
to a half ounce. Id. at 35. The evidence also showed that ``even
unskilled persons can obtain a 50-70% yield of methamphetamine.'' GX
15, at 8. Contrary to Dr. Bellenger's understanding, four sixty-
count bottles of 60 mg. pseudoephedrine would provide enough
material for even an unskilled person to manufacture a quarter ounce
of the drug; 144 bottles would provide enough material to make nine
ounces.
---------------------------------------------------------------------------
The ALJ also credited Dr. Bellenger's testimony that in reviewing
the various exhibits, he noted that while ``some of [Respondent's
customers] were buying by case lot,'' he did not find a pattern of the
customers ``buying [ten] 144s.'' Tr. 571 (cited at ALJ at 25).
Respondent's own evidence shows, however, that there were multiple
instances in which Respondent sold case quantities that suggest that
the sales were for an illicit purpose. See RX 12.
For example, during the year 2004, Respondent sold cases (144
bottles) of Max Brand Pseudo to the Coastal Food Mart of Rockmart,
Georgia, on eight occasions: January 21, February 2, March 4, April 19,
June 3, July 14, August 2, and September 5.\17\ Id. at 52, 82, 86, 91,
93, 97, 99. On cross-examination, Dr. Bellenger acknowledged that the
store was ``probably * * * buying in excess of what would be
expected,'' that ``a case over a six-month period is rational,'' but
this store's purchases ``would raise [his] suspicions.'' Tr. 619-20.
Moreover, when asked whether this store's retail sales would be ``many
standard distributions beyond'' the $175 figure he calculated for
average monthly sales, Dr. Bellenger answered: ``Right.'' Id. at 620.
Dr. Bellenger also acknowledged that it would not be logical for a
store to ``order additional inventory on a regular basis unless they
were selling it.'' Id. at 642.
---------------------------------------------------------------------------
\17\ Each case sold for $1006.56.
---------------------------------------------------------------------------
On re-direct, Dr. Bellenger opined that ``it would be highly
unlikely in the normal course of business'' for an entity like Sunny
Wholesale to detect these transactions. Id. at 646. According to Dr.
Bellenger, ``you've got to be looking real, real, real close'' to find
these transactions ``given the scope of [Respondent's] business,'' and
the fact that the product category was ``less than two percent of the
total business and these instances would account for a fraction of
that.'' Id. at 647.
The Coastal Food Mart was not, however, the only store to which
Respondent repeatedly sold large quantities of pseudoephedrine. During
the same year, it sold a case quantity to Chitra Inc.'s Quick Stop of
Rome, Georgia, on eight separate dates: January 4, April 8, June 14,
July 5, August 2, August 20, September 14, and October 11. See RX 12,
at 80, 91, 94, 95, 97, 98, 100, & 101. It sold a case to the Phillips
66 Mart of Hapeville on eight occasions: January 5, February 5, March
22, April 1, May 5, June 3, August 17, and September 12. See id. at 80,
84, 88, 89, 92, 93, 98 & 99.
It sold a case to the R & S Grocery of Columbus on nine dates:
January 21, February 2, March 2, April 1, May 5, June 21, July 7,
August 30, and September 29. See id. at 82, 86, 89, 92, 95, 96, 98, &
100. It sold a case to the Stop In of Bremen on nine occasions: January
5, February 3, March 2, April 1, May 5, June 1, July 27, August 20, and
September 14. See id. at 52, 80, 83, 86, 89, 92, 93, 98, 100.
Moreover, the record shows that there were instances in which
Respondent sold to two customers who used the same address. For
example, Respondent sold case quantities to the P & K Mini Mart, with
an address of 461 Columbia Drive, Carrollton, on January 6, February
10, March 4, April 8, and May 5. See id. at 53, 81, 84, 86, 89. Yet it
also sold a case to a customer it listed as the ``Quick Stop/Tushar/
BP'' with the same 461 Columbia Drive, Carrollton address, on February
2, March 4, April 8,\18\ May 5, July 22, and August 1. See id. at 54,
83, 86, 91, 96, 97. Moreover, Respondent sold a case to the DJ Food
Mart, with an address of 15582 HWY 27, Trion, on January 6, February
10, March 4, April 8, May 5, and June 15. See id. at 54, 81, 85, 87,
90, 94. It also sold a case to a customer it listed as ``BJ's Food
Market 1'' with the address of 15582 HWY 27 North, Trion, on
February 10, March 4, April 8, May 5, June 4, July 27, July 22, August
18, and September 5. See id. at 54, 84, 87, 90, 93, 96, 98, 99.
---------------------------------------------------------------------------
\18\ The record indicates that on this date, Respondent sold 96
bottles for a total sale of $671.04. RX 12, at 91.
---------------------------------------------------------------------------
Relatedly, Dr. Bellenger testified that ``unusual orders become
very challenging if there's a relatively small number of * * * those
orders * * * given the large numbers of people [a business is] dealing
with.'' Id. at 556. Dr. Bellenger acknowledged, however, that ``you
could create a computer program which would create an exceptions
report.'' Id. at 648. Dr. Bellenger nonetheless maintained that it
would be difficult to track these
[[Page 57660]]
purchases and that finding a high volume purchase ``in the normal
course of business would be an accident.'' Id. at 647.
I reject Dr. Bellenger's testimony regarding the difficulty of
detecting excessive purchases. As noted below, during an earlier
meeting with DEA investigators, Mr. Sayani stated that ``a typical
sale'' of listed] chemicals ``was two to three boxes,'' with each ``box
contain[ing] twelve bottles of 60-count tablets.'' Id. at 331. Notably,
during this meeting, the DI specifically told Mr. Sayani that an order
of ``ten boxes [or 120 bottles] would be suspicious,'' and that if a
customer ``requested cases quantities'' or 144 bottles, ``he was to
notify DEA.'' Id. at 336.
Moreover, Respondent's records show that many of these customers
were not trying to hide the size of their purchases by purchasing
smaller quantities on different dates. Rather, they were openly
ordering case quantities, see RX 12, at 79-101; and as found above,
several of these customers did so with disturbing frequency. Finally,
even crediting Dr. Bellenger's testimony that in some instances, a
convenience store owner could make a legitimate business decision to
purchase a case quantity, it does not require that much effort to call
up a customer's account history to determine how frequently the
customer was purchasing the products.
Respondent's History as a Registrant
In September 1999, Respondent applied for a DEA registration to
handle list I chemicals at its Forest Park warehouse. Tr. 703. Prior to
being granted the registration, DEA DIs conducted a pre-registration
inspection. Id.; see also id. at 323. During the inspection, a DI
provided Mr. Sayani with a copy of the DEA Chemical Handler's Manual
and a document which listed the thresholds for pseudoephedrine and
ephedrine (which trigger additional reporting and recordkeeping
obligations). Id. at 726-27. Moreover, Mr. Sayani told the DI that ``he
would deliver [the listed chemical products] to his customers.'' Id. at
323.\19\ Shortly after the inspection, Respondent obtained a
registration for this location.
---------------------------------------------------------------------------
\19\ Mr. Sayani made the same representation during the pre-
registration investigation of Respondent's application for the
Decatur location. Tr. 323.
---------------------------------------------------------------------------
On January 31, 2001, Respondent applied for a registration to
handle pseudoephedrine, ephedrine, and phenylpropanolamine, at its
Decatur warehouse. GX 2. Accordingly, on March 31, 2001, DEA DIs went
to Respondent's Decatur facility to conduct a pre-registration
inspection. Tr. 246. During the inspection, the DIs met with Mr. Sayani
and provided him with another copy of the Chemical Handler's Manual, as
well as notices stating that drug products containing
phenylpropanolamine were being used by drug traffickers to manufacture
amphetamine, GX 5, and combination ephedrine and pseudoephedrine were
being used to by traffickers to manufacture amphetamine and
methamphetamine. GX 6, Tr. 249. The DIs also provided Mr. Sayani with
notices pertaining to recordkeeping and reporting of theft and losses
of listed chemical products. Tr. 249.
The DI had previously requested that Mr. Sayani provide her with
lists of his suppliers, the products he intended to carry, and his
proposed customers. Id. 246-47. On the list of suppliers and products,
Mr. Sayani indicated that he intended to sell products distributed by
Compare Generics of Hauppauge, New York, including Max Brand and Heads
Up, two brands of products which ``are notoriously popular [with]
methamphetamine traffickers.'' \20\ GX 34, at 11; GX 27.
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\20\ On its product list, Respondent also indicated that he
would be distributing four products from BDI Marketing, Inc.,
another firm whose products have been found at numerous illicit
methamphetamine labs. GX 4. However, according to the DI, none of
these products contained a list I chemical. Tr. 250.
Respondent also listed three other suppliers; the listed
chemical products he listed under these suppliers were nationally
recognized brands such as Tylenol, Advil, Nyquil, Contac, and Vicks
44. See GX 27.
---------------------------------------------------------------------------
During the inspection, the DIs reviewed the Chemical Handler's
Manual with Mr. Sayani, placing special emphasis on its provisions
pertinent to record keeping, security, the need to know his customers,
and requiring proof of identity from his customers. Tr. 321. The DIs
also discussed with Mr. Sayani the listed chemical thresholds and the
requirement to report suspicious orders. Id. Mr. Sayani again
represented that the listed chemical products ``would be delivered just
like they were at his Forest Park location.'' Id. at 323. The DI
observed, however, that Respondent did not ``deliver most of the time''
as ``[t]he majority of the time the customers were coming'' to the
warehouse. Id. at 324.\21\
---------------------------------------------------------------------------
\21\ The DI also obtained information that Respondent had a
single employee who was ``his delivery guy.'' Tr. 324. The position
was vacant for some unspecified period of time. Id. at 324-25.
---------------------------------------------------------------------------
Based on Mr. Sayani's list of proposed customers, one of the DIs
checked to see if DEA's computer system held information regarding the
customers. Id. at 255. The DI also visited several of the customers'
addresses to verify whether there was a business at the location. Id.
Moreover, the DIs' supervisor decided that before sending the
report on the Decatur application to DEA Headquarters, the DIs needed
to inspect Respondent's practices at its Forest Park warehouse because
the location had ``never been audited.'' Id. at 370. Accordingly, on
June 30, 2001, several DIs went to the Forest Park warehouse and
conducted an inspection. Id. at 255.
Upon their arrival, the DIs met with Mr. Sayani and asked him to
provide them with an inventory and a list of the listed chemical
products Respondent distributed. Id. at 256. One of the DIs also asked
him for a list of his customers and suppliers and provided him with
another copy of the Chemical Handler's Manual and several DEA notices.
Id. During the inspection, the DIs observed that Respondent's list I
products were co-mingled with other products in the warehouse and were
not stored in a secure area.\22\
---------------------------------------------------------------------------
\22\ At some point between 2002 and 2005, Respondent built a
cage at its Forest Park warehouse in which it stored its list I
chemical products and installed several security cameras. RX 25a.
The cage had a separate cash register and window at which the
products were paid for and delivered to the customer. Id.
---------------------------------------------------------------------------
The DIs then proceeded to conduct an audit of Respondent's handling
of list I products for the period January 1, 2001, through the close of
business on June 30, 2001. GX 31. The DIs selected eleven non-
traditional products to audit; with the assistance of Mr. Sayani, they
counted the actual number on hand of each of the selected products. Tr.
264 & 275; GX 30.\23\ Because Mr. Sayani did not have a previous
inventory of the products,\24\ id. at 260, the DIs assigned an opening
value of zero for each of the products. Id. at 377; GX 31. Assigning an
opening value of zero for a product should result in an overage if, in
fact, there was any of the product on hand on the beginning date of the
audit and the distributor is keeping (and provides) complete records of
its purchases and distributions.\25\ Tr. 269 & 377.
---------------------------------------------------------------------------
\23\ The DIs provided Mr. Sayani with a copy of the count. Tr.
362.
\24\ At the hearing, a DI testified that DEA's regulations do
not require that a list I chemical distributor keep an inventory.
Id. at 261.
\25\ Assigning an opening value of zero will also result in an
undercount of a shortage if any product had actually been on hand on
the opening date of the audit.
---------------------------------------------------------------------------
To complete the audit, the DIs requested that Mr. Sayani provide
them with his purchase invoices and sales invoices. Id. at 266. The
sales invoices did not, however, clearly indicate the package size
(e.g., whether it was a six count packet or 60 count bottle). Id. at
[[Page 57661]]
267. The DI therefore contacted Mr. Sayani and requested additional
information. Id. at 266-67. While Mr. Sayani then provided his sales
tracking reports, even these were sometimes lacking the necessary
information. Id. at 267.
The audit found that there were shortages with respect to six of
the eleven products.\26\ See GX 31. Most significantly, Respondent was
short 7640 sixty-count bottles of Heads Up and 3656 sixty-count bottles
of Max Brand. Id. Moreover, Respondent was short 284 sixty-count
bottles of Mini 2-Way Action. Id. Respondent was also short 180 six-
count packets of Max Brand, 154 six-count packets of Mini 2-Way Action,
and 262 packets of Max Brand Pseudo (24-count). Id.
---------------------------------------------------------------------------
\26\ As the DI explained, the audit was conducted by adding
Respondent's purchases to the opening inventory figure and comparing
that figure with the total of the ending inventory plus the amounts
which Respondent distributed to its customers. Tr. 268, GX 31.
---------------------------------------------------------------------------
Regarding the audit, Mr. Sayani testified that upon being served
with the Show Cause Order, which had alleged that he was short
approximately 10,000 bottles of Max Brand and Heads Up, he checked his
July 2001 inventory and had 2069 bottles on hand and did not ``know
where this 10,000 figure came from.'' Tr. 715. Mr. Sayani further
testified that because 10,000 bottles is a large amount, he ``would
know where [it] is going.'' Id. at 716.
The ALJ did not make ``precise findings'' on the amount of the
shortages. ALJ Dec. 30 at n.6. I do.
Notably, Mr. Sayani's testimony that he had 2069 bottles on hand
according to his July 2001 inventory is consistent with the total
amount of product that he and the DIs physically counted.\27\ Moreover,
the DIs found that the largest shortage was in the Heads Up 60-count
bottles, yet none of this product was on hand when the physical count
was on hand. See GX 31. The audit of this product was thus based
entirely on Respondent's records of its purchases and distributions; if
the amount was incorrect, Respondent could have produced his records to
show that.
---------------------------------------------------------------------------
\27\ Mr. Sayani did not state which products were included in
his 2069 figure. According to GX 31, the physical count found 1584
Max Brand (60 count) bottles, 36 Mini 2-Way (48-count) and 428 (60-
count) bottles, and 18 Mini Twins (60 count bottles). These products
would total 2066 bottles. I further note the testimony that Mr.
Sayani agreed with the results of the inventory. Tr. 266.
---------------------------------------------------------------------------
Moreover, for each of the audited products, the amount of the
shortages (11,296 60-count bottles of Max Brand and Heads Up) was
determined based on the discrepancy between the amount of these
products which Respondent obtained from his suppliers during the audit
period and the sum of the amount it had on hand on June 30 and the
amount its sales records showed it had distributed during the audit
period. Mr. Sayani's assertion aside, he offered no credible evidence
that gives me reason to reject the audit's finding. Accordingly, I
adopt as findings, the audit results as listed in GX 31.
As found above, during the visit, the DIs also discussed with Mr.
Sayani the size of a normal monthly sale to a single store of non-
traditional products. Id. at 330. Mr. Sayani told the DIs that ``[a]
typical sale was two to three boxes,'' with each ``box contain[ing]
twelve bottles of 60-count tablets.'' Id. at 331. As found above,
however, Respondent frequently sold listed chemical products in far
larger quantities and did so notwithstanding that the DIs had informed
him that sales of case quantities were suspicious and should be
reported to DEA. See RX 12; Tr. 336.
Following the inspection, several DIs were assigned to conduct
customer verifications.\28\ ALJ at 15-17. The verifications serve
several purposes including determining whether the customer actually
exists, the nature of its business and whether it is legitimate, and
whether the customer has a business relationship with the distributor.
Tr. 139, 145, 187, 202, 355-56. As the ALJ found, the verifications
produced ``mixed results.'' ALJ at 15.
---------------------------------------------------------------------------
\28\ According to the record, Mr. Sayani provided two separate
customer lists. One was a list which Mr. Sayani represented as being
his actual Forest Park warehouse list I customers; the other was a
list of his potential list I customers for his Decatur warehouse.
Tr. 373-74.
---------------------------------------------------------------------------
One DI, who was assigned twelve verifications, found that several
of the businesses were convenience stores, gas stations, and a liquor
store. Tr. 142-45. Moreover, upon visiting the addresses of three of
the customers, two of which were listed as businesses (Pamela's Unique
Clothing and Reliance Wholesale Supply), and one which was listed as an
individual (M.S.), the DI found that they were residences and that
there were no signs of businesses. Tr. 142 & 144. The DI further found
that the R.S. Corporation was a Blimpie restaurant, id. at 142, and
that Artistic Sales was a gift shop which did not sell list I
chemicals. Id. at 143.
Another DI testified that when she and her partner went looking for
Ashley's Boutique, they could neither find the store nor the address
that Mr. Sayani had given for it. Id. at 202-03, 233. The DIs further
found that the Atlanta Cleaners Plus ``was closed down.'' Id. at 203.
While the DIs found that the Matierra Mexicana 3 was a
supermarket, the store did not purchase items from Respondent. Id. at
203-04. Moreover, one of the establishments was a liquor and check
cashing store. Id. at 204.
Another customer (BDI Inc.) was a Shell gas station whose manager
stated that while he had purchased products from Respondent nine months
earlier, he no longer did so. Id. at 205. Moreover, the manager told
the DIs that Respondent ``did not deliver'' and that ``he had to drive
to [Respondent's] facility to pick up his products.'' Id. Finally, the
DIs determined that another customer (Golden Dealers) ``was a house
that was located in a cul-de-sac'' and there was no store on the
premises. Id. at 206.
Following the customer verifications, one of the DIs and her
supervisor met with Mr. Sayani and his attorney Henry D. Frantz, Esq.,
to discuss their concerns that some of Respondent's customers were not
legitimate. Id. at 254. More specifically, the DI told Mr. Sayani that
the DI had ``found numerous suspect customers that normally would not
be selling these type of products.'' Id. at 372. The DI also expressed
her concern that some of Respondent's customers were engaged in
wholesale distribution out of their homes and were therefore required
to be registered under 21 U.S.C. Sec. 823(h), but were not. Id. at
259.
Upon being informed by the DIs that ``some of the customers were
suspicious,'' Mr. Sayani stated that he had ``provided * * * a list of
the customers he thought * * * would purchase from him, whether it was
list I chemicals or other products that he handled.'' Id. at 254. At
the meeting, the DIs also provided Mr. Sayani and his attorney with a
list of 147 customers who they deemed suspicious and instructed him to
investigate them. Id. at 687.
Several weeks thereafter, Respondent's attorney wrote a letter to
the DIs reporting that 119 of the customers owned either a convenience
store or grocery. RX 8, at 1. Respondent's attorney further reported
that 14 of the customers had ``never purchased a list I'' product and
that three of them ``have a DEA license.'' Id. As for the remaining
suspicious customers, the letter stated that Respondent could not
contact eight of the customers and that three of them were jobbers who
had purchased small amounts. Id.
Respondent's attorney further wrote that it ``had tightened up * *
* his business with regard to checking out the customer on all sales
pertaining to list I chemicals.'' Id. More specifically, the letter
stated Respondent ``currently asks
[[Page 57662]]
for a tax identification number, business license[,] as well as a DEA
permit if the customer does not have a store.'' Id. at 2.\29\
---------------------------------------------------------------------------
\29\ The letter also stated that Respondent would ``cross-check
* * * all customers purchasing list I items between'' its two
warehouses, and that it was maintaining ``an updated inventory.'' RX
8, at 2.
---------------------------------------------------------------------------
At the hearing, Mr. Sayani testified that he did not go to a new
customer's store to verify whether it was legitimate ``because at the
time of opening the account, we get enough proof from them that they're
legitimate * * * or that they're who they say'' they are. Tr. 768. Mr.
Sayani acknowledged, however, that anyone who applied for a state or
local tax identification number would be issued one. Id. at 769.
At the hearing, Mr. Sayani further testified that upon being served
with the Show Cause Order, which referred to Max Brand and Heads Up as
non-traditional products, he stopped selling the products. Id. at 714.
As found above, the first Show Cause Order was dated October 20, 2004,
and served on Respondent no later than November 19, 2004, when his
counsel requested a hearing.
Contrary to Mr. Sayani's testimony, Respondent's ``Sales Tracking
Report'' indicates that it repeatedly sold Max Brand after the first
Show Cause Order was served and frequently did so in large quantities.
Moreover, there is evidence that it made multiple large sales to
several stores.
For example, on November 30, 2004, it sold $504 of Max Brand 2-Way
to the Lucky Star of Brookfield, Georgia. RX 12, at 67. This was
followed by two December 12, 2004 sales, each totaling $1509.84, to the
Dixie Stop of Twion and the Modern Kwik Shop of Summerville, id. at
101, and a December 19, 2004 sale of $504 to Jay Swaminarayan, Inc., of
Tifton, Georgia. Id. at 74. On February 13, 2005, it sold an additional
$861.12 of the products to both the Dixie Stop and the Modern Kwik
Shop.\30\ Id. at 104.
---------------------------------------------------------------------------
\30\ Respondent had also sold $1509.84 of the products to the
Modern Kwik Stop on November 14, 2004. RX 12, at 53.
---------------------------------------------------------------------------
On both November 29, 2004, and January 3, 2005, it sold $1006.56 of
the products to ABJ Ashburn, Inc., of Ashburn. Id. at 106 & 101.
Respondent made further sales of the products to this store on January
27, February 17, and February 25, when it sold $430.56 worth on each
date, and on both March 20 and April 2, when it sold $861.12 of the
products to this store. Id. at 101-2, 105-6.
Moreover, on January 8, 2005, it sold $861.12 of Max Brand
pseudoephedrine to Priya Nidhi, Inc., of Calhoun, Georgia. Id. at 53.
Notably, it has previously sold this establishment $1006.56 on October
15, 2004. Id. at 52.
On February 5, 2005, it made two separate sales of the products
(one totaling $504, the other totaling $430.56) to the West Gray BP of
Gray, Georgia, id. at 78 & 112; on February 18, 2005, it sold $504 of
the product to the Razk, Inc., Marathon of Douglasville. Id. at 64. And
on February 20, 2005, it made two separate sales (one worth $504, and
one worth $430.56 of the products) to Krishna Corp. of Huntsville,
Alabama. Id. at 72 & 107.
On January 13, February 6, March 1, and April 1, 2005, it sold
$430.56 worth of the products to the Texaco 10 Opelika of Phenix City,
Alabama; on January 13, it also sold an additional $576 of the products
to this store. Id. at 102, 104-06, 113. Moreover, on both February 20
and April 2, it sold $861.12 of the products to USA Trading Inc., of
Pheonex (sic) City, Alabama. Id. at 102 & 104. It also sold $861.12 of
the products to Thakurs Fuel, Inc., of Pinehurst, Georgia, on each of
these dates: February 25, March 20, and April 8, 2005. Id. at 103, 105
& 109.
The evidence further shows numerous other instances in which
Respondent sold large quantities of Max Brand as late as April 2005.
Id. at 110-12. More specifically, on April 3, 2005, Respondent sold
$861.12 of the product to each of the following stores: Amin
Enterprises, Inc. of Lithonia, the Coastal Food Mart of Rockmart, and
the Hill Top Gas Station of Bremen. Id. at 110-11. Moreover, on April
6, it sold $861.12 worth of the products to Wendel's JKF, Inc.,
Discount Tobacco 2, and Discount Tobacco; all three stores
were located in Americus, Georgia.\31\ Id. at 111. Finally, between
April 10 and 16, 2005, it sold $504 worth of the products to eleven
establishments (the DM Cotton Patch of Richland, DM Shopper Stop
334 of Cusetta, OM Traders 271, DM Shopper Stops
s 442 and 451, all of Cataula; KDC Inv. and RDSP, both of
Columbus; Hyaat Groceries of Covington; Jai Bhrahmani, Inc., of
Buchanan; Gainesville BP of Gainesville; all in Georgia, and Prem,
Inc., of Alexander City, Alabama. Id. at 111-12.
---------------------------------------------------------------------------
\31\ The address of Discount Tobacco 2 is listed as
137 N. Lee St; the address of Discount Tobacco is listed as 107
South Lee St. RX 12, at 111.
---------------------------------------------------------------------------
The ALJ specifically found--based on Mr. Sayani's testimony--that
``Respondent stopped selling Heads Up and Max Brand products because
they were identified as `non-traditional' items by the DEA in the
October 2004 Order to Show Cause.'' ALJ at 21. To the extent this
finding implies that Mr. Sayani stopped selling the products shortly
after service of the Order, it is inconsistent with the evidence which
shows that for approximately five months after the Order was served,
Respondent continued to sell these products. Indeed, Mr. Sayani's
testimony begs the question of why, if the products were identified in
the Show Cause Order, it took five months to stop selling them.
The Government also produced evidence showing that Respondent had
distributed iodine tincture to several of its customers. See GX 46, at
1, 2, 3, 15, & 16. Moreover, Respondent's evidence shows that it
distributed 2,852 (1 oz.) units of this product to a single store
between June 8, 2003, and November 6, 2004. RX 16, at 5.
Regarding the allegation that Respondent sold excessive quantities
of iodine to convenience stores, the Government offered anecdotal
evidence in the form of a DI's testimony that she had visited more than
100 convenience stores in both the course of her official duties and as
a consumer and h