Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 11055 

Form 

Burden 

estimate per 

form 

(in minutes) 

Number of respondents 

Annual burden 

on 

respondents 

(in hours) 

On-site survey .............................................................................................................................. 15 1,250 313 

Telephone survey ........................................................................................................................ 15 500 125 

Total ...................................................................................................................................... ........................ 1,750 438 

Comments 

A notice allowing the public a 60-day 

comment period was published in the 

Federal Register on May 2, 2006 (71 FR 

25857, May 2, 2006). No comments were 

received in response to the 60-day 

comment period. The Public now has a 

second chance to comment. 

Comments are Invited on 

(a) Whether the proposed collection of 

information is necessary for the proper 

performance of our functions, including 

whether the information will have 

practical use; 

(b) the accuracy of our burden 

estimate for the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) ways to enhance the quality, 

usefulness, and clarity of the 

information to be collected; and 

(d) ways to minimize the burden of 

the collection of information on 

respondents. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. Reclamation will 

display a valid OMB control number on 

the survey forms. 

Before including your address, phone 

number, e-mail address, or other 

personal identifying information in your 

comment, you should be aware that 

your entire comment—including your 

personal identifying information—may 

be made publicly available at any time. 

While you can ask us in your comment 

to withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

Michael R. Finnegan, 

Area Manager, Central California Area Office, 

Mid-Pacific Region. 

[FR Doc. E7–4406 Filed 3–9–07; 8:45 am] 

BILLING CODE 4310–MN–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 05–22] 

Planet Trading, Inc., d/b/a/ United 

Wholesale Distributors, Inc.; Denial of 

Application 

On February 15, 2005, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Planet Trading, Inc., 

(Respondent) of Orlando, Florida. The 

Show Cause Order proposed to deny 

Respondent’s pending application for a 

DEA Certificate of Registration as a 

distributor of the list I chemicals 

ephedrine and pseudoephedrine on the 

ground that Respondent’s registration 

would be inconsistent with the public 

interest. Show Cause Order at 1, see 

also 21 U.S.C. 823(h). 

More specifically, the Show Cause 

Order alleged that both ephedrine and 

pseudoephedrine are ‘‘commonly used 

to illegally manufacture 

methamphetamine, a Schedule II 

controlled substance.’’ Show Cause 

Order at 1. The Show Cause Order 

alleged that ‘‘DEA knows by 

experience’’ that a ‘‘gray market’’ exists 

‘‘in which certain pseudoephedrine and 

ephedrine products are distributed only 

to convenience stores and gas stations, 

from where they have a high incidence 

of diversion’’ into the illicit 

manufacture of methamphetamine. Id. 

at 2. Relatedly, the Show Cause Order 

alleged that only ‘‘[a] very small 

percentage’’ of legitimate sales of list I 

chemical products occur in gray market 

retailers and that the average gray 

market retailer ‘‘could expect to sell 

* * * only about $10.00 to $30.00 

worth of pseudoephedrine products’’ a 

month. Id. at 3. The Show Cause Order 

also alleged that the expected sales for 

combination ephedrine products are 

‘‘only one-fourth of’’ this amount. Id. 

The Show Cause Order alleged that 

during a pre-registration investigation, 

Respondent’s president advised DEA 

investigators that his firm distributes 

sundry items and tobacco products to 

convenience stores, gas stations, and 

small independent groceries, which 

constitute the gray market for list I 

chemical products. Id. at 2. The Show 

Cause Order further alleged that during 

an interview, Respondent stated that he 

had ‘‘little or no background in handling 

list I chemical products.’’ Id. The Show 

Cause Order also alleged that 

Respondent told the investigators that 

he intended to sell list I products that 

were marketed in bottles and not blister 

packs because the latter ‘‘were not good 

sellers.’’ Id. 

The Show Cause Order also alleged 

that Respondent intended to store the 

list I products in a warehouse ‘‘with all 

other items [and] without any additional 

security installed.’’ Id. at 3. The Show 

Cause Order further alleged that 

‘‘[b]ecause [Respondent’s] customers are 

allowed to serve themselves from the 

warehouse shelves, all customers will 

have unescorted access to the list I 

chemicals stored in the warehouse.’’ Id. 

Finally, the Show Cause Order alleged 

that Respondent’s ‘‘proposed sales of 

combination ephedrine and 

pseudoephedrine products are 

inconsistent with the known legitimate 

market and known end-user demand for 

products of this type,’’ and thus 

Respondent ‘‘would be serving an 

illegitimate market for [these] 

product[s].’’ Id. The Show Cause Order 

concluded by alleging that because 

Respondent’s owner had ‘‘no experience 

handling list I chemicals’’ and its 

warehouse has ‘‘insufficient security,’’

its ‘‘registration would likely lead to 

increased diversion of list I chemicals.’’

Id. 

Respondent, through its owner Mr. 

Vihang Patel, requested a hearing. The 

case was assigned to Administrative 

Law Judge (ALJ) Mary Ellen Bittner, 

who conducted a hearing in Tampa, 

Florida, on November 1, 2005. At the 

hearing, both parties put on witnesses 

and introduced documentary evidence. 

Following the hearing, the Government 

submitted proposed findings of fact and 

conclusions of law. 

On April 25, 2006, the Administrative 

Law Judge submitted her decision 

which recommended that Respondent’s 

application be denied. Neither party 

filed exceptions. The record was then 

forwarded to me for final agency action. 

Having considered the record as a 

whole, I hereby issue this decision and 

final order. I adopt the ALJ’s decision in 


pwalker on PROD1PC71 with NOTICES
11056 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 

1Respondent also sought to distribute 

phenylpropanolamine (PPA), a product which is 

the subject of an FDA rulemaking which proposes 

to reclassify the drug as not generally safe and 

effective. See 70 FR 75988, 75994 (2005). 

Respondent no longer seeks registration to 

distribute PPA products. 2The FDA is, however, currently proposing to 

remove combination ephedrine-guaifenesin 

products from its over-the-counter (OTC) drug 

monograph and to declare them not safe and 

effective for OTC use. See 70 FR 40232 (2005). 

its entirety and conclude that 

Respondent’s registration would be 

inconsistent with the public interest. I 

therefore order that Respondent’s 

application be denied. 

Findings 

Respondent, a Florida corporation, 

sells sundry items and tobacco products 

to convenience stores, gas stations, and 

small independent groceries. 

Respondent does not make deliveries. 

Rather, it operates a walk-in warehouse 

which is located in an Orlando, Florida 

industrial park. Respondent’s President 

is Mr. Vihang Patel; Mr. Patel and his 

two brothers each own one-third of the 

corporation. See ALJ Dec. at 9–10. 

On August 27, 2003, Mr. Patel applied 

on Respondent’s behalf for a DEA 

Certificate of Registration to distribute 

list I chemicals. Gov. Ex. 1. As relevant 

here, Respondent sought the registration 

to distribute pseudoephedrine and 

ephedrine.1 Id. 

Methamphetamine and the Market for 

List I Chemicals 

As explained in numerous DEA final 

orders, both pseudoephedrine and 

ephedrine currently have therapeutic 

uses. See, e.g., Tri-County Bait 

Distributors, 71 FR 52160, 52161 

(2006).2 Both chemicals are, however, 

regulated under the Controlled 

Substances Act because they are 

precursor chemicals which are easily 

extracted from non-prescription 

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). 

Methamphetamine is a powerful and 

highly addictive central nervous system 

stimulant. See, e.g., Tri-County Bait 

Distributors, 71 FR at 52161. The illegal 

manufacture and abuse of 

methamphetamine pose a grave threat to 

this country. Methamphetamine abuse 

has destroyed numerous lives and 

families and ravaged communities. 

Moreover, because of the toxic nature of 

the chemicals which are used to make 

the drug, the illegal manufacture of 

methamphetamine causes serious 

environmental harms. Id., see also Tr. 

12. 

The illicit manufacture of 

methamphetamine is an increasing 

problem in the State of Florida. 

According to the testimony of a DEA 

Special Agent, during the period 

October 1, 2004, through September 30, 

2005, law enforcement authorities 

seized 340 clandestine laboratories 

statewide. Tr. 10–11. A DEA Diversion 

Investigator (DI) further testified that the 

illicit manufacture of methamphetamine 

is an especially serious problem in 

central Florida and the panhandle. Id. at 

26. 

The record further establishes that 

there is both a traditional market and a 

non-traditional (or gray) market for 

pseudoephedrine and ephedrine 

products. According to the declaration 

of Jonathan Robbin, who has testified as 

an expert on statistical analysis of these 

markets in numerous proceedings, 

pseudoephedrine products sold in the 

traditional market typically contained 

30 mg. of the chemical, are 

manufactured ‘‘in combination with 

other active ingredients,’’ and are sold 

in blister packs of 24, 36, or 96 count. 

Gov. Ex. 10, at 3–4. Ephedrine products 

sold in the traditional market typically 

contain 12.5 mg. of ephedrine and 200 

mg. of guaifenesin and are sold in boxes 

of either 24 or 60 tablets. Id. at 4. By 

contrast, the products sold in the nontraditional market typically contain 60 

mg. of pseudoephedrine, which is not 

combined with any other active 

ingredient, and are sold in bottles 

containing 60, 100, and 120 tablets. Id. 

at 5; see also Gov. Ex. 6, at 12. 

Moreover, the ephedrine products sold 

in the non-traditional market typically 

contain 25 mg. of ephedrine combined 

with 200 mg. of guaifenesin and are sold 

in bottles containing 60 tablets. Gov. Ex. 

10, at 6. 

According to the Government’s expert 

witness, who has examined both the 

1997 and 2002 United States Economic 

Censuses, approximately 97 percent of 

all non-prescription drugs are sold in 

pharmacies, supermarkets, large 

discount and general merchandise 

stores, or through electronic shopping/ 

mail order houses. Id. at 4. The data also 

show that non-prescription drug sales 

accounted for only 2.6% (in the 2002 

Economic Census) ‘‘of the overall sales 

of all convenience stores that handle’’

these products and only 0.6% of the 

total sales of convenience stores. Id. at 

4–5. The Government’s expert further 

testified that the sale of 

pseudoephedrine products comprise 

‘‘only about 2.6% of the [Health and 

Beauty Care] category of merchandise or 

0.05% of total in-store (non-gasoline) 

sales that occur at convenience stores. 

Id. The Government’s expert further 

stated that combination ephedrine 

products ‘‘have about half the over-thecounter sales volume’’ of 

pseudoephedrine products. Id. 

According to the Government’s expert, 

the normal expected sales range to meet 

legitimate demand for pseudoephedrine 

products at a non-traditional retailer is 

‘‘between $0 and $40 per month, with 

an average of $20.60’’; the expected 

sales range for combination ephedrine 

products at a convenience store is 

‘‘between $0 and $25, with an average 

of $12.58’’ per month. Id. at 8. 

Finally, the Government’s expert 

recounted numerous instances in which 

wholesale distributors sold massive 

quantities of pseudoephedrine and 

ephedrine products to convenience 

stores and other non-traditional 

retailers. See id. at 8–14. The expert 

further concluded that the massive sales 

of these products cannot be explained 

by persons buying them for non-FDA 

approved uses such as ‘‘weight loss or 

energy enhancement.’’ Id. at 16. As the 

Government’s expert concluded, DEA 

has found that these massive sales are 

‘‘indicative of diversion to illicit use.’’

Id. at 17. 

According to DI Mark J. Rubbins, who 

served as Chief of the Domestic 

Chemical Control Unit of the Office of 

Diversion Control, ‘‘[n]on-traditional 

stores * * * tend to knowingly sell [list 

I products] in large quantities to 

‘smurfers.’ ’’ Gov. Ex. 6, at 6. DI Rubbins 

further explained that smurfers ‘‘are 

groups of individuals affiliated with 

methamphetamine traffickers that 

frequent these establishments at 

different times or on different dates, 

with the aim of buying out a store’s 

supply of over-the-counter 

medications.’’ Id. at 6–7. 

DI Rubbins further testified that 

certain list I products have been 

‘‘disproportionately represented in 

clandestine lab seizures around the 

United States.’’ Id. at 12. The 

pseudoephedrine products are Mini 

Thin, Mini Twin, Unique, ActionPseudo, Revive, OTC-Pseudo, and TwinPseudo; the ephedrine products are Max 

Brand, Xtreme, Xtreme Relief Dual, 

Mini Two-Way, and Max Brand Id. at 

11–12. In addition, the brand names 

MinTwin 2-Way and Heads-Up are used 

to sell both pseudoephedrine and 

ephedrine tablets. Id. at 12. With respect 

to the pseudoephedrine products, DI 

Rubbins stated that these products are 

preferred by illicit methamphetamine 

producers because pseudoephedrine is 

their only active ingredient and they are 

packaged in ‘‘large bottle sizes.’’ Id. 

Moreover, blister packs are not preferred 

by methamphetamine producers 

because it is more ‘‘time consuming’’ to 

extract the product from its packaging. 

Tr. 35. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 11057 

3Ephedrine Two-Way tablets are manufactured 

by ProActive Labs Inc.; MiniThin Two-Way tablets 

are manufactured by B.D.I. Pharmaceutical. Gov. 

Ex. 5, at 2. Because of the extent to which these 

products have been found in illicit 

methamphetamine labs, DEA has sent numerous 

warning letters to both of these firms. See D & S 

Sales, 71 FR 37607, 37608 (2006). 

The Pre-Registration Investigation and 

Respondent’s Testimony 

On January 27, 2004, a DI visited 

Respondent’s facility and met with Mr. 

Vihang Patel, Respondent’s president, to 

conduct a pre-registration investigation. 

Tr. 29. During the inspection, Mr. Patel 

provided the DI with a list of the list I 

chemicals products his firm intended to 

sell. Gov. Ex. 5.The list included 

numerous products that are preferred by 

illicit methamphetamine producers 

including bottle sizes of Ephedrine 

Two-Way, MiniThin Two-Way, and 

Max Brand Two-Way.3 Id. at 2. 

Additionally, the list included a number 

of products that do not contain list I 

chemicals such as Goody Powder, 

Goody Body Pain Powder, BC Arthritis 

Powder, and BC Powder. Id. at 1. 

Moreover, at the hearing Mr. Patel 

demonstrated a general lack of 

knowledge as to whether particular 

products contained either 

pseudoephedrine or ephedrine. When 

asked during cross-examination whether 

certain products (Nyquil, Dayquil, 

Tylenol Cold, Tylenol Sinus, Tylenol 

Allergy, Advil Cold, Tylenol PM) 

contained pseudoephedrine, Mr. Patel 

answered: ‘‘I’m not sure if any one of 

them does or not. We have to * * * go 

to the chemical contents, or ingredients 

of that particular product.’’ Tr. 106. 

When asked whether any of these 

products contained ephedrine, Mr. Patel 

stated: ‘‘I think they do.’’ Id. at 107. 

However, none of the products contain 

ephedrine. During the inspection, Mr. Patel told 

the DI that ‘‘he would be selling bottles’’

and that ‘‘he would not be selling blister 

packs because his customers didn’t like 

them or want them.’’ Id. at 50. At the 

hearing, however, Mr. Patel testified 

that he was no longer interested in 

selling gray market products but only 

traditional allergy and cold medicines 

such as Nyquil and Tylenol Sinus. Id. at 

91, 96. 

Mr. Patel also told the DI that he had 

been ‘‘an aeronautical engineer for 

eleven years,’’ and that he ‘‘had minimal 

experience’’ in selling listed chemicals. 

Id. at 38. According to the record, 

Respondent’s experience involved 

working on weekends in a similar 

business owned by his family that is 

located in Lakeland, Florida. Id. 

Discussion 

Under 21 U.S.C. 823(h), an applicant 

to distribute list I chemicals is entitled 

to be registered unless the registration 

would be ‘‘inconsistent with the public 

interest.’’ In making this determination, 

Congress directed that I consider the 

following factors: 

(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. 

‘‘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 an 

application for 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). 

In this case, I acknowledge that 

factors two and three would not bar 

granting Respondent a registration. I 

conclude, however, that Respondent 

lacks effective controls against diversion 

(factor one), lacks relevant experience in 

the distribution of list I chemicals 

(factor four), and intends to distribute 

list I chemicals to the gray market 

(factor five), a market in which the risk 

of diversion is substantial. Consistent 

with DEA precedents, I thus hold that 

Respondent’s registration would be 

inconsistent with the public interest. 

Factor One—Maintenance of Effective 

Controls Against Diversion 

I concur with the ALJ that the 

Government has not proved that 

Respondent would fail to provide 

adequate physical security for the list I 

chemicals stored at its facility. However, 

‘‘ ‘prior agency rulings have applied a 

more expansive view of factor one than 

mere physical security.’ ’’ D & S Sales, 

71 FR 37607, 37610 (2006) (quoting 

OTC Distribution Co., 68 FR 70538, 

70542 (2003)). A registrant is ‘‘required 

to exercise a high degree of care in 

monitoring its customers’ purchases’’ of 

list I chemical products to prevent 

diversion. Id. Relatedly, DEA has 

repeatedly revoked the registrations of 

list I chemical distributors for selling 

quantities of products that clearly 

exceeded legitimate demand and were 

likely diverted into the illicit 

manufacture of methamphetamine. See 

T. Young Associates, Inc., 71 FR 60567, 

60572–73 (2006); D & S Sales, 71 FR at 

37611–12; Joy’s Ideas, 70 FR at 33198–

99; Branex, Inc., 69 FR 8682, 8693–96 

(2004). 

Here, I conclude that it is likely that 

Respondent would not properly monitor 

its customers’ purchases. Both during 

the pre-registration investigation and at 

the hearing, Respondent’s president 

demonstrated a lack of familiarity with 

OTC drug products. During the preregistration investigation, he 

represented that certain products 

contained list I chemicals when they 

did not. At the hearing, he did not know 

which products contained which 

chemicals and again referred to 

products (Tylenol PM and Tylenol 

Arthritis) that do not contain either 

ephedrine or pseudoephedrine as if they 

did. Respondent’s president further 

admitted that he would have to check 

the ingredients of the particular product 

to be sure of whether it contained a list 

I chemical. In short, his lack of such 

basic product knowledge does not 

inspire confidence that his firm would 

know which products must be 

monitored to ensure that they were not 

being purchased in excessive quantities 

and being diverted into the illicit 

manufacture of methamphetamine. I 

thus conclude that this factor support a 

finding that granting Respondent a 

registration would be inconsistent with 

the public interest. 

Factors Two and Three—Compliance 

With Applicable Laws and the 

Applicant’s Prior Record of Relevant 

Criminal Convictions 

There is no evidence that Respondent 

is not in compliance with applicable 

Federal, State, or local laws. 

Furthermore, there is no evidence that 

Respondent, or any person affiliated 

with it, has ever been convicted of a 

crime under either Federal or State laws 

relating to controlled substances or 

listed chemicals. I thus conclude that 

both factors weigh in favor of granting 

Respondent’s application. 

Factor Four—The Applicant’s Past 

Experience in the Distribution of Listed 

Chemicals 

DEA precedent establishes that ‘‘an 

applicant’s lack of experience in 

distributing list I chemicals creates a 

greater risk of diversion and thus weighs 

heavily against the granting of an 

application.’’ Tri-County Bait 

Distributors, 71 FR at 52163. According 

to the record, Respondent itself has no 

experience in distributing list I 

chemicals. The ALJ found, however, 


pwalker on PROD1PC71 with NOTICES
11058 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 

4 Initially, Respondent also sought to sell high 

strength, high count list I products including 

several brands that DEA has frequently found 

during seizures of illicit methamphetamine 

laboratories. See Gov. Exh. 5, at 2. See also OTC 

Distribution, 68 FR at 70541, MDI Pharmaceuticals, 

68 FR at 4236. At the hearing, however, Respondent 

expressed a willingness to carry only smaller 

packages of traditional cold and allergy medicines. 

See ALJ Dec. at 11. For the reasons stated above, 

I nonetheless conclude that the Government has 

shown that Respondent’s registration would be 

inconsistent with the public interest. 

that Respondent’s president does have 

‘‘some limited experience’’ working on 

weekends at another firm which 

distributes list I chemicals. ALJ Dec. at 

15. 

Distributors of list I chemicals are 

subject to a comprehensive and complex 

regulatory scheme. See 21 CFR Pts. 1309 

& 1310. Moreover, as I explained in TriCounty Bait Distributors, merely 

working as a sales clerk does not 

establish that an applicant has relevant 

experience. 71 FR at 52163. Rather, for 

an applicant’s (or its key employee’s) 

experience to be relevant, the applicant 

must have been actively involved in the 

fulfillment of a registrant’s regulatory 

obligations and demonstrate adequate 

knowledge of list I products. 

While this standard may not have 

been clear at the time of the hearing, I 

nonetheless conclude that a remand is 

unnecessary. As explained above (and 

as the ALJ found), Respondent’s 

president ‘‘has little knowledge of 

which products on his proposed 

product list contained ephedrine or 

pseudoephedrine.’’ ALJ Dec. at 15–16. 

Thus, even if Respondent’s president 

had established that he had performed 

regulatory obligations, his lack of 

knowledge of basic product information 

would still lead me to conclude that his 

experience was inadequate. I thus hold 

that this factor supports a finding that 

Respondent’s registration would be 

inconsistent with the public interest. 

Factor Five—Other Factors That Are 

Relevant to and Consistent With Public 

Health and Safety 

Numerous DEA orders recognize that 

convenience stores and gas stations 

constitute the non-traditional retail 

market for legitimate consumers of 

products containing pseudoephedrine 

and ephedrine. See, e.g., Tri-County Bait 

Distributors, 71 FR at 52161; D & S 

Sales, 71 FR at 37608–09; Branex, Inc., 

69 FR at 8690–92. DEA orders also 

establish that the sale of list I chemical 

products by non-traditional retailers is 

an area of particular concern in 

preventing diversion of these products 

into the illicit manufacture of 

methamphetamine. See, e.g., Joey 

Enterprises, 70 FR 76866, 76867 (2005). 

As Joey Enterprises explains, ‘‘[w]hile 

there are no specific prohibitions under 

the Controlled Substances Act regarding 

the sale of listed chemical products to 

[gas stations and convenience stores], 

DEA has nevertheless found that [these 

entities] constitute sources for the 

diversion of listed chemical products.’’

Id. See also TNT Distributors, Inc., 70 

FR 12729, 12730 (2005) (special agent 

testified that ‘‘80 to 90 percent of 

ephedrine and pseudoephedrine being 

used [in Tennessee] to manufacture 

methamphetamine was being obtained 

from convenience stores’’); OTC 

Distribution Co., 68 FR 70538, 70541 

(2003) (noting ‘‘over 20 different 

seizures of [gray market distributor’s] 

pseudoephedrine product at clandestine 

sites,’’ and that in an eight-month 

period distributor’s product ‘‘was seized 

at clandestine laboratories in eight 

states, with over 2 million dosage units 

seized in Oklahoma alone’’); MDI 

Pharmaceuticals, 68 FR 4233, 4236 

(2003) (finding that ‘‘pseudoephedrine 

products distributed by [gray market 

distributor] have been uncovered at 

numerous clandestine 

methamphetamine settings throughout 

the United States and/or discovered in 

the possession of individuals apparently 

involved in the illicit manufacture of 

methamphetamine’’). 

Significantly, all of Respondent’s 

proposed customers participate in the 

non-traditional market for ephedrine 

and pseudoephedrine products. DEA 

orders recognize 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’’ should 

application be granted). Under DEA 

precedents, an applicant’s proposal to 

sell into the non-traditional market 

weighs heavily against the granting of a 

registration under factor five. So too 

here. 

Because of the methamphetamine 

epidemic’s devastating impact on 

communities and families throughout 

the country, DEA has repeatedly denied 

an application when an applicant 

proposed to sell into the non-traditional 

market and analysis of one of the other 

statutory factors supports the 

conclusion that granting the application 

would create an unacceptable risk of 

diversion. Thus, in Xtreme Enterprises, 

Inc., 67 FR 76195, 76197 (2002), my 

predecessor denied an application 

observing that the respondent’s ‘‘lack of 

a criminal record, compliance with the 

law and willingness to upgrade her 

security system are far outweighed by 

her lack of experience with selling list 

I chemicals and the fact that she intends 

to sell ephedrine almost exclusively in 

the gray market.’’ More recently, I have 

denied applications explaining that an 

applicant’s ‘‘lack of a criminal record 

and any intent to comply with the law 

and regulations are far outweighed by 

his lack of experience and the 

company’s intent to sell ephedrine and 

pseudoephedrine exclusively to the gray 

market.’’ Jay Enterprises, 70 FR at 

24621. Accord Prachi Enterprises, Inc., 

69 FR 69407, 69409 (2004). 

Here, Respondent clearly lacks 

effective controls against diversion, its 

key employee has only limited 

experience in the wholesale distribution 

of list I chemical products during which 

he apparently learned very little about 

the products he seeks to carry, and yet 

it intends to distribute these products to 

non-traditional retailers, a market in 

which the risk of diversion is 

substantial.4 See Taby Enterprises of 

Osceola, Inc., 71 FR 71557, 71559 

(2006). Given these findings, it is 

indisputable that granting Respondent’s 

application would be ‘‘inconsistent with 

the public interest.’’ 21 U.S.C. 823(h). 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(h), and 28 CFR 

0.100(b) & 0.104, I order that the 

application of Planet Trading, Inc., 

d/b/a United Wholesale Distributors, 

Inc., for a DEA Certificate of Registration 

as a distributor of list I chemicals be, 

and it hereby is, denied. This order is 

effective April 11, 2007. 

Dated: February 28, 2007. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 07–1103 Filed 3–9–07; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Bureau of Labor Statistics 

Proposed Collection; Comment 

Request 

ACTION: Notice. 

SUMMARY: The Department of Labor, as 

part of its continuing effort to reduce 

paperwork and respondent burden, 

conducts a pre-clearance consultation 

program to provide the general public 

and Federal agencies with an 

opportunity to comment on proposed 

and/or continuing collections of 

information in accordance with the 

Paperwork Reduction Act of 1995 


pwalker on PROD1PC71 with NOTICES