[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Proposed Rules]
[Pages 4968-4969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2296]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA-228A]
RIN 1117-AA66


Chemical Mixtures Containing Listed Forms of Phosphorus

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Advance Notice of Proposed Rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is soliciting 
information on chemical mixtures that contain the list I chemical 
phosphorus, which includes red phosphorus, white phosphorus, and 
hypophosphorous acid (and its salts) (hereafter referred to as 
regulated phosphorus). Specifically, DEA is interested in learning what 
products contain regulated phosphorus, and what concentrations of 
regulated phosphorus and other chemicals are used in their 
formulations. DEA is also interested in how chemical mixtures 
containing regulated phosphorus are packaged, distributed and used, and 
their availability at the retail level. DEA is seeking this information 
to help determine whether there are chemical mixtures (as defined in 21 
U.S.C. 802(40)) containing regulated phosphorus that should be exempt 
from the regulations governing listed chemicals, pursuant to 21 U.S.C. 
802(39)(A)(v). Exempt chemical mixtures are those formulations that 
contain any listed chemical, but are not subject to the regulatory 
controls of the Controlled Substances Act (CSA) that pertain to listed 
chemicals because they pose a limited risk of diversion to illicit 
channels.
    On September 16, 1998, DEA published a Notice of Proposed 
Rulemaking in the Federal Register (63 FR 49506) that proposed 
regulations to define exempt chemical mixtures. Because regulated 
phosphorus was not then a listed chemical, regulations defining 
potential exempt chemical mixtures were not proposed. The information 
being requested in this Advance Notice of Proposed Rulemaking (ANPRM) 
will be used to help propose regulations to define what chemical 
mixtures containing regulated phosphorus may be exempt.

DATES: Written comments must be received on or before April 1, 2003.

ADDRESSES: Comments should be received to the Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC, 20537, Attention: DEA Federal Register 
Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537; Telephone (202) 307-
7183.

SUPPLEMENTARY INFORMATION: 

What Is Phosphorus, How Is It Used, and Which Forms Are Regulated?

    Phosphorus is a nonmetallic element that can occur in three main 
allotropic (i.e. crystalline) forms (white, red, and black), none of 
which have retail uses. White phosphorus, red phosphorus, and 
hypophosphrous acid and its salts are list I chemicals. Black 
phosphorus is not a regulated form of phosphorus. Phosphorus is used as 
a co-reactant, along with iodine or hydriodic acid, in the clandestine 
manufacture of the Schedule II controlled substances methamphetamine 
and amphetamine.
    White phosphorus is the most abundant form of phosphorus produced 
industrially. Most other forms of phosphorus and phosphorus chemicals 
are produced from white phosphorus, including phosphorus acid, 
phosphorus trichloride, phosphorus pentasulfide, and phosphorus 
pentoxide. Over 98% of the annual U.S. phosphorus demand is used in the 
production of these four compounds, none of which is regulated.
    The second crystalline form is red phosphorus. Red phosphorus is 
usually prepared as a powder and is more stable and less toxic than the 
white form. Industrial uses of red phosphorus include the manufacture 
of pyrotechnics, safety matches, phosphoric acid an other phosphorus 
compounds, fertilizers, incendiary shells, smoke bombs, tracer bullets, 
and pesticides. Red phosphorus is used to produce an ultra-high-purity 
phosphorus for application in the electronics industry. A black 
crystalline form of phosphorus is also occasionally made and is similar 
to graphite in its physical, thermal, and electrical properties. Black 
phosphorus is not regulated because it does not have the reactivity 
needed for use in clandestine operations.
    Hypophosphorus acid (H3PO2) and its salts are 
list I chemicals. Hypophosphorus acid is most commonly sold in aqueous 
solutions, all of which are regulated as list I chemicals and not 
regarded as chemical mixtures. There are no retail uses for this 
chemical. Hypophosphorus acid is commonly used by large industry as a 
bleaching, color stabilization or decoloring agent for plastics, 
synthetic fibers (primarily polyester) and chemicals. Hypophosphorus 
acid is also used as a chemical intermediate in organic synthesis and 
as a polymerization and polycondensation catalyst. It also has 
applications as a reducing agent and as an antioxidant.
    Salts of hypophosphorus acid are known as hypophosphite salts. 
Examples of these salts include: ammonium hypophosphite, iron 
hypophosphite, potassium hypophosphite, manganese hypophosphite, and 
sodium hypophosphite. The two most common salts of hypophosphorus acid 
are sodium hypophosphite and manganese hypophosphite. The sodium salt 
is used primarily in electroless nickel plating. It is also used as a 
reducing agent, analytical reagent, polymerization catalyst, polymer 
stabilizer, and fire retardant. While the manganese salt is used 
primarily in nylon fiber production, it also has application as a

[[Page 4969]]

chemical intermediate. They are not sold at retail.

How Did Red Phosphorus, White Phosphorus, and Hypophosphorus Acid (and 
Its Salts) Become List I Chemicals?

    On September 25, 2000, DEA published a Notice of Proposed 
Rulemaking (65 FR 57577) that proposed that red phosphorus, white 
phosphorus, and hypophosphorus acid (and its salts) be placed in list I 
by amending 21 Code of Federal Regulations (CFR) 1310.02(a). On October 
17, 2001, a Final Rule with request for comments was published in the 
Federal Register (66 FR 52670) which amended 21 CFR 1310.02(a) and 
placed these chemicals in list I of the CSA. Placing these forms of 
phosphorus in list I became necessary because they are used in the 
illicit manufacturing of methamphetamine, a Schedule II controlled 
substance.
    The CSA requires that all handlers of red phosphorus, white 
phosphorus, and hypophosphorus acid (and its salts) must register as 
set forth in 21 CFR part 1309 and keep records and file reports as set 
forth in 21 CFR part 1310. Until regulations that delineate criteria 
and procedures for exempting specific regulated phosphorus-containing 
chemical mixtures are finalized, DEA is treating regulated phosphorus-
containing chemical mixtures as being exempt from the chemical 
regulatory requirements of the CSA.

Why Is DEA Interested in Learning About Chemical Mixtures Containing 
Regulated Phosphorus?

    DEA is in the process of establishing regulations that define which 
chemical mixtures are exempt from CSA regulatory controls. The CSA 
defines the term ``chemical mixture'' as ``a combination of two or more 
chemical substances, at least one of which is not a list I chemical or 
a list II chemical, except that such term does not include any 
combination of a lsit I chemical or a list II chemical that is present 
solely as an impurity.'' The CSA further allows exemption of chemical 
mixtures ``based on a finding that the mixture is formulated in such a 
way that it cannot be easily used in the illicit production of a 
controlled substance and that the listed chemical or chemicals 
contained in the mixture cannot be readily recovered.''
    A notice of proposed rule making (NPRM) regarding the exemption of 
chemical mixtures was published in the Federal Register on September 
16, 1998 (63 FR 49506). The NPRM proposed regulations to identify if a 
chemical mixture is automatically exempt from CSA regulatory controls. 
When the NPRM was published, white phosphorus, red phosphorus, and 
hypophosphorus acid (and its salts) were not regulated chemicals. 
Therefore, regulations addressing the exemption of chemical mixtures 
containing regulated phosphorus were not proposed.
    The NPRM proposed a concentration limit for each listed chemical. 
If a listed chemical is found in a chemical mixture at or below the 
concentration limit, the mixture is exempt. Also proposed were 
categories of exempt chemical mixtures and an application process. The 
application process is a means to exempt chemical mixtures not 
automatically exempted by regulation. These approaches were well 
received by the regulated industry and may be proposed to identify 
exempt chemical mixtures containing regulated phosphorus.

What Is DEA Requesting in This ANPRM?

    To propose regulations in line with the above approaches, DEA is 
interested in learning about formulations that contain regulated 
phosphorus. While some formulations containing regulated phosphorus 
have been identified, DEA is not aware of the entire scope of mixtures 
containing regulated phosphorus, including how they are used, traded, 
and their chemical composition. DEA invites all interested persons to 
provide any information on chemical mixtures containing regulated 
phosphorus. Both quantitative and qualitative information is requested. 
If the concentration of a chemical(s) varies in a formulation, DEA is 
interested in the range of concentration. Also of interest is how the 
mixtures are packaged, distributed, type of application, and the target 
market (e.g., type of industry, availability at retail, Internet 
sales). This information will be used to propose regulations to exempt 
any chemical mixture that, according to 21 U.S.C. 802(39)(A)(v), is 
``formulated in such a way that it cannot be easily used in the illicit 
production of a controlled substance and that the listed chemical or 
chemicals contained in the mixture cannot be readily recovered.''
    Such information may be submitted to the address listed above and 
is requested by April 1, 2003. Information designated as confidential 
or proprietary will be treated accordingly. The release of confidential 
business information that is protected from disclosure under Exemption 
4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), is governed by 
section 310(c) of the CSA (21 U.S.C. 830(c)) and the Department of 
Justice procedures set forth in 28 CFR 16.8.

    Dated: January 22, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-2296 Filed 1-30-03; 8:45 am]
BILLING CODE 4410-09-M