[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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