[Federal Register Volume 75, Number 122 (Friday, June 25, 2010)]
[Proposed Rules]
[Pages 36306-36313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15160]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-228P]
RIN 1117-AA66
Chemical Mixtures Containing Listed Forms of Phosphorus and
Change in Application Process
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The DEA is proposing regulations which establish those
chemical mixtures containing red phosphorus, white phosphorus (also
known as yellow phosphorus), or hypophosphorous acid and its salts
(hereinafter ``regulated phosphorus'') that shall automatically qualify
for exemption from the Controlled Substances Act (CSA) regulatory
controls. DEA is proposing that chemical mixtures containing red
phosphorus in a concentration of 80 percent or less and mixtures
containing hypophosphorous acid and its salts (hypophosphite salts) in
a concentration of 30 percent and less, shall qualify for automatic
exemption. DEA is not proposing automatic exemption for chemical
mixtures containing white phosphorus. Unless otherwise exempted, all
material containing white phosphorus shall become subject to CSA
chemical regulatory controls regardless of concentration.
DEA recognizes that concentration criteria alone cannot identify
all mixtures that warrant exemption, therefore, an application process
has been implemented which allows manufacturers to apply for exemption
from CSA regulatory controls for those phosphorus chemical mixtures
that do not qualify for automatic exemption. This rulemaking also
proposes changes to the application review and notification process.
While preparing this rulemaking, DEA became aware that references
to section 1018 of the Act (21 U.S.C. 971) were inadvertently omitted
from 21 CFR 1310.12(a) and 1310.13(i). Therefore, DEA is proposing that
this rulemaking amend these sections by adding this citation. This
insertion is a clarification and does not alter the current treatment
of exempt chemical mixtures under the CSA.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before August 24, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-228P'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152. Attention: DEA Federal Register Representative/ODL. Written
comments sent via express mail should be sent to DEA Headquarters,
Attention: DEA Federal Register Representative/ODL, 8701 Morrissette
Drive, Springfield, VA 22152.
[[Page 36307]]
Comments may be directly sent to DEA electronically by sending an
electronic message to [email protected]. Comments may also
be sent electronically through http://www.regulations.gov using the
electronic comment form provided on that site. An electronic copy of
this document is also available at the http://www.regulations.gov Web
site. DEA will accept attachments to electronic comments in Microsoft
Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not
accept any file format other than those specifically listed here.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. Please note
that the Freedom of Information Act applies to all comments received.
If you wish to inspect the agency's public docket file in person by
appointment, please see the For Further Information paragraph.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152. Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control
Act of 1970, often referred to as the Controlled Substances Act (CSA)
and Controlled Substances Import and Export Act (21 U.S.C. 801-971), as
amended. DEA publishes the implementing regulations for these statutes
in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to
end. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for legitimate medical
purposes and to deter the diversion of controlled substances to illegal
purposes. The CSA mandates that DEA establish a closed system of
control for manufacturing, distributing, and dispensing controlled
substances. Any person who manufactures, distributes, dispenses,
imports, exports, or conducts research or chemical analysis with
controlled substances must register with DEA (unless exempt) and comply
with the applicable requirements for the activity. The CSA as amended
also requires DEA to regulate the manufacture, distribution,
importation, and exportation of chemicals that may be used to
manufacture controlled substances. Listed chemicals that are classified
as List I chemicals are important to the manufacture of controlled
substances. Those classified as List II chemicals may be used to
manufacture controlled substances.
Purpose of This Rule
In this rule, DEA is proposing concentration limits on chemical
mixtures containing red phosphorus and/or hypophosphorous acid and its
salts. If this rule is finalized as proposed, chemical mixtures
containing either of these listed chemicals at or below the
concentration limit would be automatically exempt from Controlled
Substances Act (CSA) regulatory controls. Mixtures containing these
chemicals above the concentration limit would be regulated as List I
chemicals. DEA is not proposing automatic exemption for chemical
mixtures containing white phosphorus. Unless otherwise exempted, all
material containing white phosphorus shall become subject to CSA
chemical regulatory controls regardless of concentration.
DEA's Requirement To Identify Exempt Chemical Mixtures
The Chemical Diversion and Trafficking Act of 1988 (Pub. L. 100-
690) (CDTA) created a definition for the term ``chemical mixture'' (21
U.S.C. 802(40)). The CDTA established 21 U.S.C. 802(39)(A)(vi) to
exclude ``any transaction in a chemical mixture'' from the definition
of a ``regulated transaction.'' This exemption was exploited by those
that traffic chemicals for illicit purposes in that it provided an
unregulated source for obtaining listed chemicals for use in the
illicit manufacture of controlled substances.
In April 1994, the Domestic Chemical Diversion Control Act of 1993
(DCDCA) corrected this situation by subjecting such chemical mixtures
to CSA regulatory requirements, unless specifically exempted by
regulation. These requirements included recordkeeping, reporting, and
security for all regulated chemical mixtures with the additional
requirement of registration for handlers of List I chemicals including
regulated chemical mixtures. The DCDCA also provided the Attorney
General with the authority to establish regulations to exempt chemical
mixtures from the definition of a ``regulated transaction.'' A chemical
mixture can be granted exemption ``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'' (21 U.S.C. 802(39)(A)(vi)).
DEA has treated all regulated chemical mixtures as non-regulated
chemicals until such time that it promulgates a final rule that
identifies specific chemical mixtures as exempt. This served to prevent
the immediate regulation of all qualified mixtures, which is not
necessary. It also allowed DEA to gather information to implement
regulations pursuant to 21 U.S.C. 802(39)(A)(vi).
Chemical Mixture Definition
Title 21 U.S.C. 802(40) 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 List I chemical or a List II
chemical with another chemical that is present solely as an impurity.''
Therefore, a chemical mixture contains any number of listed chemicals
in
[[Page 36308]]
combination with any number of non-listed chemicals.
DEA does not consider a chemical mixture to mean the combination of
a listed chemical and an inert carrier. An inert carrier can be any
chemical that does not modify the function of the listed chemical but
is present to aid in the delivery of the listed chemical. Examples
include, but are not limited to, dilutions in water, alcohol or the
presence of a carrier gas.
In determining which chemical mixtures shall be subject to control,
DEA considers the actual and potential clandestine use of such
material. 21 U.S.C. 802(39)(A)(vi) states that an exemption can be
granted if ``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.'' It should be noted that the requirements
described by statute do not allow for exemptions based on such business
practices as selling only to known customers, the cost of the mixture,
the customer's knowledge of the product's chemical content, packaging,
or such related topics.
In 2003, DEA published a Final Rule (68 FR 23195, May 1, 2003) that
identified exempt mixtures containing the chemicals ephedrine, N-
methylephedrine, N-methylpseudoephedrine, norpseudoephedrine,
phenylpropanolamine, and pseudoephedrine. The effective date of this
Final Rule was June 2, 2003. In a second Final Rule (69 FR 74957,
December 15, 2004; corrected at 70 FR 294, January 4, 2005) DEA
finalized regulations which addressed the exemption of chemical
mixtures for 27 of the remaining 38 listed chemicals. However, chemical
mixtures containing phosphorus were not included. The effective date
for that Final Rule was January 14, 2005.
Uses of Chemical Mixtures Containing Regulated Phosphorus
Chemical mixtures that contain red phosphorus are used in the
manufacture of plastics, flame retardants, pyrotechnics, striker plates
(e.g., for safety matches and flares), incendiary shells, smoke bombs,
and tracer bullets. Chemical mixtures containing hypophosphorous acid
salts (e.g., hypophosphite salts) function as catalysts, stabilizers,
and growth inhibitors. They are used in plastics, films, paints, paper
products, and fibers, with applications that include automotive parts,
furniture, wiring, containers, and housings for appliances and power
tools. DEA has not identified any chemical mixtures containing white
phosphorus.
Information Gathered by DEA Concerning Chemical Mixtures Containing
Regulated Phosphorus
On January 31, 2003, DEA published in the Federal Register an
Advance Notice of Proposed Rulemaking (ANPRM) (68 FR 4968) to solicit
input from industry regarding chemical mixtures containing regulated
phosphorus. The ANPRM invited interested persons to supply information
on formulations that contain regulated phosphorus. DEA received three
responses to this request, all from industrial firms. In addition, DEA
obtained information on types of formulations containing regulated
phosphorus and their uses separate from the ANPRM.
All three commenters informed DEA of commercial applications for
their chemical mixtures containing regulated phosphorus, which are
discussed below. The commenters also informed DEA of concentration
ranges for red phosphorus and salts of hypophosphorous acid (e.g.
hypophosphite salts). DEA has not identified any chemical mixtures
containing hypophosphorous acid or white phosphorus either through
industry comments or as a result of DEA research.
Comments to the ANPRM
One commenter stated that its red phosphorus is stabilized against
chemical reactions prior to its use by industry. To achieve this, the
red phosphorus is blended with other chemicals to become part of a
matrix that protects it from chemical reactions. The amount of red
phosphorus formulated in these types of chemical mixtures is not more
than 50 percent. The comment claimed that such red phosphorus cannot be
used for the illicit production of methamphetamine.
Another commenter reported that red phosphorus is formulated with
dust suppressing agents. These chemical mixtures have applications as
raw material used in different industrial sectors, including in the
manufacturing of flame retardants, pyrotechnics, matches, and
pesticides. The concentration of red phosphorus in these raw materials/
chemical mixtures is generally above 90 percent.
Two commenters informed DEA that sodium hypophosphite, a regulated
salt of hypophosphorous acid, is used in low concentrations as a
stabilizer or as a catalyst. Chemical mixtures for these applications
are formulated within a range of less than one percent to no greater
than 20 percent in sodium hypophosphite. Both commenters claimed that
these formulations are not useful to traffickers.
Diversion of Chemical Mixtures Containing Regulated Phosphorus
Regulated phosphorus plays an important role in the chemical
reaction to produce methamphetamine, a schedule II controlled substance
for which the public health consequences of the manufacture,
trafficking, and abuse are well known and documented. DEA has
documented that the predominant method for the illicit manufacture of
methamphetamine utilizes phosphorus.
DEA has identified chemical mixtures containing red phosphorus at
domestic illicit methamphetamine manufacturing sites. Traffickers
sometimes utilize the striker plates of safety matchbooks or boxes, or
road flares as a source of red phosphorus. The coating on the striker
plate contains from 25 to 60 percent red phosphorus. An estimated 20 to
400 striker plates are needed to obtain one gram of red phosphorus. One
gram of red phosphorus could yield approximately 1.5 grams of
methamphetamine hydrochloride, which is the end product of clandestine
manufacturing. DEA conducted a review of data collected by the El Paso
Intelligence Center (EPIC), which collects data on clandestine
laboratory seizures by federal and state authorities. In 2004, EPIC
reported 4,454 methamphetamine laboratories that utilized red
phosphorus; 458 of these obtained the red phosphorus from matchbook
striker plates, which is approximately ten percent of the total.
EPIC does not report the potential amount of methamphetamine
produced from red phosphorus extracted from striker plates. However,
only the smallest illicit laboratories (in terms of production
capability) are known to use extracted red phosphorus, and these
individuals manufacture predominantly for personal use. Although ten
percent of the laboratories use extracted red phosphorus, the total
amount of methamphetamine produced by these laboratories is relatively
small. Large scale methamphetamine laboratories which have been
identified by DEA have historically utilized bulk red phosphorus and
not red phosphorus extracted from striker plates.
Proposed Concentration Limits for Exempt Chemical Mixtures Containing
Regulated Phosphorus
DEA is proposing to establish concentration limits for chemical
[[Page 36309]]
mixtures containing phosphorus. If finalized as proposed, all chemical
mixtures that have a concentration at or below the established
concentration limit shall be automatically exempt from CSA chemical
regulatory controls. Those chemical mixtures having a concentration
above the concentration limit shall be List I regulated chemicals and
subject to the chemical regulatory requirements of the CSA.
DEA is not aware of any chemical mixtures containing white
phosphorus. It is believed that few chemical mixtures in this chemical
exist because it is too reactive and unstable when mixed with other
chemicals. Since DEA has not identified any white phosphorus mixtures,
DEA is not proposing a concentration limit for white phosphorus and
therefore, any chemical mixture containing white phosphorus would be
subject to CSA regulatory control.
Hypophosphorous acid is marketed in aqueous solutions of 50 percent
and can be readily used in the illicit manufacture of methamphetamine.
Such aqueous solutions of hypophosphorous acid, however, are not
considered chemical mixtures and are therefore currently subject to DEA
chemical regulations, regardless of concentration. (As stated earlier,
DEA does not consider a chemical mixture to mean the combination of a
listed chemical and an inert carrier. An inert carrier can be any
chemical that does not modify the function of the listed chemical but
is present to aid in the delivery of the listed chemical. Examples
include, but are not limited to, dilutions in water, alcohol or the
presence of a carrier gas.) No chemical mixtures containing
hypophosphorous acid have been identified by DEA.
Traffickers use hypophosphite salts and hypophosphorous acid
similarly. DEA has identified several chemical mixtures containing
hypophosphite salts in combination with other chemicals for use as mold
and mildew inhibitors. Additionally, DEA has identified at least one
industrial product where sodium hypophosphite is in a chemical mixture
in combination with resins. The concentration of hypophosphite salts
within these chemical mixtures does not exceed 20 percent.
The above chemical mixtures have limited potential for use in a
clandestine laboratory because of the (a) low concentrations of the
hypophosphite salts, and (b) interference from other chemicals in the
mixtures. Therefore, DEA is proposing that a 30 percent concentration
limit for hypophosphorous acid and its salts (hypophosphite salts) be
established.
It is important to clarify, again, that DEA does not consider a
chemical mixture to mean the combination of a listed chemical and an
inert carrier. Therefore, solutions of hypophosphorous acid or
hypophosphite salt in water, alcohol, or another inert carrier, are not
considered chemical mixtures and are therefore currently subject to DEA
chemical regulatory controls regardless of concentration.
As discussed above, only the smallest clandestine methamphetamine
laboratories use chemical mixtures obtained from matchbook striker
plates as a source of red phosphorus. Although concerned about this
type of diversion, DEA determined that the regulation of matchbook
striker plates is impractical and will create undue administrative
burdens for both law enforcement and the regulated sector.
DEA is proposing an 80 percent concentration limit for red
phosphorus. DEA has determined that chemical mixtures containing over
80 percent red phosphorus are useful in large-scale methamphetamine
production and therefore should not be automatically exempt from
regulatory controls.
A chemical mixture having a regulated form of phosphorus at or
below the concentration limit can still be a regulated chemical mixture
if another listed chemical is present above its concentration limit.
The exemption of chemical mixtures from regulatory controls does not
remove criminal liability for persons who knowingly sell or possess any
products containing regulated phosphorus for use in violation of the
CSA.
Exemption by Application Process
DEA recognizes that the concentration limits proposed in this rule
may not identify all phosphorus mixtures that should receive exemption
status. DEA has implemented an application process to exempt additional
mixtures (21 CFR 1310.13). This application process was finalized in
the Final Rule (68 FR 23195) published May 1, 2003. Under the
application process, manufacturers may submit an application for
exemption for those mixtures that do not qualify for automatic
exemption. Exemption status can be granted if DEA determines that the
mixture is formulated in such a way that it cannot be easily used in
the illicit production of a controlled substance and the listed
chemical cannot be readily recovered (i.e., it meets the conditions in
21 U.S.C. 802(39)(A)(vi)). An application may be for a single or a
multiple number of formulations. All chemical mixtures which are
granted exemption via the application process will be listed in 21 CFR
1310.13(i).
This rulemaking is also proposing changes to the existing
application process. 21 CFR 1310.13(e) provides that within 30 days
after the receipt of an application for an exemption, the Administrator
will notify the applicant of acceptance or rejection of the
application. This paragraph is proposed to be modified in order to
clarify that this acceptance or rejection only pertains to the
acceptance or rejection of the application ``for filing'' and does not
pertain to the granting or denial of the application based upon the
merits of the application. Furthermore, DEA is proposing that this
paragraph be modified by removing the 30-day timeframe for
notification, and instead, specify that such notification be ``in
writing'' and ``within a reasonable period of time''.
Thresholds and Excluded Transactions for Regulated Phosphorus Chemical
Mixtures
Regulated phosphorus compounds do not have a threshold as described
in 21 CFR 1310.04(g)(1). Thus, all transactions in regulated
phosphorus, including its regulated chemical mixtures, are regulated
transactions. Certain transactions, described in 21 CFR 1310.08, are
excluded from the definition of a regulated transaction. These are
domestic and international return shipments of reusable containers from
customer to producer containing residual quantities of red phosphorus
or white phosphorus in rail cars and intermodal tank containers which
conform to International Standards Organization specifications (with
capacities greater than or equal to 2,500 gallons in a single
container). This exclusion also applies to regulated chemical mixtures
containing red phosphorus or white phosphorus.
Requirements That Apply to Regulated List I Chemical Mixtures
Persons interested in handling List I chemicals, including
regulated chemical mixtures containing List I chemicals, must comply
with the following:
Registration. Any person who manufactures, distributes, imports, or
exports a List I chemical, or proposes to engage in the manufacture,
distribution, importation, or exportation of a List I chemical, must
obtain a registration pursuant to the CSA (21 U.S.C. 823, 957).
Regulations describing registration for List I chemical handlers are
set forth in 21 CFR part 1309.
[[Page 36310]]
Separate registration is required for manufacturing, distribution,
importing, and exporting. Different locations operated by a single
entity require separate registration if any location is involved with
the manufacture, distribution, import, or export of a List I chemical.
Any person manufacturing, distributing, importing, or exporting a
regulated List I chemical mixture is subject to the registration
requirement under the CSA. DEA recognizes, however, that it is not
possible for persons who manufacture, distribute, import, or export
regulated phosphorus compounds, to immediately complete and submit an
application for registration and for DEA to issue registrations
immediately for those activities. Therefore, to allow continued
legitimate commerce in the compounds, DEA is proposing to establish in
21 CFR 1310.09 a temporary exemption from the registration requirement
for persons desiring to manufacture, distribute, import, or export
regulated phosphorus compounds, provided that DEA receives a properly
completed application for registration on or before 30 days after DEA
publishes a Final Rule finalizing these requirements in the Federal
Register. The temporary exemption for such persons will remain in
effect until DEA takes final action on their application for
registration.
The temporary exemption applies solely to the registration
requirement; all other chemical control requirements, including
recordkeeping and reporting, will remain in effect. Additionally, the
temporary exemption does not suspend applicable federal criminal laws
relating to the phosphorus compounds, nor does it supersede state or
local laws or regulations. All handlers of these materials must comply
with their state and local requirements in addition to the CSA and
other federal regulatory controls.
DEA notes that warehouses are exempt from the requirement of
registration and may lawfully possess List I chemicals, if the
possession of those chemicals is in the usual course of business (21
U.S.C. 822(c)(2), 21 U.S.C. 957(b)(1)(B)). For purposes of this
exemption, the warehouse must receive the List I chemical from a DEA
registrant and shall only distribute the List I chemical back to the
DEA registrant and registered location from which it was received. All
other activities conducted by a warehouse do not fall under this
exemption; a warehouse that distributes List I chemicals to persons
other than the registrant and registered location from which they were
obtained is conducting distribution activities and is required to
register as such (21 U.S.C. 802(39)(A)(ii)).
Records and Reports. The CSA (21 U.S.C. 830) requires that certain
records be kept and reports be made that involve listed chemicals.
Regulations describing recordkeeping and reporting requirements are set
forth in 21 CFR part 1310. A record must be made and maintained for two
years after the date of a transaction involving a listed chemical,
provided the transaction is a regulated transaction.
Each regulated bulk manufacturer of a regulated mixture shall
submit manufacturing, inventory and use data on an annual basis (21 CFR
1310.05(d)). Bulk manufacturers producing the mixture solely for
internal consumption, e.g., formulating a non-regulated mixture, are
not required to submit this information. Existing standard industry
reports containing the required information are acceptable, provided
the information is readily retrievable from the report.
Title 21 CFR 1310.05 requires that each regulated person shall
report to DEA any regulated transaction involving an extraordinary
quantity of a listed chemical, an uncommon method of payment or
delivery, or any other circumstance that the regulated person believes
may indicate that the listed chemical will be used in violation of the
CSA. Regulated persons are also required to report to DEA any proposed
regulated transaction with a person whose description or other
identifying information has been furnished to the regulated person.
Finally, regulated persons are required to report any unusual or
excessive loss or disappearance of a listed chemical.
Import/Export. All imports/exports of a listed chemical shall
comply with the CSA (21 U.S.C. 957 and 971). Regulations for
importation and exportation of List I chemicals are described in 21 CFR
part 1313. Separate registration is necessary for each activity (21 CFR
1309.22).
Security. All applicants and registrants shall provide effective
controls against theft and diversion of chemicals as described in 21
CFR 1309.71.
Administrative Inspection. Places, including factories, warehouses,
or other establishments and conveyances, where regulated persons may
lawfully hold, manufacture, or distribute, dispense, administer, or
otherwise dispose of a regulated chemical/chemical mixture, or where
records relating to those activities are maintained, are controlled
premises as defined in 21 CFR 1316.02(c). The CSA (21 U.S.C. 880)
allows for administrative inspections of these controlled premises as
provided in 21 CFR 1316 subpart A.
The goal of this rulemaking is to deny traffickers access to
regulated phosphorus compounds while minimizing the burden on
legitimate industry. Persons who obtain a regulated chemical, but do
not distribute the chemical, are end users. End users are not subject
to CSA chemical regulatory control provisions such as registration or
recordkeeping requirements. Some examples of end users are those who
chemically react phosphorus compounds and change them into non-listed
chemicals, formulate phosphorus compounds into exempt chemical mixtures
or consume them in industrial processes.
Technical Revision to 21 CFR 1310.12(a) and 1310.13(i)
While preparing this rulemaking, DEA became aware that references
to section 1018 of the Act (21 U.S.C. 971) were inadvertently omitted
from 21 CFR 1310.12(a) and 1310.13(i). Therefore, DEA is proposing that
this rulemaking amend these sections by adding this citation. This
insertion is a clarification and does not alter the current treatment
of exempt chemical mixtures under the CSA.
As DEA discussed in its December 15, 2004, Final Rule (specifically
69 FR 74963, comment 10) all chemical mixtures not exempt from CSA
regulatory controls are subject to all aspects of those controls,
including importation and exportation requirements. Thus, chemical
mixtures that are exempt under 21 CFR 1310.12 and 1310.13 are also
exempt from the requirements of Section 1018 of the Act (21 U.S.C.
971). The requirements of 21 U.S.C. 971 apply to ``each regulated
person, who imports or exports a listed chemical.'' Since a person
distributing an exempt chemical mixture is not a ``regulated person''
as defined by 21 U.S.C. 802(38), that person is exempt from the
requirements of 21 U.S.C. 971.
DEA notes that this is a technical correction only. All exempt
chemical mixtures have been treated as such for import and export
purposes, and all regulated mixtures have been treated as regulated
transactions for import and export purposes. DEA is merely including a
reference which was inadvertently omitted from this regulatory
language.
Regulatory Certifications
Regulatory Flexibility and Small Business Concerns
The Deputy Administrator hereby certifies that this rulemaking has
been
[[Page 36311]]
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.
601-612). In the ANPRM, DEA sought information from manufacturers about
the impact of setting concentration limits for chemical mixtures
containing phosphorus. Only three companies, none small businesses,
provided information. Some of the mixtures sold by one of the
commenters would be subject to this proposed rule, but DEA could not
determine whether any of the products that may be produced with those
phosphorus mixtures would also be covered. DEA is, therefore, seeking
comments on whether any of the products contain phosphorus would exceed
the proposed concentration limits. DEA notes, however, that the cost of
compliance with the rule is low and is unlikely to impose a significant
cost on any manufacturing, distributing, importing, or exporting firm.
The recordkeeping requirements can be met with standard business
records; most firms maintain adequate security to meet DEA's
regulations. The primary cost of compliance is the registration fee.
For manufacturers, the registration fee is $2,293 annually; for
distributors, importers, and exporters, the fee is $1,147 annually.
These fees are substantially less than one percent of annual sales for
manufacturers, distributors, importers, and exporters. Data from the
2002 Economic Census indicate that small chemical manufacturers
generally have sales well above $1 million; most small chemical
distributors have sales above $250,000.
Executive Order 12866
This regulation has been drafted and reviewed in accordance with
Executive Order 12866, Section 1(b), Principles of Regulation. It has
been determined that this rule is a ``significant regulatory action''
under Executive Order 12866, Section 3(f), Regulatory Planning and
Review, and accordingly this rule has been reviewed by the Office of
Management and Budget. The information DEA received in response to the
ANPRM indicates that few phosphorus mixtures will be subject to the
regulation. Those mixtures appear to be produced by current DEA
registrants on whom the rule will impose no new requirements. DEA is
seeking comments on whether any firms purchasing covered mixtures are
producing products that would themselves be subject to the rule.
As stated earlier in this rulemaking the vast majority of the
chemical mixtures that will become subject to this proposed rulemaking
have large industrial uses. Regulated chemical mixtures are not items
having common household uses. Although concerned about the diversion of
matchbook striker plates, DEA determined that the regulation of
matchbook striker plates is impractical and will create undue
administrative burdens for both law enforcement and the regulated
sector.
Benefits. Phosphorus is a chemical important in the clandestine
manufacture of methamphetamine and amphetamine. This rule seeks to
eliminate the use of certain chemical mixtures whose high
concentrations of phosphorus make them valued by traffickers seeking
this chemical for their clandestine laboratory operations.
Methamphetamine remains the primary drug produced in illicit
laboratories within the U.S. Data from the El Paso Intelligence
Center's (EPIC) Clandestine Laboratory Database indicates that there
were more than 17,170 methamphetamine laboratory incidents in calendar
year 2004; in 2005, as State laws began to limit sales of over-the-
counter medications containing primary ingredients used in the illicit
manufacture of methamphetamine (ephedrine, pseudoephedrine, and
phenylpropanolamine), the number of incidents declined to 12,139. In
2006, with both State and Federal controls coming into effect, the
number of incidents fell significantly to 7,347, but that is still
about 20 clandestine laboratory incidents a day.
According to the Substance Abuse and Mental Health Services
Administration (SAMHSA), Drug Abuse Warning Network, in 2003, the
latest year for which data are available (since SAMHSA is currently
amending 2004, 2005, and 2006 data), amphetamine and methamphetamine
emergency department (ED) visits rose from 25,200 in 1995 to 38,960 in
2002 and 42,500 in 2003 If the cost of the ED visit is $500, which is
probably low in many areas, the total cost for 42,500 visits would have
been $21.25 million for 2003.
The surge in methamphetamine abuse and the manufacture of the drug
in clandestine laboratories have caused serious law enforcement and
environmental problems, particularly in rural communities. Rural areas
are frequently the site of clandestine laboratories because the
manufacturing process produces distinctive odors and can be identified
if there are close neighbors. Besides causing crime as clandestine
laboratory operators steal ingredients to make methamphetamine and
steal to support their addiction, the clandestine laboratories often
leave serious pollution behind. A laboratory can produce 6 to 10 pounds
of hazardous waste for every pound of methamphetamine produced. As DEA
noted in its Interim Final Rule implementing the retail sales
requirements of the Combat Methamphetamine Epidemic Act of 2005 (CMEA)
(Title VII of Pub. L. 109-172), clean-up costs in Fiscal Year 2006 were
more than $12 million (71 FR 56008, September 26, 2006).
The Federal and State cleanups are generally limited to removing
chemicals that could be reused; they do not address water and soil
pollution that remains. Owners of the property are responsible for
completing the cleanup of contaminated water and soil, but if the owner
cannot pay the cost, either the local governments must bear the burden
or the contamination remains.
This rule is intended to continue the trend of reducing the number
of clandestine laboratories. This trend will reduce the cost to State
and local governments as well as the hazard to law enforcement officers
and others from exposure to the toxic chemicals left behind.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in cost
or prices; or significant adverse effects on competition, employment,
investment, productivity, innovation, or
[[Page 36312]]
on the ability of United States-based companies to compete with
foreign-based companies in domestic and export markets.
Paperwork Reduction Act
This rule proposes that chemical mixtures containing 80 percent and
less of red phosphorus or 30 percent and less of hypophosphorous acid
or its salts are automatically exempt from CSA regulatory controls
pertaining to chemicals and that no automatic exemption be established
for chemical mixtures containing white phosphorus. Under this proposed
method of automatic exemption, persons who handle these exempt chemical
mixtures will not be subject to CSA regulatory controls, including the
requirement to register with DEA, the requirement to report
manufacturing activities to DEA annually, and the requirement to file
importation and exportation advance notification and return declaration
information with DEA. For persons handling regulated chemical mixtures,
DEA anticipates granting some of these mixtures exempt status by the
application process (21 CFR 1310.13).
At this time, DEA lacks specific information regarding the
potential impact of this regulation on the regulated industry. DEA does
not believe that the impact will be significant, and has been unable to
identify any chemical mixtures that are certain to be affected by this
regulation. DEA also anticipates that some chemical mixtures would be
granted exemptions based on the application process.
DEA does not have reliable estimates regarding the number of
persons who would be required to register as a result of the control of
chemical mixtures containing regulated forms of phosphorus. Nor does
DEA have accurate estimates regarding manufacturing, import and export
activities involving chemicals mixtures addressed in this rulemaking.
Responses to the previous Advance Notice of Proposed Rulemaking did not
address this issue. Therefore, DEA is specifically seeking information
regarding the number of persons affected, and the potential number of
importation and exportation transactions that would be affected by this
regulation. Therefore, DEA will revise three existing information
collections related to the handling of chemical mixtures containing
listed forms of phosphorus once it receives further information:
``Application for Registration under Domestic Chemical
Diversion Control Act of 1993 and Renewal Application for Registration
under Domestic Chemical Diversion Control Act of 1993'' [OMB
information collection 1117-0031]
``Annual Reporting Requirement for Manufacturers of Listed
Chemicals'' [OMB information collection 1117-0029]
``Import/Export Declaration for List I and List II
Chemicals'' [OMB information collection 1117-0023]
List of Subjects in 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, reporting
requirements.
For the reasons set out above, 21 CFR Part 1310 is proposed to be
amended as follows:
PART 1310-- RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES [AMENDED]
1. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
2. Section 1310.09 is amended by revising paragraph (k) to read as
follows:
Sec. 1310.09 Temporary Exemption From Registration.
* * * * *
(k) Each person required by Sections 302 and 1007 of the Act (21
U.S.C. 822 and 957) to obtain a registration to manufacture,
distribute, import, or export regulated chemical mixtures which contain
red phosphorus, white phosphorus, hypophosphorous acid (and its salts),
pursuant to Sections 1310.12 and 1310.13, is temporarily exempted from
the registration requirement, provided that DEA receives a properly
completed application for registration or application for exemption on
or before July 26, 2010. The exemption will remain in effect for each
person who has made such application until the Administrator has
approved or denied that application. This exemption applies only to
registration; all other chemical control requirements set forth in
parts 1309, 1310, and 1313 of this chapter remain in full force and
effect. Any person who manufactures, distributes, imports, or exports a
chemical mixture whose application for exemption is subsequently denied
by DEA must obtain a registration with DEA. A temporary exemption from
the registration requirement will also be provided for these persons,
provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has not been approved.
The temporary exemption for such persons will remain in effect until
DEA takes final action on their registration application.
3. Section 1310.12 is amended by revising paragraph (a) and by
amending the Table of Concentration Limits in paragraph (c) by adding
entries for ``hypophosphorous acid and its salts'', ``red phosphorus'',
and ``white phosphorus'' in alphabetical order to read as follows:
Sec. 1310.12 Exempt Chemical Mixtures.
(a) The chemical mixtures meeting the criteria in paragraphs (c) or
(d) of this Section are exempted by the Administrator from application
of Sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C.
822, 823, 830, 957, 958, and 971) to the extent described in paragraphs
(b) and (c) of this Section.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical
List I chemicals code number Concentration (percent) Special conditions
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Hypophosphorous acid and its salts.... 6797 30% by weight if a solid, The weight is determined by
weight or volume if a measuring the mass of
liquid. hypophosphorous acid and its
salts in the mixture; the
concentration limit is
calculated by summing the
concentrations of all forms
of hypophosphorous acid and
its salts in the mixture.
The Administration does not
consider a chemical mixture
to mean the combination of a
listed chemical and an inert
carrier. Therefore, any
solution consisting of
hypophosphorous acid (and
its salts), dispersed in
water, alcohol, or another
inert carrier, is not
considered a chemical
mixture and is therefore
subject to chemical
regulatory controls at all
concentrations.
[[Page 36313]]
* * * * * * *
Red Phosphorus........................ 6795 80% by weight............
* * * * * * *
White phosphorus...................... 6796 Not exempt at any Chemical mixtures containing
concentration. any amount of white
phosphorus are not exempt
due to concentration, unless
otherwise exempted.
* * * * * * *
List II chemicals.....................
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
4. Section 1310.13 is amended by revising paragraph (e) and
paragraph (i) introductory text to read as follows:
Sec. 1310.13 Exemption of chemical mixtures; application.
* * * * *
(e) Within a reasonable period of time after the receipt of an
application for an exemption under this section, the Administrator will
notify the applicant in writing of the acceptance or rejection of the
application for filing. If the application is not accepted for filing,
an explanation will be provided. The Administrator is not required to
accept an application if any information required pursuant to paragraph
(c) of this section or requested pursuant to paragraph (d) of this
section is lacking or not readily understood. The applicant may,
however, amend the application to meet the requirements of paragraphs
(c) and (d) of this section. If the exemption is subsequently granted,
the applicant shall again be notified in writing and the Administrator
shall issue, and publish in the Federal Register, an order on the
application. This order shall specify the date on which it shall take
effect. The Administrator shall permit any interested person to file
written comments on or objections to the order. If any comments or
objections raise significant issues regarding any findings of fact or
conclusions of law upon which the order is based, the Administrator may
suspend the effectiveness of the order until he has reconsidered the
application in light of the comments and objections filed. Thereafter,
the Administrator shall reinstate, terminate, or amend the original
order as deemed appropriate.
* * * * *
(i) The following chemical mixtures, in the form and quantity
listed in the application submitted (indicated as the ``date'') are
designated as exempt chemical mixtures for the purposes set forth in
this section and are exempted by the Administrator from application of
Sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822,
823, 830, 957, 958, and 971):
* * * * *
Dated: June 16, 2010.
Michele M. Leonhart,
Acting Administrator.
[FR Doc. 2010-15160 Filed 6-24-10; 8:45 am]
BILLING CODE 4410-09-P