Chemical Mixtures Containing Listed Forms of Phosphorus and Change in Application Process, 31824-31831 [2011-13686]
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Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Rules and Regulations
at 19 U.S.C. 58b, created an option for
civil aircraft desiring to land at an
airport other than an international
airport or a landing rights airport. A
civil aircraft arriving from a place
outside of the United States may ask for
permission to land at an airport
designated by the Secretary of
Homeland Security as a user fee airport.
Pursuant to 19 U.S.C. 58b, an airport
may be designated as a user fee airport
if the Commissioner of CBP as delegated
by the Secretary of Homeland Security
determines that the volume of business
at the airport is insufficient to justify
customs services at the airport and the
governor of the state in which the
airport is located approves the
designation. Generally, the type of
airport that would seek designation as a
user fee airport would be one at which
a company, such as an air courier
service, has a specialized interest in
regularly landing.
As the volume of business anticipated
at this type of airport is insufficient to
justify its designation as an
international or landing rights airport,
the availability of customs services is
not paid for out of appropriations from
the general treasury of the United States.
Instead, customs services are provided
on a fully reimbursable basis to be paid
for by the user fee airport on behalf of
the recipients of the services.
The fees which are to be charged at
user fee airports, according to the
statute, shall be paid by each person
using the customs services at the airport
and shall be in the amount equal to the
expenses incurred by the Commissioner
of CBP in providing customs services
which are rendered to such person at
such airport, including the salary and
expenses of those employed by the
Commissioner of CBP to provide the
customs services. To implement this
provision, generally, the airport seeking
the designation as a user fee airport or
that airport’s authority agrees to pay a
flat fee for which the users of the airport
are to reimburse the airport/airport
authority. The airport/airport authority
agrees to set and periodically review the
charges to ensure that they are in accord
with the airport’s expenses.
The Commissioner of CBP designates
airports as user fee airports pursuant to
19 U.S.C. 58b. If the Commissioner
decides that the conditions for
designation as a user fee airport are
satisfied, a Memorandum of Agreement
(MOA) is executed between the
Commissioner of CBP and the local
responsible official signing on behalf of
the state, city or municipality in which
the airport is located. In this manner,
user fee airports are designated on a
case-by-case basis. The regulation
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pertaining to user fee airports is 19 CFR
122.15. It addresses the procedures for
obtaining permission to land at a user
fee airport, the grounds for withdrawal
of a user fee designation and includes
the list of user fee airports designated by
the Commissioner of CBP in accordance
with 19 U.S.C. 58b. Periodically, CBP
updates the list of user fee airports at 19
CFR 122.15(b) to reflect those that have
been recently designated by the
Commissioner. On January 28, 2011, the
Commissioner signed an MOA
approving the designation of user fee
status for Dallas Love Field Municipal
Airport. This document updates the list
of user fee airports by adding Dallas
Love Field Municipal Airport, in Dallas,
Texas, to the list.
II. Statutory and Regulatory
Requirements
Order 13132, this rule does not have
sufficient federalism implications to
warrant the preparation of a federalism
summary impact statement.
E. Signing Authority
This document is limited to technical
corrections of CBP regulations.
Accordingly, it is being signed under
the authority of 19 CFR 0.1(b).
List of Subjects in 19 CFR Part 122
Air carriers, Aircraft, Airports,
Customs duties and inspection, Freight.
Part 122, Code of Federal Regulations
(19 CFR part 122) is amended as set
forth below:
PART 122—AIR COMMERCE
REGULATIONS
1. The authority citation for Part 122
continues to read as follows:
■
A. Inapplicability of Public Notice and
Delayed Effective Date Requirements
Because this amendment merely
updates the list of user fee airports to
include an airport already designated by
the Commissioner of CBP in accordance
with 19 U.S.C. 58b and neither imposes
additional burdens on, nor take away
any existing rights or privileges from,
the public, pursuant to 5 U.S.C.
553(b)(B), notice and public procedure
are unnecessary, and for the same
reasons, pursuant to 5 U.S.C. 553(d)(3),
a delayed effective date is not required.
B. The Regulatory Flexibility Act and
Executive Order 12866
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply. This
amendment does not meet the criteria
for a ‘‘significant regulatory action’’ as
specified in Executive Order 12866.
Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66,
1431, 1433, 1436, 1448, 1459, 1590, 1594,
1623, 1624, 1644, 1644a, 2071 note.
§ 122.15
[Amended]
2. The listing of user fee airports in
section 122.15(b) is amended by adding,
in alphabetical order, in the ‘‘Location’’
column ‘‘Dallas, Texas’’ and in the
‘‘Name’’ column, ‘‘Dallas Love Field
Municipal Airport’’.
■
Dated: May 24, 2011.
Alan D. Bersin,
Commissioner, U.S. Customs and Border
Protection.
[FR Doc. 2011–13615 Filed 6–1–11; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
C. 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 $100 million or more
in any one year, and it will not
significantly or uniquely affect small
governments. Therefore, no actions are
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995.
21 CFR Part 1310
D. Executive Order 13132
The rule will not have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with section 6 of Executive
SUMMARY:
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[Docket No. DEA–228F]
RIN 1117–AA66
Chemical Mixtures Containing Listed
Forms of Phosphorus and Change in
Application Process
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
This rulemaking finalizes a
June 25, 2010, notice of proposed
rulemaking in which DEA proposed
regulations which establish those
chemical mixtures containing red
phosphorus or hypophosphorous acid
and its salts (hereinafter ‘‘regulated
phosphorus’’) that shall automatically
qualify for exemption from the
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Controlled Substances Act (CSA)
regulatory controls. 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 implementing
automatic exemption for any
concentration of chemical mixtures
containing white phosphorus (also
known as yellow 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 finalizes changes
to the application review and
notification process.
DATES: This rulemaking becomes
effective July 5, 2011. Persons seeking
registration must apply on or before July
5, 2011 to continue their business
pending final action by DEA on their
application.
FOR FURTHER INFORMATION CONTACT:
Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone
(202) 307–8784.
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
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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 finalizing
concentration limits on chemical
mixtures containing red phosphorus
and/or hypophosphorous acid and its
salts. This rule is being finalized as
proposed. Chemical mixtures containing
either of these listed chemicals at or
below the concentration limit will be
automatically exempt from CSA
regulatory controls. Mixtures containing
these chemicals above the concentration
limit will be regulated as List I
chemicals. DEA did not propose
automatic exemption for chemical
mixtures containing white phosphorus.
Unless otherwise exempted, all material
containing white phosphorus shall be
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 also 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 (Pub. L.
103–200) (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
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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)). This authority has been
delegated to the Administrator of DEA
by 28 CFR 0.100 (Subpart R).
DEA has treated all regulated
chemical mixtures as non-regulated
chemicals until such time that it
promulgates a final rule that identifies
concentration limits, above which the
chemical mixtures are regulated. 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
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
combination with any number of nonlisted 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
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identified exempt mixtures containing
the chemicals ephedrine, Nmethylephedrine, Nmethylpseudoephedrine,
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.
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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.
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.
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Concentration Limits for Exempt
Chemical Mixtures Containing
Regulated Phosphorus
DEA is establishing concentration
limits for chemical mixtures containing
phosphorus. 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 did not propose a
concentration limit for white
phosphorus, and, therefore, any
chemical mixture containing white
phosphorus shall 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
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salts, and (b) interference from other
chemicals in the mixtures. Therefore,
DEA is establishing a 30 percent
concentration limit for
hypophosphorous acid and its salts
(hypophosphite salts).
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 establishing 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.
Comments to the Notice of Proposed
Rulemaking
In response to the June 25, 2010,
Notice of Proposed Rulemaking (75 FR
36306), DEA received two comments.
The first comment was received from a
large chemical company. This firm
indicated that they have one product
which they export which shall become
subject to regulation. However, the firm
stated that they will not be significantly
impacted by this rulemaking and
supported the mixture criteria proposed
in the rule. Furthermore, the comment
commended DEA for taking a reasonable
approach.
DEA Response. DEA appreciates this
comment and believes that the
concentration limits finalized in this
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rule are reasonable based on the illicit
uses of phosphorus mixtures.
The second comment was from an
association representing full-service
wholesale healthcare distributors. Their
members distribute more than 9 million
prescription and healthcare products.
The comment stated that they reached
out to their members in an attempt to
identify specific products containing
phosphorus which would be subject to
the proposed regulatory controls. Their
review indicated that they do not
believe that any healthcare product
distributors’ products are subject to the
proposed rule. However, the association
expressed concern that wholesale
distributors may be subjected to a rule
without sufficient ability to provide
meaningful public comment. The
commenter posited that, during the
comment period, other public
comments may be received that would
contain further information about
products that could be subject to the
rule and which may also pertain to
products distributed by healthcare
product distributors. The association
recommended that DEA reopen the
rule’s comment period if the notice and
comment period resulted in DEA
obtaining further information relevant to
the chemical mixtures or products
potentially subject to the rule.
DEA Response. As DEA did not
receive other comments to the NPRM
identifying chemical mixtures
containing listed forms of phosphorus,
DEA believes that it has thoroughly
examined the number and types of
mixtures potentially affected by this
rule and has adequately addressed the
impact of this rule on the regulated
community. DEA notes, in fact, that the
only other commenter to this rule
supported the rule as proposed. This
conclusion is consistent with
information developed by DEA, through
DEA’s research and comments received
in response to the Advanced Notice of
Proposed Rulemaking published
January 31, 2003, (68 FR 4968) which
specifically sought such information
from interested parties. DEA does not
believe that any products distributed by
healthcare distributors will fall under
the regulatory controls being finalized
here. Therefore, DEA does not believe
that this final rule will have any impact
on this association’s members.
After careful consideration of the
comments received, DEA is hereby
finalizing these regulatory controls
exactly as proposed in the June 25,
2010, Notice of Proposed Rulemaking
(75 FR 36306).
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Exemption by Application Process
DEA recognizes that the concentration
limits established 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 also establishes
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 being
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
modifying this paragraph 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
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capacities greater than or equal to 2500
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.
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 establishing 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 July 5, 2011.
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.
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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
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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 part 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 the June 25, 2010
Notice of Proposed 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 proposed the amendment of these
sections by adding this citation. This
Final Rule implements that
modification. 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
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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 Analyses
Regulatory Flexibility and Small
Business Concerns
The Administrator hereby certifies
that this rulemaking has been drafted in
accordance with the Regulatory
Flexibility Act (5 U.S.C. 601–612). The
RFA requires agencies to determine
whether a rulemaking could have a
significant economic impact on a
substantial number of small entities.
DEA sought comment on two separate
occasions regarding this action. On
January 31, 2003, DEA published in the
Federal Register an ANPRM (68 FR
4968) to solicit input from industry
regarding chemical mixtures containing
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 to
the ANPRM informed DEA of
commercial applications for their
chemical mixtures containing regulated
phosphorus. The commenters also
informed DEA of concentration ranges
for red phosphorus and salts of
hypophosphorous acid (e.g.
hypophosphite salts). In the NPRM,
DEA sought information from
manufacturers about the impact of
setting concentration limits for chemical
mixtures containing phosphorus. Only
two comments were received in
response to the NPRM. Neither of these
comments noted information to change
DEA’s belief that the cost of compliance
with this rule is low and is unlikely to
impose a significant cost on any
manufacturing, distributing, importing,
or exporting firm. DEA has not
identified any chemical mixtures
containing hypophosphorous acid or
white phosphorus either through
industry comments or as a result of DEA
research. It is possible, therefore, that
there are no entities that will be subject
to DEA’s requirements because of this
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rule. Nonetheless, DEA provides the
following discussion describing small
businesses that might potentially handle
these chemical mixtures.
The rules for listed chemicals apply to
chemical manufacturers, distributors,
importers, and exporters. The chemical
manufacturers that would handle
mixtures containing phosphorus would
probably be classified in the all other
basic inorganic chemical manufacturers
sector (NAICS 325188). The average
value of shipments for chemical
manufacturers in this sector with 1–9
employees ranges from $2 million to
$5.6 million. Because the recordkeeping
requirements can be met with standard
business records and most firms
maintain adequate security to meet
DEA’s regulations, the only cost directly
associated with this rule for a chemical
manufacturer would be the DEA
registration fee of $2,293, which
represents approximately 0.1 percent of
the value of shipments for the smallest
firm. DEA assumes that chemical
distributors, importers, and exporters
that would handle mixtures containing
phosphorus fall into the other chemical
and allied products merchant
wholesalers sector (NAICS 424690). The
average revenue of chemical
wholesalers with 1–4 employees is
approximately $2.5 million. The only
cost directly associated with this rule
for a chemical distributor, importer, or
exporter would be the DEA registration
fee of $1,147, which represents
approximately 0.04 percent of revenue
for the smallest chemical wholesalers.
Based on both the lack of entities
identified that may be subject to this
regulation and the low cost of the rule,
DEA certifies that the rule will not have
a significant economic impact on a
substantial number of small entities.
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.
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.
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 Orders 13563 and 12866
This regulation has been developed in
accordance with the principles of
Executive Orders 13563 and 12866 and
has been reviewed by the Office of
Management and Budget. The
information DEA received in response
to the ANPRM and NPRM indicate 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.
As stated earlier in this rulemaking
the vast majority of the chemical
mixtures that will become subject to this
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
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 $126,400,000 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.
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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 to eliminate ambiguity,
minimize litigation, establish clear legal
standards and reduce burden.
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.
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
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31829
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
Executive Order 13175
This rule will not have Tribal
implications and will not impose
substantial direct compliance costs on
Indian Tribal governments.
Paperwork Reduction Act
This rule establishes regulations
stating 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 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).
Given comments received in response
to the NPRM, DEA does not believe that
the impact will be significant. DEA
anticipates that some chemical mixtures
would be granted exemptions based on
the application process.
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 amended as follows:
PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES
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
adding paragraph (m) to read as follows:
■
§ 1310.09 Temporary exemption from
registration.
*
*
*
*
*
(m)(1) Each person required by
Sections 302 or 1007 of the Act (21
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Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Rules and Regulations
U.S.C. 822, 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 §§ 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 5, 2011. The exemption will remain
in effect for each person who has made
such application until the
Administration 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.
(2) Any person who manufactures,
distributes, imports, or exports a
chemical mixture which contains red
phosphorus, white phosphorus,
hypophosphorous acid (and its salts)
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 those persons whose
applications are denied, 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 under
‘‘List I Chemicals’’ to read as follows:
■
§ 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
code No.
Concentration
(percent)
Special conditions
List I Chemicals
*
Hypophosphorous acid
and its salts.
*
*
Red Phosphorus ............
*
*
White phosphorus ..........
*
*
6797
*
30% by weight if a solid,
weight or volume if a
liquid.
*
*
*
*
The weight is determined by measuring the mass of 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.
*
80% by weight.
*
6795
6796
*
Not exempt at any concentration.
*
*
*
*
Chemical mixtures containing any amount of white phosphorus are not
exempt due to concentration, unless otherwise exempted.
*
*
*
*
*
*
*
4. Section 1310.13 is amended by
revising paragraph (e) and paragraph (i)
introductory text to read as follows:
■
§ 1310.13 Exemption of chemical mixtures;
application.
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*
*
*
*
*
(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
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*
*
*
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
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*
Sfmt 4700
*
*
*
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):
*
*
*
*
*
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Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Rules and Regulations
Dated: May 16, 2011.
Michele M. Leonhart,
Administrator.
Table of Contents for Preamble
[FR Doc. 2011–13686 Filed 6–1–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 1, 27, 96, 101, 107, 115,
117, 135, 140, 148, 150, 151, 160, 161,
162, 164, 166, 167, and 169
[Docket No. USCG–2011–0257]
RIN 1625–AB69
Navigation and Navigable Waters;
Technical, Organizational, and
Conforming Amendments
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
This rule makes nonsubstantive changes throughout Title 33
of the Code of Federal Regulations. The
purpose of this rule is to make
conforming amendments and technical
corrections to Coast Guard navigation
and navigable water regulations. This
rule will have no substantive effect on
the regulated public. These changes are
provided to coincide with the annual
recodification of Title 33 on July 1,
2011.
SUMMARY:
This final rule is effective June
2, 2011.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2011–0257 and are
available for inspection or copying at
the Docket Management Facility (M–30),
U.S. Department of Transportation,
West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. You may also
find this docket on the Internet by going
to https://www.regulations.gov, inserting
USCG–2011–0257 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
e-mail Leo Huott, Coast Guard;
telephone 202–372–1027, e-mail
Leo.S.Huott@uscg.mil. If you have
questions on viewing the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone 202–366–
9826.
SUPPLEMENTARY INFORMATION:
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DATES:
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I. Regulatory History
II. Background
III. Basis and Purpose
IV. Regulatory Analyses
A. Regulatory Planning and Review
B. Small Entities
C. Collection of Information
D. Federalism
E. Unfunded Mandates Reform Act
F. Taking of Private Property
G. Civil Justice Reform
H. Protection of Children
I. Indian Tribal Governments
J. Energy Effects
K. Technical Standards
L. Environment
I. Regulatory History
We did not publish a notice of
proposed rulemaking (NPRM) for this
rule. Under 5 U.S.C. 553(b)(A) the Coast
Guard finds this rule is exempt from
notice and comment rulemaking
requirements because these changes
involve rules of agency organization,
procedure, or practice. In addition, the
Coast Guard finds notice and comment
procedures are unnecessary under 5
U.S.C. 553(b)(B) as this rule consists
only of corrections and editorial,
organizational, and conforming
amendments and these changes will
have no substantive effect on the public.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that, for the same reasons,
good cause exists for making this rule
effective upon publication in the
Federal Register.
II. Background
Each year, the printed edition of Title
33 of the Code of Federal Regulations is
recodified on July 1. This rule, which
becomes effective June 2, 2011, makes
technical and editorial corrections
throughout Title 33. This rule does not
create any substantive requirements.
III. Basis and Purpose
This rule amends 33 CFR part 1 to
reflect changes in agency organization
by removing § 1.01–60(a)(1)(ii) and
combining § 1.01–60(a)(1)(i) with
§ 1.01–60(a)(1). Because the Coast Guard
is no longer a component of the
Department of Transportation (DOT),
DOT Order 5610.1C (Procedures for
Considering Environmental Impacts) no
longer applies.
This rule revises 33 CFR part 27. The
Coast Guard is adjusting fines and other
civil monetary penalties to reflect the
impact of inflation. These adjustments
are made in accordance with the Federal
Civil Penalties Inflation Adjustment Act
of 1990, as amended by the Debt
Collection Improvement Act of 1996,
and implement the provisions of these
statutes. These statutes require the Coast
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31831
Guard to periodically adjust the civil
monetary penalties for inflation by a
method that is specifically prescribed
within these statutes and which allows
no discretion. The statutory method
specifies the inflation measure to be
used, the method for the calculation of
the inflation adjustment, and the
method for the numerical rounding of
the results. The last inflation
adjustments were made in 2010.
The changes in Civil Penalties for
calendar year 2011 are based on the
change in CPI–U from June 2009 to June
2010. The recorded change in CPI–U
during that period was 1.05%. Because
of the small change in CPI–U and the
required rules for rounding, there was
no change to any of the maximum
penalty amounts from the previous
adjustment.
This rule amends § 115.05 by
replacing the term ‘‘builder’’ with the
term ‘‘applicant’’ to clarify the Coast
Guard’s intent and make the affected
provision consistent with other
provisions in this section and other
sections of part 115. This rule also
corrects grammatical errors and details
established requirements regarding the
information needed on the plan sheets
that accompany a bridge permit request.
This rule removes § 115.50(d) because
the information it provides is already
explained throughout the section.
This rule amends 33 CFR part 117 to
correct the names of the S14 Bridge and
the S1 Bridge and to provide an updated
phone number to the Kansas City
Southern automated bridge. Also
‘‘Pelican Island Causeway’’ is removed
from the title of § 117.977 and the
section is redesignated to follow the
alphabetical order of state waterways set
out in this subpart.
This rule amends parts 135, 140, 148,
and 150 of Title 33 with an
organizational name change from the
Minerals Management Service (MMS) to
the Bureau of Ocean Energy
Management Regulation and
Enforcement (BOEMRE).
This rule amends paragraph 161.15(a)
to correct a typographical error that
erroneously omitted the words ‘‘within
a’’. The correction to the section is not
substantive and does not impose any
new requirement, but clarifies the
meaning of this portion of part 161.
This rule amends 33 CFR part 164 to
remove LORAN C from the list of
options for vessel electronic position
fixing devices. Removing LORAN C
from 33 CFR part 164 will have no
substantive effect on the public because
the use of LORAN C has not been
supported by the Coast Guard since
February 2010, and this section is no
longer applicable.
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]]>Agencies
[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Rules and Regulations]
[Pages 31824-31831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13686]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-228F]
RIN 1117-AA66
Chemical Mixtures Containing Listed Forms of Phosphorus and
Change in Application Process
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rulemaking finalizes a June 25, 2010, notice of proposed
rulemaking in which DEA proposed regulations which establish those
chemical mixtures containing red phosphorus or hypophosphorous acid and
its salts (hereinafter ``regulated phosphorus'') that shall
automatically qualify for exemption from the
[[Page 31825]]
Controlled Substances Act (CSA) regulatory controls. 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 implementing automatic exemption for
any concentration of chemical mixtures containing white phosphorus
(also known as yellow 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
finalizes changes to the application review and notification process.
DATES: This rulemaking becomes effective July 5, 2011. Persons seeking
registration must apply on or before July 5, 2011 to continue their
business pending final action by DEA on their application.
FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone (202) 307-8784.
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 finalizing concentration limits on chemical
mixtures containing red phosphorus and/or hypophosphorous acid and its
salts. This rule is being finalized as proposed. Chemical mixtures
containing either of these listed chemicals at or below the
concentration limit will be automatically exempt from CSA regulatory
controls. Mixtures containing these chemicals above the concentration
limit will be regulated as List I chemicals. DEA did not propose
automatic exemption for chemical mixtures containing white phosphorus.
Unless otherwise exempted, all material containing white phosphorus
shall be 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 also 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
(Pub. L. 103-200) (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)). This authority has been
delegated to the Administrator of DEA by 28 CFR 0.100 (Subpart R).
DEA has treated all regulated chemical mixtures as non-regulated
chemicals until such time that it promulgates a final rule that
identifies concentration limits, above which the chemical mixtures are
regulated. 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
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 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
[[Page 31826]]
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.
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.
Concentration Limits for Exempt Chemical Mixtures Containing Regulated
Phosphorus
DEA is establishing concentration limits for chemical mixtures
containing phosphorus. 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 did not propose a concentration limit for white phosphorus, and,
therefore, any chemical mixture containing white phosphorus shall 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 establishing a 30 percent concentration
limit for hypophosphorous acid and its salts (hypophosphite salts).
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 establishing 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.
Comments to the Notice of Proposed Rulemaking
In response to the June 25, 2010, Notice of Proposed Rulemaking (75
FR 36306), DEA received two comments. The first comment was received
from a large chemical company. This firm indicated that they have one
product which they export which shall become subject to regulation.
However, the firm stated that they will not be significantly impacted
by this rulemaking and supported the mixture criteria proposed in the
rule. Furthermore, the comment commended DEA for taking a reasonable
approach.
DEA Response. DEA appreciates this comment and believes that the
concentration limits finalized in this
[[Page 31827]]
rule are reasonable based on the illicit uses of phosphorus mixtures.
The second comment was from an association representing full-
service wholesale healthcare distributors. Their members distribute
more than 9 million prescription and healthcare products. The comment
stated that they reached out to their members in an attempt to identify
specific products containing phosphorus which would be subject to the
proposed regulatory controls. Their review indicated that they do not
believe that any healthcare product distributors' products are subject
to the proposed rule. However, the association expressed concern that
wholesale distributors may be subjected to a rule without sufficient
ability to provide meaningful public comment. The commenter posited
that, during the comment period, other public comments may be received
that would contain further information about products that could be
subject to the rule and which may also pertain to products distributed
by healthcare product distributors. The association recommended that
DEA reopen the rule's comment period if the notice and comment period
resulted in DEA obtaining further information relevant to the chemical
mixtures or products potentially subject to the rule.
DEA Response. As DEA did not receive other comments to the NPRM
identifying chemical mixtures containing listed forms of phosphorus,
DEA believes that it has thoroughly examined the number and types of
mixtures potentially affected by this rule and has adequately addressed
the impact of this rule on the regulated community. DEA notes, in fact,
that the only other commenter to this rule supported the rule as
proposed. This conclusion is consistent with information developed by
DEA, through DEA's research and comments received in response to the
Advanced Notice of Proposed Rulemaking published January 31, 2003, (68
FR 4968) which specifically sought such information from interested
parties. DEA does not believe that any products distributed by
healthcare distributors will fall under the regulatory controls being
finalized here. Therefore, DEA does not believe that this final rule
will have any impact on this association's members.
After careful consideration of the comments received, DEA is hereby
finalizing these regulatory controls exactly as proposed in the June
25, 2010, Notice of Proposed Rulemaking (75 FR 36306).
Exemption by Application Process
DEA recognizes that the concentration limits established 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 also establishes 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 being 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 modifying this paragraph 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 2500 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.
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 establishing 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 July 5, 2011. 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.
[[Page 31828]]
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 part 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 the June 25, 2010 Notice of Proposed 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 proposed the amendment of these sections by adding this
citation. This Final Rule implements that modification. 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 Analyses
Regulatory Flexibility and Small Business Concerns
The Administrator hereby certifies that this rulemaking has been
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C.
601-612). The RFA requires agencies to determine whether a rulemaking
could have a significant economic impact on a substantial number of
small entities. DEA sought comment on two separate occasions regarding
this action. On January 31, 2003, DEA published in the Federal Register
an ANPRM (68 FR 4968) to solicit input from industry regarding chemical
mixtures containing 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 to the
ANPRM informed DEA of commercial applications for their chemical
mixtures containing regulated phosphorus. The commenters also informed
DEA of concentration ranges for red phosphorus and salts of
hypophosphorous acid (e.g. hypophosphite salts). In the NPRM, DEA
sought information from manufacturers about the impact of setting
concentration limits for chemical mixtures containing phosphorus. Only
two comments were received in response to the NPRM. Neither of these
comments noted information to change DEA's belief that the cost of
compliance with this rule is low and is unlikely to impose a
significant cost on any manufacturing, distributing, importing, or
exporting firm. DEA has not identified any chemical mixtures containing
hypophosphorous acid or white phosphorus either through industry
comments or as a result of DEA research. It is possible, therefore,
that there are no entities that will be subject to DEA's requirements
because of this
[[Page 31829]]
rule. Nonetheless, DEA provides the following discussion describing
small businesses that might potentially handle these chemical mixtures.
The rules for listed chemicals apply to chemical manufacturers,
distributors, importers, and exporters. The chemical manufacturers that
would handle mixtures containing phosphorus would probably be
classified in the all other basic inorganic chemical manufacturers
sector (NAICS 325188). The average value of shipments for chemical
manufacturers in this sector with 1-9 employees ranges from $2 million
to $5.6 million. Because the recordkeeping requirements can be met with
standard business records and most firms maintain adequate security to
meet DEA's regulations, the only cost directly associated with this
rule for a chemical manufacturer would be the DEA registration fee of
$2,293, which represents approximately 0.1 percent of the value of
shipments for the smallest firm. DEA assumes that chemical
distributors, importers, and exporters that would handle mixtures
containing phosphorus fall into the other chemical and allied products
merchant wholesalers sector (NAICS 424690). The average revenue of
chemical wholesalers with 1-4 employees is approximately $2.5 million.
The only cost directly associated with this rule for a chemical
distributor, importer, or exporter would be the DEA registration fee of
$1,147, which represents approximately 0.04 percent of revenue for the
smallest chemical wholesalers. Based on both the lack of entities
identified that may be subject to this regulation and the low cost of
the rule, DEA certifies that the rule will not have a significant
economic impact on a substantial number of small entities.
Executive Orders 13563 and 12866
This regulation has been developed in accordance with the
principles of Executive Orders 13563 and 12866 and has been reviewed by
the Office of Management and Budget. The information DEA received in
response to the ANPRM and NPRM indicate 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.
As stated earlier in this rulemaking the vast majority of the
chemical mixtures that will become subject to this 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.
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.
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
to eliminate ambiguity, minimize litigation, establish clear legal
standards and reduce burden.
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
$126,400,000 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 on the ability of United
States-based companies to compete with foreign-based companies in
domestic and export markets.
Executive Order 13175
This rule will not have Tribal implications and will not impose
substantial direct compliance costs on Indian Tribal governments.
Paperwork Reduction Act
This rule establishes regulations stating 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 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).
Given comments received in response to the NPRM, DEA does not
believe that the impact will be significant. DEA anticipates that some
chemical mixtures would be granted exemptions based on the application
process.
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 amended as
follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. Section 1310.09 is amended by adding paragraph (m) to read as
follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(m)(1) Each person required by Sections 302 or 1007 of the Act (21
[[Page 31830]]
U.S.C. 822, 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 Sec. Sec. 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 5, 2011. The exemption will remain in
effect for each person who has made such application until the
Administration 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.
(2) Any person who manufactures, distributes, imports, or exports a
chemical mixture which contains red phosphorus, white phosphorus,
hypophosphorous acid (and its salts) 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 those persons whose applications are denied, 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.
0
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 under ``List I Chemicals''
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 Concentration
code No. (percent) Special conditions
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Hypophosphorous acid and its salts. 6797 30% by weight if a The weight is determined by
solid, weight or measuring the mass of
volume if a 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.
* * * * * * *
Red Phosphorus..................... 6795 80% by weight. ....................................
* * * * * * *
White phosphorus................... 6796 Not exempt at any Chemical mixtures containing any
concentration. amount of white phosphorus are not
exempt due to concentration, unless
otherwise exempted.
* * * * * * *
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* * * * *
0
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):
* * * * *
[[Page 31831]]
Dated: May 16, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-13686 Filed 6-1-11; 8:45 am]
BILLING CODE 4410-09-P
