[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Rules and Regulations]
[Pages 4584-4587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00667]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-505F]
RIN 1117-ZA05
Additions to Listing of Exempt Chemical Mixtures
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Direct final rule.
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SUMMARY: Under this direct final rule, the Drug Enforcement
Administration (DEA) is updating the Table of Exempt Chemical Mixtures
to include the listing of 15 additional preparations. This action is in
response to DEA's review of new applications for exemption. Having
reviewed applications and relevant information, DEA finds that these
preparations meet the applicable exemption criteria. Therefore, these
products are exempted from the application of certain provisions of the
Controlled Substances Act.
DATES: This direct final rule is effective March 27, 2020 without
further action, unless adverse comment is received by DEA no later than
February 26, 2020. If any comments or objections raise significant
issues regarding any findings of fact or conclusions of law upon which
the order is based, the DEA will publish a timely withdrawal of the
rule in the Federal Register.
Written comments must be postmarked and electronic comments must be
submitted on or before February 26, 2020. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after 11:59 p.m. Eastern Time on the last day of the comment
period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-505F/RIN 1117-ZA05'' on all correspondence, including
any attachments.
Electronic comments: The Drug Enforcement Administration
encourages that all comments be submitted electronically through the
Federal eRulemaking Portal, which provides the ability to type short
comments directly into the comment field on the web page or to attach a
file for lengthier comments. Please go to http://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission you will receive a Comment
Tracking Number for your comment. Please be aware that submitted
comments are not instantaneously available for public view on
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments that duplicate the
electronic submission are not necessary and are discouraged. Should you
wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attn: DEA Federal Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152. Telephone: (571) 362-
3261.
SUPPLEMENTARY INFORMATION: Any interested person may file comments or
objections to this order, on or before March 27, 2020. If any such
comments or objections raise significant issues regarding any findings
of fact or conclusions of law upon which the order is based, the DEA
will publish a timely withdrawal of the rule in the Federal Register.
The Acting Administrator may reconsider the application in light of the
comments and objections filed and reinstate, terminate, or amend the
original order as deemed appropriate.
Posting of Public Comments
Please note that all comments received are considered part of the
public record and made available for public inspection online at http://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential
[[Page 4585]]
business information to be redacted within the comment. If a comment
has so much confidential business information that it cannot be
effectively redacted, all or part of that comment may not be posted on
http://www.regulations.gov. Personal identifying information and
confidential business information identified and located as set forth
above will be redacted and the comment, in redacted form, will be
posted online and placed in the Drug Enforcement Administration's
public docket file. Please note that the Freedom of Information Act
applies to all comments received.
New Exempt Chemical Mixtures
The manufacturers of 15 chemical mixtures listed below have applied
for an exemption pursuant to 21 CFR 1310.13. The Drug Enforcement
Administration (DEA) has reviewed the applications, as well as any
additional information submitted by the respective manufacturers. DEA
has found that: (1) Each of these chemical mixtures is formulated in
such a way that it cannot be easily used in the illicit production of a
controlled substance; and (2) the listed chemical(s) contained in these
chemical mixtures cannot be readily recovered. Therefore, DEA has
determined that each of the applications should be granted, and
previously issued a letter to this effect. This regulatory action
conforms DEA regulations to the exemptions previously issued.
Background
Under 21 CFR 1310.13(a), the Acting Administrator may, by
publication of a Final Rule in the Federal Register, exempt from the
application of all or any part of the Controlled Substances Act a
chemical mixture consisting of two or more chemical components, at
least one of which is not a list I or list II chemical. Each
manufacturer must apply for such an exemption (21 CFR 1310.13) to
ensure that each manufacturer's product warrants an exemption by
demonstrating 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 or chemicals contained in the chemical
mixture cannot be readily recovered.
Any manufacturer seeking an exemption for a chemical mixture, not
automatically exempt under 21 CFR 1310.12, may apply to the Acting
Administrator by submitting an application for exemption which contains
the information required by 21 CFR 1310.13(c):
The name, address, and registration number, if any, of the
applicant;
The date of the application;
The exact trade name(s) of the applicant's chemical
mixture;
The complete qualitative and quantitative composition of
the chemical mixture (including all listed and all non-listed
chemicals); or if a group of mixtures, the concentration range for the
listed chemical and a listing of all non-listed chemicals with
respective concentration ranges;
The chemical and physical properties of the mixture and
how they differ from the properties of the listed chemical or
chemicals; and if a group of mixtures, how the group's properties
differ from the properties of the listed chemical;
A statement that the applicant believes justifies an
exemption for the chemical mixture or group of mixtures. The statement
must explain how the chemical mixture(s) meets the exemption criteria;
A statement that the applicant accepts the right of the
Acting Administrator to terminate exemption from regulation for the
chemical mixture(s) granted exemption under 21 CFR 1310.13; and
The identification of any information on the application
that is considered by the applicant to be a trade secret or
confidential and entitled to protection under U.S. laws restricting the
public disclosure of such information.
The Acting Administrator may require the applicant to submit such
additional documents or written statements of fact relevant to the
application that he deems necessary for determining if the application
should be granted.
Title 21 CFR 1310.13 further specifies that within a reasonable
period of time after the receipt of an application for an exemption,
the Acting Administrator will notify the applicant of acceptance or
rejection of the application for filing. If the application is not
accepted for filing, an explanation will be provided. The Acting
Administrator is not required to accept an application if any
information required pursuant to 21 CFR 1310.13 is lacking or not
readily understood. The applicant may, however, amend the application
to meet the requirements of this section.
If the exemption is granted, the applicant shall be notified in
writing and the Acting 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 Acting 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 DEA will publish a timely withdrawal of the rule in
the Federal Register. The Acting Administrator may reconsider the
application in light of the comments and objections filed and
reinstate, terminate, or amend the original order as deemed
appropriate.
A formulation granted exemption by publication in the Federal
Register will not be exempted for all manufacturers. The current Table
of Exempt Chemical Mixtures lists those products that have been granted
exempt status prior to this update. That table can be viewed online at:
http://www.deadiversion.usdoj.gov/schedules/exempt/exempt_list.htm.
Findings
Having considered the information provided in each of the below
listed applications, I find that each of the referenced chemical
mixtures meets the requirements for exemption under 21 CFR 1310.13(a).
Therefore, each of these mixtures is exempt from the application of
sections 302, 303, 310, 1007, and 1008 of the Controlled Substances Act
(21 U.S.C. 822, 823, 830, 957 and 958).
DEA is updating the table in 21 CFR 1310.13(i) to include each of
these exempt chemical mixtures.
Regulatory Analyses
Administrative Procedure Act
An agency may find good cause to exempt a rule from prior public
notice provisions of the Administrative Procedure Act (5 U.S.C.
553(b)(B)), if it is determined to be unnecessary, impracticable, or
contrary to the public interest. DEA finds that it is unnecessary to
engage in notice and comment procedures because this rulemaking grants
exemptions for the below listed products in accordance with standards
set by existing DEA regulations. Each of these manufacturers has
previously received a letter from DEA granting exempted status for the
specific products. This regulatory action hereby conforms DEA
regulations to the exemptions previously considered and issued.
Executive Orders 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
This direct final rule was developed in accordance with the
principles of
[[Page 4586]]
Executive Orders 12866, 13563, and 13771. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health, and safety effects; distributive impacts;
and equity). Executive Order 13563 is supplemental to and reaffirms the
principles, structures, and definitions governing regulatory review as
established in Executive Order 12866. Executive Order 12866 classifies
a ``significant regulatory action,'' requiring review by the Office of
Management and Budget (OMB), as any regulatory action that is likely to
result in a rule that may: (1) Have an annual effect on the economy of
$100 million or more or adversely affect in a material way the economy,
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order. DEA has determined that this direct final rule is
not a ``significant regulatory action'' under Executive Order 12866,
section 3(f).
This direct final rule is not an Executive Order 13771 regulatory
action pursuant to Executive Order 12866 and the Office of Management
and Budget (OMB) guidance.\1\
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\1\ Office of Mgmt. & Budget, Exec. Office of The President,
Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 Titled ``Reducing Regulation and Controlling
Regulatory Costs'' (Feb. 2, 2017).
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Executive Order 12988, Civil Justice Reform
The Acting Administrator further certifies that this rulemaking
meets the applicable standards set forth in sections 3(a) and 3(b)(2)
of Executive Order 12988 to eliminate drafting errors and ambiguity,
minimize litigation, provide a clear legal standard for affected
conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the National Government and the States, or the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of Executive Order 13175. It does not have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes.
Regulatory Flexibility Act
The Acting Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), and by approving it certifies that this regulation
will not have a significant economic impact upon a substantial number
of small entities. This regulation will not have a significant impact
upon firms who distribute these products. In fact, the approval of
Exempt Chemical Mixture status for these products reduces the
regulatory requirements for distribution of these materials.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action will not
result in any Federal mandate that may result in the expenditure by
State, local and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted for inflation) in any
one year. Therefore, neither a Small Government Agency Plan nor any
other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action does not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. This rule does not result in: An annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices for consumers, individual industries, Federal, State,
or local government agencies, or geographic regions; or significant
adverse effects on competition, employment, investment, productivity,
innovation, or on the ability of U.S.-based companies to compete with
foreign based companies in domestic and export markets. However,
pursuant to the CRA, the DEA has submitted a copy of this direct final
rule to both Houses of Congress and to the Comptroller General.
List of Subjects in 21 CFR Part 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
Under the authority vested in the Attorney General by section
102(39)(A)(vi) of the Act (21 U.S.C. 802(39)(A)(vi)) and delegated to
the Administrator of the Drug Enforcement Administration by regulations
of the Department of Justice (28 CFR 0.100), the Acting Administrator
hereby amends 21 CFR part 1310 as set forth below.
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES; IMPORTATION AND EXPORTATION OF 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. In Sec. 1310.13(i), the table is amended by:
0
a. Designating the table as table 1 to paragraph (i); and
0
b. Adding the entries ``GFS Chemicals; WaterMark[supreg] Karl-Fisher
Reagent, Pyridine-Free Single Solution, 5 mg/ml,'' ``GFS Chemicals;
WaterMark[supreg] Karl-Fisher Reagent, 5 mg/ml Single Solution NON-
HAZ,'' ``GFS Chemicals; WaterMark[supreg] Karl-Fisher Reagent,
Pyridine-Free Single Solution, 2 mg/ml,'' ``GFS Chemicals;
WaterMark[supreg] Karl-Fisher Reagent, 2 mg/ml Single Solution NON-
HAZ,'' ``GFS Chemicals; WaterMark[supreg] Karl-Fisher Reagent, 5 mg/ml,
Stabilized, Pyridine-Based,'' ``Lord Corporation; Chemlok TS701-52,''
``Lord Corporation; Chemlok TS701-53,'' ``Sigma-Aldrich;
Hydranal[supreg]-Composite 1,'' ``Sigma-Aldrich; Hydranal[supreg]-
Composite 2,'' ``Sigma-Aldrich; Hydranal[supreg]-Composite 5K,''
``Sigma-Aldrich; Hydranal[supreg]-Composite 5,'' ``Standard Homeopathic
Co.; Baby Cough Syrup,'' ``Standard Homeopathic Co.; Defend Cough &
Cold
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Night,'' ``Standard Homeopathic Co.; Defend Cough & Cold,'' and
``Standard Homeopathic Co.; Diarrex'' in alphabetical order of
Manufacturer.
The additions read as follows:
Sec. 1310.13 Exemption of chemical mixtures; application.
* * * * *
(i) * * *
Table 1 to Paragraph (i)--Exempt Chemical Mixtures
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Manufacturer Product name \1\ Form Approval date
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* * * * * * *
GFS Chemicals.......................... WaterMark[supreg] Karl-Fisher Liquid................. 11/26/2018
Reagent, Pyridine-Free Single
Solution, 5 mg/ml.
GFS Chemicals.......................... WaterMark[supreg] Karl-Fisher Liquid................. 11/26/2018
Reagent, 5 mg/ml Single
Solution NON-HAZ.
GFS Chemicals.......................... WaterMark[supreg] Karl-Fisher Liquid................. 11/26/2018
Reagent, Pyridine-Free Single
Solution, 2 mg/ml.
GFS Chemicals.......................... WaterMark[supreg] Karl-Fisher Liquid................. 11/26/2018
Reagent, 2 mg/ml Single
Solution NON-HAZ.
GFS Chemicals.......................... WaterMark[supreg] Karl-Fisher Liquid................. 11/26/2018
Reagent, 5 mg/ml, Stabilized,
Pyridine-Based.
* * * * * * *
Lord Corporation....................... Chemlok TS701-52.............. Liquid................. 05/03/2018
Lord Corporation....................... Chemlok TS701-53.............. Liquid................. 05/03/2018
* * * * * * *
Sigma-Aldrich.......................... Hydranal[supreg]-Composite 1.. Liquid................. 5/29/2013
Sigma-Aldrich.......................... Hydranal[supreg]-Composite 2.. Liquid................. 5/29/2013
Sigma-Aldrich.......................... Hydranal[supreg]-Composite 5K. Liquid................. 5/29/2013
Sigma-Aldrich.......................... Hydranal[supreg]-Composite 5.. Liquid................. 5/29/2013
Standard Homeopathic Co................ Baby Cough Syrup.............. Liquid................. 9/28/2012
Standard Homeopathic Co................ Defend Cough & Cold Night..... Liquid................. 9/28/2012
Standard Homeopathic Co................ Defend Cough & Cold........... Liquid................. 9/28/2012
Standard Homeopathic Co................ Diarrex....................... Liquid................. 9/28/2012
* * * * * * *
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\1\ Designate product line if a group.
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-00667 Filed 1-24-20; 8:45 am]
BILLING CODE 4410-09-P