[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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

[[Page 4587]]

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
----------------------------------------------------------------------------------------------------------------
              Manufacturer                      Product name \1\                   Form            Approval date
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
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
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\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