[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35747-35751]
[FR Doc No: 2012-14581]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2012-0061]

Highway Safety Programs; Conforming Products List of Evidential
Breath Alcohol Measurement Devices

AGENCY: National Highway Traffic Safety Administration, Department of
Transportation.

ACTION: Notice.

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SUMMARY: This notice updates the Conforming Products List (CPL)
published in the Federal Register on March 11, 2010 (75 FR 11624) for
instruments that conform to the Model Specifications for Evidential
Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR
48705).

DATES: Effective Date: June 14, 2012.

FOR FURTHER INFORMATION CONTACT: For technical issues: Ms. De Carlo
Ciccel, Behavioral Research Division, NTI-131, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue SE., Washington, DC
20590; Telephone;<PHONE_NUMBER>. For legal issues: Ms. Jin Kim, Office
of Chief Counsel, NCC-113, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590;
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On November 5, 1973, the National Highway
Traffic Safety Administration (NHTSA) published the Standards for
Devices to Measure Breath Alcohol (38 FR 30459). A Qualified Products
List of Evidential Breath Measurement Devices comprised of instruments
that met this standard was first issued on November 21, 1974 (39 FR
41399).
    On December 14, 1984 (49 FR 48854), NHTSA converted this standard
to Model Specifications for Evidential Breath Testing Devices (Model
Specifications), and published a Conforming Products List (CPL) of
instruments that were found to conform to the Model Specifications as
Appendix D to that notice. Those instruments are identified on the CPL
with an asterisk.
    On September 17, 1993, NHTSA published a notice to amend the Model
Specifications (58 FR 48705) and to update the CPL. That notice changed
the alcohol concentration levels at which instruments are evaluated,
from 0.000, 0.050, 0.101, and 0.151 BAC, to 0.000, 0.020, 0.040, 0.080,
and 0.160 BAC, respectively. It also included a test for the presence
of acetone and an expanded definition of alcohol to include other low
molecular weight alcohols, e.g., methyl or isopropyl. Since that time,
the CPL has been annotated to indicate which instruments have been
determined to meet the Model Specifications published in 1984, and
which have been determined to meet the Model Specifications, as revised
and published in 1993. Thereafter, NHTSA has periodically updated the
CPL with those breath instruments found to conform to the Model
Specifications. The most recent update to the CPL was published March
11, 2010 (75 FR 11624).
    The CPL published today adds nine (9) new instruments that have
been evaluated and found to conform to the Model Specifications, as
amended on September 17, 1993 for mobile and non-mobile use. One
instrument is distributed by two different companies, so it has been
listed twice, for a total of

ten (10) new entries on this CPL. In alphabetical order by company,
they are:
    (1) The ``SAF'IR Evolution'' manufactured by Alcohol Countermeasure
Systems Corp. Toronto, Ontario, Canada. This is a hand-held instrument
intended for use in stationary or mobile operations. It uses an
infrared sensor and powered by internal batteries.
    (2) The ``Intoxilyzer 600'' manufactured by CMI, Inc., Owensboro,
Kentucky. This is a hand-held instrument intended for use in stationary
or mobile operations. It uses a fuel cell sensor and powered by an
internal battery. The Intoxilyzer 600 is also distributed as the
Alcolmeter 600 by Lion Laboratories outside the U.S., so it has been
listed twice on the CPL, once under each of its distributors/
manufacturers.
    (3) The ``Guth 38'' manufactured by Guth Laboratories, Inc.,
Harrisburg, Pennsylvania. This is a hand-held instrument intended for
use in stationary or mobile operations. It uses a fuel cell sensor and
is powered by internal batteries.
    (4) The ``Alco-Sensor V XL'' manufactured by Intoximeters, Inc.,
St. Louis, Missouri. This is a hand-held instrument intended for use in
stationary or mobile operations. It uses a fuel cell sensor and is
powered by internal batteries.
    (5) The ``LifeGuard Pro'' manufactured by Lifeloc Technologies,
Inc., Wheat Ridge, Colorado. This is a hand-held instrument intended
for use in stationary or mobile operations. It uses a fuel cell sensor
and is powered by internal batteries.
    (6) The ``DataMaster DMT with fuel cell option series number (SN)
555555'' and the ``DataMaster DMT with fuel cell option series number
(SN) 100630'' manufactured by National Patent Analytical Systems, Inc.,
Mansfield, Ohio. These instruments can be used in stationary and mobile
operations. These instruments use both infrared and fuel cell sensors.
These instruments can be powered by either 110 volts alternate current
or 12 volts direct current.
    (7) The ``Alcovisor Jupiter'' and the ``Alcovisor Mercury''
manufactured by PAS International, Fredericksburg, Virginia. These are
hand-held instruments intended for use in stationary or mobile
operations. Both instruments use a fuel cell sensor and are powered by
internal batteries.
    This update also removes four (4) instruments no longer supported
by the manufacturer and makes one minor change.
    The following instruments (PBA 3000 B, PBA 3000-P, PBA 3000 C and
Alcohol Data Sensor), manufactured by Lifeloc Technologies, Inc., Wheat
Ridge, Colorado, are being removed from the CPL because these
instruments were determined to be obsolete. These instruments are no
longer manufactured, in use or being maintained by the manufacturer.
    The minor change includes a change of address for Alcohol
Countermeasure Systems Corp., from Mississauga, Ontario, Canada to
Toronto, Ontario, Canada.
    In accordance with the foregoing, the CPL is updated, as set forth
below.

    Conforming Products List of Evidential Breath Measurement Devices
------------------------------------------------------------------------
     Manufacturer/distributor and model          Mobile       Nonmobile
------------------------------------------------------------------------
Alcohol Countermeasure Systems Corp.,
 Toronto, Ontario, Canada:
    Alert J3AD *............................            X             X
    Alert J4X.ec............................            X             X
    PBA3000C................................            X             X
    SAF'IR Evolution........................            X             X
BAC Systems, Inc., Ontario, Canada:
    Breath Analysis Computer *..............            X             X
CAMEC Ltd., North Shields, Tyne and Ware,
 England:
    IR Breath Analyzer *....................            X             X
CMI, Inc., Owensboro, Kentucky:
    Intoxilyzer Model:
        200.................................            X             X
        200D................................            X             X
        240 (aka: Lion Alcolmeter 400+                  X             X
         outside the U.S.)..................
        300.................................            X             X
        400.................................            X             X
        400PA...............................            X             X
        600 (aka: Lion Alcolmeter 600                   X             X
         outside the U.S.)..................
        1400................................            X             X
        4011 *..............................            X             X
        4011A *.............................            X             X
        4011AS *............................            X             X
        4011AS-A *..........................            X             X
        4011AS-AQ *.........................            X             X
        4011 AW *...........................            X             X
        4011A27-10100 *.....................            X             X
        4011A27-10100 with filter *.........            X             X
        5000................................            X             X
        5000 (w/Cal. Vapor Re-Circ.)........            X             X
        5000 (w/\3/8\ ID Hose                X             X
         option)............................
        5000CD..............................            X             X
        5000CD/FG5..........................            X             X
        5000EN..............................            X             X
        5000 (CAL DOJ)......................            X             X
        5000VA..............................            X             X
        8000................................            X             X
        PAC 1200 *..........................            X             X
        S-D2................................            X             X
        S-D5 (aka: Lion Alcolmeter SD-5                 X             X
         outside the U.S.)..................

Draeger Safety, Inc. (aka: National Draeger)
 Irving, Texas:
    Alcotest Model:
        6510................................            X             X
        6810................................            X             X
        7010 *..............................            X             X
        7110 *..............................            X             X
        7110 MKIII..........................            X             X
        7110 MKIII-C........................            X             X
        7410................................            X             X
        7410 Plus...........................            X             X
        7510................................            X             X
        9510................................            X             X
    Breathalyzer Model:
        900.................................            X             X
        900A *..............................            X             X
        900BG *.............................            X             X
        7410................................            X             X
        7410-II.............................            X             X
EnviteC by Honeywell GmbH, Fond du Lac,
 Wisconsin:
    AlcoQuant 6020..........................            X             X
Gall's Inc., Lexington, Kentucky:
    Alcohol Detection System--A.D.S. 500....            X             X
Guth Laboratories, Inc., Harrisburg,
 Pennsylvania:
    Alcotector BAC-100......................            X             X
    Alcotector C2H5OH.......................            X             X
    Guth 38.................................            X             X
Intoximeters, Inc., St. Louis, Missouri:
    Photo Electric Intoximeter *............  ............            X
    GC Intoximeter MK II *..................            X             X
    GC Intoximeter MK IV *..................            X             X
    Auto Intoximeter *......................            X             X
Intoximeter Model:
        3000................................            X             X
        3000 (rev B1) *.....................            X             X
        3000 (rev B2) *.....................            X             X
        3000 (rev B2A) *....................            X             X
        3000 (rev B2A) w/FM option *........            X             X
        3000 (Fuel Cell) *..................            X             X
        3000 D *............................            X             X
        3000 DFC *..........................            X             X
        Alcomonitor.........................  ............            X
        Alcomonitor CC......................            X             X
        Alco-Sensor III.....................            X             X
        Alco-Sensor III (Enhanced with                  X             X
         Serial Numbers above 1,200,000)....
        Alco-Sensor IV......................            X             X
        Alco-Sensor IV XL...................            X             X
        Alco-Sensor V.......................            X             X
        Alco-Sensor V XL....................            X             X
        Alco-Sensor AZ......................            X             X
        Alco-Sensor FST.....................            X             X
        Intox EC/IR.........................            X             X
        Intox EC/IR II......................            X             X
        Intox EC/IR II (Enhanced with serial  ............            X
         number 10,000 or higher)...........
        Portable Intox EC/IR................            X             X
        RBT-AZ..............................            X             X
        RBT-III.............................            X             X
        RBT III-A...........................            X             X
        RBT IV..............................            X             X
        RBT IV with CEM (cell enhancement               X             X
         module)............................
Komyo Kitagawa, Kogyo, K.K., Japan:
    Alcolyzer DPA-2 *.......................            X             X
    Breath Alcohol Meter PAM 101B *.........            X             X
Lifeloc Technologies, Inc., (formerly
 Lifeloc, Inc.), Wheat Ridge, Colorado:
    LifeGuard Pro...........................            X             X
    Phoenix.................................            X             X
    Phoenix 6.0.............................            X             X
    EV 30...................................            X             X
    FC 10...................................            X             X
    FC 20...................................            X             X
Lion Laboratories, Ltd., Cardiff, Wales,
 United Kingdom:
    Alcolmeter Model:
        300.................................            X             X

        400.................................            X             X
        400+ (aka: Intoxilyzer 240 in the               X             X
         U.S.)..............................
        600 (aka: Intoxilyzer 600 in the                X             X
         U.S.)..............................
        SD-2 *..............................            X             X
        SD-5 (aka: S-D5 in the U.S.)........            X             X
        EBA *...............................            X             X
    Intoxilyzer Model:
        200.................................            X             X
        200D................................            X             X
        1400................................            X             X
        5000 CD/FG5.........................            X             X
        5000 EN.............................            X             X
    Luckey Laboratories, San Bernardino,
     California:............................

    Alco-Analyzer Model:....................
    1000 *..................................  ............            X
    2000 *..................................  ............            X
Nanopuls AB, Uppsala, Sweden:
    Evidenzer...............................            X             X
National Patent Analytical Systems, Inc.,
 Mansfield, Ohio:
    BAC DataMaster (with or without the                 X             X
     Delta-1 accessory).....................
        BAC Verifier DataMaster (w/ or                  X             X
         without the Delta-1 accessory).....
        DataMaster cdm (w/ or without the               X             X
         Delta-1 accessory).................
        DataMaster DMT......................            X             X
        DataMaster DMT w/ Fuel Cell option              X             X
         SN: 555555.........................
        DataMaster DMT w/ Fuel Cell option              X             X
         SN: 100630.........................
Omicron Systems, Palo Alto, California:
    Intoxilyzer Model:
        4011 *..............................            X             X
        4011AW *............................            X             X
PAS International, Fredericksburg, Virginia:
    Mark V Alcovisor........................            X             X
    Alcovisor Jupiter.......................            X             X
    Alcovisor Mercury.......................            X             X
Plus 4 Engineering, Minturn, Colorado:
    5000 Plus 4 *...........................            X             X
Seres, Paris, France:
    Alco Master.............................            X             X
    Alcopro.................................            X             X
Siemans-Allis, Cherry Hill, New Jersey:
    Alcomat *...............................            X             X
    Alcomat F *.............................            X             X
Smith and Wesson Electronics, Springfield,
 Massachusetts:
    Breathalyzer Model:
        900 *...............................            X             X
        900A *..............................            X             X
        1000 *..............................            X             X
        2000 *..............................            X             X
        2000 (non-Humidity Sensor) *........            X             X
Sound-Off, Inc., Hudsonville, Michigan:
    AlcoData................................            X             X
    Seres Alco Master.......................            X             X
    Seres Alcopro...........................            X             X
Stephenson Corp.:
    Breathalyzer 900 *......................            X             X
Tokai-Denshi Inc., Tokyo, Japan:
    ALC-PRO II (U.S.).......................            X             X
U.S. Alcohol Testing, Inc./Protection
 Devices, Inc., Rancho Cucamonga,
 California:
    Alco-Analyzer 1000......................  ............            X
    Alco-Analyzer 2000......................  ............            X
    Alco-Analyzer 2100......................            X             X
Verax Systems, Inc., Fairport, New York:
    BAC Verifier *..........................            X             X
    BAC Verifier Datamaster.................            X             X
    BAC Verifier Datamaster II *............            X             X
------------------------------------------------------------------------
*Instruments marked with an asterisk (*) meet the Model Specifications
  detailed in 49 FR 48854 (December 14, 1984) (i.e., instruments tested
  at 0.000, 0.050, 0.101, and 0.151 BAC). Instruments not marked with an
  asterisk meet the Model Specifications detailed in 58 FR 48705
  (September 17, 1993), and were tested at BACs = 0.000, 0.020, 0.040,
  0.080, and 0.160. All instruments that meet the Model Specifications
  currently in effect (dated September 17, 1993) also meet the Model
  Specifications for Screening Devices to Measure Alcohol in Bodily
  Fluids.

    Authority:  23 U.S.C. 403; 49 CFR 1.50; 49 CFR part 501.

    Issued on: June 11, 2012.
Jeff Michael,
Associate Administrator, Research and Program Development, National
Highway Traffic Safety Administration.
[FR Doc. 2012-14581 Filed 6-13-12; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Proposed Rules]
[Pages 71012-71016]
[FR Doc No: 2020-24322]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI08

Commerce Control List: Proposed Controls on ``Software'' for the
Operation of Certain Automated Nucleic Acid Assemblers and
Synthesizers; Request for Comments

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Proposed rule.

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SUMMARY: The Bureau of Industry and Security (BIS), Department of
Commerce, maintains controls on the export, reexport and transfer (in-
country) of dual-use items and less sensitive military items through
the Export Administration Regulations, including the Commerce Control
List (CCL). Certain items that could be of potential concern for export
control purposes are not yet listed on the CCL or controlled
multilaterally, because they represent emerging technologies. Among
these items is ``software'' for the operation of nucleic acid
assemblers and synthesizers controlled under Export Control
Classification Number (ECCN) 2B352 that is capable of designing and
building functional genetic elements from digital sequence data.
    BIS has determined that this ``software'' is capable of being used
to operate nucleic acid assemblers and synthesizers controlled under
ECCN 2B352 for the purpose of generating pathogens and toxins without
the need to acquire controlled genetic elements and organisms.
Consequently, the absence of export controls on this ``software'' could
be exploited for biological weapons purposes. In an effort to address
this concern, this rule proposes to amend the CCL by adding a new ECCN
2D352 to control such ``software.'' This rule also requests public
comments to ensure that the scope of these proposed controls will be
effective and appropriate (with respect to their potential impact on
legitimate commercial or scientific applications).

DATES: Comments must be received by BIS no later than December 21,
2020.

ADDRESSES: You may submit comments, identified by docket number BIS-
2020-0024 or RIN 0694-AI08, through any of the following:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. You can find this
proposed rule by searching for its regulations.gov docket number, which
is BIS-2020-0024.
     Email<EMAIL_ADDRESS>Include RIN 0694-AI08
in the subject line of the message.
    All filers using the portal or email should use the name of the
person or entity submitting the comments as the name of their files, in
accordance with the instructions below. Anyone submitting business
confidential information should clearly identify the business
confidential portion at the time of submission, file a statement
justifying nondisclosure and referring to the specific legal authority
claimed, and provide a non-confidential submission.
    For comments submitted electronically containing business
confidential information, the file name of the business confidential
version should begin with the characters ``BC.'' Any page containing
business confidential information must be clearly marked ``BUSINESS
CONFIDENTIAL'' on the top of that page. The corresponding non-
confidential version of those comments must be clearly marked
``PUBLIC.'' The file name of the non-confidential version should begin
with the character ``P.'' The ``BC'' and ``P'' should be followed by
the name of the person or entity submitting the comments or rebuttal
comments. Any submissions with file names that do not begin with a
``P'' or ``BC'' will be assumed to be public and will be made publicly
available through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions on the chemical and
biological weapons (CB) controls that would apply to the ``software''
proposed for control under ECCN 2D352, contact Dr. Wesley Johnson,
Chemical and Biological Controls Division, Office of Nonproliferation
and Treaty Compliance, Bureau of Industry and Security, Telephone:
(202) 482-0091, Email<EMAIL_ADDRESS>For questions on the
submission of comments in response to this proposed rule, contact
Willard Fisher, Regulatory Policy Division, Office of Exporter
Services, Bureau of Industry and Security, U.S. Department of Commerce,
Phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    As part of the National Defense Authorization Act (NDAA) for Fiscal
Year 2019, Public Law 115-232, Congress enacted the Export Control
Reform Act of 2018 (ECRA), 50 U.S.C. 4801-4852. Section 1758 of ECRA
(as codified under 50 U.S.C. 4817) authorizes BIS to establish
appropriate controls on the export, reexport or transfer (in-country)
of emerging and foundational technologies. Pursuant to ECRA, on
November 19, 2018, the Bureau of Industry and Security (BIS) published
an advance notice of public rulemaking (November 19 ANPRM) (83 FR
58201). That ANPRM identified biotechnology as part of a representative
list of technology categories concerning which BIS, through an
interagency process, sought public comment to determine whether there
are specific emerging technologies that are important to U.S. national
security for which effective controls can be implemented. As indicated
by the May 23, 2019 (84 FR 23886), final rule that imposed multilateral
controls on a number of items, consistent with the 2018 Plenary changes
to the Wassenaar Arrangement List of Dual-Use Goods and Technologies,
emerging technologies can include ``software'' and commodities. (See,
e.g., Export Control Classification Number 3D005, 84 FR 23894.)

Comments to the November 19 ANPRM on Biotechnology

    The biotechnology-related comments submitted to BIS in response to
its November 19 ANPRM did not specifically address the question of
export controls on ``software'' for the operation of nucleic acid
assemblers and synthesizers controlled under Export Control
Classification Number (ECCN) 2B352.

Process To Identify and Control Emerging Technology

    Under ECRA, emerging and foundational technologies are those
essential to the national security of the United States, but not
described in Section 721(a)(6)(A)(i)-(v) of the Defense Production Act
of 1950 (50 U.S.C. 4565(a)), as amended. Section 1758(a) of ECRA (50
U.S.C. 4817(a)) outlines an interagency process for identifying
emerging and foundational technologies that considers both public and
classified information, as well as information from the Emerging
Technology Technical Advisory Committee and the Committee on Foreign
Investment in the United States. In identifying specific emerging
technologies, the process also takes into account:
     The development of the emerging technologies in foreign
countries;
     The effect export controls might have on the development
of the emerging technologies in the United States; and

     The effectiveness of export controls on limiting the
proliferation of the emerging technologies in foreign countries.
    In addition, Section 1758(a)(2)(C) of ECRA (50 U.S.C.
4817(a)(2)(C)) requires that the interagency process for identifying
emerging technologies include a notice and comment period.
    The Secretary of Commerce must establish appropriate controls on
the export, reexport or transfer (in-country) of technology identified
pursuant to the Section 1758 process, and in doing so, must consider
the potential end-uses and end-users of emerging and foundational
technologies, and the countries to which exports from the United States
are restricted (e.g., embargoed countries). While the Secretary has
discretion to set the level of export controls, at a minimum he must
require a license for the export of such technologies to countries
subject to a U.S. embargo, including those countries subject to an arms
embargo.
    ``Software'' for the operation of nucleic acid assemblers and
synthesizers controlled under ECCN 2B352.j on the Commerce Control List
(CCL), in Supplement No. 1 to part 774 of the Export Administration
Regulations (EAR) (15 CFR parts 730-774), has been identified as a
technology to be evaluated as an emerging technology, consistent with
the process described in Section 1758 of ECRA. This identification is
based on a finding that such ``software'' is capable of being utilized
in the production of pathogens and toxins and, consequently, the
absence of export controls on such ``software'' could be exploited for
biological weapons purposes.
    Consistent with BIS's authority to evaluate the level of controls
that would be appropriate for the export, reexport or transfer (in-
country) of emerging technologies, this rule proposes to amend the CCL
by adding a new ECCN 2D352 to control such ``software.'' This
``software'' is not currently included on any of the Australia Group
(AG) common control lists--consequently, the controls on this
``software,'' as proposed by this rule, would be unilateral in nature,
absent the adoption of comparable controls by the Australia Group.
    In addition, although this rule does not propose to amend ECCN
2E001 (which controls, inter alia, ``technology'' for the
``development'' of the nucleic acid assemblers and synthesizers
described in ECCN 2B352.j), the heading of ECCN 2E001 indicates that,
with limited exceptions, ECCN 2E001 controls ``technology for the
``development'' of ``software'' listed under Category 2D of the CCL.
Consequently, if the changes proposed in this rule were to go into
effect, ECCN 2E001 would control ``technology'' for the ``development''
of the ``software'' that would be controlled under new ECCN 2D352. This
expansion in the scope of ECCN 2E001 would be unilateral in nature.
    Public comments submitted to BIS in response to this proposed rule
will help BIS and other U.S. Government agencies to apply the criteria
set forth in Section 1758 of ECRA and identify and assess the
appropriate level of controls that should apply to the ``software''
proposed for control under ECCN 2D352 and ``technology'' for the
``development'' of such ``software,'' as proposed to be controlled
under ECCN 2E001.

Request for Comments

    BIS is publishing this proposed rule to obtain public comments on
the proposed application of CB controls to ``software'' for the
operation of nucleic acid assemblers and synthesizers described in ECCN
2B352.j. and to ``technology'' related to such ``software'' that would
satisfy the controls described in ECCN 2E001. Consistent with Section
1758(a)(2)(C) of ECRA (50 U.S.C. 4817(a)(2)(C)), this proposed rule
provides the public with notice and the opportunity to comment on
controlling this technology as described herein. Specifically, BIS
welcomes any comments on this proposed rule relevant to the following:
    (1) Whether the proposed controls are clear and adequately address
``emerging and foundational technologies'' within the context of
biological weapons related capabilities and developments (to the extent
that this is not the case, comments should identify specific control
text that would be more appropriate to these ends);
    (2) The current capability for the ``development'' of such
``software'' in the United States and other countries, including the
extent to which the proposed controls would affect ``software'' that is
currently being produced and/or sold, either within or outside the
United States (e.g., whether the proposed controls would inadvertently
control any ``software'' that is suitable almost exclusively for
legitimate commercial or scientific applications);
    (3) The effect that implementation of the proposed controls would
have on the future ``development'' of such ``software'' and related
``technology'' in the United States; and
    (4) The effectiveness of the proposed controls in terms of limiting
the availability of such ``software'' and related ``technology''
abroad.
    BIS also welcomes comments concerning whether these controls should
be implemented multilaterally (rather than unilaterally), in the
interest of increasing their effectiveness and minimizing their impact
on U.S. industry (multilateral export controls are preferable to
unilateral controls, because the former typically place U.S. industry
on a more level playing field versus producers/suppliers in other
countries). In this regard, note that Section 1758(c) of ECRA (as
codified under 50 U.S.C. 4817(c)) provides that ``the Secretary of
State, in consultation with the Secretary [of Commerce] and the
Secretary of Defense, and the heads of other Federal agencies, as
appropriate, shall propose that any technology identified pursuant to
subsection (a) [of ECRA] be added to the list of technologies
controlled by the relevant multilateral export control regimes''.
Subsection (a) of section 1758 (as codified under 50 U.S.C. 4817(a))
addresses the interagency process for identifying emerging
technologies.
    The public comments submitted in response to this proposed rule
should address specific aspects of the proposed addition of ECCN 2D352
to the CCL in relation to the criteria described above (e.g., identify
the specific aspects in which the proposed controls would satisfy these
criteria or fail to do so).

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct 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 emphasizes the importance of quantifying both costs and
benefits and of reducing costs, harmonizing rules, and promoting
flexibility. This rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget (OMB).
    The cost-benefit analysis required pursuant to Executive Orders
13563 and 12866 indicates that this rule is intended to improve
national security as its primary direct benefit. Specifically,
implementation, in a timely manner, of the proposed changes described
herein would enhance the national security of the United States by
reducing the risk

that global international trade involving dual-use chemical/biological
items would contribute to the proliferation of chemical and biological
weapons (CBW) of mass destruction. These controls are essential given
that the international chemical and biotechnology industries are a
target for proliferators as a source of materials for CBW programs. In
calculating the costs that would be imposed by this rule, BIS estimates
that no more than 15 additional license applications would have to be
submitted to BIS, annually, as a result of the implementation of the
amendments described in this rule (see Rulemaking Requirements #2,
below). Application of the cost-benefit analysis required under
Executive Orders 13563 and 12866 to this rule, as described above,
indicates that this rule is intended to improve the national security
of the United States as its primary direct benefit. Accordingly,
consistent with the stated purpose of the proposed addition of ECCN
2D352 to the Commerce Control List (CCL), the changes proposed by this
rule meet the requirements set forth in the April 5, 2017, OMB guidance
implementing Executive Order 13771 (82 FR 9339, February 3, 2017),
regarding what constitutes a regulation issued ``with respect to a
national security function of the United States,'' and this rule is,
therefore, exempt from the requirements of E.O. 13771.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. This rule
contains the following collections of information subject to the
requirements of the PRA. These collections have been approved by OMB
under control numbers 0694-0088 (Simplified Network Application
Processing System) and 0694-0096 (Five Year Records Retention Period).
The approved information collection under OMB control number 0694-0088
includes license applications, among other things, and carries a burden
estimate of 29.6 minutes per manual or electronic submission for a
total burden estimate of 31,833 hours. The approved information
collection under OMB control number 0694-0096 includes recordkeeping
requirements and carries a burden estimate of less than 1 minute per
response for a total burden estimate of 248 hours.
    Although this proposed rule would make important changes to the EAR
for items controlled for chemical/biological (CB) reasons, BIS believes
the overall increase in costs and burdens due to this rule would be
minimal if implemented in a final rule. Specifically, BIS expects the
burden hours associated with these collections would increase,
slightly, by 7 hours and 39 minutes (i.e., 15 applications x 30.6
minutes per response) for a total estimated cost increase of $230
(i.e., 7 hours and 39 minutes x $30 per hour). The $30 per hour cost
estimate for OMB control number 0694-0088 is consistent with the salary
data for export compliance specialists currently available through
glassdoor.com (glassdoor.com estimates that an export compliance
specialist makes $55,280 annually, which computes to roughly $26.58 per
hour). This increase is not expected to exceed the existing estimates
currently associated with OMB control numbers 0694-0088 and 0694-0096.
Send comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing the
burden, to Jasmeet Seehra, Office of Management and Budget, by email to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the
Regulatory Policy Division, Bureau of Industry and Security, Department
of Commerce, 14th Street & Pennsylvania Avenue NW, Room 2705,
Washington, DC 20230 or by email to<EMAIL_ADDRESS>    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to Section 1762 of the Export Control Reform Act of
2018 (ECRA) (50 U.S.C. 4821), this action is exempt from the
Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for
notice of proposed rulemaking, opportunity for public participation and
delay in effective date. Notwithstanding, BIS believes this rule would
benefit from public comment prior to issuance. Consistent with the
Regulatory Flexibility Act, as amended by the Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et seq.), BIS
has prepared the following initial regulatory flexibility analysis
(IRFA) of the impact that this proposed rule, if adopted, would have on
small businesses.

Description of the Reasons Why Action Is Being Considered

    The policy reasons for issuing this proposed rule are discussed in
the background section of the preamble of this document and,
consequently, are not repeated here.

Statement of the Objectives of, and Legal Basis for, the Proposed Rule;
Identification of All Relevant Federal Rules Which May Duplicate,
Overlap or Conflict With the Proposed Rule

    The objective of this proposed rule, and any other emerging
technology proposed rules published by BIS, is to control emerging and
foundational technologies identified by BIS and its interagency
partners as being essential to U.S. national security. The legal basis
for this proposed rule is as follows: 50 U.S.C. 4801-4852.
    No other federal rules duplicate, overlap, or conflict with this
proposed rule.

Number and Description of Small Entities Regulated by the Proposed
Action

    This proposed rule would apply to all persons engaged in the
export, reexport or transfer (in-country) of the ``software'' proposed
for control under ECCN 2D352 and related ``technology'' subject to the
EAR. Presently, this ``software'' and related ``technology'' is used in
research and development activities in many U.S. university and
military laboratories. Therefore, BIS anticipates that the proposed
controls would result in ``deemed'' export license applications (for
exports to foreign nationals located within the United States) to allow
access to this ``technology'' by foreign students and faculty at U.S.
universities, as well as by non-U.S. employees of U.S. biochemical
firms. There would most likely also be ``deemed'' reexport license
applications for the release of this ``technology'' to third-country
foreign nationals located in foreign countries who are engaged in
research and development activities involving this ``technology.''
    BIS does not collect or maintain the data necessary to determine
how many of the affected persons are small entities as that term is
used by the Small Business Administration. Prior to issuing this
proposed rule, BIS received 36 comments on biotechnology in response to
the November 19 ANPRM. None of these commenters specifically identified
themselves as small businesses, but small businesses may have chosen to
provide input through larger entities, such as trade associations.

    However, BIS was able to estimate the number of license
applications that the agency anticipates receiving as a result of this
proposed rule and is using that estimate as a means of assessing the
impact on small businesses. Using the North American Industry
Classification System Codes (NAICS) 325414 (Biological Product (except
Diagnostic) Manufacturing), BIS determined that the standard small
business size in this industry is 1,250 employees. Using Table 1a of
the Census Bureau's 2016 Exports by Company Type and Employment Size
and extrapolating to 1,250 employees, BIS then estimated that 41% of
all identified companies that export in this industry are small
businesses. BIS also estimates that it will receive 15 license
applications per year for the items described in this proposed rule
(see the PRA estimates described in Rulemaking Requirements #2, above).
Based on that information, BIS estimates that the agency will receive
approximately 6 license applications per year from small businesses, or
roughly 41% of the 15 estimated license applications.
    In addition, based on the burden estimate for OMB under control
numbers 0694-0088 (Simplified Network Application Processing System)
and 0694-0096 (Five Year Records Retention Period), BIS expects that
the total burden hours for small businesses associated with these EAR-
related collections would increase only slightly, by just under 3 hours
and 4 minutes (i.e., 6 applications x 30.6 minutes per response), for a
total estimated cost increase of just under $92 (i.e., 3 hours and 4
minutes x $30 per hour).
    The amendments proposed in this rule, if implemented, also would
trigger a small information collection burden under the U.S. Census
Bureau's Foreign Trade Regulations (FTR) (15 CFR part 30), which
contain the Electronic Export Information (EEI) filing requirements
under the Automated Export System (AES). This FTR-related information
collection has been approved by OMB under control number 0607-0152
(Automated Export System (AES) Program) and carries a burden hour
estimate of 3 minutes per electronic submission. This collection,
together with the aforementioned EAR-related information collections,
would result in a total estimated cost increase to small businesses of
just under $94 (i.e., 3 hours and 7 minutes x $30 per hour). Note that,
for purposes of consistency, the $30 per hour cost estimate used for
the EAR-related information collections described above is also applied
to this FTR-related information collection (which also would involve
work performed by export compliance specialists).
    Based on the analysis provided above, the amendments proposed in
this rule would not impose a significant economic impact on a
substantial number of small businesses.

Description of the Projected Reporting, Recordkeeping, and Other
Compliance Requirements of the Proposed Rule

    The changes proposed in this rule, if adopted, would mean that
certain items currently eligible for export, reexport or transfer (in-
country) to most destinations under the No License Required (NLR)
designation would require an EAR authorization (i.e., in accordance
with the terms and conditions of an EAR license exception or a license
issued by BIS). Adding these items to the CCL, to be controlled under a
new ECCN 2D352, may also change the export clearance requirements under
the FTR for certain exports of these items by triggering an EEI filing
requirement in AES--this requirement generally does not apply to items
below a certain value that are classified as EAR99.
    To the extent that compliance with the changes proposed in this
rule would impose a burden on persons, including small businesses, BIS
believes the burden would be minimal. The reclassification process
would need to be done only once per license applicant for exports,
reexports or transfers (in-country) of these emerging technology items
and, consequently, would constitute a one-time burden for each
applicant. Similarly, assessing the availability of license exceptions
and/or applying for and using BIS licenses would impose some minimal
burden on persons, including small businesses.
    However, it should be noted that these EAR requirements would
likely have less impact than might otherwise be the case, because of
the resources that BIS makes available to all exporters, including
small businesses. Specifically, BIS's website has free on-line training
explaining export basics, including instructions on how to register for
and use BIS's online license application tool. BIS also provides free
export counseling by telephone and email via both its Washington, DC
and Western Regional offices. In addition, BIS accepts requests for
commodity classifications and processes them without charge to assist
those exporters who need assistance in classifying their items for the
purpose of determining whether any CCL-based license requirements would
apply.

Significant Alternatives and Underlying Analysis

    As noted above, BIS does not believe that the amendments proposed
in this rule, if published in a final rule, would have a significant
economic impact on small businesses. Nevertheless, consistent with 5
U.S.C. 603(c), BIS considered significant alternatives to these
proposed amendments to assess whether the alternatives would: (1)
Accomplish the stated objectives of this rule (consistent with the
emerging technology requirements in ECRA); and (2) minimize any
significant economic impact of this rule on small entities. BIS could
have proposed a much broader control on ``software'' capable of
operating nucleic acid assemblers and synthesizers controlled under
ECCN 2B352 that would have captured a greater amount of such
``software'' and related ``technology.'' That in turn would have had a
greater impact not only on small businesses, but also on research and
development laboratories (both academic and corporate), which are
involved in advancing biological technology. BIS has determined that
proposing focused controls on specific ``software'' and related
``technology'' (i.e., the ``software'' proposed for control under new
ECCN 2D352 and corresponding ``development'' ``technology'' in ECCN
2E001) is the least disruptive alternative for implementing export
controls in a manner consistent with controlling technology that has
been determined, through the emerging technology interagency process
authorized under ECRA, to be essential to U.S. national security.
    BIS is not proposing different compliance or reporting requirements
for small businesses. If a small business is subject to a compliance
requirement for the export, reexport or transfer (in-country) of this
``software'' and related ``technology,'' then it would submit a license
application using the same process as any other company (i.e.,
electronically via SNAP-R). The license application process is free of
charge to all entities, including small businesses. In addition, as
noted above, the resources and other compliance tools made available by
BIS typically serve to lessen the impact of any EAR license
requirements on small businesses.
    Lastly, consistent with 5 U.S.C. 603(c), BIS assessed the use of
performance standards rather than design standards and also considered
whether an exemption for small businesses was practical under the
circumstances (i.e., within the context of the changes proposed in this
rule).

    The ``software'' proposed for control under new ECCN 2D352 and
related ``technology'' that warrant control under this proposed rule
are capable of being used to operate nucleic acid assemblers and
synthesizers controlled under ECCN 2B352 for the purpose of generating
pathogens and toxins without the need to acquire controlled genetic
elements and organisms (i.e., they are capable of being used in the
production of biological agents). However, because this ``software''
and related ``technology'' are dual-use items, they also have
legitimate commercial and scientific applications. Consequently,
controlling this ``software'' and related ``technology'' based on
design standards is the most appropriate way to control these items. In
the absence of such controls, there may be an unacceptable risk of
diversion of these items to biological weapons end-uses.
    This proposed rule does not contain an exemption for small
businesses from this license requirement, because BIS and its
interagency partners are assessing whether these controls are essential
to U.S. national security. Specifically, this ``software'' and related
``technology'' could be used for biological weapons purposes and, as
such, controlling these items on the CCL is essential to U.S. national
security. An exemption for small businesses would undermine the
effectiveness of these proposed controls.

Conclusion

    BIS has identified the ``software'' and related ``technology''
addressed in this proposed rule as an emerging technology that warrants
public notice and comment. Consequently, consistent with the Regulatory
Flexibility Act, BIS has prepared this IRFA addressing the impact that
this proposed rule, if adopted, would have on small entities. BIS's
assessment indicates that the amendments proposed in this rule would
not have a significant economic impact on a substantial number of small
entities.
    Please submit any comments concerning this IRFA in accordance with
the instructions provided in the ADDRESSES section of this proposed
rule.

List of Subjects in 15 CFR Part 774

    Exports, Reporting and recordkeeping requirements, Terrorism.

    For the reasons stated in the preamble, part 774 of the Export
Administration Regulations (15 CFR parts 730-774) is proposed to be
amended as follows:

PART 774--[AMENDED]

0
1. The authority citation for 15 CFR part 774 continues to read as
follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C.
287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15
U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783.

Supplement No. 1 to Part 774--[Amended]

0
2. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2 -Materials Processing,'' ECCN 2D352 is added, immediately
following ECCN 2D351, to read as follows:

Supplement No. 1 to Part 774--The Commerce Control List

* * * * *

2D352 ``Software'' for the operation of nucleic acid assemblers and
synthesizers controlled by 2B352.j that is capable of designing and
building functional genetic elements from digital sequence data.

License Requirements

Reason for Control: CB, AT

------------------------------------------------------------------------
                                            Country chart (see supp. No.
                Control(s)                         1 to part 738)
------------------------------------------------------------------------
CB applies to entire entry................  CB Column 2.
AT applies to entire entry................  AT Column 1.
------------------------------------------------------------------------

List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)

TSR: N/A

List of Items Controlled

    Related Controls: See ECCN 1E001 for ``development'' or
``production ``technology'' for genetic elements controlled by ECCN
1C353.
    Related Definitions: See Section 772.1 of the EAR for the
definitions of ``software,'' ``program,'' and ``microprogram.''
    Items: The list of items controlled is contained in the ECCN
heading.
* * * * *

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2020-24322 Filed 11-5-20; 8:45 am]
BILLING CODE 3510-33-P


Page 1 of 8 Options Paper:

Data Submitter Rights for Data Submitted in Support of Tolerance Actions As part of the Food Quality Protection Act of 1996, Congress amended section 408( i) of the Federal Food, Drug, and Cosmetic Act to address exclusive use and compensation rights for data submitted to EPA in support of tolerance and tolerance exemption actions. This paper does not address the issue of data that are " voluntarily submitted" to the Agency. The Agency is currently evaluating how to implement this new provision and is seeking public comment.

I. Background EPA is responsible under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) for registering pesticide products on the basis of scientific data or other information adequate to show that, among other things, the products will not pose unreasonable adverse effects on the environment. EPA may require that applicants and registrants submit data to the Agency to assess whether a pesticide should be registered or continue to be registered. Persons wanting to obtain or maintain a registration for a pesticide product must submit an application package consisting of information relating to the identity and composition of the product, and supporting data or a citation to supporting data.

FIFRA section 3( c)( 1)( F) extends exclusive use or compensation rights to persons (" original data submitters") who submit proprietary data, in support of an application for registration, reregistration, or experimental use permit, or to maintain an existing registration.

Applicants who cite supporting data previously submitted to the agency by the original data submitter, must certify that an offer of compensation has been made to the original data submitter Page 2 of 8 or that the submitter has granted permission to cite data. In the case of " exclusive use" data, the applicant must obtain the permission of the original data submitter and certify with the Agency that the applicant has obtained written authorization from the original data submitter. If an applicant or registrant fails to comply with these requirements, the application/ registration is subject to denial or cancellation.

Since FIFRA places an obligation on the Agency to ensure that the original data submitter is offered compensation for the use of data, a Pesticide Data Submitters List was developed to assist applicants in fulfilling their obligation. The Data Submitters List is a compilation of names and addresses of original data submitters who wish to be notified and offered compensation for use of their data. The Data Submitters List is available via the Internet at http:// www. epa. gov/ opppmsd1/ DataSubmittersList.

For pesticides that may remain in or on food or animal feed, a maximum residue level ( tolerance) must be established. In considering a tolerance action, EPA reviews certain types of data on a pesticide to determine if residue limits will be safe. Prior to passage of the Food Quality Protection Act ( FQPA) of 1996, the Federal Food, Drug, and Cosmetic Act ( FFDCA) did not contain a data compensation and exclusive rights provision. Nonetheless, EPA has consistently taken the position that data submitted to support a tolerance or tolerance exemption are entitled to exclusive use or compensation if the data otherwise meet the requirements of section 3 of FIFRA. Specifically, the data must be submitted in support of a registration or reregistration action or must otherwise be submitted to support or maintain registration. Because most " tolerance related" data are submitted to support registration actions, these data generally are compensable under FIFRA. Page 3 of 8 II. Amendments to the Law In 1996, Congress amended the FFDCA to add a new section 408( i) that explicitly addresses compensation and exclusive use rights for data submitted to support tolerances and tolerance exemption. Congress provided that such data are compensable " to the same extent"

provided in section 3 of FIFRA. However, the statute gives no further guidance as to whether this provision is simply intended to codify EPA's current practice, or whether Congress intended to expand data compensation rights to those data that currently do not enjoy compensation or exclusive use rights. The pertinent part of the statutory language reads:

408( i) Confidentiality and Use of Data.   ( 1) General rule. Data and information that are or have been submitted to the Administrator under this section or section 409 in support of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of business confidentiality and to exclusive use and data compensation to the same extent provided by sections 3 and 10 of the Federal Insecticide, Fungicide, and Rodenticide Act.

EPA may receive data submitted in support of tolerance or tolerance exemption actions that are not submitted to support FIFRA registration actions. Specifically, data submitted by manufacturers of other, non pesticidal ingredients petitioning for the issuance of a tolerance or exemption and data submitted by persons petitioning for the issuance of a tolerance for a pesticide on imported food are generally not submitted in connection with any action under FIFRA. Under FIFRA such data would not, therefore, qualify for exclusive use or compensation status.

While the statute is silent on this matter, the legislative history in the House Committee on Page 4 of 8 Commerce Report accompanying H. R. 1627 ( the bill that was enacted as the FQPA of 1996)

provides that "[ the Committee intends that this section apply to data submitted to EPA prior to enactment, under old section 408 or 409, including data submitted under EPA guidelines by manufacturers of inert ingredients of pesticides" ( H. R. No. 669, 104th Cong., 2nd Sess., pt 2, at 50, 1996). Since most data submitted by manufacturers of other ingredients are not subject to protection under section 3 of FIFRA ( because the data generally are not submitted in connection with a registration action), the legislative history may indicate that Congress did intend to expand compensation and exclusive use rights. However, given the language of section 408( i), it is unclear to EPA precisely how such rights would be expanded. If the language " to the same extent provided by section 3" truly incorporates all the provisions of section 3, data rights could not be expanded beyond current practice because section 3 requires that the data be connected to a FIFRA registration action. Thus, if Congress did intend to expand data rights by enacting new 408( i), it may have intended the Agency to use section 3 of FIFRA merely as a guidepost for developing protections for tolerance related data.

III. Preliminary Options for Implementing Section 408( i)

EPA specifically solicits comments addressing the Agency's implementation of the provisions of section 408( i) of FFDCA that relate to exclusive use and compensation rights.

Three preliminary options are presented for consideration. The options represent different interpretations of the potential scope of the new provision focusing on who the data submitters may be. EPA also encourages commenters to submit comments on other interpretations of the new language and suggest procedures for implementing whatever option the commenter prefers. Page 5 of 8 EPA believes the new section 408( i) of FFDCA may provide the Agency with the flexibility to develop one or more possible implementation schemes. After consideration of the comments received, the Office of Pesticide Programs will develop a proposal for implementing the data compensation and exclusive use provisions for data submitted to EPA under section 408( i).

A. Option 1: Only Registrants and Applicants for Registration One approach to implementing section 408( i) would extend data compensation and exclusive use rights ( data rights) only to those persons who submit data in support of tolerances or exemptions from tolerances that also meet all the conditions necessary to obtain such rights as set forth in section 3 of FIFRA. This option would read section 408( i) as Congressional ratification of the Agency's current treatment of " tolerance" related data. Therefore, under this option, data rights under section 408( i) would only extend to those persons who qualify as " applicants" under FIFRA for a current registration or reregistration action ( See section 3( c)( 1)( F) of FIFRA).

B. Option 2: Any Person Who Submits Data Related to Current Registration/ reregistration Action This reading of section 408( i), as in option 1, would extend data rights to those persons who submit data in support of tolerances or exemptions from tolerances that also meet all the conditions necessary to obtain such rights as set forth in section 3 of FIFRA, with the exception that the submitter would not have to be an " applicant or registrant" as section 3( c)( 1)( F) of FIFRA provides. This option would give some meaning to the FQPA legislative history that Page 6 of 8 indicates that Congress intended to offer protection to data submitted by manufacturers of other ingredients. It is unlikely, however, that this option would protect much data submitted by manufacturers of other ingredients, since such data are rarely submitted for the specific purposes identified in FIFRA section 3 ( registration, reregistration, etc.).

C. Option 3: Any Person Without Regard to Whether Data Relate to Current Registration or Reregistration This reading of section 408( i) would extend data compensation and exclusive use rights to persons who submit data and who would otherwise qualify for data rights under both options 1 and 2 above. However, this option would also extend rights to data submitters without regard to whether the data submitted relates to any current registration or reregistration action or whether the data submitter is a pesticide registrant. Protections would only be linked to the issuance of tolerances and tolerance exemptions. This approach would likely extend protection to data submitted by manufacturers of other ingredients and persons submitting data in support of a tolerance or exemption to a tolerance for pesticide chemical residues on imported food. Because these individuals generally do not submit data in connection with pesticide registration activities under FIFRA, options 1 and 2 above would likely not provide the measure of data protection provided by this option.

Commenters should note that because section 408( i) by its terms is not limited to " other ingredients" data, any expansion of rights created by 408( i) may apply to data on active ingredients in a similar manner. Further, it should be noted that all three options would be implemented in connection with the FIFRA registration/ reregistration process. Because the FFDCA does not provide a licensing scheme for levying data requirements on all persons who Page 7 of 8 market products that may benefit from the issuance of tolerances or tolerance exemptions, EPA believes Congress intended that the Agency use the existing section 3 FIFRA process as a guidepost ( e. g., determining the period of exclusive use) for developing protections for tolerance related data.

A brief outline of these options was presented to the Pesticide Programs Dialogue Committee ( PPDC) in January 1999. The PPDC is an advisory committee organized under the Federal Advisory Committee Act. Currently the PPDC is comprised of approximately 27 members from the pesticide industry, user, and commodity groups; Federal and State governments; consumer and environmental/ public interest groups, including representatives from the general public; academia; and, public health organizations. The PPDC provides advice and guidance to the Office of Pesticide Programs regarding pesticide regulatory, policy, and implementation issues. Informally, several PPDC members expressed an interest in the development and implementation of the broadest interpretation of the statutory language.

IV. Submitting Comments EPA specifically solicits public comments on the options described in this paper. However,

comments submitted on other interpretations of the new language will also be considered. EPA asks commenters to also include suggested procedures for implementing whatever option the cementer prefers. To date, the Agency has already received a position paper from The Council For Advanced Agricultural Formulations, Inc., an association representing certain manufacturers of other ingredients used in pesticide products, setting forth a proposed implementation scheme for this new provision that is similar to Option 3.

Hard copies of the options paper, or copies of other public comments received can be Page 8 of 8 obtained by contacting: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. The PIRIB is open from 8: 30 a. m.

to 4: 00 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805.


[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Page 28836]
[FR Doc No: 2017-13268]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-1778-000]

HD Project One LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
HD Project One LLC`s application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 10, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: June 20, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-13268 Filed 6-23-17; 8:45 am]
 BILLING CODE 6717-01-P