[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Pages 60453-60455]
[FR Doc No: 2017-27338]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82318; File No. SR-ISE-2017-104]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to Primary
Market Maker Obligations

December 14, 2017
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 29, 2017, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 701, entitled ``Openings,'' to
specify the obligations of a Primary Market Maker (``PMM'') when
entering Valid Width Quotes \3\ during the Opening Process.
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    \3\ A ``Valid Width Quote'' is a two-sided electronic quotation
submitted by a Market Maker that consists of a bid/ask differential
that is compliant with Rule 803(b)(4). See Rule 701(a)(8).
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    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend Rule 701, Openings, to amend the
obligations of a PMM when entering Valid Width Quotes during the
Opening Process. In addition, the Exchange proposes to make clear the
obligations of a PMM and a Competitive Market Maker (``CMM'') once an
options series has opened.
    Currently, Rule 701(c)(1) provides, the Opening Process for an
option series will be conducted pursuant to paragraphs (f)-(j) of ISE
Rule 701 on or after 9:30 a.m. Eastern Time if: The ABBO, if any, is
not crossed; and the system has received, within two minutes (or such
shorter time as determined by the Exchange and disseminated to
membership on the Exchange's website) of the opening trade or quote on
the market for the underlying security in the case of equity options
or, in the case of index options, within two minutes of the receipt of
the opening price in the underlying index (or such shorter time as
determined by the Exchange and disseminated to membership on the
Exchange's website), or within two minutes of market opening for the
underlying security in the case of U.S. dollar-settled foreign currency
options (or such shorter time as determined by the Exchange and
disseminated to membership on the Exchange's website) any of the
following: (i) The PMM's Valid Width Quote; (ii) the Valid Width Quotes
of at least two CMM or (iii) if neither the PMM's Valid Width Quote nor
the Valid Width Quotes of two CMMs have been submitted within such
timeframe, one CMM has submitted a Valid Width Quote.
    Thereafter, Rule 701(c)(3) specifies that the PMM assigned in a
particular equity or index option must enter a Valid Width Quote, in
90% of their assigned series, not later than one minute following the
dissemination of a quote or trade by the market for the underlying
security or, in the case of index options, following the receipt of the
opening price in the underlying index. The PMM assigned in a particular
U.S. dollar-settled foreign currency option must enter a Valid Width
Quote, in 90% of their assigned series, not later than one minute after
the announced market opening. PMMs must promptly enter a Valid Width
Quote in the remainder of their assigned series, which did not open
within one minute following the dissemination of a quote or trade by
the market for the underlying security or, in the case of index
options, following the receipt of the opening price in the underlying
index or, with respect to U.S. dollar-settled foreign currency options,
following the announced market opening.
    The Exchange proposes to make clear that a PMM has the obligations
specified in ISE Rule 701(c)(3) to promptly enter a Valid Width Quote
in the remainder of their assigned series in cases where the PMM's
assigned series was not already opened by a CMM as permitted by Rule
701(c)(1)(ii) and (iii) as noted herein. The PMM would continue to have
the ultimate obligation to open each assigned series, however this rule
change would not require the PMM to enter a Valid Width Quote for the
10% of their assigned series, not later than one minute following the
dissemination of a quote or trade by the market for the underlying
security or, in the case of index options, following the receipt of the
opening price in the underlying index during the Opening Process if an
options series has opened pursuant to Rule 701(c)(1)(ii) and (iii)
within the timeframe specified for the PMM to enter a Valid Width Quote
as noted in Rule 701(c)(3). Also, the PMM assigned in a particular U.S.
dollar-settled foreign currency option would not be required to enter a
Valid Width Quote for 10% of their assigned series, not later than one
minute after the announced market opening during the Opening Process if
an options series opened pursuant to Rule 701(c)(1)(ii) and (iii)
within the timeframe specified for the PMM to enter a Valid Width Quote
as noted in Rule 701(c)(3).
    Today ISE Rule 701 requires a PMM to open the market and provides
an alternative mechanism to permit an alternative opening by a CMM.\4\
The proposal seeks to make clear the obligations of the PMM with
respect to options series that were open by a CMM as well as the
quoting obligations of a CMM that opened the options series. The
Exchange proposes to amend ISE Rule 701(c)(3) to state that once an
option series has opened pursuant to Rule 701(c)(1)(i)-(iii), a PMM
must submit continuous, two-sided quotes in

such option series pursuant to Supplementary .01 to ISE Rule 804. The
Exchange also proposes to amend Rule 701(c)(4) to state that a CMM that
submits a quote during the opening in any option series pursuant to
Rule 701(c)(1)(ii) or (iii) must submit continuous, two-sided quotes in
such options series pursuant to ISE Rule 804(e)(2)(iii) once an option
series has opened. Specifically, the Exchange proposes to add rule text
to Rule 701(c)(3) to provide that ``once an options series has opened f
pursuant to Rule 701(c)(1)(i)-(iii), a PMM must submit continuous, two-
sided quotes in such options series pursuant to Supplementary Material
.01 to Rule 804.'' Further, the Exchange proposes to add rule text to
Rule 701(c)(4) to states that ``A CMM that submits a quote pursuant to
Rule 701 in any option series when the PMM's quote has not been
submitted shall be required, once an options series has opened, to
submit continuous, two-sided quotes in such option series pursuant to
Rule 804(e)(2)(iii).''
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    \4\ See ISE Rule 701(c)(1)(i)-(iii).
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    The Exchange proposes to make clear that a PMM has an obligation to
enter Valid Width Quotes during the Opening Process within the
timeframes specified in Rule 701(c)(3). In the event that an options
series opened pursuant to Rule 701(c)(1)(ii) and (iii), a PMM would be
required to submit continuous, two-sided quotes in such options series
pursuant to Supplementary Material .01 to Rule 804. Also, in this
instance, a CMM would be required to submit continuous, two-sided
quotes in such option series pursuant to Rule 804(e)(2)(iii). The
Exchange notes that a CMM would not have an obligation to quote in such
option series pursuant to Rule 804(e)(2)(iii), unless the CMM submitted
a quote pursuant to Rule 701 or otherwise submitted a quote intra-
day.\5\ The purpose of this new rule text is to make clear the quoting
obligations for both PMMs and CMMs during the opening and the manner in
which Rule 701, relating to the Opening Process, and Rule 804, relating
to Market Maker quoting obligations, interact with each other.
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    \5\ See ISE Rule 804(e)(2)(i) which states, ``On any given day,
a Competitive Market Maker is not required to enter quotations in
the options classes to which it is appointed.''
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest by
amending ISE Rule 701(c)(3) to further specify a PMM's obligations
during the Opening Process and once an options series as opened as well
as the obligations of a CMM to the extent that an options series opened
pursuant to Rule 701(c)(1)(ii) and (iii). The Exchange believes that
this proposal is consistent with the Act because a PMM continues to be
responsible to enter Valid Width Quotes during the Opening Process and
thereafter submit continuous, two-sided quotes in such options series
pursuant to Supplementary Material .01 to Rule 804. In the event that
an options series opened pursuant to Rule 701(c)(1)(ii) and (iii), the
CMM must submit continuous, two-sided quotes in such option series,
once the options series has opened, pursuant to Rule 804(e)(2)(iii).
The Exchange believes that this proposed rule change will make clear
the obligations of the PMM with respect to submitting Valid Width
Quotes and thereafter, once an options series has opened, submitting
continuous two-sided quotes, when a CMM may have already entered a
quote to open an options series. The Exchange's proposal to add rule
text to clearly specify the quoting obligations of a PMM and CMM during
the Opening Process and once an option series has opened will provide
greater clarity to the Opening Process and also to the interplay
between quoting obligations during the Opening Process and intra-day
quoting obligations noted within Rule 804.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Once an options series has
opened, [sic] a PMM continues to be responsible to enter Valid Width
Quotes during the Opening Process and thereafter submit continuous,
two-sided quotes in such options series pursuant to Supplementary
Material .01 to Rule 804. Also, if an options series opened pursuant to
ISE Rule 701(c)(1)(ii) or (iii), a CMM shall be required to submit
continuous, two-sided quotes in such option series, once an option
series has opened. pursuant to Rule 804(e)(2)(iii). This proposed rule
text makes clear that CMMs are required to submit continuous, two-sided
quotes in such option series pursuant to Rule 804(e)(2)(iii), in the
event an options series opened pursuant to Rule 701(c)(1)(ii) and
(iii). The proposal provides greater clarity to the Opening Process and
also to the interplay between quoting obligations during the Opening
Process and intra-day quoting obligations noted within Rule 804.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
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    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of filing.
However, Rule 19b-4(f)(6)(iii) \10\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. In its filing with the Commission,
the Exchange requests that the Commission waive the 30-day operative
delay. The Exchange represents that the proposed rule change would
clarify the quoting obligations for both PMMs and CMMs during the
Opening Process and the manner in which Rule 701, relating to the
Opening Process, and Rule 804, relating to Market Maker quoting
obligations, interact with each other. According to the Exchange, these
obligations should be immediately clarified to prevent confusion and
uncertainty for Market Makers quoting on the Exchange. For the reasons
articulated by the Exchange, the Commission believes that waiver of the
30-day operative delay is consistent

with the protection of investors and the public interest. Therefore,
the Commission designates the proposed rule change to be operative upon
filing.\11\
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    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-ISE-2017-104 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2017-104. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-ISE-2017-104 and should be submitted on
or before January 10, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27338 Filed 12-19-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Rules and Regulations]
[Pages 42947-42952]
[FR Doc No: 2017-19452]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0308; FRL-9965-71]

EPTC; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of EPTC,
S-ethyl dipropylthiocarbamate in or on grass, forage at 0.60 ppm and
grass, hay at 0.50 ppm. Gowan Company requested these tolerances under
the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 13, 2017. Objections and
requests for hearings must be received on or before November 13, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0308, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document

applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0308 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 13, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0308, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of Friday, July 17, 2015 (80 FR 42462)
(FRL-9929-13), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 5F8355) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366.
The petition requested that 40 CFR part 180 be amended by establishing
tolerances for residues of the herbicide EPTC, S-ethyl
dipropylthiocarbamate, in or on grass grown for seed, forage at 0.6
parts per million (ppm) and grass grown for seed, hay at 0.5 ppm. That
document referenced a summary of the petition prepared by Gowan
Company, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for EPTC, including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with EPTC follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    On an acute exposure basis, EPTC is highly toxic via inhalation and
is moderately toxic via the oral and dermal routes of exposure. It is
slightly irritating to eyes and minimally-irritating to skin. It is a
weak skin sensitizer.
    EPTC is an S-alkylthiocarbamate, which consistently produced
cardiomyopathy and neuronal cell necrosis in studies of varying length
of treatment and in different species. Cardiotoxicity was observed in
subchronic and long-term studies, and in general, the severity and
incidence of the lesion increased with increasing doses of EPTC. In 90-
day feeding and inhalation studies and in two chronic feeding/
oncogenicity studies, histopathological evaluation revealed myocardial
degeneration. Myocardial degeneration in adult rats was also observed
in two separate two-generation reproduction studies. In two chronic dog
studies, degenerative changes in the cardiac muscle were observed when
EPTC was administered in a capsule, but not when administered (at
comparable doses) in the diet. In both dog studies, electrocardiograms
were taken, but only one high-dose male in the capsule study had
changes which were described as ``potentially'' treatment-related.
    EPTC, as well as other thiocarbamates (molinate, cycloate,
pebulate, vernolate and butylate), have toxic effects on the central
and peripheral nervous systems. With EPTC, there was an increased
incidence and severity of neuronal necrosis/degeneration in both the
central and peripheral nervous systems of rats and dogs. In the rat
neurotoxicity studies, dose-related increases in the incidence of
neuronal necrosis were observed in the brains after acute and
subchronic exposure to EPTC. In the rat developmental neurotoxicity
study, a

marginal decrease in absolute (not relative) pup brain weight (4-6%)
was observed in only one sex (male pups) and at only one time point
(PND63). Furthermore, this marginal effect had no dose-response, was
not seen after perfusion, and had no corresponding necrosis. Therefore,
this effect was considered marginal at best and not robust. In both of
the combined chronic toxicity/carcinogenicity studies in the rat and in
the chronic (capsule) study in the dog, treatment-related neuromuscular
lesions were observed. In all of these studies, hindquarter weakness
with corresponding histopathology findings of atrophy and degeneration
of the skeletal muscle were observed. In the dog study, the lesions
were described as Wallerian-type degeneration in the spinal cords and
various peripheral nerves.
    EPTC is a reversible acetylcholinesterase (AChE) inhibitor.
Toxicology studies with EPTC did not show any consistent pattern of
AChE-inhibition between different species, length of treatment, or the
type of AChE enzyme measured. In some studies, brain AChE activity was
inhibited without any effect on either plasma or erythrocyte AChE
activities. In other studies, erythrocyte AChE was inhibited with no
inhibition of either plasma or brain AChE. AChE-inhibition was observed
at comparable or higher doses than where cardiac/neuronal effects were
observed.
    There is no evidence of increased susceptibility following in utero
exposure to EPTC in either the rat or rabbit developmental toxicity
study or following in utero and/or postnatal exposure in the 2-
generation reproduction study in rats. EPTC is classified as ``Not
Likely to be Carcinogenic to Humans.'' This is based on the lack of
carcinogenic potential noted in the available studies. There are no
concerns for mutagenicity or clastogenicity. There is also no concern
for immunotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by EPTC as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies scan be found at https://www.regulations.gov in document EPTC: Human Health Risk Assessment for
the Proposed Section 3 Registration for Use on Grasses Grown for Seed
Production in docket ID number EPA-HQ-OPP-2015-0308.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for EPTC used for human
risk assessment is shown in Table 1 of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for EPTC for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations     LOAEL = 200 mg/kg/    aRfD/aPAD = 0.2 mg/  Acute neurotoxicity rat study.
 including infants and children).   day.                  kg/day.             NOAEL not established in males.
                                   UFA = 10x...........                       LOAEL = 200 mg/kg/day based on
                                   UFH = 10x...........                        neuronal cell necrosis in the
                                   FQPA SF/UFL = 10x...                        brain in males.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations   POD = 5 mg/kg/day...  cRfD/cPAD = 0.05 mg/ Co-critical, chronic/
 including infants and children).  UFA = 10x...........   kg/day.              carcinogenicity and 2-generation
                                   UFH = 10x...........                        reproduction in rats.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Incidental oral (short- and        POD = 5 mg/kg/day...  LOC for MOE = 100..  Chronic toxicity/carcinogenicity
 intermediate-term).               UFA = 10x...........                        rat study.
                                   UFH = 10x...........                       NOAEL = 5 mg/kg/day.
                                   FQPA SF = 1x........                       LOAEL = 25 mg/kg/day based on
                                                                               decreased body weight and
                                                                               increased incidences of
                                                                               myocardial and neuromuscular
                                                                               lesions.
----------------------------------------------------------------------------------------------------------------
Dermal (short- and intermediated-  POD = 5 mg/kg/day     LOC for MOE = 100..  2-generation reproduction toxicity
 term).                             Dermal absorption                          rat study.
                                    factor= 5%.                               Parental NOAEL = 2.5 mg/kg/day.
                                   UFA = 10x...........                       Parental LOAEL = 10 mg/kg/day
                                   UFH = 10x...........                        based on decreased body weight
                                   FQPA SF = 1x........                        and cardiomyopathy.
                                                                              Developmental NOAEL = 10 mg/kg/
                                                                               day.
                                                                              Developmental LOAEL = 40 mg/kg/day
                                                                               based on decreased mean pup
                                                                               weight during lactation days 4 to
                                                                               21.
                                                                              Reproductive NOAEL = 40 mg/kg/day.
                                                                              Reproductive LOAEL >40 mg/kg/day.
----------------------------------------------------------------------------------------------------------------

Inhalation (short- and             BMDL10 = 5.05 mg/     LOC for MOE = 30...  90-day inhalation toxicity study
 intermediated-term).               m\3\ mg/kg/day.                            in rats.
                                   UFA = 3x............                       BMD = 10.84 mg/m based on brain
                                   UFH = 10x...........                        cholinesterase inhibition in
                                   FQPA SF = 1x........                        males.
                                  -------------------------------------------
                                   Residential bystander HEC = 2.288 mg/m\3\
----------------------------------------------------------------------------------------------------------------
                                   Occupational Handler HEC = 9.609 mg/m\3\;
                                              HED = 0.91 mg/kg/day
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classified as ``Not Likely to be Carcinogenic to Humans.'' based on the lack
                                    of carcinogenic potential noted in the available studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram per kilogram per day. MOE = margin of exposure. NOAEL = no-observed-adverse-
  effect-level. PAD = population adjusted dose (a = acute, c = chronic). POD = point of departure. RfD =
  reference dose (a = acute, c = chronic). UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
  UFL = use of a LOAEL to extrapolate a NOAEL. HEC = human equivalent concentration. HED = human equivalent
  dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to EPTC, EPA considered exposure under the petitioned-for
tolerances as well as all existing EPTC tolerances in 40 CFR 180.117.
EPA assessed dietary exposures from EPTC in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for EPTC. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA incorporated tolerance-level residues (adjusted for
metabolites at 15X, to estimate the concentration of residues of
toxicological concern), 100 percent crop treated (PCT) for all
commodities, and default processing factors for all processed
commodities except for potato granules (1.4X) and for sugar beets (4X).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the same food consumption data and food residue
level information as described above for acute dietary exposure.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that EPTC does not pose a cancer risk to humans. Therefore, a
dietary exposure assessment for the purpose of assessing cancer risk is
unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for EPTC. Tolerance-level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water.
    The Agency used screening-level water exposure models in the
dietary exposure analysis and risk assessment for EPTC in drinking
water. These simulation models take into account data on the physical,
chemical, and fate/transport characteristics of EPTC. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier II Surface Water Concentration Calculator (SWCC)
and Pesticide Root Zone Model Ground Water (PRZM-GW) model, the highest
estimated drinking water concentration (EDWC) of EPTC for acute
exposure is estimated to be 378 parts per billion (ppb) from ground
water. For chronic exposure, the highest EDWC is estimated to be 335
ppb from ground water. These EDWCs were directly entered into the
dietary exposure models for both acute and chronic dietary risk
assessments to assess the contribution from drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). EPTC is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Although thiocarbamates
share some chemical and toxicological characteristics, the
toxicological database does not support a testable hypothesis for a
common mechanism of action. Therefore, for the purposes of this
tolerance action EPA has assumed that EPTC does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines

based on reliable data that a different margin of safety will be safe
for infants and children. This additional margin of safety is commonly
referred to as the FQPA Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. As discussed in Unit III.A.,
there was no qualitative or quantitative evidence of increased
susceptibility to developing fetuses following in utero exposure to
EPTC in the rabbit and rat developmental toxicity studies, or to
offspring in the rat two-generation reproduction toxicity study.
Although there was evidence of increased qualitative and quantitative
susceptibility of offspring observed in the rat developmental
neurotoxicity study. The effect on a marginal decreased absolute brain
weight was observed only in male pups at one time-point on postnatal
day 63. This effect was considered marginal and not robust since it had
no dose-response, was not seen after perfusion, and had no
corresponding necrosis. Therefore, there is low concern for
susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for assessing chronic dietary exposure but
retained at 10X for assessing acute dietary exposure to account for
extrapolating a NOAEL from a LOAEL. That decision is based on the
following findings:
    i. The toxicity database for EPTC is complete and adequate to
assess potential risk to infants and children.
    ii. There is indication that EPTC has toxic effects on the central
and peripheral nervous systems. Neuronal necrosis and degeneration were
observed in both the central and peripheral nervous systems of rats and
dogs after acute and subchronic exposure. Treatment-related
neuromuscular lesions were also observed in chronic rat and dog
studies. In all of these studies hindquarter weakness was noted, and at
necropsy evaluation atrophy and degeneration of the skeletal muscle was
observed. In the dog study, the lesions were described as Wallerian-
type degeneration in the spinal cords and various peripheral nerves.
AChE inhibition was also seen in a number of toxicology studies;
however, no consistent pattern was witnessed across studies with
respect to AChE inhibition between different species, length of
treatment, or the type of AChE enzyme measured. All studies provide
clear NOAELs and LOAELs, except the acute neurotoxicity study, and
because the Agency is relying on that study for selection of the acute
dietary exposure endpoint, EPA is retaining the 10X FQPA safety factor
to account from the extrapolation from the LOAEL to the NOAEL.
    iii. There is no evidence that EPTC results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study. Evidence of increased susceptibility to offspring
was observed in the developmental neurotoxicity study; however, this
effect was considered marginal and not robust. Therefore, there is low
concern for the susceptibility.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to EPTC in drinking water. These assessments will
not underestimate the exposure and risks posed by EPTC.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to EPTC will occupy 46% of the aPAD for children between 1-2 years old,
the population subgroup receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
EPTC from food and water will utilize 65% of the cPAD for children
between 1-2 years old, the population subgroup receiving the greatest
exposure. There are no residential uses for EPTC.
    3. Short- and intermediate-term risks. Short- and intermediate-term
aggregate exposures takes into account short-term (1 to 30 days) and
intermediate-term (1 to 6 months) residential exposure plus chronic
exposure from food and water (considered to be a background exposure
level). Short- and intermediate-term adverse effects were identified;
however, EPTC is not registered for any use patterns that would result
in residential exposure. Because there is no residential exposure and
chronic dietary exposure has already been assessed under the
appropriately protective PADs (which is at least as protective as the
PODs used to assess short- and intermediate-term risks), no further
assessment of short- and intermediate-term risks are necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risks for EPTC.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, EPTC is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to EPTC residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography with micro coulometric (GLC/MC)
detection method (RR-50) listed under Method A in the Pesticide
Analytical Manual (PAM Volume II, Section 180.117; is available for
enforcing tolerances of EPTC per se in plant commodities. For the
determination of hydroxylated metabolites (free or conjugated) of EPTC
in or on plant commodities, an adequate gas chromatography with
nitrogen-phosphorus detection (GC/NPD) enforcement method (Method RR-
96-089B) is also available.
    These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as

required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint
United Nations Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level. The Codex has not established any MRLs for EPTC.

C. Revisions to Petitioned-For Tolerances

    The Agency is establishing tolerances for the forage and hay forms
of ``grass'' rather than ``grass grown for seed'' as requested to
conform with its food and feed commodity vocabulary. Also, the Agency
is establishing the tolerance levels to conform with its policy of
significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of EPTC, S-ethyl
dipropylthiocarbamate, including its metabolites and degradates, in or
on grass, forage at 0.60 ppm and grass, hay at 0.50.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 16, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.117, add alphabetically the commodities to the table in
paragraph (a) to read as follows:

Sec.  180.117  S-ethyl dipropylthiocarbamate; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Grass, forage...........................................            0.60
Grass, hay..............................................            0.50

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-19452 Filed 9-12-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 27, 2008 (Volume 73, Number 208)]
[Notices]
[Page 63715]
[DOCID:fr27oc08-67]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Intrapartum Electronic Fetal Monitoring With Computer Assisted
Diagnosis Workshop--Exploring Methods of Evaluation

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Intrapartum Electronic Fetal Monitoring (EFM) With
Computer Assisted Diagnosis (CAD)--Exploring Methods of Evaluation.''
The objectives of this workshop are to gather ideas on how to identify
and differentiate categories of EFM/CAD devices and the corresponding
levels of evidence needed to validate these devices. Workshop
participants will also discuss how currently available databases might
be used to verify/validate intrapartum EFM/CAD algorithms.
    Date and Time: The workshop will be held on November 10, 2008, from
8 a.m. to 5 p.m. Registrations will be accepted through October 31,
2008. Participants are encouraged to arrive early to ensure time for
parking, security screening, and registration before the meeting.
Security screening will begin at 7 a.m. and registration will begin at
7:30 a.m. See Registration Information section of this document for
registration details.
    Location: The workshop will be held at the Food & Drug
Administration White Oak Campus, conference room G-2047, 10903 New
Hampshire Ave., Silver Spring, MD 20993.
    FDA will make every effort to accommodate persons with physical
disabilities or special needs. If you require special accommodations
due to a disability, please notify one of the contacts listed in this
document (see Contact) at least 7 days in advance of the workshop.
    Contact: Sharon Andrews, Center for Devices and Radiological Health
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>or
    Elaine Blyskun, Center for Devices and Radiological Health (HFZ-
470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850,<PHONE_NUMBER>, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>    Registration Information: Registration may be completed online at
the following Web site: http://www.blsmeetings.net/1368-2. There is no
registration fee for this workshop; however, all participants must
submit a registration form. Space is limited, so please register as
soon as possible to reserve a space. Registrations will be accepted
through (see Dates). Persons without Internet access may contact
Syreeta Tate-Jones at<PHONE_NUMBER>, ext. 49 by October 31, 2008, to
register.
    Agenda: The workshop will begin with a morning session to provide a
clinical and regulatory overview of intrapartum fetal monitors.
Presentation topics will address fetal monitoring in general, the
relationship between technology and clinical decisionmaking, the
current state of EFM/CAD development, and evaluation/validation methods
that may be applied to new EFM/CAD systems. In the afternoon, attendees
will break into two discussion groups: (1) EFM/CAD technological
development and validation and (2) the practicality of using existing
databases to test new EFM/CAD algorithms. The workshop will conclude
with an overview of the break-out discussions and identification of
research gaps and opportunities in the field.

    Dated: October 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25586 Filed 10-24-08; 8:45 am]

BILLING CODE 4160-01-S


                      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                                     Technical Support Document for
                                       the EPA's Rulemaking for the
                            Arizona State Implementation Plan

                          Arizona Administrative Code Title 18, Chapter 2, Article 13
                        Part B  -  Hayden, Arizona, Planning Area
             R18-2-B1302  -  Limits on SO2 Emissions from the Hayden Smelter

                                            Prepared by Kevin Gong
                          Rules Office, Air Division Region 9 (Pacific Southwest)

                                       April 2020

RULE IDENTIFICATION
 Agency
Arizona Department of Environmental Quality
 SIP Approved Rules
    R-18-2-715 (sections F, G, and H)  -  Standards of Performance for Existing Primary Copper Smelters: Site-Specific Requirements
Amended  -  March 7, 2009
Submitted  -  July 28, 2011
Supplemented  -  May 16, 2014
EPA Approved  -  September 23, 2014 (79 FR 56655)

    R18-2-715.01  -  Standards of Performance for Existing Primary Copper Smelters, Compliance and Monitoring
Amended  -  July 18, 2009
Submitted  -  September 12, 2003
EPA Approved  -  November 1, 2004 (69 FR 63321)
 Rule that is the Subject of this TSD
    Arizona Administrative Code (A.A.C.) R18-2-B1302  -  Limits on SO2 Emissions from the Hayden Smelter
Effective  -  July 1, 2018 or 180 calendar days after completion of all Converter Retrofit Project improvements authorized by Significant Permit Revision No. 60647
Submitted  -  April 6, 2017
 Completeness Finding
Determination of Completeness letter: July 17, 2017
BACKGROUND
On June 22, 2010, the EPA promulgated a new 1-hour primary sulfur dioxide (SO2) National Ambient Air Quality Standard (NAAQS) of 75 parts per billion (ppb). On August 5, 2013, the EPA designated a first set of 29 areas of the country as nonattainment for the 2010 SO2 NAAQS, including the Hayden SO2 nonattainment area (NAA) within Arizona. These area designations became effective on October 4, 2013. Section 191(a) of the Clean Air Act (CAA) directs states to submit state implementation plans (SIPs) for areas designated as nonattainment for the SO2 NAAQS to the EPA within 18 months of the effective date of the designation, i.e., by no later than April 4, 2015, in this case. Under CAA section 192(a), these plans are required to include measures that will provide for the attainment of the NAAQS as expeditiously as practicable, but no later than 5 years from the effective date of designation, which for the Hayden SO2 NAA was October 4, 2018.

The Hayden NAA in Central Eastern Arizona is home to one of three operating copper smelters in the United States. The process of extracting copper from mined ore generates various process by-products, including SO2. The Hayden Smelter is owned and operated by ASARCO LLC ("Asarco"), a subsidiary of international minerals conglomerate Grupo México S.A., and accounts for over 99 percent of SO2 Emissions in the Hayden NAA.

Asarco, as the current owner of the Hayden Smelter, is the subject of a 2015 consent decree with the EPA regarding allegations that the facility had violated the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Primary Copper Smelting, 40 CFR part 63, subpart QQQ. Asarco's actions to comply with the consent decree are also a part of its control strategy to address the SO2 NAAQS, primarily through a major retrofit project focusing on the converters, and on improvements to the control equipment capturing and controlling process emissions. The converter retrofit project (CRP) involved installation of new process and control equipment that is intended to reduce fugitive lead and other hazardous air pollutant emissions, as well as emissions of SO2 from the smelting process. This project included the replacement of the existing five converter units with three larger ones, installation of extensive, more efficient and more effective fugitive gas control ducting around the converters, and the installation of additional process gas controls before venting to the main stack.

The Arizona Department of Environmental Quality (ADEQ) regulates the Hayden SO2 nonattainment area. ADEQ submitted an attainment plan for the Hayden SO2 nonattainment area on March 9, 2017, and submitted associated final rules, including Rule R18-2-B1302, on April 6, 2017.

SO2 in the primary copper smelting process
Primary copper smelting at the Hayden Smelter can generate SO2 emissions during multiple steps of the refining process.

Copper ore concentrate (crushed metal-bearing rock) is first shipped from copper mines to a smelter for additional processing in a bedding plant. The concentrate is mixed with flux, and then dried before being fed into a primary smelting furnace. The Hayden Smelter uses an INCO Flash Furnace for primary smelting, which consists of a large rectangular refractory-lined chamber which has an off-gas flue rising from the center and burners in the end-walls. The concentrate mixture is introduced into the INCO flash furnace with oxygen-enriched air and a fuel (usually natural gas) which then reacts (with oxygen, sulfur and iron in the copper concentrate) and separates into a copper-rich matte, and a layer of slag consisting of byproduct minerals and metals, and in the process emits SO2. The slag is skimmed or tapped off for potential reprocessing or disposal. Pollutants can escape during skimming, tapping or charging of the furnace. The remaining matte is tapped into large ladles for the next step in processing in the converters.

Converters are large horizontal cylindrical chambers which further refine copper. Hayden's converters are of the Peirce-Smith type, which charge, tap, and vent through the same portal (or "mouth") by rotating the cylinder to change the position of the opening. Matte copper has a higher copper content than the copper ore concentrate in the INCO flash furnace, but still contains substantial impurities, including copper sulfides and lead. The molten matte is poured by ladles into the converters with additional silica flux, and air is blown into the converters through tubes (called tuyeres) which are submerged in the matte. The oxygen in the air reacts with the sulfides, generating SO2 process gas while further purifying the copper. This blowing can generate substantial SO2-bearing emissions, all of which is vented through the opening in the side of the Peirce-Smith converter. The blowing can go on for several hours without any additional external heating to maintain the matte's molten state, as this reaction is exothermic. Converter temperatures can be controlled by adding in cold materials, such as scrap copper. Additional slag is generated during the blowing process and can be returned to the flash furnace for reprocessing. The resulting blister copper contains few impurities at this stage, but still has substantial amounts of copper oxides that formed during converter processing.

The final primary smelter process occurs at the anode furnace, where the blister copper is blown over with natural gas, that will react with any remaining oxygen. The resultant anode copper is cast into anode sheets (at about 99% purity) for final treatment with electrowinning, an electrolytic plating process which can further purify the copper for industrial processes. The Hayden Smelter ships its copper anodes to other facilities for electrowinning. The blowing and casting processes can also generate SO2 emissions.

Process gas capture and control system and the retrofit project
The Hayden Smelter's existing capture system consists of the INCO flash furnace main flue, ventilation hoods installed at the charging and tapping points for the flash furnace, and ventilation hoods over each converter mouth. Process gas in the flash furnace main flue is sent to a venturi scrubber to capture and reduce particulate matter emissions, while the high sulfur content gas is further cleaned and processed at the acid plant.

Gases from the furnace tap points and the converters during operations are captured by the hooding system. The hoods over the tap points in the flash furnace capture SO2 gases, which are routed to an electrostatic precipitator (this device also captures particulates from hood and ventilation systems in the dryers that prepare the concentrate). The converter hoods cover the mouth during blowing operations, but the existing primary capture hoods do not operate effectively during charging or tapping operations when the converter is rotated away from the ventilation hood. This results in fugitive emissions that are vented from the smelting process and eventually emitted into the atmosphere through the converter aisle roofline. Asarco has installed covers for the converter mouths that would be in a closed position during blowing operations, to further minimize fugitive emissions, but do not seal the opening. Ventilation gas captured by the primary hooding system is routed for process gas cleaning and SO2 recovery at the acid plant. An emergency bypass stack is available for venting the entire system during malfunction or unexpected shutdowns, but is sealed during normal operations by two dampers.

Asarco's SO2 control strategy at the Hayden Smelter has included several equipment and process upgrades. The electrostatic precipitator controlling ventilation gas from the drying facility and the flash furnace has been replaced with a new vent gas baghouse system, which includes high surface area lime injection for SO2 control. The five old 13-foot diameter converters have been replaced with three new 15-foot diameter units. The new units operate more efficiently so that only one converter needs to operate at any one time (current operations may see two units operating to handle the flash furnace's output) and the capture system design will be simplified by reducing the number of converters that need to be hooded. Asarco has also installed extended secondary and tertiary hooding in the converter aisle to maximize ventilation gas capture during charging, transfer, and tapping operations. The Hayden Smelter's acid plant has also been improved with an upgraded pre-heater system, which is meant to reduce the length of start-up periods at the plant by bringing the SO2 catalyst beds up to temperature in a shorter amount of time.

ADEQ has estimated that SO2 emissions from the smelter would be reduced by 90 percent between 2011 and 2019 as a result of the CRP.

History of sulfur dioxide nonattainment in the Hayden area and existing regulations
The Hayden area has been designated as nonattainment for the 1971 SO2 NAAQS since 1978. The State of Arizona submitted regulations to the EPA in 1979 and 1980 to reduce emissions from criteria pollutant sources in Hayden and across the state. The EPA approved these measures on January 14, 1983, but found that further analysis and control of smelter fugitive emissions was needed. The smelter operators submitted fugitive emissions studies in the 1990s to better estimate fugitive emissions during typical operation to eventually determine maximum emissions. This analysis resulted in the implementation of further control measures and emission limits at the Hayden Smelter.

The current SIP-approved rules governing SO2 emissions from the Hayden Smelter include rules R18-2-715 (Rule 715) and R18-2-715.01 (Rule 715.01). Rule 715 subsection (F)(1) includes annual SO2 limits for the Hayden smelter, as well as a table outlining the number of acceptable cumulative occurrence exceedances for each of a series of specific 3-hour limits. Subsection (G) establishes an annual average fugitive emissions limit of 295 pounds per hour.

Rule 715.01 was previously revised on July 18, 2002 and approved by the EPA on November 1, 2004 (69 FR 63321). Rule 715.01 addresses compliance and monitoring requirements at the Hayden Smelter (in addition to similar requirements for the Miami Smelter), including: specific requirements for compliance determination, compliance dates for limits, averaging methods, violation provisions, emissions monitoring requirements, measurement system requirements, maintenance requirements for monitoring systems, and other related provisions.

RULE SUMMARY
Rule R18-2-B1302  -  Limits on SO2 Emissions from the Hayden Smelter
R18-2-B1302 (Rule B1302) is a source-specific regulation in the AAC that limits SO2 Emissions from processes at the Hayden Smelter. This rule has an effective date of the earlier of July 1, 2018 or 180 days after the completion of the retrofit project.

This rule includes relevant definitions, an hourly SO2 emission limit for the main stack, operational standards for process equipment and control devices, baseline requirements for the process gas capture system and control devices operations and maintenance plan (O&M plan), performance testing and compliance demonstration requirements, and recordkeeping and reporting requirements.

Rule B1302 also requires the owner or operator of the smelter to conduct a fugitive emissions study following the completion of the CRP, in accordance with Appendix 14 of Title 18, Chapter 2. The EPA approved Appendix 14 into the SIP on November 14, 2018.

EVALUATION CRITERIA
The following criteria were used to evaluate the submitted rule.

 Enforceability - CAA section 110(a)(2)(A) requires SIPs to "include enforceable emission limitations and other control measures, means, or techniques . . . as may be necessary or appropriate to meet the applicable requirements of [the CAA]." Similarly, CAA section 172(c)(6) requires that attainment SIPs "include enforceable emission limitations, and such other control measures means or techniques . . . as well as schedules and timetables for compliance, as may be necessary or appropriate to provide for attainment of such standard in such area by the applicable attainment date . . ." The Bluebook (Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations, EPA, May 25, 1988) and the Little Bluebook (Guidance Document for Correcting Common VOC & Other Rule Deficiencies, EPA Region 9, August 21, 2001) were used to help evaluate compliance with the CAA requirements for enforceability.

 Stringency  -  CAA section 172(c)(1) requires that SIPS for nonattainment areas provide for the implementation of all reasonably available control measures (RACM), including any reasonably available control technology (RACT), in order to provide for attainment of the NAAQS.

 SIP Revisions  -  CAA section 110(l) prohibits the EPA from approving any SIP revision that would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. In addition, CAA section 193 prohibits the modification of any SIP-approved control requirement in effect before November 15, 1990, in a nonattainment area, unless the modification insures equivalent or greater emission reductions of the relevant pollutant(s).

EPA EVALUATION
 Enforceability of Rule B1302
Rule B1302 sections (E), (F), (G), and (H) contain detailed monitoring, recordkeeping, and reporting requirements, which support the enforceability of the main stack emission limit. However, the EPA has identified several issues with the enforceability of Rule B1302:

 Lack of a numerical emission limit for fugitives
The attainment demonstration modeling in the Hayden SO2 Plan includes emissions emanating from five locations around the facility: the main smelter stack, the anode furnace roofline, the converter aisle roofline, the flash furnace building roofline, and the outdoor slag pouring area. Of these, only the main stack is subject to a numeric emission limit and ongoing monitoring under Rule B1302. The EPA believes that the emissions from outdoor slag pouring are not susceptible to monitoring and therefore it is not reasonable to require a numeric emission limit for these emissions. Conversely, we find that emissions from the anode furnace roofline, the converter aisle roofline, and the flash furnace building roofline (collectively "building fugitive emissions"), are susceptible to monitoring, as further detailed below, and therefore must be subject to a numeric limit. Instead of such a limit, Rule B1302 relies on requirements in an operations and maintenance plan and two fugitive emissions studies lasting one year each to evaluate whether actual emissions correspond with the modeled levels of building fugitive emissions. While the fugitive emissions studies will provide useful information to verify the nature and extent of building fugitive emissions from the facility, this approach does not satisfy the requirements for enforceable limits that provide for attainment of the SO2 NAAQS under CAA section 172(c)(6).

In particular, we note that updated modeling performed subsequent to the submittal of the Hayden SO2 plan indicates that these emissions have the potential to cause or contribute to violations of the 2010 SO2 NAAQS. We also note that the SO2 rule controlling emissions from the Miami Smelter (A.A.C. R18-2- C1302) includes fugitive emissions in the facility-wide emissions limit and establishes permanent continuous monitoring requirements for fugitives at that facility. Furthermore, the fact that Asarco is able to monitor these emissions on a temporary basis through the fugitive emissions studies suggests that it would be feasible to monitor them on an ongoing basis. Such ongoing monitoring would allow for the establishment of an enforceable numeric limit that would ensure that fugitive emissions remain at a level consistent with attainment of the SO2 NAAQS.

 Option for alternative sampling points
Rule B1302 subsection (E)(4) provides that:

      If the owner or operator can demonstrate to the Director that measurement of stack gas volumetric flow rate in the outlet of any particular piece of SO2 control equipment would yield inaccurate results or would be technologically infeasible, then the Director may allow measurement of the flow rate at an alternative sampling point.

This provision could undermine the enforceability of the stack emission limit by providing undue flexibility to change sampling points without undergoing a SIP revision. While such flexibility might have been necessary at the time of rule development, as capture and control upgrades were still being installed, it appears that this flexibility is no longer necessary. We note that the Miami SO2 Rule, also contained a similar provision, but ADEQ withdrew this provision from EPA's consideration.  The EPA approved the Miami SO2 Rule (excluding this provision) on November 14, 2018 and we approved the related attainment plan for the Miami SO2 nonattainment area on March 12, 2019.

 Option for removal of the CEMS requirement
Rule B1302 subsection (E)(6) provides that:

      The owner or operator of the Hayden Smelter may petition the Department to substitute annual stack testing for the tertiary ventilation or the anode furnace baghouse stack CEMS if the owner or operator demonstrates, for a period of two years, that either CEMS contribute(s) less than five percent individually of the total sulfur dioxide emissions. The Department must determine the demonstration adequate to approve the petition.

These captured emissions from the tertiary ventilation and anode furnace bag house are then ducted to the main stack. The main stack does not have its own CEMS: rather, the monitoring strategy relies on multiple CEMS that are upstream of the stack that are then summed up to generate a main stack emission value. As a result, this provision would allow just under 10% of total facility SO2 emissions annually to be exempt from CEMS, which could compromise the enforceability of the main stack emission limit.

 Lack of method for measuring or calculating emissions from shutdown ventilation flue
Rule B1302 subsection (F)(1) requires Asarco to include emissions vented to "each uncontrolled shutdown ventilation flue" in determining compliance with the main stack emission limit, but the rule does not specify how these emissions are to be measured or estimated. Although subsection (G)(2)(e) requires Asarco to maintain "records of planned and unplanned shutdown ventilation flue utilization events and calculations used to determine emissions from shutdown ventilation flue utilization events if the owner or operator chooses to use the alternative compliance determination method," it does not specify how these calculations are to be performed. Because emissions from the shutdown ventilation flue are subject to the main stack emission limit, the lack of a calculation methodology could compromise the enforceability of this limit.

 Lack of a method for calculating hourly SO2 emissions
Rule B1302, section (F)(2) contains a procedure for substituting emissions data for compliance demonstration purposes, "when no valid hour or hours of data have been recorded by a continuous monitoring system." However, Rule B1302 lacks a requirement similar to subsection (F)(2) of the Miami SO2 rule, R18-2-C1302. Therefore, it is unclear what constitutes a "valid hour" for purposes of allowing data substitution under subsection (F)(2). This omission could compromise the enforceability of the main stack emission limit.

 Stringency of SO2 Controls at the Hayden Smelter in Rule B1302
Rule B1302 subsection (C)(1) establishes a main stack emission limit of 1069.1 pounds per hour (lb/hr) on a 14-operating day average (unless 1,518 pounds or less is emitted during each hour of the 14-operating day period). This limit is more stringent than the annual-average limit of 6,882 lb/hr and three-hour limits of 8,556 -24,641 lb/hr in SIP-approved Rule 715 subsection (F)(1). Therefore, approval of Rule B1302 would increase the stringency of the SIP.

In a separate action on the Hayden SO2 plan, we are proposing to find that ADEQ has not satisfied the requirement in section 172(c)(1) to adopt and submit all RACM/RACT as needed to attain the standards as expeditiously as practicable in the Hayden SO2 area. Therefore, in this action we are not further evaluating whether Rule B1302 implements RACM/RACT for this facility.

 SIP Revisions
ADEQ submitted revisions to SIP-approved Rules R18-2-715 (Rule 715), R18-2-715.01 (Rule 715.01) and R18-2-715.02 (Rule 715.02) concurrently with Rule B1302. These revisions in the 715 series clarify references to other sections within each of these rules and add new language that provide for the 715 series to sunset upon the effective date of the new regulations. In 2018 we approved the revisions to 715.02, which allowed for the existing provisions of that rule to sunset. We have not yet acted on the revisions to 715 and 715.01 because we need to evaluate the effect of sunsetting the existing SIP-approved requirements of those rules in conjunction with the new requirements for the Hayden smelter established in Rule B1302.

As described above, Rule B1302's numeric limit for main stack emissions is more stringent than those found in the SIP-approved existing regulations.  However, Rule B1302 does not include a numeric fugitive emission limit, whereas Rule 715 subsection (G) includes an annual average fugitive limit of 295 lb/hr.

In order to ensure that the existing fugitive limit of 295 lb/hr remains in the SIP, we are not acting on the revisions to Rule 715 at this time. Similarly, we are not acting on Rule 715.01, which includes requirements for SO2 compliance determination and monitoring that support the enforceability of the emission limits and requirements in Rule 715.

Approval of Rule B1302 by itself would not result in removal of any control requirements from the SIP and would therefore comply with CAA section 110(l) and 193.

ADDITIONAL RECOMMENDATIONS
 In subsection D(1) revise the reference to " emission control and/or control equipment" to "emission capture and/or control equipment"
 In section (H), add a requirement for reporting of any control equipment malfunctions.

THE EPA'S PROPOSED ACTION
Rule B1302 strengthens the SIP by establishing a more stringent SO2 emission limit for the main stack at the Hayden smelter, as well as operational standards for process equipment and control devices, baseline requirements for the process gas capture system and control devices O&M plan, performance testing and compliance demonstration requirements, and recordkeeping and reporting requirements. However, the rule does not fully meet CAA requirements for enforceability for the reasons described above. Therefore, EPA staff recommends a limited approval and limited disapproval of B1302 pursuant to CAA section 110(k)(3) and section 301(a).

REFERENCES
 "Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations," (a.k.a., Bluebook) EPA OAQPS (May 25, 1988).
 "Guidance Document for Correcting Common VOC & Other Rule Deficiencies," (a.k.a., Little Bluebook), EPA Region 9 (August 21, 2001).
        Arizona State Implementation Plan Revision: Hayden Sulfur Dioxide Nonattainment Area for the 2010 SO2 NAAQS  ("Hayden SO2 Plan") (March 9, 2017).
        National Emission Standard for Hazardous Air Pollutants for Primary Copper Smelting (40 CFR part 63, subpart QQQ).
        Notice of Final Rulemaking, Title 18. Environmental Quality, Chapter 2. Department of Environmental Quality Air Pollution Control, Arizona Administrative Register, Vol. 23, Issue 14 (April 7, 2017).
        Letter dated April 29, 2019 from Elizabeth Adams, Air Division Director, to Timothy Franquist, Air Director, ADEQ, "Re: Comments on draft letter regarding R18-2-B1302."
        "Processing of State Implementation Plan (SIP) Submittals," Memorandum from John Calcagni, Director Air Quality Management Division, to EPA Regional Air Directors, Regions I-X, dated July 21, 1992.
        Consent Decree No. CV-15-02206-PHX-DLR (D. Ariz).