[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56672-56673]
[DOCID:fr28se05-108]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-450-001]

Wyoming Interstate Company, Ltd.; Notice of Compliance Filing

September 16, 2005.
    Take notice that on September 9, 2005, Wyoming Interstate Company,
Ltd. (WIC) submitted a compliance filing pursuant to Commission Letter
Order dated August 26, 2005 at Docket No. RP05-450-000.
    WIC states that copies of the filing were served on parties on the
official service list.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5224 Filed 9-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Proposed Rules]
[Pages 5679-5681]
[FR Doc No: 2016-01897]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-1011]
RIN 1625-AA09

Drawbridge Operation Regulation; Broad Creek, Laurel, DE

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to change the operating schedule that
governs the Norfolk Southern Railroad Bridge over Broad Creek, mile
8.0, at Laurel, DE. This proposed rule will change the current
regulation requiring a four-hour advance notice and allow the bridge to
remain in the closed position for the passage of vessels.

DATES: Comments and related material must reach the Coast Guard on or
before March 21, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-1011 using Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mrs. Jessica Shea, Fifth Coast Guard District
(dpb), at<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose and Legal Basis

    The current operating schedule for the bridge is set out in 33 CFR
117.233 (a) issued September 11, 2006. As outlined in this regulation,
the Norfolk Southern Railroad Bridge shall open on signal if at least
four hours notice is given. The Fifth Coast Guard District Commander
received a request from the bridge owner in July 2015 to consider
making a permanent change to the operating regulation for the Norfolk
Southern Railroad Bridge per 33 CFR 117.8(a).

This proposed rulemaking aligns the new schedule with the observed lack
of marine traffic that requires a bridge opening and the operating
regulations for the Poplar Street and US Highway 13A, which also cross
Broad Creek. The proposed change would amend the existing regulation to
state that the bridge need not open.
    The Norfolk Southern Railroad Bridge over Broad Creek, mile 8.0, at
Laurel, DE, has a vertical clearance of fourteen feet above mean high
water in the closed position and is unlimited in the open position. The
charted depth at the bridge is four feet. The existing structure is a
swing bridge that was authorized in 1910. The structure has been used
by trains since it was completed in 1915; however, the bridge owner
reported that no openings have been requested since it was acquired by
Norfolk Southern in 1999.
    Milford Fertilizer had a dock that was used by commercial traffic
upstream of the railroad bridge when the existing structure was issued
a bridge permit in 1910. Prior to publishing this NPRM, the Coast Guard
contacted the fertilizer company to determine if there would be any
impacts to their operations. The fertilizer plant modified the
operations conducted in this location and has not used the dock since
the 1970s. There is no record of any other commercial maritime traffic
on Broad Creek, DE. There are residential docks and municipal boat
ramps downstream of the Norfolk Southern Railroad Bridge. Recreational
traffic is present during the boating season with the peak during the
summer months.

III. Discussion of Proposed Rule

    This NPRM proposes to change the status of the Norfolk Southern
Railroad Bridge to need not open for the passage of vessels. In order
to align the operating schedule of the bridge with observed marine
traffic, the proposed change amends the regulation to state that the
bridge need not open. The lack of requests from vessels for bridge
openings since 1999 illustrate that the vessels that use this waterway
can safely navigate while the drawbridge is in the closed-to-navigation
position.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders (E.O.s) related to rulemaking. Below we summarize
our analyses based on these statutes and E.O.s and we discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This NPRM has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, the NPRM has not
been reviewed by the Office of Management and Budget. Based on current
maritime traffic, using Norfolk Southern documentation and notes in the
Coast Guard bridge files, there will be few, if any, vessels impacted
by this proposed change as there has not been a requested opening since
1999.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. While some owners or operators of
vessels intending to transit the bridge may be small entities, since
there have been no requests for openings since 1999, this proposed rule
would not have a significant economic impact on any vessel owner or
operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of

actions which do not individually or cumulatively have a significant
effect on the human environment. This proposed rule simply promulgates
the operating regulations or procedures for drawbridges. Normally such
actions are categorically excluded from further review, under figure 2-
1, paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this document, and all public comments, are
in our online docket at http://www.regulations.gov and can be viewed by
following that Web site's instructions. Additionally, if you go to the
online docket and sign up for email alerts, you will be notified when
comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Revise Sec.  117.233(a) to read as follows:

Sec.  117.233  Broad Creek.

    (a) The draw of the Norfolk Southern bridge at mile 8.0, at Laurel,
need not open for the passage of vessels.
* * * * *

    Dated: January 14, 2016.
Stephen P. Metruck,
Rear Admiral, United States Coast Guard Commander, Fifth Coast Guard
District.
[FR Doc. 2016-01897 Filed 2-2-16; 8:45 am]
BILLING CODE 9110-04-P


Page 1 of 19 DATE: April 1, 2004 MEMORANDUM SUBJECT: ZINC PYRITHIONE ( ZINC OMADINE ® )  REVISED Toxicology Endpoint Selection Report   Revised to address Registrant Error comments FROM: Timothy F. McMahon, Ph. D. Senior Toxicologist Antimicrobials Division ( 7510C)

THROUGH: John Redden, Roger Gardner, Ph. D., Stephen Dapson, Ph. D., Karen Hamernik, Ph. D., Melba Morrow, D. V. M., Sanyvette Williams Foy, D. V. M, Jonathan Chen, Ph. D.; Michelle Centra; Najm Shamim, Ph. D.; Timothy Leighton.

PC Code: 088002 On February 4, 1999, the Health Effects Division's Hazard Identification Assessment Review Committee ( HIARC) evaluated the toxicology data base of zinc pyrithione ( zinc omadine ® ) , established acute and chronic Reference Doses ( RfD) and selected the toxicological endpoints for acute dietary as well as occupational exposure risk assessments. The HIARC also addressed the potential increased susceptibility of infants and children from exposure to zinc pyrithione as required by the Food Quality Protection Act ( FQPA) of 1996.

On September 3rd and September 30th, 2003, the Antimicrobials Division's Toxicology Endpoint Selection Committee ( ADTC) met to discuss scientific issues with respect to the endpoints previously selected for zinc pyrithione. Specifically, discussions were held to determine the suitability of bridging the toxicology data for sodium pyrithione to be applicable to zinc pyrithione risk assessments, the determination of the need for a developmental neurotoxicity study for zinc Page 2 of 19 pyrithione, the use of a maternal endpoint for selection of the chronic Reference Dose value for zinc pyrithione, and the magnitude of the special hazard based FQPA factor and database uncertainty factor for zinc pyrithione . The results of the ADTC's discussions are included in this memorandum and this memorandum reflects the latest conclusions regarding endpoint selection for zinc pyrithione, thus superceding the previous HIARC memo ( HED document number 013318).

1999 HIARC Committee Members in Attendance Members present were: David Anderson, Bill Burnam, Virginia Dobozy, Pam Hurley, Mike Ioannou, Tina Levine, Sue Makris, Nicole Paquette, Kathleen Raffaele, Jess Rowland, PV Shah, and Brenda Tarplee ( executive secretary). Data was presented by Tim McMahon of the Risk Assessment and Science Support Branch, Antimicrobials Division.

2003 ADTC Committee Members in Attendance John Redden, Roger Gardner, Ph. D., Stephen Dapson, Ph. D., Sanyvette Williams Foy, D. V. M, Jonathan Chen, Ph. D., Timothy F. McMahon, Ph. D; Najm Shamim, Ph. D.; Timothy Leighton.

Member( s) in absentia: Karen Hamernik, Melba Morrow ( provided comments via email) Michelle Centra ( provided comments via email)

Other Attendees: Debbie Smegal, Bill Burnam Data evaluation prepared by: Timothy F. McMahon, Ph. D. Page 3 of 19 COMMITTEE MEMBERS ( Signature indicates concurrence unless otherwise stated)

Stephen Dapson Jonathan Chen Roger Gardner Karen Hamernik Tim McMahon ( chair)

Melba Morrow John Redden Sanyvette Williams Foy Tim Leighton _______________________

Michelle Centra _______________________

Najm Shamim ______________________

OTHER ATTENDEES:

William Burnam _________________

Deborah Smegal _____________________ Page 4 of 19 I. INTRODUCTION On February 4, 1999, the Health Effects Division's Hazard Identification Assessment Review Committee evaluated the toxicology data base of zinc pyrithione, established a Reference Dose ( RfD) and selected the toxicological endpoints for acute dietary as well as occupational exposure risk assessments. The HIARC also addressed the potential increased susceptibility of infants and children from exposure to zinc pyrithione as required by the Food Quality Protection Act ( FQPA) of 1996. A report was issued by the HIARC on March 19, 1999 for zinc pyrithione.

In the 1999 report, the following recommendations were made as listed below:

1) The committee recommended retaining the special hazard based FQPA safety factor ( 10x), based on qualitative evidence of increased susceptibility in the rat and rabbit prenatal developmental toxicity studies.

Since that time, updated guidance on interpretation of the FQPA safety factor ( http:// www. epa. gov/ oppfead1/ trac/ science/ determ. pdf ) has been published which necessitated re consideration of this safety factor for zinc pyrithione.

2) The 1999 HIARC report recommended the conduct of a developmental neurotoxicity study for zinc pyrithione, based on evidence of significant nervous system deficits following either acute or subchronic oral administration of zinc pyrithione. For example, intravenous administration of 5 mg/ kg zinc pyrithione to female Yorkshire pigs produced cholinergic effects lasting for 30 60 minutes post dose ( HED document 003933). Increased salivation was reported immediately after dosing in the rat developmental toxicity study at a dose of 3 mg/ kg/ day ( MRID # 42827904). Subchronic administration of zinc pyrithione at 3.75 mg/ kg/ day has been shown to produce hindlimb weakness ( HED document no. 003933). Peripheral neuropathy in the form of axonal degeneration has been observed.

The issue of the requirement for a developmental neurotoxicity study was re considered by the ADTC.

In addition to the above, two other issues were raised from the Risk Assessment Oversight Review committee's ( RAOC) review of the draft risk assessment for zinc pyrithione as listed below:

1) Selection of the chronic dietary endpoint for zinc pyrithione. It was stated in the RAOC memo that a maternal effect should not be used for chronic risk 2) Whether the toxicology database for sodium pyrithione can be used in risk assessments for zinc pyrithione. The toxicology database for zinc pyrithione is missing a two generation reproduction toxicity study, which is required for the food contact uses of zinc pyrithione. However, a reproduction study exists for sodium pyrithione. Page 5 of 19 The ADTC's discussion of these issues and the conclusions reached are summarized below as part of the updated toxicology endpoint selection document.

II. HAZARD IDENTIFICATION A. ACUTE DIETARY ( Acute Reference Dose)

A. 1. Acute RfD Subpopulation: Females 13+

Study Selected: Developmental Toxicity  Rabbit § 83 3a MRID No.: 42827905 Executive Summary: In a developmental toxicity study in rabbits ( MRID # 42827905), inseminated New Zealand White rabbits, randomly assigned to one control and three treatment groups of 20 animals each, were administered zinc pyrithione 48% Aqueous Dispersion by oral gavage at doses of 0, 0.5, 1.5, or 3.0 mg/ kg/ day on gestation days ( GD) 6  18. Cesarean section examinations were performed on all surviving does on GD 29, followed by an examination of all fetuses. One mid dose doe died on GD 16, probably due to a gavage error. A decrease in body weight gain ( p 0.01) during the dosing period for the mid and high dose groups ( 41% and 99%, respectively) cannot be considered biologically significant since the absolute body weight changes were only  4% and  6%, respectively. There was no dose related effect on food consumption. The does' body weights rebounded after the dosing interval. There were no compound related gross lesions. One high dose doe aborted on GD 27, and five others had total resorptions. One mid dose doe had total litter resorption. Dose related early resorptions were seen in the mid and high dose does. These findings corresponded with a dose related increase in postimplantation loss( early resorption) and a decrease in viable fetuses. It is not clear whether the resorptions were due to maternal or developmental toxicity. No statistically significant differences were seen in the incidence of external, visceral, or skeletal anomalies in the treated groups as compared to controls. Three fetuses from two high dose litters contained multiple cephalic and limb malformations. The Maternal/ Developmental NOAEL is 0.5 mg/ kg/ day. The LOAEL is 1.5 mg/ kg/ day, based on increased postimplantation loss and decreased number of viable fetuses ( it is not clear whether the resorptions were due to maternal or developmental toxicity).

Dose Selected for Risk Assessment: NOAEL= 0.5 mg/ kg/ day based on increased postimplantation loss and decreased viable fetuses at 1.5 mg/ kg/ day ( LOAEL).

Uncertainty Factors: 300 ( 10 x for inter species variation and 10x for intra species extrapolation; 3x database UF for lack of neurotoxicity studies)

Comments about Study/ Endpoint Uncertainty Factor: The endpoint of concern ( increased post implantation loss and decreased viable fetuses) is an in utero effect, and therefore is applicable only to this subpopulation ( Females 13+). Also, these developmental effects are Page 6 of 19 presumed to occur after a single exposure ( dose), thus are applicable for this exposure period of concern. The additional database UF of 3x was applied based on lack of acute and subchronic neurotoxicity studies determined to be necessary by the ADTC for proper dose response characterization for neurotoxic effects of zinc pyrithione.

Acute RfD ( aPAD) ( Females 13+) = 0.5 mg/ kg/ day ( NOAEL) = 0.0016 mg/ kg 300 ( UF)

This risk assessment is required.

A. 2. Acute RfD Subpopulation: General Population including Infants and children Study Selected : Developmental Toxicity  Rat Guideline #: § 83 3 MRID No.: 42827905 Executive Summary: In a developmental study ( MRID 42827904), thirty pregnant Sprague Dawley rats per group were administered Zinc Pyrithione by oral gavage on days 6 15 of gestation at doses of 0, 0.75, 3, or 15 mg/ kg/ day. One dam in the 15 mg/ kg/ day dose group died on gestation day 16 of unspecified causes. No maternal or developmental toxicity was observed at 0.75 mg/ kg/ day. The most sensitive indicator of maternal toxicity was increased salivation immediately after dosing which was observed in the 3 and 15 mg/ kg/ day groups ( 27% and 97% of dams, respectively). Other dose related signs seen at 15 mg/ kg/ day included biologically significant decreases in body weight gains ( 67%; p 0.01; absolutes of 4 12%) and food consumption ( 24% during dosing, 16% throughout gestation; p 0.01), and dilated pupils ( 57%). The maternal toxicity NOEL is 0.75 mg/ kg/ day, and the maternal toxicity LOAEL is 3.0 mg/ kg/ day, based upon excessive salivation during the dosing period.

Developmental toxicity was characterized by a dose related increase in post implantation loss at the mid and high doses with the 15 mg/ kg/ day group being significantly different than controls ( p < 0.01). This correlated with an increase in early resorptions ( 3.6%/ dam) with whole litter resorption occurring in 3 high dose dams. There was also a significant reduction ( p < 0.05) in the number of live fetuses per litter ( 12.5/ litter compared to 14.5/ litter in the controls), mean fetal weights ( 16%), and gravid uterine weights ( 16%; p 0.01) in the 15 mg/ kg/ day group as compared to controls. A significantly greater number of litters in the 15 mg/ kg/ day group contained fetuses with external, visceral, or skeletal malformations/ variations. The most common were digit anomalies ( 5 of 24 treated litters vs. 0 of 27 control litters; p 0.05), dilated renal pelvis ( 7 of 24 treated litters vs. 1 of 27 control litters; p 0.05) which is considered indicative of hydronephrosis, and a vertebral/ rib anomaly ( 24 of 24 treated litters vs. 0 of 27 control litters; p < 0.01). Others included sternal, rib, and limb ( radius or ulna absent) malformations. Dose related fused ribs were observed in the mid and high dose groups ( 3 fetuses/ 2 litters, and 5 fetuses/ 4 litters, respectively). Although pairwise comparisons, on the basis of litters, were not statistically significant ( p= 0.226 and p= 0.060 for the mid and high dose groups, respectively), a statistically significant linear trend was evident ( Cochran Armitage test; p= 0.009), and historical control values were exceeded. The developmental toxicity NOEL is Page 7 of 19 0.75mg/ kg/ day, and the developmental toxicity LOAEL is 3.0 mg/ kg/ day, based upon increased incidences of fused ribs.

Dose Selected for Risk Assessment: NOAEL= 0.75 mg/ kg/ day based on salivation in dams at 3.0 mg/ kg/ day ( LOAEL).

Uncertainty Factor: 300 ( 10 x for inter species variation and 10x for intra species extrapolation; 3x for database uncertainty)

Acute RfD ( aPAD gen. pop.) = 0.75 mg/ kg/ day ( NOAEL) = 0.0025 mg/ kg 300 ( UF)

Comments about Study/ Endpoint Uncertainty Factor: The endpoint ( salivation) was seen in maternal animals during the dosing period, and is thus relevant for this subpopulation and exposure period of concern. In addition, the ADTC expressed concern that, although the chemical may have been irritating, that it may also be reflective of a neurotoxic effect.

B. CHRONIC DIETARY ( Chronic Reference Dose)

Type of Study: Developmental Toxicity  Rabbits Guideline #: § 83 3 MRID No.: 42827905 Executive Summary: See Acute Dietary Females 13+.

Uncertainty Factor: 300 ( 10 x for inter species variation, 10x for intra species extrapolation and 3x for database uncertainty).

Chronic RfD = 0.5 mg/ kg/ day ( NOAEL) = 0.0016 mg/ kg/ day 300 ( UF)

Comments about Study/ Endpoint Uncertainty Factor: The ADTC concluded that a chronic toxicity study is not required for the indirect food use of zinc pyrithione, based upon the Tier I data requirements for indirect food uses for antimicrobial pesticides that do not require such studies. Therefore, use of the rabbit developmental toxicity study is conservative by nature since, of the data available for zinc pyrithione, this study showed the lowest NOAEL value. As support, the committee also noted the available chronic toxicity study for for sodium pyrithione ( MRID 42100901) with a NOAEL of 0.5 mg/ kg/ day. Page 8 of 19 C. OCCUPATIONAL / RESIDENTIAL EXPOSURE 1. DERMAL ABSORPTION Study Selected: Dermal Absorption  Domestic Swine Guideline #: § 85 2 MRID No.: HED document no. 003933 Executive Summary: Twenty six mature Yorkshire pigs were used in this study. Radiolabeled zinc pyrithione was applied for 8 hours either as a single dose ( 50,100, and 400 mg/ kg) or as a 5 day repeated dose ( 100 mg/ kg). Serial samples of blood, urine, and feces were taken after dosing. Radioassay of necropsy material, urine, blood, and feces showed recovery of 86.8 98.2% of applied radioactivity. Greater than 90% of recovery was obtained from washings of the application site. Urinary excretion was 3% in animals with intact skin. Levels of radioactivity in blood, urine, and feces returned to background by 48 hours post application.

Dermal Absorption Factor: 3%

Comments about Dermal Absorption Factor: A dermal absorption factor is not required since a dermal NOAEL was selected for dermal risk assessments. However, it is noted that the 3% dermal absorption factor demonstrated in the swine study is supported by a literature study in mice ( 1975; HED Doc. No. 003933) which also showed a dermal absorption of 3%. Additionally, low dermal absorption is indicated by the lack of systemic toxicity in male rats following repeated dermal applications at the Limit Dose ( 1000 mg/ kg/ day) for 90 days in a dermal toxicity study.

2. SHORT TERM DERMAL ( 1  7 days)

Study Selected: 90 Day Dermal Toxicity  Rats Guideline#: § 82 3 MRID No.: 42827902 Executive Summary: In a subchronic dermal toxicity study ( MRID # 42827902), male and female CrlCD BR rats were treated with Zinc pyrithione FPS by dermal occlusion at doses of 0, 20, 100, and 1000 mg/ kg/ day for 6hours/ day, 5 days/ week for 13 weeks. Treatment related effects included decreased food consumption ( 91.6% of control), decreased body weight gain ( 48.9% of control), and decreased food efficiency ( 53.8% of control) over the entire treatment period for females in the 1000mg/ kg/ day dose group. Group mean body weights for females ( 1000 mg/ kg/ day) were decreased 13% to 21% relative to controls for weeks 2 13. The systemic NOAEL = 100 mg/ kg/ day in females, and 1000 mg/ kg/ day in males. The systemic LOAEL = 1000 mg/ kg/ day in females ( decreased body weight gain, food consumption, and food efficiency), and > 1000 mg/ kg/ day in males . Page 9 of 19 Comments about Study/ Endpoint: This study is appropriate for the route ( dermal) and exposure period ( 1 7 days) of concerns since the route o treatment ( dermal) in animals simulates real life occupational exposure ( dermal) scenarios.

This risk assessment is required.

3. INTERMEDIATE TERM DERMAL ( 1 Week to Several Months)

Study Selected: 90 Day Dermal Toxicity  Rats Guideline#: § 82 3 MRID No.: 42827902 Executive Summary: See Short Term Comments about Study/ Endpoint: This study is appropriate for the route ( dermal) and exposure period ( 7 90 days) of concerns since the route o treatment ( dermal) in animals simulates real life occupational exposure ( dermal) scenarios.

This risk assessment is required.

4. LONG TERM DERMAL ( Several Months to Lifetime)

Study Selected: 90 Day Dermal Toxicity  Rats Guideline#: § 82 3 MRID No.: 42827902 Executive Summary: See Short Term Comments about Study/ Endpoint: The 90 day dermal study was deemed to be appropriate since following repeated dermal dosing, there was no systemic toxicity in males at the Limit Dose and in females toxicity at this dose was limited decreased body weight gain and food consumption.

5. INHALATION ( ANY TIME PERIOD).

Study Selected: Subchronic Inhalation  Rats Guideline #: § 82 4 MRID No.: 42827903 Executive Summary: Groups of 15 male and 15 female Sprague Dawley rats were dynamically exposed in whole body exposure chambers to zinc pyrithione aerosols at concentrations of 0.0005, 0.0025, or 0.01 mg/ L/ day for 6 hours/ day, 5 days/ week for 13 weeks. One male and 1 female exposed to 0.0025 mg/ L/ day and 3 males and 4 females exposed to 0.01 mg/ L/ day died over the course of the study. Treatment related clinical signs of toxicity included rales, labored breathing, and gasping in animals that died on study. At 0.01 mg/ L/ day, body weights of females were depressed as much as 23%, compared to controls, total food consumption Page 10 of 19 was decreased 10%, and food efficiency was decreased 53%. Hematologic, clinical chemistry, or urinalysis effects were not considered biologically significant for any of the exposure groups, and ophthalmologic examinations and gross necropsy findings were negative. Biologically significant increases in absolute and ( relative) lung weights of + 20% (+ 34%) and + 22% (+ 38%) in males, and + 13% (+ 18%) and + 25% (+ 68%) in females were seen at concentrations of 0.0025 and 0.01 mg/ L/ day, respectively. The increased lung weights corresponded to histopathologic findings of trace to mild subacute inflammation of the interstitial tissue of the lung and medial hypertrophy of pulmonary arteries which were biologically significant at 0.01 mg/ L/ day. NOAEL = 0.0005 mg/ L/ day. LOAEL = 0.0025 mg/ L/ day ( labored breathing, rales, increased salivation, decreased activity, dry red brown material around the nose, increased absolute and relative lung weights, and death of undetermined cause).

Comments about Study/ Endpoint: The selected endpoint will be used for short, intermediate and long term exposure risk assessments.

D. Recommendation of Margins of Exposure A MOE of 100 is adequate for occupational exposure risk assessments. A MOE of 300 is considered adequate for residential exposures to zinc pyrithione.

E. Aggregate Exposure Risk Assessments ( Food+ water+ Residential exposures)

For acute aggregate exposure risk assessment, combine the high end exposure values from food + water and compare it to the acute RfD for Females 13+ and the acute RfD for the General Population including Infants and Children.

For Short, intermediate and long term aggregate exposure risk assessment, the oral, dermal and inhalation MOEs cannot be combined due to different toxicological endpoints for oral ( developmental), dermal ( decreased body weight gain and food consumption) and inhalation ( clinical signs) routes.

IV. CLASSIFICATION OF CARCINOGENIC POTENTIAL No chronic toxicity or carcinogenicity studies are available to assess the carcinogenic potential of zinc pyrithione. Two studies are available for sodium pyrithione. The first study ( MRID 42100901) showed no evidence of carcinogenicity when administered to Sprague Dawley rats by oral gavage for 2 years at doses of 0, 0.5, 1.5, and 5.0 mg/ kg/ day. The second study ( MRID 42100801) showed no evidence of carcinogenicity when sodium pyrithione was administered dermally to CD 1 mice at doses of 0, 5, 15, and 40 mg/ kg/ day for 18 months. As noted in the sodium pyrithione RED, sodium pyrithione is classified as Group " D" ( insufficient evidence to Page 11 of 19 classify). Page 12 of 19 V. MUTAGENICITY I. Salmonella typhimurium Assay In a mutagenicity study ( MRID # 41906502), doses of zinc omadine ( 48% aqueous dispersion) ranging from 0.03 5.0 g/ plate under non activated conditions and 10 333 g/ plate under S 9 activated conditions were evaluated for the potential to induce reverse gene mutations in five tester strains of Salmonella typhimurium ( TA98, TA100, TA1535, TA1537, TA1538). Cytotoxicity was observed in this assay at 3.3 g/ plate and above under non activated conditions, and at 333 g./ plate and above under activated conditions. There was no reproducible evidence of a mutagenic effect in either the absence or presence of metabolic activation in this study.

ii. Gene Mutation in Cultured Chinese Hamster Ovary Cells In a mutagenicity study using Chinese Hamster Ovary ( CHO) cells ( MRID # 41906503) assays were conducted in the absence of metabolic activation ( doses of 0.25 2.0 g/ ml) and the presence of metabolic activation ( 2.5 30 g/ ml). In this study, zinc pyrithione failed to induce a mutagenic response.

iii. In vivo Micronucleus Assay in Mice In this study ( MRID # 41906501), intraperitoneal injection of single doses of 11, 22, or 44 mg/ kg zinc pyrithione ( 48% aqueous dispersion) to ICR mice did not cause a significant increase in the frequency of micronucleated polychromatic erythrocytes ( MPEs) in bone marrow cells harvested 24, 48, or 72 hours post dose. High dose mice exhibited signs of toxicity ( including mortality, lethargy, piloerection, and diarrhea) but there was no evidence of a cytotoxic effect on the target organ. Therefore, zinc pyrithione is concluded to be negative for mutagenicity in this test system.

VI. FQPA CONSIDERATIONS 1. Adequacy of the Data Base The toxicology data base is not complete with respect to assessing adequate to assess the increased susceptibility to infants and children as required by FQPA. Acceptable developmental toxicity studies in the rat and rabbit are available as well as reproduction toxicity data in the rat for sodium pyrithione, however, a datagap exists for acute and subchronic neurotoxicity of zinc pyrithione.

2. Neurotoxicity Data There are currently no guideline neurotoxicity studies for zinc pyrithione. The existing database, however, shows significant nervous system deficits following either acute or Page 13 of 19 subchronic oral administration of zinc pyrithione. For example, intravenous administration of 5 mg/ kg zinc pyrithione to female Yorkshire pigs produced cholinergic effects lasting for 30 60 minutes post dose ( HED document 003933). Increased salivation was reported immediately after dosing in the rat developmental toxicity study at a dose of 3 mg/ kg/ day ( MRID # 42827904). Subchronic administration of zinc pyrithione at 3.75 mg/ kg/ day has been shown to produce hindlimb weakness ( HED document no. 003933). Peripheral neuropathy in the form of axonal degeneration has been observed.

3. Developmental & Reproductive Toxicity ( I) Developmental Toxicity:

Executive summaries for the prenatal developmental studies are provided under acute RfD ( Rat) and chronic RfD ( rabbit). These studies showed no quantitative evidence of increased susceptibility ( i. e., maternal and developmental NOAELs/ LOAELs were the same). There was, however, qualitative evidence of increased susceptibility ( i. e., fetal effects were considered to be severe in the presence of minimal maternal toxicity).

( ii) Reproductive Toxicity:

A two generation reproduction study in rats is available for sodium pyrithione to assess the reproductive toxic potential of zinc pyrithione.

4. Determination of Susceptibility Qualitative evidence of increased susceptibility was demonstrated both in the rat and rabbit prenatal developmental toxicity studies. In rats, fetal effects were manifested as increased incidence of fused ribs at the same dose that caused only minimal maternal toxicity characterized as salivation. In the rabbit study, fetal effects were manifested as increased post implantation loss and decreased viable fetuses at the same dose that caused only minimal maternal toxicity characterized as resorptions. A two generation reproduction study is not available in the database. Although no fetal abnormalities were seen in the prenatal studies, available data indicated neurotoxic effects in adult animals at doses of approximately 3 mg/ kg/ day and higher.

5. Determination of the Need for Developmental Neurotoxicity Study The HIARC in 1999 initially determined that, based on the observed effects of zinc pyrithione to the nervous system from available reviewed data, that a developmental neurotoxicity study will be required for zinc pyrithione. However, the ADTC, in revisiting this issue in 2003, concluded that the requirement for the developmental neurotoxicity study should be held in reserve pending submission of acute and subchronic neurotoxicity studies for zinc pyrithione. Page 14 of 19 6. Special FQPA Safety Factor:

The HIARC in 1999 recommended retention of the 10x safety factor for the protection of infants and children based on qualitative evidence of increased susceptibility in the rat and rabbit prenatal developmental toxicity studies. Since that time, updated guidance on interpretation of the FQPA safety factor ( http:// www. epa. gov/ oppfead1/ trac/ science/ determ. pdf ) has been published. Based on this updated guidance and the determination of the Antimicrobials Division's Toxicology Endpoint Selection Committee, the special hazard based FQPA safety factor for zinc pyrithione was reduced to 1x. This reduction was based on the following: For zinc pyrithione, the developmental toxicity database shows effects in offspring at similar dose levels as effects in adults, while the reproductive toxicity database for sodium pyrithione ( a structurally related chemical) shows effects in offspring at doses above those occurring in parental animals. Effects observed in offspring from developmental toxicity studies have been selected for use in dietary risk assessments, thus being protective of infants and children. Therefore the hazard based FQPA safety factor can be reduced to 1x since the degree of concern is low ( i. e. a complete developmental and reproductive database is available with clear NOAELs/ LOAELs for parental and offspring toxicity) and there are no residual uncertainties for prenatal toxicity.

7. Database Uncertainty Factor Based on the need for additional neurotoxicity testing and evidence of neurotoxicity in the open scientific literature ( Ross and Lawhorn, Neurotoxicol. Teratol 12( 2): 153 159, 1990; Snyder et al., Food Cosmet. Toxicol. 17( 6), 651 660, 1979; Grant, W. M. Toxicology of the Eye. 3rd ed. Springfield, IL. Charles C. Thomas, Pub.) , a database uncertainty factor of 3x is applied to nonoccupational risk assessments for zinc pyrithione, due to the lack of characterization of neurotoxic dose response relationships for zinc pyrithione. A 3x factor for lack of neurotoxicity data ( as opposed to a higher factor of 10x) is adequate because neurotoxicity observed in the available data occurs at similar effect levels as other adverse responses, the doses and endpoints selected for dietary and non dietary assessments encompass the doses at which neurotoxicity is observed, there is no quantitative evidence of susceptibility to the toxic effects of zinc pyrithione, and traditional uncertainty factors afford a degree of protection that is considered conservative.

VII. Bridging of Toxicology Data for Sodium Pyrithione Zinc pyrithione is structurally related to sodium pyrithione, the primary differences being the presence of zinc vs. sodium and the presence of two pyrithione moieties for zinc vs. one moiety for sodium. It is useful to compare the results of toxicity testing of zinc and sodium pyrithione when considering the bridging issue. The tables below provide a comparison of results from both chemicals: Page 15 of 19 Study Type2 ZINC Pyrithione Doses ( mg/ kg/ day) ZINC Pyrithione NOAEL/ LOAEL SODIUM Pyrithione Doses ( mg/ kg/ day) SODIUM Pyrithione NOAEL/ LOAEL 81 1 Acute Oral MRID # 42827901 ( Zn) MRID # 40247801 ( Na) 260, 329, 417, 529, 668 mg/ kg LD50 = 267 mg/ kg ( M+ F) LD50 = 1500 mg/ kg ( M+ F)

81 2 Acute Dermal MRID # 42146701 ( Zn) MRID # 40247802 ( Na) 2000 mg/ kg ( limit dose) LD50 > 2000 mg/ kg LD50 = 1800 mg/ kg ( M+ F)

81 3 Acute Inhalation MRID # 42146703 ( Zn) MRID # 40339001 ( Na) 0.24, 0.61 mg/ L LC50 > 0.61 mg/ L LC50 = 1.08 mg/ L 81 4 Primary Eye MRID # 42154601; 42146702 ( Zn) 0.1ml of a 48% solution severe eye irritant data gap 81 5 Primary Dermal MRID # 42146704 ( Zn) MRID # 40247803 ( Na) 0.5g as an aqueous paste slight erythema and edema, reversible by 48 hr. slight erythema and edema 81 6 Dermal Sensitization MRID # 43950201 ( Zn) MRID # 40247804 ( Na) Buehler method using 0.4ml undiluted 48% solution non sensitizer non sensitizer 82 1a 90 day feeding rat Doc no. 003933 ( Zn) MRID # 40756901 ( Na) 0.75, 3.75, 9.4, 18.75, 37.5, 46.9, and 93.75 mg/ kg NOAEL = 0.75 mg/ kg LOAEL = 3.75 mg/ kg ( increased liver, kidney, testes weight; decreased survival, hindlimb weakness 0, 0.5, 2.0, 8.0 mg/ kg/ day NOAEL = 0.5 mg/ kg/ day LOAEL = 2.0 mg/ kg/ day ( evidence of neurotoxicity) Page 16 of 19 83 3a Developmental tox rat MRID # 42827904 ( Zn) 0, 0.75, 3, and 15 mg/ kg/ day Mat. NOAEL = 0.75 mg/ kg/ day; Mat. LOAEL = 3.0 mg/ kg/ day ( excessive salivation). Devel. NOAEL = 0.75 mg/ kg/ day; Devel. LOAEL = 3.0 mg/ kg/ day ( increased incidence of fused ribs) no data 83 3b Developmental tox  rabbit MRID # 42827905 ( Zn) MRID # 40487201 ( Na) 0, 0.5, 1.5, 3.0 mg/ kg/ day Mat./ Devel. NOAEL = 0.5 mg/ kg/ day; Mat./ Devel. LOAEL = 1.5 mg/ kg/ day ( incr. Post impl. loss and decr. Viable fetuses). 0, 1, 2.5, and 5 mg/ kg/ d NOAEL = 5 mg/ kg/ d LOAEL = 7.5 mg/ kg/ d ( based on toxicity observed in range finding study)

82 3 90 Day dermal MRID # 42827902 ( Zn) MRID # 40936201 ( Na) 0, 20, 100, 1000 mg/ kg/ day NOAEL = 100 mg/ kg/ day LOAEL = 1000 mg/ kg/ day ( decr. B. w., food cons., food eff.) 0, 5, 15, and 50 mg/ kg NOAEL = 15 mg/ kg/ d ( M); 5 mg/ kg/ d ( F) LOAEL = 50 mg/ kg/ d ( M); 15 mg/ kg/ d ( F) [ atrophy of hindlimb muscles and panniculus muscles] 82 4 90 Day inhalation MRID # 42827903 ( Zn) MRID # 41178201 ( Na) 0.0005, 0.0025, 0.01 mg/ L NOAEL = 0.0005 mg/ kg/ day LOAEL = 0.0025 mg/ kg/ day ( clinical toxicity, incr. Abs. And rel. Lung weights) 0, 0.00046, 0.0011, and 0.0038 mg/ L ( 0.0038 mg/ L changed to 0.0081 mg/ L after 6 weeks) NOAEL = 0.0081 mg/ L ( M); 0.0011 mg/ L ( F) LOAEL = 0.0081 mg/ L ( F, based on hindlimb dysfunction) 83 4 Reproduction MRID # 41097201 ( Na) no data 0, 0.5, 1.5, 3.5 mg/ kg/ day Systemic NOAEL = 0.5 mg/ kg/ d Systemic LOAEL = 1.5 mg/ kg/ d ( F); 3.5 mg/ kg/ d ( M) [ histologic atrophy of hindlimb skeletal muscles] Repro NOAEL = 1.5 mg/ kg/ d; Repro LOAEL = 3 5 mg/ kg/ d ( decr. no. of pups/ litter, decr. pup b. w. and wt. gain) Page 17 of 19 83 2 Carcinogenicity MRID # 42100901 ( Na) no data 0, 0.5, 1.5, 5.0/ 3.5 g/ day NOAEL = 0.5 mg/ kg/ day LOAEL = 1.5 mg/ kg/ day ( degeneration of skeletal muscle in both sexes)

84 2 Mutagenicity MRID # 40411501 ( Na) MRID # 41906502 ( Zn) non mutagenic to Salmonella in the presence and absence of metabolic activation negative for forward gene mutations in CHO cells up to 0.08

g/ ml 84 2 Mutagenicity MRID # 40343701 ( Na) MRID # 41906503 ( Zn) negative for gene mutation at the HGPRT locus in CHO cells up to cytotoxic concentrations negative for micronucleus induction in CD 1 mice up to toxic doses ( 238 mg/ kg)

84 2 Mutagenicity MRID # 40387501 ( Na) MRID # 41906501 ( Zn) not clastogenic in mouse bone marrow cells no induction of UDS in rat hepatocytes up to cytotoxic concentrations 85 1 Metabolism MRID # 41269001 ( Na) rapidly absorbed and excreted; Sglucuronide the major metabolite.

The tables above show that in large part, both zinc and sodium pyrithione produce similar toxic responses at similar dose levels. Some differences are noted with respect to the dermal NOAELs for the two chemicals ( NOAEL of 15 mg/ kg/ day for sodium pyrithione; NOAEL of 100 mg/ kg/ day for zinc pyrithione) and the observation that sodium pyrithione resulted in apparent neurotoxic effects by the dermal route vs. zinc pyrithione. The dermal absorption values also differ between zinc ( 3.0%) and sodium ( 0.1%) pyrithione, although the value for sodium pyrithione was estimated and not measured directly. Outside of these issues, however, the oral toxicity data do show a similarity in toxic response at similar dose levels, so in the case of bridging, as it involves oral exposure, it is possible to use the reproduction study for sodium pyrithione as a substitute for zinc pyrithione. Since a 90 day dermal toxicity study is available for both zinc and sodium pyrithione, bridging of dermal toxicity data is not necessary, as a chemical specific endpoint can be selected in this case as needed. Page 18 of 19 VII. HAZARD CHARACTERIZATION Zinc Pyrithione demonstrates developmental toxicity as well as neurotoxicity. In the developmental toxicity studies in the rat and rabbit, severity of effects in offspring were significant in comparison to maternal effects, even though the doses at which developmental and maternal effects occurred were the same. Zinc pyrithione also demonstrates significant neurotoxic effects in a variety of studies as shown by hindlimb weakness and distal axonopathy. Acute and subchronic neurotoxicity testing is necessary to define the dose response relationships for the neurotoxic effects of zinc pyrithione. Reproductive toxicity data for zinc pyrithione are not available. Data are available for sodium pyrithione and can be used as bridging data for this aspect of zinc pyrithione hazard as concluded by the ADTC in 2003.

VIII. DATA GAPS Data gaps exist for the standard Subdivision F Guideline requirements for the proposed uses of zinc pyrithione. Acute and subchronic neurotoxicity studies will be required for zinc pyrithione.

IX. ACUTE TOXICITY ENDPOINTS:

Guideline No. Study Type MRID # Results Tox. Cat.

§ 81 1 ( OPPTS870.1100) Acute Oral 42827901 LD50 = 267 mg/ kg II § 81 2 ( OPPTS 870.1200 Acute Dermal 42146701 LD50 > 2000 mg/ kg III § 81 3 Acute Inhalation 42146703 LC50 > 0.61 mg/ L III § 81 4 ( OPPTS 870.2400) Primary Eye Irritation 42146702 severe irritant I § 81 5 ( OPPTS 870.2500) Primary Dermal Irritation 42146704 slight erythema and edema IV § 81 6 ( OPPTS 870.2600 Dermal Sensitization 43950201 no sensitization observed using Buehler method N/ A § 81 8 ( OPPTS 870.6200) Acute and Subchronic Neurotoxicity study not available Page 19 of 19 X SUMMARY OF TOXICOLOGY ENDPOINT SELECTION The doses and toxicological endpoints selected for various exposure scenarios for zinc pyrithione are summarized below.

Exposure Scenario Dose Used in Risk Assessment, UF LOC for Risk Assessment Study and Toxicological Endpoints Acute Dietary ( Females 13  50) NOAEL = 0.5 mg/ kg/ day UF = 300 Acute RfD = 0.0016 mg/ kg/ day FQPA SF = 1x aPAD = acute RfD FQPA SF aPADa ( females 13+) = 0.0016 mg/ kg/ day Developmental Toxicity Study in Rabbits LOAEL = 1.5 mg/ kg/ day, based on increased post implantation loss and decreased viable fetuses Acute Dietary ( General population, including infants/ children) NOAEL = 0.75 mg/ kg/ day UF = 300 Acute RfD = 0.0025 mg/ kg/ day FQPA SF = 1x aPAD = acute RfD FQPA SF aPAD = 0.0025 mg/ kg/ day Developmental Toxicity Study in Rats LOAEL = 3.0 mg/ kg/ day based on increased salivation in maternal rats.

Chronic Dietary ( all populations) NOAEL = 0.5 mg/ kg/ day UF = 300 Chronic RfD = 0.0016 mg/ kg/ day FQPA SF = 1x cPAD = acute RfD FQPA SF cPAD = 0.0016 mg/ kg/ day Developmental Toxicity Study in Rabbits LOAEL = 1.5 mg/ kg/ day, based on increased post implantation loss and decreased viable fetuses Incidental Oral, Short and Intermediate Term Maternal NOAEL= 0.75 mg/ kg/ day MOE = 300 ( residential) Developmental Toxicity Study in Rats LOAEL = 3.0 mg/ kg/ day, Based on increased salivation in maternal rats.

Short, Intermediate, and Long Term Dermal Dermal NOAEL = 100 mg/ kg/ day MOE = 300 ( residential) MOE = 100 ( occupational) Subchronic Dermal Toxicity in Rats LOAEL = 1000 mg/ kg/ day, based on decreased body weight gain, food consumption, and food efficiency in female rats.

Short, Intermediate, and Long Term Inhalation Inhalation NOAEL = 0.0005 mg/ L MOE = 300 ( residential) MOE = 100 ( occupational) Subchronic Inhalation Toxicity Study in Rats LOAEL = 0.0025 mg/ L Based on clinical signs of toxicity, decreased activity, and increased lung weights..


[Federal Register Volume 87, Number 97 (Thursday, May 19, 2022)]
[Notices]
[Pages 30542-30546]
[FR Doc No: 2022-10737]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94912; File No. SR-C2-2022-011]

Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fees Schedule Relating to the Sale of Open-Close Volume Data

May 13, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on May 2, 2022, Cboe C2 Exchange, Inc. (the ``Exchange'' or
``C2'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III 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

    Cboe C2 Exchange, Inc. (the ``Exchange'' or ``C2 Options'')
proposes to amend its Fees Schedule relating to the sale of Open-Close
volume data. The text of the proposed rule change is provided in
Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/options/regulation/rule_filings/ctwo/), at the Exchange's Office of the Secretary, 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 proposes to amend its Fees Schedule to (i) offer a
free trial during the months of May, June and July 2022 for an ad-hoc
request of three (3) historical months of Intraday Open-Close
historical data to all C2 Trading Permit Holders (``TPHs'') and non-
TPHs who have never before subscribed to the Intraday Open-Close
historical files and (ii) adopt fees for the external distribution of
products derived from Open-Close Data, effective May 2, 2022.
    By way of background, the Exchange currently offers End-of-Day
(``EOD'') and Intraday Open-Close Data (collectively, ``Open-Close
Data''). EOD Open-Close Data is an end-of-day volume summary of trading
activity on the Exchange at the option level by origin (customer,
professional customer, broker-dealer, and market maker), side of the
market (buy or sell), price, and transaction type (opening or closing).
The customer and professional customer volume is further broken down
into trade size buckets (less than 100 contracts, 100-199 contracts,
greater than 199 contracts). The Open-Close Data is proprietary C2
Options trade data and does not include trade data from any other
exchange. It is also a historical data product and not a real-time data
feed. The Exchange also offers Intraday Open-Close Data, which provides
similar information to that of Open-Close Data but is produced and
updated every 10 minutes during the trading day. Data is captured in
``snapshots'' taken every 10 minutes throughout the trading day and is
available to subscribers within five minutes of the conclusion of each
10-minute period.\3\ The Intraday Open-Close Data provides a volume
summary of trading activity on the Exchange at the option level by
origin (customer, professional customer, broker-dealer, and market
maker), side of the market (buy or sell), and transaction type (opening
or closing). The customer and professional customer volume are further
broken down into trade size buckets (less than 100 contracts, 100-199
contracts, greater than 199 contracts). The Intraday Open-Close Data is
also proprietary C2 Options trade data and does not include trade data
from any other exchange.
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    \3\ For example, subscribers to the intraday product will
receive the first calculation of intraday data by approximately 9:42
a.m. ET, which represents data captured from 9:30 a.m. to 9:40 a.m.
Subscribers will receive the next update at 9:52 a.m., representing
the data previously provided together with data captured from 9:40
a.m. through 9:50 a.m., and so forth. Each update will represent the
aggregate data captured from the current ``snapshot'' and all
previous ``snapshots.''
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    Cboe LiveVol, LLC (``LiveVol''), a wholly owned subsidiary of the
Exchange's parent company, Cboe Global Markets, Inc., makes the Open-
Close Data available for purchase to TPHs and non-TPHs on the LiveVol
DataShop website (datashop.cboe.com). Customers may currently purchase
Open-Close Data on a subscription basis (monthly or annually) or by ad
hoc request for a specified month (e.g., request for Intraday Open-
Close Data for month of January 2022).
    Open-Close Data is subject to direct competition from similar end-
of-day and intraday options trading summaries offered by several other
options exchanges.\4\ All of these exchanges offer essentially the same
end-of-day and intraday options trading summary information.
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    \4\ These substitute products are: Nasdaq PHLX Options Trade
Outline, Nasdaq Options Trade Outline, ISE Trade Profile, GEMX Trade
Profile data; open-close data from Cboe Options, BZX, and EDGX; and
Open Close Reports from MIAX Options, Pearl, and Emerald.
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Free Trial
    The Exchange first seeks to adopt a free trial for historical ad
hoc requests for Intraday Open-Close Data for new purchasers.
Currently, ad hoc requests for historical Intraday Open-Close Data are
available to all customers at the same price and in the same manner.
The current charge for this historical Intraday Open-Close Data
covering all of the Exchange's securities (Equities, Indexes & ETF's)
is $500 per month. The Exchange now proposes to adopt a free trial
available during the months of May, June and July 2022 to provide a
total up to three (3) historical months of Intraday Open-Close Data to
any TPH or non-TPH that has not previously subscribed to this
offering.\5\ The Exchange notes that it previously offered this free
trial period last year for the months of June and July 2021.\6\ The
Exchange believes bringing back the proposed trial will again serve as
an incentive for new users who have never purchased Intraday Open-Close
historical data to start purchasing Intraday Open-Close historical
data. Particularly, the Exchange believes it will give potential
subscribers the ability to use and test the data offering before
signing up for additional months. The Exchange also notes another
exchange offers a free trial for new subscribers of a similar data
product.\7\ Lastly, the purchase of Intraday Open-Close historical data
is discretionary and not compulsory.
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    \5\ For example, if a TPH or non-TPH that has never made an ad-
hoc request for a specified month of Intraday Open-Close historical
data wishes to purchase Intraday Open-Close Data for the months of
January, February and March 2022 during the month of June 2022, the
historical files for those months would be provided free of charge.
If a new user wishes to purchase Intraday Open-Close historical data
for the months of January, February, March and April 2022 during the
month of June 2022, then the data for January, February and March
2022 would be provided free of charge, and the new user would be
charged $500 for the April 2022 historical file.
    \6\ The Exchange notes it inadvertently never eliminated the
obsolete rule text language from the Fees Schedule. The Exchange
proposes to update the text to conform to the proposed fee change.
    \7\ See Nasdaq ISE, Options 7 Pricing Schedule, Section 10A.,
Nasdaq ISE Open/Close Trade Profile End of Day.
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External Distribution of Derived Data
    The external distribution of Open-Close Data or any product derived
from such data is not currently permitted. The Exchange proposes to
remove that prohibition and allow vendors to distribute ``Derived
Data'' based on Open-Close Data. ``Derived Data'' is pricing data or
other data that (i) is created in whole or in part from Exchange Data,
(ii) is not an index or financial product, and (iii) cannot be readily
reverse-engineered to recreate Exchange Data or used to create other
data that is a reasonable facsimile or substitute for Exchange Data.\8\
Derived Data may be created by Distributors for a number of different
purposes, as determined by the Distributor. The Exchange believes
allowing market data vendors to identify, develop, and sell derived
market data products, enables them to harness the power of the
competitive marketplace to promote innovation.
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    \8\ ``Derived Data'' is not currently a defined term in the C2
Options Fees Schedule. The Exchange proposes to add the definition
to the Notes section of the LiveVol Fees table for clarity.
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    The Exchange proposes to adopt a fee of $5,000 per month to allow
the unlimited external distribution of Derived Data from Open-Close
Data.\9\ The fee charged to distribute the Derived Data will be
constrained by potential competition, as any exchange with an options
trading product would be able to submit an immediately-effective fee
filing to allow redistribution, most likely without needing to modify
the underlying product in any way, thereby subjecting the proposed fee
to market competition. Moreover, the Exchange notes at least

one other Exchange currently allows, and charges for, external
distribution of derived data based on similar open-close data.\10\
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    \9\ The External Distribution Fee for Derived Open-Close Data
will be in addition to fees for the underlying data. For example,
external distribution of data derived from the Intraday product will
be $1,000 per month (the monthly subscription fee), plus the
proposed $5,000 per month External Distribution fee.
    \10\ See Nasdaq PHLX, Options 7 Pricing Schedule, Photo
Historical Data, External Distribution.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\11\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \12\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, 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. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \13\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ Id.
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to the public. It was
believed that this authority would expand the amount of data available
to consumers, and also spur innovation and competition for the
provision of market data. The Exchange believes the proposed fee
changes will further broaden the availability of U.S. option market
data to investors consistent with the principles of Regulation NMS.
Open-Close Data is designed to help investors understand underlying
market trends to improve the quality of investment decisions. Indeed,
subscribers to the data may be able to enhance their ability to analyze
option trade and volume data and create and test trading models and
analytical strategies. The Exchange believes Open-Close Data provides a
valuable tool that subscribers can use to gain comprehensive insight
into the trading activity in a particular series, but also emphasizes
such data is not necessary for trading and as noted above, is entirely
optional. Moreover, several other exchanges offer a similar data
product which offer same type of data content through end-of-day or
intraday reports.\14\
---------------------------------------------------------------------------

    \14\ See supra note 4.
---------------------------------------------------------------------------

    The Exchange also operates in a highly competitive environment.
Indeed, there are currently 16 registered options exchanges that trade
options. Based on publicly available information, no single options
exchange has more than 16% of the market share.\15\ The Commission has
repeatedly expressed its preference for competition over regulatory
intervention in determining prices, products, and services in the
securities markets. Particularly, in Regulation NMS, the Commission
highlighted the importance of market forces in determining prices and
SRO revenues and, also, recognized that current regulation of the
market system ``has been remarkably successful in promoting market
competition in its broader forms that are most important to investors
and listed companies.'' \16\ Making similar data products available to
market participants fosters competition in the marketplace, and
constrains the ability of exchanges to charge supracompetitive [sic]
fees. In the event that a market participant views one exchange's data
product as more or less attractive than the competition they can and do
switch between similar products. The proposed fees are a result of the
competitive environment, as the Exchange seeks to adopt fees to attract
purchasers of historical Intraday Open-Close Data, as well as attract
Distributors for derived data of its Open-Close Data.
---------------------------------------------------------------------------

    \15\ See Cboe Global Markets U.S. Options Market Month-to-Date
Volume Summary (April 29, 2022), available at https://markets.cboe.com/us/options/market_statistics/.
    \16\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    The Exchange believes that the proposed free trial for any TPH or
non-TPH who has not previously purchased Intraday Open-Close historical
data is reasonable because such users would not be subject to fees for
up to 3 months' worth of Intraday Open-Close historical data. The
Exchange believes the proposed free trial is also reasonable as it will
give potential subscribers the ability to use and test the Intraday
Open-Close historical data prior to purchasing additional months and
will therefore encourage and promote new users to purchase the Intraday
Open-Close historical data. The Exchange believes that the proposed
discount is equitable and not unfairly discriminatory because it will
apply equally to all TPHs and non-TPHs who have not previously
purchased Intraday Open-Close historical data. Also as noted above,
another exchange offers a free trial to new users for a similar data
product \17\ and the Exchange itself previously offered a similar free
trial.\18\ Lastly, the purchase of this data product is discretionary
and not compulsory.
---------------------------------------------------------------------------

    \17\ See Nasdaq ISE, Options 7 Pricing Schedule, Section 10A.,
Nasdaq ISE Open/Close Trade Profile End of Day.
    \18\ See Securities Exchange Act Release No. 92173 (June 14,
2021), 86 FR 33399 (June 24, 2021) (SR-C2-2021-010).
---------------------------------------------------------------------------

    Next, the Exchange notes that the proposal to allow the external
distribution of derived data is subject to competition as discussed
above, and also introduces a new category of market participant for
Open-Close Data--market data vendors--into the equation. Currently,
Open-Close data is not available for redistribution, in either native
form or through Derived Data. This proposal will create a new market
for the sale of Derived Data from the Exchange's Open-Close Data
products to the general investing public. This is itself evidence of
the competitive environment for Open-Close and its substitutes, as it
is exactly the type of innovation one would expect to see in a
competitive market. It will also spur further innovation by challenging
market data vendors to create new and innovative Derived Data products.
Any exchange that wishes to allow distribution of a Derived Data
product based on options trading information would be able to do so
with an immediately effective fee filing similar to this proposal, most
likely without requiring any technological enhancement to the
underlying product. Indeed, as discussed, another Exchange already
allows, and charges for, external distribution of derived data based on
similar open-close data.\19\
---------------------------------------------------------------------------

    \19\ See Nasdaq PHLX, Options 7 Pricing Schedule, Photo
Historical Data, External Distribution.
---------------------------------------------------------------------------

    Allowing the redistribution of Derived Data, but not the underlying
information, to the general investing public is an equitable allocation
of reasonable dues, fees and other charges because it is the most
efficient mechanism for widespread delivery of market sentiment
information. The proposal is designed to promote the dissemination of a
variety of analytical insights--previously available only to investment
banks, market makers, asset managers and other buy-side investors--to
the general investing public by creating an incentive for market data
vendors to identify, develop, and sell

such indicators. Ordinarily, neither exchanges nor vendors allow
redistribution of analytic products--such products are typically
designed solely for the use of direct customers, not for redistribution
to the customers of customers in the manner of a data feed. Allowing
the redistribution of Derived Data provides an incentive for vendors to
innovate with new compelling and varied analytic products for the
general investing public that will provide broader access to market
sentiment insights currently available only to sophisticated investors.
    The Exchange believes that the proposed fee for the external
distribution of Derived Data from Open-Close Data is reasonable because
the rate is the same as the amount charged by another exchange that
also allows, and charges for, external distribution of derived data
from similar open-close products.\20\ Furthermore, the proposed fee
will only apply to Distributors that elect to distribute Derived Data
from Open-Close Data and as discussed, Open-Close Data, and Derived
Data therefrom, is purchased on a voluntary basis, in that neither the
Exchange nor market data distributors are required by any rule or
regulation to make this data available. Accordingly, Distributors can
discontinue use at any time and for any reason, including due to an
assessment of the reasonableness of fees charged. Firms have a wide
variety of alternative market data products from which to choose, such
as similar proprietary data products offered by other exchanges.
Moreover, the Exchange is not required to make any proprietary data
products available or to offer any specific pricing alternatives to any
customers. While the Exchange has no way of predicting with certainty
the impact of the proposed changes, it anticipates at least two
Distributors will create Derived Data from Open-Close Data. Also, while
the Exchange does not have a precise estimate of the number of
individuals expected to benefit, which will ultimately depend on the
usefulness of the Derived Data products that reach the market it
expects this to be a popular product that may benefit thousands of
investors.
---------------------------------------------------------------------------

    \20\ Id.
---------------------------------------------------------------------------

    The Exchange also believes it is reasonable, equitable and not
unfairly discriminatory to charge an external distributor of Derived
Data a $5,000 fee as vendors will ordinarily charge a fee to their
downstream customers for this service, and, even if the vendor is not
charging a specific fee for this particular service, the Exchange
expects Derived Data products from Open-Close Data to be part of a
suite of offerings from distributors that generally promote sales.
External distribution is also fundamentally different than internal
use, in that the former generates revenue from external sales while the
latter does not. Therefore, the Exchange believes it is reasonable,
equitable and not unfairly discriminatory to charge a fee for a product
that generates downstream revenue. Further, the proposed fee will apply
equally to all distributors that choose to distribute Derived Data from
Open-Close Data.
    Additionally, the Exchange does not believe it is unfair
discrimination to allow the redistribution of Derived Data, but not the
underlying information, to the general investing public. As explained
above, neither exchanges nor vendors ordinarily allow redistribution of
analytic products--such products are typically designed solely for the
use of direct customers, not for redistribution to the customers of
customers in the manner of a data feed. Allowing the redistribution of
Derived Data provides an incentive for vendors to innovate with new
compelling and varied analytic products for the general investing
public that will provide access to market sentiment insights currently
available only to sophisticated investors. This proposal is therefore
not unfair discrimination, but rather allows for more equitable access
to market sentiment information to the general investing public.

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. The Exchange operates in a
highly competitive environment in which the Exchange must continually
adjust its fees to remain competitive. Because competitors are free to
modify their own fees in response, the Exchange believes that the
degree to which fee changes in this market may impose any burden on
competition is extremely limited.
    As discussed above, Open-Close Data is subject to direct
competition from several other options exchanges that offer substitutes
to Open-Close. Moreover, purchase of Open-Close is optional. It is
designed to help investors understand underlying market trends to
improve the quality of investment decisions, but is not necessary to
execute a trade.
    The proposed rule changes are grounded in the Exchange's efforts to
compete more effectively. The Exchange is proposing to broaden
distribution of Open-Close information beyond investment banks, market
makers, asset managers and other buy-side investors to market data
vendors and the general investing public, and to provide a free trial
for market participants to test investment strategies and trading
models, and develop market sentiment indicators. These changes will not
cause any unnecessary or inappropriate burden on intermarket
competition, but rather will promote competition by expanding the
market for Open-Close data and encouraging new market participants to
investigate the product. Other exchanges are, of course, free to match
these changes or undertake other competitive responses, enhancing
overall competition.
    The proposed rule changes will not cause any unnecessary or
inappropriate burden on intramarket competition. Particularly, the
proposed fee applies uniformly to any Distributor, in that it does not
differentiate between distributors that choose to distribute Derived
Open-Close Data. Additionally, the Exchange believes it will foster
competition by expanding dissemination of data to vendors and the
general investing public, and by encouraging more market participants
to use Open-Close data to help inform their investments strategies and
analytic models. Lastly, the proposed fee will only apply to
Distributors that elect to distribute Derived Data from Open-Close Data
and as discussed, Open-Close Data, and Derived Data therefrom, is
purchased on a voluntary basis.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \21\ of the Act and subparagraph (f)(2) of Rule
19b-4 \22\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(A).
    \22\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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 under Section 19(b)(2)(B) \23\ of the Act to determine
whether the proposed rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-C2-2022-011 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-C2-2022-011. 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; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2022-011 and should be
submitted on or before June 9, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-10737 Filed 5-18-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Notices]
[Pages 62317-62318]
[FR Doc No: 2018-26159]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the

communication, if written, or a summary of the substance of any oral
communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
             Docket No.                  File date                      Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    1. ER18-1314-000................      11-14-2018  A. Jeanne Graham.
    2. ER18-1314-000................      11-14-2018  Mass Mailing.\1\
    3. ER18-1314-000................      11-14-2018  Mass Mailing.\2\
    4. CP17-117-000; CP17-118-000...      11-15-2018  Louisiana Mid-Continent.
                                                      Oil and Gas Association.
    5. EL18-178-000.................      11-19-2018  Citizens Utility Board.
Exempt:
    1. CP17-117-000; CP17-118-000...      11-15-2018  State of Louisiana.
                                                      House Representative Stuart J. Bishop.
    2. CP18-102-000; CP18-103-000...      11-20-2018  FERC Staff.\3\
----------------------------------------------------------------------------------------------------------------
\1\ Thirty Seven letters have been sent to FERC Commissioners and staff under this docket number.
\2\ Two Hundred Twenty Five letters have been sent to FERC Commissioners and staff under this docket number.
\3\ Phone Memorandum for call on November 15, 2018 with the U.S. Fish and Wildlife Service.

    Dated: November 27, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-26159 Filed 11-30-18; 8:45 am]
 BILLING CODE 6717-01-P