[Federal Register: February 24, 2006 (Volume 71, Number 37)]
[Notices]
[Page 9627-9629]
[DOCID:fr24fe06-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53328; File No. SR-Amex-2006-11]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to the Adoption of an Options Licensing Fee for Options on
Certain SPDR ETFs

February 16, 2006.
    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 February 3, 2006, the American Stock Exchange LLC (``Amex'' or
``Exchange'') submitted to the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by Amex. Amex has
designated this proposal as one establishing or changing a due, fee, or
other charge imposed by the self-regulatory organization under Section
19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders it effective upon filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify its Options Fee Schedule by
adopting a per contract license fee for the orders of specialists,
registered options traders (``ROTs''), firms, non-member market makers,
and broker-dealers in connection with options transactions in three new
exchange-traded funds (``ETFs''): the SPDR Biotech ETF (symbol: XBI);
the SPDR Homebuilders ETF (symbol: XHB); and the SPDR Semiconductor ETF
(symbol: XSD).
    The text of the proposed rule change is available on the Amex's Web
site at http://www.amex.com, at the principal office of the Amex, 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, Amex 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. Amex 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
    Amex proposes to to adopt a per contract licensing fee for options
on XBI, XHB, and XSD. These fee changes will be assessed on members
commencing February 6, 2006. Amex also proposes to correct the Options
Fee Schedule to reflect the elimination of the equity option fee
discount for member firms facilitation customer orders.\5\
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    \5\ See Securities Exchange Act Release No. 52754 (November 9,
2005), 70 FR 69998 (November 18, 2005) (File No. SR-Amex-2005-113).
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    The Exchange has entered into numerous agreements with various
index providers for the purpose of trading options on certain ETFs.
This requirement to pay an index license fee to a third party is a
condition to the listing and trading of these ETF options. In many
cases, the Exchange is required to pay a significant licensing fee to
the index provider that may not be reimbursed. In an effort to recoup
the costs associated with certain index licenses, the Exchange has
established a per contract licensing fee for the orders of specialists,
ROTs, firms, non-member market makers and broker-dealers, which is
collected on every option transaction in designated products in

which such market participant is a party.\6\
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    \6\ See, e.g., Securities Exchange Act Release No. 52493
(September 22, 2005), 70 FR 56941 (September 29, 2005).
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    The purpose of this proposal is to charge an options licensing fee
in connection with options on XBI, XHB and XSD (collectively, the
``SPDR ETFs''). Specifically, Amex seeks to charge an options licensing
fee of $0.09 per contract side for each SPDR ETF option for specialist,
ROT, firm, non-member market maker and broker-dealer orders executed on
the Exchange. In all cases, the fees will be charged only to the
Exchange members through whom the orders are placed.
    The proposed options licensing fee will allow the Exchange to
recoup its costs in connection with the index license fee for the
trading of the SPDR ETF options. The fees will be collected on every
order of a specialist, ROT, firm, non-member market maker, and broker-
dealer executed on the Exchange. The Exchange believes that the
proposal to require payment of a per contract licensing fee in
connection with the SPDR ETF options by those market participants that
are the beneficiaries of Exchange index license agreements is justified
and consistent with the rules of the Exchange.
    The Exchange notes that the Amex, in recent years, has revised a
number of fees to better align Exchange fees with the actual cost of
delivering services and reduce Exchange subsidies of such services.\7\
Amex believes that the implementation of this proposal is consistent
with the reduction and/or elimination of these subsidies. Amex believes
that these fees will help to allocate to those market participants
engaging in SPDR ETF options, a fair share of the related costs of
offering such options.
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    \7\ See, e.g., Securities Exchange Act Release Nos. 45360
(January 29, 2002), 67 FR 5626 (February 6, 2002); and 44286 (May 9,
2001), 66 FR 27187 (May 16, 2001).
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    The Exchange asserts that the proposal is equitable as required by
Section 6(b)(4) of the Act.\8\ In connection with the adoption of an
options licensing fee for SPDR ETF options, the Exchange believes that
charging an options licensing fee, where applicable, to all market
participant orders except for customer orders is reasonable, given the
competitive pressures in the industry.\9\ Accordingly, the Exchange
seeks, through this proposal, to better align its transaction charges
with the cost of providing products.
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    \8\ Section 6(b)(4) states that the rules of a national
securities exchange provide for the equitable allocation of
reasonable dues, fees, and other charges among its members and
issuers and other persons using its facilities.
    \9\ Telephone call between Jeffrey Burns, Vice President and
Associate General Counsel, Amex, and Angela Muehr, Attorney,
Division of Market Regulation (``Division''), Commission, on
February 15, 2006.
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    In addition, the Exchange recently eliminated the equity options
transaction fee discount for member firms facilitating customer
orders.\10\ However, in a later filing, File No. SR-Amex-2005-126,\11\
the Exchange inadvertently failed to incorporate in the Options Fee
Schedule the elimination of the equity option transaction fee discount
for members firms; therefore, the current fee schedule is
inaccurate.\12\ Accordingly, in this filing, the Exchange proposes to
correct the Options Fee Schedule to once again reflect the elimination
of the equity option transaction fee discount for member firms that was
previously adopted by the Exchange.
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    \10\ See Securities Exchange Act Release No. 52754, supra note
5. This proposal was immediately effective and was noticed in the
Federal Register on November 18, 2005.
    \11\ See Securities Exchange Act Release No. 52925 (December 8,
2005), 70 FR 74065 (December 14, 2005).
    \12\ Telephone call between Jeffrey Burns, Vice President and
Associate General Counsel, Amex, and Angela Muehr, Attorney,
Division of Market Regulation (``Division''), Commission, on
February 15, 2006.
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2. Statutory Basis
    Amex believes that the proposed fee change is consistent with
Section 6(b)(4) of the Act \13\ regarding the equitable allocation of
reasonable dues, fees and other charges among exchange members and
other persons using exchange facilities.
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    \13\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Amex believes that the proposed rule change does not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change was filed pursuant to Section
19(b)(3)(A)(ii) of the Act \14\ and Rule 19b-4(f)(2) thereunder,\15\
because it establishes or changes a due, fee, or other charge imposed
by the self-regulatory organization.
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    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \15\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-Amex-2006-11 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC, 20549-1090.
    All submissions should refer to File Number SR-Amex-2006-11. This
file number should be included on the subject line if e-mail 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 Web site (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 inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Amex. 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-Amex-2006-11 and should be submitted on or before March
17, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-2644 Filed 2-23-06; 8:45 am]

BILLING CODE 8010-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 18, 2002 MEMORANDUM SUBJECT: RESPONSE TO COMMENTS. Response to Comments on EPA's Human Health Risk Assessment of Endosulfan 01/ 31/ 01. PC Code: 079401, Case # 819236, DP Barcode D279252.

FROM: Diana Locke, Ph. D. Toxicologist Reregistration Branch II Health Effects Division (7509C)

THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division (7509C)

TO: Dan Helfgott, Acting Chief Reregistration Branch II Special Review and Reregistration Division (7508W)

The attached document titled, "HED's Response to Comments for Endosulfan," was generated in Phase 4 of the Proposed Public Participation Process (FR Notice 03/ 15/ 00) to address comments submitted by the Endosulfan Task Force (Aventis CropScience USA LP, FMC Corporation, and Makhteshim Agan of North America, Inc.), the Natural Resources Defense Council (NRDC), the Farmworker Justice Fund, Inc., the Institute for Agriculture and Trade Policy, the Pesticide Action Network North America (PANNA) and their affiliate, the Pesticide Action Network Asia and Pacific (PANAP), Respiratory and Environmental Disabilities Association of Hawaii, and the Rural Action Safe Pest Control Program (RASPCP) to the Agency during Phase 3 concerning the Agency's Human Health Risk Assessment of Endosulfan 01/ 31/ 01. The attached document is the Agency's response to those comments. This response includes input from John Punzi (Residue Chemistry), Sherrie Kinard (Dietary Assessment) Robert Fricke (Toxicology), Elizabeth Mendez (Toxicology), Renee Sandvig (Occupational and Residential Exposure), Ruth Allen (Incident Data), and Diana Locke (Risk Assessment).

cc: Stacey Milan Margaret Stasikowski Lois Rossi Pauline Wagner TABLE OF CONTENTS I. Introduction ............................................................. 1 II. ResidueChemistry........................................................ 1 III. Dietary (Food) Assessment ................................................. 4 IV. DrinkingWater.......................................................... 4 V. Toxicology ............................................................. 4 VI. OccupationalExposure.................................................... 7 VII. IncidentData ......................................................... 10 1 January 18, 2002 HED'S RESPONSE TO COMMENTS FOR ENDOSULFAN I. Introduction The following is the Health Effects Division's (HED) response to comments (Phase 4) for endosulfan, generated in response to the comments submitted to the public docket by the Endosulfan Task Force (ETF), environmental interests, and consumer concerns groups in Phase 3 of the Proposed Public Participation Process. Some of the responses serve as clarification or a restatement of Agency policies and guidance and it is hoped that this will provide a greater understanding of the Agency's position and procedures on these matters. During Phase 3, HED's endosulfan risk assessment document was placed in the public docket and all interested parties were given 60 days to comment to the Agency in writing. Comments concerning the rationale behind Agency decisions, endpoints selected, exposure assessment, and interpretation of available data, were submitted. Since there were a number of comments submitted from very differing sources, HED's responses will be directed to the issues raised and not to each of the commentors. In many cases, the same subject matter was raised by several of the commentors but with very different view points.

Several issues related to the quantitative risk assessment and characterization cannot be dealt with in the Phase 4 timeframe. Emerging Agency policy on these issues is expected to impact the risk assessment and will be incorporated into a revised risk assessment document in the Spring of 2002. During Phase 3, the ETF submitted new data and information that may also impact the quantitative risk assessment. These data/ information are being reviewed and will be included, where appropriate, in the revised risk assessment (Spring 2002).

II. Residue Chemistry The reregistration requirements for magnitude of the residue studies in grains and processed grains are fulfilled according to an HED memo dated January 10, 2001 (DP Barcode, D268415).

This conclusion will be incorporated into a revised chapter.

Existing labels carry a Lima bean use restriction. The Agency agreed to remove this restriction (July 2001, J. Punzi written reply to Nang Ly Chow).

This restriction will be removed in the revised chapter.

The ETF is proposing a tolerance of 1. 0 ppm for crop group 9. 2 As noted in the January 3, 2001 Residue Chemistry Chapter, the available residue data are adequate to support this use.

The existing tolerance for mustard seed will be maintained.

The Agency will review MRID# 00003724 for this use and examine application rates and use parameters.

The ETF and IR 4 are asking the Agency to review MRID# s 00138256, 00003587, and 00003843, as well as available raspberry data for adequacy in supporting a crop group tolerance for cane berry.

The Agency will review the appropriate studies for this use and examine application rates and use parameters.

The ETF are asking the Agency to consider available data to support a crop group tolerance for fruiting vegetables (Crop Group 8).

The Agency will review the available data.

The ETF is proposing that the Agency translate existing residue data from potatoes and carrots (root portion) and turnip greens, sugarbeet tops, kale and spinach (leafy portion) to rutabaga and radish. The ETF notes that radish and rutabaga use is permitted on Canadian labels and for harmonization reasons under NAFTA, the data translation described above is appropriate.

The Agency will review the appropriate data.

The ETF is requesting a tolerance for pistachio nuts by translation of the available data for almonds (MRID# s 00003713 and 00004254).

The Agency will review the available data.

The ETF is proposing to retain current labeled Post Harvest Intervals for celery and leaf lettuce and to raise the tolerances to 8 ppm (celery) and 6 ppm (leaf lettuce). The proposal is supported by residue chemistry studies MRID# s 44346904, 44346906 performed in 1995.

The Agency will review all available data for endosulfan in/ on lettuce and celery and determine the adequacy of the data.

The ETF notes that the Agency used a pineapple processing study (MRID# 00157147) to determine the concentration factors in pineapple peel and pineapple wet bran. The Agency did not review MRID# 44617402 for tolerance reassessment. Therefore, the ETF requests that the data be reviewed to determine processing factors for pineapple juice and pineapple processed 3 residue/ wet bran.

The Agency will review all available data for endosulfan in/ on pineapple and determine the adequacy of the data.

The ETF does not agree with the Agency's calculation of a maximum dietary burden (MDB) using pineapple processed residues as 20 30 % of the total diet. The ETF correctly states this would be very localized since Hawaii is the only state where pineapples are grown. Furthermore, since the MDB is based on the pineapple residues from the processing study, inappropriate values were used in the computation.

The MDB reflects very conservative diets based on worst case scenarios. Livestock used for meat and milk in Hawaii and subsequent exposure to residues of endosulfan is not unrealistic in acute assessments. While the animal diet may be inappropriate to use for an exposure assessment, the dietary risks are small.

Based on a revised MDB, reassessed tolerances for fat, meat byproducts, liver, meat and milk need to be revised.

We will review the appropriate pineapple study and make a recommendation.

The ETF identified one error in the end use labels; The maximum application rate for the emulsifiable concentrate (EC) formulation used on walnuts reads 2.5 lb ai/ A in the text. The ETF believes this is an error as the labels read 2.0 lb ai/ A.

The Agency has indeed verified that there is a label (reg.# 10163 110) for an EC formulation to be used at 2. 5 lbs ai/ A. As a point of reference, 2 lbs ai/ A was used for the wettable powder (reg.# 279 2659). The Agency assesses exposures up to the highest application rate for which there is a current registration. The Agency is reviewing whether the submitted residue data support these application rates.

The ETF has noted possible errors and requests correction for revisions to the chapter:

Errors in Table 8: Almonds reassessed to 0. 2 ppm vs 0.3 ppm as listed in the text.

Cotton gin byproducts reassessed to 30 ppm vs 28 ppm listed in the text.

The Agency will revise the appropriate sections as identified in this response before the RED for endosulfan is finalized. 4 III. Dietary (Food) Assessment 99.9 th Percentile Policy Not Consistently Applied In HED's dietary assessment, exposure to all populations was assessed at the 99. 9 th percentile, not just children 1 6 years of age. Regulating at the 99.9 th percentile is HED's current approach when the assessment includes such refinements as the use of monitoring data, percent crop treated, and processing data. The endosulfan assessment includes all of these refinements.

Percent of Food Treated in Acute Risk Assessment The current approach for the application of percent crop treated estimates was used in the endosulfan dietary assessment. The maximum percent crop treated estimates were used in the acute dietary assessment, and the weighted average estimates were used in the chronic dietary assessment. The acute dietary assessment was also done in accordance with HED SOP 99.6: Classification of Food Forms With Respect to Level of Blending (8/ 20/ 99).

IV. Drinking Water Drinking Water Levels of Comparison, derived from dietary (food) exposures estimated at the 99.9 th percentile, were compared to drinking water exposures calculated at the 90 th percentile. This underestimates risk.

The Environmental Fate and Effects Division (EFED), which conducts the drinking water assessment, uses the 90 th percentile in its calculations to provide HED with a somewhat conservative estimate in which it is assumed that one high/ maximum concentration event will occur once every ten years for just one day during that year. It is EFED's standard policy to use this 1 in 10 year storm event. With additional data, further refinements could be made.

V. Toxicology Endocrine disruption As part of the hazard characterization required for risk assessment, the toxicological database for endosulfan was reviewed and evaluated, and is suggestive of endocrine related effects due to endosulfan exposure. The concern that endosulfan may be an endocrine disruptor is based on reports in the open literature and in studies submitted to the Agency. The Agency's weight of evidence that endosulfan may be an endocrine disruptor is presented in Appendix A of the HED Toxicology Chapter (HED DOC Number: 014049, dated November 12, 1999). The ETF submitted its own weight of evidence report (MRID 44939102) in evaluating the potential endocrine effects of endosulfan; which was reviewed by the Agency (ENDOSULFAN: 1 Crisp, T. M. et al. Environmental Endocrine Disruption: An Effects Assessment and Analysis. Environmental Health Perpectives 106 pp. 11 56.

2 ATSDR Toxicity Profile for Endosulfan. September, 2000.

5 Evaluation of Registrant Submission Endosulfan: Evaluation of Possible Endocrine Effects in Mammalian Species. Elizabeth Méndez. December 11, 2000). After reviewing several published articles, the ETF concluded that "endosulfan does not meet the criteria of an endocrine disruptor." The registrant stated that in vitro studies show that endosulfan has a low binding potency to the human estrogen receptors and that "no effects were found on endocrine, reproductive or sexually regulated systems in vivo at doses causing clear toxicity."

The Agency identifies an environmental endocrine disruptor as an exogenous agent that interferes with the synthesis, secretion, transport, binding action, or elimination of natural hormones in the body that are responsible for the maintenance of homeostasis, reproduction, development, and/ or behavior. 1 Based on these criteria, the Agency disagrees with the conclusion by the registrant that endosulfan does not meet the definition of an endocrine disruptor. Binding to the estrogen receptor is only one potential mode of action for endocrine disruptors, namely direct interaction with a receptor in the target cells. Substances that act as endocrine disruptors may perturb the endocrine system in a variety of ways including but not limited to interfering with the synthesis, secretion, or transport of hormones in the organism. Some examples of endocrine disruption that do not involve receptor binding are: 1) depression of the steroidogenic enzymes and cytochrome P450 dependent monooxygenases, which suggests that conversion of cholesterol to testosterone may be affected by endosulfan; 2) decreases in luteinizing hormone (LH) activity that may result in decreases in the activity of Steroidogenic Acute Regulatory Protein responsible for translocation of cholesterol from the cytosol to the inner mitochondria [transport and synthesis affected]; and 3) effects on the sex hormone binding globulin (SHBG) as indicated by decreases in plasma and testicular testosterone in conjunction with serum testosterone [effect on hormone transport]. 2 Consequently, the absence of high binding affinity to the estrogen receptor should not be interpreted as lack of endocrine disruption potential. The Agency notes that other organochlorines (i. e. DDT, DDE, dieldrin, and methoxychlor) have been demonstrated to interact with the endocrine system in spite of differing binding affinities to the estrogen receptor.

Finally, the registrant states that no effects were reported after administration of endosulfan on the endocrine, reproductive or sexually regulated systems at doses causing clear toxicity. However, it is noteworthy that testicular atrophy was reported during a Chronic Oral Toxicity Study in Rats (MRID# 00004256) submitted to the Agency. Additionally, increased pituitary and uterine weights were also observed during a Multi Generation Reproduction Study (MRID# 00148264). Furthermore, an increase in the incidence of parathyroid hyperplasia was also reported during the Chronic Oral Toxicity study in Rats. The Agency emphasizes the fact that the endocrine system integrates a variety of CNS pituitary target organ pathways that not only affect reproductive or sexually regulated parameters but also regulates a wide array of bodily 3 R. L. Cooper and R. J. Kavlock. Endocrine Disruptors and Reproductive Development: a Weight of Evidence Overview. J. Endocrinology 152 pp. 159. 166 6 functions and homeostasis. 3 Though this is not the case for endosulfan, it is important to note that a lack of overt toxicity to the reproductive system should not be interpreted as conclusive evidence of a lack of endocrine disruption. Given the effects noted in the Chronic Oral Toxicity Study in Rats and the Multi Generation Reproduction Study submitted to the Agency, the potential of endosulfan to act as an endocrine disruptor can not be discounted. The Agency has requested that a Developmental Neurotoxicity Study be conducted; the Agency believes that this study will provide additional data that may help elucidate this matter.

Selection of toxicology endpoints for dermal and inhalation NOAELs A re review of the of the study (MRID# 00146841, 00147744) selected for establishing the dermal NOAEL and LOAEL indicates that 9 mg/ kg/ day is not an effect level. In this study, rats were treated dermally for 21 days at dose levels of 0, 1, 3, 9, 27 or 81 (males only) mg/ kg/ day. At 9 mg/ kg/ day, 2/ 6 males died; at 27 mg/ kg/ day no mortalities were observed in males and 3/ 6 females died, and at 81 mg/ kg/ day 3/ 6 males died. The two males which died at 9 mg/ kg/ day may have been a result of non treatment related causes (very small immature testes and livers). It is biologically improbable to have lethality at one dose, no lethality at a three fold higher dose and lethality again at a nine fold higher dose The histopathological findings were also reexamined. The study pathology report states that the two males in the 9 mg/ kg/ day group and the 5 females in the 27 mg/ kg/ day group "showed signs of incipient and in some cases advanced, autolysis." Further, there was no apparent dose response for the incidence of histopathological findings in the liver.

In another dermal toxicity study, animals were dosed at 0, 3, 6, 12, 48, 96 (males only) or 192 (males only) mg/ kg/ day. The NOAEL for this study was established at 12 mg/ kg/ day in females and 96 mg/ kg/ day in males, based on increased mortalities at 48 mg/ kg/ day in females and at 192 mg/ kg/ day in males.

The selection of the appropriate NOAEL for dermal toxicity will be deferred to HED's Hazard Identification Assessment Review Committee (HIARC).

Endosulfan is not likely to bioaccumulate The most compelling evidence to support the ETF claim that endosulfan does not bioaccumulate was presented in a recently submitted toxicokinetic study (MRID# 45546201). In this study, 14 C endosulfan (1 mg/ kg/ day) was administered to male and female rats for up to 28 days. A steady state concentration in blood and tissues was achieved by day 23. At day 28, 7 treatment was stopped and blood and tissue levels of labeled residues were measured for 5 days. At the end of the treatment free period, there was no evidence that indicated that endosulfan bioaccumulates. Only 9.253% of the total administered dose remained in males and 9. 794%, in females at the end of the treatment free period (i. e. over 90% of the radioactivity was eliminated).

The use of a 3 fold factor to account for lack of long term dermal study In the absence of dermal toxicity studies beyond 30 days exposure, the HIARC concluded (HED Doc No: 014024) that an additional 3X factor is needed to address the uncertainty in extrapolating data from greater than 30 days up to several months and/ or years. This factor was added based on concerns that endosulfan bioaccumulates. A recently submitted toxicokinetic study (MRID# 45546201) provides evidence that endosulfan does not bioaccumulate. However, the decision to retain or remove the 3 fold safety factor will be made by the HIARC.

The NOAEL from the oral study for assessing worker inhalation risks While there appears to be merit to the ETF evaluation of the inhalation data, the action requested by the ETF is global in nature and effects not only endosulfan, but other chemicals as well. The use of oral toxicity data to establish an inhalation NOAEL will have to be deferred until management review.

VI. Occupational Exposure Spray Drift and Take home Exposures, and Exposures to Farmworker Children Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from groundboom application methods. The Agency has been working with the Spray Drift Task Force, EPA regional offices and state lead agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, of which U. S. pesticide registrants are members, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off target drift and risks associated with aerial as well as other application types, where appropriate.

In addition, the Agency is currently in the process of revising its guidance for completing other types of assessments, such as exposure to farmworker children. Modifications to this assessment shall be incorporated as updated guidance becomes available. This will include 8 expanding the scope of the residential exposure assessments by developing guidance for characterizing exposures from other sources already not addressed, such as from spray drift; residential residue track in; exposures to farmworker children; and exposures to children in schools.

Assessing baseline clothing for occupational mixing/ loading activities using endosulfan is inconsistent with the product labels and US EPA's Worker Protection standard and should be dropped from the assessment.

Baseline clothing attire is always assessed in reregistration assessments. This is done for informational purposes in order to determine at which mitigation level the risks to the workers are no longer of concern. Also, personal protective equipment (PPE) and engineering control requirements often differ on currently registered labels for older chemicals, because many older chemicals, including endosulfan, have a large number of registered products held by several different manufactures and the registration approval dates can often vary widely. The Agency does take the present PPE and engineering controls on the product labels into consideration during the risk mitigation process.

Many of the occupational handler scenarios presented in the RED represent uses that are not supported by ETF labels and should be removed from the assessment. These are: (1e) mixing/ loading of liquids for rights of way application; (2d) mixing/ loading of wettable powders for rights of way applications; (6) rights of way spray application; (8) mixing/ loading/ applying of liquids with a low pressure handwand; (9) mixing/ loading/ applying of wettable powders with a low pressure handwand; (10) mixing/ loading/ applying of liquids with a high pressure handwand.

The rights of way sprayer, the low pressure handwand, and the high pressure handwand are considered the application techniques used to apply liquids and wettable powders in tree bark treatments. The low and the high pressure handwands are also known to be commonly used in greenhouses and in drench treatments. Since uses in greenhouses, bark and drench treatments are all currently registered for endosulfan, the above occupational scenarios will continue to be assessed by the Agency and included in the risk assessment.

The use of a 50 percent protection factor for a second layer of clothing is conservative and overestimates exposure. This is in conflict with the 90% protection factor used by the California Department of Pesticide Regulation.

According to Agency data, there is a range of protection levels provided by a second layer of clothing. While the 90% protection factor is included in this range, the Agency uses the 50 percent protection factor in order to provide the maximum protection to the worker. This number takes into account the variations in the types of clothing that could be used and any possible rips or holes in the second layer of clothing.

In the case of endosulfan, it is more appropriate to use the NOEL from the oral study for 9 assessing worker inhalation risks than the NOEL from the inhalation study.

The Agency is currently considering this matter, since this is an issue that has arisen for several other pesticides and will affect the overall regulation of all pesticides. When there is a decision on this issue in the Agency, the occupational risk assessment will be revised as appropriate. Until then, the inhalation endpoint will be used as it currently stands and this issue will be considered when characterizing the inhalation risk during the risk mitigation phase. Also see Section V above.

Use of biphasic kinetics to calculate predicted dislodgeable foliar residue (DFR) values better represents the data and provides higher R squared values for the critical phase 1 period than a linear assumption.

HED will reanalyze the distribution of the DFR data using the biphasic method and will determine which method, linear or biphasic, best represents the distribution of the data and produces the highest R squared value. Any changes in the analysis of the DFR data will be reflected in the next revision of the occupational exposure assessment.

ETF believes that a 50% protection factor is a reasonable default for the use of protective headgear.

HED agrees that a chemical resistant headgear may reduce pesticide exposure. A protection factor has not been established by the Agency for the use of headgear; therefore, occupational exposure risk estimates are not quantitatively reduced to take this protective clothing into account. One problem in setting a generic protection factor for chemical resistant headgear is that headgear can come in a wide range of styles, materials, etc. This causes the amount of protection that headgear can provide to vary widely. Even so, the MOEs for airblast applicators presently range from 3. 2 to 24 at the additional PPE mitigation level for dermal risk. The use of a 50% protection factor for head/ neck exposure would not increase the highest MOE to more than 36, which is still far below the target MOE of 100. HED will take into consideration any data submitted to support the ETF's assumption that chemical resistant headgear reduces head/ neck exposure by 50%.

600 acres/ day should be used for applications to small grains instead of 1200 acres/ day, based on California Department of Pesticide Regulation defaults. Due to the small size of ornamental operations, 40 acres per day is not realistic, and 10 acres per day should be used.

The small grains treated with endosulfan; rye, oats, barley and wheat; were considered to have a 1, 200 acre per day amount treated rate based on the values for wheat in the National Agricultural Aviation Association's 1998 Industrial Survey for Agricultural Aviation, Timber Mill Research, Inc., June 1998 (values for acres treated per day range from 970 to 1,625 for wheat ). Barley, rye, oats and wheat all have the same maximum application rate of 0. 75 lbs ai/ acre. HED considers 1, 200 acres per day to be a reasonable assumption for small grains treated with 10 endosulfan. HED now considers 10 acres treated per day to be a realistic assumption for ornamentals and future revisions of the occupational assessment will reflect this.

Some of the MOEs are calculated assuming that PPE or engineering controls will be in use. EPA must remember that in many instances PPE is not provided, does not fit properly or is uncomfortable to wear.

Occupational risks are assessed with PPE or engineering controls in order to determine what risk mitigation can be employed. If PPE or engineering controls are determined to be necessary to reduce the risk to a pesticide, then that condition/ restriction will be placed on the label (if not already present). Any deviations from the use of required label PPE or engineering controls is considered by the EPA to be a misuse of the pesticide product. HED does not assess risks resulting from the misuse of a pesticide product.

VII. Incident Data The Agency has not included a number of important incident reports in its evaluation of the incident data.

The Agency's Incident Report was written in the year 2000 and the Agency is aware that a great deal more information is now available. A quick MEDLINE/ PubMed search at the National Library of Medicine web site, revealed 560 entries for endosulfan. Many recent entries use new multiresidue analytical chemistry measurement methods. Some poisonings date back to 1970 in Germany. The literature entries reflect mostly international pesticide poisoning incident case reports referred to by PAN Asia and the Pacific/ PAN North America {Docket #34242} and Ohio based Rural Action Safe Pest Control Program {Docket #34242}, and some studies appear to be consistent with the thrust of their concerns.

Specifically, endosulfan is a wide spread and commonly measured contaminant of the human environment. Evidence from various places and test systems is beginning to suggest internal enzyme, endocrine, and neuronal regulation changes at the cellular and sub cellular levels. Of particular concern are the neuronal gap junction and MAP K (kinase) nerve to nerve cell communication disturbances in test cell systems and other evidence of endocrine disruption. A further concern is that persistent organochlorine pesticides (POPS) tend to co occur in fatty foods like fish, thus necessitating more complex analysis on the implications of aggregate and cumulative exposure. The number and diversity of recent publications that include endosulfan, suggest the need for a more careful literature review during the upcoming risk assessment revision process.


[Federal Register Volume 83, Number 133 (Wednesday, July 11, 2018)]
[Notices]
[Page 32121]
[FR Doc No: 2018-14944]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9980-61-ORD]

Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA), Office of the
Science Advisor announces two separate public meetings of the Human
Studies Review Board (HSRB) to advise the Agency on the ethical and
scientific review of research involving human subjects.

DATES: A virtual public meeting will be held on Wednesday, July 25,
2018, from 1:00 p.m. to approximately 5:30 p.m. Eastern Time. A
separate, subsequent teleconference meeting is planned for Thursday,
September 13, 2018, from 2:00 p.m. to approximately 3:30 p.m. Eastern
Time for the HSRB to finalize its Final Report of the July 25, 2018
meeting and review other possible topics.

ADDRESSES: All of these meetings will be conducted entirely by
telephone and on the internet using Adobe Connect. For detailed access
information visit the HSRB website: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact the HSRB Designated Federal
Official (DFO), Thomas O'Farrell on telephone number<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address: [email protected]; or
mailing address: Environmental Protection Agency, Office of the Science
Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW, Washington, DC
20460.

SUPPLEMENTARY INFORMATION:
    Meeting access: These meetings will be open to the public. The full
Agenda and meeting materials will be available at the HSRB website:
http://www2.epa.gov/osa/human-studies-review-board. For questions on
document availability, or if you do not have access to the internet,
consult with the DFO, Thomas O'Farrell, listed under FOR FURTHER
INFORMATION CONTACT.
    Special accommodations. For information on access or services for
individuals with disabilities, or to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in
these meetings by following the instructions in this section.
    1. Oral comments. To pre-register to make oral comments, please
contact the DFO, Thomas O'Farrell, listed under FOR FURTHER INFORMATION
CONTACT. Requests to present oral comments during the meeting will be
accepted up to Noon Eastern Time on Wednesday, July 18, 2018, for the
July 25, 2018 meeting and up to Noon Eastern Time on Thursday,
September 6, 2018 for the September 13, 2018 meeting. To the extent
that time permits, interested persons who have not pre-registered may
be permitted by the HSRB Chair to present oral comments during either
meeting at the designated time on the agenda. Oral comments before the
HSRB are generally limited to five minutes per individual or
organization. If additional time is available, further public comments
may be possible.
    2. Written comments. Submit your written comments prior to the
meetings. For the Board to have the best opportunity to review and
consider your comments as it deliberates, you should submit your
comments by Noon Eastern Time on Wednesday, July 18, 2018, for the July
25, 2018 meeting and up to Noon Eastern Time on Thursday, September 6,
2018 for the September 13, 2018 meeting. If you submit comments after
these dates, those comments will be provided to the HSRB members, but
you should recognize that the HSRB members may not have adequate time
to consider your comments prior to their discussion. You should submit
your comments to the DFO, Thomas O'Farrell listed under FOR FURTHER
INFORMATION CONTACT. There is no limit on the length of written
comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 5 U.S.C. App. 2 sec. 9. The
HSRB provides advice, information, and recommendations on issues
related to scientific and ethical aspects of third-party human subjects
research that are submitted to the Office of Pesticide Programs (OPP)
to be used for regulatory purposes.
    Topic for discussion. On July 25, 2018, EPA's Human Studies Review
Board will consider a study protocol titled ``Laboratory evaluation of
mosquito bite protection from permethrin-treated clothing after 0, 50,
75, and 100 washings'' submitted by Pulcra Industries.
    The Agenda and meeting materials for this topic will be available
in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On September 13, 2018, the HSRB will review and finalize their
draft Final Report from the July 25, 2018 meeting, in addition to other
topics that may come before the Board. The HSRB may also discuss
planning for future HSRB meetings. The agenda and the draft report will
be available prior to the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings,
summarizing the matters discussed and recommendations made by the HSRB,
will be released within 90 calendar days of the meeting. These minutes
will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will
be found at http://www2.epa.gov/osa/human-studies-review-board or from
Thomas O'Farrell listed under FOR FURTHER INFORMATION CONTACT.

     Dated: July 3, 2018.
Jennifer Orme-Zavaleta,
EPA Science Advisor.
[FR Doc. 2018-14944 Filed 7-9-18; 4:15 pm]
 BILLING CODE 6560-50-P


Form for Compliance with E. O. 12866 Docket Requirements Title of Regulation: Final National Pollutant Discharge Elimination System ( NPDES) General Permit for Storm Water Discharges from Construction Activities Contact person: Jack Faulk Phone number: 202 564 0768 Was this regulation reviewed by OMB under Executive Order 12866  Regulatory Planning and Review?

Yes

No.

If you checked " no", you are done with this form. Simply place it in the docket for your regulation. If you checked " yes", please fill out the remainder of the form before placing it in the docket. Also docket any relevant documents referenced in the form.

For regulations that are checked " Yes" above:

This regulation was reviewed by OMB under Executive Order 12866  Regulatory Planning and Review.

Attached is the draft regulation and any other documents sent to OMB for review, such as analyses and assessments. E. O. 12866 requires agencies to make these publicly available.

E. O. 12866 also requires agencies to identify the substantive changes between the draft regulation sent to OMB for review and the regulation subsequently announced [ Please check the appropriate box below:]

EPA made substantive changes to this regulation ( includes changes initiated by EPA or OMB). Attached is a document which: ( 1) identifies all the substantive changes made, and ( 2) notes those changes OMB suggested or recommended.

No substantive changes were made to this regulation Therefore, no further attachments are required..

If you have questions about this regulation, please call the EPA contact person listed above.


[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Proposed Rules]
[Pages 56234-56236]
[FR Doc No: 2021-21862]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0811; Airspace Docket No. 19-AAL-60]
RIN 2120-AA66

Proposed Amendment to United States Area Navigation Route (RNAV)
T-227; Fairbanks, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend United Stated Area Navigation
(RNAV) route T-227 in the vicinity of Fairbanks, AK in support of a
large and comprehensive T-route modernization project for the state of
Alaska.

DATES: Comments must be received on or before November 22, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0811; Airspace Docket No. 19-AAL-60 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of the Order at NARA, email<EMAIL_ADDRESS>or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessening the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0811; Airspace Docket No. 19-AAL-60) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-0811; Airspace Docket No. 19-AAL-60.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments

received. All comments submitted will be available for examination in
the public docket both before and after the comment closing date. A
report summarizing each substantive public contact with FAA personnel
concerned with this rulemaking will be filed in the docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    In 2003, Congress enacted the Vision 100-Century of Aviation
Reauthorization Act (Pub L. 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the nation's air
transportation system to make flying safer, more efficient, and more
predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive T-route modernization project in the state of Alaska. The
project mission statement states: ``To modernize Alaska's Air Traffic
Service route structure using satellite based navigation Development of
new T-routes and optimization of existing T-routes will enhance safety,
increase efficiency and access, and will provide en route continuity
that is not subject to the restrictions associated with ground based
airway navigation.'' As part of this project, the FAA evaluated the
existing Colored Airway structure for: (a) Direct replacement (i.e.,
overlay) with a T-route that offers a similar or lower Minimum En route
Altitude (MEA) or Global Navigation Satellite System Minimum En route
Altitude (GNSS MEA); (b) the replacement of the colored airway with a
T-route in an optimized but similar geographic area, while retaining
similar or lower MEA; or (c) removal with no route structure (T-route)
restored in that area because the value was determined to be
insignificant.
    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from
dependency on Non-Directional Beacons (NDB), and move to develop and
improve the RNAV route structure. The FAA proposes to amend segments of
RNAV route T-227. The amendments would include replacing the Port
Heiden, AK, (PDN) NDB reporting point with WIXER, AR, waypoint (WP).
The proposed amendment of these segments would provide for lower MEAs
while also ensuring that the appropriate route criteria is met along
the entire route.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend RNAV
route T-227 in the vicinity of Fairbanks, AK in support of a large and
comprehensive T-route modernization project for the state of Alaska.
The proposed route changes are described below.
    T-227: T-227 currently extends from Shemya, AK, (SYA) VHF
Omnidirectional Range Tactical Air Navigation (VORTAC) to Deadhorse,
AK, (SCC) VHF Omnidirectional Range/Distance Measuring Equipment (VOR/
DME). The FAA proposes to rename PDN to WIXER, AK, WP. The segment
between WIXER, AK, WP and AMOTT, AK, WP would include three additional
WPs (CULTI, FEDGI, and WEZZL) eliminating the use of the BATTY, AK, Fix
on this route. Additionally, the FAA proposes to reroute the airway
over PERZO, AK, WP to provide instrument approach connectivity to
Fairbanks International Airport (PAFA) and route continuity with T-282.
The rest of the route would remain unchanged.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV route listed in this document would be published subsequently
in the Order.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-227 Shemya, AK to Deadhorse, AK [Amended]

SHEMYA, AK (SYA)                                  VORTAC                        (Lat. 52[deg]43'05.78'' N, long. 174[deg]03'43.50'' E)
JANNT, AK                                         WP                            (Lat. 52[deg]04'17.88'' N, long. 178[deg]15'37.23'' W)
BAERE, AK                                         WP                            (Lat. 52[deg]12'11.96'' N, long. 176[deg]08'08.53'' W)
ALEUT, AK                                         WP                            (Lat. 54[deg]14'16.58'' N, long. 166[deg]32'51.82'' W)
MORDI, AK                                         WP                            (Lat. 54[deg]52'49.87'' N, long. 165[deg]03'15.24'' W)
GENFU, AK                                         WP                            (Lat. 55[deg]23'18.64'' N, long. 163[deg]06'20.78'' W)
BINAL, AK                                         WP                            (Lat. 55[deg]45'59.99'' N, long. 161[deg]59'56.43'' W)
WIXER, AK                                         WP                            (Lat. 56[deg]54'29.00'' N, long. 158[deg]36'10.00'' W)
CULTI, AK                                         WP                            (Lat. 58[deg]15'11.91'' N, long. 156[deg]31'19.57'' W)
FEDGI, AK                                         WP                            (Lat. 59[deg]30'10.87'' N, long. 154[deg]14'14.80'' W)
WEZZL, AK                                         WP                            (Lat. 59[deg]53'13.86'' N, long. 152[deg]24'12.63'' W)
AMOTT, AK                                         FIX                           (Lat. 60[deg]52'26.59'' N, long. 151[deg]22'23.60'' W)
BIG LAKE, AK (BGQ)                                VORTAC                        (Lat. 61[deg]34'09.96'' N, long. 149[deg]58'01.77'' W)
GLOWS, AK                                         WP                            (Lat. 64[deg]26'15.88'' N, long. 148[deg]15'17.88'' W)
PERZO, AK                                         WP                            (Lat. 64[deg]40'22.99'' N, long. 148[deg]07'20.15'' W)
FAIRBANKS, AK (FAI)                               VORTAC                        (Lat. 64[deg]48'00.25'' N, long. 148[deg]00'43.11'' W)
DEADHORSE, AK (SCC)                               VOR/DME                       (Lat. 70[deg]11'57.11'' N, long. 148[deg]24'58.17'' W)

* * * * *

    Issued in Washington, DC, on September 30, 2021.
Michael R. Beckles,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-21862 Filed 10-7-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Pages 37986-37988]
[FR Doc No: 2020-13537]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89093; File No. SR-MIAX-2020-15]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Temporarily Extend Filing Deadlines for Certain
Supervision-Related Reports

June 18, 2020.
    Pursuant to the provisions of 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 June 4, 2020, Miami International Securities
Exchange, LLC (``MIAX Options'' or the ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') a 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend Exchange Rule 1308,
Supervision of Accounts, to temporarily extend the filing requirements
for certain supervision-related reports, currently given an extension
to June 1, 2020, to June 30, 2020.
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/ at MIAX Options'
principal office, 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
    Given current market conditions, the Exchange proposes to provide
its members temporary relief from filing certain supervision-related
reports pursuant to Exchange Rule 1308 (Supervision of Accounts).\3\
---------------------------------------------------------------------------

    \3\ The Exchange notes that MIAX Rule 1308 is incorporated by
reference into the rulebooks of MIAX PEARL, LLC (``PEARL'') and MIAX
Emerald, LLC (``Emerald''). As such, the amendments to MIAX Rule
1308 proposed herein will also impact PEARL and Emerald Rules 1308.
The Exchange initially filed the proposal on June 1, 2020 (SR-MIAX-
2020-14). On June 4, 2020, the Exchange withdrew that filing and
submitted this filing.
---------------------------------------------------------------------------

    The Exchange has been closely monitoring the current situation
regarding the novel coronavirus (``COVID-19'') pandemic. The Exchange
understands COVID-19 has placed stress on market participants'
information technology infrastructure and the required deployment of
significant resources, including to implement and continuously adapt
business continuity plans. On March 11, 2020, the World Health
Organization characterized COVID-19 as a pandemic.\4\ To slow the
spread of the disease, federal and state officials implemented social-
distancing measures, placed significant limitations on large
gatherings, limited travel, and closed non-essential businesses, all of
which are largely still in place for the foreseeable future. The
Exchange also notes that in response to COVID-19, the Financial
Industry Reporting Authority (``FINRA'') recently reissued temporary
relief for member firms by, among other things, extending the deadline
for submitting their supervision-related reports (FINRA Rule 3120
Report and FINRA Rule 3130 certification) from their initial extension
deadlines of June 1, 2020 \5\ to June 30, 2020.\6\ The Exchange notes,
too, that other options exchanges that had previously extended the
supervisory report deadlines from April 1 to June 1 for their
members,\7\ also plan to submit similar filings to, again, extend their
deadlines through June 30, 2020.
---------------------------------------------------------------------------

    \4\ See WHO Director-General's Opening Remarks at the Media
Briefing on COVID-19 (March 11, 2020), available at https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarksat-the-media-briefing-on-covid-19---11-march-2020.
    \5\ See FINRA Regulatory Notice 20-08 (March 9, 2020) available
at https://www.finra.org/rules-guidance/notices/20-08.
    \6\ See FINRA Regulatory Notice 20-08, FAQs, Supervision (May
19, 2020) available at https://www.finra.org/rules-guidance/key-topics/covid-19/faq#supe.
    \7\ See SR-CBOE-2020-049 (May 29, 2020). See Securities Exchange
Act Release Nos. 88524 (March 31, 2020), 85 FR 19198 (April 6, 2020)
(SR-ISE-2020-14); and 88527 (March 31, 2020), 85 FR 19190 (April 6,
2020) (SR-Phlx-2020-16).
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    By way of background, Exchange Rule 1308(g) requires each Exchange
member that conducts a non-member customer business to submit to the
Exchange a written report on the member's supervision and compliance
effort during the preceding year and on the adequacy of the member's
ongoing compliance processes and procedures. Each member that conducts
a public customer options business is also required to specifically
include its options compliance program in the report.\8\ The Exchange
Rule 1308(g) report is due on April 1 of each year. Exchange Rule
1308(h) requires that each member submit, by April 1 of each year, a
copy of the Rule 1308(g) report to one or more control persons or, if
the member has no control person, to the audit committee of its board
of directors or its equivalent committee or group.\9\
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    \8\ The report shall include, but not be limited to, the
information set out in Exchange Rule 1308(g)(1)-(6).
    \9\ See Exchange Rule 1308(h) for the meaning of the term
``control person'' and requirements in the case of a control person
that is an organization.
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    Rule 1308 currently provides relief to members and their employees
by extending these deadlines to June 1, 2020.\10\ However, as COVID-19
remains an ongoing pandemic, to meet the current June 1 deadlines in
Rule 1308, member personnel would have to divide their efforts and
resources that are otherwise necessary to address continued disruptions
and stresses as a result of the ongoing COVID-19 pandemic. Therefore,
the Exchange proposes to extend the filing deadline through June 30,
2020, thus allowing

member personnel that are tasked with organizing, compiling and filing
such reports, but are also tasked with maintaining critical operations
and sustainable business continuity plans, and otherwise adjusting the
member's trading operations in line with evolving market conditions and
initiatives to address such conditions to focus their attention on
those immediate needs.
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    \10\ See Securities Exchange Act Release No. 88543 (April 2,
2020), 85 FR 19788 (April 8, 2020) (SR-MIAX-2020-06).
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2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \11\ in general, and furthers the
objectives of Section 6(b)(5) of the Act \12\ in particular, in that it
is 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.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
    \13\ Id.
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    In particular, the Exchange believes that the proposed rule will
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities. The proposed rule change will
allow the Exchange to extend temporary relief to its members by issuing
another extension of certain supervisory reporting deadlines from June
1, 2020 to June 30, 2020 in light of the ongoing COVID-19 crisis. The
Exchange understands this pandemic has caused, and continues to cause,
stress on market participants' information technology infrastructure
and the deployment of significant resources to address ongoing
disruptions and continued stresses. By allowing the Exchange to re-
extend the deadlines for filing certain supervision related reports in
Rule 1308, the Exchange believes the proposed rule will allow member
personnel, who would normally be tasked with organizing and compiling
such reports, to focus their attention on maintaining critical
operations and sustainable business continuity plans, and otherwise
adjusting their trading operations in line with evolving market
conditions and initiatives in response to the ongoing COVID-19
pandemic. The Exchange also believes the proposed rule change removes
impediments to and perfects the mechanism of a free and open market and
a national market system because, as noted above, FINRA has also re-
extended the time for their members to file supervision-related reports
from June 1, 2020 to June 30, 2020.\14\ Additionally, as indicated
above, other options exchanges that had previously extended the
supervisory report deadlines from April 1 to June 1 for their
members,\15\ plan to submit similar filings to re-extend their
deadlines through June 30, 2020.
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    \14\ See supra note 6.
    \15\ See supra note 7.
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues. The Exchange does not
believe the proposed rule would impose any burden on intramarket
competition that is not necessary or appropriate in furtherance of the
Act, because the additional June 30, 2020 extension for supervision-
related reports in Rule 1308 will apply equally to all members. The
Exchange does not believe that the proposed rule change would impose
any burden on intermarket competition because it relates only to the
extension of the filing deadline for supervision-related reports.
Additionally, and as stated above, FINRA has recently notified its
members that the filing deadline for their supervision-related reports
has again been extended from June 1, 2020 to June 30, 2020,\16\ and
other options exchanges plan to file for the same relief through June
30, 2020, as well.
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    \16\ See supra note 6.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor 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) of the Act \17\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\18\
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    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 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 Commission has waived this requirement.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \19\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \20\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay so
that the proposed rule change may become operative upon filing. The
Commission notes that the proposed rule change would allow the
Exchange, in light of the COVID-19 pandemic, to provide temporary
relief for members by extending the deadlines in paragraphs (g) and (h)
of Exchange Rule 1308 (Supervision of Accounts) from June 1, 2020 to
June 30, 2020. This is consistent with the extension FINRA has provided
its members for supervision-related reports and certifications required
pursuant to FINRA Rule 3120 and FINRA Rule 3130 \21\ and the extension
for certain supervision-related reports Cboe Exchange, Inc. has
provided its trading permit holders.\22\ The Commission believes that
waiver of the 30-day operative delay is consistent with the protection
of investors and the public interest. Accordingly, the Commission
hereby waives the operative delay and designates the proposed rule
change operative upon filing.\23\
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    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6)(iii).
    \21\ See supra note 6.
    \22\ See Securities Exchange Act Release No. 88978 (June 1,
2020), 85 FR 34688 (June 5, 2020) (SR-CBOE-2020-049).
    \23\ 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.

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_ADDRESS>Please include
File Number SR-MIAX-2020-15 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-MIAX-2020-15. 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-MIAX-2020-15 and should be submitted on
or before July 15, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-13537 Filed 6-23-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Notices]
[Page 29255]
[FR Doc No: 2011-12454]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1975-DR; Docket ID FEMA-2011-0001]

Arkansas; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arkansas (FEMA-1975-DR), dated May 2, 2011, and
related determinations.

DATES: Effective Date: May 7, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Arkansas is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of May 2, 2011.

    Crittenden, Madison, Montgomery, Phillips, and Washington
Counties for Individual Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-12454 Filed 5-19-11; 8:45 am]
BILLING CODE 9111-23-P