[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Proposed Rules]
[Pages 43095-43097]
[FR Doc No: 2019-17892]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0661]
RIN 1625-AA00

Safety Zone, Swim Around Charleston; Charleston, SC

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary moving
safety zone during the Swim Around Charleston, a swimming race
occurring on the Wando River, the Cooper River, Charleston Harbor, and
the Ashley River, in Charleston, South Carolina. The temporary moving
safety zone is necessary to protect swimmers, participant vessels,
spectators, and the general public during the event. Persons and
vessels would be prohibited from entering the safety zone unless
authorized by the Captain of the Port Charleston or a designated
representative. We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before September 19, 2019.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0661 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Chad Ray, Sector
Charleston Office of Waterways Management, Coast Guard; telephone (843)
740-3184, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On July 24, 2019, Kathleen Wilson notified the Coast Guard that she
will be sponsoring the Swim Around Charleston occurring October 6,
2019. The race will impact waters of the Wando River, Cooper River,
Charleston Harbor, and Ashley River, in Charleston, South Carolina. The
Captain of the Port Charleston (COTP) has determined that potential
hazards associated with the event would be a safety concern for race
participants, spectators, and others on the navigable waters around the
event.
    The purpose of this rulemaking is to ensure the safety of persons,
vessels, and the marine environment before, during, and after the
scheduled event. The Coast Guard is proposing this rulemaking under
authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP proposes to establish a temporary safety zone on the
waters of the Wando River, Cooper River, Charleston Harbor, and Ashley
River, in Charleston, South Carolina during Swim Around Charleston from
8:00 a.m. to 2:45 p.m. on October 6, 2019. Approximately 50 swimmers
are anticipated to participate in the race. Persons and vessels
desiring to enter, transit through, anchor in, or remain within the
regulated area may contact the COTP by telephone at<PHONE_NUMBER>, or
a designated representative via VHF radio on channel 16, to request
authorization. If authorization to enter, transit through, anchor in,
or remain within the regulated area is granted, all persons and vessels
receiving such authorization must comply with the instructions of the
COTP or a designated representative. The COTP will provide notice of
the safety zone by Local Notice to Mariners, Broadcast Notice to
Mariners, and on-scene designated representatives. The regulatory text
we are proposing appears at the end of this document.

IV. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on: (1) Non-
participant persons and vessels may enter, transit through, anchor in,
or remain within the regulated area during the enforcement periods if
authorized by Sector Charleston COTP or a designated representative;
(2) vessels not able to enter, transit through, anchor in, or remain
within the regulated area without authorization from Sector Charleston
COTP or a designated representative may operate in the surrounding
areas during the enforcement period; (3) the Coast Guard

will provide advance notification of the safety zone to the local
maritime community by Local Notice to Mariners and Broadcast Notice to
Mariners; (4) the regulated area will be limited in time, scope, and
only impact small designated areas of Wando River, Cooper River, and
Charleston Harbor; and (5) the moving safety zone will only impact the
main shipping channel for approximately 30 minutes as the swimmers
cross the Cooper River at the beginning of the race.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 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
safety zone may be small entities, for the reasons stated in section
IV.A above, 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
section. 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 not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    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 Executive Order
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 call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

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 would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01 and Environmental Planning COMDTINST 5090.1
(series), which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting less than 7 hours that would prohibit entry within the
safety zone. Normally such actions are categorically excluded from
further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard
Environmental Planning Implementing Procedures 5090.1. A preliminary
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES. 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 call or email 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 https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email 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 https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit https://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website'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 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping

requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T07-0661 to read as follows:

Sec.  165.T07-0661   Safety Zone; Swim Around Charleston, Charleston,
SC.

    (a) Regulated area. The following regulated area is a moving safety
zone: All waters 50 yards in front of the lead safety vessel preceding
the first race participants, 50 yards behind the safety vessel trailing
the last race participants, and at all times extend 100 yards on either
side of safety vessels. The Swim Around Charleston swimming race
consists of a 12 mile course that starts at Remley's Point on the Wando
River in approximate position 32[deg]48'49'' N, 79[deg]54'27'' W,
crosses the main shipping channel under the main span of the Ravenel
Bridge, and finishes at the I-526 bridge and boat landing on the Ashley
River in approximate position 32[deg]50'14'' N, 80[deg]01'23'' W. All
coordinates are North American Datum 1983.
    (b) Definition. As used in this section, ``designated
representative'' means Coast Guard Patrol Commanders, including Coast
Guard coxswains, petty officers, and other officers operating Coast
Guard vessels, and Federal, state, and local officers designated by or
assisting the COTP in the enforcement of the regulated areas.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
regulated area, except persons and vessels participating in the Swim
Around Charleston, or serving as safety vessels.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the COTP by
telephone at<PHONE_NUMBER>, or a designated representative via VHF
radio on channel 16, to request authorization. If authorization to
enter, transit through, anchor in, or remain within the regulated area
is granted, all persons and vessels receiving such authorization must
comply with the instructions of the COTP or a designated
representative.
    (3) The Coast Guard will provide notice of the regulated area by
Marine Safety Information Bulletins, Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
    (d) Enforcement period. This rule will be enforced on October 6,
2019 from 8:00 a.m. until 2:45 p.m.

    Dated: August 2, 2019.
J.W. Reed,
Captain, U.S. Coast Guard, Captain of the Port, Charleston.
[FR Doc. 2019-17892 Filed 8-19-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Rules and Regulations]
[Page 51388-51392]
[DOCID:fr20au10-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2002-0185; FRL-8838-3]

2-methyl-1,3-propanediol; Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-methyl-1,3-propanediol (CAS Reg. No.
2163-42-0) when used as an inert ingredient in pesticide formulations
applied to growing crops and raw agricultural commodities after
harvest, and when used as an inert ingredient solvent and/or surfactant
in pesticide formulations applied to animals (used for food). Lyondell
Chemical Company submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of 2-methyl-1,3-propanediol.

DATES: This regulation is effective August 20, 2010. Objections and
requests for hearings must be received on or before October 19, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2002-0185. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

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

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180

through the Government Printing Office's e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. How Can I File an Objection or Hearing Request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2002-0185 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 19, 2010. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2002-0185, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Exemption

    In the Federal Register of August 28, 2002 (67 FR 55243) (FRL-7194-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 2E6484) by
Lyondell Chemical Company, 1221 McKinney Street, Suite 1600, Houston,
TX 77253-2583. The petition requested that 40 CFR part 180 be amended
by establishing an exemption from the requirement of a tolerance for
residues of 2-methyl-1,3-propanediol (CAS Reg. No. 2163-42-0) in or on
all raw agricultural commodities. That notice referenced a summary of
the petition prepared by Lyondell Chemical Company, the petitioner,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for 2-methyl-1,3-propanediol
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with 2-
methyl-1,3-propanediol follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Acute toxicity studies of 2-methyl-1,3-propanediol in the rat
indicate that this compound is practically non-toxic (EPA Toxicity
Category IV) by the oral and inhalation exposure routes. The oral
LD50 is greater than 5,000 milligrams/kilogram (mg/kg) and
the inhalation LC50 is greater than 5,100 mg/m3.
It is slightly toxic by the dermal exposure route (EPA Toxicity
Category III) with an acute dermal LD50 in rabbits of
greater than 2,000 mg/kg. Acute irritation studies in rabbits indicate
that 2-methyl-1,3-propanediol is not irritating to the skin and eyes.
Based on the results of a dermal sensitization study in guinea pigs, 2-
methyl-1,3-propanediol was determined to have mild sensitizing
potential.

    Repeat oral exposure produced no toxicity at doses up to and
including 1,000 mg/kg/day. No neurotoxicity studies are available;
however, no clinical signs of neurotoxicity or any systemic toxicity
were observed in any of the available studies. 2-methyl-1,3-propanediol
was not mutagenic in an in vitro chromosome aberration test, bacterial
gene mutation test, and mammalian cell gene mutation assay. No
developmental, reproductive, or teratogenic effects were seen in the
available studies at doses up to and including 1,000 mg/kg/day (highest
dose tested).
    No carcinogenicity studies are available for 2-methyl-1,3-
propanediol and it has not been evaluated by the International Agency
for Research on Cancer (IARC). Based on available studies, there is no
evidence of genotoxic activity. There is no evidence of systemic
toxicity at doses up to and including 1,000 mg/kg/day in the available
toxicity studies, such as 14-day oral gavage study in rats, 90-day oral
gavage study in rats, developmental toxicity studies in rats and
rabbits and 2-generation reproduction study in rats. In addition, a
qualitative structure activity relationship database, DEREK Version 11,
identified no structural alerts suggestive of carcinogenicity. Based on
the weight of the evidence, the Agency has determined that 2-methyl-
1,3-propanediol is not anticipated to be carcinogenic.
     Specific information on the studies received and the nature of the
adverse effects caused by 2-methyl-1,3-propanediol as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document ``Decision Document for Petition
Number 2E6484; 2-methyl-1,3-propanediol [CAS Reg. No. 2163-42-0],
requesting the establishment of an inert ingredient exemption from the
requirement of a tolerance'' in docket ID number EPA-HQ-OPP-2002-0185.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    There was no hazard identified in repeat dose toxicity and
reproductive/developmental studies at the limit dose of 1,000 mg/kg/day
to either parental animals or their offspring. Thus, due to its low
potential hazard and lack of a hazard endpoint, the Agency has
determined that a quantitative risk assessment using safety factors
applied to a point of departure protective of an identified hazard
endpoint is not appropriate.
    2-methyl-1,3-propanediol was not mutagenic in an in vitro
chromosome aberration test, bacterial gene mutation test, and mammalian
cell gene mutation assay and based on the available information, it is
not anticipated to be carcinogenic.

C. Exposure Assessment

    No hazard was identified for the acute and chronic dietary
assessment (food and drinking water), or for the short, intermediate,
and long term residential assessments, and therefore no aggregate risk
assessments were performed.
     1. Dietary exposure from food and feed uses and drinking water.
Since an endpoint for risk assessment was not identified, an exposure
assessment for 2-methyl-1,3-propanediol was not conducted. The primary
route of exposure to 2-methyl-1,3-propanediol from its use as an inert
ingredient in pesticide products would most likely be through
consumption of food to which pesticide products containing it have been
applied, and possibly through drinking water (from runoff).
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g. textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). Since
an endpoint for risk assessment was not identified, a quantitative
residential exposure assessment for 2-methyl-1,3-propanediol was not
conducted. Residential (dermal and inhalation) exposures from home
garden uses are possible.
    3. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found 2-methyl-1,3-propanediol to share a common
mechanism of toxicity with any other substances, and 2-methyl-1,3-
propanediol does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that 2-methyl-1,3-propanediol does not have a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    The toxicity database for 2-methyl-1,3-propanediol is adequate for
FQPA assessment and the potential exposure is adequately characterized
given the low toxicity of the chemical. No hazard was identified and
there is no residual uncertainty regarding prenatal and/or postnatal
toxicity. No acute or subchronic neurotoxicity studies are available,
but there were no clinical signs of neurotoxicity or any systemic
toxicity observed in the available database at doses up to 1,000 mg/kg/

day. No developmental, reproductive, or teratogenic effects were seen
in the available studies at doses up to and including 1,000 mg/kg/day.
    Based on this information, there is no concern, at this time, for
increased sensitivity to infants and children to 2-methyl-1,3-
propanediol when used as an inert ingredient in pesticide formulations
for pre-harvest and post-harvest uses, as well as, for application to
animals, and a safety factor analysis has not been used to assess risk.
For the same reason, EPA has determined that an additional safety
factor is not needed to protect the safety of infants and children.

E. Aggregate Risks and Determination of Safety

     Given the lack of concern for hazard posed by 2-methyl-1,3-
propanediol, EPA concludes that there are no dietary or aggregate
dietary/non-dietary risks of concern as a result of exposure to 2-
methyl-1,3-propanediol in food and water or from residential exposure.
Residues of concern are not anticipated for dietary exposure (food and
drinking water) or for residential exposure from the use of 2-methyl-
1,3-propanediol as an inert ingredient in pesticide products. As
discussed above, EPA expects aggregate exposure to 2-methyl-1,3-
propanediol to pose no appreciable dietary risk given that the data
show a lack of any systemic toxicity at doses up to 1,000 mg/kg/day and
a lack of any apparent developmental effects.
    Taking into consideration all available information on 2-methyl-
1,3-propanediol, EPA has determined that there is a reasonable
certainty that no harm to any population subgroup will result from
aggregate exposure to 2-methyl-1,3-propanediol under reasonably
foreseeable circumstances. Therefore, the establishment of an exemption
from tolerance under 40 CFR 180.910 and 180.930 for residues of 2-
methyl-1,3-propanediol when used as an inert ingredient in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest, and to animals (used for food), is safe under FFDCA
section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes
since the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
     The Codex has not established a MRL for 2-methyl-1,3-propanediol.

VI. Conclusions

     Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 and 40 CFR 180.930 for 2-methyl-1,3-
propanediol (CAS Reg. No. 2163-42-0) when used as an inert ingredient
in pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and to animals (used for food).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.910, the table is amended by adding alphabetically the
following inert ingredient to read as follows:

Sec.  180.910  Inert Ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
2-methyl-1,3-propanediol (CAS     ..................  Solvent,
 Reg. No. 2163-42-0)                                   surfactant
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  180.930, the table is amended by adding alphabetically the
following inert ingredient to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
2-methyl-1,3-propanediol (CAS     ..................  Solvent,
 Reg. No. 2163-42-0)                                   surfactant
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-20581 Filed 8-19-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)] [Notices] [Page 11066] [FR Doc No: C1-2022-02694]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9448-01-OAR]

Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2020

Correction

    In notice document 2022-02694, appearing on page 8583 in the issue  of Tuesday, February 15, 2022, make the following correction:     On page 8583, in the second column, in the DATES section, in the  fourth line, ``March 11, 2022'' is corrected to read ``March 17,  2022''.

[FR Doc. C1-2022-02694 Filed 2-25-22; 8:45 am] BILLING CODE 0099-10-P


[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75173-75174]
[FR Doc No: 2012-30511]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1202]

Comprehensive Assessment of the Process for the Review of Device
Submissions; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the statement of work for an
assessment of the process for the review of medical device submissions.
The assessment is part of the FDA performance commitments relating to
the Medical Device User Fee Amendments of 2012 (MDUFA III), which
reauthorized device user fees for fiscal years 2013-2017. The
assessment is described in section V, ``Independent Assessment of
Review Process Management'', of the commitment letter entitled ``MDUFA
Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter).
The assessment will be conducted by an independent contractor in two
phases. FDA is providing a period of 30 days for public comment on the
statement of work before requesting proposals for the assessment.
---------------------------------------------------------------------------

    \1\ http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM295454.pdf.

---------------------------------------------------------------------------
DATES: Submit electronic or written comments by February 4, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sligar, Office of Planning, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3291,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, President Obama signed into law the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA).\2\
Title II of FDASIA is MDUFA III, which gives FDA the authority to
collect device user fees from industry for fiscal years (FYs) 2013 to
2017. MDUFA III took effect on October 1, 2012, and will sunset in 5
years on October 1, 2017.
---------------------------------------------------------------------------

    \2\ http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf.
---------------------------------------------------------------------------

    Device user fees were first established by Congress in 2002.
Medical device companies pay fees to FDA when they register their
establishment and list their devices with the Agency, whenever they
submit an application or a notification to market a new medical device
in the United States, and for certain other types of submissions. Under
MDUFA III, FDA is authorized to collect user fees that will total
approximately $595 million (plus adjustments for inflation) over 5
years. With this additional funding, FDA will be able to hire more than
200 full-time-equivalent workers over the course of MDUFA III. In
exchange, FDA has committed to meet certain performance goals outlined
in the MDUFA III Commitment Letter.

II. Assessment of FDA's Process for the Review of Device Submissions

    Section V of the MDUFA III Commitment Letter states that FDA and
the device industry will participate in a comprehensive assessment of
the process for the review of device applications. The assessment will
include consultation with both FDA and industry. The assessment will be
conducted in two phases by a private, independent consulting firm,
under

contract with FDA, capable of performing the technical analysis,
management assessment, and program evaluation tasks required to address
the assessment as described in the MDUFA III Commitment Letter. For
Phase 1, FDA will award the contract no later than the end of the
second quarter of FY2013. Findings on high-priority recommendations
(i.e., those likely to have a significant impact on review times) will
be published within 6 months of award; final comprehensive findings and
recommendations will be published within 1 year of contract award. FDA
will publish an implementation plan within 6 months of receipt of each
set of recommendations. For Phase 2 of the independent assessment, the
contractor will evaluate the implementation of recommendations and
publish a written assessment no later than February 1, 2016.
    The assessment will address FDA's premarket review process using an
assessment framework that draws from appropriate quality system
standards, including, but not limited to, management responsibility,
document controls and records management, and corrective and preventive
action.
    The assessment will include, but not be limited to, the following
areas:
    1. Identification of process improvements and best practices for
conducting predictable, efficient, and consistent premarket reviews
that meet regulatory review standards.
    2. Analysis of elements of the review process (including the
presubmission process, and investigational device exemption, premarket
notification (510(k)), and premarket approval application reviews) that
consume or save time to facilitate a more efficient process. This
includes analysis of root causes for inefficiencies that may affect
review performance and total time to decision. This will also include
recommended actions to correct any failures to meet MDUFA goals.
Analysis of the review process will include the impact of combination
products, companion diagnostic products, and laboratory developed tests
on the review process.
    3. Assessment of FDA methods and controls for collecting and
reporting information on premarket review process resource use and
performance.
    4. Assessment of effectiveness of FDA's Reviewer Training Program
implementation.
    5. Recommendations for ongoing periodic assessments and any
additional, more detailed or focused assessments.
    FDA will incorporate findings and recommendations, as appropriate,
into its management of the premarket review program. FDA will analyze
the recommendations for improvement opportunities identified in the
assessment, develop and implement a corrective action plan, and assure
its effectiveness. FDA also will incorporate the results of the
assessment into a Good Review Management Practices (GRMP) guidance
document. FDA's implementation of the GRMP guidance will include
initial and ongoing training of FDA staff, and periodic audits of
compliance with the guidance.
    FDA is seeking public comment now on the proposed statement of work
for the assessment, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/UCM331516.pdf.

III. Comments

    Interested persons may submit either written comments regarding the
statement of work to the Division of Dockets Management (see ADDRESSES)
or electronic comments to http://www.regulations.gov. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.

    Dated: December 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30511 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request  EPA/ OSWER/ OEPPR 2. OMB control number b. G None a. 2 0 5 0  0 0 4 6 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title  Notification of Episodic Releases of Oil and Hazardous Substances ( Renewal)

8. Agency form number( s) ( If applicable) EPA No. 1049.10 9. Keywords  Environmental protection, Reporting and record keeping requirements, Oil pollution, Hazardous substances, Episodic releases, National Response Center, Reportable Quantity, Emergency Response Notification System ( ERNS).

10. Abstract  Federal law requires the person in charge of a facility or vessel to immediately notify the Federal government of a release of a reportable quantity or more of a hazardous substance into the environment and of an oil spill into U. S. navigable waters if the spill causes a sheen or violates applicable water quality standards. The reporting of hazardous substance releases and oil spills allows the Federal government to determine whether a response action is required to protect public health and the environment. Further, release information helps the Federal government evaluate the need for additional regulations and informs emergency response planners.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. X Individuals or households d. X Farms b. P Business or other for profit e. X Federal Government c. X Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 24,082 b. Total annual responses 24,082 1. Percentage of these responses collected electronically 0% c. Total hours requested 98,736 d. Current OMB inventory 97,277 e. Difference 1,459 f. Explanation of difference 1. Program Change 0 2. Adjustment 1,4 59 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 0 c. Total annualized cost requested $ 0 d. Current OMB inventory $ 0 e. Difference $ 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. X Program planning or management b. X Program evaluation f. X Research c. General purpose statistics g. P Regulatory or compliance d. Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) When reportable release occurs 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Lynn M. Beasley Phone: ( 703) 603 9086 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Mark Mjoness, Director Emergency Response Staff Office of Emergency Prevention, Preparedness, and Response Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


Page 1 of 7 IUR Petition Review Report June 13, 2005 CASRN and TSCA Inventory Chemical Name: 106 63 8 2 propenoic acid, 2 methylpropyl ester Alternate Chemical Name Used in Petitions: iso Butyl Acrylate Petitioners and Petition Docket Numbers: The Basic Acrylic Monomer Manufacturers, Inc. ( BAMM) OPPT 2004 0008 BASF Corporation OPPT 2004 0044 Note: The petitions contained additional chemicals. These additional chemicals are addressed in other petition review reports.

Summary of Decision: The petition review group recommends a denial for these petitions, as EPA has a current interest in the processing and use information collected under the Inventory Update Reporting ( IUR) rule ( see 40 CFR Part 710) for 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8). This recommendation is based, in part, on the determination by the petition review group that there is a direct application of the IUR processing and use information to complement data collected by or identified for use under the HPV Challenge Program. See Considerations A, C, D, and E.

Background: EPA received two petitions requesting that 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8) be added to the 40 CFR 710.46( b)( 2)( iv) list of specific chemical substances which are exempt from the reporting of industrial processing and use and commercial/ consumer use information required by 40 CFR 710.52( c)( 4). The chemical substances included on this " partial exemption" list are substances for which EPA has previously determined that there is a low current interest in the IUR processing and use information. However, as stated in the preamble to the amendment to the IUR rule promulgated on January 7, 2003 ( 68 FR 854), "... the need for processing and use information ... changes over time. The inclusion of a chemical substance under this partial exemption is not based on the potential risks of a chemical. This partial exemption is solely intended to provide a tool to assist the Agency in better managing the collection of processing and use information..." and is also " based on the Agency's current need for collecting IURA processing and use information." ( 68 FR 855) Additionally, the preamble states, " In determining whether there is low current interest in IURA processing and use information related to a specific chemical substance, EPA will look to the specific circumstances surrounding the chemical in question, and may use one or more of the considerations identified below, and/ or considerations not identified below, to make an informed decision." The considerations used by EPA in reviewing these petitions and an analysis of how those considerations relate to the chemical identified in these petitions are set forth below. 1 See the attached list of acronyms at the end of this report.

Page 2 of 7 Discussion: The petition review group considered information submitted with the two petitions, as well as other information including ( but not limited to): whether the petition substance is included in TRI, IRIS, or IARC; OECD HPV SIDS program status; HPV Challenge Program status; and the petition chemical's inclusion in other regulatory programs administered by EPA. 1 The petition from the BASF Corporation ( docket number OPPT 2004 0044) stated that 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8) is in the OECD HPV SIDS program, and referred EPA to the completed OECD HPV SIDS program documents for this chemical. The petition stated that the BASF Corporation believes that the information in the OECD HPV SIDS program documents demonstrates that there is little need at this time to collect processing and use information for this chemical.

The petition from the BAMM ( docket number OPPT 2004 0008) also referred EPA to the OECD HPV SIDS program documents for this chemical, and stated that the information provided therein " should be sufficient for EPA to make the necessary determination to include this chemical on the list for partial reporting exemption under IURA." Additionally, this petition stated that " There is a great deal of information on the basic acrylates use and exposure."

The petitions did not link information furnished in the petitions to specific considerations cited in 40 CFR 710.46( b)( 2)( ii), but provided a general citation, as noted above, to OECD HPV SIDS program documents for 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8). General citations alone are of limited use in establishing a rationale for adding a chemical to the IUR partial exemption list.

Consideration A: Production volume.

The petition review group found that there was at least one site reporting in 2002 with a production volume for this chemical of 300,000 pounds or greater.

Consideration B: The substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects.

The petitions did not identify specific information from the OECD HPV SIDS review that pertained to Consideration B. The OECD HPV SIDS program SIAP indicated that 2 propanoic acid, butyl ester ( CASRN 141 32 2) was used as an analog for 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8) based on structural similarities and similar toxicokinetics, acute toxicity, corrosiveness and irritation, and genetic toxicity ( in vitro and in vivo) data. The SIAP contained summary results of a variety of studies associated with human health and the environment and a conclusion that 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8) " possesses properties indicating a hazard for human health and the environment" ( Ref. 1). 2 Risk is composed of hazard and exposure. In order to screen for potential risk in the U. S., both hazard data and exposure related data relative to U. S. situations are needed. Exposure is based upon manufacturing, processing, and use scenarios, all of which change over time as technology and other societal effects change. The changing nature of exposure scenarios means the potential risks associated with a chemical can also change, and therefore the collection of exposure related information over time is fundamental to identifying potential risks. ( See 68 FR 848, 852 for further discussion)

3 For additional information on uses of IUR processing and use information, see IURA Data Use Plan, located in EPA's electronic docket OPPT 2002 0054, item number 0261.

4 The OECD HPV SIDS program, while it is not United States based, is a program where different countries are combining their resources to investigate at least the hazards associated with different chemicals. This allows all of the countries to benefit from this information. The United States can use information collected during and generated by the OECD HPV SIDS program to address domestic issues.

Page 3 of 7 Consideration C: The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

The petition review group found that this chemical is part of EPA's HPV Challenge Program. The HPV Challenge Program seeks to collect and, where necessary, develop a screening level hazard data set for chemicals produced or imported in large quantities in the United States. EPA plans to screen and, as needed, further assess chemicals included under the HPV Challenge Program. For this purpose, the IUR processing and use information is needed by EPA to put the hazard data into context, complementing the HPV Challenge Program submission by providing EPA with exposure related information. 2 The reporting of IUR processing and use information is needed at least once and, potentially, periodically thereafter to more accurately and realistically gauge potential exposure and provide information needed for screening, assessing, and managing exposures and risk. Other important uses of the reported information, even for low hazard chemicals, may include comparative exposure analyses, identification of safer substitutes, or pollution prevention investigations. 3 Consideration D: The availability of other complementary risk screening information.

The petitions referred EPA to the OECD HPV SIDS review documents of 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8), but did not identify specific information within those documents that would address Consideration D. The results of the OECD HPV SIDS review, as documented in the SIAP, indicate that this chemical is currently a low priority for further work because exposure to humans and the environment is anticipated to be low, but, as this chemical possesses properties indicating a hazard for human health and the environment, countries " may desire to investigate any exposure scenarios that were not presented by the Sponsor country." With the collection of IUR processing and use data for this chemical, the United States will be able to identify domestic situations by combining the OECD HPV SIDS program hazard data4 with the IUR exposure related information, thereby identifying new or revised exposure scenarios. These new or revised scenarios will likely have differing potential risk screening results than the previous scenarios and will be specific to situations in the United States. See Consideration E below for further discussion of the IUR exposure related processing and use information. Page 4 of 7 Consideration E: The availability of comparable processing and use information.

The petition referred EPA to the OECD HPV SIDS review documents for this chemical, but did not identify specific information within those documents that addresses Consideration E. The SIAP for this chemical ( dated October 2002) contains some general information on uses and worldwide annual production quantity, and states that this chemical is used as a co monomer in the manufacture of polymers. The polymers are then used for applications such as surface coatings, in films and pressure sensitive adhesives, in dispersions, and construction materials. The SIAP also indicates that exposure may occur during manufacture, transportation and industrial use, but that worker exposure is adequately controlled at production plants in the United States and that as a result of polymerization, end use products contain only trace amounts of 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8).

The conclusion expressed in the SIAP indicated that countries " may desire to investigate any exposure scenarios that were not presented by the Sponsor country." Although the U. S. was one of the sponsors of the OECD HPV SIDS program evaluation, the petition review group recognizes that since exposure scenarios change based on uses and available technology, information quickly becomes outdated and of limited use. Because of this, the relative importance of each use may change or new uses may develop. EPA believes tracking these changes is important, especially since the SIAP indicated that this chemical " possesses properties indicating a hazard for human health and the environment." Since the collection occurs on a regular basis, the IUR facilitates tracking changes in use patterns and the identification of new exposure scenarios, which is an important component of risk screening.

Additionally, the IUR contains some exposure related data elements not provided in the OECD HPV SIDS submission, such as data on the function of the chemical in the industrial processing and use category, the NAICS code associated with the use, and the number of potentially exposed workers and the number of sites associated with each use. For commercial and consumer uses, the IUR collects data on the amount of the chemical in various use categories, the concentration of the chemical in the use category, and the likelihood of inclusion in products intended for children. Furthermore, IUR information is updated every four years, is quantitative, and is specific to the United States.

Consideration F: Whether the potential risks for the chemical substance are adequately managed by EPA or another agency or authority.

The petitions did not identify or discuss any risk management actions taken by EPA or another agency or authority with respect to the petitioned chemical. The petitions did not explain why the downstream processing and use information should be of low current interest in light of any such risk management actions. Page 5 of 7 Other Considerations/ Notes:

The October 2002 SIAP for 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8) noted a conclusion of " low priority for further work" under the OECD HPV SIDS program since exposure to humans and the environment is anticipated to be low, but also noted that the chemical " possesses properties indicating a hazard for human health and the environment." A designation of low priority for further work within the OECD HPV SIDS program means that no further hazard testing is needed to meet the purposes of the OECD HPV SIDS program at the time the review was completed. These judgements, however, do not determine the approach that an individual OECD member country must take in considering such a chemical. Rather, the OECD HPV SIDS program assessment is seen as a starting point for assessment in countries. In the U. S. case, it is a starting point for a screening level risk assessment, for which IUR processing and use information provides screening level exposure information. In the past there have been a number of chemicals identified by the OECD HPV SIDS program as a " low priority for further work," but for which EPA wanted to make a confirmatory priority judgement based on risk   i. e., screeninglevel hazard information based on the OECD HPV SIDS program work plus screening level exposure information based on the U. S. situation.

Cited Reference: 1) SIAP for 2 propenoic acid, 2 methylpropyl ester ( CASRN 106 63 8). October 2002. Available on the web at http:// cs 3 hq. oecd. org/ scripts/ hpv/ NewSIDS. asp Sources Searched: ( Note: These sources are typically searched or reviewed to gather information presented in the petition review report.)

American Conference of Governmental Industrial Hygienists ( ACGIH) Threshold Limit Values ( TLV TWA). 2003. ACGIH, Cincinnati OH. pp. 12 61.

Agency for Toxic Substances and Disease Registry ( ATSDR) ToxFAQsTM ( Frequently asked questions about contaminants found at hazardous waste sites). Available at http:// www. atsdr. cdc. gov/ toxfaq. html California Air Resources Board List of Toxic Air Contaminant Fact Sheets, available at http:// arbis. arb. ca. gov/ toxics/ tac/ toctbl. htm California EPA, Safe Drinking Water and Toxic Enforcement Act of 1986: List of chemicals known to the State to cause cancer or reproductive toxicity. Listing as of Nov. 14, 2003. Available at http:// www. oehha. ca. gov/ prop65/ CRNR_ notices/ list_ changes/ 111403lsta. html International Agency of Research on Cancer ( IARC) Overall Evaluations of Carcinogenicity to Humans. Available at http:// monographs. iarc. fr/ monoeval/ crthall. html Interagency Testing Committee ( ITC) Priority Testing List. Available at http:// tsca itc. syrres. com/ Chemicals/

National Advisory Committee Acute Exposure Guideline Levels ( AEGLs). Available at http:// www. epa. gov/ oppt/ aegl/ index. htm Organisation for Economic Cooperation and Development ( OECD) Integrated HPV Database, http:// cs3 hq. oecd. org/ scripts/ hpv/ index. asp United Nations Environment Programme ( UNEP) persistent organic pollutants ( POPs), available at http:// www. chem. unep. ch/ pops/ default. html Page 6 of 7 United Nations Environment Programme ( UNEP) Ozone Secretariat, Summary Control Measures, available at http:// www. unep. org/ ozone/ Treaties_ and_ Ratification/ 2B_ montreal_ protocol. asp U. S. EPA Clean Air Act ( CAA) Hazardous Air Pollutants ( HAPs). Available in the Clean Air Act, section 112( b), available at http:// www. epa. gov/ air/ caa/ caa112. txt U. S. EPA. Emergency Planning and Community Right to Know Act Section 313, List of Toxic Chemicals. 2001. Office of Environmental Information, EPA 260 B 01 001, available at http:// www. epa. gov/ tri/ chemical/ chemlist2001. pdf U. S. EPA HPV ( High Production Volume) Challenge Program and Voluntary Children's Chemical Evaluation Program ( VCCEP) Web sites under the EPA Chemical Right to Know Initiative, http:// www. epa. gov/ chemrtk U. S. EPA Integrated Risk Information System ( IRIS) Substance List. Available at http:// www. epa. gov/ iris/ subst/ index. html U. S. EPA. National Recommended Water Quality Criteria: 2002. Office of Water. EPA 822 R 02 047. Available at http:// www. epa. gov/ waterscience/ pc/ revcom. pdf U. S. EPA. 2004 Edition of the Drinking Water Standards and Health Advisories. Office of Water. EPA 822 R 04 005. Available at http:// www. epa. gov/ waterscience/ drinking/ standards/ dwstandards. pdf U. S. EPA Substance Registry System ( SRS). Available at http:// www. epa. gov/ srs/

U. S. Occupational Safety and Health Administration ( OSHA) Permissible Exposure Limits ( PELs), available at http:// www. osha. gov/ SLTC/ pel/ index. html List of Acronyms Page 7 of 7 ACGIH American Conference of Governmental Industrial Hygienists AEGL Acute Exposure Guideline Level ARB Air Resources Board ATSDR Agency for Toxic Substances and Disease Registry CAA Clean Air Act CASRN Chemical Abstract Service Registry Number CICAD Concise International Chemical Assessment Document CPSC Consumer Product Safety Commission EHC Environmental Health Criteria EPA Environmental Protection Agency EU European Union FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act GRAS Generally Recognized as Safe HAP Hazardous Air Pollutant HPV High Production Volume HSDB Hazardous Substances Databank IARC International Agency of Research on Cancer ICCA International Council of Chemical Associations IFCS International Forum on Chemical Safety IPCS International Programme on Chemical Safety IRIS Integrated Risk Information System IRPTC International Register of Potentially Toxic Chemicals ITC Interagency Testing Committee IUCLID International Uniform Chemical Information Database IUR Inventory Update Reporting Rule IURA Inventory Update Reporting Rule Amendment NAICS North American Industry Classification System NIOSH National Institute for Occupational Safety and Health OECD Organisation for Economic Cooperation and Development OECD HPV SIDS or OECD HPV SIDS program OECD/ SIDS HPV Chemicals Programme OPP Office of Pesticide Programs OPPT Office of Pollution Prevention and Toxics OSHA Occupational Safety and Health Administration PEL Permissible Exposure Limit POP Persistent Organic Pollutant SIAM SIDS Initial Assessment Meeting SIAP SIDS Initial Assessment Profile SIAR SIDS Initial Assessment Report SIDS Screening Information Data Set SRS Substance Registry System TLV TWA Threshold Limit Value Time Weighted Average TRI Toxics Release Inventory TSCA Toxic Substances Control Act UNEP United Nations Environment Programme VCCEP Voluntary Children's Chemical Evaluation Program


[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90893-90895]
[FR Doc No: 2016-30079]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79515; File No. SR-NYSE-2016-80]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Section 902.04 of the NYSE Listed Company Manual

December 9, 2016.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'' or ``Exchange Act'') \2\ and Rule 19b-4 thereunder,\3\
notice is hereby given that, on November 30, 2016, New York Stock
Exchange LLC (``NYSE'' or ``Exchange'') filed with 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 the self-regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Section 902.04 of the NYSE Listed
Company Manual (the ``Manual'') to adopt a fee discount for issuers
that list 20 or more closed-end funds on the Exchange. The proposed
rule change is available on the Exchange's Web site at www.nyse.com, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend Section 902.04 of the Manual to
adopt a fee discount for issuers that list 20 or more closed-end funds
on the Exchange. The proposed new discount will take effect on January
1, 2017. Currently, fund families that list between three and 14
closed-end funds receive a 5% discount off the calculated Annual Fee
for each fund listed, and those with 15 or more listed closed-end funds
receive a discount of 15%.\4\ Aggregate Annual Fees for any fund family
are capped at $1,000,000 in any given year.
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    \4\ Closed-end funds are charged Annual Fees at a rate of
$0.001025 per share.
---------------------------------------------------------------------------

    Currently, a small number of fund families benefit from the
$1,000,000 fee cap. In most cases, fund families that benefit from the
cap have a significant number of funds listed on the Exchange

and would otherwise have paid fees far in excess of $1,000,000.
Therefore, the effective discount they receive to their uncapped fees
typically exceeds 50%.
    There are a number of other, smaller fund families that have 20 or
more funds listed on the Exchange whose aggregate fees approach but do
not exceed $1,000,000 and who therefore do not benefit from the cap.
Consequently, those fund families pay fees at a far higher effective
fee rate than is paid by those fund families whose fees are capped. The
purpose of the proposed 50% discount is to significantly reduce this
disparity.
    The Exchange believes that a reduction in the effective fee rate
paid by fund families that have 20 or more listed funds, but do not
benefit from the cap, would create an incentive for them to initiate
new funds, increasing competition in the industry. In particular, the
Exchange believes that the proposed amendment may create an incentive
for fund families to create a greater number of smaller funds than is
currently the case, as smaller funds are particularly concerned about
limiting their operating costs.
    The Exchange believes that it is not unfairly discriminatory to
provide a greater discount for fund families listing more than [sic] 20
funds than for smaller fund families, as a significant amount of the
costs of conducting the Exchange's regulatory activities and providing
client services with respect to a fund family are fixed costs and,
consequently, the cost to the Exchange of servicing any incremental
fund are smaller when that fund is part of a larger fund family than
when it is part of a smaller fund family.
    The Exchange does not believe that the proposed fee discount will
have any effect on its ability to fund its regulatory activities.
    The Exchange also proposes to amend Section 902.04 to remove
obsolete references to fee levels that are no longer applicable.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Exchange Act,\5\ in general, and furthers the
objectives of Sections 6(b)(4) \6\ of the Exchange Act, in particular,
in that it is designed to provide for the equitable allocation of
reasonable dues, fees, and other charges and is not designed to permit
unfair discrimination among its members and issuers and other persons
using its facilities. The Exchange also believes that the proposed rule
change is consistent with Section 6(b)(5) of the Exchange Act, in
particular in that it is designed 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.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
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    The Exchange believes that the proposed rule change is consistent
with Sections 6(b)(4) and 6(b)(5) of the Exchange Act in that it
represents an equitable allocation of fees and does not unfairly
discriminate among listed companies. In particular, the Exchange
believes the proposal represents an equitable allocation of fees and is
not unfairly discriminatory because it would create an effective fee
rate for a group of smaller fund families that is more consistent with
the effective fee rate paid by larger fund families that benefit from
the fee cap provision of the rule. The proposed amendment would also
promote competition, as it would lower the costs of operating a fund
for many issuers and will therefore incentivize those issuers to create
new funds.
    The Exchange believes that it is not unfairly discriminatory to
provide a greater discount for fund families listing more than [sic] 20
funds than for smaller fund families, as a significant amount of the
costs of conducting the Exchange's regulatory activities and providing
client services with respect to a fund family are fixed costs and,
consequently, the cost to the Exchange of servicing any incremental
fund are smaller when that fund is part of a larger fund family than
when it is part of a smaller fund family.

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 Exchange Act. The proposed rule
change is designed to provide a group of smaller issuers of closed-end
funds with an effective fee rate that is closer to the effective rate
charged to larger issuers that benefit from the rule's fee cap
provision. The market for listing services is extremely competitive.
Each listing exchange has a different fee schedule that applies to
issuers seeking to list securities on its exchange. Issuers have the
option to list their securities on these alternative venues based on
the fees charged and the value provided by each listing. Because
issuers have a choice to list their securities on a different national
securities exchange, the Exchange does not believe that the proposed
fee change imposes a burden on competition.

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 is effective upon filing pursuant to
Section 19(b)(3)(A) \7\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \8\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 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) \9\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \9\ 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_ADDRESS>Please include
File Number SR-NYSE-2016-80 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2016-80. 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 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 Web site 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 such 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-NYSE-2016-80, and should be
submitted on or before January 5, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2016-30079 Filed 12-14-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Page 9502]
[FR Doc No: 2017-02456]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-1021]

Drawbridge Operation Regulation; St. Johns River, Jacksonville,
FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Florida East Coast Railway Bridge,
St. Johns River, mile 24.9, at Jacksonville, FL. The deviation is
necessary to perform major bridge repairs. This deviation allows the
bridge to remain in the closed-to-navigation position.

DATES: This deviation is effective from 7 a.m. on January 11, 2017 to 6
p.m. on February 10, 2017.

ADDRESSES: The docket for this deviation, [USCG-2016-1021] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Rod Elkins, Seventh Coast Guard
District, Bridge Branch; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Florida East Coast Railway requested a
temporary deviation from the operating schedule that governs the
Florida East Coast Railway Bridge, St. Johns River, mile 24.9,
Jacksonville, FL. The bridge is a single leaf bascule railway bridge
with a five foot vertical clearance in the closed position. The
deviation is necessary to perform major bridge repairs. The normal
operating schedule for the bridge is found in 33 CFR 117.325 which
indicates that the draw is normally in the fully open position,
displaying flashing green lights to indicate that vessels may pass.
    The deviation period is from 7 a.m. on January 11, 2017 to 6 p.m.
on February 10, 2017. During this period, the bridge is allowed to
remain closed to navigation from 7 a.m. to 11 a.m., and from 1 p.m. to
5 p.m. on January 11, 2017 from 7 a.m. to noon and from 2 p.m. to 5
p.m. on January 12, 2017 from 8 a.m. to noon, and from 2:30 p.m. to
6:30 p.m. on January 13, 2017 from 7 a.m. to 11 a.m., and from 1 p.m.
to 5 p.m. on January 18, 2017 and January 19, 2017 and from 8 a.m. to
noon, and from 2:30 p.m. to 6:30 p.m. on January 20, 2017.
Additionally, the bridge will be allowed to remain closed to navigation
from 7 a.m. January 30, 2017 through 6 p.m. on February 10, 2017.
    The Coast Guard coordinated this closure period with the bridge
owner and the waterway users. The bridge will be unable to open for
emergencies; the small boat span can be used as an alternate route for
vessels unable to pass through the bridge while in the closed-to-
navigation position. The Coast Guard will also inform the users of the
waterways through Local and Broadcast Notices to Mariners of the change
in operating schedule for the bridge to ensure vessel operators can
arrange their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: 18 January 2017.
Barry Dragon,
Director, Bridge Branch, Seventh Coast Guard District.
[FR Doc. 2017-02456 Filed 2-6-17; 8:45 am]
 BILLING CODE 9110-04-P


"King, Heidi R."<EMAIL_ADDRESS> 04/24/2008 05:07 PM

To

Zachary Pekar/RTP/USEPA/US@EPA, "Rodan, Bruce D." <EMAIL_ADDRESS> cc

Lydia Wegman/RTP/USEPA/US@EPA

Subject

Bruce and Zach - contact info

Bruce Rodan

Office of Science and Tech Policy

202 456-6006