[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Rules and Regulations]
[Page 50621]
[FR Doc No: 2016-18257]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2016-0602]

Eighth Coast Guard District Annual Recurring Marine Events

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce special local regulations during
the Pittsburgh Three Rivers Regatta on the Ohio River, from mile 0.0-
0.5, Allegheny River mile 0.0-0.6, Monongahela River mile 0.0-0.5
extending the entire width of all three rivers. These regulations are
needed to protect vessels transiting the area and event spectators from
the hazards associated with a regatta on the navigable waterway. During
the enforcement period, entry into, transiting, or anchoring in the
regulated area is prohibited to all vessels not registered with the
sponsor as participants or official patrol vessels, unless specifically
authorized by the Captain of the Port (COTP) Pittsburgh or a designated
representative.

DATES: The regulations in 33 CFR 100.801, Table 1, Sector Ohio Valley,
No. 22 are effective from 12 noon until 11:30 p.m. daily, from August
5, 2016 through August 7, 2016.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST1 Jennifer Haggins, Marine
Safety Unit Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations for the annual Pittsburgh Three Rivers Regatta listed in 33
CFR 100.801 Table 1, Sector Ohio Valley, No. 22 from 12:00 noon until
11:30 p.m., from August 5, 2016 through August 7, 2016. Entry into the
regulated area is prohibited unless authorized by the COTP or a
designated representative. Persons or vessels desiring to enter into or
pass through the area must request permission from the COTP or a
designated representative. If permission is granted, all persons and
vessels shall comply with the instructions of the COTP or designated
representative.
    This notice of enforcement is issued under authority of 33 CFR
100.801 and 5 U.S.C. 552(a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of this enforcement period via Local Notice to
Mariners and updates via Marine Information Broadcasts.

L. McClain, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Pittsburgh.
[FR Doc. 2016-18257 Filed 8-1-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Rules and Regulations]
[Page 18219-18227]
[DOCID:fr11ap06-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2005-0131; FRL-8157-5]
RIN 2060-AM46

Protection of Stratospheric Ozone: Recordkeeping and Reporting
Requirements for the Import of Halon-1301 Aircraft Fire Extinguishing
Vessels

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to exempt entities that import aircraft fire extinguishing
spherical pressure vessels containing halon-1301 (``aircraft halon
bottles'') for hydrostatic testing from the import petitioning
requirements for used controlled substances. The petitioning
requirements compel importers to submit detailed information to the
Administrator concerning the origins of the substance at least forty
working days before a shipment is to leave a foreign port of export.
This direct final rule reduces the administrative burden on entities
that are importing aircraft halon bottles for the purpose of
maintaining these bottles to commercial safety specifications and
standards set forth in Federal Aviation Administration airworthiness
directives. This direct final rule does not exempt entities that wish
to import bulk quantities of halon-1301 in containers that are not
being imported for purposes of hydrostatic testing.

DATES: The direct final rule is effective on June 12, 2006 without
further notice, unless EPA receives adverse comments by May 11, 2006,
or by May 26, 2006 if a hearing is requested. If adverse comments are
received, EPA will publish a timely withdrawal in the Federal Register
informing the public that this rule will not take effect. If anyone
contacts the EPA requesting to speak at a public hearing by April 21,
2006, a public hearing will be held on April 25, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2005-
0131, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, attn: Hodayah Finman.
     Mail: Air Docket, Environmental Protection Agency,
Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery or Courier. Deliver your comments to: EPA
Air Docket, EPA West, 1301 Constitution Avenue, NW., Room B108, Mail
Code 6102T, Washington, DC 20004. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2005-0131. EPA's policy is that all comments received will be included
in the public

docket without change and may be made available online at http://www.regulations.gov
, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ``anonymous

access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov
, your e-mail address will be automatically captured

and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm    Docket: All documents in the docket are listed in the http://.

http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/

DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC.
This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Hodayah Finman, EPA, Stratospheric
Protection Division, Office of Atmospheric Programs, Office of Air and
Radiation (6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460,
(202) 343-9246.

SUPPLEMENTARY INFORMATION: EPA is publishing this amendment without
prior proposal because the Agency views this as a noncontroversial
action and anticipates no adverse comment. The Agency does not
anticipate any adverse comment because of the importance of testing
aircraft halon bottles for safety purposes and the environmental
benefit resulting from the preventative maintenance of these
containers. If EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect. Should EPA receive adverse comments, the Agency
would consider and address all public comments received on this direct
final rulemaking in any subsequent final rule. EPA will not institute a
second comment period on this action. Any parties interested in
commenting must do so at this time.

Table of Contents

I. General Information
    A. Regulated Entities
    B. What Should I Consider When Preparing My Comments?
II. Background
    A. Stratospheric Protection
    B. Halons
    C. Statutory Authority
    D. Summary of Direct Final Rule
III. Aircraft Halon Bottle Exemption from the Import Petitioning
Process
    A. Import of Aircraft Halon Bottles for Hydrostatic Testing
    B. Import Petition Requirements for Used Controlled Substances
    C. Exemption to the Import Petition Requirements
    D. Reporting Requirements for Importers and Exporters
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from
Environmental Health & Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Congressional Review Act

I. General Information

A. Regulated Entities

    The aircraft halon bottle exemption will affect the following
categories:

------------------------------------------------------------------------
                                        NAICS     Examples of regulated
              Category                   code            entities
------------------------------------------------------------------------
Hydrostatic testing laboratories or      541380  Halon aircraft bottle
 services.                                        testing facilities.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA believes could
potentially be regulated by this action. Other types of entities not
listed in this table could also be affected. To determine whether your
facility, company, business organization, or other entity is regulated
by this action, you should carefully examine these regulations. If you
have questions regarding the applicability of this action to a
particular entity, consult the person listed in the FOR FURTHER
INFORMATION CONTACT section.

B. What Should I Consider When Preparing My Comments?

    1. Confidential Business Information. Do not submit this
information to EPA through http://www.regulations.gov or e-mail.

Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark
the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI). In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at

your estimate in sufficient detail to allow for it to be reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. Stratospheric Protection

    The stratospheric ozone layer protects the Earth from penetration
of harmful ultraviolet (UV-B) radiation. International consensus exists
that releases of certain man-made halocarbons, including
chlorofluorocarbons (CFCs), halons, carbon tetrachloride, methyl
chloroform, and methyl bromide, contribute to the depletion of the
stratospheric ozone layer and should be controlled. Ozone depletion
harms human health and the environment through increased incidence of
certain skin cancers and cataracts, suppression of the immune system,
damage to plants including crops and aquatic organisms, increased
formation of ground-level ozone, and increased weathering of outdoor
plastics. Under the Clean Air Act Amendments of 1990 (CAAA of 1990),
the domestic implementing legislation for ozone layer protection,
ozone-depleting substances (ODSs) have been designated as either class
I or class II controlled substances (see 40 CFR part 82, appendices A
and B to subpart A). Class I controlled substances are CFCs, halons,
carbon tetrachloride, methyl chloroform, methyl bromide,
hydrobromofluorocarbons and chlorobromomethane; class II controlled
substances are hydrochlorofluorocarbons (HCFCs).

B. Halons

    Halons are gaseous or easily vaporized halocarbons used primarily
for extinguishing fires, and for explosion protection. The two halons
most widely used in the United States are halon-1211 and halon-1301.
Halon-1211 is used primarily in streaming applications while halon-1301
is typically used in total flooding applications. Some limited use of
halon-2402 also exists in the United States, but only as an
extinguishant in engine nacelles (the streamlined enclosure surrounding
the engine) on older aircraft and in the guidance system of Minuteman
missiles. The action in this direct final rule is not expected to
affect the supply of unblended halons for these uses.
    Halons are used in a wide range of fire protection applications
because they combine four characteristics. First, they are highly
effective against solid, liquid/gaseous, and electrical fires (referred
to as Class A, B, and C fires, respectively). Second, they dissipate
rapidly, leaving no residue, and thereby avoid secondary damage to the
property they are protecting. Third, halons do not conduct electricity
and can be used in areas containing live electrical equipment where
they can penetrate to and around physical objects to extinguish fires
in otherwise inaccessible areas. Finally, halons are generally safe for
limited human exposure when used with proper exposure controls.
    Despite these advantages, halons have a significant drawback; they
are among the most ozone-depleting substances in use today. With an
ozone depleting potential (ODP) of 0.2 representing the threshold for
classification as a class I substance, halon-1301 has an estimated ODP
of 10.0 and an atmospheric lifetime of 65 years. Halon-1211 has an
estimated ODP of 3.0 and an atmospheric lifetime of 16 years. As an
illustration of the significance of halons as ODSs, while total halon
production (measured in metric tons) consisted of just 2 percent of the
total production of class I substances in 1986, halons represented 23
percent of the total estimated ozone depletion attributable to class I
substances produced during that year. Prior to the early 1990s, the
greatest releases of halon into the atmosphere occurred not in
extinguishing fires, but during testing and training, service and
repair, and accidental discharges. Data generated as part of the
Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal
Protocol) technology assessment indicated that only 15 percent of
annual halon-1211 emissions and 18 percent of annual halon-1301
emissions occur as a result of use to extinguish actual fires. These
figures indicated that significant gains could be made in protecting
the ozone layer by revising testing and training procedures and by
limiting unnecessary discharges through better detection and dispensing
systems for halon and halon alternatives.
    The fire protection community began to conserve halon reserves in
response to the impending ban of the production and consumption of
halons 1211, 1301, and 2402, which became effective January 1, 1994. In
the context of the regulatory program, the use of the term consumption
may be misleading. Consumption does not mean the ``use'' of a
controlled substance, but rather is defined as production plus imports
minus export of controlled substances (Article I of the Protocol and
Section 601 of the CAAA of 1990).

C. Statutory Authority

    The current regulatory requirements of the Stratospheric Ozone
Protection Program that limit production and consumption of ODSs can be
found at 40 CFR part 82. The regulatory program was originally
published in the Federal Register on August 12, 1988 (53 FR 30566), in
response to the 1987 signing and subsequent ratification of the
Montreal Protocol. The U.S. was one of the original signatories to the
1987 Montreal Protocol and the U.S. ratified the Protocol on April 21,
1988. Congress then enacted, and President Bush signed into law, the
CAAA of 1990, which included Title VI on Stratospheric Ozone
Protection, codified as 42 U.S.C. Chapter 85, to ensure that the United
States could satisfy its obligations under the Protocol. EPA issued new
regulations to implement this legislation and has made several
amendments to the regulations since that time.
    Since January 1, 1994, in accordance with the Montreal Protocol and
the CAAA of 1990's accelerated phaseout provision, U.S. production and
consumption of halon-1301 has been prohibited (40 CFR 82.4(c)(1), 58 FR
65018). The Montreal Protocol mandated a freeze in the production and
consumption of halon-1211, halon-1301, and halon-2402 in 1992 at the
1986 baseline levels and, as subsequent adjustments adopted by the
Parties at their Fourth Meeting in 1992, required a 100 percent
phaseout by January 1, 1994. EPA issued regulations under authority of
sections 604 and 606 of the CAAA of 1990 reflecting this phaseout
schedule. Section 604 of the CAAA of 1990 sets forth initial phaseout
dates for certain Class I substances, including halons, while section
606 states that EPA shall promulgate an accelerated phaseout schedule
if the Agency determines that it may be necessary to protect human
health and the environment; if the Agency determines that is
practicable based on the availability of substitutes; or if the
Montreal Protocol is modified to include a more stringent schedule. EPA
found that all of these criteria were met with respect to the
accelerations adopted at the Parties' Fourth Meeting (58 FR 65024).
    Although the regulations phased out the production and consumption
of class I, Group II substances (halons) on January 1, 1994, most other
class I controlled substances on January 1,

1996, and methyl bromide on January 1, 2005, a very limited number of
exemptions exist, consistent with U.S. obligations under the Protocol.
The regulations allow for the manufacture of phased-out class I
controlled substances, provided the substances are either transformed
or destroyed (40 CFR 82.4(b)). They also allow limited manufacture if
the substances are (1) exported to developing countries listed under
Article 5 of the Protocol to meet basic domestic needs, or (2) produced
for essential or critical uses as authorized by the Protocol and the
regulations (40 CFR 82.4 (b)).
    The regulations allow for the import of phased-out class I
controlled substances provided the substances are either transformed or
destroyed (40 CFR 82.4(d)). Limited exceptions to the ban on the import
of phased-out class I controlled substances also exist if the
substances are: (1) Previously used, recycled, or reclaimed and the
importer files a petition and receives a non-objection notice from the
Administrator (40 CFR 82.4(j)); (2) imported for essential or critical
uses as authorized by the Protocol and the regulations, or (3) a
transhipment or a heel (40 CFR 82.4(d)).
    When the Stratospheric Ozone Protection Program was first
implemented in the U.S., EPA did not make a distinction between the
import of new and used controlled substances. In 1992, Decision IV/24
taken by the Parties to the Montreal Protocol interpreted Article 2 of
the treaty as allowing a country to import a used ODS beyond the
phaseout date of that substance. Specifically, the decision indicates
the Parties' interpretation that import of a ``used'' substance does
not constitute ``consumption'' of a substance. The Parties took this
decision to promote the use of banks of ODS and thus facilitate the
transition to ozone-safe alternatives. Following Decision IV/24, EPA
added a regulatory provision to allow for the import of previously used
or recycled controlled substances without allowances (December 10,
1993, 58 FR 65018). Prior to that time, all imports of controlled
substances, whether new or used, could only occur if the importing
entity held and expended sufficient allowances for the transaction
(July 30, 1992, 57 FR 33754).
    The Agency found, however, that the December 1993 rule was too
permissive and that containers of virgin ODS could be, and in fact
were, easily imported as fraudulently labeled used material. Other
countries also experienced a rise in the illegal shipment of
fraudulently labeled ODS following the reclassification of used ODS in
Decision IV/24. Therefore, in 1994, EPA proposed to revise its
regulations and require all importers to petition the Agency prior to
importing a used ODS (November 10, 1994, 59 FR 56275). This petition
process would allow the Agency to verify that a shipment in fact
contained a used controlled substance and thus reduce, although not
eliminate, the potential for illegal trade. In addition, the Agency
also proposed to amend the definition of ``used and recycled controlled
substances'' to include only the term ``used.'' In its description of
the proposed changes to the definition of used controlled substances,
the Agency further stated that: ``[i]n this manner, a controlled
substance is defined as used if it was recovered from a use system,
regardless of whether it was subsequently recycled or reclaimed'' (59
FR 56285). These proposed changes, with minor adjustments based on
comments, were finalized by the Agency and the petition process for the
import of used ODS was codified into EPA regulation (May 10, 1995, 60
FR 24970).
    The Agency later addressed the petition process in a direct final
rulemaking (August 4, 1998, 63 FR 41626). This rule made several
modifications to the petition process including changing the amount of
time the Administrator has to review transactions and reducing the de
minimis threshold for the petition process from 150 pounds of ODS to 5
pounds. Some of the changes associated with the import petition process
received adverse comment and were withdrawn (October 5, 1998, 63 FR
53290). A subsequent final rule issued by the Agency established the
requirements that are currently in effect for the import petition
process (December 31, 2002, 67 FR 79861).
    Additional authority for the amendments in this direct final rule
is found in section 608(a)(2) of the CAAA of 1990, which directs EPA to
establish standards and requirements regarding use and disposal of
class I and II substances other than refrigerants. The goal of section
608(a) is to reduce the use and emission of ODS to the lowest
achievable level and maximize the recapture and recycling of such
substances. EPA previously issued a rule implementing this provision
with respect to halon use generally. 63 FR 11084 (March 5, 1998); 40
CFR part 82, subpart H.
    In the instance of aircraft halon bottles, EPA believes that this
direct final rule will create a further incentive for industry to
minimize emissions of halons by exempting certain importers from the
up-front petition process in order to facilitate proper maintenance of
the bottles and thereby minimize the potential for fissures and leaking
of ODS from these bottles.

D. Summary of Direct Final Rule

    In this action, EPA is further amending its regulations to exempt
the import of aircraft halon bottles for hydrostatic testing from the
import petition process.
    EPA classifies halon-1301 contained in aircraft halon bottles
removed from an on-board fire suppression system as used controlled
substances. EPA regulations define ``used controlled substances'' as
``controlled substances that have been recovered from their intended
use systems (may include controlled substances that have been, or may
be subsequently, recycled or reclaimed)'' (40 CFR 82.3). Halon-1301 is
placed into aircraft bottles and the bottles are then inserted into a
fire suppression system. When the system is dismantled or the bottles
are removed from the system, the halon-1301 contained in the bottles is
considered used since it was removed from a use system.
    In the history of the program, the mechanisms that govern the
import of used ODS have ranged from no controls to a detailed up-front
petition process. The Agency, to a significant extent, selected
implementation mechanisms based on parameters such as practicability
and protection of the ozone layer. When EPA believed it was to the
benefit of the environment to encourage the import of used ODS, the
Agency implemented a nonrestrictive import mechanism. When the Agency
discovered a rise in illegal trade of ODS, EPA instituted a thorough
petition process to curb the traffic of illicit material.
    EPA does not believe that it is economically feasible to illegally
import halon-1301 in aircraft bottles due to the size, costs, and
uniqueness of the bottles. Thus, part of the basis for EPA's action to
establish a rigorous petition process does not apply in this instance.
Furthermore, EPA believes that a narrow exemption for aircraft halon
bottles is appropriate because it will remove impediments to the proper
maintenance of these halon-1301 containing bottles. In the United
States and abroad the exclusion of these aircraft bottles from the
import petition process will cause transit and testing to occur in a
more expeditious fashion, thus promoting proper maintenance of these
five suppression devises. Proper maintenance of these bottles is
crucial, not only from a safety perspective as described in the
following section of this preamble, but from an

environmental point of view as well. Halon-1301 has a high ODP and the
Agency supports prevention of accidental emissions through proper
maintenance of the storage vessels.

III. Aircraft Halon Bottle Exemption from the Import Petitioning
Process

A. Import of Aircraft Halon Bottles for Hydrostatic Testing

    Halon-1301 is a gaseous compound used in fire suppression systems
and devices. The chemical is used in aircraft halon bottles that are
components of larger fire suppression systems used on aircraft. Halon
bottles are pressurized containers that typically contain from one to
one hundred pounds of a halon-1301/nitrogen mixture. As halon bottles
are under high pressure in severe environments, they are at risk of
leakage and their effectiveness may decrease over time. Hydrostatic
testing of the bottles detects such leakage and determines whether the
bottles are functioning properly.
    The halon bottles must be tested routinely under Federal Aviation
Administration (FAA) and United States Department of Transportation
(DOT) regulations. Federal Aviation Regulations (FAR) section
25.851(a)(6) (14 CFR part 25) requires the presence of halon bottles
aboard transport category aircraft. The FAA Flight Standards Handbook
Bulletin for Airworthiness 02-01B (effective July 16, 2002 and amended
February 10, 2003) provides guidance on the maintenance and inspection
of the halon bottles and states in paragraph 3(b) that ``pressure
cylinders that are installed as aircraft equipment will be maintained
and inspected in accordance with manufacturer's requirements.''
Manufacturer's requirements specify periodic testing of aircraft halon
bottles.
    Halon bottles may be serviced by an on-site facility at an airport
or may be removed from the aircraft, shipped to a testing facility at a
location in the U.S. or abroad, and then returned to the airline. Once
a hydrostatic testing company receives the halon bottles, the used
halon-1301 is removed and recovered for future reclamation. The bottles
are then hydrostatically tested to ensure durability and effectiveness,
after which they are re-filled with halon-1301 and returned to the
customer.
    EPA is aware of two major service companies and about 15 other
companies that provide hydrostatic testing services to the airline
industry. Industry experts estimate that approximately 60,000 bottles
are in service globally, some portion of which are serviced in U.S.
testing facilities. Information provided to the Agency from the two
major U.S. companies indicates that each year those companies service
about 5,000 bottles, some portion of which are imported. The amount of
halon in the aircraft bottles can range from 1 to 100 pounds of halon-
1301, although most bottles contain between 5 to 25 pounds. If EPA were
to assume that, in total, the smaller companies service half as many
bottles as the two major companies do together, and EPA were to assume
that each of those bottles contained 25 pounds of halon, that would
mean that in a given year the U.S. is servicing bottles containing
187,500 pounds of halon-1301 per year, which is equivalent to 850 ODP
weighted metric tons. However, EPA understands that not all aircraft
bottles are imported with complete charges, meaning that a bottle
capable of holding 25 pounds of halon-1301 may in fact contain less. It
is industry practice, however, to export the bottles back to the
country of origin with a full charge of halon-1301. Thus, the U.S. is
likely a net exporter of used halon in aircraft bottles.
    A recent industry estimate on the amount of halon-1301 imported
into the U.S. in aircraft bottles indicated that some 2,700 bottles are
imported for testing on an annual basis. These bottles are imported
containing 24,000 pounds of halon and exported containing 28,000 pounds
of halon. These estimates are based on data from seven companies which
the industry believes represents 90 percent of the market. This data
confirms EPA's understanding of the relatively small amount of halon
imported for the purpose of testing aircraft bottles and the practice
of exporting more halon than is imported in the process of such routine
servicing.

B. Import Petition Requirements for Used Controlled Substances

    The final rule published in the Federal Register on May 10, 1995
(60 FR 24970), established a petitioning system for the import of class
I controlled substances. The system required a person to submit a
petition to import used class I controlled substances prior to the
import of each shipment over a de minimis amount. A de minimis amount
of 150 pounds was initially established in the May 10, 1995 final rule
to allow companies to import small samples of material for testing or
lab analysis without the requirement to submit a petition to EPA prior
to import of the controlled substance; that amount was later lowered to
5 pounds.
    As explained in the preamble to the May 10, 1995, final rule, the
intent of the petition process is to allow EPA to independently verify
whether a class I controlled substance is, in fact, previously used.
EPA established the petition process because quantities of class I
controlled substances were entering the U.S. mis-identified as ``used''
when they were, in fact, newly produced. Under the Montreal Protocol,
trade in of previously used controlled substances is permitted even
after the phaseout dates. To independently verify that a quantity of
class I controlled substance was previously used, EPA needs detailed
information about the source facility from which the material was
recovered.
    On August 4, 1998 (63 FR 41625), EPA finalized changes to the
petitioning process that included a more comprehensive and detailed
list of required information for petitions to import used class I
controlled substances, including a requirement to provide information
documenting the custody chain of the controlled substance starting from
the point of origin and continuing throughout the entire custody chain.
Most of these changes were intended to make the regulatory text more
explicit regarding the type of information that EPA needs to
independently verify the previous use of the controlled substance. One
of the amendments affecting importers of halon-1301 bottles was the
change in the de minimis amount to five pounds. The de minimis
provision was intended to allow companies to import samples of material
for laboratory analysis. The de minimis amount was lowered because EPA
learned that such samples are generally taken from large tanks in
special cylinders that weigh less than 2 pounds.
    The import petition requirements are specified at 40 CFR
82.13(g)(2). They state, in part, that 40 days prior to shipment from
the foreign port of export, the importer must provide information to
the Administrator including, but not limited to the following: Name and
quantity of controlled substance to be imported; name and address of
the importer along with information for a contact person; name and
address of source facility along with information for a contact person;
detailed description of the previous use providing documents where
possible; a list of the name, make and model of the equipment from
which the ODS was recovered; name and address of exporter along with
contact information; the U.S. port of entry and expected date of
shipment; a description of the intended use of the controlled
substance; and the name and address of the U.S. reclamation facility
where applicable. EPA may issue an objection

to the petition if the information submitted by the importer lacks or
appears to lack any of the information required under 40 CFR
82.13(g)(2). The Agency recognizes that this level of detail is not
necessary to control the import of halon-1301 contained in aircraft
halon bottles destined for service and is therefore amending its
regulations as described in the following section of this preamble.

C. Exemption to the Import Petition Requirements

    This direct final rule exempts importers of halon-1301 shipped in
aircraft halon bottles from the petition import requirements under 40
CFR 82.13(g)(2), as described in the previous section of this preamble.
An importer or exporter of halon-1301 contained in aircraft halon
bottles is typically a maintenance and testing facility that is a
certified repair station under 14 CFR part 145 or an aircraft halon
bottle manufacturer that imports and exports aircraft fire
extinguishing pressure vessels for servicing, maintenance, and
hydrostatic testing. Under this direct final rule, importers of
aircraft halon bottles are no longer required to submit petition data
to, and seek approval from, the Administrator prior to individual
imports.

D. Reporting and Recordkeeping Requirements for Importers and Exporters

    The Agency tracks the amount of used halon-1301 imported and
exported annually in aircraft bottles because such movement of halon
across U.S. borders constitute import and export as characterized under
40 CFR part 82. EPA reminds importers that they are still required to
maintain import records, as set forth in 40 CFR 82.13(g)(1), including
but not limited to the following: (i) The quantity of each controlled
substance imported, either alone or in mixtures, including the
percentage of each mixture which consists of a controlled substance;
(ii) The quantity of those controlled substances imported that are used
(including recycled or reclaimed) and the information provided with the
petition as under Sec.  82.13(g)(2), where applicable; (iii) The
quantity of controlled substances other than transhipments or used,
recycled or reclaimed substances imported for use in processes
resulting in their transformation or destruction and quantity sold for
use in processes that result in their destruction or transformation;
(iv) The date on which the controlled substances were imported; (v) The
port of entry through which the controlled substances passed; (vi) The
country from which the imported controlled substances were imported;
(vii) The commodity code for the controlled substances shipped, which
must be one of those listed in Appendix K to 40 CFR part 82, subpart A;
(viii) The importer number for the shipment; (ix) A copy of the bill of
lading for the import; (x) The invoice for the import; (xi) The
quantity of imports of used, recycled or reclaimed class I controlled
substances; and (xii) The U.S. Customs entry form.
    EPA is amending the recordkeeping requirement at 40 CFR 82.13(g)(1)
to state that information provided through the petition process is only
to be maintained ``where applicable.'' No such information will have
been provided in the case of aircraft halon bottles. EPA is not
amending the remaining reporting and recordkeeping requirements for
importers and exporters, found at 40 CFR 82.13(g)(4) and (h)(1)
respectively, but is restating them in this preamble for convenience of
the public.
    EPA reminds importers of aircraft halon bottles that they are
required to submit quarterly reports within 45 days of the end of the
applicable quarter, in accordance with 40 CFR 82.13(g)(4), that include
but are not limited to the following information: (i) A summary of the
records required in paragraphs 40 CFR 82(g)(1) (i) through (xvi) for
the previous quarter; (ii) the total quantity imported in kilograms of
each controlled substance for that quarter; and (iii) the quantity of
those controlled substances imported that are used controlled
substances.
    EPA reminds persons that may test aircraft halon bottles and
subsequently export them that they must submit an annual report (45
days after the end of the calendar year, in accordance with 40 CFR
82.13(h). The annual report must includes but is not limited to the
following information: (i) The names and addresses of the exporter and
the recipient of the exports; (ii) The exporter's Employee
Identification Number; (iii) The type and quantity of each controlled
substance exported and what percentage, if any, of the controlled
substance is used, recycled or reclaimed; (iv) The date on which, and
the port from which, the controlled substances were exported from the
United States or its territories; (v) The country to which the
controlled substances were exported; (vi) The amount exported to each
Article 5 country; (vii) The commodity code of the controlled substance
shipped.
    EPA has provided guidance on the reporting and recordkeeping
requirements. The importer quarterly report form and the annual
exporter report form may be found on EPA's Web site at http://www.epa.gov/ozone/record/index.html.
 This information is also available

via the Ozone Hotline at<PHONE_NUMBER>.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether this regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines a
``significant'' regulatory action as one that is likely to result in a
rule that may:
    (1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal government or communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been
determined that this is a ``significant regulatory action'' within the
meaning of the Executive Order. EPA has submitted this action to OMB
for review. Changes made in response to OMB suggestions or
recommendations will be documented in the public record.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
Current recordkeeping and reporting requirements under 40 CFR 82.13
allow EPA to implement the provisions of this direct final rule. This
action will reduce the reporting burden that would otherwise be
required under 40 CFR 82.13 (g) by removing the requirement to submit
information to EPA prior to each import of aircraft halon bottles. OMB
has previously approved the information collection requirements
contained in the existing regulations under the provisions of the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

and has assigned OMB control number 2060-0170, EPA ICR number 1432.25.
A copy of the OMB approved Information Collection Request (ICR) may be
obtained from Susan Auby, Collection Strategies Division; U.S.
Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW.,
Washington, DC 20460 or by calling<PHONE_NUMBER>. Burden means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or
for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations in 40 CFR are listed in
40 CFR part 9.

C. Regulatory Flexibility Act

    EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. For purposes
of assessing the impacts of this direct final rule on small entities,
small entity is defined as: (1) A small business that is primarily
engaged in the hydrostatic testing of aircraft halon bottles as defined
in NAIC code 541380 with annual receipts less than $10,000,000 (based
on Small Business Administration size standards); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of this final rule on small
entities, EPA has concluded that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may conclude that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    This final rule will reduce the administrative burden on all
entities who import aircraft halon bottles. We have therefore concluded
that this direct final rule will relieve regulatory burden for all
affected small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    Section 203 of UMRA requires the Agency to establish a plan for
obtaining input from and informing, educating, and advising any small
governments that may be significantly or uniquely affected by the rule.
Section 204 requires the Agency to develop a process to allow elected
state, local, and tribal government officials to provide input in the
development of any proposal containing a significant Federal
intergovernmental mandate.
    This direct final rule contains no Federal mandates (under the
regulatory provision of Title II of the UMRA) for State, local, or
tribal governments or the private sector. This rule imposes no
enforceable duty on any State, local or tribal government or the
private sector. Thus, this direct final rule is not subject to the
requirements of sections 202 and 205 of UMRA. EPA has also determined
that this rule contains no regulatory requirements that might
significantly or uniquely affect small governments; therefore, EPA is
not required to develop a plan with regard to small governments under
section 203. Finally, because this rule does not contain a significant
intergovernmental mandate, the Agency is not required to develop a
process to obtain input from elected state, local, and tribal officials
under section 204.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects 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.''
    This rule does not have federalism implications. It will not have
substantial direct effects 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, as
specified in Executive Order 13132. This direct final rule is expected
to primarily affect importers and exporters of halons. Thus, Executive
Order 13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. It does not
impose any enforceable duties on communities of Indian tribal
governments. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health & Safety Risks

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    While this final rule is not subject to the Executive Order because
it is not economically significant as defined in E.O. 12866, we
nonetheless have reason to believe that the environmental, health, or
safety risk addressed by this action may have a disproportionate effect
on children. Depletion of stratospheric ozone results in greater
transmission of the sun's ultraviolet (UV) radiation to the earth's
surface. The following studies describe the effects on children of
excessive exposure to UV radiation: (1) Westerdahl J, Olsson H, Ingvar
C. ``At what age do sunburn episodes play a crucial role for the
development of malignant melanoma,'' Eur J Cancer 1994; 30A: 1647-54;
(2) Elwood JM, Jopson J. ``Melanoma and sun exposure: an overview of
published studies,'' Int J Cancer 1997; 73:198-203; (3) Armstrong BK.
``Melanoma: childhood or lifelong sun exposure'' In: Grobb JJ, Stern
RS, Mackie RM, Weinstock WA, eds. ``Epidemiology, causes and prevention
of skin diseases,'' 1st ed. London, England: Blackwell Science, 1997:
63-6; (4) Whiteman D., Green A. ``Melanoma and Sunburn,'' Cancer Causes
Control, 1994: 5:564-72; (5) Kricker A, Armstrong, BK, English, DR,
Heenan, PJ. ``Does intermittent sun exposure cause basal cell
carcinoma? A case control study in Western Australia,'' Int J Cancer
1995; 60: 489-94; (6) Gallagher, RP, Hill, GB, Bajdik, CD, et. al.
``Sunlight exposure, pigmentary factors, and risk of nonmelanocytic
skin cancer I, Basal cell carcinoma,'' Arch Dermatol 1995; 131: 157-63;
(7) Armstrong, BK. ``How sun exposure causes skin cancer: an
epidemiological perspective,'' Prevention of Skin Cancer. 2004. 89-116.
    EPA anticipates that this rule will have a positive impact on the
environment and human health by removing a disincentive to preventive
maintenance of aircraft halon bottles and reducing the likelihood of
accidental emissions. Thus, this rule is not expected to increase the
impacts on children's health from stratospheric ozone depletion.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. Further, we have
concluded that this rule is not likely to have any adverse energy
effects.

I. The National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law No. 104-113, section 12(d) (15
U.S.C. 272 note) directs EPA to use voluntary consensus standards in
its regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
rulemaking does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective June 12, 2006.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Chemicals, Exports, Halon, Imports, Ozone Layer, Reporting and
recordkeeping requirements.

    Dated: April 5, 2006.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, 40 CFR part 82 is amended as
follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

0
2. Section 82.3 is amended by adding a definition for ``Aircraft halon
bottle'' to read as follows:

Sec.  82.3  Definitions for class I and class II controlled substances.

* * * * *
    Aircraft halon bottle means a vessel used as a component of an
aircraft fire suppression system containing halon-1301 approved under
FAA rules for installation in a certificated aircraft.
* * * * *

0
3. Section 82.4 is amended by revising paragraph (j) to read as
follows:

Sec.  82.4  Prohibitions for class I controlled substances.

* * * * *
    (j) Effective January 1, 1995, no person may import, at any time in
any control period, a used class I controlled substance, except for
Group II used controlled substances shipped in

aircraft halon bottles, without having received a non-objection notice
from the Administrator in accordance with Sec.  82.13(g)(2) and (3).
* * * * *

0
4. Section 82.13 is amended by revising paragraphs (g)(1)(ii) and
(g)(2) introductory text to read as follows:

Sec.  82.13  Recordkeeping and reporting requirements for class I
controlled substances.

* * * * *
    (g) * * *
    (1) * * *
    (ii) The quantity of those controlled substances imported that are
used (including recycled or reclaimed) and, where applicable, the
information provided with the petition as under paragraph (g)(2) of
this section;
* * * * *
    (2) Petitioning--Importers of Used, Recycled or Reclaimed
Controlled Substances. For each individual shipment over 5 pounds of a
used controlled substance as defined in Sec.  82.3, except for Group II
used controlled substances shipped in aircraft halon bottles, an
importer must submit directly to the Administrator, at least 40 working
days before the shipment is to leave the foreign port of export, the
following information in a petition:
* * * * *
[FR Doc. 06-3461 Filed 4-10-06; 8:45 am]

BILLING CODE 6560-50-P


Slide 1 of 84 Preliminary N Methyl Carbamate Cumulative Risk Assessment Preliminary N Methyl Carbamate Cumulative Risk Assessment FIFRA Scientific Advisory Panel August 23 26, 2005 FIFRA Scientific Advisory Panel August 23 26, 2005 Slide 2 of 84 Session 1 Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Background and Overview Session 1 Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Background and Overview Dr. Anna Lowit Health Effects Division Office of Pesticide Programs Dr. Anna Lowit Health Effects Division Office of Pesticide Programs Slide 3 of 84 Introduction  Fourth in a series of scientific peer reviews regarding cumulative risk assessment of the N methyl carbamates  Previous reviews:

° December 2003:

Physiologically Based Pharmacokinetic/

Pharmacodynamic Modeling: Preliminary Evaluation and Case Study for the N Methyl Carbamate Pesticides ° December 2004:

The N Methyl Carbamate Cumulative Risk Assessment: Strategies and Methodologies for Exposure Assessment ° February 2005:

N Methyl Carbamate Cumulative Risk Assessment:

Pilot Cumulative Analysis Slide 4 of 84 Background Presentation  A " roadmap" for the documents and presentations for the four day SAP meeting  Scope of the preliminary CRA  Session 1 ° Public Comments ° Hazard Assessment  Session 2 ° Drinking Water Exposure Assessment  Session 3 ° Food & Residential Exposure Assessment  Session 4 ° Model Results Comparison, Cumulative (

Multipathway Analysis, & Risk Characterization Sessions Roadmap Slide 5 of 84 Slide 6 of 84 Cumulative Risk Assessment Background  Food Quality Protection Act ( 1996)

° Requires EPA to take into account when setting pesticide tolerances:

" available evidence concerning the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity." Slide 7 of 84 Cumulative Risk Assessment Background  Aggregate risk assessment:

° Single chemical, multipathway ° Includes various durations of exposure and variety of toxicity endpoints  Cumulative risk assessment:

° Multichemical, multipathway ° Limited to the common mechanism endpoint Slide 8 of 84 General Steps Outlined in the OPP Cumulative Guidance  Identify common mechanism effect and common mechanism group ( CMG)

 Identify cumulative assessment group ( CAG)

 Determine relevant exposure scenarios/ pathways  Consider appropriate method( s)

 Conduct cumulative risk assessment Nerve Axon U. S. EPA 2001 Policy Paper Determining the Common Mechanism Group ( CMG)

 Identified based on:

° Structural characteristics ° AChE inhibition by carbamylation of serine hydroxyl group ° AChE inhibition in:

 Brain,

 Peripheral nervous system,

 Surrogate measures in blood ( RBC or plasma) Slide 9 of 84 Slide 10 of 84 Pesticides Included:

 Aldicarb/ Aldoxycarb  Carbaryl  Carbofuran  Formetanate HCl  Methiocarb  Methomyl  Oxamyl  Pirimicarb  Propoxur  Thiodicarb Slide 11 of 84 Develop Exposure Scenarios for CAG  Use available information to develop exposure scenarios ° Food

USDA Pesticide Data Program

FDA Monitoring Data ° Drinking Water

Use/ Usage Information

Labels

PRZM EXAMS and ground water model ° Residential

Use/ Usage Information

Labels Slide 12 of 84 General Steps Outlined in the OPP Cumulative Guidance  Identify common mechanism effect and common mechanism group ( CMG)

 Identify cumulative assessment group ( CAG)

 Determine relevant exposure scenarios/ pathways  Consider appropriate method( s)

 Conduct cumulative risk assessment Slide 13 of 84  February 2005 SAP:

° Focused on methods development and proposed approaches  Current SAP Meeting:

° Application of methods and approaches ° Risk characterization Purpose and Scope Slide 14 of 84  Key Issues NOT yet addressed:

° Extrapolation and Uncertainty Factors  Intraspecies, Interspecies  FQPA 10X Factor ° Sensitivity analyses for food, water,

and residential still on going ° Residential exposure with LifeLineTM and CARESTM ° Percentile of exposure for regulation Purpose and Scope Slide 15 of 84 Session 1:

Hazard Assessment  Collaborative efforts of OPP and ORDNHEERL ORD NCCT  Relies on rat toxicity studies for estimation of relative potency  Issues:

° Dose and time response modeling

Empirical modeling & Data used ° Index chemical ° Endpoint selected for Relative Potency Factors and Points of Departure Slide 16 of 84 Session 2:

Drinking Water Exposure  Surface water exposure estimates similar to OP methods ° Estimated exposures from surface water do not contribute substantially to cumulative exposure  Ground water exposure estimates using 3 models ( new for NMC)

° Estimates for shallow private wells in highly permeable soils ° Estimates to other localized areas Slide 17 of 84 Session 2:

Drinking Water Exposure  Seeking panel input on:

° Revised conceptual model for ground water sources of drinking water ° Comparisons of the three ground water models ° Extrapolation of ground water model exposure estimates to other potential high exposure areas Slide 18 of 84 Session 3:

Food & Residential Exposure  Methodology similar to OP assessment  Four age groups ° Children 1 2, Children 3 5, Adults 20 49, Adults 50+

 Three models ° DEEM/ Calendex   , LifeLine   ,

CARES   Slide 19 of 84 Session 3:

Food & Residential Exposure  Seeking panel input on:

° Methodologies and assumptions ° Statistical and related issues involving the selection and parameterization of distributions ° Information sources used in the preliminary residential assessment Slide 20 of 84 Session 4:

Cumulative Analysis & Risk Characterization  Methodology similar to OP assessment  Three pathways ° Food, drinking water, residential  Four age groups ° Children 1 2, Children 3 5, Adults 20 49,

Adults 50+

 Multipathway results for DEEM/ Calendex   ° Analyses with LifeLine   and CARES   are on going Slide 21 of 84 Session 4:

Cumulative Analysis & Risk Characterization  Seeking panel input on:

° Issues associated with characterization and timeframes of exposure ° Additional data sources which may enhance the assessment  Session 1 ° Public Comments ° Hazard Assessment  Session 2 ° Drinking Water Exposure Assessment  Session 3 ° Food & Residential Exposure Assessment  Session 4 ° Model Results Comparison, Cumulative (

Multipathway Analysis, & Risk Characterization Sessions Roadmap Slide 22 of 84 Slide 23 of 84 Session 1 Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Session 1 Preliminary N Methyl Carbamate Cumulative Risk Assessment:

Public Comments Public Comments  Session 1 ° Public Comments ° Hazard Assessment  Session 2 ° Drinking Water Exposure Assessment  Session 3 ° Food & Residential Exposure Assessment  Session 4 ° Model Results Comparison, Cumulative (

Multipathway Analysis, & Risk Characterization Sessions Roadmap Slide 24 of 84 Slide 25 of 84 Session 1 Preliminary N Methyl Carbamate Cumulative Hazard Assessment:

Introduction Session 1 Preliminary N Methyl Carbamate Cumulative Hazard Assessment:

Introduction Dr. Anna Lowit Health Effects Division Office of Pesticide Programs Dr. Anna Lowit Health Effects Division Office of Pesticide Programs Slide 26 of 84 Introduction  Preliminary CRA relies on the Relative Potency Factor ( RPF) method  Ongoing research effort to develop PBPK/ PD model for carbaryl ° Presentation at 02/ 05 SAP meeting ° Insufficient data to develop multichemical/ multipathway PBPK or BBDR model ° Lessons learned will aid the Agency in future assessments  EPA encourages the development of PK and PD data to characterize internal dosimetry and timing of toxic effects Slide 27 of 84 Introduction  Relative Potency Factor Method  Relative toxic potency of each chemical was calculated in comparison to " index chemical"

 Exposure equivalents of index chemical are combined in the cumulative risk assessment Slide 28 of 84 Session 1: Topics  Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates  Laboratory Studies with the NMethyl Carbamate Insecticides  Relative Potency Factors and Points of Departure Slide 29 of 84 Session 1 Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates Session 1 Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates Dr. R. Woodrow Setzer National Center for Computational Toxicology Office of Research and Development Dr. R. Woodrow Setzer National Center for Computational Toxicology Office of Research and Development Slide 30 of 84 Some Responses to February, 2005 SAP Comments  Dose model may be overparameterized ° Preliminary analysis of " estimability" triggers default values of some parameters  Possible need for dose time interaction term ( product term suggested)

° Interaction term included when designs allowed  Greater emphasis on statistical hypothesis testing ° Models simplified from " full" to " reduced" using likelihood ratio tests and Wald tests of linear combinations of fixed parameters as appropriate  Possibly use a simpler model for time component ° Biphasic model replaced with a model giving exponential decay of inhibition Slide 31 of 84 What Do We Want From Modeling?

1. Estimates of potency and relative potency for AChE inhibition 2. Estimates of recovery rate or half life of AChE inhibition 3. Tissues: brain and RBC Slide 32 of 84 What Kind of Data Do We Have?

 Designs:

° Dose response:

Measures of AChE activity at the time of peak effect for a range of doses ( multiple tissues,

one or both sexes)

° Time course:

Measures of AChE activity at one or a few dose levels at several time points soon after a single gavage exposure ° Repeated gavage exposures on a subchronic time scale

Possibly with time course information for some of them Slide 33 of 84 What Kind of Data Do We Have?

 Data Characteristics ° For most chemicals, we have more than one study, usually a mix of design types ° Aggregated ( means, standard deviations,

sample sizes) for brain AChE, individual data for RBC AChE ° Units of AChE activity vary among studies ° Background ( control) AChE activity varies among studies

Even for the same species strain ° In time course designs, there are few if any measurements before the time of peak effect Slide 34 of 84 Strategy  Develop a single model that describes AChE activity as a function of dose and time post dosing  Parameters include:

° log( BMD) = lBMD for 10% ( or other specified)

inhibition ° Recovery half life  Fit the model to all relevant data sets, treating some of the variation among data sets as:

° Random

e. g. lBMD ° Fixed effects

With specific values for each data set and sex

e. g. background levels  This gives a nonlinear mixed effects model Slide 35 of 84 The Model  Inhibition is the product of a function that depends only on dose and estimated parameters, and a function that depends only on time and estimated parameters:

 Activity is ( ignoring the parameters for the moment): ( ) ( )

1 A g d h t   ×   ×   ( )

; , , , ( ; )

Fractional Inhibition R R g d R P D h t T   = × Slide 36 of 84 Time Course Model  Time course for fractional inhibition represents exponential decay of the inhibition:

  represents the time of the first sample ln( 2)

( ; ) R t T R h t T e

=

e R lT R T = Slide 37 of 84 Alternative Form of Time

Course Model  In this parameterization,

TR is a " recovery" half life,

and TA is an " absorption" half life ( ) ( )

( )( )

( ) ( ) ( )

( )

( )( )

( ) ( )

* *

ln 2 ln 2 0 * *

0 ln 2 ln 2 ( ) ln ln ln 2 1 ln 2 ln 1 R A R A t t T T R A R A R R A R T T A T T h t C e e T T T T T T T T T T C T e e

    =

  =

=

=

=   Slide 38 of 84 Comparison of Time Course Models 0 5 10 15 20 25 30 35 0.0 0.2 0.4 0.6 0.8 1.0 T* = 1 Time Fractional AChE Inhibition   = 10   = 50 Slide 39 of 84 Dose Response Model  The dose response model gives the fraction of inhibition at the time of peak effect. In this model, any low dose shoulder is modeled with the shape parameter  : ( ) 1 log 1 ( ; , , , ) 1 1 1 : :

1 e e e:

: benchmark response 1  max. inhibition : benchmark dose shape parameter dose R R P d P D R tz lD l R g d R P D P e R R P D d

   =

= +

= = Slide 40 of 84 Dose Response Examples 0 10 20 30 40 0.0 0.2 0.4 0.6 0.8 1.0 DR = 3 Dose ( mg/ kg)

Max.

Fraction Inhibition P = 0.1 P = 0.4   = 1   = 2 Slide 41 of 84 Estimation Issues  Want to fit all data sets for a chemical simultaneously  Allow for variation among studies, sexes,

time on study ( in sub chronic studies)

 Time course parameter TR may ( probably does) depend on dose  Some parameters or sets of parameters may not be uniquely estimable with current data  Error variance probably depends upon activity level, and may differ among studies Slide 42 of 84 Statistical Model  The full statistical model used for estimating parameters is, using the following indexes: d l k Index Dose Subject Time on study Factor j Sex i Study ( MRID) Index Factor ( )( )

( )

( )

( ) * * 2 2 2 E | , , , , , , , , ,

Var | , , , , , , , ( )

, , , if repeated observations on same subject ijkl ijkl k d ijk ijkl ijkl k d ijk e ijk jk lD ijkl ijk lA y dose time lA lT la tP lD lg f dose time y dosetimelA lT la tPlD lg f lD lA A     µ     = =

  N N Slide 43 of 84 Estimation Strategy

Evaluate estimability of parameters given the data set( s)

Compare variance models ° Constant variance ° Power model for variance

Fit a " full" model to the data set( s) with separate values of BMD and recovery half life among sexes, studies ( and time points in subchronic studies); differences among half lives among doses ° Lindstrom and Bates approach to nonlinear mixed effects models ( nlme() in R)

° Generalized non linear least squares ( gnls() in R) in the absence of random effects

Test differences:

° Likelihood ratio tests for variance models first ° Wald tests ( conditional on estimates of variance parameters) for differences in parameter values

Pinheiro and Bates, 2000 recommend against likelihood ratio tests for fixed effects

Fit simplified model for estimates; confidence limits based on standard errors Slide 44 of 84 Problems Estimating Parameters ( Estimability)

Single parameter:

° Design does not allow estimate

e. g. doses too low to estimate P in dose response model ° Time interval too wide to estimate TR

Response has recovered by the next time point

Multiple parameters:

° Redundancy   design does not allow unique estimate of two or more parameters

e. g. lg and lD

Often a range of values for these two parameters result in very similar fitted values at design points.

Diagnosis of both based on analyzing the ( unscaled)

parameter covariance matrix:

° ( XWX') 1, where each row of X is the matrix of the derivatives of the model function wrt to the parameters evaluated at one of the design points

i. e. sex, dose, time, study, etc.

° W is the ( diagonal, in this case) matrix of weights

Derived from the error variance model Slide 45 of 84 More on Diagnosing Estimability Problems  Single parameter estimability determined by estimated relative standard error ° If there is a problem, the estimated relative standard error for the implicated parameter will be orders of magnitude greater than for the other parameters  Multi parameter estimability determined using eigen analysis of ( XW ½ ) , analogously to the analysis of collinearity in linear models ° Belsley, et al, 1980; Reich, 1981 Slide 46 of 84 Example: Oxamyl Dose

Time Response, EPA data Slide 47 of 84 Example: Oxamyl Dose Time Response, MRID 44420301 Slide 48 of 84 Oxamyl Dose Response, All Data: Observed versus Fitted Slide 49 of 84 Summary  BMDs and relative potencies are estimated along with recovery half lives from rat dose time response data  The dose response portion of model is similar to that used for AChE inhibition by organophosphates  The time course model reflects an exponential decay of inhibition  The estimation process accounts for variability among studies ° When appropriate data are available Slide 50 of 84 Session 1: Topics  Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates  Laboratory Studies with the NMethyl Carbamate Insecticides  Relative Potency Factors and Points of Departure Slide 51 of 84 Session 1 Laboratory Studies with the N Methyl Carbamate Insecticides Session 1 Laboratory Studies with the N Methyl Carbamate Insecticides Dr. Stephanie Padilla National Health and Environmental Effects Research Laboratory Office of Research and Development Dr. Stephanie Padilla National Health and Environmental Effects Research Laboratory Office of Research and Development Slide 52 of 84 Outline of the Presentation  Studies to address questions raised at the previous SAP meeting  Mixture Study using seven Nmethyl carbamates Slide 53 of 84 Questions Raised in the February 2005 SAP Meeting  Length of waiting time for samples between homogenization and assay  Panel suggested the Agency investigate the potential for reactivation before the assay Study of Reactivation Parameters Brains from Oxamyl Treated Animals TIME ( minutes)

2 4 6 8 10 12 14 Cholinesterase Activity (%

Control) 0 10 20 30 40 50 60 70 80 90 100 110 120 Control 0.0666 mg/ kg 0.1 mg/ kg 0.5 mg/ kg 1.0 mg/ kg 1.5 mg/ kg Original Rad 3/ 27/ 04 1: 3 immed 1: 3, 1.5 hrs 1: 9 immed Slide 54 of 84 Slide 55 of 84 Conclusions from Studies  Storage of unhomogenized tissue at  80  C for one year did not affect reactivation  Dilution of samples promoted reactivation ( 7 10%)

° This level of reactivation probably happens when the tissue is homogenized  Samples waiting 90 minutes on ice caused some reactivation ( 0 5%) Slide 56 of 84 Brain Dose Response Cholinesterase Activity Dose ( mg/ kg)

0.1 1 10 Cholinesterase (%

control) 0 10 20 30 40 50 60 70 80 90 100 110 120 Propoxur Carbaryl Oxamyl Methomyl Methiocarb Folrmetanate Carbofuran Slide 57 of 84 29.10%

Propoxur 1.49%

Oxamyl 5.05%

Methomyl 19.60%

Methiocarb 1.63%

Formetanate 1.46%

Carbofuran 41.60%

Carbaryl Percentage of Mixture Carbamate Slide 58 of 84 Mixture Study Design  13 dose groups:

° Mixture at 5 levels, each carbamate alone,

and control ° 10 animals per group  Adult male, Long Evans rats  Dosed orally ° Two vehicles ° All animals received both vehicles  Tissues taken at 40 min. after dosing Slide 59 of 84 Dose of Mixture ( mg/ kg)

0 2 4 6 8 10 12 14 16 Cholinesterase activity (%

control) 20 30 40 50 60 70 80 90 100 110 120 Expected Values (+ 95% confidence limits)

Actual Data (+ sem)

Carbamate Mixture Study:

Brain Cholinesterase Activity Dose Additive Design Equipotent Mixture Control Comparison of the Brain Dose Response and Single Dosing in the Mixture Study Dose ( mg/ kg)

0.1 1 10 100 Cholinesterase (%

control) 0 10 20 30 40 50 60 70 80 90 100 110 120 Propoxur Carbaryl Oxamyl Methomyl Methiocarb Formetanate Carbofuran Open Symbols are Single Dose Repeats in Mixture Study Slide 60 of 84 Slide 61 of 84 Conclusions  Increasing dosages of the mixture decreased brain cholinesterase activity  The changes in brain cholinesterase activity in the animals dosed with the carbamate mixture appears to fit the dose additive model Slide 62 of 84 Session 1: Topics  Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates  Laboratory Studies with the NMethyl Carbamate Insecticides  Relative Potency Factors and Points of Departure Slide 63 of 84 Session 1:

Relative Potency Factors and Points of Departure Session 1:

Relative Potency Factors and Points of Departure Dr. Elissa Reaves Health Effects Division Office of Pesticide Programs Slide 64 of 84 Relative Potency Factors  Steps:

° Estimate chemical potency  Calculate benchmark dose estimates ° Selection of the endpoint for Relative Potency Factors and Points of Departure ° Select index chemical Slide 65 of 84 ChE Data  Toxicity studies in the rat provide the most extensive and robust database of ChE inhibition data and were focus of assessment  RBC and brain ( whole and half)

ChE extracted ° Appendix II. B. I Slide 66 of 84 Oral Studies  Studies submitted for registration:

° Gavage administration ° At or near time of peak effect ° Single or repeated dosing with or without recovery data

Acute neurotoxicity, subchronic toxicity,

developmental neurotoxicity  EPA NHEERL data available for ° Aldicarb, carbaryl, formetanate,

methiocarb, methomyl, oxamyl, propoxur  Number of available studies varies among chemicals ° At least one study per NMC ° Most chemicals two or more studies Slide 67 of 84 ChE SOPs  Registration studies used modified Ellman method ° Spectrophotometric method  EPA NHEERL used radiometric method  Good concordance between registration studies and EPA's radiometric experiments  Preliminary evaluation of submitted registration SOPs provided in CRA ° Additional SOPs submitted in recent weeks Slide 68 of 84 Dermal and Inhalation Studies  Compiled for pesticides with residential exposure potential and index chemical  Dermal studies include both rat and rabbit studies  Inhalation studies available only for propoxur and oxamyl ° Oral studies used for carbaryl and methiocarb Slide 69 of 84 Index Chemical: Oxamyl  Considered all NMCs as possible candidates for index chemical  Oxamyl:

° Most robust database for oral,

dermal, and inhalation studies ° High quality dose response data for RBC and brain ChE inhibition Slide 70 of 84 Brain ChE for RPFs and PoDs  Represents a direct measure of the common mechanism of toxicity  BMD10 estimates for ChE inhibition generally similar for brain and RBC  Tighter confidence intervals compared to than RBC ChE Slide 71 of 84 Comparison of RBC and Brain ChE BMD 10' s Chemical Name Aldicarb Carbofuran Formetanate Oxamyl Methomyl Thiodicarb Propoxur Methiocarb Carbaryl Pirimicarb BMD 10 (

95%

confidence limits) 0.01 0.1 1 10 100 RBC Brain RBC, index chemical Brain, index chemical Slide 72 of 84 Rat Brain ChE Inhibition Chemical Name Aldicarb Formetanate Carbofuran Oxamyl Thiodicarb Methomyl Methiocarb Carbaryl Propoxur Pirimicarb BMD 10 (

95%

confidence limits) 0.01 0.1 1 10 100 Slide 73 of 84 Half Life Time to Recovery  Brain and RBC estimates generally range from < 1 hour to 6 hours  Recovery is dose dependent for some chemicals  Overall, half life to recovery data support the use of acute, single day exposures Slide 74 of 84 Points of Departure  Point of departure is a point estimate on the index chemical's dose response curve used to extrapolate risk to exposure levels anticipated in the human population Slide 75 of 84 0.00024 mg/ L 0.050 mg/ kg 17.05 mg/ kg 0.14 mg/ kg BMDL10 0.00040 mg/ L 0.083 mg/ kg 34.91 mg/ kg 0.18 mg/ kg BMD10 Inhalation Dermal Oral Endpoint Brain BMD10s and BMDL10s for Oxamyl Slide 76 of 84 Conclusions  Oxamyl contained most robust database for all 3 routes of exposure  Brain ChE data provide a supportable common endpoint for extrapolating cumulative risk Slide 77 of 84 Session 1: Topics  Empirical Models for Acetylcholinesterase Inhibition by N Methyl Carbamates  Laboratory Studies with the NMethyl Carbamate Insecticides  Relative Potency Factors and Points of Departure Slide 78 of 84 Session 1 Preliminary Cumulative Hazard Assessment:

Questions to the Panel Session 1 Preliminary Cumulative Hazard Assessment:

Questions to the Panel Dr. Elissa Reaves Health Effects Division Office of Pesticide Programs Dr. Elissa Reaves Health Effects Division Office of Pesticide Programs Slide 79 of 84 Hazard Question # 1  Empirical Dose Response and Time Course Modeling ° At the February, 2005 meeting of the FIFRA SAP,

EPA proposed an empirical model for use in the cumulative risk assessment of the N methyl carbamates. This model contains a dose response and a time to recovery component. Based on the comments from the Panel and following experience with its application, EPA made some modifications to this proposed model. EPA has applied this revised empirical model to the available RBC and brain cholinesterase data for the N methyl carbamates. BMD and BMDL estimates provided in the preliminary assessment were derived from cholinesterase data from multiple studies and in some cases, using different cholinesterase measurement techniques. Slide 80 of 84 Hazard Question # 1 H1a. Please comment on the mathematical/ statistical approach to modeling cholinesterase data used to estimate benchmark dose values and time to half life recovery in the preliminary cumulative risk assessment.

Please address biological and mathematical/ statistical considerations in your response.

H1b. Please comment on the adequacy,

clarity, and transparency of the documentation provided for the empirical dose response and time course modeling. Slide 81 of 84 Hazard Question # 2  Selection of the Index Chemical ° EPA's cumulative risk assessment guidance indicates that the index chemical should be selected based on the availability of high quality toxicity database for the common mechanism endpoint.

The selection of the index chemical is an important step in the cumulative risk assessment; the BMD for oxamyl was used to calculate RPFs and the BMDL for oxamyl was used as the PoD for extrapolating cumulative risk. Slide 82 of 84 Hazard Question # 2 H2. Please comment on the rationale provided for the selection of the index chemical. Should any additional factors be included in the rationale for the selection of oxamyl as the index chemical? Slide 83 of 84 Hazard Question # 3  Selection of Brain ChE data for developing RPFs and PoDs ° EPA has used data for brain ChE as the basis for the RPFs and PoDs.

The rationale for this selection was provided in I. B. Slide 84 of 84 Hazard Question # 3 H3. Please comment on the rationale provided for the selection of the brain ChE as the basis for RPFs and PoDs in the preliminary cumulative risk assessment. Should any additional factors be considered?


[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27459-27460]
[FR Doc No: 2013-11176]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69524; File No. SR-NYSEMKT-2013-35]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Establishing a Schedule
of the NYSE Amex Options Proprietary Market Data Fees

May 6, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on April 25, 2013, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
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.
---------------------------------------------------------------------------

    \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 establish a schedule of the NYSE Amex
Options Proprietary Market Data Fees (``Market Data Fee Schedule'').
The text of 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 establish a Market Data Fee Schedule. The
market

data fees on the proposed Market Data Fee Schedule for NYSE ArcaBook
for Amex Options have been previously filed with the Commission.\4\
NYSE ArcaBook for Amex Options includes Trades, Top of Book, Depth of
Book, Complex, Series Status, and Order Imbalance data. At this time,
the Exchange does not offer separate pricing for each of the individual
data products. The Exchange is proposing the Market Data Fee Schedule
in order to provide greater transparency to its customers.
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    \4\ See Securities Exchange Act Release No. 68004 (Oct. 9,
2012), 77 FR 62582 (Oct. 15, 2012) (SR-NYSEMKT-2012-49).
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \5\ of the
Act, in general, and furthers the objectives of Section 6(b)(5) \6\ of
the Act, in particular, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in 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, and it is not designed to permit unfair discrimination
among customers, brokers, or dealers. The Exchange believes that
establishing the Market Data Fee Schedule will remove impediments to
and help perfect a free and open market by providing greater
transparency for the Exchange's customers. In addition, the market data
fees have been previously filed with the Commission.\7\
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ See supra n. 4.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition because the Exchange is merely
establishing a Market Data Fee Schedule for fees that have been
previously filed with the Commission.\8\
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    \8\ Id.
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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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) \9\ of the Act and Rule 19b-4(f)(6) thereunder.\10\
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\11\
However, Rule 19b-4(f)(6)(iii) \12\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. The Exchange believes that
the proposed rule change will make the Exchange's proprietary market
data fees more transparent. The Commission believes that permitting the
Exchange to make this change without delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission designates the proposed rule change to be operative upon
filing.\13\
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    \11\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
    \12\ Id.
    \13\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of 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.

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-NYSEMKT-2013-35 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2013-35. 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 publicly available. All
submissions should refer to File Number SR-NYSEMKT-2013-35 and should
be submitted on or before May 31, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-11176 Filed 5-9-13; 8:45 am]
BILLING CODE 8011-01-P