[Federal Register Volume 84, Number 158 (Thursday, August 15, 2019)]
[Proposed Rules]
[Pages 41667-41670]
[FR Doc No: 2019-17450]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, and 1926

[Docket No. OSHA-2010-0034]
RIN 1218-AD18

Occupational Exposure to Respirable Crystalline Silica--Specified
Exposure Control Methods

AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.

ACTION: Request for Information (RFI).

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SUMMARY: OSHA is requesting information on the effectiveness of
engineering and work practice control methods not currently included
for the tasks and equipment listed on Table 1 of the Respirable
Crystalline Silica standard for construction. The agency is also
requesting information on tasks and equipment involving exposure to
respirable crystalline silica that are not currently listed on Table 1,
along with information on the effectiveness of engineering and work
practice control methods in limiting worker exposure to respirable
crystalline silica when performing those tasks. Finally, OSHA is
requesting information and comment on whether there are additional
circumstances where it would be appropriate to permit employers covered
by the Respirable Crystalline Silica standards for general industry and
maritime to comply with the silica standard for construction. This RFI
requests comment and information, including exposure data, which could
assist the agency in assessing whether revisions to the standards may
be appropriate.

DATES: Submit comments on or before October 15, 2019.

ADDRESSES: Submit comments and additional materials using any of the
following methods:
    Electronically: You may submit comments and attachments
electronically via https://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for making
electronic submissions.
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Regular mail, express mail, hand delivery, or messenger/courier
service (hard copy): You may submit your comments and any additional
materials to the OSHA Docket Office, Docket No. OSHA-2010-0034,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210;
telephone:<PHONE_NUMBER> (TTY<PHONE_NUMBER>). OSHA's Docket Office
accepts deliveries (hand deliveries, express mail, and messenger/
courier service) from 10 a.m. to 3 p.m. ET, weekdays.
    Because of security-related procedures, submission by regular mail
may result in significant delay. Please contact the OSHA Docket Office
(telephone:<PHONE_NUMBER>; email: [email protected]) for
information about security procedures concerning delivery of materials
by express mail, hand delivery, and messenger service.
    Instructions for submitting comments: All submissions must include
the agency's name (OSHA), the title of this RFI (Occupational Exposure
to Respirable Crystalline Silica--Specified Exposure Control Methods),
and the docket number for this RFI (OSHA-2010-0034). OSHA will place
all comments and other materials, including any personal information
you provide, in the public docket without revision, and these materials
will be available online at https://www.regulations.gov. Therefore,
OSHA cautions you about submitting statements that you do not want made
available to the public, or submitting comments that contain personal
information such as Social Security numbers, birth dates, and medical
data.
    Docket: To read or download submissions or other material in the
docket, go to https://www.regulations.gov or the OSHA Docket Office at
the above address. The https://www.regulations.gov index lists all
documents in the docket. However, some information (e.g., copyrighted
material) is not available to read or download through the website. All
submissions, including copyrighted material, are available for
inspection at the OSHA Docket Office. Contact the OSHA Docket Office
for assistance in locating docket submissions.

FOR FURTHER INFORMATION CONTACT:
    Press Inquiries: Frank Meilinger, Director, OSHA Office of
Communications, telephone:<PHONE_NUMBER>; email:
[email protected].
    General and technical information: William Perry or David O'Connor,
Directorate of Standards and Guidance, telephone:<PHONE_NUMBER>; email:
[email protected].
    Copies of this Federal Register notice: Electronic copies of this
Request for Information are available at https://www.regulations.gov.
This Federal Register notice, as well as news releases and other
relevant information, is also available at OSHA's web page at https://www.osha.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 25, 2016, OSHA published a final rule regulating
occupational exposure to respirable crystalline silica (81 FR 16286).
The final rule established a new permissible exposure limit (PEL) for
respirable crystalline silica of 50 micrograms per cubic meter of air
(50 [mu]g/m\3\) as an 8-hour time-weighted average in all industries
covered by the rule. The rule also included other provisions, such as
requirements for exposure assessment, methods for controlling exposure,
respiratory protection, medical surveillance, hazard communication, and
recordkeeping. OSHA issued two separate standards--one for construction
(29 CFR 1926.1153) and one for general industry and maritime (29 CFR
1910.1053).\1\
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    \1\ ``Maritime'' refers collectively to shipyards, marine
terminals, and longshoring. While the shipyard standard is
technically a separate standard, it is identical to the general
industry standard. See 29 CFR 1915.1053 (cross-referencing 29 CFR
1910.1053). Marine terminals and longshoring are covered under 29
CFR 1910.1053. See 29 CFR 1917.1(a)(2)(xiii)) and 29 CFR
1918.1(b)(9)).

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    The construction standard provides employers with two options to
limit worker exposures to respirable crystalline silica. Employers can
assess employee exposures to silica and implement control measures that
limit such exposures to the PEL (29 CFR 1926.1153(d)). But employers
may instead choose to fully and properly implement the requirements in
Table 1 for employees engaged in the 18 common construction tasks
therein (29 CFR 1926.1153(c)). Table 1 lists each task's corresponding
engineering and work practice control methods and respiratory
protection requirements, if any.
    For some Table 1 tasks, there was substantial evidence in the
rulemaking record that exposure to respirable crystalline silica would
be limited to the PEL most of the time using the specified engineering
and work practice controls, so no respiratory protection is required.
For the other Table 1 tasks, available evidence indicated that
exposures would remain above the PEL after implementation of
engineering and work practice controls, so respiratory protection is
required. Several tasks listed on Table 1 provide a choice of
compliance methods because each can consistently reduce exposures to
the PEL or below, or are equally effective in limiting exposure. For
example, for jackhammers and handheld powered chipping tools, employers
can satisfy Table 1's requirements by using either a tool with a water
delivery system that supplies a continuous stream or spray of water to
the point of impact, or a tool equipped with a commercially available
shroud and dust collection system.
    OSHA developed Table 1's list of controls using data from sources
including National Institute for Occupational Safety and Health
reports, OSHA compliance case files, published literature, and
unpublished information submitted to the rulemaking docket. These data
sources encompassed several types of studies assessing the
effectiveness of control methods, including air-sampling studies
performed during normal work activities and experimental studies
performed in controlled environments.
    OSHA concluded that Table 1 was the best approach for protecting
employees exposed to respirable crystalline silica and also simplified
compliance and reduced burdens on employers in the construction
industry. Table 1's approach further recognizes and avoids the
challenges of accurately assessing employee exposures to respirable
crystalline silica in construction work due to frequent changes in
workplace conditions, such as environment and location.
    During the rulemaking process, some stakeholders urged OSHA to
consider how to update Table 1 in the future to include new control
methods that might be developed. OSHA responded that it saw the value
in periodically updating Table 1 and that a static Table 1 could
discourage the development of new control technologies for reducing
silica exposure. OSHA is now requesting information on additional
engineering and work practice control methods that could limit
exposures generated by the equipment and tasks currently listed on
Table 1. The agency is also requesting information on engineering and
work practice control methods that could limit exposures generated by
equipment or tasks not already included on Table 1. This information
will help OSHA decide whether to revise Table 1.
    During the rulemaking, some commenters expressed concerns about
determining which standard--general industry or construction--applies
to certain activities. OSHA recognized that in some circumstances,
general industry activities may be indistinguishable from the
construction tasks listed on Table 1, and may be performed in varied
environments and conditions. To address those circumstances, OSHA
included paragraph (a)(3) in the general industry and maritime
standard. Paragraph (a)(3) permits general industry and maritime
employers to follow the construction standard when (1) the task
performed is indistinguishable from a construction task listed on Table
1, and (2) the task will not be performed regularly in the same
environment and conditions. The second requirement recognizes that
Table 1 was intended, in part, to accommodate situations where tasks
will be performed in different environments and conditions. OSHA is
interested in information and comment on whether there are additional
circumstances where similar flexibility would benefit employers while
maintaining protections for workers, such as when Table 1 tasks are
regularly performed in general industry or maritime in a relatively
stable and predictable environment.
    If the information submitted in response to this RFI indicates that
revisions to the silica standards may be appropriate, OSHA will publish
a Notice of Proposed Rulemaking and provide an opportunity for public
comment on the proposed revisions before making any changes to the
standards.

II. Request for Data, Information, and Comment

A. Questions Regarding Possible Additions to Table 1

    OSHA requests data, information, and comment on possible additions
to Table 1. The agency is especially interested in responses to the
numbered questions presented below. OSHA requests that comments
reference the numbered questions to the extent possible. Commenters
should explain their rationale and, if possible, provide information
and data to support their comments and recommendations.
    OSHA requests that submissions of exposure monitoring data include
the following information, where possible:
     Description of task: A description of the task(s)
performed and work practices followed during the exposure monitoring,
including any housekeeping measures, as well as job titles and number
of workers monitored during the task(s). The description should also
include information regarding the frequency and duration of the task
being performed. For example, the description should report the number
of times a task (e.g., drilling holes in concrete) was performed during
the exposure monitoring period.
     Description of equipment: Indicate the make and model of
the equipment used to perform the task. Provide a copy of equipment
manufacturer's instructions, if available.
     Description of engineering and work practice control
methods: Indicate the make and model of any equipment used to control
exposures, as well as information on the condition (e.g., intact hoses,
connections) and maintenance of the equipment. For vacuum dust
collection systems, indicate the air flow rate, type of filter, and
filter cleaning mechanism, if any. For water delivery systems, indicate
the water source, volume, and flow rate. Provide a copy of the control
equipment manufacturer's instructions, if available. If a work practice
control was used to control exposures, describe the work practices that
were implemented in as much detail as possible.
     Description of materials: Describe the material worked on
during the task(s) and indicate its crystalline silica content, if
possible. When working with concrete or other materials with
characteristics that may change over time, please note how long a
substrate was cured before starting work.
     Description of environmental conditions: Characterize the
environmental conditions during monitoring, such as whether the work
was performed outdoors, indoors, or in

an enclosed area with restricted air flow. For work performed indoors,
describe the size of the room. For work performed outdoors, note
weather conditions such as temperature, humidity, and precipitation, as
well as the presence of water in the soil or on surfaces. Also note the
presence of natural or mechanical ventilation, such as air movement
caused by the wind; doors or windows (open or closed and their number
and sizes); or ventilation systems for heating and cooling and whether
they were operational during monitoring.
     Sampling and analytical procedures: Describe sampling
results, sampling and analytical methods (e.g., OSHA ID-142; NMAM
7500), and the devices used to obtain samples. Indicate the sampling
duration and whether the samples represent a personal breathing zone or
a well-defined area. While OSHA requests all sampling results, it is
especially interested in personal breathing zone samples with a
duration of 120 minutes or greater. Report the detection limit and air
volume where the concentration of respirable crystalline silica falls
below the limit of detection. Indicate whether a laboratory that
analyzes air samples for respirable crystalline silica in accordance
with Appendix A of the silica standards evaluated the samples. Please
present sample results in units of micrograms of respirable crystalline
silica per cubic meter of air.
Additional Exposure Control Methods for Equipment or Tasks Listed on
Table 1
    OSHA requests information and data on the effectiveness of the
following control methods for reducing respirable crystalline silica
exposure for equipment and tasks listed on Table 1:
    1. Commercially available dust collection systems for stationary
masonry saws;
    2. Commercially available dust collection systems for handheld
power saws (any blade diameter), including handheld masonry saws;
    3. Commercially available dust collection systems for walk-behind
saws, including ``soft cut'' saws used for cutting ``green'' concrete
(i.e., concrete that has set but has not fully cured);
    4. Commercially available dust collection systems for drivable
saws;
    5. Commercially available dust collection systems for rig-mounted
core saws or drills;
    6. Integrated water delivery systems for handheld and stand-mounted
drills (including impact and rotary hammer drills);
    7. Commercially available dust collection systems incorporating
hollow drill bits for handheld and stand-mounted drills (including
impact and rotary hammer drills), including information on any
relationship between the drill bit size and the amount of airborne
respirable crystalline silica generated or the performance of
engineering controls;
    8. Commercially available dust collection systems, with or without
filter-cleaning mechanisms, for cordless handheld drills;
    9. Integrated water delivery systems for dowel drilling rigs for
concrete, including information on any relationship between drill bit
size and the amount of airborne respirable crystalline silica generated
or the performance of engineering controls;
    10. Commercially available dust collection systems with general
purpose filters instead of filters with 99% or greater efficiency;
    11. Commercially available dust collection systems equipped with
cyclonic pre-separators--instead of filter-cleaning mechanisms--for
handheld power saws (any blade diameter), handheld and stand-mounted
drills (including impact and rotary hammer drills), jackhammers and
handheld powered chipping tools, and walk-behind milling machines and
floor grinders;
    12. Floor fans or pedestal fans positioned to disperse dust away
from workers when using handheld power tools, including handheld power
saws (any blade diameter), handheld and stand-mounted drills (including
impact and rotary hammer drills), and jackhammers and handheld powered
chipping tools; and
    13. Any other exposure control methods that you believe should be
included for equipment or tasks listed on Table 1.
Additional Equipment or Tasks To Include on Table 1
    OSHA requests information and data on the effectiveness of the
following exposure control methods for equipment or tasks not listed on
Table 1:
    14. Commercially available dust collection systems for power
sanders (e.g., belt sanders, orbital sanders);
    15. Commercially available dust collection systems for power paint
scrapers;
    16. Commercially available hoods with dust collection systems for
reciprocating saws;
    17. Integrated water delivery systems for wire saws; and
    18. Wet methods, commercially available dust collection systems,
commercially available dust suppression compounds, or work practices
that minimize generation of dust for clean-up tasks, including changing
or cleaning filters in dust collection systems.
    OSHA requests information and data on the effectiveness of any
exposure control methods for the following equipment or tasks not
listed on Table 1:
    19. Mixing of dry materials containing crystalline silica (e.g.,
mortar, plaster, drywall compound, fireproofing, exterior insulation
and finishing system base and finish coats);
    20. Application of shake (e.g., coloring and/or texturizing
material) on poured concrete floors;
    21. Use of chainsaws to cut silica-containing materials;
    22. Use of powered sweepers (e.g., trucks equipped with rotating
brushes) to clean surfaces;
    23. Application of dry-mix or wet-mix shotcrete;
    24. Drywall finishing; OSHA did not include drywall finishing on
Table 1 because use of drywall compounds containing silica only as a
trace contaminant was generally expected to result in low exposures
even without additional controls. However, the agency recognizes that
some drywall finishing may involve compounds with higher or unknown
silica content, or circumstances that may warrant concern for exposure
above the PEL;
    25. Demolition of silica-containing materials using manual tools
(e.g., sledgehammer, mason hammer, pry bar, chisel); and
    26. Any other equipment or task you believe should be included on
Table 1.

B. Additional Requests

    27. OSHA requests information on stakeholders' experience with
Table 1 controls, including any challenging aspects of implementing
specified controls; situations where specified controls were not
available; and situations where specified controls were infeasible, but
alternative controls were feasible and effective;
    28. OSHA requests any alternative names used by workers or
manufacturers to describe the tasks and equipment on Table 1 in
different industry sectors or areas of the country;
    29. Employers covered by the respirable crystalline silica standard
for general industry and maritime have the option to follow Table 1 and
the standard for construction where the task performed is
indistinguishable from a construction task listed on Table 1, and

the task will not be performed regularly in the same environment and
conditions (29 CFR 1910.1053(a)(3)). Are there any other circumstances
where similar flexibility would benefit employers while maintaining
protections for workers? Describe those circumstances, state your
reasoning, and include any relevant data;
    30. OSHA requests information on any economic impacts that should
be considered in determining whether to update Table 1 or broaden the
circumstances under which general industry and maritime employers could
comply with the silica standard for construction. Include quantitative
safety and health benefits (e.g., information on the duration and
magnitude of workers' silica exposure), cost savings (e.g., lower
operations costs, more efficient use of capital, less expensive
equipment, increased productivity, decreased need for exposure
monitoring), and costs (e.g., increased compliance costs, decreases in
productivity, increased need for exposure monitoring); and
    31. The Regulatory Flexibility Act (5 U.S.C. 601, as amended)
requires OSHA to assess the impact of proposed and final rules on small
entities. How many and what kinds of small businesses, or other small
entities, could be affected if OSHA decides to revise Table 1 and
related provisions in 29 CFR 1910.1053, 1915.1053, or 1926.1153?
Describe any such effects, including the size and scope of operation
for affected small entities and the likely technical, economic, and
safety impacts for those entities. Explain how answers to any of the
questions in this RFI would be different for small entities, and
describe any problems or issues related to Table 1 that are unique to
small entities.

Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice pursuant to 29 U.S.C. 653, 655, 657; 33 U.S.C. 941; 40 U.S.C.
3704 et seq.; Secretary of Labor's Order 1-2012 (77 FR 3912, 1/25/
2012); and 29 CFR part 1911.

    Signed at Washington, DC, on August 9, 2019.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2019-17450 Filed 8-14-19; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35687-35688]
[FR Doc No: 2012-14487]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0564]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Dietary Supplement Labeling Requirements and
Recommendations Under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (the DSNDCPA) and the guidance document entitled
``Guidance for Industry: Questions and Answers Regarding the Labeling
of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.''

DATES: Submit either electronic or written comments on the collection
of information by August 13, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Dietary Supplement Labeling Requirements and Recommendations Under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act--
(OMB Control Number 0910-0642)--Extension

    In 2006, the DSNDCPA (Pub. L. 109-462, 120 Stat. 3469) amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to
serious adverse event reporting for dietary supplements and
nonprescription drugs marketed without an approved application. The
DSNDCPA also amended the FD&C Act to add section 403(y) (21 U.S.C.
343(y)), which requires the label of a dietary supplement marketed in
the United States to include a domestic address or domestic telephone
number through which the product's manufacturer, packer, or distributor
may receive a report of a serious adverse event associated with the
dietary supplement.
    In the Federal Register of September 1, 2009 (74 FR 45221), FDA
announced the availability of a guidance document entitled, ``Guidance
for Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.'' The guidance document contains
questions and answers related to the labeling requirements in section
403(y) of the FD&C Act and provides guidance to industry on the use of
an explanatory statement before the domestic address or telephone
number. The guidance document provides the Agency's interpretation of
the labeling requirements for section 403(y) of the FD&C Act and the
Agency's views on the information that should be included on the label.
The Agency believes that the guidance will enable persons to meet the
criteria for labeling that are established in section 403(y) of the
FD&C Act.
    FDA estimates the burden of this collection of information as
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                  respondent \2\                    disclosure
----------------------------------------------------------------------------------------------------------------
Domestic address or phone number           1,460             3.8           5,560             0.5           2,780
 labeling requirement (21 U.S.C.
 343(y))........................
FDA recommendation for label               1,460             3.8           5,560             0.5           2,780
 statement explaining purpose of
 domestic address or phone
 number.........................
                                 -------------------------------------------------------------------------------

    Total.......................  ..............  ..............  ..............  ..............          5,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Number has been rounded to the nearest tenth.

    The labeling requirements of section 403(y) of the FD&C Act became
effective on December 22, 2007, although FDA exercised enforcement
discretion until September 30, 2010, to enable all firms to meet the
labeling requirements for dietary supplements. FDA estimates that all
labels required to include the domestic address or telephone number
pursuant to section 403(y) of the FD&C Act have been revised by the
effective date. Thus, in succeeding years, the Agency estimates that
the burden hours associated with the labeling requirements of section
403(y) of the FD&C Act and the Agency's recommendations on the use of
an explanatory statement will apply only to new product labels. Based
on the A.C. Nielsen Sales Scanner Data, FDA estimated that the number
of dietary supplement SKUs for which sales of the products are greater
than zero is 55,600. Assuming that the flow of new products is 10
percent per year, then approximately 5,560 new dietary supplement
products will come on the market each year. FDA also estimates that
there are about 1,460 dietary supplement manufacturers, re-packagers,
re-labelers, and holders of dietary supplements. Assuming the
approximately 5,560 new products are split equally among the firms,
then each firm would prepare labels for close to four new products per
year (5,560 new products/1,460 firms is approximately 3.8 labels per
firm). Thus, the estimated total annual disclosures are 5,560 (1,460
firms x 3.8 labels per year = 5,560).
    The Agency expects that firms prepare the required labeling for
their products in a manner that takes into account at one time all
information required to be disclosed on their product labels. Based
upon its knowledge of food and dietary supplement labeling, FDA
estimates that firms would require less than 0.5 hour per product to
comply with the requirement to include the domestic address or
telephone number pursuant to section 403(y) of the FD&C Act. The total
hour burden of this task is shown in row 1 of table 1.
    FDA estimates that all firms will include an explanatory statement
on the label, which lets consumers know the purpose of the domestic
address or telephone number on the label of the dietary supplement
product. Based upon its knowledge of food and dietary supplement
labeling, FDA estimates that firms would require less than 0.5 hour per
product to comply with the Agency's recommendations on the use of an
explanatory statement. The total hour burden of this task is shown in
row 2 of table 1.
    The total reporting hour burden is 5,560 hours, which equals the
burden for the required domestic address or telephone (2,780) plus the
burden for the explanatory statement before the domestic address or
telephone number (2,780).

    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14487 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P


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

1. Agency/ Subagency originating request EPA/ OSWER/ Office of Solid Waste 2. OMB control number b. G None a 2050 0152 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. X Other Specify:

7. Title: State Program Adequacy Determination: Municipal Solid Waste Landfills ( MSWLFs) and Non municipal, Non hazardous Waste Disposal Units that Receive Conditionally Exempt Small Quantity Generator ( CESQG) Hazardous Waste 8. Agency form number( s) ( If applicable) ICR#: 1608.03 9. Keywords:

Solid Waste, Subtitle D, CESQG, SIR, State Implementation Rule, Conditionally Exempt Small Quantity Generator, Municipal 10. Abstract To avail owners and operators of flexibility in meeting the requirements of 40 CFR Part 257, Subpart B and 40 CFR Part 258, states must comply with requirements in the State Implementation Rule ( SIR) permit program approval process. To determine the adequacy of state permit programs to ensure that owners and operators comply with the federal criteria under Part 257, Subpart B and Part 258, EPA must collect and analyze permit program applications from states.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. Business or other for profit e. X Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. X Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 18 b. Total annual responses 6 1. Percentage of these responses collected electronically 0% c. Total hours requested 3189 d. Current OMB inventory 6510 e. Difference 3321 f. Explanation of difference 1. Program Change 0 2. Adjustment 3321 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

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

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Steven J Levy Phone: ( 703)  308 7267 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

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

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

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

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

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

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

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

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

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

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

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

Signature of Program Official Thea McManus, Acting Director Office of Solid Waste Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

OMB 83 I ( Instructions) 10/ 95


[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[Notices]
[Page 11178-11181]
[DOCID:fr29fe08-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57359; File No. SR-Phlx-2008-07]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Create a Delta Hedging Exemption From Equity Options Position Limits

February 20, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 12, 2008, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by Phlx. The
Exchange has filed the proposal as a ``non-controversial'' rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Phlx Rule 1001 to establish a delta
hedge exemption from equity options position limits.\5\ The text of the
proposed rule change is available at Phlx, the Commission's Public
Reference Room, and http://www.phlx.com.
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    \5\ The proposed filing is being done pursuant to an industry-
wide initiative, under the auspices of the Intermarket Surveillance
Group (``ISG''), to establish comparable delta hedge exemption rules
among exchanges. ISG is a regulatory information-sharing
organization comprised of all U.S. national securities exchanges and
national securities associations, most U.S. futures exchanges, and
non-U.S. exchanges and associations trading securities and related
products.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Phlx included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed

rule change. The text of these statements may be examined at the places
specified in Item IV below. Phlx has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to permit expanded hedge
positions pursuant to a carefully crafted delta hedge exemption from
equity options position limits in Phlx Rule 1001.
    Background. All options traded on the Exchange are subject to
position and exercise limits, as provided under Phlx Rules 1001 and
1002, respectively.\6\ Position limits are imposed, generally, to
maintain fair and orderly markets for options and other securities by
limiting the amount of control one or more affiliated persons or
entities may have over one particular options class or the security or
securities that underlie that options class.
---------------------------------------------------------------------------

    \6\ Position and exercise limits for index options are provided
separately under Phlx Rules 1001A and 1002A.
---------------------------------------------------------------------------

    Over the years, Phlx has increased the size of options position and
exercise limits, as well as the size and scope of available hedge
exemptions to the applicable position limits.\7\ These hedge exemptions
generally require a one-to-one hedge (e.g., one stock option contract
must be hedged by the number of shares underlying the options contract,
typically 100 shares). In practice, however, many firms do not hedge
their options positions in this manner. Instead, these firms engage in
what is commonly known as ``delta hedging.'' Delta hedging varies the
number of shares of the underlying security used to hedge an options
position based upon the relative sensitivity of the value of the option
contract to a change in the price of the underlying security.\8\ The
Exchange believes that delta hedging is a widely accepted method for
risk management.
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    \7\ See Securities Exchange Act Release Nos. 51071 (January 21,
2005), 70 FR 4911 (January 31, 2005) (SR-Phlx-2005-05); 55285
(February 13, 2007), 72 FR 8053 (February 22, 2007) (SR-Phlx-2007-
10); 45899 (May 9, 2002), 67 FR 34980 (May 16, 2002) (SR-Phlx-2002-
33); 42386 (February 4, 2000), 65 FR 6680 (February 10, 2000) (SR-
Phlx-98-55); and 40400 (September 3, 1998), 63 FR 48777 (September
11, 1998) (SR-Phlx-98-36).
    \8\ To illustrate, a stock option contract with a delta of .5
will move $0.50 for every $1.00 move in the underlying stock.
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    Delta Neutral-Based Equity Hedge Exemption. The Exchange proposes
to adopt a new exemption from equity options position and exercise
limits \9\ for positions held by Phlx members and certain of their
affiliates that are ``delta neutral'' \10\ under a ``permitted pricing
model'' (as defined below), subject to certain conditions
(``Exemption''). The proposed Exemption would apply only to equity
options (stock options and options on exchange-traded funds
(``ETFs'')).\11\
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    \9\ Phlx Rule 1002 establishes exercise limits for an option at
the same level as the option's position limit under Phlx Rule 1001;
therefore, no changes are proposed to Rule 1002.
    \10\ The term ``delta neutral'' is defined in proposed
Commentary .09(a) to Phlx Rule 1001 as referring to an equity option
position that is hedged, in accordance with a permitted pricing
model, by a position in the underlying security or one or more
instruments relating to the underlying security, for the purpose of
offsetting the risk that the value of the option position will
change with incremental changes in the price of the security
underlying the option position.
    \11\ The Exchange intends to submit a separate proposed rule
change, in conjunction with an industry initiative, to adopt a delta
neutral-based hedge exemption for certain index options and to
expand the delta neutral-based hedge exemption for ETF options to
allow highly correlated instruments to be included in any ETF option
net delta calculation.
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    Any equity option position that is not delta neutral would be
subject to position and exercise limits, subject to the availability of
other exemptions. Only the ``option contract equivalent of the net
delta'' of such position would be subject to the appropriate position
limit.\12\
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    \12\ Under proposed Commentary .09(b) to Phlx Rule 1001, the
term ``options contract equivalent of the net delta'' is defined as
the net delta divided by the number of shares underlying the option
contract, and the term ``net delta'' is defined as, at any time, the
number of shares (either long or short) required to offset the risk
that the value of an equity option position will change with
incremental changes in the price of the security underlying the
option position, as determined in accordance with a permitted
pricing model.
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    Only financial instruments relating to the security underlying an
equity options position could be included in any determination of an
equity options position's net delta or whether the options position is
delta neutral. In addition, members could not use the same equity or
other financial instrument position in connection with more than one
hedge exemption. Therefore, a stock position used as part of a delta
hedging strategy could not also serve as the basis for any other equity
hedge exemption.
    Permitted Pricing Model. Under the proposed rule, the calculation
of the delta for any equity option position, and the determination of
whether a particular equity option position is delta neutral, must be
made using a permitted pricing model. A ``permitted pricing model'' is
defined in proposed Commentary .09(c) to mean the pricing model
maintained and operated by The Options Clearing Corporation (``OCC'')
and the pricing models used by: (i) A member or its affiliate subject
to consolidated supervision by the Commission pursuant to Appendix E of
Rule 15c3-1 under the Act; (ii) a financial holding company (``FHC'')
or a company treated as an FHC under the Bank Holding Company Act of
1956, or its affiliate subject to consolidated holding company group
supervision; \13\ (iii) a Commission-registered OTC derivatives dealer;
\14\ and (iv) a national bank.\15\
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    \13\ The pricing model of an FHC or of an affiliate of an FHC
would have to be consistent with: (i) The requirements of the Board
of Governors of the Federal Reserve System (``Fed''), as amended
from time to time, in connection with the calculation of risk-based
adjustments to capital for market risk under capital requirements of
the Fed, provided that the member or affiliate of a member relying
on this exemption in connection with the use of such model is an
entity that is part of such company's consolidated supervised
holding company group; or (ii) the standards published by the Basel
Committee on Banking Supervision, as amended from time to time and
as implemented by such company's principal regulator, in connection
with the calculation of risk-based deductions or adjustments to or
allowances for the market risk capital requirements of such
principal regulator applicable to such company--where ``principal
regulator'' means a member of the Basel Committee on Banking
Supervision that is the home country consolidated supervisor of such
company--provided that the member or affiliate of a member relying
on this exemption in connection with the use of such model is an
entity that is part of such company's consolidated supervised
holding company group. See proposed Commentary .09(c)(3) to Phlx
Rule 1001.
    \14\ The pricing model of a Commission-registered OTC
derivatives dealer would have to be consistent with the requirements
of Appendix F to Rule 15c3-1 and Rule 15c3-4 under the Act, as
amended from time to time, in connection with the calculation of
risk-based deductions from capital for market risk thereunder. Only
an OTC derivatives dealer and no other affiliated entity (including
a member) would be able to rely on this part of the Exemption. See
proposed Commentary. 09(c)(4) to Phlx Rule 1001.
    \15\ The pricing model of a national bank would have to be
consistent with the requirements of the Office of the Comptroller of
the Currency, as amended from time to time, in connection with the
calculation of risk-based adjustments to capital for market risk
under capital requirements of the Office of the Comptroller of the
Currency. Only a national bank and no other affiliated entity
(including a member) would be able to rely on this part of the
Exemption. See proposed Commentary .09(c)(5) to Phlx Rule 1001.
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    Aggregation of Accounts. Members and non-member affiliates relying
on the Exemption would be required to ensure that the permitted pricing
model is applied to all positions in or relating to the security
underlying the relevant options position that are owned or controlled
by the member, or its affiliates.
    However, the net delta of an options position held by an entity
entitled to rely on the Exemption, or by a separate

and distinct trading unit of such entity, may be calculated without
regard to positions in or relating to the security underlying the
option position held by an affiliated entity or by another trading unit
within the same entity, provided that: (i) The entity demonstrates to
the Exchange's satisfaction that no control relationship, as defined in
Commentary .06 to Phlx Rule 1001, exists between such affiliates or
trading units, and (ii) the entity has provided the Exchange written
notice in advance that it intends to be considered separate and
distinct from any affiliate, or, as applicable, which trading units
within the entity are to be considered separate and distinct from each
other for purposes of the Exemption.\16\
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    \16\ See proposed Commentary .09(d) to Phlx Rule 1001.
---------------------------------------------------------------------------

    The Exchange has set forth, in Phlx Memorandum No. 0025-08
(``Aggregation Memo''), the conditions under which it will deem no
control relationship to exist between affiliated broker-dealers, and
between separate and distinct trading units within the same broker-
dealer. Subsequent to this proposal the Exchange intends to update the
Aggregation Memo to clarify the inclusion of affiliated entities, not
only affiliated broker-dealers as in the current version of the
Aggregation Memo.
    Any member or non-member affiliate relying on the Exemption must
designate, by prior written notice to the Exchange, each trading unit
or entity whose options positions are required by Exchange rules to be
aggregated with the options positions of such member or non-member
affiliate relying on the Exemption for purposes of compliance with
Exchange position or exercise limits.\17\
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    \17\ See proposed Commentary .09(d)(3) to Phlx Rule 1001.
---------------------------------------------------------------------------

    Obligations of Members and Affiliates. Any member relying on the
Exemption would be required to provide a written certification to the
Exchange that it is using a permitted pricing model as defined in the
rule for purposes of the Exemption. In addition, by such reliance, such
member would authorize any other person carrying for such member an
account including, or with whom such member has entered into, a
position in or relating to a security underlying the relevant option
position to provide to the Exchange or OCC such information regarding
such account or position as the Exchange or OCC may request as part of
the Exchange's confirmation or verification of the accuracy of any net
delta calculation under this exemption.\18\
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    \18\ See proposed Commentary .09(e) to Phlx Rule 1001.
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    The options positions of a non-member affiliate relying on the
Exemption must be carried by a member with whom it is affiliated. A
member carrying an account that includes an equity option position for
a non-member affiliate that intends to rely on the Exemption would be
required to obtain from such non-member affiliate a written
certification that it is using a permitted pricing model as defined in
the rule for purposes of the Exemption.\19\
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    \19\ In addition, the member would be required to obtain from
such non-member affiliate a written statement confirming that such
non-member affiliate: (a) Is relying on the Exemption; (b) will use
only a permitted pricing model for purposes of calculating the net
delta of its option positions for purposes of the Exemption; (c)
will promptly notify the member if it ceases to rely on the
Exemption; (d) authorizes the member to provide to the Exchange or
the OCC such information regarding positions of the non-member
affiliate as the Exchange or OCC may request as part of the
Exchange's confirmation or verification of the accuracy of any net
delta calculation under the Exemption; and (e) if the non-member
affiliate is using the OCC Model, has duly executed and delivered to
the Exchange such documents as the Exchange may require to be
executed and delivered to the Exchange as a condition to reliance on
the Exemption. See proposed Commentary .09(e)(3)(ii) to Phlx Rule
1001.
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    Reporting. Under proposed Commentary .09(f) to Phlx Rule 1001, each
member relying on the Exemption would be required to report, in
accordance with Phlx Rule 1003,\20\ (i) all equity option positions
(including those that are delta neutral) that are reportable
thereunder, and (ii) on its own behalf or on behalf of a designated
aggregation unit pursuant to Commentary .09(d), for each such account
that holds an equity option position subject to the Exemption in excess
of the levels specified in Phlx Rule 1001, the net delta and the
options contract equivalent of the net delta of such position.
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    \20\ Phlx Rule 1003 requires, among other things, that members
report to the Exchange aggregate long or short positions on the same
side of the market of 200 or more contracts of any single class of
options contracts dealt in on the Exchange.
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    The Exchange and other self-regulatory organizations are working on
modifying the Large Options Position Report (``LOPR'') system and/or
OCC reports to allow a member to indicate that an equity options
position is delta neutral.
    Records. Under proposed Commentary .09(g) to Phlx Rule 1001, each
member relying on the Exemption would be required to (i) retain, and
would be required to undertake reasonable efforts to ensure that any
non-member affiliate of the member relying on the exemption retains, a
list of the options, securities and other instruments underlying each
options position net delta calculation reported to the Exchange
hereunder, and (ii) produce such information to the Exchange upon
request.\21\
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    \21\ A member would be authorized to report position information
of its non-member affiliate pursuant to the written statement
required under proposed Commentary .09(e)(3)(ii) to Phlx Rule 1001.
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    Reliance on Federal Oversight. As provided under proposed
Commentary .09(c) of Phlx Rule 1001, a permitted pricing model includes
proprietary pricing models used by members and affiliates that have
been approved by the Commission, the Fed or another federal financial
regulator. In adopting the proposed Exemption, the Exchange would be
relying upon the rigorous approval processes and ongoing oversight of a
federal financial regulator. The Exchange notes that it would not be
under any obligation to verify whether a member's or its affiliate's
use of a proprietary pricing model is appropriate or yielding accurate
results.
    The Exchange will announce the operative date of the proposed rule
change in a regulatory circular to be published no later than 30 days
after the Commission issues a release regarding the proposal herein.
The operative date shall be no later than 15 days after publication of
the regulatory circular.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act,\22\ in general, and furthers the objectives of
Section 6(b)(5) of the Act,\23\ in particular, in that it is designed
to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts and practices, 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. The Exchange believes the proposed delta neutral-based hedge
exemption from equity options position and exercise limits is
appropriate in that it is based on a widely accepted risk management
method used in options trading. Also, the Commission has previously
stated its support for recognizing options positions hedged on a delta
neutral basis as properly exempted from position limits.\24\
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    \22\ 15 U.S.C. 78f(b).
    \23\ 15 U.S.C. 78f(b)(5).
    \24\ See Securities Exchange Act Release No. 40594 (October 23,
1998), 63 FR 59362, 59380 (November 3, 1998) (S7-30-97) (adopting
rules relating to OTC Derivatives Dealers).

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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \25\ and Rule 19b-4(f)(6) thereunder.\26\
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    \25\ 15 U.S.C. 78s(b)(3)(A).
    \26\ 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.\27\
However, Rule 19b-4(f)(6)(iii) \28\ 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 Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because such waiver
would allow the Exchange to implement the delta hedging exemption from
equity options position limits without needless delay. The Commission
notes that it recently approved a substantially similar proposal filed
by the Chicago Board Options Exchange, Incorporated.\29\ The Commission
believes that Phlx's proposal to create a delta hedging exemption from
equity options position limits raises no new issues. For these reasons,
the Commission designates the proposed rule change to be operative upon
filing with the Commission.\30\
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    \27\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of 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 the five-day pre-filing
notice requirement.
    \28\ Id.
    \29\ See Securities Exchange Act Release No. 56970 (December 14,
2007), 72 FR 72428 (December 20, 2007) (SR-CBOE-2007-99).
    \30\ 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 may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2008-07 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2008-07. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of Phlx. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2008-07 and should be
submitted on or before March 21, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
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    \31\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-3843 Filed 2-28-08; 8:45 am]

BILLING CODE 8011-01-P