  SEQ CHAPTER \h \r 1

									February 5, 2007

MEMORANDUM

SUBJECT:		Science Chapter: Revised Environmental Fate Studies and
Environmental Fate Assessment of Propylene Glycol

FROM			A. Najm Shamim, Ph.D., Chemist

			Regulatory Management Branch II

			Antimicrobials Division (7510P)

TO:			Sanyvette Williams, D.V.M., Science Coordinator

			Antimicrobials Division (7510P)

				And

			Michelle Centra, Chemical Review Manager

Diane Isbell, Acting Team Leader

Mark Hartman, Branch Chief

			Regulatory Management Branch II

			Antimicrobials Division (7510P)

	Environmental Fate Science Chapter and Fate Assessment on Propylene
Glycol is submitted for Reregistration Eligibility Decision (RED).

EXECUTIVE SUMMARY

	Environmental Fate Assessment:

	For the assessment of environmental health risks, the Agency has relied
on data and fate properties of propylene glycol obtained from published
literature.  Propylene glycol has a high vapor pressure (0.129 mm Hg at
25 oC) in the atmosphere, however, this poses no concern because it
degrades rapidly (estimated half-life of 32 hours) as a result of an
induced photochemical reaction with hydroxyl radicals.  This chemical
has a low absorptivity to sediment and is consequently very mobile in
soil.  Propylene glycol rapidly degrades to CO2 in soil within 4 days
under aerobic conditions and within 4-9 days under anaerobic conditions.
 Degradation does not appear to be dependent on high glycol
concentrations.  It is highly miscible in water and does not hydrolyze
due to the lack of a hydrolysable hydrogen within its structure, an
aliphatic trihydroxy chemical.  For these reasons, the Agency has
granted a data waiver from the requirement of an aquatic hydrolysis
study for propylene glycol.  The low octanol/water partition coefficient
(log KOW of -0.92) indicates that propylene glycol is not likely to
bioaccumulate in aquatic organisms such as fish and its low Henry’s
Law Constant (air/water partition coefficient (1.31 x 10-10 atm-cu
m/mole at 25 oC) limits the potential to partition from surface water to
air.  These data suggest that aquatic hydrolysis, oxidation,
volatilization, bioconcentration, and absorptivity to soil are not
expected to be significant fate processes for propylene glycol and
therefore, the presence of this chemical in the environment does not
pose a risk of concern.

	Environmental Fate Science Chapter For Propylene Glycol:

	Propylene Glycol is registered with OPP as an active product and is
used as a solvent in foods, pharmaceuticals, and cosmetics.  Propylene
glycol has a major use as a deicing fluid.  OPP has no data base on
environmental fate studies for propylene glycol as a solvent or deicing
fluid.  For the reregistration eligibility decision (RED) process the
Agency has relied on open literature and fate properties of Propylene
Glycol obtained from the open literature. The following fate properties
were obtained from an open literature search.

	Vapor Pressure: 0.129 mm Hg at 25 oC (2)

	Henry law Constant (air/water partition coefficient):1.31 x 10-10
atm-cu m/mole at 25 oC (1)

	KOC (organic carbon ratio in soil): 8 (3)(4) *

	Low absorptivity and therefore very high mobility in soil

	Log KOW (octanol/water partition coefficient):  - 0.92 (1)

	100% degradation in 4 days (aerobic conditions) and 4-9 days (anaerobic
conditions)(1)

	Miscible in water (1)

	Does not undergo direct air photolysis, but half life in air
(estimated) is 32 hours due to induced photochemical reaction of
atmospheric hydroxyl radical.  Physical removal of dipropylene glycol
from air by precipitation possible.(2)

	BCF < 1 (1)

*  The Koc of propylene glycol is estimated as 8 (SRC), using a log Kow
of -0.92 (3) and a regression-derived equation (4)  According to a
classification scheme (5), this estimated Koc value suggests that
propylene glycol is expected to have very high mobility in soil (SRC).

Aquatic hydrolysis, oxidation, vitalization, bioconcentration, and
absorption to sediment are not expected to be significant fate processes
for propylene glycol because of its high water solubility and lack of
hydrolyzable hydrogen.  Because of a low Henry Law Constant, it has a
low potential to partition from surface water to air.  Propylene glycol
has low Kd and therefore very high mobility in soil.  Propylene glycol
rapidly degrades to CO2 in soil without any lag time in 4 days (aerobic
conditions).  Degradation does not appear to depend on high glycol
concentrations.  The low KOW indicates that it is not likely to
bioaccumulate in aquatic organisms like fish.  With a vapor pressure of
0.129 mm Hg at 25 oC propylene glycol exists almost entirely in the
vapor phase in the atmosphere and can degrade rapidly by reaction with
photochemically produced hydroxyl radicals (half-life of 32 hours).

	Surface Water and Ground Water Contamination:

Due to the use of propylene glycol as a deicing fluid there is a
scenario for ground water and surface water contamination.  Although,
propylene glycol is biodegradeable in aerobic soil and in water and
therefore has a low potential to migrate to ground water.

					BIBLIOGRAPHY

	Hazard Substances Databank (HSDB), A Database of the National Library
of Medicine’s

TOXNET System.

	Environmental Fate Database.  A Database of the Syracuse Research
Corporation (SRC).

         Hansch C. et al; (1995). Exploring QWAR. Hysdrohobic,
Electronic, and Steric Constants.  ACS Prof Ref Book.  Heller SR,
consult. Ed., Washington, Dc: Amer Chem Soc p.7.

4.         Lyman, WJ et al; (1990). Handbook of Chemical Property
Estimation Methods. Washington, DC:  Amer Chem Soc. p. 4-9.

5. 	Swann, RL et al; (1983). Res Rev 85: 17-28.


[Federal Register Volume 80, Number 25 (Friday, February 6, 2015)]
[Notices]
[Pages 6707-6708]
[FR Doc No: 2015-02489]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9922-60-OGC]

Proposed Settlement Agreement, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency.

ACTION: Notice of proposed settlement agreement; request for public
comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA'' or the ``Act''), notice is hereby given of a proposed
settlement agreement to address a lawsuit filed by Finger Lakes Zero
Waste Coalition, Inc. and Katherine M. Bennett Roll (collectively
Plaintiffs''): Finger Lakes Zero Waste Coalition, Inc. v. McCarthy, No.
6:14-cv-06542 (W.D.N.Y.). On September 16, 2014, Plaintiffs filed this
complaint alleging that Gina McCarthy, in her official capacity as
Administrator of the United States Environmental Protection Agency
(``EPA''), failed to perform a non-discretionary duty to grant or deny
within 60 days a petition submitted by Plaintiffs. In their petition,
Plaintiffs requested that EPA object to a CAA Title V permit issued by
the New

York State Department of Environmental Conservation to Seneca Energy
II, LLC, for purposes of operating a landfill gas-to-energy facility in
Stanley, New York. The proposed settlement agreement would establish a
deadline for EPA to respond to this petition.

DATES: Written comments on the proposed settlement agreement must be
received by March 9, 2015.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2015-0080, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Zach Pilchen, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement Agreement

    This proposed settlement agreement would resolve a lawsuit filed by
Plaintiffs seeking to compel the Administrator to take actions under
CAA section 505(b)(2). Under the terms of the proposed settlement
agreement, EPA would agree to sign a response to the petition by June
30, 2015. The proposed settlement agreement also provides for the
possibility that circumstances beyond EPA's reasonable control could
delay compliance with the June 30, 2015 deadline, and provides a
framework for extending that deadline. In addition, the proposed
settlement agreement also enumerates Plaintiffs' costs of litigation,
including attorney fees, and provides that payment of those costs will
constitute a full and complete settlement of all of Plaintiffs' costs
in connection with this litigation.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed settlement agreement from persons who are not named as parties
or intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed settlement
agreement if the comments disclose facts or considerations that
indicate that such consent is inappropriate, improper, inadequate, or
inconsistent with the requirements of the Act. Unless EPA or the
Department of Justice determines that consent to this settlement
agreement should be withdrawn, the terms of the settlement agreement
will be affirmed.

II. Additional Information About Commenting on the Proposed Settlement
Agreement

A. How can I get a copy of the proposed settlement agreement?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2015-0080) contains a copy of the proposed settlement
agreement. The official public docket is available for public viewing
at the Office of Environmental Information (OEI) Docket in the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The EPA Docket Center Public Reading Room 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 (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
www.regulations.gov. You may use the www.regulations.gov to submit or
view public comments, access the index listing of the contents of the
official public docket, and access those documents in the public docket
that are available electronically. Once in the system, key in the
appropriate docket identification number then select ``search.''
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or CD
ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: January 29, 2015.
Brian L. Doster,
Acting Associate General Counsel.
[FR Doc. 2015-02489 Filed 2-5-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 15, 2008 (Volume 73, Number 241)]
[Notices]
[Page 76080-76081]
[DOCID:fr15de08-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59066; File No. SR-ISE-2008-78]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Order Approving Proposed Rule Change Relating to Quoting
Obligations for Competitive Market Makers

December 8, 2008.

I. Introduction

    On October 21, 2008, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change relating to the Exchange's
quoting obligations for Competitive Market Makers (``CMMs''). The
proposed rule change was published for comment in the Federal Register
on November 3, 2008.\3\ The Commission received no comments on the
proposal. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 58861 (October 27,
2008), 73 FR 65432 (the ``Notice'').
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II. Description of the Proposal

    The Exchange proposes to amend ISE Rules 713, 804 and 805 to change
the quoting obligation for the Exchange's CMMs. ISE currently requires
CMMs to participate in the opening and maintain continuous quotations
in all of the series of at least 60 per cent of the options classes in
the bin or 60 classes, whichever is less. In addition, if a CMM chooses
to quote any series of an options class above and beyond this minimum
requirement, it must then maintain continuous quotations in all of the
series of that class throughout that trading day. In September 2007,
the Exchange initiated a pilot to reduce the quoting obligations for
CMMs in 20 options classes.\4\ Under the Pilot, CMMs were required to
maintain quotations in only 60 per cent of the series of an options
class overlying the pilot program securities. The Pilot recently
expired and the Exchange now proposes to change the quoting
requirements for CMMs on a permanent basis.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 56444 (September 14,
2007), 72 FR 54089 (September 21, 2007) (Order Granting Approval of
SR-ISE-2007-45 Relating to a Quote Mitigation Plan for Competitive
Market Makers) (the ``Pilot'').
---------------------------------------------------------------------------

    The Exchange does not believe that the reduced quoting obligations
adopted as part of the Pilot have had any negative effect on the
quality of its markets.\5\ Therefore, ISE proposes to adopt the 60 per
cent standard for all options series on a permanent basis, except for
CMMs that receive preferenced order flow. The Exchange proposes that a
CMM will be required to maintain continuous quotations in at least 90%
of the series of any option class in which it receives preferenced
orders.
---------------------------------------------------------------------------

    \5\ According to the Exchange, in practice, market makers simply
widen their quotations when they do not want to trade in a
particular series, so requiring them to maintain continuous
quotations in all series merely increases capacity requirements for
the market makers.
---------------------------------------------------------------------------

    The Exchange also proposes to lower the minimum number of options
classes that a CMM is required to quote from 60 to 40. The Exchange
believes that lowering the requirement will attract additional market
making participants on the ISE.
    Finally, the Exchange proposes to amend Rule 805 (Market Maker
Orders) regarding the percentage of volume a CMM may execute in options
to which it is not appointed. Specifically, Rule 805 currently provides
that a CMM may execute up to 25% of its volume in options classes to
which it is not appointed. Because the Exchange is lowering the number
of appointed classes in which a CMM is required to quote, the Exchange
believes it is appropriate to base the 25% allowance on volume that is
executed while a CMM is actually fulfilling its market maker quotation
obligations.

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\6\
In particular, the Commission finds that the proposal is consistent
with Section 6(b)(5) of the Act,\7\ which requires that an exchange
have rules designed to promote just and equitable principles of trade,
to remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest.
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    \6\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the proposed rule change, which is
intended to reduce the number of options quotations required to be
submitted without adversely affecting the quality of the Exchange's
markets, is consistent with the Act. The Commission notes that the
Exchange has operated a one-year Pilot program that reduced the quoting
obligations for CMMs and during the Pilot period the Exchange did not
observe any adverse effect on its market.\8\ The Commission believes it
is appropriate to adopt the modified quotation obligations for CMMs on
a permanent basis. In addition, the Commission believes that it is
appropriate to reduce the quoting obligations of a CMM because the
percentage of volume a CMM may

execute in options classes to which it is not appointed will be based
on volume that is executed in those options classes in which a CMM
maintains continuous quotes in fulfillment of its obligations as a
market maker.
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    \8\ The Commission notes that it has already approved internal
quote mitigation strategies on other exchanges that relieve some
market makers of the obligation to quote every series of every class
to which they are appointed. See Phlx Rule 1014(b)(ii)(D)(1) and
Amex Rule 994(c)(iv).
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    Finally, the Commission believes that it is appropriate to impose a
higher continuous quoting requirement on CMMs who receive preferenced
order flow because such CMMs receive the benefit of enhanced allocation
rights and therefore should assume an increased obligation to provide
continuous quotations. The Commission notes that a similar quotation
standard for preferred market makers was previously adopted on another
exchange.\9\
---------------------------------------------------------------------------

    \9\ See CBOE Rule 8.13(b)(iii) (requiring a preferred market-
maker to provide continuous electronic quotes in at least 90% of the
series of each class for which it receives preferred market-maker
orders).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-ISE-2008-78) be, and hereby
is, approved.
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-29559 Filed 12-12-08; 8:45 am]

BILLING CODE 8011-01-P