[Federal Register: November 10, 2008 (Volume 73, Number 218)]
[Notices]
[Page 66687]
[DOCID:fr10no08-92]

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DEPARTMENT OF TRANSPORTATION

[Docket No. OST-2007-27407]

National Surface Transportation Infrastructure Financing
Commission

AGENCY: Department of Transportation (DOT).

ACTION: Notice of meeting location and time.

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SUMMARY: This notice lists the location and time of the sixteenth
meeting of the National Surface Transportation Infrastructure Financing
Commission.

FOR FURTHER INFORMATION CONTACT: John V. Wells, Chief Economist, U.S.
Department of Transportation,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: By Federal Register Notice dated March 12,
2007, and in accordance with the requirements of the Federal Advisory
Committee Act (``FACA'') (5 U.S.C. App. 2) and the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for Users
(``SAFETEA-LU'') (Pub. L. 109-59, 119 Stat. 1144), the U.S. Department
of Transportation (the ``Department'') issued a notice of intent to
form the National Surface Transportation Infrastructure Financing
Commission (the ``Financing Commission''). Section 11142(a) of SAFETEA-
LU established the National Surface Transportation Infrastructure
Financing Commission and charged it with analyzing future highway and
transit needs and the finances of the Highway Trust Fund and with
making recommendations regarding alternative approaches to financing
surface transportation infrastructure.

Notice of Meeting Location and Time

    The Commissioners have agreed to hold their sixteenth meeting from
8:30 a.m. to 4 p.m. on Thursday, November 20, 2008, at the office of
the Information Technology and Innovation Foundation (ITIF), 1250 I
(``Eye'') Street, NW., Suite 200, Washington, DC 20005. The meeting
will be open to the public.
    If you need accommodations because of a disability or require
additional information to attend the meeting, please contact John V.
Wells, Chief Economist, U.S. Department of Transportation, (202) 366-
9224<EMAIL_ADDRESS>
    Issued on this 4th day of November 2008.
John V. Wells,
Chief Economist, U.S. Department of Transportation, Designated Federal
Official.
[FR Doc. E8-26694 Filed 11-7-08; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Pages 41852-41853]
[FR Doc No: 2022-14849]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0034]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 22 individuals from the
hearing requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. The exemptions enable these hard of hearing and deaf
individuals to operate CMVs in interstate commerce.

DATES: The exemptions are applicable on July 11, 2022. The exemptions
expire on July 11, 2024.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2022-0034, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

II. Background

    On June 3, 2022, FMCSA published a notice announcing receipt of
applications from 22 individuals requesting an exemption from the
hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in
interstate commerce and requested comments from the public (87 FR
33875). The public comment period ended on July 5, 2022, and one
comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would achieve
a level of safety equivalent to, or greater than, the level that would
be achieved by complying with Sec.  391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received one comment in this proceeding. One of the
applicants, Vikramdeep Singh, stated his that his name was spelled
incorrectly in the notice published on June 3, 2022 (87 FR 33875). The
spelling of Mr. Singh's name has been corrected in this notice
exempting him from the hearing standard in Sec.  391.41(b)(11).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on current medical information and literature, and the 2008
Evidence Report, ``Executive Summary on Hearing, Vestibular Function
and Commercial Motor Driving Safety.'' The evidence report reached two
conclusions regarding the matter of hearing loss and CMV driver safety:
(1) no studies that examined the relationship between hearing loss and
crash risk exclusively among CMV drivers were identified; and (2)
evidence from studies of the private driver's license holder population
does not support the contention that individuals with hearing
impairment are at an increased risk for a crash. In addition, the
Agency reviewed each applicant's driving record found in the Commercial
Driver's License Information System, for commercial driver's license
(CDL) holders, and inspections recorded in the Motor Carrier Management
Information System. For non-CDL holders, the Agency reviewed the
driving records from the State Driver's Licensing Agency. Each
applicant's record demonstrated a safe driving history. Based on an
individual assessment of each applicant that focused on whether an
equal or greater level of safety is likely to be achieved by permitting
each of these drivers to drive in interstate commerce as opposed to
restricting him or her to driving in intrastate commerce, the Agency
believes the drivers granted this exemption have demonstrated that they
do not pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the hearing standard in Sec.  391.41(b)(11) is likely
to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the

applicants in the exemption document and includes the following: (1)
each driver must report any crashes or accidents as defined in Sec.
390.5; (2) each driver must report all citations and convictions for
disqualifying offenses under 49 CFR 383 and 49 CFR 391 to FMCSA; and
(3) each driver is prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 22 exemption applications, FMCSA
exempts the following drivers from the hearing standard, Sec.
391.41(b)(11), subject to the requirements cited above:

Christopher Adams (IA), Jerritt Boehle (IL), Nathan Bohannon (TX), John
Darr (TN), Jeremy Earl (IL), Taniko Graham (TN), Rodney Henley (AL),
Quincy Hicks (VA), Omar Ibrahim (MN), Larry Mancill (MO), Glenn
McCormack (IL), Carlos Morales (FL), Steven Morris (TX), Tisha Simmons
(NC), Vikramdeep Singh (NY), Joseph Stanford, III (OR), Charles Stire
(KY), Amanda Sturdevant (TX), Robert Walker, Jr. (WA), Joshua Wayland
(IL), Kevin Young (AL), Karisa Zapotocky (CA)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-14849 Filed 7-12-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11362-11364]
[FR Doc No: 2019-05699]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85368; File No. SR-BX-2019-004]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Adopt a New SCAR
Routing Option Under Rule 4758

March 20, 2019.
    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 March 6, 2019, Nasdaq BX, Inc. (``BX'' 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
prepared by the Exchange. 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.

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

    The Exchange proposes to a proposal to [sic] adopt a new SCAR
routing option under Rule 4758.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange is proposing to adopt SCAR, a new order routing \3\
option under Rule 4758(a)(1)(A). The Exchange currently provides a
variety of routing options under Rule 4758(a)(1)(A). Routing options
may be combined with all available Order Types and Times-in-Force, with
the exception of Order Types and Times-in-Force whose terms are
inconsistent with the terms of a particular routing option. The SCAR
routing option would allow members to seek liquidity on the Exchange
and the other equity markets operated by Nasdaq, Inc., The Nasdaq Stock
Market (``Nasdaq'') and Nasdaq PSX (``PSX'' and together with Nasdaq
and the Exchange, the ``Nasdaq Affiliated Exchanges''). SCAR will
operate in the same manner as the current BCRT strategy, but will
differ in the initial order routing to the Nasdaq Affiliated Exchanges.
Whereas BCRT orders check the Exchange for available shares and then
route to PSX and Nasdaq sequentially,\4\ SCAR orders will route
simultaneously to all three Nasdaq Affiliated Exchanges in accordance
with the System routing table.\5\
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    \3\ Routing is an Order Attribute that allows a Participant to
designate an Order to employ one of several Routing Strategies
offered by the Exchange, as described in Rule 4758; such an Order
may be referred to as a ``Routable Order.'' Upon receipt of an Order
with the Routing Order Attribute, the System will process the Order
in accordance with the applicable Routing Strategy. In the case of a
limited number of Routing Strategies, the Order will be sent
directly to other market centers for potential execution. For most
other Routing Strategies, the Order will attempt to access liquidity
available on the Exchange in the manner specified for the underlying
Order Type and will then be routed in accordance with the applicable
Routing Strategy. Shares of the Order that cannot be executed are
then returned to the Exchange, where they will (i) again attempt to
access liquidity available on the Exchange and (ii) post to the
Exchange Book or be cancelled, depending on the Time-in-Force of the
Order. See Rule 4703(f).
    \4\ See Rule 4758(a)(1)(A)(vii).
    \5\ The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. The
Exchange reserves the right to maintain a different System routing
table for different routing options and to modify the System routing
table at any time without notice. See Rule 4758(a)(1)(A).
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    Specifically as proposed, SCAR would be a routing option under
which orders check the System \6\ for available shares and
simultaneously route \7\ to Nasdaq and PSX in accordance with the
System routing table.\8\ Similar to BCRT, if shares remain unexecuted
after routing, they are posted on the Exchange's book or cancelled,
depending on the Time-in-Force of the order.\9\ Once on the book,
should the order subsequently be locked or crossed by another market
center, the System will not route the order to the locking or crossing
market center. This is also similar to how BCRT treats shares that
remain unexecuted after completing the initial order route and posting
to the Exchange book. Like all of the Exchange's routing strategies,
SCAR is designed to comply with Rule 611 and the other provisions of
Regulation NMS.\10\
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    \6\ The term ``System'' shall mean the automated system for
order execution and trade reporting owned and operated by the
Exchange. See Rule 4701(a).
    \7\ As with all routing strategies that provide for simultaneous
routing, the incoming SCAR order would be broken up into child
orders. For SCAR routing, the orders would be sent to the Exchange,
Nasdaq, and PSX at the same time based on the available displayed
interest on these exchanges. In particular, the Exchange would
allocate the number of shares from the parent order based on the
System routing table for SCAR, and route the allocated shares (i.e.,
the child orders) to the executing venues simultaneously.
    \8\ As is the case today for all market destinations on the
System routing table, the placement of the Exchange, Nasdaq and PSX
on the applicable System routing table for SCAR will depend on the
Exchange's ongoing assessments of factors such as latency, fill
rates, reliability, and cost.
    \9\ Unexecuted shares of a SCAR order will return to the
Exchange after routing and check the System for available shares
before cancelling if the order has a Time-in-Force of IOC.
Otherwise, shares that remain unexecuted after routing will return
to the Exchange and check the System for available shares before
posting on the Exchange's book (e.g., the SCAR order has a Time-in-
Force of DAY).
    \10\ 17 CFR 242.611.
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    The Exchange will implement the proposal in the second quarter of
2019, subject to approval by the Commission. The Exchange will provide
prior notice of the implementation date in an Equity Trader Alert.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\11\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\12\ in particular, in that it is designed to
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. The Exchange believes that the proposed rule change will
accomplish those ends by providing market participants with an
additional voluntary routing option that will allow them to easily
access liquidity available on all Nasdaq Affiliated Exchanges. The
Exchange expects the proposed routing strategy will benefit firms that
do not employ routing or trading strategies under which the firm itself
would rapidly access liquidity provided on the multiple venues. SCAR
would not provide any advantage, including latency and priority, to
members when routing to the Nasdaq Affiliated Exchanges as compared to
other methods of routing or connectivity available to members by the
Exchange.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    Lastly, the Exchange notes that routing options enabling the
routing of orders between affiliated exchanges is not unique, and that
the proposed SCAR routing option is similar to those already offered by
the Exchange (i.e., BCRT) and by other exchange groups. Specifically,
Cboe BZX Exchange (``BZX''), Cboe BYX Exchange (``BYX''), Cboe EDGA
Exchange (``EDGA''), and Cboe EDGX Exchange (``EDGX'') offer a routing
option called ALLB that enables an order, whether sent to BZX, BYX,
EDGA, or EDGX, to check the BZX, BYX, EDGA, and EDGX books for
liquidity before optionally posting on the BZX, BYX, EDGA, or EDGX
book.\13\ For the foregoing reasons, the Exchange believes that the
proposed rule change is consistent with the Act.
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    \13\ See BZX Rule 11.13(b)(3)(O), BYX Rule 11.13(b)(3)(M), EDGA
Rule 11.11(g)(7), and EDGX Rule 11.11(g)(7). ALLB is also
substantially similar to the Exchange's BCRT strategy, as described
above.

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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 not necessary or appropriate in
furtherance of the purposes of the Act. As discussed above, the
proposed functionality is partly based on existing functionality
available on competitor exchanges.\14\ Furthermore, the Exchange
provides routing services in a highly competitive market in which
participants may avail themselves of a wide variety of routing options
offered by other exchanges, alternative trading systems, other broker-
dealers, market participants' own proprietary routing systems, and
service bureaus. In such an environment, system enhancements such as
the changes proposed in this rule filing do not burden competition,
because they can succeed in attracting order flow to the Exchange only
if they offer investors higher quality and better value than services
offered by others. Encouraging competitors to provide higher quality
and better value is the essence of a well-functioning competitive
marketplace. Lastly, SCAR would not provide any advantage to members
when routing to the Nasdaq Affiliated Exchanges as compared to other
methods of routing or connectivity available to members by the
Exchange. For the foregoing reasons, the Exchange does not believe the
proposed rule change will result in any burden on competition that is
not necessary or appropriate in furtherance of the purposes of the Act.
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    \14\ 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 either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-
4(f)(6) thereunder.\16\
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give 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 this requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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-BX-2019-004 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2019-004. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2019-004 and should be submitted on
or before April 16, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-05699 Filed 3-25-19; 8:45 am]
BILLING CODE 8011-01-P


     1    17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Chemical: MCPB, MCPB Sodium PC Code: 019202, 019201 DP Barcodes: D314042, D314043, D314045, D319762 MEMORANDUM DATE: 22 February 2006 SUBJECT: Comment Phase III for Reregistration of MCPB and MCPB Sodium FROM: Marie Janson, Environmental Scientist Ed Odenkirken, Senior Scientist Amer Al Mudallal, Chemist Nadar Elkassabany, Acting Branch Chief Environmental Risk Branch 1 Environmental Fate and Effects Division ( 7507C)

TO: Susan Lewis, Branch Chief Demson Fuller, CRM James Parker, CRM Registration Branch 1 SRRD Division ( 7505C)

Attached please find the Environmental Fate and Effects Division's ( EFED) revised comments environmental risk assessment for the proposed registration of MCPB as an herbicide on peas. Supported formulations of MCPB are Thistrol ® Herbicide ( 71368 5) and Sodium MCPB Solution ( 71368 7).

The registrant's comments on the draft risk assessment which dealt with substantive questions on science or interpretation are addressed in this Phase III, the response to public comment.      2    17 Environmental Fate and Ecological risk assessment Potential risks to non target organisms MCPB Task Force comment # 1 Chronic Risk to Freshwater Fish Although no chronic freshwater fish toxicity data were submitted for MCPB, longer term exposure will be effectively to the metabolite MCPA. This is because ß oxidation potential is universal in animals ( as mentioned in the introduction). It should be noted that in the MCPA RED it was determined that chronic risks to freshwater fish and invertebrates were low and OPP inferred that chronic risk to estuarine/ marine fish and invertebrates would also be low under the assumption that the acute: chronic ratio of toxicity endpoints remains constant across freshwater and estuarine/ marine organisms. In view of the relatively minor use of MCPB and as MCPA is the proximate metabolite in most species, the MCPB Task Force contends that no significant errors would be introduced by extrapolation from the MCPA data for these risk assessments.

MCPB Task Force comment # 2 Chronic Risk to Freshwater Invertebrates Similar considerations to those stated above for fish are appropriate.

EFED response comments # 1 and # 2 The risk assessment for aquatic organisms estimated exposure concentrations on the basis of residual MCPB plus the degradate MCPA. If both are assumed to be of equal toxic potency, no bias has been introduced to the risk assessment by this assumption. However, A comparison of MCPB toxicity data with the available toxicity for MCPA published in the EPA RED chapter for that compound, indicates that some differences in toxic potency may exist for the two compounds. Using common aquatic species tested for each compound ( acid equivalent) the following comparisons can be made:

Species Test Type MCPB Result MCPA Result Rainbow trout 96 h LC50 3.9 mg ae/ L 96 mg ae/ L Daphnid 48 h LC50 50 mg ae/ L 82 mg ae/ L The aquatic organism comparisons would suggest that MCPA ( acid equivalent) is less toxic that the MCPB. Therefore, assuming equal potency between the two compounds, and adding the exposures together would likely overestimate risk for aquatic organisms. This finding, however, does not alter the conclusions of the aquatic risk assessment, which suggests no concern for acute effects in freshwater aquatic organisms. Chronic data for risks to freshwater fish, freshwater invertebrates, estuarine marine fish and acute estuarine marine fish for MCPB were calculated via acute to chronic ratios from MCPA data due to lack of submitted data for MCPB.      3    17 There were no LOC exceedences for chronic risks to freshwater fish, freshwater invertebrates, estuarine marine fish and acute estuarine marine fish for MCPB based on values calculated from MCPA on a acute to chronic ratio for both Oregon and California scenarios.

However, there is low confidence in these numbers due to interspecies differences and toxicity differences between MCPB and MCPA for freshwater fish and invertebrates. Higher uncertainty exists with estuarine marine acute and chronic fish. Estuarine marine invertebrates were calculated with acute to chronic ratio but with little confidence. LOCs were exceeded for acute estuarine marine invertebrates ( RQs 0.07  0.01) for acute restricted use and acute endangered species.

Therefore, acute estuarine marine fish and acute estuarine marine invertebrates for MCPB are requested because no estuarine marine studies were submitted for MCPB, low confidence in estuarine marine and invertebrate calculations from acute to chronic ratios and the apparent differences in endpoints for MCPA and MCPB. These endpoint differences are as follows: MCPA is less toxic to acute freshwater fish ( 96 mg ae/ L) than MCPB ( 3.9 mg ae/ L) However, MCPB is more toxic to acute freshwater invertebrates ( 50 mg ae/ L) than MCPA ( 82 mg ae/ L). Therefore, chronic studies for freshwater fish and invertebrates will be requested due to endpoint differences and low confidence in acute to chronic ratios as mentioned above. The chronic studies for estuarine marine fish and estuarine invertebrates are reserved based on the outcome of acute estuarine marine fish and invertebrate submitted studies.

The following table of endpoints was used to calculate chronic freshwater fish and invertebrate RQ's with acute to chronic ratios for freshwater fish and invertebrates.

Summary of endpoints ( LC50 or EC50, mg ae/ L) for MCPA acute and chronic aquatic toxicity studies ORGANISM GROUP MCPA ( acute) MCPB ( acute) MCPA ( chronic) MCPB ( chronic)

freshwater fish ( rainbow trout) 96 ( MCPA DMAS) 3.9 No data No data freshwater fish ( fathead minnow) only chronic freshwater fish study for MCPA No data No data 12 No data freshwater inverts ( Daphnid) only one study chronic freshwater invertebrate study for MCPA 82 ( MCPA DMAS) 50 11 No data estuarine/ marine fish Atlantic Silverside 179 ( MCPA Acid) No data No data No data estuarine/ marine inverts eastern oyster 4.9 ( MCPA sodium salt) No data No data No data      4    17 Summary of endpoints ( LC50 or EC50, mg ae/ L) determined by acute and chronic ratios ORGANISM GROUP MCPB ( acute) MCPB ( chronic)

freshwater fish 3.9 .5 a Acute to chronic ratio freshwater inverts 50 6.7b Acute to chronic ratio estuarine/ marine fish 7.3c Acute to chronic .9d Acute to chronic estuarine/ marine invert 2.9e Freshwater / estuarine marine ratio .4f aMCPB Freshwater fish ( chronic) .5= [ 12( chronic freshwater fish MCPA ) / 96( acute freshwater fish MCPA)] x3.9( acute freshwater fish MCPB) b MCPB Freshwater invertebrate ( chronic) 6.7=[ 11( chronic freshwater invertebrate MCPA ) / 96( acute freshwater invertebrate MCPA)] x 50( acute freshwater invertebrate MCPB) cMCPB Estuarine marine fish ( acute) 7.3=[ 96( acute freshwater fish MCPA ) / 179( acute estuarine marine fish MCPA)] x 3.9( acute freshwater fish MCPB) dMCPB Estuarine marine fish ( chronic) .9=(. 5 chronic freshwater fish MCPB ) / 3.9( acute freshwater fish MCPB)] x 7.3( acute estuarine marine fish MCPB) eMCPB Estuarine marine invertebrates ( acute) 2.9=[ 50( acute freshwater invertebrate MCPB ) / 82( acute freshwater invertebrates MCPA)] x 4.9( acute estuarine marine invertebrates MCPA) FMCPB Estuarine marine invertebrates ( chronic) .4 =[ 50( acute freshwater invertebrate MCPB ) / 82( acute freshwater invertebrates MCPA)] x 4.9( acute estuarine marine invertebrates MCPA) x[ 11( chronic freshwater invertebrate MCPA ) / 82( acute freshwater invertebrates MCPA)]

Summarized Chronic Aquatic Organism Risk Quotients for MCPB Acid a, b      5    17 Application/ Scenario Freshwater Fishc, d Freshwater Invertebrates e, f Estuarine Fishc, d Estuarine Invertebrates e, f Peas ( ground spray application) Oregon 0.06 <. 01 0.03 0.07 Peas ( aerial spray application) Oregon 0.06 <. 01 0.04 0.08 Peas ( ground spray application) California 0.07 <. 01 0.04 0.10 Peas ( aerial spray application) California 0.07 <. 01 0.04 0.10 a Detailed calculations of PRZM 3.12/ EXAMS 2.98 modeling for peas grown in Oregon and California are provided in Appendix B. bChronic toxicity thresholds ( LC50 or EC50) calculated by acute to chronic ratio with values from MCPA were .5 and 6.7 mg ae/ L for freshwater fish and freshwater invertebrates, respectively. Chronic toxicity thresholds ( LC50 or EC50) calculated by acute to chronic ratio with values from MCPA were .9 and .4 mg ae/ L for estuarine marine fish and estuarine marine invertebrates, respectively. Chronic Fish C EECs for Oregon bean Scenario were 28.1 and 31.5 µ g/ L for ground spray and aerial spray, respectively. DEECs for California lettuce Scenario were 36.4 and 38.9 µ g/ L for ground spray and aerial spray, respectively Chronic Invertebrates eEECs for Oregon bean Scenario were 29.0 and 32.5 µ g/ L for ground spray and aerial spray, respectively. FEECs for California lettuce Scenario were 39.0 and 41.7 µ g/ L for ground spray and aerial spray, respectively.

Summarized Acute Aquatic Organism Risk Quotients for MCPB Acid a, b Application/ Scenario Freshwater Fisha, b Freshwater Invertebrates a, b Estuarine Fisha, b Estuarine Invertebrates a, b Peas ( ground spray application) Oregon < 0.01 < 0.01 < 0.01 0.07 Peas ( aerial spray application) Oregon < 0.01 < 0.01 < 0.01 0.08 Peas ( ground spray application) California 0.01 < 0.01 < 0.01 0.10 Peas ( aerial spray application) California 0.01 < 0.01 < 0.01 0.10 For an estuarine marine and freshwater ratio MCPB and MCPA: Acute toxicity thresholds ( LC50 or EC50) calculated with acute estuarine marine fish and estuarine invertebrate values from MCPA 179 and 4.9 respectively; Values from MCPB were 3.9 and 50 mg ae/ L for acute freshwater fish and freshwater invertebrates, respectively.

Acute Fish and Invertebrates      6    17 a EECs for Oregon bean Scenario were 29.5 and 33.1 µ g/ L for ground spray and aerial spray, respectively. BEECs for California lettuce Scenario were 40.4 and 43.2 µ g/ L for ground spray and aerial spray, respectively.

MCPB Task Force comment # 3 Chronic Risk to Birds An avian reproduction study was submitted for the proximate metabolite MCPA. The MCPB Task Force contend that this is applicable to MCPB as this metabolite will dominate exposures of a repeat nature.

EFED response comments # 3:

Terrestrial wildlife exposures were conducted solely on the exposure for MCPB. MCPA was not included in the exposure assessment. A comparison of MCPB toxicity data with the available toxicity for MCPA published in the EPA RED chapter for that compound, indicates that some differences in toxic potency may exist for the two compounds. Using common avian species tested for each compound ( acid equivalent) the following comparisons can be made:

Species Test Type MCPB Result MCPA Result Bobwhite LD50 257 221 377 The comparison for bobwhite quail would suggest that the acute potency of MCPB lies within the range of toxicity for acid equivalent MCPA. EFED considered MCPA as a substitute for MCPB for chronic risk to birds, because the LD50 for bobwhite quail suggests that the acute potency of MCPB lies within the range of toxicity for acid equivalent MCPA. Also, rapid dissociation of MCPB to MCPA is expected to occur in the bird gut due to the chemical properties of MCPB. Therefore, the terrestrial model TREX was used to determine the chronic risk to birds. MCPA NOAEC of 1000 mg/ kg diet ( MRID # 435052 01) . Chronic RQs ranged from 0.02 to 0.36. which is below LOC of 1. No further studies are required for chronic risk to birds for MCPB at this time.

Uncertainties and data gaps MCPB Task Force comment # 4 Terrestrial field dissipation Evidence presented in this document indicates that MCPB has a half life of between 4 and 11 days in soil, dependent on conditions. Data indicate that by day 120 there is no parent or metabolite material detectable in the soil. The pea crop is sprayed with MCPB before flowering, which means that spray application takes place at least two months ( and probably longer) before harvest. The subsequent crops will not normally be planted until at least 3 to 4 months after spray application and no residue of MCPB will be expected to remain to affect succeeding crops. Further, the major metabolites of MCPB in soil are carbon dioxide and MCPA, although the latter is not seen to accumulate after the first few days following application. Thus, it is the contention of the Task Force that sufficient data exist to render this study unnecessary, and a waiver will be applied for on this basis.      7    17 EFED Response comment # 4: The purpose of field dissipation studies for pesticides with terrestrial uses is to determine the extent of pesticide residue dissipation under actual use condition. A guideline field dissipation study will generate data required for the evaluation of mobility, degradation, and dissipation of residues. Terrestrial field dissipation studies are required because pesticide dissipation may proceed at a different rate under field conditions and therefore result in the formation of levels of degradates differing from those observed in laboratory studies. EFED recommends that the registrant submit a guideline terrestrial field dissipation study.

MCPB Task Force comment # 5 Multigeneration study  It has already been mentioned that the mammalian reproduction study for MCPA will serve as a surrogate for MCPB and has been accepted as such in EPA's HED evaluation.

EFED response comments # 5 The rabbit study is the most sensitive endpoint for MCPB and will remain in the risk assessment for assessing chronic LOCs for mammals.

Stressor Source and Distribution MCPB Task Force comment # 6 Paragraph 2 It is stated that no data are available for MCPB biodegradation in water. A water/ sediment study is available for MCPB ( Van Dijk 2003), and was summarised in detail in a previous submission. In this study two sediments collected in Holland were used to determine degradation rate in accordance with OECD Guideline 308. The sediments differed mainly in their organic carbon content, but degradation of MCPB was similar for both, with a DT50 of 9.3 to 10 days in the aqueous phase and 16 to 18 days in the entire system. There was no evidence for selective accumulation of MCPB in the sediment phase, and as with other systems, degradation was via MCPA. After an initial small build up of MCPA, this metabolite was removed from the system more rapidly than it was created, so that it only transiently exceeded 10% of added radioactivity, and in only one of the systems. These findings are consistent with the known degradation rate of MCPA in water/ sediment studies.

EFED response comment # 6 EFED is unaware of any guideline water/ sediment study for MCPB submitted to the Agency. Since no aerobic aquatic metabolism studies have been submitted to the Agency, EFED used twice the aerobic soil metabolism half life as a substitute for the aerobic aquatic metabolism half life input parameter in the PRZM/ EXAMS modeling in accordance with EFED's PRZM/ EXAMS modeling input parameter guidance ( Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II, February 28, 2002). A guideline aerobic aquatic metabolism study should provide data on the effects of pesticide exposure to aerobic conditions in water or sediment during the period of dispersal of the pesticide throughout the aquatic environment and to compare rates of formation of metabolites with those observed under conditions of anaerobic aquatic metabolism. The Registrant need to submit a      8    17 guideline aerobic aquatic metabolism study to satisfy the data requirement.

MCPB Task Force comment # 7 Paragraph 3 The solubility of MCPB in water is strongly dependant on pH ( see earlier comment, Bass 1999, MRID 45735301) such that at pH 7, concentration will be about 4400 mg/ l rather than the quoted 200,000. This will likely have a minimal effect on any risk assessment.

EFED response comment # 7 The solubility value of 200,000 mg/ l ( 2kg/ l ) for MCPB sodium salt in water was provided in the study MRID 42714301 ( MCPB Sodium Salt: Determination of Physical Chemical Properties, P Sydney, 1993) that was submitted to the Agency. The same solubility value of 200,000 mg/ l for MCPB sodium salt in water is also quoted in the WSSA ( Weed Science Society of America) Herbicide Handbook. Ahrens W. H., Ed., 1994 Champaign, IL. p. 352, the material data sheet for the formulated product " Tropotox ( R) Plus", and in the OSU extension pesticide properties database. The above mentioned study ( MRID 45735301) does not provide a solubility value for MCPB sodium salt in water.

However, it should be noted that, using the solubility value of 4400 mg/ l instead of the value of 200,000 mg/ l in the PRZM/ EXAMS modeling will have no effect on the estimated concentrations of MCP in water.

MCPB Task Force comment # 8 Page 11, paragraph 2 Aerobic degradation is established in a number of publications to have a DT50 in the region of 6 days. This has been mentioned in a previous submission. It is inappropriate to use the value of 26 days. It is not clear from whence this value is derived. The study quoted ( John et al 1994a, MRID 43247601) shows a rapid decline in MCPB with a small ( about 1%) residue remaining after 65 days. This residue shows no decline between days 65 and 120. The major metabolites are MCPA and HMCPA either free or conjugated. The question is how this profile should be converted to an assessment factor. Both the original study director and the contract reviewer chose to apply a dual approach with an overall rate and an initial rate. The initial rate has been accepted for use in the EU; the difference is one of calculation   see table below. Half lives calculated/ used for MCPB based on John et al ( 1994a)      9    17 The study director's calculation assumed first order kinetics and achieved an initial value of 6.8 days with a secondary value of 31 days. EPA's reviewer used a least squares fit to give values which are higher but which show a lower correlation coefficient. As there was no evidence of further decomposition after the 65 day point, this is arguably inappropriate. It must be presumed that under the experimental conditions, the residue at 65 days is firmly bound and will not degrade, so that further prolongation will artificially increase the " half life" value. Presumably, the value of 26 days adopted for calculations is derived as a " composite" half life based on MCPB, MCPA and HMCPA conjugate, although it is stated elsewhere that the latter two values make very little difference. This value is at variance with other published information which is generally closer to the 6 days calculated by the study director. It should be further noted that in the study by Goodyear ( 1993, MRID 43015501), which was reviewed and which was conducted according to Guideline No. 162 2, anaerobic conditions were established after a calculated halflife of MCPB had been exceeded. This was 4 days. A subsequent anaerobic half life of approx. 11 days has been calculated from these data. This relationship is in accord with that predicted by structure/ function from other phenoxy herbicides i. e. the anaerobic degradation rate is significantly less than the aerobic rate. It should also be noted that in column leaching studies ( John et al 1994b, MRID 43466401) conducted according to Guideline N163 1, four soil types and aquatic sediment were used. Preliminary investigations established the half life of MCPB in these soils, and these values ranged from 4.75 to 7.13 days ( see table below).      10    17 In these circumstances the use of a single experimental value for risk assessment is questionable. Specifically, both the adopted value and the tripling of this value are inappropriate. The best estimate of aerobic half life in soil is approximately 6 days. Application of this figure is likely to have significant influence on the risks calculated. Comments on photolysis in the subsequent paragraph are noted. The Task Force agrees with the later statement to the effect that following considerations of water depth, etc., photolysis is not an important route of degradation for MCPB in the environment.

EFED Response comment # 8:      11    17 The aerobic soil metabolism half life of 26 days was calculated using linear regression of the natural logarithm of the mean value of the percent of applied total residue over the whole duration of the study ( 0 120 days). All reported data points were used with the exception of day 3 because of the loss of some extract and overheating problems during the sample analysis. For the PRZM/ EXAMS modeling purposes, the aerobic soil metabolism half life of 26 days was multiplied by three ( 26 x 3 = 78 days) to represent the 90th upper percentile of the mean, in accordance with EFED's PRZM/ EXAMS modeling input parameter guidance ( Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II, February 28, 2002), since there was only one soil used in the aerobic soil metabolism study ( MRID 43247601). Multiplying the half life by a factor of 3 is used to account for variability in half lives in the field which represent approximately 90th percentile of the mean. It should be noted that the use of a half life of 78 days in the modeling did not trigger any exceedance for any of the aquatic species considered in the risk assessment.

MCPB Task Force comment # 9 Page 20, paragraph 1 Preliminary identification of Data Gaps and Methods. Task Force comments on aerobic and anaerobic aquatic biodegradation have already been made in the context of the summary. It is unlikely that soil photolysis would be an important route of degradation as MCPB is unlikely to remain on the soil surface for significant periods.

EFED response comment # 9: Although the photodegradation on soil study ( MRID 43829901) was determined to be unacceptable and does not satisfy the data requirement, It appears that MCPB is stable to photodegradation on soil and hence, no new study is required at this time.

MCPB Task Force comment # 10 Page 20, Paragraph 2 Refer to MCPA data for chronic toxicity studies for fish and invertebrates, as previously discussed. EFED response comment # 10: Refer to EFED response to comment 1 and 2.

MCPB Task Force comment # 11 Page 28   Residues Studies Residues studies conducted on peas in Northern Europe are available. These used application rates of 1.6 kg/ ha and were thus > 90% of the rate used in the USA. Immediately following application whole plants showed concentrations ranging from 35 62 ppm and these residues declined rapidly thereafter so that by 28 days residues in all crops were below 0.21 ppm. All values were based on fresh weight. In the absence of specific US data it may be more appropriate to use these values than those from a model system. Thus, conservatively an initial concentration of approximately 70 ppm is arguably more applicable than the Kenaga default value. Similarly, application of first order kinetics to this value and the 28 day residue, indicates a half life just less than 3.5 days. This refinement is a more realistic value than the 35 days currently incorporated into the risk assessment. These considerations are likely to have a significant impact on the outcome of EPA's assessment.      12    17 EFED response to comment # 11: These residue studies have not yet been submitted to the Agency, and when they are submitted in the future, then they will be reviewed at that time.

MCPB Task Force comment # 12 Page 32, Table 3G The studies tabulated were all conducted at Springborn Laboratories, USA in 1992. Studies performed in this laboratory during the period with various phenoxy acids have given results which are atypical of similar studies performed elsewhere. This has been reviewed in detail for Selenastrum capricornutum and MCPA ( MRID 45554404). An independent consultant's report of the various studies conducted with this active ingredient and test organism has been submitted to EPA in connection with the MCPA RED. A document containing additional investigations with the related compound MCPP p, where concurrent investigations were compared with those in other laboratories, is in preparation and will be submitted to EPA shortly. A critique of the studies with MCPB is attached to this overview and demonstrates why, in the opinion of the MCPB Task Force, the majority of these studies conducted at Springborn Laboratories are considered unacceptable. Replacement studies have been performed as follows:

Duckweed ( Lemna gibba) Billing and Albuquerque 2003 This study performed at HLS in the UK to OPPTS 850.4400 and the OECD draft Guideline for Lemna species, reports a EbC50 of 37 mg/ l ( expressed as acid) with a NOAEC at 2.8 mg/ l. Selenastrum capricornutum Albuquerque and Utting 2003 This study reports an EbC50 at 41 mg/ l ( expressed as acid) and a NOEC 0.87 mg/ l Navicula pelliculosa Albuquerque and Firth 2003 This study reports an EbC50 of 1.5 mg/ l with a NOEC 0.56 mg/ l The reports for these studies have been submitted to EPA. The MCPB Task Force considers that the toxicity values derived from these recent guideline and GLP compliant studies are more appropriate for use in risk assessment than those from the earlier Springborn studies. The study with the blue green alga Anabaena flos aquae was not repeated as the initial result was not ratelimiting in determining toxicity. Similarly, there is currently no additional study with the marine diatom Skeletonema costatum. EFED response to comment # 12:

When these studies are submitted then they will be reviewed according to SOP. According to our Overview of the Ecological Risk Assessment Process Office of Pesticides Document , all submitted studies will be included in the risk assessment after they are individually reviewed.

MCPB Task Force comment # 13 Terrestrial effects, characterisation   birds, chronic Because MCPB is metabolised to MCPA by the process of ß oxidation, which is ubiquitous in animal and avian species, the MCPB Task Force considers that the avian reproduction study for MCPA can serve as an acceptable surrogate for a study with MCPB.

EFED response to comment # 13: Refer to comment # 3      13    17 MCPB Task Force comment # 14 Mammals, sub chronic and developmental/ reproductive Effects noted in the dog study are established as having limited relevance. As stated in EPA's HED chapter the dog has an impaired ability to excrete various organic acids, including MCPB and MCPA, and is thus not typical of other species. Timchalk (" Comparative inter species pharmacokinetics of phenoxyacetic acid herbicides and related organic acids. Evidence that the dog is not a relevant species for evaluation of human health risk"; Toxicology 200, pages 1 19, 2004, MRID 46328601) has extensively reviewed this for related compounds 2,4 D and MCPA and shown that of the species tested, the dog is an outlier. It is possible that other carnivorous species would show a similar reaction, although this has not been tested experimentally; but, for the majority of wild mammals, results from the dog are not relevant.

Kinetic studies have shown that there is saturation of renal excretion of MCPA in the rat at doses around 80 100 mg/ kg/ day. It is therefore likely that in the rat 90 day study decreased food consumption and bodyweight gains seen at the high dose level reflect a direct effect of compound, rather than simple palatability. On this basis this high dose should be considered an effect level. This means that for the rat 90 day study the NOAEL should be set at 500 ppm in diets ( approx 35 mg/ kg/ day). MRID# 40041701 In determining developmental effects, it should be noted that no developmental changes were seen in the rabbit study at the dose of 20 mg a. i/ kg/ day. Although it is accepted that maternal effects were seen in rabbits at this level, the value of 20 mg/ kg/ day is logically the NOEL for developmental toxicity.

In the rat reproduction study, pup effects were confined to the high dose; which corresponds to 450 ppm in the diet. As growth reduction was confined to pups in the lactation and perilactational period, it is important to note that the effective dose rate during this period is considerably in excess of the mean for the study as a whole ( see above). The NOEC from the one generation study ( Milburn 2004, MRID 46411201) is a more appropriate value to use for determining the LOAEL and NOAEL for these parameters.

EFED response comment # 14: The dog study will remain in the risk characterization for risk characterization purposes because wild canine mammals may be exposed to MCPB Other comments are to be answered by HED MCPB Task Force comment # 15 Page 37   Terrestrial Field Studies It is stated here that the requirement for terrestrial field studies was waived. The MCPB Task Force accepts that this is a logical position and recommends that Table I. c. be corrected accordingly.

EFED response comment # 15: Table Ic is terrestrial field dissipation ( 164 2) which is a different study than terrestrial field studies ( 124 1). Terrestrial field studies ( 124 1) was waived. Therefore, no changes will be made to Table Ic.      14    17 IV Risk Characterization MCPB Task Force comment # 16 Non target aquatic animals and plants The statement that " MCPA has been shown to be less toxic to aquatic organisms than the parent MCPB" is not correct when the newer studies submitted are taken into account. This means that the inclusion of MCPA metabolites remains an appropriate approach.

EFED response comment # 16: When the newer studies are submitted for MCPB and MCPA these will then be reviewed. Therefore, statement " MCPA has been shown to be less toxic to aquatic organisms than the parent MCPB" will remain in the assessment.

MCPB Task Force comment # 17 Non target terrestrial animals and plants, Table 4c summary of end points The mammalian LD50 from MRID 116340 should be " 1570" rather than the " 832" quoted in this table. An additional study is submitted ( Wainwright 2002) which shows that the LD50 both acute and oral for the honey bee is considerable in excess of the value quoted in this table. As no risk to bees is established in the risk assessment this will have no practical impact on the outcome.

EFED response comment # 17: The mammalian LD50 from MRID 116340 table 4c is correct with the value of 832 ae/ kg bw which was the endpoint used for RQ evaluation. This value is discussed throughout the chapter.

MCPB Task Force comment # 18 Birds Page 46, paragraph 4 The comments regarding uncertainty in EC05 values are noted. Inherently these values will have high uncertainty, because the studies from which they are derived use relatively small groups of plants ( as recommended in the relevant guideline). Thus, in a group of 20 seedlings an EC05 represents a single affected plant. It is unlikely that repeat studies in the range EC05 to EC25 would produce significant clarification of the " true" value. It can be argued that the use of EC05 values represents extrapolation beyond what is justified by the data requirement.

EFED response comment # 18: Comment noted. However, no changes will be incorporated into the risk assessment.

MCPB Task Force comment # 19      15    17 Risk Description Birds Paragraph 2 It is agreed that there is a significant difference in acute lethality when MCPB is administered as a gavage dose compared to that when mixed with the diet. Consideration of the properties of MCPB ( shared with other phenoxy herbicides) indicates that at least for small birds the use of the dietary study LC50 value is more representative of potential effects in the field than that of the gavage LC50. In the gavage case, birds are deprived of food for 18 hours before dosing. Thus, the entire dose is deposited in an empty crop where it is available for absorption immediately. By contrast, mixture with the diet ensures that the dose is received in a more realistic manner. For highly water soluble compounds such as MCPB, absorption will be rapid and followed by equally rapid excretion. When dosing is spread over a period of time, as with admixtures in feed, this process is allowed to reach equilibrium and produces a more realistic prediction of effect. It can be argued that larger birds may consume food as available in a non uniform manner and thus, effectively, receive the dose over a shorter period. Even in these instances, admixture with the feed will attenuate absorption and thus the feed contamination route is more realistic. For the small bird species ( which are considered most at risk) the daily food intake, in terms of wet weight, often exceeds the bird's body weight and it is self evident that this cannot be consumed in a single meal. Thus, in all these circumstances assessments based on the dietary route are more realistic. It should also be recognized that the " sub lethal effects observed in both studies" were in the dietary studies confined to reduced food consumption; no clinical signs were seen in either the bobwhite quail or the mallard duck at any of the dietary concentrations examined. Although this is undoubtedly an adverse effect over a longer period, in terms of an acute risk assessment it would serve to limit exposure, and is a further indication that the dietary route is more representative of field conditions. The evaluators may be interested to know that a similar debate has been held in the EU. A recent report from the Scientific Committee, based on questions relating to the active ingredient pirimicarb methyl, is attached. In Europe, these decisions from the Scientific Committee are considered generic and have been accepted for the phenoxy herbicides.

EFED response comment # 19: For the purpose of this screening level assessment, the more conservative RQs ( in this case, dose based) are used to estimate risk. At the screening level, there appears to be a considerable difference between the dose based and dietary based RQs. This is likely partly due to the inherent uncertainties surrounding the two acute/ subacute toxicity tests. Each of these studies has limitations for estimating the risk to wild species exposed to pesticides in the environment. Both studies have a fixed exposure period and do not allow for the differences in response of individuals to different durations of exposure. With the acute oral study, the chemical is administered in a single dose. This does not mimic wild bird exposure through multiple feedings. Also, it does not account for the effect of different environmental matrices on absorption rate into the gastrointestinal tract of the animal. With the acute dietary study, the endpoint is reported as the concentration mixed with food that produces a response rather than as the dose ingested. Although food consumption sometimes allows for estimation of a dose, calculations of the mg/ kg/ day are confounded by undocumented spillage of feed and how consumption is measured over the duration of the test. Usually, if measured at all, food consumption is estimated once at the end of the five day exposure period. Group housing of birds      16    17 undergoing testing only allows for a measure of the average consumption per day for a group and consumption estimates can be further confounded if birds die within a treatment group. In addition, the dietary study utilizes young birds. The exponential growth of young birds complicates the estimate of the dose; controls often nearly double in size over the duration of the test. Since weights are only taken at the initiation of the exposure period and at the end, the dose per body weight ( mg/ kg) is difficult to estimate with any precision. The interpretation of this test can be further confounded by dietary consumption. Estimation of the acute LC50 value is not only a function of the intrinsic toxicity of the pesticide, but also the willingness of the birds to consume treated food.

In addition to the uncertainties surrounding the two toxicity studies utilized for estimating acute risk to birds, other factors, not normally taken into account in a screening level risk assessment may narrow the differences between the dose based and dietary based acute RQs for birds. The factors include differences in gross energy and assimilative efficiency of laboratory feed versus food items in the field, basic maintenance metabolic rates between wild birds and captive birds, seasonal free living dietary requirements for wild birds ( including gorging behavior) and specific food avoidance behavior. These uncertainties may either overestimate or underestimate the risk in a screening level assessment.

Since liver abnormalities in birds were observed in both acute dose based and acute dietary based MCPB studies and mortalities occurred at all concentration levels in the acute dose based bobwhite quail study comments; conclusions in the risk assessment concerning acute risk to birds will remain the same in this assessment.

MCPB Task Force comment # 20 Mammals The special considerations relating to the dog and also the NOEC for developmental toxicity have already been mentioned previously. These differences, if accepted by EPA, will likely impact on the risk assessment. The low maternal NOEL in the rabbit developmental toxicity study is derived from the study with gavage dosing. The limitations of this procedure were discussed above with respect to birds, although similar considerations apply to mammals. It is therefore unlikely that any affect on foraging behaviour will be seen in practice.

EFED response comment # 20: As previously stated the dog study will be used in risk characterization and the rabbit value is the same because it is the most sensitive endpoint. Please refer to comment # 14 and comment# 19 for further explanation.

MCPB Task Force comment # 21 Terrestrial Plants in Dry Land and Semi aquatic areas First paragraph, page 51 The MCPB Task Force will consider a label amendment to require medium or coarser droplet size for all applications.

EFED response comment # 21: Comment noted. When a label amendment is negotiated with risk managers, EFED will be able to incorporate this information in the risk assessment.      17    17 MCPB Task Force comment # 22 Review of Incident Data The MCPB Task Force accepts that the lack of mortality incidents in the EIIS database is not definitive evidence of a lack of hazard to aquatic and/ or terrestrial organisms. However, it is also consistent with the low risk predicted from the toxicity studies.

EFED response comment # 22: The EIIS database is dependent on reported incident information and can not be compared to low risk predicted from toxicity studies due to reporting inconsistencies.


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            REGION IX AIR DIVISION

                          Technical Support Document
                                      for
                              EPA's Rulemaking
                                    for the
                     California State Implementation Plan

                   El Dorado Air Quality Management District
                         Ozone Emergency Episode Plan

                          Prepared by: Vanessa Graham
                         Reviewed by: Andrew Steckel

                                   May 2016

RULE IDENTIFICATION -
Agency
                        EL Dorado County Air Quality Management District (EDCAQMD)

SIP Approved Plan
None

Subject of this TSD
Ozone Emergency Episode Plan
Adopted  -  January 12, 2016
Submitted  -  April 6, 2016

Completeness Finding
Determination of Completeness letter: April 21, 2016

BACKGROUND  -  Section 110(a) of Clean Air Act (CAA) requires each state to develop and submit to the EPA a plan that provides for the implementation, maintenance, and enforcement of the national ambient air quality standards (NAAQS). Section 110(a)(1) also requires that each state make a new State Implementation Plan (SIP) submission within 3 years after the promulgation of a new or revised primary or secondary NAAQS, for approval into the existing SIP to assure that the SIP meets the applicable requirements for the new or revised NAAQS. This type of SIP submission is commonly referred to as an "infrastructure SIP".

To facilitate planning efforts, the state of California is divided into air quality control regions (AQCR). Each AQCR is assigned Priority I, II or III with respect to emergency episode classification, based on threshold levels specified in the Code of Federal Regulations (CFR) at 40 CFR Part 51, Subpart H. Priority I and II areas have specific emergency episode plan requirements designed to prevent ambient concentrations from reaching specified significant harm levels (SHL). Priority III areas have no emergency plan requirements.

SUMMARY  -  AQCRs with ozone concentrations greater than 0.10 ppm must be classified Priority I. Review of EDCAQMD 2011-2014 air quality data revealed that EDCAQMD exceeded the 0.10 threshold on numerous occasions and recorded high one-hour ambient levels of 0.117 ppm. Therefore, EDCAQMD is considered a Priority I region and is required to prepare an ozone emergency episode plan. EDCAQMD's Ozone Emergency Plan, adopted on January 12, 2016, and submitted on April 6, 2016, was developed to fulfill the Infrastructure SIP emergency episode requirements as outlined in 40 CFR Part 51, Subpart H.

Each Priority I contingency plan must, at a minimum:

 Specify two or more stages of episode criteria;
 Provide for public announcement whenever any episode stage has been determined to exist;
 Specify adequate emission control actions to be taken at each episode stage;
 Provide for prompt acquisition of forecasts of atmospheric stagnation conditions and forecast updates as frequently as they are issued by the National Weather Service;
 Provide for inspection of sources to ascertain compliance with applicable control action requirements;
 Provide communication procedures for transmitting status reports and orders as to emission control action to be taken during an episode stage, including contact with public officials, major emission sources, public health, safety, and emergency agencies and news media.

EVALUATION AND ACTION  -  EPA previously approved an analogous contingency plan for Placer County.  The El Dorado County Ozone Emergency Plan was largely modelled after the April 15, 2015 Placer County Air Pollution Control District Ozone Emergency Episode Plan.  The El Dorado plan was tailored to meet the specific ozone emissions generated within El Dorado County. Our evaluation of the El Dorado County Ozone Emergency Episode Plan finds the plan to be sufficiently clear and enforceable consistent with the general SIP enforceability requirements of CAA Section 110(a)(2). This plan is specifically intended to address CAA Section 110(a)(2)(G) requirements for an emergency episode plan or rule, which is summarized in the list of six items above and described in greater detail in 40 CFR part 51, subpart H (40 CFR 51.150 through 51.153). The six requirements above are fulfilled by requirements on pages seven thru eleven of the plan. There were no deficiencies found, and the addition of the Ozone Emergency Episode Plan strengthens the SIP. Nothing in the EDCAQMD plan, or EPA's approval of this plan, interferes with EPA's independent federal authority in CAA Section 303.

EPA RECOMMENDED ACTIONS  -  EPA staff recommends full approval of the plan as adopted on January 12, 2016 and submitted on April 6, 2016.

ADDITIONAL RECOMMENDATIONS FOR THE NEXT RULE REVISION  -  EPA staff have no additional recommendations.

REFERENCES

 California Infrastructure SIP prepared by ARB; Report Release December 23, 2013.
 California Infrastructure SIP Emergency Episode Planning Technical Support Document September 2014; prepared by USEPA, Region 9.
 40 CFR Part 51, Subpart H - Prevention of Air Pollution Emergency Episodes.
 USEPA Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2), Stephen D. Page (EPA),  September 13, 2013.
 Placer County Ozone Emergency Episode Plan (80 FR 76230, January 7, 2016)
 65 FR 53602, September 5, 2000 (EPA approval of SMAQMD Rule 701).