            2014 Compliance Recertification Application (CRA-2014)         Compliance Application Review Document (CARD for Section 194.41)                          Active Institutional Controls

41.0  Background

	Assurance requirements were included in the disposal regulations to compensate in a qualitative manner for the inherent uncertainties in projecting the behavior of natural and engineered components of the Waste Isolation Pilot Plant (WIPP) for many thousands of years (50 FR 38072).  Section 194.41 is one of the six assurance requirements in the Compliance Criteria.  Active institutional controls (AICs) are defined in 40 CFR 191.12 as "controlling access to a disposal site by any means other than passive institutional controls, performing maintenance operations or remedial actions at a site, controlling or cleaning up releases from a site, or monitoring parameters related to disposal system performance."  Section 194.41 requires AICs to be maintained for as long a period of time as is practicable after disposal; however, contributions from AICs for reducing the rate of human intrusion in the PA may not be considered for more than 100 years after disposal.

41.1  Requirements

	(a) "Any compliance application shall include detailed descriptions of proposed active institutional controls, the controls' location, and the period of time the controls are proposed to remain active.  Assumptions pertaining to active institutional controls and their effectiveness in terms of preventing or reducing radionuclide releases shall be supported by such descriptions."

	(b) "Performance assessments shall not consider any contributions from active institutional controls for more than 100 years after disposal."

41.2  1998 Certification Decision 	 	To meet the requirements for Section 194.41, the U.S. Environmental Protection Agency (EPA or Agency) expected the Compliance Certification Application (CCA) to describe in detail the proposed AICs and their location and function, and to identify the period of time they are expected to remain active.  EPA also expected the U.S. Department of Energy (DOE or Department) to provide detailed information regarding implementation of the controls, any assumptions pertaining to the effectiveness of active controls, a justification for any credit for AICs used in performance assessments (PA), and the methodology for determining the credit.  EPA specified that PAs could not assume that AICs would be effective for a period longer than 100 years after disposal.

	In Chapter 7 and Appendix AIC of the CCA, DOE described their plan for AICs, including constructing a fence and roadway around the surface footprint of the repository, posting warning signs, routine patrols and surveillance.  DOE stated that the AICs will be maintained for 100 years after closure of the WIPP facility and would effectively prevent human intrusion during that time.

	EPA reviewed DOE's proposed plans for AICs in connection with the types of activities that may be expected to occur in the vicinity of the WIPP site during the first 100 years after disposal (i.e., ranching, farming, hunting, scientific activities, utilities and transportation, ground water pumping, surface excavation, potash exploration, construction and hostile or illegal activities.)  EPA also examined the assumptions made by DOE to justify the assertion that AICs will be completely effective for 100 years.

	Because DOE adequately described the proposed AICs and the basis for their assumed effectiveness and did not assume in the PA that AICs would be effective for more than 100 years, EPA found DOE in compliance with Section 194.41 	 	A complete description of EPA's 1998 Certification Decision for Section 194.41 can be obtained from EPA Air Docket, A-93-02, Items V-A-1 and V-B-2.

41.3  Changes in the 2004 Compliance Recertification Application (2004 CRA)

	DOE did not report any significant changes to the information on which EPA based the 1998 Certification Decision.  Chapter 7 of the 2004 Compliance Recertification Application (2004 CRA) (2004 CRA p.7-1 to 7-24) contains all the changes related to AICs since 1998.  DOE reported that CCA Appendix AIC is unchanged since 1998.

41.3.1  Evaluation of Compliance for the 2004 Recertification 	 	Based on EPA's review of the activities and conditions in and around the WIPP site, EPA did not identify any significant changes in the planning and execution of the DOE's AICs plan since the 1998 Certification Decision.

	2004 CRA adequately described, in detail, the proposed AICs and their location and function, and identified the basis for their assumed effectiveness.  EPA confirmed that DOE's 2004 CRA performance assessment (Performance Assessment Baseline Calculations, PABC04) used the maximum allowable credit for AICs against human intrusion (100 years).  EPA continued to find reasonable DOE's assertion that AICs will completely prevent human intrusion for 100 years.   	In the 2004 CRA, DOE accurately described EPA's approval to remove Appendix LMP from recertification applications.  Information from Appendix LMP was not used as a basis for EPA's 1998 Compliance Decision on Section 194.41 (A-98-49, Item II-B2-27).  Since it did not directly support compliance demonstrations for EPA's disposal regulations, its removal was not significant nor did it affect our evaluation on continued compliance for 2004 CRA.

	EPA did not receive any public comments on DOE's continued compliance with the AICs requirements of Section 194.41.

41.3.1  2004 Recertification Decision

	Based on a review and evaluation of the 2004 CRA, CCA Appendix AIC (1998), and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2004-0025, Air Docket A-98-49), EPA determined that DOE continued to comply with the requirements for Section 194.41.

41.4  Changes in the 2009 Compliance Recertification Application (2009 CRA)

	DOE did not report any significant changes to the information on which EPA based the 1998 Certification or the 2004 CRA decisions.  DOE 2009 CRA Section 41 documented that no changes have taken place to AICs since 1998 and 2004.  DOE reported that CCA Appendix AIC and 2004 CRA Appendix AIC are unchanged since 1998 and 2004.

41.4.1  Evaluation of Compliance for 2009 Recertification 	 	Based on EPA's review of the activities and conditions in and around the WIPP site, EPA did not identify any significant changes in the planning and execution of the DOE's AICs plan since the 1998 Certification Decision or 2004 CRA.

	2009 CRA adequately described the proposed AICs and their location and function, and identified the basis for their assumed effectiveness.  EPA confirmed that DOE's 2009 CRA performance assessment and the 2009 Performance Assessment Baseline Calculations (2009 PABC) used the maximum allowable credit for AICs against human intrusion (100 years).  EPA continued to find reasonable DOE's assertion that AICs will completely prevent human intrusion for 100 years.   	EPA did not receive any public comments on DOE's continued compliance with the AICs requirements of Section 194.41.

41.4.2  2009 Recertification Decision

	Based on a review and evaluation of the 2009 CRA, 2004 CRA, CCA Appendix AIC (1998), and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2009-0330, Air Docket A-98-49), EPA determined that DOE continued to comply with the requirements for Section 194.41.

41.5  Changes in the 2014 Compliance Recertification Application (2014 CRA)

	DOE 2014 CRA Section 41 documents that no changes have taken place to AICs since 1998, 2004 and 2009.  DOE reported that CCA Appendix AIC and 2004 CRA Appendix AIC are unchanged since 1998, 2004, and 2009.

41.5.1  Evaluation of Compliance for 2014 Recertification 	 	Based on EPA's review of the activities and conditions in and around the WIPP site, EPA did not identify any significant changes in the planning and execution of the DOE's AICs plan since the 1998 Certification Decision, the 2004 CRA and the 2009 CRA.

	2014 CRA adequately describes the proposed AICs and their location and function, and identified the basis for their assumed effectiveness.  EPA confirms that DOE's 2014 CRA performance assessment and the 2014 Performance Assessment Baseline Calculations (2014 PABC) uses the maximum allowable credit for AICs against human intrusion (100 years).  EPA continues to find reasonable DOE's assertion that AICs will completely prevent human intrusion for 100 years.   	EPA did not receive any public comments on DOE's continued compliance with the AICs requirements of Section 194.41.

41.5.2  2014 Recertification Decision

	Based on a review and evaluation of the 2014 CRA, 2009 CRA, 2004 CRA, CCA Appendix AIC (1998), and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2014-0609), EPA determines that DOE continues to comply with the requirements for Section 194.41.


[Federal Register: August 3, 2007 (Volume 72, Number 149)]
[Notices]
[Page 43265-43266]
[DOCID:fr03au07-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-421-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Request Under
Blanket Authorization

July 27, 2007.
    Take notice that on July 17, 2007, Southern Star Central Gas
Pipeline, Inc (Southern Star), 4700 Highway 56, Owensboro, Kentucky
42301, filed in Docket No. CP07-421-000 a prior notice request pursuant
to sections 157.205 and 157.211 of the Commission's regulations under
the Natural Gas Act (NGA) to construct and operate a new 12-inch
delivery meter station and interconnecting facilities to serve as a
bypass of a local distribution company. The proposed facilities would
serve Aquila, Inc. (Aquila) d/b/a Aquilia Networks at Aquila's electric
generating plant Buchanan County, Missouri, all as more fully set forth
in the application, which is on file with the Commission and open to
public inspection. The filing may also be viewed on the Web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,

(202) 502-8659.
    Specifically, Southern Star proposes to install a side valve, an 8-
inch lateral pipeline approximately 59 feet long, a flow computer and
communications equipment necessary for the new interconnection with
Aquila. Aquila will construct associated metering facilities within its
electric generation plant site. The new meter station will be known as
the Aquila-St. Joe/Lake Road Delivery Measurement setting
16911. The cost of the facilities is estimated to be $296,000.
    Aquila currently receives its natural gas service from Missouri Gas
Energy (MGE), a local distribution company. Aquila wishes to receive
its primary gas service from Southern Star and would maintain its
connection with MGE in order to serve as backup gas delivery service.
Aquila has requested Southern Star to provide interruptible natural gas
delivery service to its electric generating plant of up to 17,500 Mcf
per day through the delivery point described above. Southern Star
states that it has notified MGE of the proposed delivery point
directly.
    Any questions concerning this application may be directed to David
N. Roberts, Manager of Regulatory Affairs, Southern Star Central Gas
Pipeline, Inc., 4700 Highway 56, Owensboro, Kentucky 42301, or
telephone<PHONE_NUMBER>.
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the Natural Gas Act (NGA) (18 CFR
157.205) a protest to the request. If no protest is filed within the
time allowed therefore, the proposed activity shall be deemed to be

authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request shall be treated as
an application for authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15072 Filed 8-2-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 4, 2009 (Volume 74, Number 171)]
[Rules and Regulations]
[Page 45754-45756]
[DOCID:fr04se09-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0804; Directorate Identifier 2008-SW-56-AD;
Amendment 39-16013; AD 2009-18-17]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A. Model AB412 and AB412 EP
Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
specified Agusta S.p.A. (Agusta) Model AB412 and AB412 EP helicopters.
This AD results from mandatory continuing airworthiness information
(MCAI) issued by the European Aviation Safety Agency (EASA), which is
the Technical Agent for the Member States of the European Community.
The MCAI establishes a life limit for certain rescue hoist cable
assemblies and introduces the term ``hoist lift'' for determining cable
life instead of the term ``hoist cycle.'' The MCAI also establishes a
replacement time for each affected rescue hoist cable assembly (hoist
cable assembly) for which the accumulated number of ``hoist cycles''
cannot be determined. The actions are intended to prevent failure of a
hoist cable and inadvertent loss of a load.

DATES: This AD becomes effective on September 21, 2009.
    We must receive comments on this AD by November 3, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
Agusta, Via Giovanni Agusta, 520 21017 Cascina

Costa di Samarate (VA), Italy, telephone 39 0331-229111, fax 39 0331-
229605/222595, or at http://customersupport.agusta.com/technical_
advice.php.
    Examining the Docket: You may examine the AD docket on the Internet
at http://www.regulations.gov or in person at the Docket Operations
office between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, any comments received, and
other information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is stated in the ADDRESSES section of this
AD. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sharon Miles, Aviation Safety
Engineer, FAA, Rotorcraft Directorate, Regulations and Guidance Group,
2601 Meacham Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>,
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Community, has issued EASA AD No. 2008-0142-E, dated July 30,
2008, to correct an unsafe condition associated with hoist cable
assemblies installed on Agusta Model AB412 and AB412 EP helicopters.
The MCAI establishes a life limit for certain hoist cable assemblies
and introduces the term ``hoist lift'' for determining cable life
instead of the term ``hoist cycle.'' The MCAI also establishes a
replacement time for each affected hoist cable assembly for which the
accumulated number of ``hoist cycles'' cannot be determined. The
actions are intended to prevent failure of a hoist cable assembly and
inadvertent loss of a hoist load.
    You may obtain further information by examining the MCAI and any
related service information in the AD docket.

Related Service Information

    Agusta has issued Alert Bollettino Tecnico No. 412-126, dated July
28, 2008 (ABT). The actions described in the MCAI are intended to
correct the same unsafe condition as that identified in the service
information.

FAA's Evaluation and Unsafe Condition Determination

    The Agusta Model AB412 and AB412 EP helicopters have been approved
by the aviation authority of Italy and are approved for operation in
the United States. Pursuant to our bilateral agreement with Italy,
EASA, Italy's Technical Agent, has notified us of the unsafe condition
described in the MCAI. We are issuing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other Model AB412 and AB412 EP
helicopters of these same type designs.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Registry in the future.

Differences Between This AD and the MCAI AD

    We use the term ``before further flight'' rather than ``before next
flight. Also, we are using ``before further flight'' rather than
October 31, 2008, for replacing a hoist cable assembly if you cannot
determine the ``hoist cycles'' or the date of hoist cable installation.

Costs of Compliance

    There are no costs of compliance since there are no helicopters of
this type design on the U.S. Registry.

FAA's Determination of the Effective Date

    Since there are currently no affected U.S. registered helicopters,
we have determined that notice and opportunity for prior public comment
before issuing this AD are unnecessary and that good cause exists for
making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. However, we invite you to send us any written data, views, or
arguments concerning this AD. Send your comments to an address listed
under the ADDRESSES section of this AD. Include ``Docket No. FAA-2009-
0804; Directorate Identifier 2008-SW-56-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. We will
consider all comments received by the closing date and may amend this
AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on product(s) identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    Therefore, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2009-18-17 Agusta S.p.A.: Amendment 39-16013. Docket No. FAA-2009-
0804; Directorate Identifier 2008-SW-56-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective on
September 21, 2009.

Other Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model AB412 and AB412 EP helicopters,
with internal hoist, part number (P/N) 214-070-300-1 (Goodrich P/N
42277-1); external hoist P/N BL-10300-60 (Breeze Eastern) or P/N BL-
20200-SERIES (Breeze Eastern), installed, certificated in any
category.

Reason

    (d) The actions are intended to prevent failure of a hoist cable
and inadvertent loss of a load.

Actions and Compliance

    (e) Required as indicated, do the following:
    (1) Before further flight, for rescue hoist cable assemblies, P/
N 42305-179, 42277-178 (internal hoist cable assembly) and P/N BL-
6260, BL-9149-3 (external hoist cable assembly), determine the
number of accumulated ``hoist cycles'' for each hoist cable assembly
and add that to the number of accumulated ``hoist lifts.'' A hoist
lift is defined as an unreeling and recovery of the cable with a
load attached to the hook, regardless of the length of the cable
that is deployed or recovered. An unreeling or recovery of the cable
with no load on the hook is not considered to be a lift.
    (2) Before conducting the next hoist operation, replace any
hoist cable assembly that has reached or exceeded 1,500 accumulated
hoist lifts or 4 years from initial installation, whichever occurs
first.
    (3) If you cannot determine the ``hoist cycles'' or the date of
the hoist cable assembly installation, before further flight,
replace the hoist cable assembly with an airworthy hoist cable
assembly.
    (4) This AD revises the Airworthiness limitations section of the
maintenance manual by adding a life limit of 1,500 hoist lifts or 4
years, whichever occurs first, for the affected hoist cable
assemblies.

Differences Between This AD and the MCAI AD

    (f) We use the term ``before further flight'' rather than
``before next flight. Also, we are using ``before further flight''
rather than October 31, 2008, for replacing a hoist cable if you
cannot determine the ``hoist cycles'' or the date of hoist cable
assembly installation.

Other Information

    (g) Alternative Methods of Compliance (AMOCs): The Manager,
Safety Management Group, FAA, ATTN: Sharon Miles, Aerospace
Engineer, Regulations and Policy Group, 2601 Meacham Blvd.,
Rotorcraft Directorate, Fort Worth, Texas 76137, telephone (817)
222-5122, fax<PHONE_NUMBER> has the authority to approve AMOCs for
this AD, if requested, using the procedures found in 14 CFR 39.19.

Related Information

    (h) The European Aviation Safety Agency (EASA) MCAI
Airworthiness Directive No. 2008-0142-E, dated July 30, 2008, and
Agusta Alert Bollettino Tecnico No. 412-126, dated July 28, 2008,
contain related information.

Joint Aircraft System/Component (JASC) Code

    (i) JASC Code 1400: Miscellaneous Hardware.

    Issued in Fort Worth, Texas, on August 26, 2009.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. E9-21116 Filed 9-3-09; 8:45 am]

BILLING CODE 4910-13-P


From:
"David Ailor"<EMAIL_ADDRESS>Sent:
Fri, 26 Aug 2022 14:54:00
To:
"'Jones; DonnaLee'"<EMAIL_ADDRESS>Subject:
RE: DRAFT LISTS OF COETF AND EPA "DO-OUTS" FROM YESTERDAY'S CALL ON 114 TESTING
Donna Lee:

As follow-up to my e-mail yesterday, the COETF would appreciate a response ASAP to all the concerns we raised in our August 2 letter (attached), including our deadline extension requests.  We request that EPA respond to us with the utmost urgency.

Thanks, DCA

David C. Ailor, P.E.

President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.	Suite 800	Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>www.accci.org

<<August 2 2022 COETF Letter Detailing ICR Concerns.pdf>>

From: David Ailor<EMAIL_ADDRESS>Sent: Thursday, August 25, 2022 10:31 AM
To: 'Jones, DonnaLee'<EMAIL_ADDRESS>Cc: 'Daly, Owen'<EMAIL_ADDRESS>'French, Chuck'<EMAIL_ADDRESS>'Fruh, Steve'<EMAIL_ADDRESS>'Lin, Walter'<EMAIL_ADDRESS>'Mcginn, Kevin'<EMAIL_ADDRESS>'GABRIELLE RAYMOND'<EMAIL_ADDRESS>'Shappley, Ned'<EMAIL_ADDRESS>Subject: RE: DRAFT LISTS OF COETF AND EPA "DO-OUTS" FROM YESTERDAY'S CALL ON 114 TESTING

Hello again, Donna Lee.

Just wanted to check and see if you have any better idea yet when we might receive a response on the COETF's request for changes to the ICR schedule.  I'm hearing from COETF members on a call now that all are struggling to make next Friday's deadline, and urgently need an extension.  If one is not granted, it appears likely that most/all will be submitting late.

Thanks for any news you can share.  DCA

David C. Ailor, P.E.

President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.	Suite 800	Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>www.accci.org

From: David Ailor (ACCCI<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Sent: Friday, August 19, 2022 6:48 PM
To: Jones, DonnaLee<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Cc: Daly, Owen<EMAIL_ADDRESS><EMAIL_ADDRESS>>; French, Chuck<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Fruh, Steve<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Lin, Walter<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Mcginn, Kevin<EMAIL_ADDRESS><EMAIL_ADDRESS>>; GABRIELLE RAYMOND<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Shappley, Ned<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Subject: Re: DRAFT LISTS OF COETF AND EPA "DO-OUTS" FROM YESTERDAY'S CALL ON 114 TESTING

Thanks!  You, too!  DCA
Sent from my iPhone

David C. Ailor, P.E.

President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.	Suite 800	Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>www.accci.org

On Aug 19, 2022, at 3:41 PM, Jones, DonnaLee<EMAIL_ADDRESS>wrote:

1.	Thank you for this information and attending to your to do list. I see the one remaining item on your list is "Follow-up on EPA request for information on composition/speciation of VOC from byproduct plant processes (LDAR program)."

In regard to the EPA list, we plan to respond to all items listed in your earlier email below, except #3, which we don't believe we agreed to do and I believe I addressed in my earlier email of 8/8/22 where I provided an EPA website for our ambient data. For the other EPA items, the team has provided a draft of our responses to Chuck French , who is reviewing the draft responses now. Chuck will need to discuss the responses with our division director before we can provide a response back to you. Hopefully, this will all happen next week. Sorry I can't be more definitive, but it's out of my hands now.

Hope you have a good weekend.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711
Tele:<PHONE_NUMBER>
--------------------------------------------------------------------------------
Fax<PHONE_NUMBER>
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Sent: Friday, August 19, 2022 3:19 PM
To: Daly, Owen<EMAIL_ADDRESS><EMAIL_ADDRESS>>; French, Chuck<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Fruh, Steve<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Jones, DonnaLee<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Lin, Walter<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Mcginn, Kevin<EMAIL_ADDRESS><EMAIL_ADDRESS>>; 'GABRIELLE RAYMOND'<EMAIL_ADDRESS><EMAIL_ADDRESS>>; Shappley, Ned<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Subject: RE: DRAFT LISTS OF COETF AND EPA "DO-OUTS" FROM YESTERDAY'S CALL ON 114 TESTING

Hello again, Donna Lee.

	I'm following up on two of the three COETF "do-outs" from our Tuesday, August 9 call to discuss the Coke Ovens ICR.  The two do-outs are (1) "Provide close-up images of battery bench showing safety hazards  -  tight spaces, moving equipment, etc." and (2) "Provide OSHA reports on previous injuries/fatalities."  What we are providing on each of these is discussed below:

1.	Provide close-up images of battery bench showing safety hazards  -  tight spaces, moving equipment, etc.  During the August 9 call, EPA requested close-up images of the battery bench showing the potential safety hazards, including narrow spaces and areas where there is moving equipment on the bench.  Two example photos are included in the attached ".pdf" file (see "COETF Example Bench Photos.pdf").

2.	Provide OSHA reports on previous injuries/fatalities.  EPA also requested that the COETF provide examples of OSHA incident reports for accidents on coke battery benches.  A ".pdf" file listing several examples is attached (see "Accident Report Detail _ Occupational Safety and Health Administration (SIC 3312).pdf").

Lastly, two of EPA's "do-outs" from the August 9 call are a "Response to COETF's letter requesting changes to the ICR schedule (expedited response requested)" and a "Response to COETF's letter requesting changes to the ICR scope."  Can you please advise when EPA will be providing responses to these time-sensitive requests?  The COETF would greatly appreciate knowing as soon as possible if EPA is making changes to the ICR scope and providing the requested extensions of time.

Thanks.  And, please contact me if you have any questions.  DCA

David C. Ailor, P.E.

President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.	Suite 800	Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>www.accci.org

From: David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Sent: Wednesday, August 10, 2022 4:59 PM
To<EMAIL_ADDRESS><EMAIL_ADDRESS>; 'French, Chuck'<EMAIL_ADDRESS><EMAIL_ADDRESS>><EMAIL_ADDRESS><EMAIL_ADDRESS>; 'Jones, DonnaLee'<EMAIL_ADDRESS><EMAIL_ADDRESS>><EMAIL_ADDRESS><EMAIL_ADDRESS>; 'Mcginn, Kevin'<EMAIL_ADDRESS><EMAIL_ADDRESS>>; 'GABRIELLE RAYMOND'<EMAIL_ADDRESS><EMAIL_ADDRESS>>; 'Shappley, Ned'<EMAIL_ADDRESS><EMAIL_ADDRESS>>
Subject: DRAFT LISTS OF COETF AND EPA "DO-OUTS" FROM YESTERDAY'S CALL ON 114 TESTING

Donna Lee et al.:

	Thanks again for making the time to meet with the Coke Oven Environmental Task Force (COETF) yesterday to discuss 114 testing the Agency is requesting.  Below, as promised, are draft lists developed by the COETF inclusive of what we believe are the COETF and EPA "do-outs" from the call.  Please let us know ASAP of any errors/omissions you might identify.
Thanks, David Ailor

COETF Do-Outs:

1.	Provide close-up images of battery bench showing safety hazards  -  tight spaces, moving equipment, etc.
2.	Provide OSHA reports on previous injuries/fatalities
3.	Follow-up on EPA request for information on composition/speciation of VOC from byproduct plant processes (LDAR program)

EPA Do-Outs:

1.	Response to COETF's letter requesting changes to the ICR schedule (expedited response requested)
2.	Response to COETF's letter requesting changes to the ICR scope
3.	Provide list of ambient monitoring stations for which EPA already has data
4.	If any interior/fenceline fugitive monitoring remains in the ICR, confirm whether method can be limited to passive samplers and fenceline locations reduced to 1-2 upwind and 1 downwind
5.	Confirm whether EPA will accept USS SCOT plant stack test data in lieu of performing new testing
6.	Confirm whether EPA will accept DTE/EES COG sample data in lieu of performing new testing

David C. Ailor, P.E.

President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.	Suite 800	Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS><EMAIL_ADDRESS>www.accci.org


	 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF PREVENTION,

 PESTICIDES AND

TOXIC SUBSTANCES

				April 12, 2007

MEMORANDUM

SUBJECT:	RESPONSE TO PUBLIC COMMENTS.  The Health Effects Division’s
Response to Comments on EPA’s Phase 3 Reregistration Eligibility
Decision Document for Chloropicrin (OPP Docket# OPP-2006-0661).  DP
Barcode D305332, Chloropicrin PC Code: 081501.

FROM:	Elissa Reaves, Ph.D., Toxicologist/Risk Assessor

		Charles Smith, Environmental Scientist/Risk Assessor

Reregistration Branch II

Health Effects Division (7509P)

THRU:	Alan Nielsen, Branch Senior Scientist

		William J. Hazel, Ph.D., Branch Chief

Reregistration Branch II

Health Effects Division (7509P)

TO:		Nathan Mottl, Chemical Review Manager

		Special Review & Reregistration Division (7508P)

The attached document titled, “HED’s Response to Comments on EPA’s
Phase 3 Reregistration Eligibility Decision Document for Chloropicrin”
was generated in the post-Phase 4 period of the Proposed Public
Participation Process to address comments submitted by the Chloropicrin
Manufacturer’s Task force (CMTF), the California Department of
Pesticide Regulation (CDPR), the National Resource Defense Council
(NRDC), Beyond Pesticides, California Rural and Legal Assistance
Foundation (CRLA), and members of the general public to the Agency
following the publication of the Agency’s Phase 3 Reregistration
Eligibility Decision Document for Chloropicrin in the Federal Register
November 29, 2006.  The attached document is the Agency’s response to
those comments.TABLE OF CONTENTS

 TOC \f

I.  Introduction	Page 3 of  11

II.  Toxicology	Page 3 of  11

III.  Occupational and Residential Exposures	Page 9 of  11

EPA’S RESPONSE TO COMMENTS FOR CHLOROPICRIN

I.  Introduction tc \l1 "I.  Introduction

The following is EPA’s response to comments on the Phase 3
Reregistration Eligibility Document (RED) for chloropicrin, generated in
response to the comments submitted to the public docket by the
registrant, grower groups, consumer groups, and environmental advocacy
groups to the Agency following the publication of the Phase 3 RED on
chloropicrin in the Federal Register November 29, 2006.  Some of the
responses serve as clarification or a restatement of Agency policies and
guidance and it is hoped that this will provide a greater understanding
of the Agency’s position and procedures on these matters.  Comments
concerning the rationale behind Agency decisions, toxicology, exposure
assessment, and interpretation of available data, were submitted.

Issues related to the availability/efficacy of substitute pesticides or
the environmental fate and persistence of chloropicrin raised in the
comments and will be addressed in separate documents by the appropriate
divisions; the Biological and Economics Assessment Division (BEAD) and
the Ecological Fate and Effects Division (EFED).

II.  Toxicology tc \l1 "II.  Toxicology

A. NRDC Comments on Chloropicrin Risk Assessment (Phase 3)

NRDC 1.  EPA failed to adequately adjust for scientific uncertainties
left by the human study on which the Agency relied

Despite concerns raised both during and outside the HSRB process, the
EPA failed to make additional adjustments for adverse effects other than
eye irritation, failed to adjust for routine occupational exposures (8
hour or more per day), and failed to adjust for bystander populations
with additional uncertainty factors. Overall, EPA failed to respond
appropriately to many legitimate concerns raised by HSRB experts.

EPA Response:  The human study provides threshold eye irritation
information for the inhalation route of concern for the bystander risk
assessment. This eye irritation threshold information is not available
from the rodent toxicity database. The subjects participating in the
study are considered the most sensitive to the detection of sensory
irritants.  Protection of transient eye irritation in this sensitive
subpopulation also protects against adverse eye and respiratory
irritation.  The one hour inhalation endpoint is appropriate in the
modeling output data used for the exposure assessment.  Furthermore, the
HSRB concluded the human study was scientifically sound for the purpose
of estimating a safe level of inhalation exposure to chloropicrin.
Therefore, phase 3 of the human study provides the appropriate point of
departure for the acute inhalation risk assessment.

NRDC 2.  EPA failed to protect bystanders from harmful exposures

EPA failed to adjust for the sensitivities of the worker and general
population, including asthmatics and others with existing pulmonary
conditions, as recommended by the HSRB. Chloropicrin, like the other
soil fumigants, has the potential to move off-site following field
applications, resulting in exposure to bystanders near treated areas and
to people far away from treated areas as it moves through the ambient
air (HED at 7, 29).  In fact, the Centers for Disease Control (CDC) and
California officials have documented chloropicrin drift problems and, in
some cases, illnesses in nearby residents. EPA states that the key
concern in this assessment was inhalation exposures to bystanders –
members of the general population who are in proximity to treated fields
and facilities.  The EPA reports that from 1993-2001, there were 36
exposure incidents reported among workers (adults and older children)
and 104 exposure incidents reported by the general population (Incidents
at 5, HED at 27-29). Although none were life-threatening, between 25%
(non-occupational) and 73% (occupational) were serious enough that the
victim was seen in a hospital health care facility (Incidents at 5). The
California Pesticide Illness Surveillance Program (1982-2002) reported a
total of 45 cases attributed to chloropicrin (Incident at 6). The EPA
incident report concludes that soil fumigation with chloropicrin in
California has resulted in widespread adverse effects to nearby
neighborhoods in 1984, 1995, and 2003 (Incident at 16, HED at 27).

EPA Response:  Information from the available incident reports indicate
that children and asthmatics respond in a similar fashion as that of
adults.  There is currently no information to suggest that asthmatics or
children would respond differently than adults.  There is, however, some
information to suggest that asthmatics may be capable of detecting
sensory irritants at lower concentrations than non-asthmatics.
Individuals capable of detecting at lower concentrations are at less
risk of irritation since they have an earlier “warning” of chemical
exposure.  Furthermore, protection of eye irritation protects bystanders
and workers from respiratory irritation.

NRDC 3.  EPA failed to consider effects other than eye irritation

EPA failed to adjust for the sensitivities of the general population,
including asthmatics and others with existing pulmonary conditions.
Relying on the industry-sponsored human testing study, EPA
inappropriately concluded that “eye irritation is an appropriate
marker for protection of more serious respiratory outcomes” (HED at
8).  In addition, the failure by EPA to use more than a 10X factor to
adjust for differences between individuals (HED at 26) ignores sensitive
populations with pre-existing respiratory conditions such as asthma. In
fact, the HSRB, when discussing the eye irritant chemical MITC (methyl
isothiocyanate), raised the concern that the presumption that eye
irritation is more sensitive than inhalation risk is actually inaccurate
because sensitive individuals, such as asthmatics, often show a
pulmonary physiological response at significantly lower doses than
objective eye irritation (HRSB meeting, May 2-3, 2006). The adverse
effects of chloropicrin exposure are commonly known to include breathing
difficulties. Of 46 poisoning cases attributable to chloropicrin in the
California surveillance program, one included respiratory effects and
three reported a combination of eye, skin, and respiratory effects
(Incidents at 6, 7, 14). The EPA incident report concludes that symptoms
from exposure are principally lacrimation (eye tearing), throat
irritation, headache, coughing, and difficulty breathing (Incident at
16, HED at 7). The label for chloropicrin alerts treating physicians to
symptoms that include “respiratory distress.” This demonstrates the
recognized relevance of respiratory effects following exposure to
chloropicrin, particularly for sensitive populations.

EPA Response:  The Agency has take into account the sensitivity of
individuals participating in the human study.  Information from the
human study suggests that protection of eye irritation protects against
respiratory irritation. The subjects participating in the human study
were of the sensitive subpopulation capable of detecting chloropicrin at
lower concentrations.  Furthermore, the physiological parameters
evaluated in phase 3 of the human study support the lack of respiratory
irritation from a one hour exposure.  Consideration has also been given
to individuals with pre-existing conditions such as asthma.  The
incidents reports do no suggest that asthmatics are responding
differently than other individuals.  As for the comparison of MITC with
chloropicrin, this comparison can not be made.  First, the mode of
action for chloropicrin is sensory irritation.  The mode of action for
MITC has not been identified and therefore should not be compared with
chloropicrin.  The human study has defined a level at which chloropicrin
may be detected in the eyes but without producing severe irritation in
the eyes, nose or tracheobronchial region of the respiratory tract.
Finally, detecting chloropicrin at lower concentrations results in less
risk of chemical exposure.

NRDC 4.  EPA failed to retain the FQPA factor

EPA failed to adjust for exposure to bystander populations that include
children, pregnant women, asthmatics, and others with existing pulmonary
conditions. EPA also expected no dietary exposure to chloropicrin based
on the rapid dissipation and complete metabolism in soil and plants (HED
at 27).  Therefore, EPA determined no acute and chronic dietary
reference doses and thus found that the 10X factor provided by the Food
Quality Protection Act of 1996 does not apply (HED at 27). However, this
determination ignores the children and early life stage fetuses of
pregnant women that may be exposed as bystanders from spray drift and
other agricultural uses of chloropicrin. EPA did not require food
tolerances for chloropicrin, stating that metabolism studies in soil and
plants indicated no reasonable expectation of finite residues in raw
agriculture commodities when the chemical is applied according to label
directions (HED at 7). Because there are no food tolerances, EPA also
required no aggregate assessment be performed (HED at 7).

EPA Response:  Although chloropicrin does not require food tolerances
and is not subject to the amendments to the Federal Food, Drug, and
Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) promulgated under the Food Quality Protection
Act (FQPA) of 1996, consideration was given to children, pregnant women,
and others with pre-existing respiratory conditions. The rodent
inhalation database, specifically, the reproductive and developmental
inhalation studies for chloropicrin, do not suggest qualitative or
quantitative susceptibility.  The chloropicrin incidents reports do no
suggest that asthmatics or children are responding differently than
other individuals. Therefore, an additional uncertainty factor is not
warranted.

B.  California Rural Legal Assistance Foundation Comments on
Chloropicrin Risk Assessment Docket PEA-HQ-OPP-2006-0661

CRLA 1.  The proposed HECs are not Health Protective

The Benchmark approach used in the HED assessment is not transparent or
health protective.  It is troubling that the margin of exposure between
the LOAEL of 100 ppb and the acute HEC of 73 ppb is less than 1.4
especially since this LOAEL is not relevant to sensitive populations
because it is derived from a study of young adults with no history of
eye or respiratory problems.  The CRLA supports the comments of the NRDC
which detail the need for more health protective HECs that incorporate
additional uncertainty factors to compensate for the poor quality of the
toxicology data and the need to protect children and other sensitive
populations.

EPA Response:  The young adults participating in the human study are
considered to be more sensitive to the detection of sensory irritants
than older adults.  The public literature suggests that the ability of
an individual to detect sensory irritation likely decreases with age.
Therefore, the human study provides threshold eye irritation information
in the more sensitive population.  In addition, concentrations up to 150
ppb only produced transient physiological changes in the nasal region.
No respiratory changes (e.g., tracheobronchial) occurred at the 150 ppb
level.  Therefore, protection of transient eye irritation at 73 ppb also
protects for transient nasal irritation at 150 ppb.  The chloropicrin
incident reports do no suggest that asthmatics are responding
differently than other individuals.  Furthermore, the physiological
response of asthmatics is typically the result of inflammation of the
tracheobronchial region. Physiological parameters evaluated in the human
study suggest this region was not affected.  Therefore, the eye
irritation endpoint defined from the chloropicrin human study is health
protective of both bystanders and workers.

CRLA 2.  Comments on Review of Chloropicrin Incident Reports

The incident review appears to be quite thorough for California
incidents between 1982 and 2002.  This review needs to be updated to
incorporate data on chloropicrin use and poisoning incidents since 2002.
 Starting in 2003, California has experienced an upsurge in poisoning
incidents which track with increased usage of chloropicrin.

EPA Response:  The Agency acknowledges that the occurrence of the
incidents serves to demonstrate, as the HED modeling predicts, that
chloropicrin exposures to bystanders may occur following soil
treatments.  The Agency has included an updated review of chloropicrin
incidents in the Phase 5 revised risk assessment.  Please refer to
section 5.0 of the risk assessment for this updated incident review.  In
some instances, recent chloropicrin incidents occurred as a result of
doing something wrong or not at all (for example, from improper sealing
of the soil after application or failure to flush irrigation pipes).  In
other instances, it is unclear due to the lack of information available,
what the cause was of the incidents.  The incident indicate that there
have been fewer chloropicrin incidents in CA in recent years (2002 = 191
reported incidents, 2003 = 61 reported incidents, and 2004 = 1 reported
incident) not an upsurge as the CRLA claims.  This reduction in
incidents could be due to a combination of changing use patterns, state
or local regulatory changes, and/or better worker education and
outreach.  Tthe Agency does acknowledge that few states have as
stringent controls in place as California.  The fact that even in
California, incidents continue to occur confirms the need for additional
measures to reduce exposures to the public (i.e., bystanders).

C.  Beyond Pesticides Comments, Re: Chloropicrin Risk Assessments

1.  Beyond Pesticides requests EPA reject data obtained through human
testing.

The study does not meet the ethical standards prevailing at the time it
was conducted…. EPA has accepted data from a human study that caused
intentional harm to its subjects by a chemical described as “the major
toxic gas used in WWI.”  The study intentionally exposed human
subjects, using a “walk-in chamber” for two of three research
phases, to a toxic chemical, for data that offers no societal benefit,
was indeed procurable by other methods and was unnecessary.  This is
fundamentally unethical.  Beyond Pesticides continues to be extremely
alarmed that EPA has not evidenced a procedure or protocol for
evaluating the societal benefits of pesticides that are tested on humans
with results utilized in risk assessments for pesticide registration or
reregistration. In this context, chloropicrin human data violates
national and international standards.

EPA Response:  The human study with chloropicrin provides eye irritation
threshold information that is not available from rodent studies.  This
threshold information does serve to protect both bystanders and workers.
 The human study also provides irritation information in sensitive
subjects such that protecting sensitive subjects to the feel of
chloropicrin will also protect others from respiratory irritation.
Therefore, the human study provides the most appropriate irritation
threshold information for the acute inhalation risk assessment.
Furthermore, the HSRB reviewed the ethical considerations of the human
study and determined that the human study was both ethically conducted
and scientifically robust for estimating a safe level of inhalation
exposure.

2.  Beyond Pesticides also requests, at a minimum, EPA restore
uncertainty factors to uncompromised levels for all scenarios.

Clearly, the rejection of the human testing data dictates that the
interspecies uncertainty factor must be reestablished to at least 10X.
We also request EPA reestablish the FQPA factor of 10X due to potential
bystander exposure. EPA did not deem the FQPA factor necessary. However,
spray drift and other agricultural uses of chloropicrin may result in
exposure of sensitive populations, such as pregnant women and children.
In conclusion, Beyond Pesticides requests EPA reject human testing data
for chloropicrin on the grounds that the study is fundamentally
unethical, and requests EPA restore uncertainty factors to protective
levels.

EPA Response:  Although chloropicrin does not require food tolerances
and is not subject to the amendments to the Federal Food, Drug, and
Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) promulgated under the Food Quality Protection
Act (FQPA) of 1996, consideration was given to children, pregnant women,
and others with pre-existing respiratory conditions. The rodent
inhalation database, specifically, the reproductive and developmental
inhalation studies for chloropicrin, do not suggest qualitative or
quantitative susceptibility.  The chloropicrin incidents reports do no
suggest that asthmatics or children are responding differently than
other individuals. Therefore, additional uncertainty factors are not
warranted.

D.  Comments from the Chloropicrin Manufacturers’ Task Force (CMTF)

CMTF 1. A 10X Uncertainty Factor  For Intraspecies Variability Is Not
Appropriate For The Agency’s Level Of Concern For Acute Inhalation
Exposure To Chloropicrin.

EPA Response:  The Agency has addressed the intraspecies variability
factor for chloropicrin in the Phase 5 risk assessment.  Please refer to
the uncertainty factor section of the risk assessment for further
details (Section 4.2).

CMTF 2. EPA Should Not Use Animal Toxicology Data to Establish
Short-Term

and Intermediate-Term (ST-IT) Level of Concern for Inhalation Exposure
to Chloropicrin

Human ocular sensory irritation is the most sensitive endpoint of
exposure to chloropicrin. The threshold for this effect, a mild,
transient effect, is below the NOAEL for respiratory effects seen in
rodents exposed at higher concentrations. Measures to protect
individuals from sensory irritation will also protect against
respiratory effects, which were examined for but not observed in the
human study.  Lifetime whole-body inhalation exposure of rodents to
chloropicrin vapor produced no evidence of an adverse effect at 100
ppb…. Dr. Ross has included an analysis of interspecies uncertainty in
his report. He has generated a BMCL10 for the mouse RD50 study (130 ppb)
and compared the variability associated with that data set and sensory
responses to the human subject study. Dr. Ross observes that the BMCL10
for the mouse RD50 study compares favorably with the aximum exposure
(150 ppb) employed in the human subject study. In presenting his
analysis of these data Dr. Ross points out that concordance in the
toxicocokinetics of chloropicrin in laboratory animals and humans is
strong. An interspecies UF of less than 10 therefore is inappropriate
and if an interspecies UF if used it should not be greater than 2.5.

EPA Response:  The Agency notes the rationale provided by the CMTF for
the short- and intermediate- inhalation durations for chloropicrin.
However, the Human Studies Review Board concluded the human study was
appropriate for use in the acute inhalation assessment.  Furthermore,
the human study does not provide physiological parameters of the nasal
and upper respiratory tract beyond a one hour exposure.  The animal
database, therefore, provides the most appropriate inhalation
information for the short- and intermediate-term durations.  Therefore,
the short- and intermediate-term inhalation assessments for chloropicrin
will rely on the RfC methodology as with the other fumigants being
assessed.

III. Occupational and Residential Exposures

 tc \l1 "IV.  Occupational and Residential Exposures

A.  Occupational Comments from the Chloropicrin Manufacturers’ Task
Force (CMTF)

CMTF 1.  The CMTF stated that the importance of soil moisture in
controlling chloropicrin emissions has been confirmed in recent studies
conducted by researchers at the USDA-ARS San Joaquin Valley Agricultural
Sciences Center, Water Management Research Unit in Parlier.  These
studies indicate that soil moisture can be effective in reducing
emissions of chloropicrin.  The CMTF believes that the mass loss values
for all flux studies in the Agency’s risk assessment should be
adjusted to reflect fields that have proper soil moisture.

EPA Response: The Agency acknowledges that soil moisture is important in
controlling chloropicrin emissions.  However, there are other
application factors (e.g., tarped vs. untarped) and environmental
factors (e.g., soil temperature) that could have an effect on
chloropicrin emissions coming off of treated fields.  The Agency
believes that the chloropicrin assessment represents a range of possible
real world application conditions and does not believe that the mass
loss values for all flux studies in the Agency’s risk assessment
should be adjusted to reflect fields that have proper soil moisture.

CMTF 2.  The CMTF stated that mass loss from drip irrigation
applications has been well studied and an emission factor of 15% of
applied from the Salinas (PRS02004) site is a conservative mass loss
value.  Instead, EPA used much higher values in it draft risk
assessment.  For the greenhouse drip irrigation method, the appropriate
“released amount” should be 15% of the applied chloropicrin.

EPA Response: The Agency has used a range of mass loss values in its
assessment of greenhouse drip irrigation applications.  This assessment
shows that generally, if less than 25% mass loss occurs then risks are
below the Agency’s level of concern at 0 meters.

CMTF 3.  The CMTF commented that there are inherent limitations to any
field air dispersion model used to predict the potential for bystander
exposure.  The relatively short exposure intervals that may be
appropriate for chloropicrin have raised concerns among modelers
regarding the limitations of the model currently being used by EPA.
Both PERFUM, as used by EPA, and FEMS originally incorporated the ISCST3
engine; however since the Science Advisory Panel hearing on soil
fumigant modeling, the CALPUFF 6 model has been developed and both
PERFUM and FEMS have the ability to incorporate CALPUFF 6 into their
respective models.  The design of

CALPUFF 6 allows it to use less than one hour meteorological data.  It
is likely that the

incorporation of CALPUFF 6 will result in more accurate off-site
dispersion modeling.

EPA Response: The Agency agrees that there are limitations to any field
air dispersion model used to predict the potential for bystander
exposure.  The limitations associated with the Agency’s use of the
PERFUM model have been described in detail in the Phase 5 chloropicrin
risk assessment.  Also, the Agency has stated that submissions based on
FEMS, CALPUFF, or any other applicable and valid publicly available
model, would be considered by the Agency in the course of developing its
risk management decisions in context with the results of this assessment
provided sufficient supporting information were also provided in order
to document such analyses.

B.  Occupational Comments from the California Rural Legal Assistance
(CRLA) Foundation

CRLA 1.  The CRLA Foundation commented that the length of the workday is
underestimated in the Agency’s risk assessments.

EPA Response:  The Agency acknowledges that worker exposures may exceed
the typical workday (8 hours/day) in some instances.  However, the
Agency uses an 8 hour day which is found to be a typical full day for
most agricultural worker surveys.  The use of an 8 hour workday should
be taking into context with acute results generated using high end
inputs.

CRLA 2.  The CRLA stated that respiratory protection factors are
overestimated in the Agency’s risk assessments.  The pesticide
applicator respiratory protection regulations incorporated in the Worker
Protection Standard (WPS) and California pesticide use regulations are
much less protective than OSHA respirator regulations, particularly in
the area of fit-testing of respirators to prevent leakage.

EPA Response: The Agency assumes respirator protection factors based on
the OSHA fit factors but acknowledges that there are uncertainties
because of lack of fit testing, medical monitoring, etc.

CRLA 3.  The CRLA commented that the chloropicrin risk assessment states
that dermal exposure to chloropicrin is not anticipated because handlers
are required to wear personal protective equipment.

EPA Response:  The Agency disagrees with the CRLA’s statement.  The
Agency has stated that dermal exposure resulting from typical use is not
expected.  As a result, the Agency is not conducting a quantitative
dermal risk assessment at the present time.  However, it is noted that
handlers are required by the current labels to wear personal protective
equipment (PPE) due to the corrosivity of chloropicrin to skin.

CRLA 4.  The CRLA referenced previous comments made by the Pesticide
Action Network North America (PANNA)  that stated that ISCST3 is not
capable of modeling fumigant emissions during calm atmospheric
conditions.  PANNA believes that AERMOD should be used in place of
ISCST3 as it is the only model that has undergone extensive validation
by the EPA.  PANNA states that the following new and improved algorithms
are included in AERMOD but not in ISCST3:

1) dispersion in both the convective and stable boundary layers,

2) plume rise and buoyancy,

3) plume penetration into elevated inversions,

4) treatment of elevated, near-surface, and surface level sources,

5) computation of vertical profiles of wind, turbulence, and
temperature, and

6) the treatment of receptors on all types of terrain (from the surface
up to and above the plume height.

EPA Response: The treatment of calm periods (wind speeds below 1 m/s) in
PERFUM/ISCST3 is an uncertainty in the Agency’s fumigant assessments.
PERFUM runs the ISCST3 model in the “regulatory default option” (the
default setting for ISCST3), which includes the use of the calms
processing routine as is described in Agency guidance.  The calms
processing routine for wind speeds below 1 m/s essentially ignores any
hourly sequence in the calculations that meets this criteria.  The
Agency agrees that this approach can possibly skew results, particularly
for shorter averaging times (like metam sodium) because an analysis
period that contained several calm hours would be dominated by any
period where there was a windspeed above 1m/s.  This is a common
approach in Gaussian plume modeling.  See the U.S. Environmental
Protection Agency’s Guideline on Air Quality Models, which is
published as Appendix W to 40 CFR Part 51 1-4
(http://www.epa.gov/scram001/guidance/guide/appw_05.pdf).

AERMOD is also a Gaussian plume model and it too has issues in dealing
with wind speeds below 1 m/s.  The new and improved algorithms included
in AERMOD have little to no effect on the Agency’s approach to
modeling fumigant applications as area sources.  In fact, preliminary
work has shown that AERMOD produces neligible differences when compared
to ISCST3 for modeling fumigant applications as area sources.

The Agency has begun to examine PUFF-based models such as CALPUFF that
have meander algorithms that can account for calm conditions by
accounting for static or near static plume conditions and representing
such events in the results.  Whether or not buffer estimates are
enhanced or under-reported as a result of this phenomenon depends upon
the nature of the weather data used for the calculations.  Preliminary
analysis in a general sense related to this issue does not indicate
significant differences when hourly calculation steps are used.  If less
than hourly steps (e.g., minute by minute calculations such as in
CALPUFF v6) are used, the effect is attenuated because the relative
percentage of calm periods in the available weather data seems to be
diminished.

C.  Occupational Comments from the California Department of Pesticide
Regulation (CDPR)

CDPR 1.  CDPR stated that water solubility is reported inconsistently in
the Phase 3 document.

EPA Response: The Agency has corrected the inconsistency in the Phase 5
chloropicrin risk assessment.

 See, e.g., CDC, “Brief Report: Illness Associated with Drift of
Chloropicrin Soil Fumigant into a Residential Area—Kern County,
California, 2003,” Mortality & Morbidity Weekly Report, August 20,
2004,   HYPERLINK
"http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5332a4.htm"
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5332a4.htm ; California
Department of Pesticide Regulation, “Chloropicrin,” at   HYPERLINK
"http://www.cdpr.ca.gov/docs/dprdocs/methbrom/rafnl/attach_e.pdf"
http://www.cdpr.ca.gov/docs/dprdocs/methbrom/rafnl/attach_e.pdf .

 Chloropicrin labels and MSDS.
http://www.arystalifescience.com/default.asp?V_DOC_ID=866

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[Federal Register: April 1, 2009 (Volume 74, Number 61)]
[Rules and Regulations]
[Page 14738-14743]
[DOCID:fr01ap09-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0362; FRL-8405-2]

Quinoxyfen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
quinoxyfen in or on artichoke, globe; fruit, stone, group 12; squash,
winter; pumpkin; and gourd, edible. This regulation also deletes the
established cherry, sweet;

and cherry, tart tolerances, as they will be superseded by inclusion in
the stone fruit crop group. This regulation additionally deletes the
time-limited tolerances for pumpkin; winter squash; and melon subgroup
9A, as the tolerances expired on December 31, 2007. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 1, 2009. Objections and
requests for hearings must be received on or before June 1, 2009, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0362. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

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

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0362 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before June 1, 2009.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0362, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of June 4, 2008 (73 FR 31862) (FRL-8365-3),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 8E7325)
by Interregional Research Project Number 4 (IR-4), 500 College Rd.
East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40
CFR 180.588 be amended by establishing tolerances for residues of the
fungicide quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or
on artichoke, globe at 1.4 parts per million (ppm); fruit, stone, group
12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin at 0.20 ppm; and
gourd, edible at 0.20 ppm. IR-4 additionally proposed to remove the
established tolerances for the residues of quinoxyfen in or on the food
commodities cherry, sweet; and cherry, tart at 0.30 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by Dow
AgroSciences LLC, the registrant, which is available to the public in
the docket, http://www.regulations.gov There were no comments received
in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes

exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of quinoxyfen on artichoke, globe at 1.4 ppm;
fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20 ppm; pumpkin
at 0.20 ppm; and gourd, edible at 0.20 ppm. EPA's assessment of
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The existing quinoxyfen data indicate that it possesses low acute
toxicity via the oral, dermal and inhalation routes. It is a mild eye
irritant and dermal sensitizer, but it is not a dermal irritant.
    The primary target organs affected by quinoxyfen are the liver and
kidney. Subchronic effects in rats and mice included increased liver
weights, hepatocellular hypertrophy and individual cell hepatocellular
necrosis, and chronic effects in the dog included increased liver
weights, increased alkaline phosphatase levels and increased incidences
of slight microscopic hepatic lesions. Kidney effects were noted only
in the rat combined chronic/carcinogenicity study, resulting in an
increased severity of chronic progressive glomerulonephropathy in
males. Rabbits were much more susceptible to the effects of quinoxyfen
than any other species. Systemic effects observed in the rabbit
developmental study included inanition, loss of body weight, perineal
soiling, blood in the cage pan associated with urine, and abortions.
    Long-term dietary administration of quinoxyfen did not result in an
overall treatment-related increase in incidence of tumor formation in
rats or mice. As a result, EPA classified quinoxyfen as ``not likely to
be carcinogenic to humans.'' Quinoxyfen did not show evidence of
mutagenicity in in vitro or in vivo studies. No evidence of
neurotoxicity or neuropathology was seen in any of the submitted
studies, including the acute and subchronic neurotoxicity studies.
    The toxicology data for quinoxyfen provides no indication of
increased susceptibility, as compared to adults, of rat and rabbit
fetuses to in utero exposure in developmental studies. No maternal or
developmental toxicity was observed in the rat developmental toxicity
study. The rabbit developmental toxicity study included maternal toxic
effects (inanition, decreased body weight and weight gain, decreased
fecal output, perineal soiling, blood in the cage pan associated with
urine, and abortions) at the same dose as developmental effects
(increased abortions). In the 2-generation reproduction study conducted
with rats, increased quantitative susceptibility of offspring
(minimally reduced pup weights) was noted in the absence of maternal
toxicity at the high dose. There was no evidence of immunotoxicity in
the database.
    Specific information on the studies received and the nature of the
adverse effects caused by quinoxyfen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document ``Quinoxyfen. Human Health Risk
Assessment for the Proposed Food Use of Quinoxyfen on Stone Fruits Crop
Group 12 (excluding Cherry), Artichoke, Winter Squash, (Pumpkin and
Edible Gourds),'' at pages 45-48 in docket ID number EPA-HQ-OPP-2008-
0362.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the LOAEL or a Benchmark Dose (BMD)
approach is sometimes used for risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction with the POD to take into account
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. Safety is assessed for
acute and chronic dietary risks by comparing aggregate food and water
exposure to the pesticide to the acute population adjusted dose (aPAD)
and chronic population adjusted dose (cPAD). The aPAD and cPAD are
calculated by dividing the POD by all applicable UFs. Aggregate short-
term, intermediate-term, and chronic-term risks are evaluated by
comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for quinoxyfen used for
human risk assessment can be found at http://www.regulations.gov in
document ``Quinoxyfen. Human Health Risk Assessment for the Proposed
Food Use of Quinoxyfen on Stone Fruits Crop Group 12 (excluding
Cherry), Artichoke, Winter Squash, (Pumpkin and Edible Gourds),'' at
pages 25-26 in docket ID number EPA-HQ-OPP-2008-0362.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quinoxyfen, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinoxyfen tolerances in 40 CFR
180.588. EPA assessed dietary exposures from quinoxyfen in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
quinoxyfen; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998

Continuing Survey of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA used tolerance-level residues, Dietary Exposure
Evaluation Model (DEEM) default processing factors, and assumed 100
percent crop treated (PCT) for all proposed commodities.
    iii. Cancer. Based upon lack of evidence of carcinogenicity in rats
and mice by all routes of exposure, EPA has classified quinoxyfen as
``not likely to be carcinogenic to humans;'' therefore, a quantitative
exposure assessment to evaluate cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for quinoxyfen. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quinoxyfen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of quinoxyfen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) model for
surface water, and the Screening Concentration in Ground Water (SCI-
GROW) model for ground water, the estimated drinking water
concentrations (EDWCs) of quinoxyfen for surface water are estimated to
be 9.9 parts per billion (ppb) for acute exposures, and 0.66 ppb for
chronic exposures. For ground water, the estimated drinking water
concentration is 0.0034 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.66 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Quinoxyfen is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found quinoxyfen to share a common mechanism of
toxicity with any other substances, and quinoxyfen does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
quinoxyfen does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The toxicology data for
quinoxyfen provides no indication of increased susceptibility, as
compared to adults, of rat and rabbit fetuses to in utero exposure in
developmental studies up to the limit dose of 1,000 milligrams/
kilogram/day (mg/kg/day). In the multi-generation rat reproduction
study, offspring effects were noted at the high dose of 100 mg/kg/day
tested (minimally reduced F1a pup weights) in the absence of
maternal toxicity at the same level; thereby showing quantitative
evidence of increased susceptibility in rat offspring. However, concern
is low since:
    i. The effects in pups are well-characterized with a clear NOAEL of
20 mg/kg/day.
    ii. The pup effects are minimal at the LOAEL and only noted in the
first generation offspring.
    iii. The doses and endpoints selected for regulatory purposes would
address the concerns of the pup effects noted in the rat reproduction
study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for quinoxyfen is complete except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. The available data for
quinoxyfen do not show potential for immunotoxic effects. Therefore,
EPA does not believe that conducting the immunotoxicity study will
result in a NOAEL lower than the NOAEL of 20 mg/kg/day already set for
quinoxyfen. Consequently, an additional database uncertainty factor
does not need to be applied.
    ii. There is no indication that quinoxyfen is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. Although there is quantitative evidence of increased
susceptibility of offspring (minimally reduced pup weights) in the
absence of maternal effects in the rat multi-generation reproduction
study, the Agency did not identify any residual uncertainties after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment. Therefore, there are no residual concerns regarding
developmental effects in the young.
    iv. There are no residual uncertainties identified in the exposure
databases. Dietary food exposure assessments were performed based on
100% crop treated and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to quinoxyfen in drinking water. These
assessments will not underestimate the exposure and risks posed by
quinoxyfen.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by

all applicable UFs. For linear cancer risks, EPA calculates the
probability of additional cancer cases given the estimated aggregate
exposure. Short-term, intermediate-term, and chronic-term risks are
evaluated by comparing the estimated aggregate food, water, and
residential exposure to the POD to ensure that the MOE called for by
the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No acute dietary endpoint was identified for any
segment of the United States (U.S.) population. Therefore, quinoxyfen
is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
quinoxyfen from food and water will utilize 2% of the cPAD for children
1 to 2 years old, the population group receiving the greatest exposure.
There are no residential uses for quinoxyfen to consider.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Quinoxyfen is not registered for any use patterns that would result
in residential exposure. Therefore, the short-term and intermediate-
term aggregate risk is the sum of the risk from exposure to quinoxyfen
through food and water and will not be greater than the chronic
aggregate risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, quinoxyfen was
classified as ``not likely to be carcinogenic to humans.'' Therefore,
quinoxyfen is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to quinoxyfen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with mass-
selective detection (GC-MSD)) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Mexican maximum residue limits (MRLs) established for
residues of quinoxyfen in crops associated with this review. Codex MRLs
exist for quinoxyfen on cherry, sweet and tart at 0.4 ppm; and Canadian
MRLs exist for cherry, sweet and tart at 0.3 ppm. However, the proposed
tolerance for fruit, stone, group 12 (0.70 ppm), of which cherry is a
part, cannot be harmonized with the Codex or Canadian MRLs on these
commodities because field trial data supporting the stone fruit group
tolerance shows residue levels that are higher than 0.4 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of quinoxyfen,
5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or on artichoke, globe at
1.4 ppm; fruit, stone, group 12 at 0.70 ppm; squash, winter at 0.20
ppm; pumpkin at 0.20 ppm; and gourd, edible at 0.20 ppm. This
regulation also deletes the established tolerances in or on cherry,
sweet; and cherry, tart, as they are superseded by inclusion in fruit,
stone, group 12. This regulation additionally deletes the time-limited
tolerances for pumpkin; winter squash; and melon subgroup 9A, as the
tolerances expired on December 31, 2007.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the

Federal Register. This final rule is not a ``major rule'' as defined by
5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 19, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.588 is amended in paragraph (a), by removing the
commodities ``Cherry, sweet'' and ``Cherry, tart''; and by
alphabetically adding the following commodities to the table; and in
paragraph (b), by removing all of the commodities and reserving the
paragraph designation and heading to read as follows:

Sec.  180.588  Quinoxyfen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Artichoke, globe.....................................                1.4
Fruit, stone, group 12...............................               0.70
                                * * * * *
Gourd, edible........................................               0.20
                                * * * * *
Pumpkin..............................................               0.20
Squash, winter.......................................               0.20
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. E9-7046 Filed 3-31-09; 8:45 am]

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