Date:	  DATE \@ "MMMM d, yyyy"  March 24, 2011

Subject:	Inventory of Hospital/Medical/Infectious Waste Incinerators
Potentially Covered by the Proposed Section 111(d)/129 Federal Plan

EPA Contract No. EP-D-07-019; Work Assignment No. 4-13

From:	Thomas Holloway

To:	Amy Hambrick

OAQPS/SPPD (E143-03)

U.S. Environmental Protection Agency

Research Triangle Park, NC  27711

Introduction

Under sections 111 and 129 of the Clean Air Act (CAA), U.S.
Environmental Protection Agency (EPA) is required to develop emissions
guidelines (EG) for existing hospital/medical/ infectious waste
incinerators (HMIWI) and new source performance standards (NSPS) for new
HMIWI.  The regulations are designed to limit emissions of nine
pollutants and opacity from these HMIWI.  The nine pollutants are
hydrogen chloride (HCl), carbon monoxide (CO), lead (Pb), cadmium (Cd),
mercury (Hg), particulate matter (PM), dioxins/furans (CDD/CDF),
nitrogen oxides (NOX), and sulfur dioxide (SO2).  Regulations for the
HMIWI category were promulgated on September 15, 1997.  The EG are
codified in 40 CFR part 60, subpart Ce, and the NSPS are codified in 40
CFR part 60, subpart Ec.  The HMIWI regulations were remanded by the
U.S. Court of Appeals for the D.C. Circuit (the Court) on March 2, 1999
for further explanation by EPA regarding the approach and methodology
that EPA used to develop the HMIWI regulations.  On October 6, 2009, the
EPA promulgated amended EG and NSPS for HMIWI to address the concerns
raised in the Court’s remand.

Unlike the subpart Ec NSPS, which apply directly to new sources, states
must develop a State Plan in order to compel existing sources to meet
the subpart Ce EG.  Together, subpart B and subpart Ce of part 60
specify the State Plan content and the general rules for adopting and
submitting these State Plans.  State Plans were developed previously to
implement the EG adopted on September 15, 1997.  Revised or new State
Plans to implement the amended EG adopted on October 6, 2009 were due to
EPA for review and approval on October 6, 2010.  The EG require EPA to
develop and implement a Federal Plan for each state that does not have
an approved revised or new State Plan in place within 2 years after
promulgation of the EG.  A Federal Plan to implement the September 15,
1997 EG was promulgated on August 15, 2000 and is codified in 40 CFR
part 62, subpart HHH.  Amendments to the Federal Plan are currently
being developed to implement the October 6, 2009 amendments to the EG.

For approval, one of the requirements of a State Plan is a source
inventory and an emissions inventory.  Likewise, the Federal Plan must
contain a source and emissions inventory for HMIWI not covered under a
State Plan.  The purpose of this memorandum is to present an updated
source and emissions inventory of the HMIWI industry for the proposed
amendments to the Federal Plan and to document the sources of the
database information.  The database fields are listed in Table 1 below,
along with descriptions of their respective information sources.  The
database is presented in Appendix A.  The acronyms and abbreviations
used in the database are presented in Appendix B.

Updates to 2010 Inventory

For the October 6, 2009 amendments to the EG, EPA estimated there were
57 HMIWI currently operating in the U.S.1  Based on recently obtained
inventory information, EPA has determined that three of those HMIWI have
shut down and now estimates there are 54 HMIWI currently operating.2-4
The inventory of HMIWI was developed and updated as a result of contacts
with EPA Regions, States, and HMIWI facilities and review of existing
HMIWI inventories, title V permits, emissions test reports, and facility
websites.1-5

References

Memorandum from Thomas Holloway, RTI, to Project File.  July 6, 2009.
Updated Hospital/Medical/Infectious Waste Incinerator (HMIWI) Inventory
Database.

Letter from James Bukowski, Johns Hopkins Institutions, to EPA Region
III.  January 28, 2010.

Zentner, Sonny.  May 5, 2008.  Analysis, Preliminary Determination and
Draft Permit for the Renewal of Operation Permit Number<PHONE_NUMBER>-P10
for St. Joseph’s Hospital.  Wisconsin Department of Natural Resources.

Letter from Wilkes-Barre General Hospital to EPA Region III.  June 7,
2009.

Memorandum from Thomas Holloway, RTI, to Mary Johnson, EPA.  July 6,
2009.  Revised Baseline Emissions and Emissions Reductions for Existing
and New HMIWI.Table 1.  Fields Included in HMIWI Source and Emissions
Inventory

  SEQ CHAPTER \h \r 1 Field name	Description	Information sources

No	Unique number assigned by RTI to each record.	Assigned by RTI for
each record.  Records sorted by EPA Region, State, city, facility name,
unit number, and pollutant.

Fac ID	Unique ID number assigned by RTI to identify a facility.	Assigned
by RTI for each facility.  Facilities sorted by EPA Region, State, city,
and facility name.

Unit ID	Unique ID number assigned by RTI to identify each unit at a
facility.	Assigned by RTI for each unit at a facility.  Units sorted by
EPA Region, State, city, facility name, and unit number.

Facility Name	The name of the facility.	Based on latest facility name
from permits, test reports, inventories, EPA’s Envirofacts website,
and facility websites.

Unit Number	The unit number of the incinerator, if the facility has more
than one incinerator.	Based on unit numbers from permits, test reports,
and inventories.

Previous Facility Name	The previous name of the facility.	Based on
previous facility names from permits, test reports, inventories, EPA’s
Envirofacts website, and facility websites.

Location Address	Physical location of the front door/main entrance of
the facility site.	Based on facility address information from permits,
test reports, inventories, EPA’s Envirofacts website, and facility
websites.  Included physical address and, if applicable, post office
box.

City	The name of the city.	Based on city name from permits, test
reports, inventories, and facility websites.

State	State abbreviation.	Based on State or territory name from permits,
test reports, and inventories.

Zip Code	The U.S. Postal Service zip code.	Based on zip code from
permits, test reports, inventories, and facility websites.

County	The name of the county.	Based on county name from permits, test
reports, inventories, and facility websites.

EPA Region	The EPA Region where the State or territory is located.	Based
on EPA Region assignments for States and territories from EPA website.

X Coordinate	Longitude measure in decimal degrees of the angular
distance on a meridian east or west of the prime meridian.  Negative (-)
data point for N. America.  Include (-) sign, e.g., -123.234561.	Most
based on the most accurate longitude data available from NEI (based on
horizontal accuracy measure).  Data for some units not available from
the NEI.  Obtained data for these units from EPA’s Envirofacts or from
RTI’s GIS group.

Y Coordinate	Latitude measure in decimal degrees of the angular distance
on a meridian north or south of the equator.  Positive (+) data point
for N. America.  Include (+) sign, e.g., +78.123456.	Most based on the
most accurate latitude data available from NEI (based on horizontal
accuracy measure).  Data for some units not available from the NEI.
Obtained data for these units from EPA’s Envirofacts or from RTI’s
GIS group.

UTM Zone	Zone number in UTM coordinate system.	Determined using an
online program that converts latitude and longitude measures to UTM zone
numbers.

Plan Status (1997 HMIWI Rule)	Status of State/Federal Plans implementing
the 1997 HMIWI rule.	Taken from EPA’s State/Federal plan status
website for 1997 HMIWI rule.

Compliance Date (1997 HMIWI Rule)	Date of compliance with the
State/Federal plans implementing the 1997 HMIWI rule.	Based on
compliance dates in permits and inventories.

Facility Contact Name	The name of the facility contact.	Based on
facility contact name from permits, test reports, inventories, facility
websites, and facility contacts.

Facility Contact Phone	The phone number of the facility contact.	Based
on facility contact phone numbers from permits, test reports,
inventories, facility websites, and facility contacts.

SIC Primary	Standard Industrial Classification code.	Taken from NEI and
SIC code table.

NAICS Primary	North American Industry Classification System code.	Taken
from NEI and NAICS code table.

Site Description	Comments/description for this facility.	Based on
SIC/NAICS code assigned to the facility.

Size Category	The size category of the incinerator (i.e., large (L),
medium (M), small (S), or small rural (SR)).	Based on size information
from permits, test reports, and inventories.

New Existing	Whether the incinerator is new (N) or existing (E).	Based
on incinerator description from permits, test reports, and inventories.

Mode	The mode of operation of the incinerator (i.e., continuous (C),
inter-mittent (I), or batch (B)).	Based on operating information from
permits, test reports, and inventories.

Waste Heat Recovery Boiler	Whether the facility has a waste heat
recovery boiler to recover as steam the energy from the HMIWI	Based on
facility description from permits and test reports.

Commercial	Whether the facility is a commercial incineration facility
(Yes/No).	Based on incinerator description from permits, test reports,
and inventories.

Dun & Bradstreet Number	Dun & Bradstreet no. for the facility.	Based on
information from Dun & Bradstreet Million Dollar Directory, NEI, and
EPA’s Envirofacts website.

Parent Company	The name of the parent company of the facility.	Based on
information from permits, test reports, inventories, and facility
websites.

Parent Company Employment	Number of employees in the parent company.
Based on information from Dun & Bradstreet Million Dollar Directory,
Hoovers, Inc., and facility websites.

Parent Company Sales	Sales for the parent company ($million).	Based on
information from Dun & Bradstreet Million Dollar Directory, Hoovers,
Inc., and facility websites.

Year of Sales/Emp. Data	The year for which sales and employment data
were obtained for the parent company	Based on information from Dun &
Bradstreet Million Dollar Directory and Hoovers, Inc.

Size Standards	SBA size standards for the parent company (i.e., sales in
$million, or number of employees).	Based on SBA Table of Small Business
Size Standards Matched to NAICS Codes.

Small Business	Small business status based on SBA size standards
(Yes/No/ Borderline).	Determined based on comparison of SBA size
standards to employment and sales information for parent companies.

Facility Registry Identifier	The ID number assigned by the EPA Facility
Registry System.	Taken from NEI, permits, test reports, State
correspondence, and EPA’s Envirofacts website.

Other Facility Registry Identifiers	Other ID numbers assigned by the EPA
Facility Registry System.	Taken from NEI, permits, test reports, State
correspondence, and EPA’s Envirofacts website.

Emission Unit ID	Unique ID reported consistently over time by
State/local/tribal agency.	In most cases, based emission unit IDs on
permits, test reports, inventories, State correspondence, and NEI.
Otherwise, assigned an emission unit ID of “1.”

Emission Unit Description	A text description of the Emission Unit.
Described emission units as “hospital/medical/infectious waste
incinerators.”  Also included information about the model of
incinerator, if available.

Emission Process ID	Unique ID reported consistently over time by
State/local/tribal agency.	In some cases, based emission process IDs on
permits, test reports, inventories, State correspondence, and NEI.
Otherwise, assigned the same ID as the emission unit ID.

Emission Process Description	A text description of the Emission Process.
Described emission processes as “hospital/medical/infectious waste
incineration.”

Emission Release Pt ID	State/local/tribal ID for point/location where
emissions are released to ambient air.	In some cases, based emission
release point IDs on permits, test reports, inventories, State
correspondence, and NEI.  Otherwise, assigned the same ID as the
emission unit ID.

Emission Release Pt Description	A text description of the Emission
Release Point.	All but two facilities have one stack serving each
incinerator.  The remaining two facilities have one stack serving two
incinerators (although one of the facilities is not currently using the
second incinerator).  Provided text descriptions based on these
configurations.

SCC	EPA Source Category Code for Point Sources.	Taken from NIF SCC code
table.  Assigned SCC code of “50200501” to those
commercial/institutional HMIWI operating on a continuous or intermittent
basis (most units).  Assigned SCC code of “50200502” to the
commercial/institutional HMIWI operating on a batch basis (one unit).
Assigned SCC code of “50200503” to those commercial/institutional
HMIWI which use a rotary kiln incinerator (three units).  Assigned SCC
code of “50100505” to locally-operated HMIWI (two units at one
facility).

Control System Description	Description of control equipment chain.	Most
control devices based on information from permits and test reports, but
one based on information from website.

Control System Abbr	Abbreviation of control equipment used (FF= fabric
filter, DIFF=dry injection fabric filter, WS=wet scrubber, CC=
combustion control, ESP= electrostatic precipitator, WESP=wet ESP, CA=
carbon adsorber).	Based on control system description.

Waste Types	Types of waste incinerated at the facility.	Based on waste
type information from test reports.

Design Capacity (lb/hr)	Numeric value of average operational capacity
(in lb/hr) for an emission unit	Based on design capacity information
from permits, test reports, and inventories.

Design Capacity Notes	Notes regarding calculation of design capacity.
Documented inputs used to calculate design capacity.

Design Capacity Batch (lb/batch)	Numeric value of average operational
capacity (in lb/batch) for a batch emission unit.	Based on batch design
capacity information from test reports.

Max Charge Rate (lb/hr)	Numeric value of maximum charge rate (in lb/hr)
for an emission unit if different from design capacity.	Based on maximum
charge rate information from permits, test reports, inventories, and
facility contacts.  Several facilities chose to have their permits
revised to reduce their allowable HMIWI charge rates below design
capacity in order to qualify for a smaller HMIWI size category with less
stringent emission limits.

Max Charge Rate Notes	Notes regarding calculation of maximum charge
rate.	Documented inputs used to calculate maximum charge rate.

Avg Throughput (lb/hr)	Average numeric value of throughput over entire
emission test.	Based on average of test throughput data from test
reports.

Annual Throughput for 2002 (tpy)	Numeric value of 2002 annual throughput
(in tpy)	Most based on 2002 annual throughput values from facilities,
EPA Regions, and States.  Data not available for several units, so
annual throughput values were calculated using hourly throughputs from
stack test and annual operating hours from facilities.

Annual Throughput for 2002 Notes	Notes regarding calculation of 2002
annual throughput.	Documented inputs used to calculate annual
throughput.

Est. Annual Throughput	Numeric value of estimated annual throughput (in
tpy)	Calculated based on maximum charge rate and annual operating hours,
assuming the unit operates at 2/3 capacity.

Est. Annual Throughput Notes	Notes regarding calculation of estimated
annual throughput (in tpy)	Documented method used to calculate estimated
annual throughput

Winter Throughput PCT	The percentage a process operates during the
winter months.  Whole number between 0 and 100.	Taken from NEI and
EPA’s Envirofacts website.  Otherwise assumed “25 percent” for
each season.

Spring Throughput PCT	The percentage a process operates during the
spring months.  Whole number between 0 and 100.	Taken from NEI and
EPA’s Envirofacts website.  Otherwise assumed “25 percent” for
each season.

Summer Throughput PCT	The percentage a process operates during the
summer months.  Whole number between 0 and 100.	Taken from NEI and
EPA’s Envirofacts website.  Otherwise assumed “25 percent” for
each season.

Fall Throughput PCT	The percentage a process operates during the fall
months.  Whole number between 0 and 100.	Taken from NEI and EPA’s
Envirofacts website.  Otherwise assumed “25 percent” for each
season.

Annual Avg Hours Per Day	Average number of hours per day an emission
process is active within year.	Most based on data from facilities, EPA
Regions, and States, with a few based on data from NEI and one based on
data from a permit.

Annual Avg Hours Per Day Notes	Notes regarding calculation of annual
average hours per day.	Documented inputs used to calculate annual
average hours per day.

Annual Avg Days Per Week	Average number of days per week an emission
process is active within year.	Most based on data from facilities, EPA
Regions, and States, with four based on data from NEI and two based on
data from a permit.

Annual Avg Days Per Week Notes	Notes regarding calculation of annual
average days per week.	Documented inputs used to calculate annual
average days per week.

Annual Avg Weeks Per Year	Average number of weeks per year an emission
process is active.	Most based on data from facilities, EPA Regions, and
States, with four based on data from NEI and two based on data from a
permit.

Annual Avg Weeks Per Year Notes	Notes regarding calculation of annual
average weeks per year.	Documented inputs used to calculate annual
average weeks per year.

Annual Avg Hours Per Year	Average number of hours per year an emission
process is active.	Most based on data from facilities, EPA Regions, and
States, with four based on data from NEI and two based on data from a
permit.

Annual Avg Hours Per Year Notes	Notes regarding calculation of annual
average hours per year.	Documented inputs used to calculate annual
average hours per year

Stack Height (ft)	The height (in feet) of a stack.	Most based on stack
height data from test reports.  Several based on stack height data from
permits, EPA’s Envirofacts website, and NEI.

Stack Diameter (ft)	The diameter (in feet) of a circular stack.	Based on
stack diameter data from test reports.  Stack diameter values also could
be calculated based on data for stack area, or data for exit gas flow
rate and exit gas velocity.

Stack Dimensions (ft x ft)	The dimensions (in feet x feet) of a
non-circular stack.	One unit has rectangular, not circular, stack.
Therefore, stack diameter is not relevant for this units.  Provided
stack dimensions in units of feet x feet.

Stack Area (ft2)	The area (in square feet) of a stack.	Based on stack
area data from test reports.  Stack area values also could be calculated
based on data for stack diameter, or data for exit gas flow rate and
exit gas velocity.

Exit Gas Temperature (deg F)	The temperature of an exit gas stream
(degrees Fahrenheit).	Based on average stack temperatures from test
reports.

Exit Gas Velocity (ft/s)	The velocity of an exit gas stream (feet per
second).	Based on average exit gas velocities from test reports.  Exit
gas velocities also could be calculated based on data for exit gas flow
rate and stack diameter.

Exit Gas Flow Rate (acfm)	Numeric value of stack gas flow rate in actual
cubic feet per minute.	Based on average actual gas flow rates from test
reports.

Exit Gas Flow Rate Std (dscfm)	Numeric value of stack gas flow rate in
dry standard cubic feet per minute.	Based on average standard gas flow
rates from test reports.

HCl Unit Average Concentration (ppmvd)	Numeric value of average HCl
concentration (in ppmvd) for an emission unit	Based on average HCl
concentration data from test reports.

CO Unit Average Concentration (ppmvd)	Numeric value of average CO
concentration (in ppmvd) for an emission unit	Based on average CO
concentration data from test reports.

Pb Unit Average Concentration (mg/dscm)	Numeric value of average Pb
concentration (in mg/dscm) for an emission unit	Based on average Pb
concentration data from test reports.

Cd Unit Average Concentration (mg/dscm)	Numeric value of average Cd
concentration (in mg/dscm) for an emission unit	Based on average Cd
concentration data from test reports.

Hg Unit Average Concentration (mg/dscm)	Numeric value of average Hg
concentration (in mg/dscm) for an emission unit	Based on average Hg
concentration data from test reports.

PM Unit Average Concentration (gr/dscf)	Numeric value of average PM
concentration (in gr/dscf) for an emission unit	Based on average PM
concentration data from test reports.

Total CDD/CDF Unit Average Concentration (ng/dscm)	Numeric value of
average CDD/CDF concentration (in ng/dscm) for an emission unit	Based on
average CDD/CDF concentration data from test reports.

CDD/CDF TEQ Unit Average Concentration (ng/dscm)	Numeric value of
average TEQ concentration (in ng/dscm) for an emission unit	Based on
average TEQ concentration data from test reports.

NOX Unit Average Concentration (ppmvd)	Numeric value of average NOX
concentration (in ppmvd) for an emission unit	Based on average NOX
concentration data from test reports.

SO2 Unit Average Concentration (ppmvd)	Numeric value of average SO2
concentration (in ppmvd) for an emission unit	Based on average SO2
concentration data from test reports.

HCl Annual Emissions (lb/yr)	Numeric value of annual HCl emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

CO Annual Emissions (lb/yr)	Numeric value of annual CO emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

Pb Annual Emissions (lb/yr)	Numeric value of annual Pb emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

Cd Annual Emissions (lb/yr)	Numeric value of annual Cd emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

Hg Annual Emissions (lb/yr)	Numeric value of annual Hg emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

PM Annual Emissions (lb/yr)	Numeric value of annual PM emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

Total CDD/CDF Annual Emissions (g/yr)	Numeric value of annual CDD/CDF
emissions (in g/yr) for an emission unit	Based on emissions and
parameter data from test reports and annual operating hours.

CDD/CDF TEQ Annual Emissions (g/yr)	Numeric value of annual TEQ
emissions (in g/yr) for an emission unit	Based on emissions and
parameter data from test reports and annual operating hours.

NOX Annual Emissions (lb/yr)	Numeric value of annual NOX emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

SO2 Annual Emissions (lb/yr)	Numeric value of annual SO2 emissions (in
lb/yr) for an emission unit	Based on emissions and parameter data from
test reports and annual operating hours.

 Appendix A

HMIWI Source and Emissions Inventory

Appendix B

Acronyms and Abbreviations Used in HMIWI Source and Emissions Inventory

 PAGE

 PAGE   2

 PAGE   3


 C:\ dmautop\ temp\ DCTM_ ARP. wpd MEMORANDUM TO: File; Carey Johnston, USEPA/ EAD FROM: Mary Willett and Mark Briggs, ERG DATE: July 15, 2004 SUBJECT: Screen Configurations This memorandum documents the information gathered from Johnson Screens on the geometry and flow profile to prevent entrainment and impingement of marine life on cooling water intake structures per the proposed CWA 316( b) Phase III rule. Included as attachments to this memo are design information and typical configurations for screening systems on cooling water intake structures ( Attachment 1) and telephone correspondence between ERG and Johnson Screens ( Attachment 2).

Simple Pipe, Caisson, and Submersible Pump Intake Screens Simple pipes, caissons and submersible pumps used for cooling water extraction can be fitted with pre manufactured cylindrical wedge wire screens to prevent entrainment and impingement of marine life. These screens, manufactured by Johnson Screens1 can be manufactured from stainless steel or a copper nickel alloy (" Z Alloy") if additional bio fouling resistance is required. All cylindrical wedge wire screens purchased from Johnson Screens are designed to provide a cooling water through put velocity of less than 0.5 feet per second ( ft/ s) 2. Wedge wire screen openings on Johnson Screens vary depending on size of the organisms that will be entrained. Typically, screen openings range between 0.002 and 0.25 inches. The size of the screen opening is selected based on the smallest marine organism that the facility is trying keep from being entrained. Design information on cylindrical wedge wire screens is included in Attachment 1 of this memo.

Simple pipes, caissons and submersible pump cooling water intake structures ( CWIS) with openings less than 40 to 50 feet can also be fitted with an air sparging system ( Johnson Screens " Hydroburst" system) to periodically remove bio growth. The air sparging system includes an air compressor system, piping and valves, and controls. The system delivers a timed burst of air through the screens in or der to knock off any growth ( e. g., zebra mussels) from the surface. According to Linda Cook at Johnson Screens2, air sparge systems on CWIS are typically not required at depths below 50 feet due to limited bio growth. Memorandum 2 July 2004 Page 2 C:\ dmautop\ temp\ DCTM_ ARP. wpd Sea Chest Screens Johnson Screens also manufactures flat panel wedge wire screens with no sharp edges that can be placed over existing sea chests3. These screens have smooth surfaces to minimize the risk of injury to fish and prevent entrainment. Slot sizes are selected based on the smallest size of marine organism that the facility is trying to prevent entrainment. Slot sizes on flat panel screens are as small as 0.002 inches, and have high open areas to allow natural flow with no turbulence. Information on flat panel screens for fish protection is included in Appendix A of this memo. Unlike cylindrical screens placed on simple pipes, caissons, and submersible pumps, flat panel screens can not limit flow velocity to less than 0.5 fts and therefore have no impingement prevention qualities. Sea chests require installation of horizontal flow diverters to lessen the flow velocity and decrease impingement.

References 1. Johnson Screens, 1950 Old Highway 8 NW, New Brighton, MN. Telephone: ( 651) 636 3900, internet: www. johnsonscreens. com 2. Telephone conversation between Ms. Linda Cook, Johnson Screens ( 651 636 3900) and Mark Briggs, ERG, May 18, 2004.

3. Email communication between Ms. Linda Cook, Johnson Screens ( email: cookls@ johnsonscreens. com) and Mark Briggs, ERG ( email: mark. briggs@ erg. com) Memorandum 2 July 2004 Page 3 C:\ dmautop\ temp\ DCTM_ ARP. wpd Attachment 1 Johnson Screens Product Literature Memorandum 2 July 2004 Page 4 C:\ dmautop\ temp\ DCTM_ ARP. wpd Attachment 2 Telephone Correspondence


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30046-30047]
[FR Doc No: 2012-12057]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Ninth Meeting: RTCA Special Committee 222, Inmarsat Aeronautical
Mobile Satellite (Route) Services

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

ACTION: Meeting Notice of RTCA Special Committee 222, Inmarsat
Aeronautical Mobile Satellite (Route) Services.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
Ninth meeting of RTCA Special Committee 222, Inmarsat Aeronautical
Mobile Satellite (Route) Services.

DATES: The meeting will be held June 12-13, 2012, from 8:30 a.m.-3:00
p.m.

ADDRESSES: The meeting will be held at JW Marriott Hotel, 1109 Brickell
Avenue Miami, FL 33131.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 222. The agenda will
include the following:

June 12, 2012

1:00 a.m.-5:00 p.m.

June 13, 2012

8:30 a.m.-12:00 p.m.

     Greetings & Attendance
     Review report of November 2011 meeting.
     Chair report on PMC actions
     Detailed review of generic MASPS draft. This completely
redesigned MASPS draft is the result of direction received at the March
21, 2011 meeting of the PMC. A detailed review and informal approval of
the document is expected at this meeting, to facilitate timely progress
on Inmarsat SwiftBroadband-specific material.
     Status and update on SBB-specific material for MASPS.
     Status and update of SBB-specific material for DO-262A
     Other items
     Schedule for 10th Plenary
     Plenary Adjourns
     A meeting of SC-222 leadership team will be held on
Wednesday morning. The room can be available for informal working
sessions leading to progress on the DO-262A MOPS, modifications to the
DO-210D MOPS, and/or SwiftBroadband-specific material in accordance
with the draft generic MASPS. The room will be available through 12
Noon on Wednesday for informal working group meetings in parallel with
scheduled meetings of the Inmarsat Aero Conference, if desired.

*This meeting is being held in parallel with the Inmarsat Aero
Conference to facilitate the in-person participation of as many
equipment manufacturers as practical. Attendance at the SC-222
meeting does not include admittance to the Inmarsat Aero Conference.

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on May 9, 2012.
John Raper,
Manager, Business Operations Branch, Federal Aviation Administration.
[FR Doc. 2012-12057 Filed 5-18-12; 8:45 am]
BILLING CODE 4910-13-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

	OFFICE OF PREVENTION,

	PESTICIDES AND TOXIC

SUBSTANCES

MEMORANDUM

	Date:  	Nov 5, 2007

	Subject:	Zeta-Cypermethrin.  Petitions for Use on Citrus (Crop Group 10), Oilseeds (Prooposed Crop Group 20), Safflower, Wild Rice and Okra.  Summary of Analytical Chemistry and Residue Data.  Petition Numbers 6F7132, 6E7133, and 7E7255

DP Numbers:	335223, 335226, 343052	Decision Nos.:	371717, 371868, 382487

PC Code:	129064	MRID(s):	46969201, 46971402

40 CFR	180.418 (a)(2)	Chemical Class:	Pyrethroid Insecticide

	From:	Dennis McNeilly, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

	Through:	Michael Doherty, Ph.D., Senior Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

			and

		David Soderberg, Chemist

		Registration Action Branch 2

		Health Effects Division (7509P)

	To:	Daniel Rosenblatt, Chief

		Insecticide Branch

		Division (7505P)

This document was originally prepared under contract by Dynamac Corporation (1910 Sedwick Road, Building 100, Durham NC 27713; submitted 6/20/2007), except for the sections concerning the proposed Oilseed Crop Group 20 uses.  The document has been reviewed by the Health Effects Division (HED) and revised to reflect current Office of Pesticide Programs (OPP) policies.

Executive Summary

Zeta-cypermethrin [(S-cyano(3-phenoxyphenyl)methyl (±))-cis-trans 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate] is a broad spectrum, synthetic pyrethroid insecticide containing the same eight stereoisomers that are present in cypermethrin.  However, zeta-cypermethrin is enriched in the four insecticidally active S isomers and contains ≤1% each of the inactive R isomers.  Tolerances for residues of zeta-cypermethrin, including its inactive R isomers, have been established in/on plant and animal commodities at levels ranging from 0.05-40 ppm [40 CFR 180.418(a)(2)].

Zeta-cypermethrin is currently registered to FMC Corporation for use on a wide variety of food/feed crops, primarily as repeated broadcast foliar applications.  In the current petitions, the Interregional Project Number 4 (IR-4) is proposing new uses on citrus fruits, safflower, okra and wild rice for two formulations of zeta-cypermethrin.  These formulations are a 1.5 lb ai/gal emulsifiable concentrate (EC; Fury® and Mustang® 1.5 EC Insecticides, EPA Reg. No. 279-3125), and a 1.5 lb ai/gal water in oil emulsion (EW; Mustang® 1.5 EW Insecticide, EPA Reg. No. 279-3126).  IR-4 is proposing that the existing uses on fruiting vegetables and rice be expanded to include, respectively, okra and wild rice.  These uses allow for repeated broadcast foliar applications of zeta-cypermethrin at up to 0.05 lb ai/A/application at retreatment intervals (RTIs) of no less than 7 days, for totals of 0.2 lb ai/A/season on rice and 0.3 lb ai/A/season on fruiting vegetables.  The proposed use on citrus fruits is for repeated foliar applications at up to 0.05 lb ai/A, and minimum RTIs of 14 days, for a total of 0.2 lb ai/A/season.  The proposed use on safflower is for repeated broadcast foliar applications at up to 0.05 lb ai/A at minimum RTIs of 14 days, for a total of 0.15 lb ai/A/season.  In conjunction with these uses, IR-4 is proposing the following permanent tolerance for zeta-cypermethrin:

Fruit, citrus, group 10	0.25

Citrus, dried pulp	0.5

Citrus, oil	0.9

Safflower	0.2

Okra	0.2

Rice, wild, grain	1.5

In addition, IR-4 has submitted a petition (7E7255) to establish a tolerance for the proposed Oilseed Crop Group 20.  No residue date were submitted with this petition, instead IR-4 has cited data for rapeseed, sunflower, and safflower (which have the same or similar use pattern).  This Oilseed Crop Group is not yet established and therefore individual tolerances are being recommended for every commodity in the proposed Oilseed Crop Group 20. The proposed use on the oilseed crops is for repeated broadcast foliar applications at up to 0.05 lb ai/A at minimum RTIs of 7 days, for a total of 0.25 lb ai/A/season.

Borage, seed	0.2

Castor oil plant, seed	0.2

Chinese tallowtree, seed	0.2

Crambe, seed	0.2

Cuphea, seed	0.2

Echium, seed	0.2

Euphorbia, seed	0.2

Evening primrose, seed	0.2

Flax, seed	0.2

Gold of pleasure, seed	0.2

Hare’s ear mustard, seed	0.2

Jojoba, seed	0.2

Lesquerella, seed	0.2

Lunara, seed	0.2

Meadowfoam, seed	0.2

Milkweed, seed	0.2

Mustard, seed	0.2

Niger seed, seed	0.2

Oil radish, seed	0.2

Poppy, seed	0.2

Rose hip, seed	0.2

Sesame, seed	0.2

Stokes aster, seed	0.2

Sweet rocket, seed	0.2

Tallowwood, seed	0.2

Tea oil plant, seed	0.2

Vernonia, seed	0.2

The nature of zeta-cypermethrin in plants and animals is adequately understood.  The parent compound is the only residue of concern for tolerance and dietary risk assessment.

Adequate tolerance enforcement methods are available in PAM Volume II for determining residues of cypermethrin and zeta-cypermethrin in/on plant (Method I) and livestock (Method II) commodities.  Both methods are GC methods with electron capture detection (ECD) and have undergone successful Agency method validations.  Method I has a detection limit of 0.01 ppm, and Method II has detection limits of 0.005 ppm for milk and 0.01 ppm for livestock tissues.  These methods are not stereospecific; thus no distinction is made between residues of cypermethrin (all eight stereoisomers) and zeta-cypermethrin (enriched in S-isomers).

Adequate GC/ECD methods are also available for collecting data on zeta-cypermethrin residues in commodities from the submitted safflower and citrus field trials and processing studies.  These methods are more recent derivations of the tolerance enforcement method.  For these methods, residues in safflower seeds and meal, and citrus fruits, dried pulp and juice are extracted with acetone:water (70:30 or 85/15, v:v) and purified by solvent partitioning and silica gel solid phase extraction (SPE) cleanup.  Residues in safflower and citrus oil are dissolved in hexane and purified by solvent partitioning and SPE cleanup.  Residues are then determined by GC/ECD using external standards.  The limits of quantitation (LOQ) are approximately 0.05 ppm for each commodity, and the limit of detection (LOD) is 0.01 ppm.

The citrus field trials are supported by existing storage stability data.  Zeta-cypermethrin is stable in frozen tomatoes and tomato processed commodities for up to 26-27 months, it has also been shown to be stable in citrus commodities for up to a year.  The safflower field trials and processing studies are supported by new data indicating that zeta-cypermethrin is stable in frozen safflower seeds for up to 15.8 months and in frozen safflower meal and oil for up to 12-13 months.

In the 23 citrus fruit field trials (12 orange, 5 lemon, 6 grapefruit) conducted during 2004/2005, zeta-cypermethrin (1.5 lb/gal EC or EW) was applied to citrus trees as four foliar applications using 0.05 lbs ai/A/application and RTIs of 12-15 days, for a total application of 0.2 lb ai/A/season (1x rate).  The EC formulation was used in 12 tests (6 orange, 3 lemon, 3 grapefruit), and the EW formulation was used in 11 tests (6 orange, 2 lemon, 3 grapefruit).  Applications were made using ground equipment as either dilute sprays (158-264 gal/A) in 11 trials or as concentrated sprays (52-97 gal/A) in 12 trials.  None of the applications include the use of any spray adjuvants.  At 1 day after the last application (DALA), zeta-cypermethrin residues were highest in/on grapefruits (0.05-0.20 ppm), followed by oranges (<0.05-0.16 ppm), and lemons (0.05-0.09 ppm).  Overall average residues were 0.119 ppm in/on grapefruit, 0.103 ppm in/on oranges, and 0.07 ppm in/on lemons.  The highest average field trial (HAFT) residues were 0.20 ppm for grapefruit, 0.16 ppm for oranges, and 0.08 ppm for lemons.  There were no substantial differences in residue levels between the two formulations or between the dilute and concentrated application volumes.

In the 5 safflower field trials conducted during 2003, zeta-cypermethrin (1.5 lb/gal EC or EW) was applied to safflower as three broadcast foliar applications during bloom and seed development at rates of 0.047-0.052 lb ai/A/application and RTIs of 10-18 days, for a total of 0.144-0.153 lb ai/A/season (1x rate).  All applications were made using ground equipment in spray volumes of 13-22 gal/A, and did not include the use of any spray adjuvants.  Residues of zeta-cypermethrin were <0.05-0.15 ppm in/on 14 samples of safflower seed harvested at 13-14 DALA.  The average residue was 0.065 ppm and the HAFT residue was 0.145 ppm.  The side-by-side tests with the EC and EW formulations indicated that there was no significant difference in residues levels between the two formulations.

No field trial data were submitted on okra or wild rice; however, the purposed uses are identical to the current uses on fruiting vegetables and rice.  Therefore, the existing field trial data on fruiting vegetables and rice will respectively support the proposed uses on okra and wild rice.

No field trial date were submitted for any of the Oilseed commodities; however, the purposed uses are identical to the current uses on sunflower.  The proposed use is similar to the use on canola, although canola allows for one more application per season (six applications) and a higher maximum seasonal rate of 0.3 lb ai/A.  Oilseeds include those crops from which oil is extracted from their seed and used to produce edible or inedible oils as well as a high-protein livestock meal.  Oils may be extracted from plants by applying pressure to the seed, or by dissolving parts of the plants in water or another solvent, and distilling the oil, or by infusing parts of the plant in base oil.  The oilseeds are primarily soybeans, sunflower seed, canola, rapeseed, safflower, flax seed, or castor bean, mustard seed, peanut and cottonseed, used for the production of cooking oils, protein meals for livestock and industrial uses.

Adequate processing studies were submitted for both citrus fruits and safflower.  In the orange processing study, residues in/on whole oranges (0.03 ppm) treated at a 1x rate did not concentrate in juice (<0.3x), but concentrated by 9x in dried pulp and 19x in oil.  Based on the HAFT residues from the citrus field trials (0.2 ppm) and the above processing factors, the maximum expected residues in citrus dried pulp and oil would be 1.8 and 3.8 ppm, respectively.  In the safflower processing study, residues were 0.05 ppm in/on safflower seeds following applications at a 1x rate.  Residue did not concentrate (<1x) in either safflower meal or oil; therefore, separate tolerances are not required for these safflower commodities.

The potential maximum dietary burden (MDB) of livestock to zeta-cypermethrin residues was recalculated based on the existing and recommended tolerances for livestock feedstuffs and using recent revisions to guidance on constructing livestock diets.  The MDB was calculated to be 19.8 ppm for beef cattle, 22.0 ppm for dairy cattle, and 0.7 ppm for poultry and swine.  Based on these levels of dietary exposure and the data from the adequate ruminant and poultry feeding studies, no changes in the existing tolerances on livestock commodities are required for the current petitions.

Adequate confined and limited field rotational crop studies are available for cypermethrin, and these studies are also adequate for zeta-cypermethrin.  The studies indicate that residues of cypermethrin and its metabolites were nondetectable (<0.01 ppm) in/on representative rotational crops planted 30 days after a soil application of cypermethrin at 0.5 lb ai/A.  These data support the current label restriction of a 30-day plant-back interval for crops not listed on the label, and indicate that tolerances are not required for inadvertent residues in rotational crops.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry Deficiencies

No deficiencies were noted in the subject petition that would preclude establishing permanent tolerances for zeta-cypermethrin residues in/on the requested crops/crop groups.  HED recommends establishing permanent tolerances for residues of zeta-cypermethrin, and its inactive R-isomers, at 0.35 ppm in/on citrus fruit (Crop Group 10), at 1.8 ppm in dried citrus pulp, at 4.0 ppm in citrus oil, at 0.2 ppm in/on safflower seeds, at 0.2 ppm in other oilseed commodities (see Table 9 for the specific tolerances required) at 0.4 ppm for oilseed, refine oils; at 0.2 ppm in/on okra, and at 1.5 ppm in/on wild rice grain.

Background

≤1% each of the inactive R isomers.  Zeta-cypermethrin is currently registered to FMC Corporation for use as broadcast foliar applications on a wide variety of food/feed crops as a 1.5 lb/gal EC and a 1.5 lb/gal EW.  Permanent tolerances for residues of zeta-cypermethrin and its inactive R-isomers have been established on plant commodities at levels ranging from 0.05 to 40 ppm [40 CFR§180.418(a)(2)], and tolerances have been established on animal commodities at levels ranging from 0.05 ppm (meat byproducts and poultry) to 2.5 ppm in milk fat.

IR-4 has submitted tolerance petitions (PP# 6E7132, 6E7133, and 7E7255) proposing new uses for zeta-cypermethrin, formulated as an EC or EW, on citrus fruits, oilseed commodities (proposed Crop Group 20), okra, safflower, and wild rice.  The nomenclature and physicochemical properties of zeta-cypermethrin are presented in Tables 1 and 2.

-α-cyano-3-phenoxybenzyl (1R)-cis-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

or

(S)-α-cyano-3-phenoxybenzyl (1RS, 3RS, 1SR, 3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

CAS name	(S)-cyano(3-phenoxyphenyl)methyl (±)-cis-trans-3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxyla te

CAS registry number	52315-07-8

End-use product (EP)	1.5 lb/gal EC (Fury® or Mustang® 1.5 EC Insecticide; EPA Reg. No. 279-3125)

1.5 lb/gal EW (Mustang® 1.5 EW Insecticide; EPA Reg. No. 279-3126)

Table 2.  Physicochemical Properties of the Technical Grade Test Compound:  Zeta-Cypermethrin.

Parameter	Value	Reference

Melting point	-22.4°C	MRID 46971402 1

pH	4.5 (1% suspension)

	Density	1.219 g/mL at 25°C

	Water solubility (25°C)	45 ppb

	Solvent solubility	miscible in acetone, acetonitrile, methylene chloride, and toluene

	Vapor pressure	1.9 x 10-9 mm Hg at 25°C

	Dissociation constant, pKa	Not available

	Octanol/water partition coefficient, Log(KOW)	>6

	UV/visible absorption spectrum	Not available

	1	Values as reported by the petitioner.

860.1200 Directions for Use

IR-4 is proposing the use of two zeta-cypermethrin end-use products (EPs), a 1.5 lb/gal EC (Fury® or Mustang® 1.5 EC Insecticide; EPA Reg. No. 279-3125) and a 1.5 lb/gal EW (Mustang® 1.5 EW Insecticide; EPA Reg. No. 279-3126) for use on citrus, okra, oilseeds, safflower, and wild rice.  The petitioner provided draft labels containing the proposed use directions (Table 3).

Table 3.  Summary of Directions for Use of Zeta-Cypermethrin.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations 1

Citrus Fruits

Broadcast foliar applications during fruit development using ground or aerial equipment	1.5 lb/gal EC

[279-3125]

1.5 lb/gal EW

[279-3126]	0.05	4	0.2	1	Apply in a minimum of 10 gal/A by air.  For ground applications apply in a minimum of 20 gal/A for concentrate sprays and a minimum of 100 gal/A for a dilute sprays.

A minimum RTI of 14 days is specified.

Fruiting Vegetables (Including Okra)

Broadcast foliar applications based on insect populations, using ground or aerial equipment.	1.5 lb/gal EC

[279-3125]

1.5 lb/gal EW

[279-3126]	0.05	6	0.3	1	Apply in a minimum of 10 gal/A by ground and 2 gal/A by air.  A minimum RTI of 7 days is specified.

Rice and Wild Rice

Broadcast foliar applications based on insect populations, using ground or air equipment	1.5 lb/gal EC

[279-3125]

1.5 lb/gal EW

[279-3126]	0.05	4	0.4	14	Apply in a minimum of 5 gal/A by air.   Do not apply as an ultra-low volume application.

A minimum RTI of 7 days is specified.

Do not release flood water within 7 days of application, and do not use treated rice fields for aquaculture of edible fish or crustacean.

Safflower

Broadcast foliar applications as determined by scouting practices, using ground or air equipment	1.5 lb/gal EC

[279-3125]

1.5 lb/gal EW

[279-3126]	0.05	3	0.15	14	A minimum application volume of 15 gal/A is specified along with a minimum RTI of 14 days.

                                                                Oilseed Commodities (proposed Crop Group 20)

Borage, seed; Castor oil plant, seed; Chinease tallowtree, seed; Crambe, seed; Cuphea, seed; Echium, seed; Euphorbia, seed; ZEvening primrose, seed; Flax, seed; Gold of pleasure, seed; Hare’s ear mustard, seed; Jojoba, seed; Lesquerella, seed; Lunara, seed; Meadowfoam, seed; Milkweed, seed; Mustard, seed; Niger seed, seed; Oil radish, seed; Poppy, seed; Rose hip, seed; Sesame, seed; Stokes aster, seed; Sweet rocket, seed; Tallowwood, seed; Tea oil plant, seed; Vernonia, seed.

Broadcast foliar applications as determined by scouting practices, using ground or air equipment	1.5 lb/gal EC

[279-3125]

1.5 lb/gal EW

[279-3126]	0.05	5	0.25	30	Apply in a minimum of 2 gal/A when using aerial equipment or 10 gallons per acre when using ground equipment.

A minimum RTI of 7 days is specified.

1 Both labels specify a rotational crop restriction of 30 days for replanting of any crops not listed on the label.

Conclusions:  The proposed use directions are adequate and are supported by the available field trial data.

  SEQ CHAPTER \h \r 1 860.1300 Nature of the Residue – Plants and Animals

HED MARC Determination of Residues of Concern (D269584, Y. Donovan, 11/3/2000)

The nature of the residue in plants and animals is adequately understood.  The HED Metabolism Assessment Review Committee concluded that, for the case of cypermethrin and zeta-cypermethrin, the parent compound is the only residue of concern which needs to be included in the tolerance expression and used for dietary risk assessment, including drinking water.  The Committee also concluded that the metabolite DCVA [1-(RS)-cis-trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxyl ic acid] need not be included in the risk assessment and, therefore, can be waived in future residue analyses of samples from cypermethrin and zeta-cypermethrin studies.  This decision regarding DCVA does not extend to other pyrethroids which generate this metabolite.  Each such insecticide needs to be examined individually with respect to DCVA.

860.1340 Residue Analytical Methods

Enforcement methods

Adequate enforcement methods are available in PAM Volume II for determining residues of both cypermethrin and zeta-cypermethrin in plant (Method I) and livestock (Method II) commodities.  These GC/ECD methods have undergone successful Agency method tryouts.  These methods are not stereospecific; thus no distinction is made between residues of cypermethrin (all eight stereoisomers) and zeta-cypermethrin (an enriched isomer form of cypermethrin).

For Method I, residues of cypermethrin are extracted from crop samples with acetone:hexane (1:1, v:v) and from water by partitioning with hexane.  Some oily crop extracts require partitioning with acetonitrile to remove co-extracted lipids.  Residues in crop samples are also cleaned up by gel permeation chromatography.  Residues are then determined by GC/ECD.  The LOQ is 0.05 ppm and the LOD is 0.01 ppm for residues in plant samples.

For Method II, residues of cypermethrin are extracted from milk and tissue samples with acetone:hexane (1:1, v:v) in the presence of potassium oxalate (milk) or anhydrous sodium sulfate (tissues) after addition of a standard.  Co-extracted lipids are removed by partition column chromatography on Florisil.  Tissue sample extracts undergo additional cleanup by adsorption column chromatography on Florisil.  Residues are then determined by GC/ECD.  The LOD is 0.005 ppm for milk and the LOD and LOQ are 0.01 ppm and 0.05 ppm, respectively, for livestock tissues.

Data-collection methods

The data-collection methods use for determining zeta-cypermethrin residues in the current citrus and safflower field trials and processing studies are GC/ECD methods which are recent adaptations of Method I in PAM Volume II.

For each method,   SEQ CHAPTER \h \r 1 residues are extracted from safflower seeds and meal and citrus fruit, pulp and juice with acetone:water (85/15 or 70/30, v/v).  Samples are then centrifuged, NaCl is added, and residues are partitioned into hexane.  Residues are then concentrated and cleaned-up by eluting a silica gel SPE cartridge with hexane:ethyl acetate.  For analysis of safflower and citrus oils, samples are dissolved in hexane and partitioned against 0.1M NaOH in 10% aqueous NaCl, discarding the aqueous fraction.  Residues are then partitioned into acetonitrile, concentrated, redissolved in hexane, and cleaned-up by using a silica gel SPE cartridge eluted with either 2.5% tert-butyl ether or 5% ethyl acetate in hexane.  The purified residues from all matrices are analyzed by GC/ECD, using external standards.  The validated LOQ for zeta-cypermethrin in all matrices is 0.05 ppm and the LOD is 0.01 ppm.  Each of the data collection methods were adequately validated in conjunction with the analysis of samples from field and processing studies.

Conclusions.  Adequate GC/ECD methods are available for both tolerance enforcement and data collection.

860.1360 Multiresidue Methods

The 1/94 FDA PESTDATA database (PAM Volume I) indicates that residues of cypermethrin are completely recovered (>80%) using multiresidue method Sections 302 (Luke), 303 (Mills, Onley, and Gaither) and 304 (Mills fatty food).

860.1380 Storage Stability

The storage intervals and conditions for samples from the field trial and processing studies submitted with these petitions are presented below in Table 4.

Table 4.  Sample Storage Conditions and Intervals.

MRID Number	Crop Matrices	Storage Conditions (°C)	Maximum Storage Interval (Months)

46971402	Citrus fruits	-18	8

	Orange Oil

<1

	Orange, Dried Pulp

<1

	Orange Juice

<1

4696201	Safflower Seed	-26 to -13	15.8

	Safflower meal

10.0

	Safflower oil

12.6

Adequate storage stability data are available to support the storage conditions and intervals of samples collected from field and processing studies.  Previously reviewed data from numerous petitions indicate that zeta-cypermethrin is reasonably stable under frozen storage conditions in/on tomato and its processed commodities (paste and puree) for 26-27 months.  These data will support the sample storage intervals for whole citrus fruits and fresh pulp.  No supporting storage stability data are required on orange processed fractions as the frozen processed samples were analyzed within 1 month of collection.

Storage stability data were provided on zeta-cypermethrin in safflower, safflower meal, and safflower oil.  Control samples of these commodities were fortified with zeta-cypermethrin at approximately 0.3 ppm and analyzed after various intervals of frozen storage, together with freshly fortified samples.  The data indicate that zeta-cypermethrin is stable in frozen storage for at least 15.8 months in safflower seeds and 12-13 months in safflower meal and oil.

Conclusions:  The available storage stability data are adequate and support the sample storage intervals and conditions used in the citrus and safflower field trials and processing studies.

860.1400 Water, Fish, and Irrigated Crops

As wild rice is an aquatic crop, the proposed use could have an impact on the exposure of fish and irrigated crops to zeta-cypermethrin residues.  However, aquatic issues pertaining to uses on rice were previously addressed in conjunction the earlier petition on rice (PP#9F6040).  Concerns for inadvertent exposure of fish and crops were mitigated by modifications to the use directions.  The current use directions for rice specify that flood waters are not to be released within 7 days of application, and prohibit the use of treated rice fields for aquaculture of edible fish or crustaceans.

860.1480 Meat, Milk, Poultry, and Eggs

D289422, W. Donovan, 9/25/03 (HED Chemistry Chapter of Cypermethrin RED)

D283584, D. McNeilly, 7/7/06

D334263  D. McNeilly, 11/29/06

Tolerances for residues of zeta-cypermethrin and its inactive R-isomers are established [40 CFR §180.418(a)(2)] for the fat (1.0 ppm), meat (0.2 ppm), and meat-byproducts (0.05 ppm) of cattle, goat, hog, horse, and sheep.  The established tolerance for milk fat is 2.5 ppm (reflecting 0.10 ppm in whole milk).  Tolerances for poultry fat, meat, and meat byproducts and eggs are established at 0.05 ppm each. The HED Residue Chemistry Chapter for the Cypermethrin RED (9/2003) concluded that because the analytical method does not distinguish between residues of cypermethrin and zeta-cypermethrin, tolerance levels for milk, meat, and poultry commodities should be the same for cypermethrin and zeta-cypermethrin.  Adequate ruminant and poultry feeding studies are available and were summarized in the Cypermethrin RED.

The potential maximum dietary burden (MDB) of livestock to zeta-cypermethrin residues was recently calculated to be 27.6 ppm for beef and dairy cattle, 0.39 ppm for poultry, and 2.02 ppm for swine under several earlier petitions (D283584, D. McNeilly, 7/7/06).  The current petition for citrus fruits includes a new livestock feed (dried pulp).  In addition, HED has recently revised its guidance on calculating potential residues in livestock diets and updated the types and percentages of feedstuffs listed in Table 1 of Guideline 860.1000.  Therefore, the potential MDBs for livestock to zeta-cypermethrin residues were recalculated using a reasonably balance diet for livestock.  The dietary exposure was recalculated to be 19.8 ppm for beef cattle, 22.0 ppm for dairy cattle, and 0.7 ppm for poultry and swine (Table 5).

As the recalculated MDBs for cattle and swine are slightly lower than previously determined, the existing tolerances for milk and cattle, goat, hog, horses and sheep commodities are adequate.  The revised MDB for poultry (0.7 ppm) is higher than previously calculated, but the data still support tolerances in eggs and poultry commodities at 0.05 ppm.

Table 5.   Calculation of Dietary Burdens of Zeta-Cypermethrin Residues to Livestock.

Feedstuff	Type 1	% Dry Matter2	% Diet 2	Established Tolerances (ppm) Dietary Contribution (ppm) 3

Beef Cattle

Clover, hay	R	89	20	40.0	8.99

Trefoil, hay	R	85	20	40.0	9.41

Cotton, undelinted seed	P	88	15	0.5	0.085

Apple, wet pomace	C	40	20	2.0	1.00

Rice grain	C	88	20	1.5	0.34

TOTAL BURDEN	--	--	100	--	19.83

Dairy Cattle

Trefoil, hay	R	85	40	40.0	18.82

Clover, hay	R	25	5	40.0	2.25

Cotton, undelinted seed	P	88	15	0.5	0.085

Rice Grain	C	88	20	1.5	0.34

Apple, wet pomace	C	40	10	2.0 1	0.50

TOTAL BURDEN	--	--	100	--	22.00

Poultry

Cotton, meal	P	NA	20	0.5 1	0.10

Sorghum, grain	C	NA	60	0.5	0.30

Rice, grain	C	NA	20	1.5	0.30

 TOTAL BURDEN	--	--	100	--	0.70

Swine

Cotton, meal	P	NA	15	0.5 1	0.08

Flax, meal	P	NA	5	0.2 1	0.01

Sorghum, grain	C	NA	60	0.5	0.30

Rice, grain	C	NA	20	1.5	0.30

TOTAL BURDEN	--	--	100	--	0.69

1	R - Roughage, P – Protein source, C – Carbohydrate source.  Residues in cottonseed meal, flax meal and wet apple pomace are based on tolerances from the respective RACs.

860.1500 Crop Field Trials

46971402.de1 (Citrus fruits)

46969201.de1 (Safflower)

IR-4 has submitted field trial data for citrus and safflower.    SEQ CHAPTER \h \r 1 The results from these studies are discussed below and summarized in Table 6.  In addition, IR-4 is requesting that the existing field trial data on fruiting vegetables and rice be use to support expanded uses, i.e., to support  tolerances for okra and wild rice.

Table 6.	  Summary of Residue Data from Crop Field Trials with Zeta-Cypermethrin (EC and EW).

Crop matrix	Total Applic. Rate  (lb ai/A)	PHI (days)	Residue Levels (ppm)

	n	Min.	Max.	HAFT1	Median	Mean	Std. Dev.

Citrus Fruits (Proposed use = 0.2 lb ai/A total application rate, 1-day PHI)

Orange	0.20	1	24	<0.05	0.16	0.16	0.125	0.103	0.047

Lemon

	10	0.05	0.09	0.08	0.070	0.070	0.012

Grapefruit

	12	0.05	0.20	0.20	0.120	0.119	0.054

Combined Citrus

	46	<0.05	0.20	0.20	0.085	0.100	0.046

Safflower (Proposed use = 0.15 lb ai/A total application rate, 14-day PHI)

Safflower seed	0.144-0.153	13-14	14	<0.05	0.15	0.145	0.05	0.065	0.034

Citrus Fruits.  A total of 23 citrus fruit field trials (12 orange, 5 lemon, 6 grapefruit) were conducted in Zones 3, 6 and 10 during the 2004/2005 growing season.  In each test, zeta-cypermethrin (1.5 lb/gal EC or EW) was applied to citrus as four foliar applications during fruit maturation at 0.05 lb ai/A/application with RTIs of 12-15 days, for a total application of 0.2 lb ai/A/season (1x rate).  The EC formulation was used in 12 tests (6 orange, 3 lemon, 3 grapefruit), and the EW formulation was used in 11 tests (6 orange, 2 lemon, 3 grapefruit).  Applications were made using ground equipment as either dilute sprays (158-264 gal/A) in 11 trials or as concentrated sprays (52-97 gal/A) in 12 trials.  None of the applications included the use of any spray adjuvants.  Single control and duplicate treated samples of citrus fruits were collected from each test at 1 DALA, and additional duplicate treated samples were collected at 7-8, 14-15 and 21-22 DALA from one test each on lemon, orange and grapefruit, to assess residue decline.  In four of the orange trials and two each of the lemon and grapefruit trials, whole fruit were also subsampled and separated into peel and pulp to assess residue levels in fresh pulp.  Samples were stored frozen up to 8 months prior to analysis, an interval supported by available storage stability data.

The GC/ECD method used to determine zeta-cypermethrin residues in/on citrus fruits was adequately validated in conjunction with the analysis of field trial samples.  The validated LOQ was 0.05 ppm, and the reported LOD was 0.01 ppm.

Although the different formulation types and different application volumes were not compared in side-by-side tests, there was no substantial difference in residue levels between the two formulations or between the dilute and concentrated application volumes.  For all citrus fruits harvested at 1 DALA, the overall average residues of zeta-cypermethrin were 0.098 ppm for the EC formulation and 0.102 ppm for the EW formulation, and 0.111 ppm for the dilute volume applications and 0.090 ppm for concentrated volume applications.

Differences in residue levels were more pronounced between the different types of citrus fruits.  Considering both types of formulations and application volumes, zeta-cypermethrin residues at 1 DALA were highest on grapefruits (0.05-0.20 ppm), followed by oranges (<0.05-0.16 ppm), and lemons (0.05-0.09 ppm).  Overall average residues were 0.119 ppm in/on grapefruit, 0.103 ppm in/on oranges, and 0.070 ppm in/on lemons.  The HAFT residues were 0.20 ppm for grapefruit, 0.16 ppm for oranges, and 0.08 ppm for lemons.

Data from the three residue decline trials also showed that residues in/on all three types of citrus fruit remained relatively unchanged from 1 to 22 DALA.  In addition, the analysis of fresh pulp subsamples from eight of the tests indicated that residues were located primarily on the fruit surface.  Zeta-cypermethrin residues were non-detectable (<0.01 ppm) in all 16 samples of pulp from all three types of citrus fruits.

Safflower.  In 5 field trials conducted during 2003 in Zones 5, 7 and 10, zeta-cypermethrin (1.5 lb/gal EC) was applied to safflower as three broadcast foliar applications during bloom and seed development at rates of 0.047-0.052 lb ai/A/application and RTIs of 10-18 days, for a total of 0.144-0.153 lb ai/A/season (1x rate).  Two of the field trials also included side-by-side tests using similar applications of a 1.5 lb/gal EW formulation, at rates of 0.047-0.052 lb ai/A/application and RTIs of 13-15 days, for a total of 0.146-0.152 lb ai/A/season.  All applications were made using ground equipment at volumes of 13-22 gal/A, and did not include the use of any spray adjuvants.  Duplicate control and treated samples of safflower seed were collected from each test at 13-14 DALA.  Samples were stored frozen up to 14.9 months prior to analysis, an interval supported by available storage stability data.

The GC/ECD method used to determine zeta-cypermethrin residues in/on safflower was adequately validated in conjunction with  the analysis of field trial samples.  The lowest level of method validation (LLMV) was 0.05 ppm in/on seeds, and the statistically calculated LOQ and LOD were 0.042 and 0.014 ppm, respectively.

In the two trials using side-by-side tests with the EC and EW formulations, there were no differences in residues between the two formulations.  Following the last of three broadcast foliar applications totaling 0.144-0.153 lb ai/A, residues of zeta-cypermethrin were <0.05-0.15 ppm in/on 14 samples of safflower seed harvested at 13-14 DAT.  Nine of the 14 samples had residues <0.05 ppm.  The average residue was 0.065 ppm and the HAFT residue was 0.145 ppm.

Okra.  No field trial data on okra were submitted the current petitions.  IR-4 is requesting that the available field trial data on fruiting vegetables (PP#0F6207, D268861, Y. Donovan, 11/19/01) be used to support expanding the use on fruiting vegetables to include okra.

Wild Rice.  No field trial data on wild rice were submitted the current petitions.  IR-4 is requesting that the available field trial data on rice (PP#9F6040, D258805, Y. Donovan, 5/22/01) be used to support expanding the current use on rice to include wild rice.

Oilseed Commodities.  No field trial data for any oilseed commodity were submitted with the current petition.  IR-4 is requesting that the available field trial data on canola, sunflower and safflower be used to support expanding the current use on other oilseed commodities.  They also cite that a 0.2 ppm time-limited tolerance has been established to support a Section 18 use for flax.

Oilseed Crop Definition:  Oilseeds include those crops from which oil is extracted from their seed and used to produce edible or inedible oils as well as a high-protein livestock meal.  Oils may be extracted from plants by applying pressure to the seed, or by dissolving parts of the plants in water or another solvent, and distilling the oil, or by infusing parts of the plant in base oil.  The oilseeds are primarily soybeans, sunflower seed, canola, rapeseed, safflower, flax seed, or castor bean, mustard seed, peanut and cottonseed, used for the production of cooking oils, protein meals for livestock and industrial uses.

OPP is currently working with USDA/IR-4 in evaluating the establishment of an Oilseed Crop Group 20, with three subgroups under that oilseed crop group, each subgroup with representative commodities.  The three pending subgroups under the Oilseeds crop group are as follows:

Subgroup 20A.  Rapeseed Subgroup (Representative commodity: Rapeseed, canola varieties only): Borage, Crambe, Cuphea, Flax seed, Gold of pleasure, Hare's-ear mustard, Lesquerella, Meadowfoam, Milkweed seed, Mustard seed, Oil radish, Poppy seed, Rapeseed, Sesame, Sweet rocket.

Subgroup 20B.  Sunflower Subgroup (Representative commodity: Sunflower): Castor oil plant, Chinese tallowtree, Euphorbia, Evening primrose/common, Jojoba, Niger seed, Rose hip, Safflower, Stokes aster seed, Sunflower, Tallowwood, Tea oil plant, Vernonia.

Subgroup 20C.  Cottonseed Subgroup (Representative commodity: Cottonseed): Cottonseed.

Fury® 1.5 EC and Fury® 1.5 EW draft product labels are labeled for multiple foliar applications of 0.05 lb ai/A (minimum interval of 7 days), for a maximum of 0.3 lb ai/A/season, with a PHI of 7 days.  The proposed labels state that applications can be made aerially (2 gal/A finished spray) or by  ground equipment by (10 gal/A finished spray).  The maximum number of applications was not specified.

Canola field trial dare are available for translation to the pending Subgroup 20A commodities , while both sunflower and safflower field trial data are available for subgroup 20B commodities.   The canola data (D283584, D. McNeilly; July 7, 2006) indicated that residues of zeta-cypermethrin were 0.011-0.04 ppm in or on all 16 canola seed samples at 7 DAT, and the average residues were calculated to be 0.025 ppm (below the LOQ).  The canola seed samples were harvested 7 days after a single preplant soil and five broadcast foliar applications at 0.05 lb ai/A/application, for a total application of 0.3 lb ai/A.  The residue data supported a tolerance of 0.05 ppm for canola seed.  However, in order to harmonize with the Codex MRL on oilseeds (except peanut) and take into account the commodity definition in 40 CFR 180.1(h), HED recommended that a tolerance of 0.2 ppm be established for “rapeseed” (Note: this tolerance  will cover residues in both canola and crambe).

Subgroup 20A Processed Commodities.  The maximum theoretical concentration factor (OPPTS 860.1520, Table 1) for canola is 3x, and the theoretical concentration factors based on separation into components (OPPTS 860.1520, Table 3) are 1.9x for canola meal and 3.0x for oil.  The determined processing factor for canola oil (1.4x) does not exceed the theoretical concentration factor.

Table 7.  Residue Data from Canola Processing Study with Zeta-Cypermethrin.

RAC	Processed Commodity	Total Rate

(lb ai/A) 	PHI

(days)	Residues 1

(ppm)	Processing

Factor 2

Canola	Seed (RAC, processor sample)	0.50	7	0.415, 0.406  (0.411)	--

	Meal

	ND, ND  (<0.01)	<0.03x

	Refined oil

	0.499, 0.674  (0.587)	1.4x

1  Average residues are in parentheses.  ND = nondetectable (<0.01 ppm).

2  Processing factors were calculated using the RAC subsamples collected at the processing facility.

As shown in the table above, residues of zeta-cypermethrin decreased in canola meal (<0.03x processing factor) and concentrated slightly in oil (1.4x processing factor).  Although a marginal concentration in oil was observed, HED did not recommend the establishment of tolerances for canola oil and meal as any expected residues in these commodities, will be covered by the recommended tolerance for rapeseed (which covers canola).

Subgroup 20B Processed Commodities.  For the two regulated sunflower seed commodities meal and refined oil, cypermethrin did not concentrate in the meal but did in the refined oil by a factor of 1.4.  This concentration factor was calculated by dividing the mean of the processed commodity residue level, by the mean of the RAC sample and subsample residue levels.  HED concluded that the processing study was adequate and can be bridged to zeta-cypermethrin.  Multiplying the concentration factor by the highest field trial residue (PP# 1F3994, D165012, J. Herndon, 9/17/91) gives 0.31 ppm (1.4 x 0.22 ppm = 0.31 ppm) which is more than the 0.2 ppm recommended tolerance for sunflower seed.  Therefore, a separate tolerance was recommended for sunflower refined oil at 0.4 ppm.  Cypermethrin also concentrated 1.4-fold in crude oil.  Therefore, a 0.4 ppm tolerance should be established for refined oil for all Subgroup 20B commodities.  See Table 9 for a detailed listing of the tolerances required.

Conclusions.  The citrus and safflower field trials are adequate and support the proposed use patterns.  An adequate number of tests were conducted on each crop in the appropriate geographical regions.  Samples were analyzed for the residues of concern using an adequate method, and the sample storage conditions and intervals are supported by available or concurrent storage stability data.

Utilizing the tolerance harmonization spreadsheet and the available residue data on grapefruit, which had the highest residues of the three representative citrus crops, the appropriate tolerance for the citrus fruits crop group is 0.35 ppm.  The available safflower residue data support the proposed 0.2 ppm tolerance.

Although no field trial data are available on okra, HED has recommended that okra be included in the fruiting vegetable crop group.  As the proposed use on okra is identical to the current use on fruiting vegetables, the available residue data on representative fruiting vegetables (Crop Group 8) will support a 0.2 ppm tolerance on okra.

The existing residue data on rice will support the proposed 1.5 ppm tolerance on wild rice grain as the proposed use on wild rice is identical to the existing use on rice.

The existing residue data for rapeseed, sunflower, and safflower will support the proposed 0.2 ppm tolerance for the oilseed commodities in the proposed Crop Group 20 (as defined above), as the proposed uses are identical to the existing use of either canola (for the proposed Subgroup 20A commodities) or sunflower (for the proposed Subgroup 20B commodities).  Additional, tolerances are required for refined oil for all of the Subgroup 20B commodities (see Table 9 for details).

860.1520 Processed Food and Feed

46971402.de2 (Citrus fruits)

46969201.de2 (Safflower)

  SEQ CHAPTER \h \r 1 Table 8.	Summary of Processing Factors for Zeta-Cypermethrin.

RAC	Processed Commodity	Processing Factor

Orange	Dried Pulp	9x

	Orange Oil	19x

	Juice	<0.3x

Safflower Seed	Safflower Meal	<1x

	Safflower Oil	<1x

Citrus Fruits.  Zeta-cypermethrin (1.5 lb/gal EC) was applied to orange trees as four broadcast foliar applications during late fruit development at 0.05 lb ai/A and at RTIs of 13-14 days, for a total of 0.2 lb ai/A (1x rate).  Applications were made using ground equipment at volumes of 72-74 gal/A, and did not include the use of any spray adjuvants.  A single bulk control sample and duplicate bulk treated samples of citrus fruits were collected at 1 DALA, and immediately shipped under refrigerated conditions to the processing facility.  Whole fruit were processed into juice, dried pulp and oil using simulated commercial procedures.  Samples of whole fruit were stored frozen for up to 8 months prior to analysis, and processed fractions were analyzed within one month of collection.  Adequate data are available to support the storage interval for whole fruits, and no storage stability data are required to support the processed fractions.

The GC/ECD method used to determine zeta-cypermethrin residues in whole fruit, juice, oil and dried pulp was adequately validated in conjunction with the analysis of processing study samples.    The validated LOQ was 0.05 ppm for each matrix, and the reported LOD was 0.01 ppm.

Following four foliar applications at a 1x rate, average residues were 0.03 ppm in/on whole fruit harvested at 1 DALA.  Average residues after processing were <0.01 ppm in juice, 0.27 ppm in dried pulp, and 0.57 ppm in oil.  These residue levels corresponded to processing factors of <0.03x for juice, 9x for dried pulp, and 19x for citrus oil.  The maximum theoretical processing factor for citrus is 1000x (oil).

Safflower.  In a single field trial conducted in 2003, zeta-cypermethrin (1.5 lb/gal EC) was applied to safflower as three broadcast foliar applications during seed development at rates of 0.049-0.051 lb ai/A/application and at RTIs of 10-18 days, for a total of 0.151 lb ai/A/season (1x rate).  Applications were made using ground equipment at volumes of 13-14 gal/A, and did not include the use of any spray adjuvants.  Single bulk control and treated samples of seed were collected at maturity, 13 DALA.  Seeds were processed into meal and oil using simulated commercial procedures.  Samples of seeds, meal and oil were stored frozen for 10-14.8 months prior to analysis; these intervals are supported by available storage stability data.

The GC/ECD method used to determine zeta-cypermethrin residues in safflower seeds, meal and oil was adequately validated in conjunction with the analysis of processing study samples. The LLMV was 0.05 ppm for all three matrices, and the statistically calculated LOQs were 0.042, 0.035, and 0.049 ppm for seeds, meal and oil, respectively.  The calculated LOD were 0.014, 0.012, and 0.016 ppm.

Following three applications totaling 0.151 lb ai/A, residues were 0.05 ppm in safflower seed harvested at 13 DALA.  Residues in safflower meal and oil were <0.05 ppm, indicating that zeta-cypermethrin residues do not concentrate in safflower processed fractions.

Conclusions.  The orange and safflower processing studies are adequate and support the proposed use pattern.  As residues were reduced in safflower oil and meal and orange juice, separate tolerances are not required for these commodities.  However, residues were shown to concentrate appreciably in orange dried pulp (9x) and oil (19x).  Based on the HAFT residues of 0.20 ppm from the citrus field trials and these processing factors, the maximum expected residues in citrus dried pulp and oil would be 1.8 and 3.8 ppm respectively.  These values will support tolerances of 1.8 ppm for dried citrus pulp and 4.0 ppm for citrus oil.

860.1650 Submittal of Analytical Reference Standards

  SEQ CHAPTER \h \r 1 Analytical standards for zeta-cypermethrin are currently available in the National Pesticide Standards Repository.

860.1850 and 1900 Confined and Field Accumulation in Rotational Crops

The HED Chemistry Chapter of the Cypermethrin RED (D289422, W. Donovan, 9/25/03) reported that adequate confined and limited field rotational crop studies are available for cypermethrin.  The results of the limited field rotational crop study indicate that residues of cypermethrin and its metabolites were nondetectable (<0.01 ppm) in/on the rotational crop commodities of leafy vegetables, root and tuber vegetables, and cereal grain crops that were planted 30 days after the soil plots were treated with cypermethrin at 0.5 lb ai/A (1.7x the maximum seasonal rate).  The study supports the labeled PBI of 30 days, and no additional rotational crop data are required for cypermethrin.  This conclusion also applies to zeta-cypermethrin.

860.1550 Proposed Tolerances

Tolerances for residues of zeta-cypermethrin are listed under 40 CFR §180.418(a)(2), and are expressed in terms of for zeta-cypermethrin and its inactive R-isomers.  The inclusion of the inactive R-isomers in the tolerance expression is appropriate because the enforcement methods listed in PAM Volume II are not stereospecific; thus no distinction is made between residues of cypermethrin (all eight stereoisomers) and zeta-cypermethrin (an enriched isomer form of cypermethrin).  The proposed and recommended tolerances for the each commodity are listed in Table 9.

For Citrus Fruits, Crop Group 10, the residue data from grapefruit were utilized to recommend an appropriate tolerance, as residues in/on grapefruit were higher than the other two representative crops of oranges and lemons.  Using the grapefruit residue data and the tolerance harmonization spreadsheet (Appendix II), the appropriate tolerance for citrus fruits was calculated to be 0.35 ppm.  Although MRLs have been establish on citrus fruits by both Canada (1.0 mg/kg) and Codex (2.0 mg/kg; Appendix I), harmonization is not possible as the MRL levels are considerably above the residues resulting from the proposed use rate in the U.S.

For safflower, the recommended tolerance level of 0.2 ppm is based on the maximum residues (0.15 ppm) observed in the field trials.  The tolerance harmonization spreadsheet was not utilized as 9 of the 14 safflower seed samples had residues <LOQ.  In addition, the 0.2 ppm tolerance on safflower seed is harmonized with the current Codex MRL of 0.2 mg/kg on oilseeds.

As residues did not concentrate in orange juice or safflower meal and oil, separate tolerances are not required for these processed commodities.  However, residues were shown to concentrate in orange dried pulp (9x) and oil (19x).  Based on the HAFT residues of 0.20 ppm from the citrus field trials (grapefruit) and the above processing factors, the maximum expected residues in citrus dried pulp and oil would be 1.8 and 3.8 ppm respectively.  Considering HED guidance on rounding of residue values for determining tolerances (ChemSAC memo, 3/23/05), the appropriate tolerances for citrus dried pulp and oil would be 1.8 and 4.0 ppm, respectively.

As the proposed use on okra is identical to the current use on fruiting vegetables, the existing field trial data on fruiting vegetables will support the proposed 0.2 ppm tolerance on okra.  HED has recommended that okra be included in the fruiting vegetable crop group; however, until the new crop group regulation is published a separate tolerance will be required for okra.  Similarly, the existing residue data on rice will support the proposed 1.5 ppm tolerance on wild rice grain as the proposed use on wild rice is identical to the existing use on rice.

Based on current and proposed tolerances for livestock feedstuffs, residues are not expected to exceed the established tolerances for meat, milk, poultry, and eggs when the maximum dietary burden is extrapolated with the feeding levels used in the available animal feeding studies.  Therefore, no revision of the existing animal commodity tolerances is required.

Table 9. 	Tolerance Summary for Zeta-Cypermethrin.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;

Correct Commodity Definition

Fruit, citrus, group 10	0.25	0.35	Adequate residue data are available on oranges, lemons and grapefruit.  The tolerance was calculated using the tolerance harmonization spreadsheet and the residue data from grapefruits, which had the highest residues of the three representative crops.

Citrus, dried pulp	0.5	1.8	Considering processing factors for citrus dried pulp (9x) and oil (19x) and the HAFT residues of 0.20 ppm from the citrus field trials, the maximum expected residues in dried pulp and oil would be 1.8 and 3.8 ppm, respectively.

Citrus, oil	0.9	4.0

	Okra	0.2	0.2	Adequate residue data are available on fruiting vegetables.  These data will be translated to support a separate tolerance on okra at the same level.

Safflower	0.2	0.2	Adequate residue data are available.

Safflower, seed

Rice, wild, grain	1.5	1.5	Adequate residue data are available on rice.  These data will be translated to support a separate tolerance on wild rice at the same level.

Oilseed commodities

(proposed Subgroup 20A):

Borage, seed

Crambe, seed

Cuphea, seed

Echium, seed

Flax, seed (see note)

Gold of pleasure, seed

Hare's-ear mustard, seed

Lesquerella, seed

Lunaria, seed

Meadowfoam, seed

Milkweed, seed

Mustard, seed

Oil radish, seed

Poppy, seed

Sesame, seed

Sweet rocket, seed

Oilseed commodities

(proposed Subgroup 20B):

Castor oil plant, seed

Chinese tallowtree, seed

Euphorbia, seed

Evening primrose, seed

Jojoba, seed

Niger seed, seed

Rose hip, seed

Stokes aster, seed

Tallowwood, seed

Tea oil plant, seed

Vernonia, seed

0.2

0.2

0.2

0.2	Adequate residue data are available for canola (Subgroup 20A) and sunflower (Subgroup 20B).  These data will be translated to support separate tolerances for each oilseed commodity at the same level.  (Note: When the Flax seed permanent tolerance is established the temporary tolerance should be cancelled.)

Subgroup 20B

Oilseed, refined oil

Castor oil plant, refined oil

Chinese tallowtree, refined oil

Euphorbia, refined oil

Evening primrose, refined oil

Jojoba, refined oil

Niger seed, refined oil

Rose hip, refined oil

Stokes aster, refined oil

Tallowwood, refined oil

Tea oil plant, refined oil

Vernonia, refined oil	--	0.4	Adequate processing data are available for sunflower.  These data will be translated to support separate tolerances for all Subgroup 20B oilseed commodities at the same level.

References

	  SEQ CHAPTER \h \r 1 D  SEQ CHAPTER \h \r 1 269584;   SEQ CHAPTER \h \r 1 Cypermethrin and Zeta-Cypermethrin – Conclusions of the Meeting of Metabolism Assessment Review Committee (10/10/00); Y. Donovan;   SEQ CHAPTER \h \r 1 11/3/00.

  SEQ CHAPTER \h \r 1

	  SEQ CHAPTER \h \r 1 D  SEQ CHAPTER \h \r 1 258805;   SEQ CHAPTER \h \r 1 PP#9F6040  Zeta-Cypermethrin - Proposal for Permanent Tolerance on Rice and Processed Rice Products.  Evaluation of Analytical Method and Magnitude of the Residue Data;   SEQ CHAPTER \h \r 1 Y. Donovan;   SEQ CHAPTER \h \r 1 5/22/01.

	  SEQ CHAPTER \h \r 1 D  SEQ CHAPTER \h \r 1 268861;   SEQ CHAPTER \h \r 1 PP#0F6207.  Zeta-Cypermethrin – Proposal for Permanent Tolerance on Cereal Grains, Legumes, Soy Beans, and Fruiting Vegetables.  Evaluation of Analytical Method and Magnitude of the Residue Data;   SEQ CHAPTER \h \r 1 Y. Donovan;   SEQ CHAPTER \h \r 1 11/19/01.

	  SEQ CHAPTER \h \r 1 D  SEQ CHAPTER \h \r 1 289422;   SEQ CHAPTER \h \r 1 Cypermethrin (PC Code 109702) HED Chemistry Chapter of the Reregistration Eligibility Decision (RED):  Summary of Product and Residue Chemistry Residue Data.  Reregistration Case 2130; W  SEQ CHAPTER \h \r 1 . Donovan;   SEQ CHAPTER \h \r 1 9/25/03.

	  SEQ CHAPTER \h \r 1 D283584;   SEQ CHAPTER \h \r 1 Zeta-Cypermethrin.  Petitions (PP#s 3F6577, 3E6677, 2F6444, 4F6893, and 5F6896) for the Establishment of Tolerances on Various Raw Agricultural, Processed Commodities and Food Items in Food Handling Establishments.  Summary of Analytical Chemistry and Residue Data; D. McNeilly;   SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 7/07/06.

D334263.  Zeta-cypermethrin: Revised Human Health Risk Assessment for Proposed Uses on Numerous Raw Agricultural Commodities.  Petitions: 3F6577, 3E6677, 2F6444, 4F6893, and 5F6896 for the Establishment of Tolerances on Various Raw Agricultural, Processed Commodities and Food Items in Food Handling Establishments.  Dennis McNeilly, 11/29/2006.

  SEQ CHAPTER \h \r 1 Attachments:

Appendix I - International Residue Limits Status

Appendix II- Tolerance Spreadsheet Calculations.

Appendix I – International Tolerances.

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name:

(s-cyano(3-phenoxyphenyl) methyl (±)cis, trans 3- (2,2-dichloroethenyl)-2,2- dimethylcyclo propanecarboxylate	Common Name:

Zeta-cypermethrin	x Proposed toler湡散

 Reevaluated tolerance

 Other	Date: 12/18/05

Codex Status (Maximum Residue Limits)	U. S. Tolerances

 No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition Numbers:  6E7132, 6E7133

DP Numbers:  335223, 335226

Other Identifier: EPA Reg. Nos. 279-3125, 279-3126

Residue definition (step 8/CXL):

 No Limits

   No limits for the crops requested	 No Limits

X No Limits for the crops requested

Residue definition:

cypermethrin: (RS)-alpha-cyano-3-phenoxy-benzyl (1RS,3RS)-(1RS, 3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropane-carboxylate	Residue definition:  zeta-cipermetrina

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

Apples	1.0	Cottonseed	0.5

Celery	1.0	Onion	0.1

Citrus fruit	1.0	corn (maize)	0.05

Beans	0.5	Soybean	0.05

Broccoli	0.5

Brussels sprouts	0.5

Cabbage	0.5

Cauliflower	0.5

Grapes	0.5

Pears	0.5

Tomatoes	0.3

Peaches/nectarines	0.2

Strawberries	0.2

Notes/Special Instructions:

Appendix II - Tolerance Assessment Calculations.

The Agency’s Guidance for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels on citrus fruits.  The dataset used to establish the tolerance for zeta-cypermethrin residues on citrus fruits consisted of field trial data representing applications of the appropriate EC and EW formulations at 1x the maximum use rate.  As specified by the Guidance for Setting Pesticide Tolerances Based on Field Trial Data SOP, the field trial application rates were within 25% of the maximum label application rate, and the PHI is consistent with the appropriate stage of maturity and the proposed PHI.  The residue values used to calculate tolerance are provided in Table II-1.

The residue data for grapefruits was utilized to determine the appropriate tolerance for the citrus fruits crop group as grapefruits had the highest residues of the three representative crops.  Residues were lower in both oranges (<0.05-0.16 ppm) and lemons (0.05-0.09 ppm).

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s was entered into the tolerance spreadsheet.  Visual inspection of the lognormal probability plot (Figure II-1) indicates that the dataset is reasonably lognormal and the result from the approximate Shaprio-Francia test statistic (Figure II-2) confirms that assumption.  The calculated tolerance level for citrus fruits 0.35 ppm.

For safflower, the recommended tolerance level of 0.2 ppm is based on the maximum residues (0.15 ppm) observed in the field trials.  The tolerance harmonization spreadsheet was not utilized as 9 of the 14 safflower seed samples had residues <LOQ.  In addition, the 0.2 ppm tolerance on safflower seed is harmonized with the current Codex MRL of 0.2 mg/kg on oilseeds.

Table II-1.	Zeta-Cypermethrin Residue Data on Citrus Fruits.

Regulator:	EPA

Chemical:	Zeta-cypermethrin

Crop:	Oranges	Lemons	Grapefruit

PHI:	1 day

App. Rate:	0.2 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 46971402

	Residues	Residues	Residues

	0.05	0.08	0.12

	0.05	0.07	0.16

	0.16	0.08	0.20

	0.13	0.05	0.06

	0.05	0.06	0.05

	0.12	0.08	0.11

	0.11	0.09	0.12

	0.14	0.06	0.15

	0.05	0.07	0.20

	0.05	0.06	0.07

	0.15

0.05

	0.13

0.14

	0.05

	0.05

	0.16

	0.14

	0.05

	0.13

	0.16

	0.16

	0.05

	0.05

	0.14

	0.13

Values below the LOQ (0.05 ppm) are designated in bold.

Figure II-1.	Lognormal Probability Plot for Zeta-Cypermethrin Residues in/on Grapefruits.

Figure II-  SEQ Figure_II \* ARABIC  1 .	Data Summary Table for Zeta-Cypermethrin Residues In/On Grapefruits.

Summary of Analytical Chemistry and Residue Data

Zeta-Cypermethrin                                                           DP Numbers 335223, 335226

						Page 	  PAGE  5  of   NUMPAGES  28

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