Document ID: EPA-HQ-OPP-2004-0385-0123
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-02-27T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

                                                                        
                                    OFFICE OF

				PREVENTION, PESTICIDES

	AND TOXIC SUBSTANCES

September 26, 2007

MEMORANDUM

SUBJECT:  	RESPONSE TO COMMENTS.  The Special Review and Reregistration
Division’s (SRRDs) Response to Comments on EPA’s Reregistration
Eligibility Decision (RED) Document for Permethrin (OPP Docket
#OPP-2004-0385).

FROM:	Jacqueline B. Guerry

		Chemical Review Manager

		Reregistration Branch III

		Special Review and Reregistration Division		

TO:		Michael Goodis

		Branch Chief

		Reregistration Branch III

		Special Review and Reregistration Division

	The attached document titled “Special Review and Reregistration
Division’s (SRRDs) Response to Comments on EPA’s Reregistration
Eligibility Decision (RED) Document for Permethrin” was developed in
coordination with the Registration Division (RD) and the Biological and
Economic Affects Division (BEAD) to respond to comments submitted by the
CA Regional Water Quality Control Board, San Francisco Bay Region,
Delaware Mosquito Control Section, Lee County Mosquito Control District,
Maryland Mosquito Control Section, the National Pest Management
Association, Permethrin Issues Reregistration Task Force, SC Johnson &
Sons as well as public citizens during the post-Phase 4 period of the
public participation process of the Permethrin RED.  SRRD is responding
to comments that were directed towards product labeling, risk
mitigation, or the upcoming registration review process for the
pyrethroids, pyrethins, and synergist chemicals.  The Health Effects
Division (HED) and the Ecological and Environmental Effects Division
(EFED) responded to public comments specific to the human health and
ecological risk assessments, respectively.  

SRRD’s Response to Public Comments to the Permethrin Reregistration
Eligibility Decision and Label Table

Public Health Uses

The Delaware Mosquito Control Section (DMCS) of the Division of Fish and
Wildlife, Delaware Department of Natural Resources and Environmental
Control commented that the environmental hazard statement, which appears
on wide area public health use permethrin products, is not applicable to
public health uses of permethrin.  Further, the DMCS proposed adding the
following statement to the label:  if used in accordance with the label,
permethrin poses no unreasonable risk to human health, aquatic
organisms, wildlife, or the environment.  The Maryland Mosquito Control
Section submitted similar comments.  

SRRD Response:  The Environmental Hazard Statement (EHS) for adult
mosquito control programs was taken out of the PR Notice 2005-1,
Labeling Statements on Products Used for Adult Mosquito Control.  The
Agency is adopting this language on all products used for wide area
adult mosquito control, not just the permethrin labels.  Therefore, the
EHS will not be revised or removed from permethrin products used for
wide area adult mosquito control.  Further, although the Agency was able
to mitigated potential risks to aquatic organisms through a reduction in
the maximum daily application rate and maximum year application rate, as
well as specifying a minimum boom height for aerial applications, the
Agency acknowledges in the Permethrin RED that there is still a
potential for acute risks to freshwater and estuarine invertebrates. 
Therefore, we do not believe the label statement suggested by the DMCS
would be appropriate to include on permethrin public health labels.  

The DMCS commented the following part of the EHS, “(w)hen applying as
a wide area mosquito adulticide, do not apply over bodies of water
(lakes, rivers, permanent streams, natural ponds, commercial fish ponds,
swamps, marshes or estuaries), except when…weather conditions will
facilitated movement of applied material away from the water in order to
minimize incidental deposition into the body of water,” should be
advisory, not mandatory, since permethrin will cause very little to no
adverse effects to non-target organisms.  The Maryland Mosquito Control
Section submitted similar comments.  

SRRD Response:  See response above.  

The DMCS also stated that the bodies of water identified in the EHS need
to be better defined.  The Maryland Mosquito Control Section submitted
similar comments.  

SRRD Response:  See response above.

The Lee County Mosquito Control District (LCMCD) recommends dropping the
maximum boom height requirement of 300 feet on existing and proposed
labels used in permethrin labels used in aerial applications for
mosquito control programs in the interest of safety. 

SRRD Response: The maximum boom height that appears on current
permethrin labels for aerial applications for mosquito control programs
is not a requirement of the Agency.  Instead, the maximum boom height is
established by the registrant of the permethrin end use product.  

The following comments applies to the following label statement,
“Ground-based application: Spray equipment must be adjusted so that
the volume median diameter is less than…” The LCMCD believes a more
appropriate description to frame this reference would be to substitute
the word “capable” in lieu of “adjusted.”  

SRRD Response:  The label statements pertaining to droplet size for both
ground and aerial applications are taken directly out of the Pesticide
Registration Notice 2005-1.  Further, the Agency believes it is implied
in the statement that the spray equipment must be capable of delivering
the required droplet sizes.  Therefore, the label statement will not be
changed at this time.  

On some permethrin labels, the following label statement appears, “For
best results treat when mosquitoes or insects are most active and
weather conditions are conducive to keeping the fog near the ground e.g.
cool temperatures, and consistent wind speeds are not greater than
10mph.”  The LCMCD recommends removing “e.g. cool temperatures, and
consistent wind speeds are not greater than 10mph” from the statement.
 According to the LCMCD adult mosquitoes are more active when ambient
temperatures are high as opposed to cool.  Further, along the coastal
areas of the U.S. and in particular Southwest Florida consistent winds
at sunrise will range between 10 mph and 15 mph on a typical day.  

SRRD Response:  This is not a label statement required by the Agency. 
In addition, the statement is advisory, not mandatory.  This statement
has been established by the registrant of the end use product to advise
the applicator on how to best use its product.  Unlike label statements
required by the Agency, this statement does not appear on all permethrin
labels.

The LCMCD recommends reformatting the current EHS for wide are public
health uses by replacing the language “except when necessary to target
areas where adult mosquitoes are present, and weather conditions will
facilitate movement of applied material away from the water in order to
minimize incidental deposition into the water,” with the “Directions
for Use” portion of the label.  Because this statement is a direct
reference to spray drift, this caveat would be more prominent and,
thereby, effective in the “Directions for Use Section.”  

SRRD Response:  The EHS for adult mosquito control programs was taken
out of the PR Notice 2005-1.  Although the Agency appreciates the
LCMCD’s point regarding the reference to spray drift, we believe the
statement is appropriate in the EHS section of the label.  Further, the
PR notice 2005-1 was developed to create consistency and an even playing
field for all adult mosquito control products.  Therefore, we do not
believe changing the statement for permethrin is warranted at this time.
 

 

Outdoor Residential Misting Systems (ORMS)

The National Pest Management Association (NPMA) commented that the
Agency should adopt the term “urban” when describing ORMS in order
to differentiate between similar systems used in agricultural settings. 

SRRD Response:  The Agency believes the term outdoor residential misting
system is appropriate for these systems, since the term residential is
defined in the US Code of Regulations (CFR) Part 152.3.  According to 40
CFR Part 152.3, the term Residential use includes use of a pesticide
directly “in, on, or around any structure, vehicle, article, surface,
or area associated with the household, including but not limited to
areas such as non-agricultural outbuildings, non-commercial greenhouses,
pleasure boats and recreational vehicles.”

The NPMA also commented that there should be standardized label language
for all products use in ORMS, not just products currently in
reregistration, such as permethrin, pyrethrins, and PBO.  

SRRD Response:  The Agency is aware of permethrin, pyrethrins, and PBO
currently being used in these systems.  Therefore, the same label
language required on permethrin products used in ORMS is also required
for pyrethrins and PBO products.  To date, the Agency has little or no
evidence that 25(b) chemicals or others are used instead of permethrin,
pyrethrins, and PBO. 

Since the permethrin RED was signed, the Agency has developed an
informational website for consumers interested in purchasing or that
have purchased an ORMS
(http://www.epa.gov/pesticides/factsheets/misting_systems.htm).  The
website, as well as industry guidelines developed by NPMA, promotes the
use of pesticide products specifically labeled for use in misters.   

NPMA commented that the use direction for ORMS should appear on a
separate part of the product label, distinct from other uses.  

SRRD Response:  The permethrin label table requires the use directions
for ORMS to be captured under the heading “Directions for use in
outdoor residential misting systems.”   

NPMA, as well as an individual pest control operator, suggested the
systems should be installed and maintained by a certified applicator or
person working under their supervision.  Additionally, the following
label language was suggested:  (Product Name) may only be applied
through systems serviced and maintained by certified applicators or
persons working under their direct supervision. 

SRRD Response:  Permethrin products for use in outdoor residential
misting systems are not restricted use products, and therefore, the
Agency cannot place a certified applicator restriction on an
unrestricted product.   However, the Agency recommends having an ORMS
professionally installed and maintained.  In the ORMS website developed
for consumers, the Agency recommends the following when having a system
installed, “always use installers and service technicians that comply
with the state’s license, certification, and registration
requirements.”

The NPMA also suggested the following label statements be added to
products for use in ORMS:

Operators of Urban Misting Systems must consider the following when
calculating application rates: landscaping/topography, environmental
issues, and system requirements. 

SRRD Response:  The Agency acknowledges many factors should be
considered when the system are installed, and in the calculation of the
application rates.  Therefore, to ensure these systems are properly
installed and the application rate is accurately calculated, the Agency
has added the following to the amended label table.  

“Contact the system manufacture for guidance or assistance to ensure
compliance with the following requirement:  

This product may only be used in systems that have been calibrated to
apply no more than the maximum application rate of 0.25 grams per 1000
cubic feet per day.”  

Do not apply this pesticide when people, pets, and food are present.

SRRD Response:  A similar statement is currently in the permethrin RED
label table; however, the statement has been modified to read “Do not
apply this pesticide when people, pets, and/or food are present” (see
the amended permthrin label table).

Mists should be directed away from swimming pools, or ponds containing
fish and other organisms sensitive to (active ingredient name).

SRRD Response:  A similar statement is currently in the permethrin RED
label table; however, the statement addresses all water bodies, not just
those which contain fish or aquatic organisms.  The current label
statement reads, “Direct nozzles to spray towards the target area and
away from swimming pools, water bodies, or eating and cooking areas.” 

This product may not be used in an evaporative cooling system. 

SRRD Response:  This statement has been added to the amended permethrin
label table.  

To ensure compliance with the label, the end uses shall not allow the
system to operate when off-site drift will occur or when target insects
are not likely to be present.  

SRRD Response:  The Agency believes this statement it is too vague to be
enforceable.  

If used in a system with a reservoir for end use dilution, the reservoir
shall be locked and accessible only be opened by a certified applicator
or person working under his/her direct supervision.  

SRRD Response:  The first part of the label statement already appears in
the Permethrin RED label table; however, since the Agency is not
restricting the use of permethrin products used in ORMS, the second part
of the sentence will not be adopted.  

Do not set nozzles to direct mist near outside air conditioners or other
home air intakes.  

SRRD Response:  This statement has been added to the amended permethrin
label table.  

The Permethrin Issues Reregistration Task Force (PIRTF) support the
maximum use rates for outdoor mosquito misting systems and the required
re-entry restrictions for the various application methods employed, and
believe these measures will greatly limit exposure to permethrin
residues and protect the public from possible adverse affects.

SRRD Response:  The Agency agrees that the risk mitigation measures
implemented for permethrin products used in ORMS will greatly limit
exposure both human and ecological to permethrin residues.

The PIRTF and SC Johnson & Sons submitted comments expressing concern
that the requirement that certain permethrin products which do not
contain directions for use in outdoor mister systems must additionally
contain the label statement, “Not for use in outdoor residential
misting systems.”  We would suggest that the fact that the product is
not labeled for use in outdoor misting systems, and already contains the
EPA-required statement, “It is a violation of Federal law to use this
product in a manner inconsistent with its labeling.” should be
sufficient to direct the consumer that the product may not be used in
such systems.  We think this additional labeling requirement is
unnecessarily redundant of labeling statements already required, and
reverses what we thought was a long-standing Agency policy of not
labeling pesticide products for misuse.  

SRRD Response:  The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizes limited variations from the use directions specified
on pesticide labels under Section 2(ee).  Specifically, 2(ee) allows for
alternate methods of applications other than those specified on the
label, as long as the method is not prohibited on the pesticide
labeling.  Therefore, when appropriate, it is the Agency practice to
prohibit application methods to ensure the product is not used in a
manner inconsistent with proper use directions and application rates
specified for that application method.    

Impregnated Materials

The CA Environmental Protection, Office of Environmental Health and
Hazard Assessment suggested including the following statement on
permethrin products intended to fabric, “Do not exceed an application
rate equivalent to 1.25 grams of a.i.  per square meter of fabric.”  

SRRD Response:  The Agency agrees with CA EPA’s suggested label
language and the following statement has been added to all Manufacturer
Use Products (see amended permethrin label table):

Formulations into products intended for impregnated fabric applications:

“Do not exceed an application rate equivalent to 1.25 grams of a.i.
per square meter of fabric.  

  

The CA Water Quality Control Board, San Francisco Bay Region commented
that the permethrin RED found significant risks to aquatic organisms
form sewer discharges of permethrin.  Uses and subsequent washing of
treated clothing, mattress pads, and similar items contributes to this
risk.  Users of such products should be made aware of this risk.  These
products (and all indoor use products) should be labeled with aquatic
environmental hazard statements required for outdoor products.  It is
particularly important that the aquatic EHA be included on clothing and
mattress pads.  

SRRD Response:  The Agency recognizes the potential for risks to aquatic
organisms through waste water discharge.  However, the Agency also
believes its down-the-drain risk assessment for permethrin products was
highly conservative.  The Agency included permethrin pesticide products
(pre-treated clothing and pets products), as well as permethrin
pediculicide pharmaceutical products, both over the counter (OTC) and
prescription, in the down-the-drain assessment.  The Agency assumed the
total yearly production volume, approximately 252,000 kg a.i. of
permethrin, is being wasted down-the-drain per year.   

Through various labeling initiatives (some discussed in the Section IV
below), OPP hopes to reduce the overall amount of permethrin discharge
into both storm water and sewage drainage systems.  However, at this
time, the Agency does not believe adding aquatic environmental hazard
statements, similar to the EHS on outdoor products, is appropriate on
indoor use products, especially impregnated clothing and mattress pads. 
Permethrin binds very well with fabric fibers and the goal of permethrin
impregnated clothing is to keep the permethrin in the clothing.  If the
permethrin is not retained in the clothing the product will not be
efficacious.  Wash-off data for permethrin impregnated clothing shows
that much of the permethrin that is removed during washing does not end
up in the wash water, but rather it actually comes off bound to the
clothing particles that end up in the dryer’s lint trap.

The following EHS, however, is being required for all indoor use
products (except RTU impregnated materials, see reason above).  

“This pesticide is toxic to aquatic organisms, including fish and
invertebrates.  Do not contaminate water when disposing of equipment
wash waters.”

For commercial, industrial, and institutional use products packaged in
containers equal or greater than 5 gallons or 50 labs, add the following
statement:

“This pesticide is toxic to aquatic organisms, including fish and
invertebrates.  Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or other waters unless in
accordance with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge.  Do not discharge effluent
containing this product to sewer systems without previously notifying
the local sewage treatment plant authority.  For guidance contact your
State Water Board or Regional Office of the EPA.”

Outdoor Residential, Industrial, and/or Institutional Use

The California Stormwater Quality Association (CASQA) recommended the
Agency clarify the additional application restrictions for outdoor
residential products on the label table intended to prevent to release
of permethrin into urban run-off.  CASQA stated the language would more
fully meet this intent if modified as shown below (additions in italics,
deletions in strikeout): 

Requirements for Granular Formulations labeled or intended for outdoor
uses: 

“Do not apply directly to or near water, storm drains, gutters,
sewers, or drainage ditches. Do not apply within 25 feet of rivers, fish
ponds, lakes, streams, reservoirs, marshes, estuaries, bays, and oceans.
 Do not apply when windy. Apply this product directly to your lawn or
garden, and sweep any product landing on the driveway, sidewalk, gutter,
or street, back onto the treated area. To prevent product run-off, do
not over water the treated area to the point of runoff or apply when
raining or when heavy rain is expected that day.” 

Requirements for Liquid and Dust products labeled or intended for
outdoor uses (excludes Ready to Use Products): 

“Do not apply directly to or near water, storm drains, gutters,
sewers, or drainage ditches. Do not apply within 25 feet of rivers, fish
ponds, lakes, streams, reservoirs, marshes, estuaries, bays, and oceans.
 Do not apply when windy. To prevent product run-off, do not over water
the treated area(s) to the point of runoff or apply when raining or when
heavy rain is expected that day. Rinse applicator over lawn or garden
area only.” 

Requirements for Ready to Use Formulations labeled or intended for
outdoor use: 

“Do not apply directly to or near water, storm drains, gutters,
sewers, or drainage ditches. Do not apply within 25 feet of rivers, fish
ponds, lakes, streams, reservoirs, marshes, estuaries, bays, and oceans.
 Do not apply when windy.  To prevent product run-off, do not over water
to the point of runoff, or apply when raining or when rain is expected
that day.” 

CASQA proposed the above modifications to clarify that gutters are
connected to storm drains (application in a gutter is essentially the
same as application directly to a storm drain), to recognize that sewers
and storm drains are often confused, and to clarify that applications
should not be made in the rain or when rain is forecast. We strongly
recommend that the word “heavy” be deleted, as it is a qualitative
term that will be unclear to the consumer—and there is no scientific
basis for this limitation. Runoff depends on surface (e.g., water does
not “soak in” to impervious surfaces) and on ground saturation. Even
light rain can generate runoff.   The CA Regional Water Quality Control
Board, San Francisco Bay Region submitted similar comments.  

SRRD Response:  EPA agrees with the comments above, and the suggested
revisions will be made to the referenced label statements in the amended
permethrin label table.  

CASQA also stated that professional products for urban use (i.e.,
products for above ground structural pest control, landscaping, rights
of way, etc.) should have stewardship language on their labels. We
understand that this language would not be applicable to mosquito
abatement applications. We believe that the language proposed for
consumer products would also work for professional products with urban
applications. The first sentence of the label language (the sentence
about not applying to drains) is not as clear and specific as the
language that U.S. EPA plans to require on cypermethrin labels. We
recommend that the cypermethrin language be substituted for this first
sentence as modified below. This would be clearer and more appropriate
to the goal of reducing permethrin levels in urban runoff.  CASQA
suggested the following language:

“Do not apply directly into sewers or drains, or to any area like a
gutter where drainage to storm sewers, water bodies, or aquatic habitat
can occur. When making an application around or near a floor drain,
limit the application to a spot treatment and do not allow the product
to enter the drain during or after the application.” 

“For outdoor uses, do not apply within 10 feet of storm drains. Do not
apply within 25 feet of rivers, fish ponds, lakes, streams, reservoirs,
marshes, estuaries, bays, and oceans.” 

Professional products that direct users to “water in” the product
should have language directing professional users not to allow water to
run off of treated sites.

The CA Regional Water Quality Control Board, San Francisco Bay Region
submitted similar comments.  

SRRD Response:  Permethrin is registered for application directly into
sewers or drains.  In addition, the permethrin RED risk mitigation does
not limit outdoor residential applications to spot treatments, where as
cypermethrin does limit all outdoor applications to spot or
crack-and-crevice treatment.  Therefore, the first label statement
suggested by CASQA above is not appropriate for all outdoor permethrin
labels.  However, we do agree that permethrin products for professional
use should have stewardship language on the labels to prevent the
run-off of permethrin residues.  Therefore, in addition to the revisions
made to the stewardship language above, the following statements have
been added to the amended permethrin label table for permethrin end use
products primarily intended for WPS and occupational use (including
commercial pest control operators).  

Products labeled for use around or near floor drains.  Products labeled
for use in drains or sewers are excluded from this label requirement:

 “Do not apply directly into sewers or drains, or to any area like a
gutter where drainage to storm sewers, water bodies, or aquatic habitat
can occur.  Do not allow the product to enter any drain during or after
application.”

CASQA also commented that permethrin products labeled for control of
nuisance insects around structures (e.g., ants) often call for a
barrier, perimeter, or band application around a structure and up the
walls of the structure. Label instructions vary, but commonly call for a
band up to 6 to 10 feet away from the building and up to 3 feet up the
walls of the building. The exact width of the band does not appear to be
based on scientific studies showing that such large applications are
necessary for the application to be effective. To afford flexibility to
professional pest control operators who do not believe such wide bands
are necessary, we request that product labels be required to clarify
that widths narrower than those specified on the label are allowable. 
The CA Regional Water Quality Control Board, San Francisco Bay Region
submitted similar comments.  

SRRD Response:  The Agency believes that the use directions referenced
above, which call for a band up to 6 to 10 feet away from the building
and up to 3 feet up the walls of the building allow for applications
less than the maximum height and width specified on the label.  However,
in order to ensure this flexibility is clear to all applicators, the
following statement has been added to the amended label table.

Products labeled for use on and around buildings and other structures:

“For Band applications to and around buildings foundations, band up to
a maximum of 10 feet away from the building and up to a maximum of 3
feet up the walls of the building.”

CASQA stated, for cypermethrin, U.S. EPA has proposed label statements
designed to prevent runoff of the active ingredient from
pre-construction termiticide applications. These simple, straightforward
measures should be applied to pre-construction termiticide applications
of permethrin—and to all pesticides labeled for pre-construction
termiticide uses.

SRRD Response:  The following label statements are required for
permethrin products with pre-construction termiticide use (see Amended
Label Table).  

Products labeled for preconstruction termiticide applications:

The applicator must insure the treatment site is covered.  The
applicator can cover the soil him/herself or notify the contractor on
the site that: 1) if the concrete slab cannot be poured over the treated
soil within 24 hours of application the treated soil should be covered
with a waterproof covering (such as polyethylene sheeting), and 2) that
the contractor should cover the treated soil if precipitation occurs
before the concrete slab is poured.

Do not treat soil that is water-saturated or frozen.

Do not treat when raining.

Do not allow treatment to runoff from the target area.

Do not apply within 25 feet of aquatic habitats (such as, but not
limited to, lakes; reservoirs; rivers; permanent streams; marshes or
natural ponds; estuaries; and commercial fish farm ponds).  

Do not make on-grade applications when sustained wind speeds are above
10 mph (at application site) at nozzle end height.

Agricultural Use 

The CA Water Quality Control Board comments the Agency should modify the
description of run-off mechanism on agricultural product labels.  The
Water Board quotes the environmental hazard statement for agricultural
products, which states permethrin run-off can occur “primarily in
runoff events accompanied by erosion.”  The Water Board states there
is no scientific basis for this phrase, which should not be included on
the labels.  The Water Board concludes visible erosion is not needed for
fine particles to run-off.  

SRRD Response:  The Agency agrees that visible erosion is not necessary
for permethrin run-off potential, and this is not the intent of the
statement referenced above.  Additionally, the label statement does not
specify the erosion has to be visible.  Recent studies show pyrethoids
have been transported to surface water in run-off that is caused by the
movement of soil, whether fine particle transfer or visible erosion. 
Because permethrin, specifically, binds so tightly to organic matter,
the Agency believes there is scientific basis for this phrase to be
included in the environmental hazard statement of agricultural products.
 

The American Mushroom Institute (AMI) commented that the RED identifies
the maximum application rate for fogging and aerosol applications of the
EC and D formulations as 1 oz/qt (1 oz per 35000 ft3 or 8000 ft2).  The
current rate used by growers is 2.0 to 2.5 oz/30 oz of H2O (1 quart of
solution per standard double house, 8000 sq ft of crop area or 35,000 cu
ft of enclosed area is used per application).   The AMI contends it is
critical to maintain this use rate on permethrin labels.

SRRD Response:  The maximum use rate for mushrooms listed in the
Permethrin RED, Appendix A was a typo.  The correct use rate should be
2.0 to 2.5oz/30 oz of water as identified by the AMI above.  The
correction has been made to the RED Appendix A.

General Comments Regarding Labeling

The PIRTF included a general comment with respect to the label table is
that it is somewhat confusing distinguishing which language needs to go
on labels for which uses.  Granted, the number of uses permethrin
products can have is extensive and varied, and we hope that we can work
further with the Agency to clarify how some of these labels should read.
 While it is important to have the right information on particularly
consumer labels, it is also important that it be readable and not
daunting for the consumer to read and to understand how to use the
product correctly.

SRRD Response:  The Agency agrees that due to the large and varied use
pattern of products containing permethrin, the label table is quite
lengthy and possibly difficult to interpret.  Therefore, in response to
the PIRTF comments and in an effort to ensure clear and interpretable
label language, the Agency has revised the label table by eliminating
repetitive sections and clarifying certain language.   The Agency also
made an effort to create consistent label statements, when appropriate,
on the various pyrethroid, pyrethrins, and synergist label tables

Risk/Benefit Balancing Analysis

The PIRTF strongly disagrees with the assertion that permethrin can be
replaced in the consumer market by other pyrethroids.  The PIRTF asserts
that of those pyrethroids listed in the RED, only a few are residual
pyrethroids, and none are as economical as permethrin.  Further, the low
price of permethrin allows availability for lower income groups to
control public health pests in their homes and yards. 

SRRD Response:  The PIRTF did not include any data on consumer pesticide
product prices to support their contention.  The Agency does not have
access to consumer pesticide price data.  The Biological and Economical
Affects Division’s (BEAD) informal survey of local Home Depot and
Giant Food pesticide displays revealed that several alternative
pyrethroid active ingredients are available and are comparably priced. 
These alternative pyrethroid products included: lambda cyhalothrin,
cypermethrin, imiprothrin, esfenvalerate, tetramethrin, allethrin, and
prallethrin as active ingredients.

The PIRTF also states that Permethrin’s combination of qualities such
as persistency and repellency along with its efficacy
characteristics permit it to be used in a manner that reduces overall
pesticide use over time. 

SRRD Response:  The PIRTF did not include any data documenting
Permethrin's repellency characteristics.  The Agency does acknowledge
that permethrin is one of the few registered repellents for ticks and
mosquitoes on human clothing.

The PIRTF contends that compared to other residual pyrethroids,
permethrin has less chance of causing paresthesia if someone
accidentally comes in contact with permethrin.  Permethrin is one of the
very few residual pyrethroids without a cyano group, thought to be one
of the contributing factors to paresthesia reactions.

SRRD Response:  A paresthesia reaction is a sensation of tingling,
pricking, or numbness of a person's skin with no apparent long-term
physical effect, more generally known as the feeling of pins and needles
or of a limb being "asleep".   The Agency is aware that the use of some
pyrethroids (e.g. tefluthrin) are commonly known to cause paresthesia
reactions.   Although the pemethrin incident report, available in the
public docket OPP-2004-0385, does report the large majority of cases
resulted in minor effects to the skin (primarily rash, irritation,
itching), eyes (redness, pain, burning), headache, dizziness, nausea,
vomiting, and shortness of breath or difficulty breathing.  However,
acknowledges that compared to other pesticides, permethrin is much less
likely to result in serious or persistent medical outcome/conditions.

Registration Review of Pyrethroid Chemicals

The California Stormwater Quality Association (CASQA) and the CA
Regional Water Control Board, San Francisco Bay stated concern that the
pyrethroids are not scheduled for Registration Review until 2010, and
mitigation would not occur until 2011.  This pits municipalities in an
untenable position because they must comply with the Clean Water Act
immediately.  CASQA requested Registration Review be initiated
immediately for the pyrethroids, or a special review be initiated. 
Additionally, according to the Water Board, pyrethroids are anticipated
to be the cause of impaired water bodies, listed on the 2008 303(d)
list.  

SRRD Response:  The Permethrin, Resmethrin, Cypermethrin, Pyrethrins,
PBO, and MGK-264 Reregistration Eligibility Decisions were signed in
Spring/Summer 2006, and decisions for non-food pyrethroids are due in
2007 and 2008 (allethrin stereoisomers, tetramethrin, and sumethrin). 
Therefore, the 2010 date for registration review to begin for the
pyrethoid, pyrethrins, and synergists (PPS) group of chemicals allows
additional time for the risk mitigation and label changes identified in
these REDs to be incorporated. 

Further, in the recent PPS REDs, the Agency identified a number of
limitations in the reregistration of these chemicals, such as no
urban/residential model available to assess potential ecological risks
from residential uses; and an inability to assess (or compare)
ecological impacts from PPS chemicals as a group because a large
majority were registered after 1984.  

In order to address these limitations and allow the registration review
risk assessments to be more refined, there is an on-going effort several
years in advance to prepare for registration review of the PPS
chemicals, such as determine whether the pyrethroids share a common mode
of action; revise spray drift language for pyrethroid agricultural
labels; identify a model and appropriate scenarios for use in urban
run-off modeling; compile detailed use and usage information about the
PPS chemicals, both agricultural and residential uses; and
identification of data needs and possible group data call in. 
Additionally, the Agency is coordinating with the California Department
of Pesticide Regulation (CDPR), which is currently conducting its
reevaluation of pyrethroids.  The reevaluation includes calling in new
and additional data, which will be useful to the Agency’s registration
review process of the PPS chemicals.  These studies have not yet been
conducted or submitted to CDPR.  Therefore, the Agency does not believe
it would not be prudent to initiate the Registration Review of the PPS
chemicals any earlier.  

CASQA and the CA Regional Water Control Board, San Francisco Bay stated
that OPP needs initiate development of an urban run-off model as soon as
possible.  An empirical model should be used opposed to the mechanistic
model OPP typically uses.    

SRRD Response:  The Agency recognizes the need to identify a
screening-level model for urban pesticide uses and has begun to discuss
the state of urban modeling and the potential avenues for future
advances internally and with stakeholders.  Improvements in the
resolution of GIS databases may allow better representation of the
impervious and pervious portions of a typical urban landscape.  For
example, as it becomes more clean which uses are most likely to lead to
transport of pyrethroids to surface water, the conceptual model of how
urban transport should be simulated will be more focused.  

CASQA commented that U.S. EPA may be generating a “Data Call-In”
(DCI) for pyrethroids to provide data for future pyrethroids reviews. We
appreciate that U.S. EPA recognizes that data critical to managing risks
from pyrethroids is currently not available and that it intends to
require that pyrethroid manufacturers provide the needed data. Among
data needed for pyrethroids water quality management, we believe the
following information is high priority: data to support urban runoff
modeling, application instructions, and aquatic sediment data.  In
addition, the California Department of Pesticide Regulation (DPR) has
initiated a data call in process for pyrethroids called
“re-evaluation”. We anticipate that this process will generate a
substantial amount of information that would be useful to U.S. EPA. We
recommend that U.S. EPA coordinate with DPR in developing the DCI. We
ask U.S. EPA to request, obtain, and review all data submitted to
DPR.CASQA stands ready to provide formal support for U.S. EPA’s
request to review data submitted to DPR. 

SRRD Response:  The Agency appreciates the recommendation provided by
the CASQA, and is in the process of planning for the pyrethroid
registration review process, which may include a special group DCI for
the pyrethroids.  The Agency also recognizes that it needs to gain a
better understanding of the residential and urban application of
pyrethroids, to identify an urban run-off model, and more aquatic
sediment data.  The Agency is coordinating with the CDPR, and the two
organizations have agreed to share data.  

CASQA stated U.S. EPA has taken important steps toward protecting water
quality throughout its various reregistration processes. However, U.S.
EPA needs continued significant efforts to better integrate surface
water quality protection into its pesticide registration and regulatory
review programs. Coordination between U.S. EPA offices in reviewing
pesticide ingredients is essential to Clean Water Act implementation; it
also provides an appropriate method of meeting the Federal Insecticide,
Fungicide, and Rodenticide Act’s goal of preventing unreasonable
adverse impacts from pesticide use. The CA Regional Water Control Board,
San Francisco Bay submitted similar comments.

SRRD Response:  The Office of Pesticide Programs (OPP) agrees that
coordination is essential between OPP and the Office of Water.  In its
effort to plan for the upcoming registration review of the pyrethroid
case of chemicals, OPP has initiated discussions with OW to address
issues that affect both Offices.  

The CA Regional Water Control Board, San Francisco Bay Region included
steps to be taken in the near tern in their comments to the Agency.  The
steps include OPP completing a cumulative environmental risk assessment
for pyrethroids; completing an alternatives assessment that considers
both low risk and non-pesticide alternatives; completing a cluster
assessment for problematic outdoor urban insecticide application; and
assessing whether urban uses of pyrethroids pose unreasonable risks,
taking into account the above information and the cost of non-compliance
with the Clean Water Act.  

SRRD Response:  The Agency appreciates the suggestions provided by the
CA Regional Water Board, San Francisco Bay Region.  As stated above, OPP
is in the process of planning for the registration review of
pyrethroids, pyrethrins, and synergists chemicals.  As part of its
planning effort, OPP is working closely with CA DPR as its conducts its
reevaluation or pyrethroids, as well as coordinating with EPA Office of
Water.  As the planning progresses, OPP will discuss the feasibility of
conducting the assessments suggested by the Water Board above.  

 PAGE   

 PAGE   1