EPA 730-N-96-006.
£
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
. WASHINGTON, D.C. 20460
"... • . .OFFICEOF
. • PREVENTION, PESTICIDES AND
'..-'. TOXIC SUBSTANCES
. October 1, 1996
PESTICIDE REGULATION (PR) NOTICE 96-7
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for the Registration of
Pesticide Products '
•SUBJECT: .TERMITICIDE LABELING
This notice sets forth the Agency's policy with respect to certain
labeling statements and minimum product performance (5 year period) for soil
treatment termiticide products. -
j
I. BACKGROUND
Because of the highly specialized nature of termiticides, a number of
labeling issues have evolved over the years regarding: 1) limitations on
distribution, sale or use; 2) precautionary" statements; 3) environmental
hazards statements; 4) storage and disposal statements; 5) use directions; 6)
the minimum product performance of termiticide treatments; and 7) application
at less than .labeled rates. This notice describes the Agency's policies on
these issues for,current and future termiticide products. ' .
II. SCOPE
This notice addresses product labeling statements for currently
registered uses and future uses of soil treatment termiticide products. The
labeling statements addressed by the notice include labeling statements »
regarding environmental hazards, .exposure information•for construction
workers, retreatment, and use directions. This notice is not applicable to
fumigant type termiticides such as sulfuryl fluoride,and nitrogen, and dry
baits, such as hexaflumuron.
In addition,'this notice addresses questions about minimum product
performance and application at less than labeled rates., EPA believes that the
label changes; and policy clarifications set forth in this PR Notice will
reduce risk while maintaining the efficacy associated with currently
registered products.. Accordingly, failure of any registrant subject to this
notice to adopt the label changes set forth in this policy may result in the
issuance ,of a notice of intent to cancel or an enforcement action. . It should
be noted, however, that wherever there is a more protective existing label
requirement, the more protective requirement supersedes the PR Notice
provisions. ' ' '
, . ' /
Lastly, the Agency is announcing a new procedure for submission of new
termiticide registration applications and significant amendments to current
termiticide registrations that will ensure coordination with the Association
of Structural Pest Control Regulatory Officials (ASPCRO).
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at least 50% recycled fiber
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III. EFFECTIVE DATES ' ,
Registrants should make the changes specified in this notice on all
applicable termiticide products and submit an application for amendment to the
appropriate Product Manager in accordance with Section XII. of this notice.
All' products distributed or sold by registrants and supplemental registrants-
should bear approved labeling which is consistent with this notice and
complies with the Federal Insecticide,.Fungicide and Rodenticide Act (FIFRA)
by October 1. 1997. All products distributed or sold by any person after
October 1, 1999 should bear this same approved labeling. After these dates,
the Agency may either -issue a Notice of Intent to Cancel a product or bring
enforcement action against registrants or other persons distributing or
selling products bearing -labeling inconsistent with this notice.. Registrants
should submit their applications for amendment as soon as possible to ensure
adequate time for review and approval from EPA before the effective dates in
this notice. '•'..••
IV* EFFICACY ' , . '
A. MINIMUM PRODUCT PERFORMANCE
The current Agency policy (see Pesticide Assessment Guidelines,
Subdivision G, Product Performance, Section 95-12(b)(i)(C)) regarding
termiticides is that soil treatment termiticide products 'should demonstrate
efficacy for at least five years against termites. The most recent data from
the USDA Gulfport Mississippi Laboratory indicate that most currently
registered•products are effective for three to five or more years. In
addition, the information from the USDA Gulfport Mississippi Laboratory
supports the current five year termite soil treatment warranties required by
Federal housing agencies concerned with new construction.
The Agency believes that registration of a product demonstrating less '
than five (5) years of efficacy for control of termites is generally not
appropriate from a safety or efficacy standpoint, considering, the costs of
treatment and the potential damage that could occur. The Agency does not
believe that the homeowner should be subjected to such costly protection as
would occur with products that are only efficacious for one year. Such
products could, quite possibly,, pose unreasonable adverse effects to the
environment and/or humans because of higher risks than longer—acting ;
alternatives. The more frequent treatments required could result in greater
exposure and risk, or lower benefits, because of being less effective if not
retreated, or more expensive if retreated. ...
Thus, the Agency will generally not -grant a registration for a
termiticide that requires annual retreatment. The Agency will continue its
current policy of requiring that applications for registration of soil
'treatment termiticide products be supported by data showing a minimum of 5
years of efficacy which is accepted by the Agency, unless the applicant can :
demonstrate that the pesticide is either significantly less toxic than
currently registered pesticides or the benefits from the use of the pesticide
are much greater than currently registered alternatives • .
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Until more data can be gathered and evaluated regarding what the
longevity of termiticide treatments should be, the Agency'will consider
applications requesting registration of termiticide products on an individual ..
basis. However, in addition to the standard data package for termiticide
products and.the risk and benefit information just described, the Agency will
require additional•data on anticipated homeowner and/or applicator exposure
risks resulting from treatment and retreatment over the projected life-span of
the structure to be treated and/or retreated.'
B. MINIMUM APPLICATION RATE . • . '
.: • / ~^ . ' • .
Under Section 2(ee) of' FIFRA, a pesticide may be applied at any dosage,
concentration, or frequency less than that specified on the labeling, unless
the labeling specifically prohibits such a deviation.'. However, EPA has been ,
informed by state enforcement agencies of inadequate efficacy and unnecessary
retreatments resulting from termiticide applications at less than the labelled
rates-. Xn this regard some states have in accordance with FIFRA section 24(a)
regulated the use of termiticides to prohibit the application of less than the
specified dosage or concentration. Until now, the Agency has not officially
addressed the application of termiticides at less than the labeled rate. ..
EPA has always required efficacy data to be submitted by registrants to
• demonstrate that termiticides perform their intended function as claimed.. EPA
has reviewed such data prior to registration to assure that the benefits of
the use would outweigh the potential risks. .
.No efficacy data have been submitted by registrants or reviewed by EPA
. concerning use of termiticides at rates lower than the minimum rate specified
on the label. Consequently, EPA has no evidence that such lower rates would
result in adequate efficacy. Accordingly, EPA is concerned that registered
termiticides used at rates lower than those specified on the label may not
achieve adequate.benefits to counterbalance the risks from use.
'EPA is further concerned that application at rates lower than the .minimum
would likely necessitate more frequent applications which, in turn, would
increase the risks to applicators and users. Such increased risks, when
' balanced against lower or inadequate efficacy, -would likely make a product
unregisterable (or subject to cancellation). EPA realizes however, that'there
are significant differences between pre-construction and post-construction :
. treatment which affect the applicators ability to•apply the full label rate.
For the purposes of this PR Notice, pre-construction applications are defined
as those applications made prior to the finished grade being installed, and
post-construction applications are defined as those applications made after
the final grade is installed. There are often circumstances encountered in
post-construction treatment that make application at the full label rate
impossible or undesirable. These circumstances could include environmental
conditions such as the presence of a :well, structural, barriers that do not
allow application of the labeled volume, or construction elements that would
encourage a reduced volume. Treatment to the top of the fo'oting is sometimes
not po&sible because^of equipment limitations or the inordinate amount of
labor involved. ;
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In order to assure that termiticide products perform their intended
function, that the benefits of their use outweigh their risks, and that state.s
are*able to carry out enforcement necessary to protect the,public, EPA has
determined that, for pre-construct:lon applications, no termiticide should be
used at less than the dosage and/or concentration specified on the labeling.
Accordingly, registrants should add the following statement to the labeling of
tentuLticides: . v •
"PRE-CONSTRUCTION TREATMENT: DO NOX APPLY AX A LOWER DOSAGE AND/OR
CONCENTRATION THAN SPECIFIED ON THIS LABEL FOR APPLICATIONS PRIOR TO
INSTALLATION OF THE FINISHED GRADE."
EPA has also determined thcit for post-construction applications, the
dosage and/or concentration of use may be less than label rates. However,
states may continue to prohibit applications at less than label dosage and/or
concentration if they so choose.,
V. LIMITATIONS ON USE " .
Most currently registered termiticide products are not classified for
restricted use, but contain label statements limiting their, use to commercial
applicators. Registrants should replace the current statement on the labeling
of general use termiticide products intended for use by commerical
applicators, or individuals/firms licensed or registered by the state to apply
termiticide products, with the following statement: - .
"For use by individuals/firms licensed or registered by the state '
to apply termiticide products. States may have more restrictive
requirements regarding qualifications of persons using this
product. Consult the structural pest control regulatory agency of
your state,prior to use of this product."
Termiticide products, already classified for "Restricted Use" will remain
so classified and must bear the required restricted use statements on product
labeling. ,'•-•:
VX. PERSONAL PROTECTIVE EQUIPMENT STATEMENTS
Registrants of end-use termiticide products should make revisions
necessary to ensure that their product labeling contains.the current personal,
protective equipment (PPE) terminology described in this section.' An end-use
termiticide -product is a product for which the labeling bears instructions for
using or applying the product (as packaged and sold, or after dilution by the
applicator) for controlling termites. In general, PPE requirements for.
pesticide handlers should be based on the acute toxicity of the end-use
product, by route of entry, and the amount of expected exposure. Handlers,
under this guidance, are defined as persons directly exposed to a. pesticide,
such as mixers, loaders, and applicators. Registrants of end-use termiticide
products should refer to the acute toxicity data for the end-use product and
determine the PPE required based on that data. Additionally, the Agency
through the pesticide reregistration program may impose additional PPE and/or
engineering control requirements due to the toxicity of the active ingredient..
Such requirements will be imposed through Reregistration Eligibility Decision
documents.
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The following sample personal protective equipment statements are for
products with acute toxicity endpoints in the same acute toxicity category;
reflect the minimum requirements, based on the acute toxicity of the end-use
product, and expected exposure; and contain.acceptable terminology. Refer to
the footnotes for specific guidance on respiratory and ocular protection.,
A. Toxicity Category I. "Signal Word: DANGER ,(Add POISON + Skull and Cross-
bones if Toxicity Category I by oral, inhalation or dermal routes)
"All pesticide handlers (mixers, loaders, and applicators) must wear
long—sleeved coveralls worn over long—sleeved shirt and long pants,
socks, chemical—resistant'footwear, chemical—resistant gloves, ,
respiratory protection device1,and protective eyewear2."
B. Toxicity Category II. Signal Word: WARNING
"All pesticide handlers (mixers, loaders, and applicators) must wear
long-sleeved coveralls worn over a minimum of short-sleeved shirt and
. short pants, socks, chemical—resistant footwear, chemical—resistant
gloves, and protective eyewear2. In addition, all pesticide handlers-
must wear a respiratory protection device1 when handling the concentrate
'or when working in a non—ventilated space." '
C. Toxicity Categories III or IV. Signal Word: CAUTION
"All pesticide handlers (mixers, loaders, and applicators) must wear -
long—sleeved shirt and long, pants, socks, shoes, and chemical—resistant
. gloves-. In addition: all pesticide handlers must wear a respiratory
protection device1 when'working in a non—ventilated .space; all pesticide
_.. handlers must wear protective eyewear2 when working in a non-ventilated
space or when applying termiticide by rodding or sub-slab injection."
1 If the,inhalation Toxicity of the end-use.product is Category !• or II,
or if the Inhalation Toxicity of the end-use product is Category III or
.IV, but the termiticide is being applied in a non-ventilated space, then
one of the following respirator types and the appropriate Mine Safety
and Health Administration (MSHA)/National Institute.for Occupational
Safety and Health (NIOSH) approval number prefix must be indicated: (i)
Dust/mist filtering respirator with,MSHA/NIOSH approval number prefix
TC-21C; or (ii) Respirator with an organic-vapor removing cartridge and
a prefilter approved for pesticides with -MSHA/NIOSH approval number
prefix TC-14G; or (iii) Supplied-air respirator with MSHA/NIOSH approval
number prefix TC-19C or self-contained breathing apparatus (SCBA) with
MSHA/NIOSH approval number TC-13F. ' _ ,
2 Protective eyewear is goggles, a faceshield,. or safety glasses with
front, brow,- and temple protection. "Protective eyewear" is the term to
be used instead of-goggles and/or faceshield and/or shielded safety
^glasses. . •
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VII. PRECAUTIONARY STATEMENTS •
The Agency's current policy regarding precautionary statements is that
they apply to both the concentrate and any use dilution unless the registrant
provides data on the use dilution product which demonstrate lower toxicity
than the concentrate. For example, if a label states "Do not get in eyes or
on skin. Wear chemical-resistant gloves and protective eyewear. etc.," the
Agency means that a handler must abide by those precautions during handling of
the concentrate and during application .of the product diluted for use unless
specifically stated otherwise on the pesticide labeling.
Termiticide labels should be consistent with respect to precautionary
statements for applicators, bystanders, and pets. In order to standardize
termiticide labels so that they include precautions for each of these three
groups, the following additional precautionary statements should be added to
all termiticide labels that contain directions for subterranean use: ,
"When treating adjacent to an existing structure, the applicator must
check the area to be treated, and immediately adjacent areas of the.
structure, for visible and accessible cracks and holes to prevent any
leaks or significant exposures to persons occupying the structure.
People present or residing .in the structure during application must be
advised to remove their pets and themselves from the structure if they
see any signs of leakage.. After application, the applicator is required
to check for leaks.. All leaks resulting in the deposition of
termiticide in -locations other than those prescribed on this label must
be cleaned up prior to leaving the application site. Do not allow
people or pets to contact contaminated areas or to reoccupy contaminated
areas of the structure until the clean up is completed."
VIII. ENVIRONMENTAL HAZARDS STATEMENTS
Because termiticides are applied both indoors .and outdoors, product
labels are required to carry generic environmental hazard statements that may,-
in some cases, result in inappropriate information. For example, a statement
such as "Cover and incorporate spills" on a product intended .to be applied
only indoors would be inappropriate. Some termiticides may also carry a bee
toxicity statement. Such a statement would not be applicable to products
intended only to be injected into the soil or applied as a trench treatment.
Registrants should modify the Environmental Hazard statements on termiticide
products labeled for indoor use where existing Environmental Hazard statements
transmit inappropriate .or inapplicable information. Existing Environmental
Ha'zard statements should, however, be retained on termiticide products labeled
for other uses for which the Environmental Hazard statements are appropriate.
IX. ' STORAGE AND DISPOSAL STATEMENT'S
The Agency has proposed revised Storage and Disposal statements for
pesticide products (59 FR 6712, Feb. 11, 1994).. Until those statements are
issued in final form, the Agency will continue to require the standard storage
and disposal label language, as specified in P.R. Notices 83-3,, Label
Improvement Program for Storage and. Disposal Labeling Statements, and 84-1,
Clarification of Label Improvement for Farmworker, Safety and Pesticide Storage
and Disposal Instructions. . ,
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X. USE DIRECTIONS ' ','
A. RETREATMENT
. To .remain-consistent with the requirements, of FIFRA, registrants should
-add the following retreatment statement to their labels: ,,
"Retreatment for subterranean termites can only be performed if
there is clear evidence of reinfestatiori or disruption of the
barrier due to construction, excavation, or landspaping and/or
evidence of the breakdown of the termiticide barrier in the soil.
These vulnerable or. reihfested areas may be retreated in .
accordance with application techniques described in this product's .
labeling. The timing and type of these retreatments wi3,l vary,
depending on'factors such as termite pressure, soil types, soil
conditions anol other factors which may reduce the effectiveness of
the barrier.
Annual retreatment of the structure is prohibited unless there is
clear evidence that reinfestation or barrier disruption'has
occurred." , .
B. MIXING DIRECTIONS
To remain consistent with the requirements of- FIFRA,. -registrants should <
include clear and specific mixing directions for each application rate on the"
label. A table should be added to each label to make the label mixing
directions as simple as possible. Only the rates 'that are applicable to'the
product, at that site and target pest should be on the label. •
The following generic directions should be used in labeling each
termiticide for soil treatment: • . .
"Mix the termiticide use dilution in the following.manner: ,
1. Fill tank. 1/4 to' 1/3 full. ,
2. Start pump to begin by-pass -agitation and place end of treating
tool in tank to allow circulation through hose.
3. Add appropriate amount of (product name).
4. , Add remaining amount of water. . ' .
5. Let pump run and allow recirculatipn through the hose for. 2 to 3
•minutes. ' ' >
; To prepare a % water emulsion, ready for use, dilute
gallons of (product name) with gallons of water., To prepare
a ____'%' (for labels with moire than one rate) water emulsion, ready
.for.use, dilute gallons of (product name) with gallons
of water. For termite control operations requiring smaller
volumes use fluid ounces of (product name) per gallon of :
water to achieve a _% concentration.
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Application Volume; To provide maximum control and protection
against termite infestation apply the specified volume of the
finished water emulsion and active ingredient as set forth in the
directions for use section of this label. If soil will not accept
the labeled application volume, the volume may be 'reduced provided
there is a corresponding increase in concentration so that the
amount of active ingredient applied to the soil remains the same.
NOTE: Large reductions of application volume reduce the ability
to obtain a continuous barrier^ Variance is allowed when volume
and concentration are consistent with label directed rates and a
continuous barrier can still be achieved."
All labels should contain the following statement:
"Do not treat soil that is water saturated or frozen. Do not treat
while precipitation is occurring."
C. PRE-CONSTRUCTION SUBTERRANEAN TERMITE TREATMENT
1. TREATMENT OF FOUNDATIONS
Registrants should add the following statement to the pre-r
construction section of their label: . •
"PRE-CONSTRUCTION TREATMENT: DO NOT APPLZ AT A LOWER. DOSAGE
AND/OR CONCENTRATION THAN SPECIFIED ON THIS LABEL FOR APPLICATIONS
PRIOR TO THE INSTALLATION OF THE FINISHED GRADE.
When treating foundations deeper than 4 feet, apply the • , .
termiticide as the backfill is 'being replaced, or if the
construction contractor fails to notify the applicator to permit
this, treat the foundation to a minimum depth of 4 feet after the
backfill has been installed. The applicator must trench and rod
into the trench or trench along the foundation walls and around
pillars and other foundation elements, at the rate prescribed from
" grade to a minimum depth of 4 feet. When the top of the footing
is exposed, the applicator must treat the soil adjacent to the
footing to a depth not to exceed the bottom of the footing.
However, in no case should a structure be treated below the
footing."
D. POST-CONSTRUCTION SOIL TREATMENT
•1. TREATMENT OF FOUNDATIONS - '
Treatment to the top.of the footing is sometimes not possible in
post-construction soil treatment because of equipment limitations or the
inordinate amount of labor involved. Also, termite activity is ..
generally limited to the upper four (4) feet of soil. The following
statements should be'added to the post—construction soil treatment
section of all termiticide labels: • •
"POST-CONSTRUCTION TREATMENT: For,applications made after the
final grade is installed, the applicator must trench and rod into
the trench or trench along the foundation walls and around pillars
and other foundation elements, at the rate prescribed .from grade
to the top of the footing. When the footing is more than four (4)
feet below grade, the applicator must trench and rod into the
trench or trench along the foundation walls at the rate prescribed
to a minimum depth of four feet. The actual depth of treatment
will vary depending on soil type, degree of compaction, and
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location of termite activity. When the top of the footing is
exposed, the applicator must treat the soil adjacent to the
footing to a depth not to exceed the bottom of the footing.
However, in no case should a structure be treated below the
footingi"
2. CRAWL SPACES ,
The wording used on labels dealing with overall crawl space
treatment must- indicate precisely where and how overall soil treatment
may be applied in crawl spaces. To provide standardized labeling for
treating crawl spaces (both accessible and inaccessible'), the following
standardized wording for treatment of crawl space areas should be used.
a. Accessible Crawl Spaces .
"For crawl spaces, apply vertical termiticide barriers at
the rate of>4 gallons of.emulsion per- 10 linear feet per
foot of depth from'grade to the top of the footing, or if
the footing is more than 4 feet below grade, to a minimum
depth of 4 feet. Apply by trenching and rodding into the
trench, or trenching. Treat both sides of foundation and
around all piers and pipes. Where physical obstructions,
such as concrete walkways adjacent to foundation elements,
prevent trenching, treatment may be made by rodding alone.
When soil type and/or conditions make trenching prohibitive, •
rodding may be used. When the top of the footing is
exposed, the applicator must treat the soil adjacent to. the
footing to a depth not to exceed the bottom of the footing.
Read and follow the mixing and use direction section of the
label if situations are, encountered where the soil will not . :
accept the full -application volume.
,1). Rod holes and trenches must not extend below the
bottom of the footing. • . • .
2). Rod holes must be spaced so as to achieve a continuous
chemical barrier but in no.case more than 12 inches.
apart. '',•'•' . .
s ' f ' • •
, 3). Trenches, must be a minimum^ of 6 'inches deep or to the
bottom of the footing, whichever is less, and need not
be wider than 6 inches. When trenching in sloping
. (tiered) soil, the trench must be stepped to ensure
adequate distribution .and to prevent termiticide from
running off. The. emulsion must be mixed with the soil
as it is. replaced in the trench.
4). when tre'ating crawl spaces, turn of f the air circulation
system of the structure until application has been completed
and all termiticide has been absorbed by.the soil."
b. Inaccessible Crawl Spaces • .
"For inaccessible interior areas, such as areas where there
is insufficient clearance between floor joists and ground
surfaces to allow operator access, excavate, if possible,
and treat according to the instructions for accessible crawl
spaces. Otherwise, apply one, or a combination of the
following two methods. .
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10 .
1). To establish a horizontal barrier, apply to the soil
surface, 1 gallon of emulsion per 10 sq. ft. overall
using a nozzle pressure .of less.than 25 p.s.i. and a
coarse application nozzle (e.g., Delavan Type RD.
Raindrop, RD-7 or larger, or Spraying Systems Co.
8010LP TeeJet or comparable nozzle). For an area that
cannot be reached with the application wand, usie one
or more extension rods to make the application to the . <
soil. Do not broadcast or powerspray with higher
pressures. . -
2). To establish a horizontal barrier, drill through-the
foundation wall or through the. floor above and treat the
" soil perimeter at a rate of 1 gallon of emulsion, per 10
square feet. Drill spacing must be at intervals not to
exceed ,16 inches. Many states have smaller intervals so
check state regulations which may apply. .
When treating crawl spaces, turn off the air circulation system.of
the structure until application has been completed and all
termiticide has been absorbed by the soil."
Because overall surface application may increase indoor air
concentrations of termiticides, the Agency has required registrants with these
use patterns on their product label to submit air monitoring data or relevant
information to assess the risk to applicators and inhabitants from inhalation
exposure. Accordingly, the Agency will generally require
registrants/applicants applying to add these uses" to currently registered
termiticide products or applying to register new products with .these uses to
use the above standard labeling language and to submit air monitoring data or
relevant information to assess the risk from exposure via the respiratory
route to applicators and inhabitants. Such labeling and data must be accepted
by the Agency before applications for these uses will be approved. . ,
Registrants who have currently registered products with these use
patterns on their label shpuld submit an amended application to add the above
standard language to the label. No additional data are required for these
registrants, at this time, if they have already submitted acceptable air
monitoring data or exposure information.
E. TREATMENT OF VOIDS
The Agency requires that, termiticide product labels provide clear and
specific instructions for the treatment of different types of structural
voids. In order to provide more adequte treatment of voids and to remain
consistent with the requirements of FIFRA, registrants should adopt the
following label language on all termiticide product .labels intended for
treatment of voids: , , .
"Drill and treat voids in multiple masonry elements pf the structure
extending from the structure to the soil in "order to create a continuous
treatment barrier in the area to be treated. Apply at the rate of 2
gallons of emulsion per 10 linear feet of footing using a nozzle
pressure of less than 25 p.s.i. When using this treatment access holes
must be drilled below the sill plate and should be as close as possible
to the footing as is practical. Treatment of voids ±n block or rubble
.foundation walls must be closely examined: Applicators must inspect
areas of possible runoff as a precaution against application leakage in
the treated areas. Some areas may not be treatable or may require
mechanical alteration prior to treatment. .
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All leaks resulting in the deposition of termiticide in locations other
than those prescribed on this label must be cleaned up prior to leaving
' the application site. Do not allow people or pets to contact
contaminated areas or to reoccupy the contaminated areas of the
structure until the clean up is completed."
It.should be .noted that newly constructed buildings may contain rigid
foam insulation. If the registrant intends for its, product to be used in
voids containing rigid foam insulation, then use directions must be provided
on the label. If the registrant does not intend for its product to be used on
these systems, then the label should prohibit such use with the following
statement.
"Not for use in voids insulated with rigid foam."
The Agency also encourages more training of applicators in the treatment
of different types of structural voids and encourages national and state pest
cpntrol associations, termiticide registrants, State Cooperative Extension
Services, and State Lead Agencies to continue to provide training and
materials in these areas. . •
P. FOAM TREATMENT
Foam application is a recent innovation enabling volumetric treatment of
certain inaccessible voids. It has been found to be useful in treating areas
where, conventional application may not give acceptable distribution of an
aqueous emulsion. These sites would include situations such as sub-slab
treatments where the fill has settled, and voids in and behind fireplaces,
veneers, piers, etc. ! .
Most current labels give dilution directions only for water and provide
treatment information in gallons per square feet. Because foam applications
involve the vise of foaming agents other than water, termiticide labels must
bear specific instructions for use of such agents or such use constitutes a
misuse pursuant to section 12 of FIFRA. Registrants must have specific rates
for using foam or liquid, including proper dosage and dilution, incorporated
into the Directions for Use'under post-construction treatments. The sites of
, application where foam treatment is appropriate, recommended.expansion ratios
for .each site, and the methods of application must be provided. The. labels
must include an explanation of what an expansion ratio actually is; meaning
how many gallons of foam are required to move one gallon of termiticide
solution. Also there must be an explanation of how to determine the expansion
ratio by calibration-of the foaming equipment. Also, the label must indicate
what the desired ratio would'be to yield effective delivery of their product.
Generally, the Agency recommends that the termiticide solution be applied with
.at least 75% of the labeled rate delivered with typical liquid.application.
The remaining 25% or less may be delivered to appropriate areas, such as
hollow voids, beneath concrete slabs, and earth-filled porches,, using foam- '
application. "
Registrants should develop language of their own which follows the above "
guidelines or add the following label statement which addresses foam treatment
to their labels:
"FOAM APPLICATIONS: The emulsion may be converted to a foam and the
foam used to control or prevent termite infestations.
'. Depending on the circumstances, foam applications may be used alone or
in combination with liquid emulsion applications. Applications may be"
made behind veneers, piers, chimney bases, into rubble foundations, into
block voids or structural voids, under slabs, stoops, porches, or to,the
soil in crawlspaces,-and other similar voids.
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Foam and liquid application must be consistent with volume and active
ingredient instructions in order to ensure proper application has been
made. The volume and amount of active ingredient are essential to an
effective treatment. At.least X% (fill in the correct number) of the
labeled liquid emulsion volume of product must be applied, with the
remaining percent delivered to appropriate areas using foam application.
Refer to label and use recommendations of the foam manufacturer and the
foaming equipment manufacturer. .
Foam applications are generally a good' supplement to liquid treatments .
in difficult areas r but may be used alone in difficult spots."
Registrants applying to add these uses to currently registered
termiticide products or to register new products with these uses should
incorporate the above instructions or develop language of their own which
follows the above guidelines. Product performance data are required to
support new label uses unless adequate distribution data are provided, with the
submission. Such data will be-reviewed by the Agency in light of the
Pesticide Assessment Guidelines, Subdivision G, Product Performance, Section
95-12(b)(i)(C), which states that soil treatment termiticide products should
demonstrate efficacy for at least five years (Refer to Section IV. Efficacy).
Such labeling and,data must be accepted by the Agency before applications for
these uses will be approved. . , • • " .
Registrants who currently have registered products With these use
patterns on their label should submit an amended application to add the above
standard language or language they developed which follows, the above
guidelines-to the label.. No additional data are required for these . • .
registrants, at this time, if they have already submitted acceptable
data/information. • . .
G. TREATMENT AROUND WELLS OR CISTERNS . , •
To remain consistent with the. requirements, of FIFRA,.registrants should
have specific instructions for treatment of structures that contain wells or
cisterns which address the following general guidelines. Treatment
restrictions on structures which contain a cistern should be limited to a
cistern in use or in usable condition. Structures which contain cisterns
which have been permanently disabled may be treated by normal methods. For
wells, the treatment technique(s) specified must consider the proximity of the.
well to the structure, soil type, and the characteristics of the termiticide.
The applicator should be instructed to take these and other site specific
conditions into consideration when selecting a treatment method. The label .
should refer the applicator to state, county, and local authorities, including
the state Wellhead Protection Program, for good practices .to determine proper
treatment procedures relating to factors such as water table, soil conditions,
etc. The treated backfill technique may be permitted to allow treatment of a
structure when a well is within, adjacent, or near the structure.
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To remain consistent with the requirements of .FIFRA, registrants should
add the following specific label statement which addresses treatment around
wells or cisterns. • .
"Do not contaminate wells or cisterns.
"STRUCTURES WITH WELLS/CISTERNS INSIDE FOUNDATIONS
Structures that contain wells or cisterns within the .
foundation of a structure can only be treated using the following
techniques: •
(1) Do hot treat soil while it is beneath or within the foundation or
along the exterior perimeter of a structure that contains a well
or cistern. The treated backfill method must be used if soil is
removed and treated outside/away from the foundation. The treated
backfill -technique, is described as follows:
(a) trench and remove soil to be treated onto heavy plastic
sheeting or similar material or into a wheelbarrow.
(b) treat the soil at the rate of 4 gallons of dilute emulsion
, per 10 linear feet per foot of depth of the trench, or 1
gallon per 1.0 cubic feet of soil. See "Mixing Directions"
section of the label. (If Mixing Directions are-not already
on the label, provide directions in this section.) Mix
thoroughly into the soil taking care to contain the liquid
and prevent runoff or spillage. .
(c) After the treated soil has absorbed the diluted emulsion,
replace the soil into the trench.
(2) Treat 'infested and/or damaged wood in place using an injection
technique such as described in the "Control-of Wood Infesting
Insects" section of this label. . . •
STRUCTURES WITH ADJACENT WELLS/CISTERNS '
'• ,., AND/OR OTHER WATER BODIES -
Applicators must inspect all structures with.nearby water sources
such as wells, cisterns, surface ponds, streams, and other bodies of
water and. evaluate, at a minimum, the'treatment recommendations listed '
below prior to making an application. ' '
(1) Prior to treatmentf if feasible, expose the water pipe(s) coming
from the well to the structure, if the pipe(s) enter the structure
within 3 feet of grade.
(2). Prior to,treatment applicators are advised to take precautions to
limit the risk of applying the.termiticide into subsurface drains
that could empty into any bodies of water. These precautions
include -evaluating whether application of the termiticide to the
top of the footer may result in contamination of the subsurface
drain. Factors such as depth to the drain system and soil type
and degree of compaction should be taken into account in
determining the depth of treatment.
(3) When appropriate (i.e., on the water side of the structure), the
•treated backfill technique (described above) can also be used to
minimize off-site movement of termiticide."
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H. PLUGGING OP HOLES .
For safety reasons all exterior holes and accessible drilled holes in
commonly occupied areas into which material has been applied must be plugged. ,
To remain consistent with the requirements of FIFRA, registrants of currently
registered termiticide products should add the following statements to the
product label:
"All holes in commonly occupied areas into which material has been
applied must be plugged. Plugs must be of a non-cellulose material or
covered by an impervious, non-cellulose material." .
I. COVERING TREATED SOIL . . .
The Agency no longer requires the label statement "cover treated soil
with a layer of untreated soil'! and this statement has been deleted on most
termiticide labels. This statement was originally required due to the cpncern
for exposure to certain termiticides such as. chlordane and heptachlor.
Because all termiticide products containing these active ingredients have been
cancelled, the Agency believes this statement is no longer necessary to •
prevent adverse health effects and may in fact limit the efficacy of all
currently registered products. To remain consistent with the requirements of
'FIFRA, registrants should delete this statement from all termiticide products.
. J. EXPOSURE INFORMATION FOR CONSTRUCTION WORKERS
EPA does not have any information demonstrating that a precautionary
statement informing construction workers to wear protective clothing during or
subsequent to pre-construction termiticide applications is necessary. In
general, construction .personnel or other individuals on-site during or
subsequent to a pre-c,onstruction treatment application are neither directly
nor frequently exposed to the- pesticides being applied and, therefore, are
generally considered not to be at risk. However, to ensure that construction
personnel and other individuals are not exposed, to termiticides during or
subsequent to treatment, the Agency believes that label precautions are '
necessary. Accordingly, to remain" cpnsistent with the requirements of FIFRA,
the following-statement should be added to the label of all termiticide. •
products with pre-construction application use directions:
"Prior to each application, applicators must notify
the general contractor, construction superintendent, 1
or. similar responsible party, of the intended
termiticide application and intended sites of .
application and instruct the responsible person to
notify construction workers and other individuals to
leave the area to be treated during application and
until the termiticide is absorbed into the soil."
K. VARIABLE CONCENTRATIONS '
The Agency encourages termiticide registrants, pest control companies,
national and state pest control associations, state Cooperative Extension
Services, State Lead Agencies and others responsible for applicator training
to emphasize the importance of training applicators in the use of- proper
application volumes, dosages, and uniform distribution to control all species
of subterranean termites in.their applicator training plans and in their
research and development plans. Termiticide product registrants, pest control
companies, and others responsible for applicator training should incorporate
data from USDA's starkville,-Mississippi Laboratory, as well as regional
research centers, together with recommendations of appropriate state
entomologists, in the training of applicators in order to facilitate their ,
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choice.of the proper concentration where variable concentrations exist on the
termiticide product label. '
The Agency is also receptive to the generation of data supporting
variable concentrations and appropriate label provisions regarding variable
concentrations. In addition, the Agency encourages the development of
information and label provisions regarding the efficacy of such treatments in
different soil types.
'. However, any change in concentration will likely affect the product's
efficacy and the duration of the efficacy. Therefore, product performance
data to support use of lower concentrations than those currently specified on
the label must be submitted to the Agency with an application to amend the
product registration to add those lower concentrations (refer to Section
XII.). Such data will be reviewed by the Agency in light of the Pesticide
Assessment Guidelines, Subdivision G, Product Performance, Section 95-
12(b)(i)(C), which states that soil treatment termiticide products should
demonstrate efficacy for at least five years (Refer'to Section IV. Efficacy).
Such labeling and data must be accepted by the Agency before applications for
these uses will be approved. , •
L. FORMOSAN TERMITES .
The Agency encourages:termiticide registrants, pest control companies, •
national and state 'pest control associations, State Cooperative Extension
Services, State Lead Agencies and others responsible for applicator training
to emphasize the importance of training applicators in the control of Formosan
termites. Applicators should be instructed in the. use of proper•application
volumes, dosages and uniform distribution to control Formosan termites in
their applicator.training plans and in their research arid development plans in
areas where Formosan termites are known or suspected to occur. In this
regard, considerable data concerning application rates for Formosan termites
and other types of termites are well documented by the United States
• Department of Agriculture's Forest Service (USDA-FS). USDA-FS can provide
such data to interested parties. Requests for such, data should be sent to:
USDA-FS, Southern Research Station • , .
P.O. Box 928 ' '
Starkville^ Mississippi 39760-0928 ,
Street .Address: , .
201 Lincoln Green
Starkville, Mississippi 39759 '
Phone Number: •.'•...
601-325-0199 -
Because application rates and method of control for the treatment of
Formosan termites may differ from current labeling, any registrant adding
Formosan Termite Treatment to his/her product label or seeking to register a
new product for Formosan Termite Treatment may have to submit applicator
exposure and pos-sibly air monitoring data to the Agency. Registrants
contemplating adding this use pattern to their product label should consult •-'
with the .A.gency Product Manager for guidance prior to submitting their
application. • • '
M. PLENUM CONSTRUCTION -
The Agency's policy with regard to plenum construction is that label
directions for use in plenum construction will be the responsibility of the
individual registrant, subject to Agency approval. ;However, registrants
should be aware that they should also .contact the Agency to determine any data
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needed to support application to such areas. For-example", because these
treatments are likely to increase air concentrations, adequate air monitoring
data or relevant information to assess the risk from exposure via the
respiratory route to applicators and inhabitants must first be submitted by
the registrant and accepted by the Agency. •
At a minimum, labels which include directions for application in plenum
airspaces should include the following standard language:
"When treating plenums, turn off the .air circulation system of the
structure until application has been completed and all termiticide has
been absorbed by the soil."
Registrants applying to add these uses to currently registered
termiticide products or to register new products with these uses.should use
the above labeling statement and submit air monitoring data or relevant
information to assess the risk from exposure via the respiratory route to
applicators and inhabitants. Such labeling and data must be accepted by the
Agency before applications for these uses will.be approved.
Registrants who have currently registered products with these use
patterns on their label should submit an amended application to add .the above
standard language .to the label. No additional data are required for these
registrants, at this time, i£ they have already submitted acceptable air
monitoring data or exposure information.
/
XI. COORDINATION WITH THE ASSOCIATION OP STRUCTURAL PEST -
CONTROL REGULATORY OFFICIALS (ASPCRO)
Effective as of.the date of this notice, the Agency requests that
registrants submit a copy of the.proposed label and the relevant efficacy data
for any new termiticide product or .for any significant amendment to a •
currently registered termiticide product, such as a change in concentration or
method of .application, to the Association of Structural Pest Control
Regulatory Officials (ASPCRO) at the same time the application is 'submitted to
the Agency. This will allow ASPCRO the opportunity to review the pertinent
portions of the proposed registration or amendment and communicate any
concerns or, questions they have regarding the proposed' registration or
amendment to the Agency and the registrant in the early stages of the
registration process and to provide sufficient time for resolving any issues
prior to a registration decision.
ASPCRO-will designate 3 to 5 state officials to serve on a Termiticide
Review Committee whose function will be 'to review the proposed
registrations/amendment's. ASPCRO agrees to appoint to this committee only-
representatives from those states whose pesticide laws provide the ability to
maintain the integrity of Confidential Business Information (CBI) received
with the submission. ASPCRO and its representatives assigned to this •
committee agree that they will sign and abide by confidentiality agreements
provided by the registrants with respect to. any information provided to them
that is not available to the general public under federal law, and' is clearly
marked as CBI. Further, no information which later becomes public shall be
covered by these agreements. ASPCRO representatives agree to sign such
agreements prior to receiving any information under this PR Notice. ASPCRO
will review the submission and submit written recommendations to the Agency •
within 90 days of their receipt of the submission. ASPCRO's recommendations
will be one of the factors considered in the Agency's decision making process.-
The specifics of this coordinated review process will be further detailed in a
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Memorandum of Understanding (MOU) between the Agency and ASPCRO. The Agency
believes that the involvement of ASPCRO in the review process will speed
review of 'amendments and applications and therefore strongly encourages
registrants to submit applications to ASPCRO. Copies of termiticide
applications should be sent to the .following address:
' . " * /• ' ' , '
ASPCRO Termiticide Review ' .
c/o George Saxton . .
Office of the Indiana State Chemist
Purdue University .
1154 Biochemistry Building
West Lafayette, IN'47907-1154
ATTN: Jim Wright
•XI I.* PROCEDURES
All modifications to termiticide product labeling should be submitted! as
proposed amendments on the EPA application form 8570-1. In Section I. of the
application, indicate the Registration Division (RD) Product Manager (PM) for
the product^ In ..Section II. of the application, make the following notation:
"Amendment to product label in accordance with PR Notice 96-7 on
Termiticides." The amendment should be accompanied by five (5)
copies of the proposed revised labeling. Applications should be sent to the
following address:
For USPS Submissions: ,
Document Processing Desk (AMEND)
Office of Pesticide Programs (75Q4-C) "
U.S. Environmental Protection Agency , :
401 M Street, S.W.
Washington, D.C. 20460-0001 . .
For Courier Deliveries:
Office of Pesticide Programs
Document Processing Desk (AMEND)
Room 266A, Crystal Mall 2 .
1921 Jefferson Davis Highway -...-.
Arlington, Virginia 22202
XIII. FOR FURTHER INFORMATION
You may call Rebecca S. Cool, Insecticide-Rodenticide Branch, RD at (703)
305-7690 if you have any questions^about fchis notice. *
, Director
sion
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Office of Pesticide Programs
Fall 1996 Labeling Alert Number 2
TO: Manufacturers, Formulators, Producers and Registrants of
Pesticide Products
FROM: The Labeling Unit 7505W
Protecting Life Through Better Pesticide Labeling
SUBJECT: Supplemental Distribution (Private labels)
BACKGROUND: Regarding Supplemental Distribution, 40 CFR 152.132(d), provides that
the label for the distributor product must be the same as that of the basic product, except that:
(1) The product name of the distributor product may be different (but may not be misleading);
(2) The name and address of the distributor may appear instead of that of the registrant;
(3) The registration number of the registered product must be followed by a dash, followed
by the distributor's company number (obtainable in advance from the Agency);
(4) The establishment number must be that of the final establishment at which the product
was produced; and
(5) Specific claims may be deleted, provided that no other changes are necessary.
ALERT: You must ensure that labeling statements made on a distributor product are
identical to those made for the EPA-reviewed and approved basic product labeling.
Distributors who seek to revise label statements must work through the product registrant to
make changes to the base product label. Only after the base product bears approved
changes can the distributor product label reflect those changes. The Agency will generally
permit, minor formatting differences, such as different label colors and backgrounds, type
styles or label sizes, provided the text, prominence and location of labeling statements on the
distributor product are identical (subject to the exceptions listed above) to that of the basic
product. If you have questions about the acceptability of a specific label formatting change,
you should contact the EPA Product Manager responsible for the registration of the product.
It is important to note that it is the responsibility of both you, the registrant and the
supplemental distributor to ensure that the distributor label is in compliance with the
requirements of FIFRA and EPA's implementing regulations.
Contact the Labeling Unit if you have any questions about this issue. Phone:
703-308-8641 FAX: 703-308-8369
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