United States Prevention, Pesticides EPA 738-R-96-017
Environmental Protection And Toxic Substances January 1997
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Trichlorfon
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%PRo^
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case 0104 which
includes the active ingredient trichlorfon. The enclosed Reregi strati on Eligibility Decision
(RED) contains the Agency's evaluation of the data base of this chemical, its conclusions of
the potential human health and environmental risks of the current product uses, and its
decisions and conditions under which these uses and products will be eligible for
reregi strati on. The RED includes the data and labeling requirements for products for
reregi strati on. It may also include requirements for additional data (generic) on the active
ingredient to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses is due 90 days from the
date of receipt of this letter. The second set of required responses is due 8 months from
the date of receipt of this letter. Complete and timely responses will avoid the Agency
taking the enforcement action of suspension against your products.
Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act of 1996 ("FQPA") became effective, amending portions
of both the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did not
take into account any changes in tolerance assessment procedures required under FQPA. To
the extent that this RED indicates that a change in any tolerance is necessary, that
determination will be reassessed by the Agency under the standards set forth in FQPA before
a proposed tolerance is issued. To the extent that the RED does not indicate that a change in a
tolerance is necessary, that tolerance too will be reassessed in the future pursuant to the
requirements of FQPA.
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If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregi strati on Division representative
Barbara Briscoe at (703) 308-8177. Address any questions on required generic data to the
Special Review and Reregi strati on Division representative Dana Lateulere at (703) 208-8044.
Sincerely yours,
Lois Rossi, Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE RE REGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3 APPLICATION FOR RE REGISTRATION OR "8-MONTH RESPONSE"-You
must submit the following items for each product within eight months of the date of this
letter (RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in
item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and
current regulations (40 CFR 156.10) and policies. Submit any other amendments
(such as formulation changes, or labeling changes not related to reregistration)
separately. You may delete uses which the RED says are ineligible for reregistration.
For further labeling guidance, refer to the labeling section of the EPA publication
"General Information on Applying for Registration in the U.S., Second Edition,
August 1992" (available from the National Technical Information Service, publication
#PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the
EPA identifier (MRID) numbers. Before citing these studies, you must make sure
that they meet the Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product
must comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard
certified limits (see 40 CFR §158.175) or (2) provide certified limits that are supported
by the analysis of five batches. If you choose the second option, you must submit or
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cite the data for the five batches along with a certification statement as described in 40
CFR §158.175(e). A copy of the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete
and sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR RE REGISTRATION (8-MONTH RESPONSES)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
Bv express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are
not complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregi strati on determination within 14 months after the RED
has been issued.
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United States Prevention, Pesticides EPA-738-F-96-017
Environmental Protection And Toxic Substances ¦ • January 1997
Agency (7508W) - ¦
&EPA R.E.D. FACTS
Trichlorfon
Pesticide All pesticides sold or distributed in the United States must be
Reregistration registered by EPA (the Agency), based on scientific studies showing that
they can be used without posing unreasonable risks to people or the
environment. Because of advances in scientific knowledge, the law
requires that pesticides which were first registered before November 1,
1984, be reregistered to ensure that they meet today's more stringent
standards.
In evaluating pesticides for reregistration, the Agency obtains and
reviews a complete set of studies from pesticide producers, describing the
human health and environmental effects of each pesticide, The Agency
develops any mitigation measures or regulatory controls needed to
effectively reduce each pesticide's risks. The Agency then reregisters
pesticides, that can be used without posing unreasonable risks to human
health or the environment.
When a pesticide is eligible for reregistration, the Agency explains the
basis for its decision in a Reregistration Eligibility Decision (RED)
document. This fact sheet summarizes the information in the RED
document for reregistration case 0104, Trichlorfon.
Use Profile Trichlorfon is an insecticide* that historically has been used to control
indoor and outdoor pests on agricultural, non-agricultural, residential and
commerci al sites. Through the RED process many uses have been
voluntarily canceled. Those that are supported through reregistration
include indoor non-food uses in residential and commercial institutions to
control, among other pests, flies, roaches and ants. The outdoor uses of
trichlorfon include treatment to ornamentals, golf courses and residential
turf to control various Lepidopteran larvae pests. Also, trichlorfon may be
used in various agricultural farm premise sites, such as kennels, chicken
houses, dairy milking stalls and barns, but only in areas inaccessible to
animals; these uses are predominantly for fly control. Trichlorfon may also
be used as a mound treatment to control Harvester ants.
Trichlorfon may be formulated as a soluble powder, granular or bait.
Soluble powders may be applied through ground boom sprayers and hand-
held sprayers to turf and ornamentals or indoor spot treatments. Aerial
application is prohibited for trichlorfon. All turf uses of trichlorfon now
must include pre-treatment watering-in. The application of granular
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formulations with chest-mounted rotary spreaders are prohibited based on
potential health risks. Granular baits are used both indoors and outdoors by
scattering in problem areas. The bait is also used as a mound treatment to
control Harvester ants. The bait can no longer be used on residential lawns
and all indoor residential use of bait must be through a prepackaged child-
resistant bait station. '
Regulatory
History
Trichlorfon was first registered as a pesticide in the U.S. in 1955 by
USDA. The Agency issued a Registration Standard for trichlorfon in June
1984. A 1991 Data Call-In (DCI) required additional data. Currently, 24
trichlorfon products are registered.
Human Health
Assessment
Toxicity
In studies using laboratory animals, trichlorfon generally has been
shown to be of moderate acute toxicity. It is moderate by the oral route and
has been placed in Toxicity Category II (the second highest of four
categories) for this effect. It is slightly toxic by the dermal route, Toxicity
Category III and practically non-toxic by the dermal route, Toxicity
Category IV. Trichlorfon causes moderate eye irritation, Toxicity Category
HI. It is classified as a moderate contact allergen with skin effects classified
as Toxicity Category IV.
Dietary Exposure
People may be exposed to residues of trichlorfon through the diet.
Tolerances or maximum residue limits have been established for many
agricultural and livestock commodities (please see 40 CFR 180.198 and
186.2325). The Agency is proposing to revoke all tolerances for trichlorfon
except cattle meat, cattle fat and cattle meat by-products. The registrant is
not supporting the domestic use of the cattle treatment but will support the
tolerances needed for the continuing importation of trichlorfon treated cattle
products. In order to reassess the tolerances additional residue data are
required within 24 months. Residue and metabolism data are required to
reassess the tolerances, specifically, dermal metabolism in cattle (171-4b),
magnitude of the residue for meat (171-4j), residue analytical method
(171-4d), and storage stability (171-4e).
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to trichlorfon during and after normal use of
all formulations. The Agency has determined that there are unacceptable
risks posed to handlers in several use scenarios. In response to these
concerns, the registrant voluntarily canceled sod farm use and will prohibit
aerial application and application of granular formulations with chest-
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mounted, rotary spreaders. Upon recommendation by the Agency, the
registrants have agreed to voluntarily cancel domestic lawn use with the
bait formulations." Also, indoor residential use of the bait formulation is
prohibited unless housed in prepackaged bait stations. Additional PPE was
required for handlers in other use scenarios.
Human Risk Assessment .
Trichlorfon generally is of moderate acute toxicity and has been
classified as a Group E, no evidence of carcinogenicity for humans. All
trichlorfon food and feed crop uses have been voluntarily canceled! The
only dietary exposure to trichlorfon residues in foods will be through
imported cattle meat, cattle fat and cattle meat-by-products. However, the
theoretical maximum residue contribution (TMRC) to the two highest
exposed subgroups, children (1-6 years old) and non-nursing infants (< 1
j year old) is relatively low, representing 14.33% and 7.32% of the RfD,
respectively. These estimates indicate the import of trichlorfon treated
cattle products does not present a chronic dietary risk.
The acute dietary exposure was estimated for the import of trichlorfon
treated cattle using established tolerances and was determined to be very
low. The estimated Margins of Exposure (MOEs) were greater than 10,
suggesting that there is little likelihood of an appreciable acute dietary risk
¦ from the import of trichlorfon treated cattle products.
The Agency has determined that there is a concern for exposure to
children and pets from the indoor residential uses of the bait formulations.
In response, the Agency is requiring that all baits formulated for use inside
residential dwellings must be housed in child-resistant bait stations. Baits
not housed in child resistant packaging must include label statements
restricting use from indoor residential areas.
The Agency has determined that there are mitigatable risks associated
with mixer and loaders who handle the soluble powder formulation to
support typical area (40 acres per day) application to turfgrass. The risk can
be adequately mitigated with the additional PPE of chemical resistant
gloves. Also, the risk to commercial mixers/loaders/applicators handling the
| granular formulation for application to turfgrass using push-type spreaders
could be adequately mitigated with the additional PPE of double-layer
body wear and chemical resistant gloves. The Agency also determined that
there was unacceptable risk posed to handlers in several other exposure
scenarios. In response to these concerns, the registrant voluntarily canceled
; • sod farm use and will prohibit aerial application and application of granular
formulations with chest-mounted rotary spreaders. Post-application reentry
workers will be required Jo observe a 24-hour Restricted Entry Interval.
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Environmental
Assessment
Environmental Fate
Potential for contamination of groundwater by trichlorfon and
trichlorfon degradates cannot be adequately assessed because acceptable
field dissipation data are not available. Potential to leach is suggested by
findings of high mobility in soil. Risk of contamination of surface and
ground water may be moderated by rapid degradation of trichlorfon in soil
and water. The major degradate in both soil and water is dichlorvos
(DDVP) with desmethyl DDVP also reported as a degradate in soil. DDVP
is itself a registered pesticide active ingredient. '
Ecological Effects
On an acute basis, trichlorfon is highly toxic to moderately toxic to
birds. Trichlorfon subacute dietary toxicity is classified as moderately toxic
to practically non-toxic. Avian reproductive studies indicate that there will
be effects on reproduction at levels of trichlorfon as low as 30 mg/L.
Trichlorfon was determined to have low toxicity to honey bees.
Acute toxicity measurements with trichlorfon range from highly toxic
to practically non-toxic to freshwater fish. Chronic toxicity testing with fish
indicate that the maximum allowable toxicant concentration (MATC) for
trichlorfon is between 110 and 160 /Ug/L. Acute toxicity testing on aquatic
invertebrates indicate that trichlorfon is very highly toxic to all test species
except crayfish, to which it was found to be moderately toxic. Chronic
toxicity testing with aquatic invertebrates indicate that the MATC for
trichlorfon is between 5.6 and 8.6 ng/L.
Ecological Risk Assessment
Based on the exposure from the turf uses, acute risk levels of concern
are exceeded for freshwater, marine and estuarine fish and invertebrates and
birds. Chronic risk levels of concern are exceeded for freshwater
invertebrates and birds. The registrant has agreed to require buffer strips
from aquatic habitats, mandatory watering-in for turf sites to reduce surface
run-off, the prohibition of aerial application which can result in spray drift
and the prohibition of residential lawn use with the bait formulations.
These measures will greatly reduce the exposure of aquatic habitats to
trichlorfon as well as reduce the residues available for dietary consumption
by birds. The acreage of trichlorfon usage has also been reduced by the
cancellation of all field crops and sod farm use. The Agency has
determined that although levels of concern are exceeded for non-target
organisms, the exposure has been adequately mitigated.
Additional Data
Required
The Agency is requiring the following additional generic studies for
trichlorfon to confirm its regulatory assessments and conclusions: estuarine
' or marine mollusk acute toxicity study (72-3b), life cycle aquatic
-1 ¦**'
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invertebrate (72-4b), terrestrial field dissipation (164-1), evaluation of
worker exposure from hydraulic low pressure handwand application (231
and 232) and worker reentry exposure from turf and greenhouse use (132-1,
133-3 and 133-4), droplet size spectrum (201) and drift field evaluation
(202-1). Residue and metabolism data are required to reassess the cattle
meat, cattle fat and cattle meat-by-products tolerances (171-4b, 171-4d,
171-4e, 171-4j).
The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregi strati on.
Product Labeling All trichlorfon end-use products must comply with the Agency's
Changes current pesticide product labeling requirements and with the following. For
Reauired a comPrehensive list of labeling requirements, please see the trichlorfon
RED document.'
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain trichlorfon,
the product labeling must be revised to adopt the handler personal
protective equipment/engineering control requirements set forth in this
section. Any conflicting PPE requirements on the current labeling must be
removed.
Products Intended Primarily for Occupational Use (WPS and
nonWPS)
Minimum ("Baseline) PPE/Engineering Control Requirements
At this time there are no engineering control requirements, such as
closed systems, currently required on labeling for trichlorfon products, the
Agency is not establishing active-ingredient-based minimum (baseline)
engineering control requirements for trichlorfon end-use products that are
intended primarily for occupational use.
The Agency is establishing minimum (baseline) PPE for some
occupational uses of trichlorfon.
For soluble powder formulations:
"Mixers and loaders must wear:
-long-sleeve shirt and long pants,
-chemical-resistant gloves*, and
—shoes plus socks,
Applicators and other handlers (other than mixers and loaders) must
wear:
-long-sleeve shirt and long pants,
—shoes plus socks.
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: ' ' i; /. ¦¦ ¦ ' " ', : .•
For granular formulations:
Applicators and other handlers must wear:
—coveralls over long-sleeve shirt and long pants,
-chemical-resistant gloves*, and
-chemical-resistant footwear.
For readv-to-use formulations:
Applicators and other handlers must wear:
-long-sleeve shirt and long pants,
-chemical-resistant gloves*, and
—shoes plus socks. . , .
*Forthe glove statement, use the statement established for tricMorfon
through the instruction in Supplement Three of PR Notice 93-7.
Determining PPE Requirements for End-use Product Labels
The PPE that would be established on the basis of the acute toxicity
category of the end-use product must be'compared to the active-ingredient-
based minimum (baseline) personal protective equipment specified above,
The more protective PPE must be placed on the product labeling. For
guidance on which PPE is considered more protective, see PR Notice 93-7.
Placement in Labeling
The personal protective equipment requirements must be placed on
the end-use product labeling in the location specified in PR Notice 93-7,
and the format and language of the PPE requirements must be the same as
is specified in PR Notice 93-7.
Products Intended Primarily for Homeowner Use
Minimum (Baseline) PPE Requirements
The Agency is not establishing active-ingredient-based minimum
(baseline) handler PPE for trichlorfon end-use products that are intended
primarily for homeowner use.
¦ . . . • , r • • •• • • •' ..
Determining PPE Requirements for End-Use Product Labels
Any necessary PPE for each trichlorfon end-use product intended
primarily for homeowner use will be established on the basis of the end-use
product's acute toxicity category.
Placement in Labeling
The personal protective equipment requirements, if any, must be
placed on the end-use product labeling immediately following the
precautionary statements in the labeling section "Hazards to Humans (and
domestic animals)."
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Entry Restrictions
For sole-active-ingredient end-use products that contain trichlorfon
the product labeling must be revised to adopt the entry restrictions set forth
in this, section. Any conflicting entry restrictions on the current labeling
must be removed.
Products Intended Primarily for Occupational Use
WPS Uses
Restricted-entry interval: A 24-hour restricted-entry interval (REI) is
required for uses within the scope of the WPS on all trichlorfon end-use
products
"Exception: if the product is soil-injected or soil-incorporated
(including watering-in), the Worker Protection Standard, under
. certain circumstances, allows workers to enter the treated area if there
will be no contact with anything that has been treated."
Early-en try personal protective equipment (PPE): The PPE required for
early entry is:
— coveralls over long-sleeve shirt and long pants,
— chemical-resistant gloves,
— chemical-resistant footwear plus socks.
Placement in labeling: The REI and the PPE required for early entry must
be inserted into the standardized REI statement required by Supplement
Three of PR Notice 93-7.
NonWPS uses
Entry restrictions: The Agency is establishing the following entry
restrictions for nonWPS occupational uses of trichlorfon end-use products:
• For liquid applications:
"Do not enter or allow others to enter the treated area until sprays
have dried."
• For granular applications:
"Do not allow people or pets to enter the treated area (except those
involved in the watering) until the watering-in is complete and the
surface is dry."
• For bait applications:
There are no entry restrictions.
Placement in labeling:
If WPS uses are also on label — Follow the instructions in PR Notice 93-7'
for establishing a Non-Agricultural Use Requirements box, and place the
appropriate nonWPS entry restrictions in that box. . ''
If no WPS uses are on the label -- Place the appropriate nonWPS entry
restrictions in the Directions for Use, under the heading "Entry
Restrictions".
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Products Intended Primarily for Homeowner Use
Entry restrictions: The Agency is establishing the following entry
restrictions for all homeowner uses of trichlorfon end-use products:
• For liquid applications:
"Do not allow people or pets to enter the treated area until sprays have
dried."
• For granular applications:
"Do not allow people or pets to enter the treated area (except those
involved in the watering) until the watermg-in is complete and the
surface is dry."
Placement in labeling: Place the appropriate entry restrictions in the
Directions for Use, under the heading "Entry Restrictions".
Other Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements be located
on all end-use products containing trichlorfon that are intended primarily
for occupational use:
Application Restrictions:
For all formulations: ^
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
"Aerial application is prohibited."
For granular formulations onlv:
"Apply with push-type granular spreaders only. Chest-mounted
, rotary spreader ("belly-grinder") application equipment is prohibited."
User Safety Requirements:
(Registrant: select this if coveralls are required for pesticide handlers
on the end-use product label:!
Discard clothing or other absorbent materials that have been drenched
• or heavily contaminated with this product's concentrate. Do not reuse
them.
(Registrant: select this always:)
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing."
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• "Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As soon
as possible, wash thoroughly and change into clean clothing."
Skin Sensitizer Statement:
"This product may cause skin sensitization in some people."
Engineering Controls:
"When handlers use closed systems, or enclosed cabs in a manner that
meets the requirements listed in the Worker Protection Standard
(WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the
handler PPE requirements may be reduced or modified as specified in
the WPS."
Products Intended.Primarily for Home Use
Application Restrictions
"Do not apply this product in a way that will contact any person
or pet, either directly or through drift. Keep people and pets out
of tie area during application."
"Do not apply this product using "chest mounted rotary-type
spreader" application equipment."
User Safety Recommendations
• "Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide
gets inside. Then wash thoroughly and put on clean
clothing."
(Select this only if gloves and/or protective eyewear are required for
homeowner users:)
• "Users should remove protective clothing and equipment
immediately after handling this product. Wash the outside
of gloves before removing. Keep and wash protective
clothing and equipment separately from other laundry."
Skim Sensitizer Statement
"This product may cause skin sensitization reactions in some
people."
Environmental Hazard Statements
All labels must have standard language, including:
"Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark."
"Do not contaminate water by cleaning of equipment or disposal or
wastes." •
"Do not apply when turf grass areas are water logged or the soil is
saturated with water (i.e. will not irrigate)."
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"Avoid run-off or puddling of irrigation water following application."
Soluble powders;
"Do not apply when average wind speeds are greater than 15 mph."
"Apply product using spray nozzles which produce a coarse droplet
size, such as flood jet nozzles or lawn care gun."
For Golf course Use:
"Do not apply within 25 feet of lakes, reservoirs, rivers, permanent
streams, marshes natural ponds, or estuaries."
"Post-application watering-in is required."
For Other Turf/Lawn Uses;
, * * > », . ; • • • «vr
"Post-application watering-in is required."
Premise Precautions
' ' '¦ !• . ¦ '• ' . ¦' . ' . : ¦ ¦
All products labeled for use in livestock premise or areas must include
the following:
"Remove animals before using products as a premise spray treatment
' * ' . • - - • • i H • . 'fife •*» frf . *.
in barns."
¦ ' ¦ .......J.
"Do not treat areas such as drinking cup, mangers, or troughs where
livestock feed."
¦ •: ¦. .
"Do not contaminate water, food, feedstuffs, food or feed handling
equipment, or milk or meat handling equipment."
'' 1 ¦ ' !¦ illlr¦, L 1 " . ¦... ¦ " ¦ ¦¦
"Do not apply bait or spray to areas accessible to animals."
All products labeled for use in indoor residential or commercial
establishments must include:
"For use in non-food/non-feed areas."
"Do not contaminate food/feed or food/feed handling equipment,"
"Do not use in the food/feed areas of food/feed handling
establishments. Dp not use in edible product areas of food or feed
processing plants, restaurants or other areas where food or feed is
commercially prepared for processed. Do not use in restaurant
serving areas while food is exposed."
" . " i-'i i'-x ¦'¦¦¦ ¦ ¦ . i- • •
All bait formulation products not housed in child-resistant bait
stations must include the following:
"Not for Indoor Residential Use" and
"Not for Lawn/Turf Use".
\V., i.f
All products labeled for use as a mound treatment for Texas Harvest
Ants must include the following:
"Apply only by hand-broadcast."
All products containing the site "area treatment" must be modified to
"nonfood/nonfeed areas". , _
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Regulatory The use of currently registered products containing trichlorfon,
Conclusion labeled for non-food uses'as specified in the RED, will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore., all uses of these products with approved labeling, are eligible for
reregi strati on.
Trichlorfon products will be reregistered once the required product-
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by the Agency.'
For More The Agency is requesting public comments on the Reregi strati on
Information Eligibility Decision (RED) document for trichlorfon during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp.on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the trichlorfon RED document also
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program,
the trichlorfon RED, or reregi strati on of individual products containing
trichlorfon, please contact the Special Review and Reregi strati on Division
(7508W), OPP, US EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
11
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RE REGISTRATION ELIGIBILITY DECISION
TRICHLORFON
LIST A
CASE 0104
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
TRICHLORFON RE REGISTRATION ELIGIBILITY DECISION TEAM I
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 5
D. Regulatory History 5
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
1. Description of Chemical 6
2. Identification of Active Ingredient 6
3. Manufacturing-use Products 6
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 7
c. Combined Chronic/Carcinogenicity 7
d. Developmental Toxicity 10
e. Reproductive Toxicity 10
f. Mutagenicity 11
g. Metabolism 12
h. Neurotoxicity 12
I. Reference Dose 12
j. Toxicological Endpoints for Risk Assessment 13
k. Other Toxicological Considerations 14
2. Exposure Assessment 14
a. Dietary 14
b. Occupational and Residential 15
3. Risk Assessment 18
a. Dietary 18
b. Occupational and Residential Risk 21
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C. Environmental Assessment 26
1. Ecological Effects 26
a. Ecological Effects Data 26
(1) Toxicity to Terrestrial Animals 26
(2) Aquatic Animal Data 28
(3) Terrestrial, Semi-Aquatic and Aquatic Plant
Data 31
b. Ecological Effects Risk Assessment 32
2. Environmental Fate 37
a. Environmental Chemistry, Fate and Transport Data .... 37
b. Environmental Fate Assessment 40
IV. RISK MANAGEMENT AND RE REGISTRATION DECISION 41
A. Determination of Eligibility 41
1. Eligibility Decision 42
2. Eligible and Ineligible Uses 42
B. Regulatory Position 42
1. Tolerance Reassessment 43
2. Restricted Use Classification 46
3. Reference Dose and Cancer Classification 46
4. Endangered Species Statement 46
5. Labeling For Non-Food Uses 46
6. Child Resistant Packaging 47
7. Spray Drift Advisory 47
8. Ecological Effects 47
9. Surface Water Advisory 48
10. Occupational/Residential Labeling Rationale/Risk Mitigation ... 48
11. Skin Sensitization 53
12. Other Labeling Requirements 53
V. ACTIONS REQUIRED OF REGISTRANTS 53
A. Manufacturing-Use Products 54
1. Additional Generic Data Requirements 54
2. Labeling Requirements for Manufacturing-Use Products 54
B. End-Use Products 55
1. Additional Product-Specific Data Requirements 55
2. Labeling Requirements for End-Use Products 55
C. Existing Stocks 62
VI. APPENDICES 63
APPENDIX A. Table of Use Patterns Subject to Reregistration 64
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 93
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Trichlorfon 105
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APPENDIX D.
Attachment
Attachment
Attachment
Attachment
APPENDIX E.
Attachment
Attachment
Combined Generic and Product Specific Data Call-In ... 121
1. Chemical Status Sheets 143
2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions
145
3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions 149
4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 157
List of Available Related Documents 161
1. List of All Registrants Sent This Data Call-In (insert)
Notice 163
2. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions .... 165
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TRICHLORFON RE REGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
William Gross
Gabe Patrick
Environmental Fate and Effects Division
David Farrar
Richard Mahler
Kathryn Montague
Ronald Parker
Health Effects Division
Susan Hummel
Laura Morris
Melba Morrow
Jane Smith
Registration Division
Dan Peacock
Biological Analysis Branch
Economic Analysis Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Reregi strati on Support Chemistry Branch
Occupational and Residential Exposure Branch
Toxicology Branch I
Risk Characterization and Analysis Branch
Insecticide-Rodenticide Branch
Special Review and Reregi strati on Division
Dana Lateulere
Brigid Lowery
Robert Richards
Carol Stangel
Reregi strati on Branch
Reregi strati on Branch
Reregi strati on Branch
Policy, Planning and Operations Branch
1
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Intentionally Blank Page
11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
DRES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
F AO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and
other organizations when emergency spills or contamination situations occur.
HDT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of
substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It
is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOC Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
jj.g/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
N/A Not Applicable
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEC
No effect concentration
NPDES
National Pollutant Discharge Elimination System
NOEL
No Observed Effect Level
NOAEL
No Observed Adverse Effect Level
OP
Organophosphate
OPP
Office of Pesticide Programs
PADI
Provisional Acceptable Daily Intake
PAG
Pesticide Assessment Guideline
PAM
Pesticide Analytical Method
PHED
Pesticide Handler's Exposure Data
PHI
Preharvest Interval
ppb
Parts Per Billion
PPE
Personal Protective Equipment
PPm
Parts Per Million
PRN
Pesticide Registration Notice
Q*i
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC
Red Blood Cell
RED
Reregistration Eligibility Decision
REI
Restricted Entry Interval
RfD
Reference Dose
RS
Registration Standard
RUP
Restricted Use Pesticide
SLN
Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC
Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD
Toxic Dose. The dose at which a substance produces a toxic effect.
TEP
Typical End-Use Product
TGAI
Technical Grade Active Ingredient
TLC
Thin Layer Chromatography
TMRC
Theoretical Maximum Residue Contribution
torr
A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
ug/L
Micrograms per liter
WP
Wettable Powder
WPS
Worker Protection Standard
iv
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EXECUTIVE SUMMARY
Background
This Reregi strati on Eligibility Decision Document (RED) addresses the reregi strati on
eligibility of the pesticide trichlorfon. Trichlorfon, an organophosphate insecticide, has been
registered since 1955 for use on a variety of food and feed crops, recreational areas, lawns
and turf, domestic dwellings and livestock. Trichlorfon is currently manufactured by Bayer
Corporation (formerly Miles Inc., formerly Mobay Inc.), the sole producer and primary
registrant. A Data Call-In issued in the 1984 Trichlorfon Registration Standard as well as a
follow-up 1991 Data Call-In required submission of data to support the reregi strati on of
trichlorfon. This document reflects a reassessment of trichlorfon following review of these
data.
Reregistration Eligibility
The Agency has determined that products containing trichlorfon are eligible for
reregistration if labeling and other changes in this document are implemented. Eligible uses
are limited to indoor and outdoor nonfood and nonfeed sites. The use on sod farms and the
bait formulation use on residential lawns have been voluntarily canceled by the effected
registrants. Also, the use of the bait in indoor domestic areas is prohibited unless
prepackaged in child resistant bait stations. All food, feed and field crop registrations have
been voluntarily canceled by the registrant; the process of amending all affected labels was
complete on November 21, 1995. The Agency is proposing to revoke all tolerances for
trichlorfon except cattle meat, cattle fat and cattle meat by-products. The registrant is not
supporting the domestic use of the cattle treatment but will support the tolerances needed for
the continuing importation of trichlorfon treated cattle products. In order to reassess the
tolerances additional residue data are required within 24 months. Residue and metabolism
data are required to reassess the tolerances, specifically, dermal metabolism in cattle (171-4b),
magnitude of the residue for meat (171-4j), residue analytical method (171 -4d), and storage
stability (171-4e).
The Agency is requiring the following confirmatory studies for trichlorfon: based on
the turf and lawn uses, an estuarine or marine mollusk acute toxicity study (72-3b), life cycle -
aquatic invertebrate (72-4d), terrestrial field dissipation (164-1); evaluation of worker
exposure from hydraulic low pressure handwand application (231 and 232) and worker
reentry exposure from turf and greenhouse use (132-1, 133-3 and 133-4), droplet size
spectrum (201-1) and drift field evaluation (202-1) are needed to support the turf and lawn
uses due to the methods of application. These data are confirmatory and are not expected to
change the regulatory decision on trichlorfon.
v
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Health Effects
The Agency has classified trichlorfon as a Group E chemical, no evidence of
carcinogenicity for humans.
Chronic and acute dietary analyses were conducted using all of the published
tolerances and assuming 100% of the crops (or cattle, domestic and import) were treated. The
Agency generally accepts that acute dietary margins of exposure (MOE's) for cholinesterase
inhibition determined to be greater than 10 indicate there is little likelihood of acute dietary
risk. The acute dietary MOE's for trichlorfon were greater than 10. The chronic dietary
analysis determined that the Reference Dose (RfD) was exceeded using the currently
published crop tolerances. However, none of the feed or field crop uses are being supported
and revocation of those tolerances is being proposed. Although the dermal cattle treatment is
being voluntarily canceled, the cattle tolerances are being supported for import purposes.
Chronic dietary analyses were conducted based on the current cattle tolerances and the
minimal data available. The theoretical maximum residue contribution (TMRC) for the U.S.
population represented 8% of the RfD, indicating that the pour-on use does not present a
chronic dietary risk concern. Residue data are required to reassess the cattle tolerances.
Occupational and Residential Exposure
When assessing the risk for occupational and residential exposure, the Agency
generally accepts an MOE of greater than 100 as indicating there is little likelihood for an
exposure related concern. The MOE's for mixer/loaders are acceptable except for the soluble
powder formulation when supporting large (500 acre per day) applications (i.e., sod farms).
Even with maximum personal protective equipment (PPE) the MOE's were <20, indicating a
risk concern. Also, the MOE of 83 indicates concern for homeowner exposures to the
granular formulation when using a chest mounted rotary spreader or other hand-operated-type
spreader equipment. MOE's for aerial applications are also low, indicating potential risk.
Mitigation for aerial application was determined to be impractical. Also, there are no
engineering controls which appear to be feasible to mitigate the mixer/loader exposure to the
soluble powder formulations (i.e., water soluble packaging). Therefore, in an effort to
mitigate the exposure, the registrant has agreed to cancel all sod farm uses and prohibit aerial
application. In order to address the homeowner risk concern, labels will prohibit the use of
chest mounted rotary type spreaders for application of the granular formulation. Also,
potential risk to children and pets from exposure to the bait formulations will be minimized by
prohibiting these from indoor domestic settings unless housed in child resistant bait stations
and prohibiting the domestic lawn use.
Product-specific data to assess post-application exposure and risk has been called-in as
confirmatory data. Although the Agency has determined that immediate post-application
exposures to turf grown for sod and ornamentals grown for sale are a risk concern, these risks
have been minimized to an acceptable level based on the registrants omission of all sod farm
vi
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uses, mandatory post-treatment watering-in for all other turf uses, and a restricted entry
interval which prohibits certain reentry until the treated turf area has dried following the
watering-in. Restricted entry intervals have also been established for ornamental uses. Post-
application risk concerns for applications to sites other than turfgrass and ornamentals are
minimal and the anticipated frequency, duration, and degree of exposure following such
applications do not warrant risk mitigation measures.
Environmental Fate
Potential for contamination of groundwater by trichlorfon and trichlorfon degradates
cannot be adequately assessed because acceptable field dissipation data are not available.
Potential to leach is suggested by findings of high mobility in soil. Risk of contamination of
surface and ground water may be moderated by rapid degradation of trichlorfon in soil and
water. It appears that hydrolysis and aerobic metabolism are the main routes of dissipation in
both soil and water. The major degradate in both soil and water is dichlorvos (DDVP) with
desmethyl DDVP also reported as a degradate in soil. DDVP is itself a registered pesticide
active ingredient.
The available data, from field studies that were not completely acceptable, suggest that
trichlorfon and DDVP may have little potential to contaminate ground water because they
degrade rapidly in soil. Acceptable field studies are required to confirm this suggestion.
Ecological Effects
Based on the exposure from the turf uses, acute risk levels of concern are exceeded for
freshwater, marine and estuarine fish and invertebrates and birds. Chronic risk levels of
concern are exceeded for freshwater invertebrates and birds. The registrant has agreed to
require buffer strips from aquatic habitats, mandatory watering-in for turf sites to reduce
surface run-off, and the prohibition of aerial application which can result in spray drift. Also,
residential lawn use of the bait formulations will be prohibited. These measures will greatly
reduce the exposure of aquatic habitats to trichlorfon as well as reduce the residues available
for dietary consumption by birds. The acreage of trichlorfon usage has also been greatly
reduced by the cancellation of all field crops and sod farm use. The Agency has determined
that although levels of concern are exceeded for non-target organisms, the exposure has been
adequately mitigated.
Before reregistering the products containing trichlorfon, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include
product chemistry for each product, acute toxicity studies for similar formulations, and
product performance data for public health uses (cockroaches and houseflies). After
reviewing these data and any revised labels and finding them acceptable in accordance with
Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those products which contain
vii
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other active ingredients will be eligible for reregi strati on only when the other active
ingredients are determined to be eligible for reregi strati on.
viii
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregi strati on process to be
completed in nine years. There are five phases to the reregi strati on process. The first four
phases of the process focus on identification of data requirements to support the reregi strati on
of an active ingredient and the generation and submission of data to fulfill the requirements.
The fifth phase is a review by the U.S. Environmental Protection Agency (referred to as "the
Agency") of all data submitted to support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregi strati on involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of trichlorfon. The document consists of six sections. Section I is the
introduction. Section II describes trichlorfon, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the
data available to the Agency. Section IV presents the reregi strati on decision for trichlorfon.
Section V discusses the reregi strati on requirements for trichlorfon. Finally, Section VI is the
Appendices which support this Reregi strati on Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Trichlorfon
Dimethyl (2,2,2-trichloro-1 -hydroxyethyl)
phosphonate
Organophosphate
52-68-6
057901
C4H804C13P
B.
Empirical Formula:
Trade and Other Names: Dylox, Dipterex, Proxol, and Neguvon
Basic Manufacturer: Bayer Corporation
Use Profile
The following use profile is based on the uses, sites and application methods that were
registered when this RED document was initiated. Some uses have been voluntarily canceled
or amended as a result of the science assessments; [major changes that have occurred are
noted in brackets], A detailed table of the uses of trichlorfon, eligible and ineligible, is in
Appendix A.
Type of Pesticide: Insecticide
Mode of Action: Acetylcholinesterase inhibitor
Use Sites:
Terrestrial food/feed/field crops: Brussels sprouts, barley, beets, blueberry, beans (dry and
snap), corn, field corn, popcorn, sweet corn, cotton, cow peas, lima beans, tomatoes, cabbage,
carrot (including tops), cauliflower, collards, cowpeas, southern peas, black-eyed peas,
crowder peas, pumpkins, collards, lettuce and alfalfa, cotton, peanuts, pepper, pumpkin,
tobacco, soybeans and treatment to manure. [Voluntary cancellation of all food/feed uses was
finalized November 21, 1995.]
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Terrestrial non-food crops: Agricultural uncultivated areas, commercial animal kennels and
sleeping quarters, recreational area and ornamental lawns, recreational areas, golf course turf,
sod farms, outdoor commercial/institutional/industrial premises and equipment,
nonagricultural uncultivated areas and soils, ornamental and/or shade trees, ornamental
herbaceous plants and ornamental non-flowering plants, ornamental woody shrubs and vines,
paths and patios, outdoor refuse/solid waste sites. [Sod farm uses have been voluntarily
canceled.]
Indoor non-food/non-feed: Greenhouses, agricultural/farm premises, cattle feedlots, dairy
farm milk storage rooms/houses/sheds, dairy farm milking stalls/parlors, non-food contact
areas of food processing plant premises, nonfood areas of eating establishments,
food/grocery/marketing/ storage/distribution facility premise, household/domestic dwellings,
indoor food handling areas, non-food contact meat processing plant premises, non-food
contact areas of poultry processing plant equipment, indoor commercial storage/warehouses
premises. [All of these sites have required, and will continue to require, label restrictions
prohibiting contamination of food/feed or food/feed handling equipment and restricting use to
areas inaccessible to animals.]
Indoor food: Dermal treatment to non-lactating dairy and beef cattle, livestock. [Voluntary
cancellation has been requested for all dermal treatment uses.]
Indoor residential: Bathroom premises/hard surfaces, indoor premises household/domestic,
refuse/solid waste containers (garbage cans).
Outdoor residential: Household/domestic dwellings outdoor premises (i.e., paths and patios).
Usage Information:
Turf management: 500,000 to 1,000,000 pounds of active ingredient per year.
Usage information on other sites is not available.
Pests:
Products are labeled for outdoor turf, ornamental and perimeter treatments to control a wide
variety of lepidopteran larvae (caterpillars), white grubs, mole crickets, sod webworms, leaf
miners, stink bugs, ants and other nuisance pests; indoor control of flies, ants, and roaches;
mound treatment for Harvester ants; pour-on livestock use to control cattle grubs and cattle
lice.
Formulation Types Registered:
Technical Active Ingredient:
98.0% trichlorfon
97.0% trichlorfon
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Formulation Intermediate Active Ingredient
80.0% trichlorfon
Soluble Powder Active Ingredient
80.0% trichlorfon
Granular Active Ingredient
6.2% trichlorfon
5.0% trichlorfon
Readv-to-Use Solution (voluntary cancellation request has been submitted)
8.0% trichlorfon
Granular Bait Active Ingredient
1.0% trichlorfon
5.0% trichlorfon
Methods of Application:
Turf, ornamentals and nurseries: mechanical and hand-held sprayers, spreaders (for granular
formulations), aerial equipment, irrigation systems.
Indoor and outdoor treatments: soluble powders in water through hand-held sprayers; dry
baits can be "sprinkled" out of a cup or spoon or put onto cardboard or plastic or applied as a
mound treatment for ants; bait mixed with water and "sprinkled" out of a cup or watering can.
Pour on: from a cup or dipper onto livestock.
Rates of Application:
Rates up to 8.0 lb a.i./acre are registered for turf.
Types of Treatment:
Surface spray, granular and bait treatment to lawns and recreational areas; general surface
treatment sprays in and around buildings, foliar sprays, mound treatment for ants, bait
treatment to cracks, crevices and wall voids.
Timing:
Product labels do not give specific timing of application of trichlorfon. The most likely
scenario is when pests have reached intolerable or damaging populations. For turf and lawns,
most labels indicate application can be made monthly beginning May or June.
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C. Data Requirements
Data required in the June 30, 1984 Registration Standard for Trichlorfon include
studies on product chemistry, toxicology, ecological effects, environmental fate, and residue
chemistry. In addition, a Data Call-In was issued in September 1991 for trichlorfon requiring
additional product chemistry, ecological effects, toxicology, residue chemistry and
occupational and residential exposure data. Appendix B includes all data requirements
identified by the Agency needed to support reregi strati on for currently registered uses.
D. Regulatory History
Trichlorfon was registered in the United States by the USD A in 1955 for use as an
insecticide on a variety of vegetable, fruit and field crops as well as livestock, ornamental and
forestry plantings, agricultural premises and domestic dwellings, and for the control of
parasites on fish in designated aquatic environments. A Registration Standard for trichlorfon
was issued in June 1984 which included a Data Call-In requiring data to support the
trichlorfon use patterns. Additional data were required in 1991 to complete the data base for
trichlorfon. This Reregi strati on Eligibility Decision reflects a reassessment of all data which
were submitted in response to the Registration Standard and the subsequent 1991 Data Call-
in.
Bayer Corporation, the manufacturer of the trichlorfon technical, requested voluntary
cancellation of all food, feed and field crop uses; all other registrants were required to remove
these uses from their product labels. The process of amendment was complete on November
21, 1995. Bayer Corp. has several products labeled for dermal pour-on treatment to cattle and
livestock; they have voluntarily requested cancellation of these products. Bayer has indicated
that they will support a "tolerance with no U.S. registration" for import purposes by providing
the necessary data to reassess the tolerances within two years.
Trichlorfon was originally referred and entered in the Rebuttable Presumption Against
Registration (RPAR, now referred to as Special Review) process because scientific studies
suggested that trichlorfon might be oncogenic, teratogenic, fetotoxic, and mutagenic (FR Vol.
43, No. 77, 4/20/78). In 1984, the Agency evaluated the available data on trichlorfon and
concluded that the existing evidence did not support the issuance of an RPAR for trichlorfon
because the existing database was inadequate for valid risk assessment.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Description of Chemical
Trichlorfon [dimethyl (2,2,2-trichloro-l-hydroxyethyl) phosphonate] is an
organophosphorus insecticide, which acts as an acetylcholinesterase inhibitor.
O
OH
H3CO
H3CO
CCI3
Empirical Formula:
Molecular Weight:
CAS Registry No.:
C4H804C13P
257.6
52-68-6
4 8 4
2. Identification of Active Ingredient
Technical trichlorfon is a white crystalline solid with a melting point of 75-84 C.
Trichlorfon is soluble in water, dichloromethane, 2-propanol, and toluene, and nearly
insoluble in n-hexane.
Trichlorfon manufacturing-use products (MPs) are registered to Bayer Corporation
(formerly Miles Inc., formerly Mobay Corp.): two 98% technical products (EPA Reg. Nos.
3125-9 and 11556-30), a 97% technical (EPA Reg. No. 3125-404), and an 80% formulation
intermediate (EPA Reg. No. 3125-371). The 97% technical (EPA Reg. No. 3125-404) was
transferred from Kaw Valley Inc. (EPA Reg. No. 44215-129) on 11/20/90. These products
are the only MPs subject to this reregi strati on eligibility decision.
B. Human Health Assessment
The toxicological data base for trichlorfon is adequate and will support reregi strati on
eligibility. Eye effects, skin effects, and skin sensitization data are not data requirements for
3. Manufacturing-use Products
1. Toxicology Assessment
a. Acute Toxicity
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the reregi strati on of the technical grade of trichlorfon. These data are presented for
information purposes only.
Table 1: Acute Toxicity Values
Gdln#
Test
MRID#
Result (mg/kg)
Category
81-1
Oral LDW
00256446
136 - 173 mg/kg
II
81-2
Dermal LDW
00090786
> 2 g/kg
III
81-3
Inhalation LC,n
00256446
533 mg/m3 - 4 hours
IV
81-4
Eye effects
41571302
Moderately irritating
III
81-5
Skin effects
40306901
Moderate contact allergen
IV
81-6
Skin Sensitization
00257599
Moderate contact allergen
-
In addition, a single dose human clinical trial conducted in 1990 was reported in a
monograph from the Joint Food and Agricultural Organization of the United Nations/World
Health Organization (F AO/WHO) for the evaluation of the use of trichlorfon in the treatment
of Alzheimer's disease. A single oral dose of 0, 2.5, 5.0, 7.5 or 15 mg/kg/day was
administered to humans. The NOEL was 2.5 mg/kg/day and the LOEL was 5.0 mg/kg/day
based upon the inhibition of plasma and red blood cell cholinesterase and clinical signs of
vomiting, nausea and diarrhea.
b. Subchronic Toxicity
In a 21-day toxicity study, trichlorfon was administered dermally to rabbits for 15 days
(5 days a week for 3 weeks) at doses of 0, 100, 300 or 1000 mg/kg/day. The systemic NOEL
was greater than the highest dose tested. The NOEL for cholinesterase inhibition was 100
mg/kg/day the LOEL for cholinesterase inhibition was 300 mg/kg/day based on depression in
red blood cell activity (GLN 82-2, MRID 40306901).
c. Combined Chronic/Carcinogenicity
Trichlorfon was administered in the diets of Fischer 344 rats at doses of 0, 100, 300 or
1750 ppm (equivalent to 0, 4.4, 13.3 and 75 mg/kg/day for males; 0, 5.8, 17.4 and 93.7
mg/kg/day for females, respectively) for 24 months. The study was designed to test both the
carcinogenic potential and the chronic toxicity of the test material. During the study, several
adjustments in the dose were made at the highest dose tested, resulting in an average dose of
1514 ppm for males (75 mg/kg/day). After 27 weeks at 1000 ppm, the dose was increased to
1250 ppm for weeks 28 to 32; increased to 1500 ppm from weeks 33 to 40; and, increased for
a third time to 1750 ppm for weeks 41 to 106. The chronic toxicity NOEL was 4.4 mg/kg/day
7
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and the LOEL was 13.3 mg/kg/day based on the observed decreases in red cell (17%) and
brain (18%) cholinesterase activity and a statistically significant increase in the incidence of
renal calcification in males.
In the highest dose tested, gross findings included granular kidneys and foci in the
lungs of females; and, thickened enlarged duodenum and thickened and granular non-
glandular stomachs in males. The gross findings were correlated with microscopic findings of
cranial hyperplasia of the small intestines, non-glandular gastritis in the stomach,
inflammation of the lung and chronic nephropathy, and renal calcification. Decreases in body
weight gain were also reported at week 13 of the study for animals in the highest dose tested
(10%) in males, 18%> in females). In high dose animals of both sexes anemia was reported,
characterized by statistically significant decreases in the hematocrit, hemoglobin, red blood
cell counts, and mean corpuscle volume. Hypercholesterolemia was also present in the high
dose males and females and in the mid-dose males. Under the conditions of the study, the test
material was associated with an increase in the incidence of benign pheochromocytomas in
high dose males which was slightly outside of the historical control range for these tumors.
Since this tumor type is very common in this strain of rats and since it was not present in the
same strain at a higher dose level (see the next study below), this tumor type was not
considered to be compound related by the Office of Pesticide Programs (OPP)
Carcinogenicity Peer Review Committee. A statistically significant increase in the incidence
of mononuclear cell leukemia was reported for low and high dose males; however, the
incidence of this tumor was within the animal supplier's historical control range for this tumor
type.
Based on the compound-related effects on clinical chemistry parameters, gross and
microscopic pathology and clinical findings of paleness and hunched backs in high dose
males and rough hair coats in high dose females, the OPP Carcinogenicity Peer Review
Committee determined that trichlorfon was tested at an adequate dose (GLN 83-1(a) and 83-
2(a), MRID 41056201).
In an additional 2-year study conducted in Fischer 344 rats at dietary dose levels of 0
or 2500 ppm (equivalent to 0 and 129 mg/kg/day in males, 0 and 159 mg/kg/day in females,
respectively), trichlorfon was associated with an increase in the incidence of
alveolar/bronchiolar adenomas in males, renal tubular adenomas in males and
alveolar/bronchiolar carcinomas in females. While none of these tumors were reported at
statistically significant levels, the incidences were well outside of the historical control range
for all three tumor types. There was no compound related increase in the incidence of either
benign pheochromocytomas or in the incidence of mononuclear cell leukemia.
In this same study, administration of the test material was associated with a decrease in
body weight and body weight gain (10.5%> males and 18.5 % females), increased incidences
of urine stain, rough coats and pale eyes, decreases in erythrocyte parameters (hematocrit,
hemoglobin, RBC count and MCV), hypercholesterolemia and increases in hepatic enzymes
8
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(SAP, AST, ALT and GGT). Decreases in plasma (63% males, 52% females) and erythrocyte
(38%) males, 30% females) cholinesterase activity were reported in both sexes of animals
when treated groups were compared to controls. Brain cholinesterase activity was 58 and
54%) lower than controls for males and females, respectively. Compound related non-
neoplastic lesions included duodenal hyperplasia, gastritis, pulmonary hyperplasia and
inflammation, nasolacrimal inflammation, hepatocellular hyperplasia and vacuolation, chronic
nephropathy and an increased incidence of dermal lesions were all reported at 2500 ppm. It
was concluded by the OPP Carcinogenicity Peer Review Committee that this study was
conducted at a level which exceeded the MTD (GLN 83-1(a) and 83-2(a), MRID 41973001,
42510301).
In a twenty-four month chronic/carcinogenicity study in CD-I mice, trichlorfon was
administered at dietary dose levels of 0, 300, 900 or 2700 ppm (equivalent to 0, 45, 135 and
405 mg/kg/day, respectively). Clinical signs of toxicity were observed at all dose levels and
included vaginal discharges, urine staining and ear lesions. Depressed plasma (57% males,
74%) females at HDT), brain (66%> males, 71% females) and erythrocyte (35% males, 38%
females) cholinesterase levels were reported in all treated animals. A NOEL for systemic
toxicity was not demonstrated in this study. There was a significant trend for increased
mortality in female mice. In the low dose females, there was a statistically significant
increase in the incidence of alveolar/bronchiolar adenomas and combined
alveolar/bronchiolar adenomas and carcinomas. In the mid-dose group, there was a
statistically significant increase in the incidence of alveolar/bronchiolar carcinomas and
combined alveolar/bronchiolar adenomas and carcinomas. However, this increased incidence
of lung tumors was not sustained at the higher dose level and resulted in a flat dose-response
curve. Therefore, the OPP Carcinogenicity Peer Review Committee (CPRC) determined the
increased incidence of lung tumors in the low and mid-level dose female mice was not
compound related. In males, there was an increase in the incidence of hepatocellular
adenomas at all dosed groups; however, the increase was not at a statistically significant level.
Based on the clinical signs of toxicity and the effects on cholinesterase activity, it was
determined by the OPP CPRC that trichlorfon was tested at adequate dose levels (GLN 83-
2(b), MRID 40782401, 40844301).
A ten year chronic toxicity/carcinogenicity study was conducted in Rhesus monkeys.
Trichlorfon was administered via Tang orange drink at doses of 0, 0.2, 1.0 or 5.0 mg/kg/day
for six days a week during the ten year testing period. At the levels tested, the compound did
not induce any increases in tumor incidence over controls nor were there any pre-neoplastic
lesions reported that could be associated with the administration of trichlorfon. The LOEL
was 0.2 mg/kg/day based on findings of decreased plasma (39% females, no decrease in
males), red cell (30% males, no change in females) and brain (22% males, no change in
females) cholinesterase activity levels. At the highest dose tested (5.0 mg/kg/day), there was
a decrease in body weight for both sexes (6 to 33%) and anemia as characterized by decreases
in erythrocyte, hemoglobin and hematocrit values. At this same dose level, transitory signs of
cholinesterase inhibition were observed in females during the first month of the study. These
9
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consisted of pupillary constriction, muscle fasciculation and diarrhea (GLN 83-1 and 83-2,
MRID 40776001).
Trichlorfon was tested in male and female beagles at dietary doses of 0, 50, 250, 500
or 1,000 ppm (equivalent to 0, 1.25, 6.25, 12.5 and 25 mg/kg/day, respectively) for one year.
There were no reported effects on mortality or on body weights nor were there any reports of
clinical signs that could be associated with trichlorfon administration. Gross findings
included mild to moderate enlargement of the spleen at the highest dose tested. Microscopic
analysis showed marked congestion of the spleen and lymphoid atrophy of this organ in high
dose animals of both sexes. Microscopic findings in the liver of high dose animals consisted
of foci of inflammatory cells. The NOEL in this study was 250 ppm and the LOEL was 500
ppm based on decreases in serum and red cell cholinesterase activity. This study was
classified as supplementary. The data requirement for a chronic non-rodent study was
satisfied by the ten year monkey study (GLN 83-1, MRID 00080593).
d. Developmental Toxicity
In a developmental toxicity study in rabbits, trichlorfon was administered by gavage to
pregnant does on gestation days 6 through 18. The doses were 0, 10, 35 or 110 mg/kg/day.
Animals were sacrificed on day 28 of gestation and litters were delivered by Cesarean section.
The NOEL and LOEL for maternal toxicity were 10 and 35 mg/kg/day, respectively.
Maternal toxicity was based on decreases in brain (38%) and red blood cell (20%)
cholinesterase activity and on abortion. The NOEL and LOEL for developmental toxicity
were 35 and 110 mg/kg/day, respectively. Developmental toxicity was based on an increase
in the number of does with resorptions, decreased fetal body weights in males and delayed
ossification, primarily in the first sternebrae (GLN 83-3(b), MRID 41565201).
In a developmental toxicity study in pregnant Sprague Dawley rats, trichlorfon was
administered in the diet at dose levels of 0, 500, 1125 or 2500 ppm (equivalent to 0, 45, 102
and 227 mg/kg/day, respectively) from days 6 through 15 of gestation. The NOEL for
developmental and maternal toxicity was less than 45 mg/kg/day based on the observed
decreases in cholinesterase activity (levels not provided) at this dose level in mothers and
reduced ossification of skulls, vertebrae and sternebrae in fetuses (GLN 83-3(a),MRID
40255601).
e. Reproductive Toxicity
In a two-generation reproduction study conducted in Sprague Dawley rats, trichlorfon
was administered at doses of 0, 150, 500 or 1750 ppm (equivalent to 0, 15, 50 and 175
mg/kg/day, respectively). Parental toxicity was observed at the lowest dose tested and was
based on decreases in plasma in F0 animals (24% lower than controls) and brain
cholinesterase activity in both generations (12% for F0 and 14% for Fx when compared to
controls). In the F0 generation, females had chronic pneumonia and in the Fx generation,
10
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pulmonary and renal lesions were present in high dose animals of both sexes. The pulmonary
lesions consisted of chronic pneumonia characterized by thickened alveolar septa,
macrophage accumulation, cholesterol clefts, pneumocyte hyperplasia and neutrophilic
infiltration. Renal lesions consisted of mineralization and hydronephrosis. The reproductive
NOEL was 500 ppm (50 mg/kg/day) and was considered to be a reproductive/systemic NOEL
based on the fact that reproductive effects appeared to be secondary to the systemic toxicity of
the compound. The reproductive LOEL was 1750 ppm (175 mg/kg/day) based on the
presence of dilated renal pelvises in pups in Fx generation and decreased weight of Fx pups on
days 7 and 21 (GLN 83-4, MRID 422283-01).
f. Mutagenicity
In gene mutation assay with Salmonella typhimurium, trichlorfon was found to be
weakly mutagenic at toxic concentrations with or without activation (MRID 249535). In a
gene mutation assay conducted with S. cerevisiae, trichlorfon was not mutagenic at levels up
to 10,000 |ig/ml, in either the presence or absence of activation (MRID 256446). In another
gene mutation assay, with Salmonella and E-coli, trichlorfon was tested at doses from 1 |ig to
10,000 |ig/plate. Trichlorfon induced reversions in Salmonella at doses greater than 5 mg and
in E-coli at doses greater than 1.0 mg (GLN 84 Series, MRID 00028625).
In an in vitro cytogenetic study in mammalian cells, trichlorfon, at doses ranging from
1 to 145 |ig/ml, induced significant increases in mutation frequencies both with and without
activation (MRID 00256446).
In an unscheduled DNA synthesis study, trichlorfon was inactive in inducing
unscheduled DNA synthesis in rat hepatocytes up to levels of severe cytotoxicity (doses not
specified) (MRID 00028625, HED doc. 003267).
Trichlorfon (doses not stated) was positive for DNA damage and repair in S.
typhimurium, but was negative in relative toxicity assays with E. coli and B. subtilis strains
(MRID 00028625, HED doc. 003267).
In a DNA damage and repair study conducted with S. cerevisiae, trichlorfon was
positive for mitotic recombination in the presence and absence of S-9 activation at
concentrations from 10 to 50 mg/Ml (MRID 00028625).
At cytotoxic levels of 1,000 ng/ml, trichlorfon was associated with a marginal but
significant increase in sister chromatid exchange in Chinese hamster ovary cells (HED doc.
003267).
Trichlorfon was demonstrated to be clastogenic in human lymphocytes in the absence
of S9 activation at doses of 3, 10 or 30 |ig/ml (HED Doc. 008481).
11
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In a recombinant DNA study conducted at doses of 3, 30 or 300 mg, trichlorfon did
not inhibit the growth of Bacillus subtilis (MRID 00256446).
g. Metabolism
A metabolism study was conducted in rats using four treatment regimes (single dose of
0.2 mg/kg in water by gavage; single dose of 20 mg/kg in water by gavage; ten gavage doses
of 0.2 mg/kg in water followed by the radio-labeled compound in water at a dose of 0.2
mg/kg; and single intravenous dose of 0.2 mg/kg into the tail vein). The data collected from
the four regimes demonstrated that 80-90% of the test material was excreted within 24 hours.
The major route of excretion was via the urine, followed by feces and expired air. One to 2%
of the dose was found in the tissues after 96 hours. In this study, the metabolites were not
adequately characterized. This study was classified as supplementary, but information was
reported which could be used for regulatory purposes (GLN 85-1, MRID 40438101).
In a 1992, International Programme on Chemical Safety (IPCS) Environmental Health
Criteria publication on trichlorfon, it is stated that trichlorfon rearranges to form dichlorvos
via dehydrochlorination. The main metabolites of trichlorfon found in mammals were
dimethyl trichlorfon, dimethyl dichlorvos, dimethyl hydrogen phosphate, methyl hydrogen
phosphate and phosphoric acid. The main degradation routes of trichlorfon are
demethylation, P-C bond cleavage and ester hydrolysis.
h. Neurotoxicity
Acute and subchronic neurotoxicity studies in mammalian species (GLN 81-8 and 82-
5) have been required and are currently underway; these studies are considered confirmatory
for the purposes of reregi strati on.
In a 90-day neurotoxicity study conducted in hens, trichlorfon was administered at
dose levels of 0, 3, 9 or 18 mg/kg/day. In this study, there were no overt indications of a
response characteristic of delayed neurotoxicity; however, histologically, a slight effect on
nervous tissue, characterized as axonal degeneration was present in hens receiving 18
mg/kg/day. Based on this finding, the NOEL for neurotoxicity was 9 mg/kg/day (GLN 82-5,
MRID 40351201 and 40879301).
i. Reference Dose
A Reference Dose (RfD) of 0.002 mg/kg/day was established based on the results of a
ten year chronic feeding study in monkeys in which a NOEL was not determined and a LOEL
of 0.2 mg/kg/day was established. The OPP RfD Peer Review Committee (PRC) considered
the inhibition of plasma red blood cells and brain cholinesterase in the monkeys at 0.20
mg/kg/day to be a marginal response. The Committee concluded that the LOEL could be
used for risk assessment purposes if an uncertainty factor of 100 was considered when
12
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establishing the RfD. One-hundred was chosen as the uncertainty factor based on the lack of
a NOEL, the inter-species extrapolation and intra-species variability. The OPP RfD Peer
Review Committee recommended review of trichlorfon by the OPP Carcinogenicity Peer
Review Committee.
The FAO/WHO recommended a chronic dietary RfD as a range between 0 and 0.01
mg/kg/day; however, the OPP PRC has deemed the OPP RfD of 0.002 mg/kg/day to be
appropriate and will be retained for chronic dietary analysis.
j. Toxicological Endpoints for Risk Assessment
The OPP Less Than Lifetime Committee determined that an occupational or
residential short term and intermediate term exposure assessment would be required based on
the results of a 21-day dermal toxicity study in rabbits in which the systemic NOEL was 100
mg/kg/day.
Based on the existing food use, i.e. the dermal pour-on to cattle, an acute dietary
toxicity endpoint was established for trichlorfon at 2.5 mg/kg bw/day from a single dose
clinical trial in humans conducted in 1990 (reported in a FAO/WHO monograph). Clinical
signs, such as vomiting, nausea, and diarrhea were reported as well as plasma and RBC
cholinesterase inhibition at 5 mg/kg/day, the LOEL. The NOEL for the study was 2.5
mg/kg/day.
On April 6 and August 31, 1994 the OPP Carcinogenicity Peer Review Committee
(CPRC) determined that based on the evidence presented, trichlorfon should be classified as a
Group E chemical - no evidence of carcinogenicity for humans. This decision was based on
the results of two animal studies in different species (mouse and rat). In the rat, although
there were statistically significant increases in tumors (lung and kidney) these occurred only
at a dose which the CPRC considered to be excessive. Although tumors of the lung were also
seen in female mice, at doses considered to be adequate, the CPRC did not consider these to
be compound-related since the increases seen at the low and mid-doses resulted in a flat dose-
response curve and were not sustained at the high dose. The increase in pheochromocytomas
seen in male rats in the multi-dose study was not confirmed in the single higher dose study.
Trichlorfon, Dichlorvos (DDVP) and Naled are structurally related organophosphate
insecticides. DDVP has been classified as a Group C chemical, possible human carcinogen,
by the CPRC and the Scientific Advisory Panel. Naled has been classified as a Group E
chemical, no evidence of carcinogenicity for humans. The structural relationship of these
chemicals was taken into consideration by the CPRC when classifying trichlorfon.
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k. Other Toxicological Considerations
Studies have been conducted to determine the toxicity of trichlorfon to various species
of livestock such as sheep and cattle. Trichlorfon caused red cell cholinesterase depression
(level not specified) in cattle and sheep. This cholinesterase depression was associated with
clinical signs, also unspecified (HED Doc 003267).
Antidotal studies have also been conducted to determine the effectiveness of 2-PAM
and atropine in cases of trichlorfon poisoning. An intraperitoneal injection of 2-PAM at doses
of 50 mg/kg protected against death in rats receiving trichlorfon at doses of 480 or 600 mg/kg.
Atropine sulfate at doses of 100 mg/kg counteracted doses that were three times the LD50 in
mice (MRID 00081337, 00090786, 00081186; HED Doc. 003267).
2. Exposure Assessment
a. Dietary
Bayer Corporation, the producer of trichlorfon, has voluntarily canceled the food, feed
and field crop uses of trichlorfon. A voluntary request for label amendments deleting these
uses was published in the Federal Register (FR Vol. 57, No. 214, 11/4/92) and final comment
period ended November 21, 1995. Bayer Corporation has also requested voluntary
cancellation of the dermal pour-on use registrations, supporting only the tolerance for
imported cattle meat, cattle fat and cattle meat by-products.
The only expected dietary exposure to trichlorfon residues will be in the form of
imported cattle meat and by-products. The current tolerance for these commodities is set at
0.1 ppm. Residue and metabolism data are required to reassess the tolerances, specifically,
dermal metabolism in cattle (171-4), magnitude of the residue for meat (171-4), residue
analytical method (171-4), and storage stability (171-4). Treatment of some of the non-food
use sites could possibly result in residues on food and feed items (i.e. food handling
establishments and livestock premises). The Agency has imposed, and will continue to
impose label restrictions designed to preclude the occurrence of such residues.
Limited residue data were available to perform risk assessments for the current
tolerances for cattle meat, fat and meat-by-products (1967, PP7F0612). These data indicate
that beef cattle sprayed consecutively for 34 days with 0.04 oz. active ingredient per animal
(avg. animal weight of 850 lbs) had a maximum residue level in fat, edible organs or steak of
0.02 ppm of trichlorfon, a level five times lower than the current established tolerances of 0.1
ppm for these commodities. Although the data were classified as valid, they do not represent
the current application rate. The current maximum label rate is approximately 0.06 oz active
ingredient per 200 lb animal, which is almost 7 times higher than the single daily application
rate used in the study.
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Although the application rate used in the study is lower than the expected actual use,
the study provides an estimate of possible residues. The residues found after 34 consecutive
days of application were five times lower than the current tolerance. Based on this, and the
fact that in actuality treatment would not occur daily and there is a 21 day pre-slaughter
interval, the Agency concludes that tolerances of 0.1 ppm are appropriate for risk assessment
purposes for the time being, until data are generated to reassess the tolerances.
Tolerances for residues of trichlorfon in/on food and feed items are currently
expressed in terms of trichlorfon [dimethyl (2,2,2-trichloro-l-hydroxyethyl) phosphonate] per
se [40 CFR §180.198], These tolerances range from 0.01 ppm (milk) to 240 ppm (range grass
and hay). A feed additive tolerance of 2.5 ppm has been established for this same residue in
dried citrus pulp [40 CFR §186.2325],
b. Occupational and Residential
Trichlorfon is currently registered for many terrestrial non-food indoor and outdoor
uses. Trichlorfon may be applied using a cup (as a pour-on to livestock or to "sprinkle" or
pour bait formulations), high-pressure hand-held sprayer, groundboom sprayer, hydraulic
low-pressure sprayer, irrigation system, watering can (to pour dissolved bait), aircraft or
granular spreader (chest mounted or push-type). (See Use Profile, page 2). Application
methods used for terrestrial food scenarios have not been included because the recent
voluntary cancellation of these uses has been finalized. Also not included in the occupational
and residential exposure analysis is the sod farm use scenario, application by aircraft or chest
mounted granular spreaders. These were determined in preliminary analysis to have
unacceptable MOE's. As a result of the preliminary analysis, the registrant agreed to
voluntarily cancel the sod farm use and prohibit aerial and chest mounted type spreader
applications through appropriate label restrictions. (Note: currently there are no trichlorfon
products that include label instructions for aerial application, nor specific aerial prohibition).
Occupational-use Products and Home-use Products: At this time, there are products
containing trichlorfon that are intended primarily for occupational use as well as some
intended primarily for homeowner use.
Summary of Toxicity Concerns Impacting Occupational and Residential Exposure:
Guideline studies for acute toxicity indicate that trichlorfon is classified as category II for
acute oral toxicity, category III for acute dermal toxicity, category IV for acute inhalation
toxicity, category III for eye irritation potential and category IV for skin irritation potential.
It is classified as a moderate contact allergen. The NOEL of 100 mg/kg/day (based on
cholinesterase inhibition) from the 21-day dermal rabbit study (MRID 40306901) has been
identified as a toxicological endpoint appropriate for short-term and intermediate term
occupational and residential exposure assessment.
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Summary of Potential Occupational and Residential Exposure: An occupational and/or
residential exposure assessment is required for an active ingredient if (1) certain toxicological
criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders,
applicators) during use or to persons entering treated sites after application is complete. EPA
has determined that there is potential exposure to mixers, loaders, applicators, and other
handlers during the usual use-patterns associated with trichlorfon. EPA specifically is
concerned with potential exposures arising from: mixing and loading soluble powder
formulations, application with a high-pressure hand-held sprayer, application with
groundboom sprayer, and from mixing/loading/applying (one person) by cup, granular
spreader, or watering ("sprinkler") can.
Based on the use-patterns and potential exposures, several exposure scenarios were
analyzed for trichlorfon: (1) mixing/loading the soluble powder formulation to support
typical (40-acre per day) applications, including average golf courses or supporting several
(8-acre per day) commercial turfgrass applicators, (2) mixing/loading the soluble powder
formulation to support typical (1,000 gallons per day) applications to ornamentals, including
greenhouse and nursery sites (3) applying (1,000 gallons per day) with a high-pressure
handwand sprayer, (4) applying with a hydraulic low-pressure handwand sprayer (commercial
turfgrass sprayer), (5) applying (40 acres per day) with a groundboom sprayer, (6)
mixing/loading/applying dry bait using a cup, (7) mixing/loading/applying the bait as a liquid
using a watering-can type method, (8) mixing/loading/applying with a chest mounted rotary-
type ("belly-grinder") granular spreader by a commercial applicator (8 acres per day) or by
homeowner (1 acre per day), and (9) mixing/loading/applying with a push-type granular
spreader by a commercial applicator (8 acres per day) or by homeowner (1 acre per day). The
exposure scenarios are presented in Table 2 along with the corresponding exposure
assessment.
Daily exposure is calculated using the following formulas:
• Daily Dermal Exposure (mg/day)
= Unit Exposure (mg/lb ai) X Appl. Rate (lb ai/area) x Area (or Volume) Treated
(A/day)
• Daily Inhalation Exposure (mg/day)
= Unit Exposure (mg/lb ai) X Appl. Rate (lb ai/area) x Area (or Volume) Treated
(A/day)
These calculations of daily exposure to trichlorfon by handlers are used to assess the
risk to those handlers and are summarized in Table 2.
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Table 2. Occupational and Homeowner Exposures to Trichlorfon
Exposure Scenario (Seen. #)
Baseline Dermjjl
Unit Exposure
(mg/lb ai)
Baseline Inhalation
Unit Exposure
(Mg/lb ai)
Crop and
Application Rate
(lb ai/acre)
Daily Acres
Treated
Daily Dernjal
Exposure
(mg/day)
Daily Inhalation
Exposure
(mg/day)
Daily Tot^l
Exposure
(mg/day)
Mixer/Loader Exposure
Soluble Powder - Golf Course (1)
3.8
43.4
8.2
40
1,246
4.2
1,260
Soluble Powder - Ornamentals (2)
15 lb ai/1,000
gallons
1,000 gallons
57.0
0.65
57.7
Applicator Exposure
High Pressure Handwand (3)
1.8
78.6
15 lb ai/1,000
gallons
1,000 gallons
27.0
1.18
28.2
Hydraulic Low Pressure Handwand (4)
No data
No data
No data
No data
No data
No data
No data
Groundboom - Golf Course (5)
0.02
0.7
8.2
40
6.6
0.23
6.8
Mixer/Loader/Applicator Exposure
Cup (6)
No data
No data
No data
No data
No data
No data
No data
Watering Can (7)
No data
No data
No data
No data
No data
No data
No data
Belly Grinder/Chest Mounted Rotary Spreader
(8)
(H) 10.4
61.8
8.1
(H) 1
(O) 8
(H) 84.2
(O) 674.0
(H) 0.50
(O) 4.0
(H) 84.7
(O) 678.0
Push-type Granular Spreader (9)
(H) 2.9
6.3
8.1
(H) 1
(O) 8
(H) 23.5
(O) 187.9
(H) 0.05
(0)0.41
(H) 23.6
(O) 188.3
Note: Originally sod farms were listed as a registered use; however, the registrant has voluntarily proposed to discontinue this use based on preliminary exposure/risk assessment that indicated unacceptable risks.
a Baseline dermal unit exposure (mg/lb ai) is for single layer clothing and no gloves,
b Baseline inhalation unit exposure (ug/lb ai) is for no respirator.
c Daily Dermal Exposure (mg/day) = Dermal Unit Exposure (mg/lb ai) * Max. Appl. Rate (lb ai/acre) * Max. Treated (acres),
d Daily Inhalation Exposure (mg/day) = Inhalation Unit Exposure (mg/lb ai) * (lmg/lOOOug) conversion * Max. treated
e Daily Total Exposure (mg/day) = Daily Dermal Exposure + Daily Inhalation Exposure.
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Post-application Exposure: EPA has determined that there is potential exposure to persons
entering treated areas after application is complete. EPA is particularly concerned with
potential post-application exposure arising from re-entry into treated greenhouses and treated
outdoor ornamental (nursery) and turfgrass sites. Post-application exposures to treated non-
sod-farm turf (turf in residential, golf-course, recreational areas, etc.) should be somewhat
minimized by a requirement for watering-in all turf applications, thus moving trichlorfon into
the soil. This mitigation would not greatly reduce the exposure for sod-farm workers who
must have contact with the soil subsurface. The Agency is concerned with the potential
exposure to children and pets from the residential uses of the bait formulations; upon
recommendation of the Agency the registrants have agreed to voluntarily cancel the
residential lawn use and prohibit the use of the bait from indoor use unless housed in
prepackaged child resistant bait stations. Post-application concerns from sites other than
turfgrass and ornamentals are expected to be minimal due to the limited frequency, duration,
and degree of exposure following such applications.
EPA has no active-ingredient-specific data upon which to assess the post-application
exposures to trichlorfon.
3. Risk Assessment
a. Dietary
Toxicological Endpoints: The chronic dietary exposure analysis used a Reference Dose
(RfD) of 0.002 mg/kg/day calculated from the LOEL of 0.2 mg/kg/day from a chronic feeding
study in Rhesus monkeys. The effect observed, decreased brain cholinesterase activity, was
marginal and considered to be a threshold effect. Therefore, an uncertainty factor of 100 was
applied to account for interspecies extrapolation and intraspecies variability. Trichlorfon has
been classified as Group E, no evidence of carcinogenicity in humans, by the OPP
Carcinogenicity Peer Review Committee.
An acute dietary risk assessment was conducted using the NOEL of 2.5 mg/kg body
weight/day from a single dose clinical trial in humans. At the LOEL (5 mg/kg body
weight/day), plasma and RBC cholinesterase inhibition were observed, and clinical signs of
nausea, vomiting and diarrhea were reported.
Residue Data: Although the Agency anticipates revocation of all existing crop food/feed
tolerances for trichlorfon, these tolerances have not yet been revoked. Therefore, chronic and
acute dietary risk assessments represent all published uses for trichlorfon. Reassessment of
the cattle meat, cattle fat and cattle meat by-products will be performed when the required
residue data are submitted within 24 months.
18
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Chronic Dietary Risk Assessment: The Agency performed a dietary risk assessment on the
published tolerances for trichlorfon. The chronic dietary analysis used tolerance level
residues to calculate the Theoretical Maximum Residue Contribution (TMRC) for the overall
U.S. population and 22 population subgroups. The dietary analysis was conducted at
tolerance levels and assumed 100% crop (or cattle) treated. No refinements to the trichlorfon
residue data were incorporated in the dietary analysis, including anticipated residues or
percent crop treated data.
The TMRC for the U.S. population from the published uses of trichlorfon is 1.79 x 10"3
mg/kg body weight/day which represents 89.35% of the RfD. The TMRC's from published
tolerances for the two most highly exposed subgroups, children (1-6 years old) and non-
nursing infants (<1 year old) are 4.20 x 10"3 and 4.71 x 10"3 mg/kg body weight/day,
respectively. These exposure estimates represent 209.11% and 235.34%) of the RfD,
respectively. Four other subgroups (Hispanics, non-Hispanics others, nursing infants, and
children (7-12 years old) also have exposure estimates exceeding the RfD. Generally,
exposure estimates in excess of the RfD indicate a potential risk concern.
The TMRC for meat, fat and meat by-products from cattle treated by the pour-on
method (the only use supported for imported meat) with trichlorfon was calculated using the
current cattle tolerances. The TMRC for the U.S. population is 1.58 x 10"4 mg/kg body
weight/day, representing 7.91% of the RfD. The TMRCs for the two highest exposed
subgroups, children (1-6 years old) and non-nursing infants (< 1 year old), are 2.87 x 10"4 and
1.46 x 10"4 mg/kg body weight/day, representing 14.33% and 1.32% of the RfD, respectively.
These estimates indicate that the pour-on use does not present a risk concern based on the
current published tolerances because the exposure estimates do not exceed the RfD; however
residue data are extremely limited for beef products. As noted previously, the only tolerance
that will remain for trichlorfon is for the import of cattle products. Since the above dietary
risk assessment included domestic usage of trichlorfon, the residue contribution of imported
beef only would result in a lower percent utilization of the RfD. The Agency is requiring that
the necessary residue data needed to reassess the tolerances be submitted within 24 months.
For details regarding this issue please see Part IV, C.l. Tolerance Reassessment.
Acute Dietary Risk Assessment: The detailed acute dietary exposure analysis evaluates
individual consumption as reported by respondents in the USDA 1977-78 Nationwide Food
Consumption Survey (NFCS) and estimates the distribution of single day exposures through
the diet for the U.S. population and certain subgroups. The analysis assumes uniform
distribution of trichlorfon in the commodity supply. Since the toxicological effect to which
the high end exposure is compared is cholinesterase inhibition, all standard population
subgroups are evaluated. The analysis includes the U.S. population - 48 states and four
subgroups: infants (< 1 year old), children (1-6 years old), females (13+ years) and males
(13+ years).
19
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The margin of exposure (MOE) is a measure of how closely the high end exposure
comes to the NOEL (the highest dose at which no effects were observed in the laboratory
test), and is calculated as the ratio of the NOEL to the exposure (NOEL/exposure = MOE).
For cholinesterase inhibition from a human study, the Agency generally accepts an MOE of
above 10 as not presenting a risk of concern.
In the analysis, tolerance level residues were used to calculate the exposure of the
highest exposed individual for the U.S. population and four population subgroups and
compared to the NOEL of 2.5 mg/kg body weight/day from a single dose clinical trial in
humans. The MOEs calculated for the U.S. population and four population subgroups are
summarized below.
Table 3: Acute Dietary Margins of Exposure based on Published Tolerances (excluding
Cattle Pour-on Use)
DRES Subgroup
MOE* (NOEL/High End Exposure)
U.S. population - 48 states
67
Infants (< 1 year old)
50
Children (1-6 years old)
50
Females (13+years)
100
Males (13+ years)
100
* An MOE of less than 10 indicates a potential risk concern.
The high-end MOEs for the published uses for trichlorfon are greater than 10,
indicating that there is little likelihood of an appreciable acute dietary risk due to the currently
registered uses of trichlorfon.
An acute dietary analysis was also conducted to estimate the potential risk presented
by the pour-on cattle use only. As for the chronic dietary analysis, the current tolerance level
for beef products of 0.1 ppm was used as the residue level for this analysis. The MOEs
calculated for the U.S. population and four population subgroups are as follows:
Table 4: The Acute Dietary Margins of Exposure based on Tolerances established for
the Cattle Pour-on Use Only
DRES Subgroup
MOE* (NOEL/High End Exposure)
U.S. population - 48 states
2000
Infants (< 1 year old)
2000a
Children (1-6 years old)
2000b
20
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DRES Subgroup
MOE* (NOEL/High End Exposure)
Females (13+ years)
5000b
Males (13+ years)
2500
*An MOE of less than 10 indicates a potential risk concern.
a 97th percentile estimate
b 98th percentile estimate
The estimated high-end MOEs for the pour-on use for trichlorfon are greater than 10,
suggesting that there is little likelihood of an appreciable acute dietary risk from the pour-on
use of trichlorfon based on the established tolerance.
Tolerances will be reassessed when the additional residue data are available. This
reassessment will be used to determine appropriate levels for tolerances with no U.S.
registration. If these data are not submitted within two years for tolerance reassessment, the
tolerances will be proposed for revocation.
b. Occupational and Residential Risk
There is a potential for mixer/1 oader/applicator exposure via the inhalation and dermal
routes. The Margins of Exposure (MOE) for workers involved in handling these chemicals is
determined by the following equations:
• Daily Dermal Dose (mg/kg/day)
= Daily Dermal Exposure (mg/day) + Handler Body Weight (70 kg)
• Daily Inhalation Dose (mg/kg/day)
= Daily Inhalation Exposure (mg/day) + Handler Body Weight (70 kg)
• Dermal MOE
= NOEL (100 mg/kg/day) + Daily Dermal Dose (mg/kg/day)
• Inhalation MOE
= NOEL (mg/kg/day) + Daily Inhalation Dose (mg/kg/day)
The daily exposure values are provided in Table 2 of the occupational exposure/risk
assessment. The MOEs for handlers for the various scenarios involved with
mixing/loading/applying trichlorfon are provided in Table 5. For occupational and residential
exposure, the Agency generally accepts an MOE of above 100 as not presenting a risk of
concern.
21
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The MOEs for handlers wearing baseline personal protective equipment (i.e., long-
sleeve shirts, long pants, shoes, and socks) using trichlorfon are reasonable with the exception
of:
• Mixers and loaders handling the soluble powder formulation to support typical
area (40 acre) applications to turfgrass (i.e. golf courses);
• Commercial mixers/loaders/applicators handling granular formulations for
application with a push-type spreader; and
• Mixer/loader/applicators handling the granular formulation for application with
chest mounted rotary spreaders ("belly grinders").
As with any risk calculations, there are uncertainties associated with the assumptions.
The addition of personal protective equipment (PPE) or engineering controls could
adequately reduce the risk to an acceptable level for several of the handler scenarios:
• The risk to mixers and loaders handling the soluble powder formulation to
support typical area (40 acres per day) applications to turfgrass could be
adequately mitigated with the addition of chemical-resistant gloves;
• The risk to commercial mixers/loaders/applicators handling the granular
formulation for application to turfgrass using push-type spreaders could be
adequately mitigated with a double layer of bodywear protection and chemical-
resistant gloves.
Additional PPE or other mitigating efforts could not be utilized to bring unacceptable
MOE's of less than 100 up to an acceptable level for the following scenarios: 1)
mixing/loading and applying using chest-mounted rotary spreader ("belly-grinder")
equipment for both the occupational and homeowner uses, even with maximum PPE of
double layers of body protection, chemical resistant gloves and a dust/mist filtering respirator;
and 2) mixing/loading/applying for aerial application; and 3) mixers and loaders handling
soluble powder formulations to support large area applications (up to 500 acres per day; i.e.
sod-farms). Engineering controls consisting of water-soluble packaging are infeasible for
trichlorfon and, therefore, cannot be used to adequately reduce the risk to mixers and loaders
handling large quantities of the soluble powder formulation. The risk associated with aerial
applications could not be any reduced by practical means. Because of this unmitigatable risk,
the registrant has agreed to prohibit these uses and therefore they are not included in the
exposure or risk Tables.
Table 5 summarizes the dose and MOE values for the trichlorfon.
22
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Table 5: Occupational and Homeowner Risk from Trichlorfon
Exposure Scenario (Number)
Baseline Total
a
Dose (mg/kg/day)
I jascitic Dermal
MOE
Risk Mitigation Measures
C
Additional PPE
Dermal Unit
Exposure (mg/lb ai)
Inhalation Unit
Exposure (ug/lb ai)
Daily Total Qose
(mg/kg/day)
e
Total MOE
Mixer/Loader Risk
Soluble Powder - Turfgrass (1)
18.0
5.6
0.16 (gloves)
43.4
0.95
105
Soluble Powder - Ornamentals (2)
0.82
122
N/A
N/A
N/A
N/A
Applicator Risk
High Pressure Handwand (3)
0.40
250
N/A
N/A
N/A
N/A
Hydraulic Low Pressure Handwand (4)
No data
No data
No data
No data
No data
No data
Groundboom - Golf Course (5)
0.10
1,000
N/A
N/A
N/A
N/A
Mixer/Loader/Applicator Risk
Cup (6)
No data
No data
No data
No data
No data
No data
Watering Can (7)
No data
No data
No data
No data
No data
No data
Belly Grinder/Chest Mounted Rotary
Spreader (8)
(H) 1.21
(O) 9.69
(H) 83
(0)10
(H) None
(O) 4.2
(H) None
(O) 12.4
(H) None
(O) 3.9
(H) None
(O) 26
Push-Type Spreader (9)
(H) 0.34
(O) 2.69
(H) 294
(O) 37
(H) N/A
(O) 0.73
(H) N/A
(O) 6.3
(H) N/A
(0)0.68
(H) N/A
(O) 147
N/A = Not applicable since baseline MOE was over 100, indicating additional mitigation is not necessary.
None = No additional PPE possible.
a Baseline total dose = (daily dermal exposure + daily inhalation exposure)/70 kg.
b Baseline MOE = NOEL (100 mg/kg/day)/Baseline total dose.
c Additional PPE: Scenarios la and 4 = single layer clothing and chemical resistant gloves.
Scenarios 8 and 9 = coveralls over single layer clothing and chemical resistant gloves, plus a dust mist respirator (5-fold protection factor) applied to scenario 8.
d Additional PPE Daily Total Dose = Additional PPE Dermal Unit Exposure + Additional PPE Inhalation Unit Exposure * Application Rate * Acres Treated per day/70 kg
e Additional PPE MOE = NOEL/Additional PPE Daily Total Dose
23
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Risk From Post-application Exposures
Post-application concerns for applications to sites other than turfgrass and ornamentals
appear to be minimal and the anticipated frequency, duration, and degree of exposure
following such applications do not warrant risk mitigation measures.
The Agency concludes that risks from post-application exposures to treated turf could
be a concern (i.e. golf courses, ornamental lawns); however, post-application risks should be
adequately mitigated by a requirement for watering-in all turf applications and by restricting
entry until the treated turf had dried following the watering-in. The risk associated with the
sod-farm uses have been determined to be unacceptable and the use has been voluntary
canceled.
The potential risk to children and pets from exposure to the bait formulations is of
concern. Upon recommendation of the Agency, the registrants have agreed to voluntarily
cancel the residential lawn use of the baits and restrict indoor domestic use to products
prepackaged in child resistant bait stations.
The risk to workers from post-application exposures to treated ornamentals not being
grown for research or commercial use (ornamentals in parks, ornamental gardens, interior
plantscapes, etc.) should be adequately minimized by restricting entry until the treated surface
has dried, since the degree of exposure of the workers to residues remaining on such
ornamentals should be relatively infrequent and generally of short duration.
Post-application exposures to ornamentals (greenhouse and nursery) grown for sale are
a risk concern for entry immediately following applications. The Agency has determined that
post-application exposures do not appear to pose an unreasonable risk to persons entering
treated areas, as long as entry is not permitted until 24 hours after application. Therefore, for
all uses within the scope of the worker protection standard (ornamentals grown in
greenhouses and nursery), EPA is requiring:
• A restricted-entry interval (REI) of 24 hours, and
• Personal protective equipment for workers who enter the treated area before the
REI has expired.
Exposure Studies for Handlers (Mixers/Loaders/Applicators)
Requirements for mixer/loader/applicator (i.e.,handler) exposure studies are addressed
in Subdivision U of the Pesticide Assessment Guidelines. Mixer/loader/applicator exposure
studies were not required in the Guidance for the Reregi strati on of Pesticide Products
Containing Trichlorfon issued in June 1984. Review of the exposure data submitted to
support reregi strati on indicates that these data still are not warranted for most scenarios. As
noted in Table I and II, there are several scenarios for which there are no exposure data
24
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available, including application by hydraulic low-pressure handwand equipment, by cup, and
by watering can. Confirmatory exposure data are required for the hydraulic low-pressure
handwand equipment. [These data have been designated as confirmatory because the MOE's
for similar uses (i.e. high pressure handwand) are above 100],
For the two other scenarios (application by cup and watering can) for which there are
no data, it is anticipated that the amount of product handled using these techniques would be
less than that in a 'paintbrush' scenario. A paintbrush scenario was utilized as a surrogate
worse case scenario for the cup and watering can scenarios. With the addition of chemical
resistant gloves, the MOE was 286, indicating there is no risk concern. Therefore, data are
still not required for application using a cup or a watering can.
Two studies are required to provide data on applicators during ground applications
using hydraulic low-pressure handwand (turf) equipment. They are:
• A dermal exposure study (Guideline 231), and
• An inhalation exposure study (Guideline 232)
These studies should be conducted concurrently; i.e., dermal and inhalation samples should be
collected from the same worker and at the same site during each trial.
Exposure Studies for Post-Application
The current data are limited and additional data are needed to confirm that these uses
do not pose unreasonable risks to reentry workers. The greenhouse/nursery ornamental uses
and residential turfgrass uses are considered worst-case scenarios for post-application
exposures to trichlorfon. Data are not being required for the other post-application exposure
scenarios because it is anticipated that the exposure levels from these uses are lower than
those in the greenhouse/nursery ornamental and turfgrass scenarios.
Postapplication/reentry exposure data are needed to determine definitive REIs for the
occupational turfgrass and greenhouse/nursery use sites. The interim REIs established in this
document will be adjusted accordingly upon submission of the additional data. In addition,
data are needed to determine the post-application exposure following applications to turfgrass
at residential sites. Post-application/reentry studies are required as confirmatory data to
support the reregi strati on of trichlorfon, these are to be performed on the following sites:
• Greenhouse-grown ornamental plants, and
• Residential sites (turfgrass)
Requirements for postapplication/reentry exposure studies are addressed by
Subdivision K of the Pesticide Assessment Guidelines. The required data include:
25
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Guidelines: 132-l(a) Foliar Residue Dissipation
*133-3 Postapplication Dermal Passive Dosimetry Exposure
*133-4 Postapplication Inhalation Passive Dosimetry Exposure
^Guidelines 133-3 and 133-4 may be reserved at this time pending completion of the databases on agricultural and residential
postapplication/reentry exposure currently being developed by the Agricultural Reentry Task Force and Outdoor Residential Exposure Task
Force, provided the registrant is a member of both Task Forces.
C. Environmental Assessment
1. Ecological Effects
a. Ecological Effects Data
(1) Toxicity to Terrestrial Animals
In order to assess the toxicity of trichlorfon to birds, the minimum data required on the
technical material are: an avian single-dose oral (LD50) study on one species, preferably
mallard or bobwhite quail; a subacute dietary (LC50) study using one waterfowl species,
preferably the mallard duck; a subacute dietary (LC50) study using one upland game species,
preferably bobwhite quail or ring-necked pheasant.
(a) Avian Acute Toxicity
Based on acute toxicity data, technical grade trichlorfon is highly toxic to moderately
toxic to birds. The available data are adequate to assess the acute toxicity to birds (MRID
00073683, 00091969, 00160000).
Table 6.
Toxicity of Trichlorfon to Birds: Acute Toxicity
Species
%Active Ingredient
LD,„ (mg/kg)
Fulfills Guidelines?
Starling
TGAI
47
No1
Red-winged blackbird
TGAI
40
No1
Bobwhite quail
42.4% (TEP)
99
Yes2
Mallard duck
98
36.8
Yes
Bobwhite quail
98
22.4
Yes
California quail
98
59.3
No1
26
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Toxicity of Trichlorfon to Birds: Acute Toxicity
Species
%Active Ingredient
LD,„ (mg/kg)
Fulfills Guidelines?
Ring-necked pheasant
98
95.9
No1
Rock dove
98
123
No1
1 The Agency restricts the species that can be used to fulfill guideline requirements. Toxicity data on
other species may be considered scientifically valid and used in the ecological risk assessment.
2 Fulfills guideline requirement for testing with an End Use Product.
(b) Avian Subacute Dietary Toxicity
Based on studies performed with the technical grade, trichlorfon is classified as
moderately toxic to practically non-toxic to birds. The available data were determined to be
adequate to assess the toxicity of trichlorfon (MRID 00034769).
Table 7.
Toxicity of Trichlorfon to Birds: Subacute Dietary Toxicity
Species
%Active Ingredient
LC,n (ppm)
Fulfills Guidelines?
Bobwhite Quail
TGAI
720
Yes
Japanese Quail
TGAI
1901
No1
Ring-necked pheasant
TGAI
3401
Yes
Mallard Duck
TGAI
>5000
Yes
1 The Agency restricts the species that can be used to fulfill guideline requirements. Toxicity data on other
species may be considered scientifically valid and used in the ecological risk assessment.
(c) Avian Chronic Toxicity
Avian reproduction studies were required for trichlorfon based on the permissibility of
multiple applications, which may result in chronic exposure. Two avian reproduction studies
show that there will be effects on reproduction at levels of trichlorfon as low as 30 mg/L
(MRID 43019601, 43119501).
27
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Table 8.
Toxicity of Trichlorfon to Birds: Measurements from Reproduction Studies
Species
%Active Ingredient
Toxicity (ppm)
Fulfills Guidelines?
Bobwhite Quail
99.8
NOEC= 9
LOEC= 30
Yes
Mallard Duck
99.8
NOEC= 27
Yes
(d) Toxicity to Mammals
A rat acute oral study resulted in an LD50 value of 400 mg/kg. A 3-generation rat
reproduction study had reproductive and maternal NOELs of 300 mg/L and an LOEL of 1000
mg/L (MRID 00128682).
(e) Toxicity to Honeybees
An acceptable study with the honey bee resulted in an estimated LD50 of 59.8 |ig/bee.
This indicates that trichlorfon technical has low toxicity to honey bees (MRID 00036935).
(2) Aquatic Animal Data
(a) Toxicity to Freshwater Fish
Acute toxicity measurements with the technical material trichlorfon (displayed below)
range from highly toxic to practically non-toxic to freshwater fish, while measurements with
formulated product indicate similar results with toxicity ranging from high to slight (MRID
05015393, 40094602, 40098001, 00091881, 00065497, 00091766, 00091942, 00091951).
Table 9.
Trichlorfon Toxicity to Fish: (I) Acute Measurements with TGAI
Species
%Active Ingredient
LC50 (mg/L)
Fulfills Guidelines?
Bluegill Sunfish
98
0.23
Yes
99
3.8
Yes
Largemouth Bass
98
3.4
Yes
F athead Minnow
98
7.9
Yes
99
51
Yes
99
110
Yes
28
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Trichlorfon Toxicity to Fish: (I) Acute Measurements with TGAI
Species
%Active Ingredient
LC50 (mg/L)
Fulfills Guidelines?
Striped Bass
80
2
No
Rainbow Trout
98
0.43
Yes
Cutthroat Trout
98
0.38
Yes
Brook Trout
98
0.24
Yes
Lake Trout
98
0.55
Yes
Channel Catfish
98
0.88
Yes
Black Bullhead
98
0.52
Yes
Goldfish
99
100
No1
Guppy
99
7.2
No1
1 The Agency restricts the species that can be used to fulfill guideline requirements. Toxicity data on other
species may be considered scientifically valid and used in the ecological risk assessment.
Table 10.
Trichlorfon Toxicity to Fish: (ii) Acute Measurements with Formulated Product
Species
%Active Ingredient
LC,n (mg/L)
Fulfills Guidelines?
Bluegill Sunfish
40EC
5.2
No
8
100
No
18.6
10
Yes
Cutthroat Trout
80 WP
3.25
No
Rainbow Trout
12.2
<37.1
No
80 WP
0.78
No
18.6
9.5
Yes
A fish chronic toxicity measurement (i.e., early life stage test) was required because
trichlorfon has high potential to be transported to aquatic habitats via runoff, has an LC50
below 1.0 mg/L, and has an EEC greater that 1% of the LC50. A study performed with a
99.6% active ingredient material on rainbow trout, resulted in a MATC between 110 and 160
|ig/L. This result was based on the impairment of growth and survival of juvenile rainbow
trout at concentrations greater than 110 |ig/L (MRID 42571701).
29
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(b) Toxicity to Freshwater Invertebrates
Several species of aquatic invertebrates were tested for acute toxicity to technical
trichlorfon. The results indicated that trichlorfon is very highly toxic to all tested species
except crayfish. Trichlorfon was found to be moderately toxic to crayfish.
Based on this high toxicity and the resultant estimated environmental concentration
(EEC) which was greater than the EC50, acute toxicity with the formulated product testing
was required. The studies submitted were not entirely acceptable based on Agency
guidelines. Nevertheless, these studies gave ample data to determine that the formulated
product is more toxic than the technical in those species tested; therefore, no further studies
are required (MRID 00065497, 40094602, 40228401, 40098001).
Based on the same criteria as noted for chronic fish testing, chronic toxicity to aquatic
invertebrates was required for trichlorfon. The acceptable study performed with Daphnia
magna resulted in a MATC between 5.6 and 8.6 ng/L. This result indicates that technical
trichlorfon will cause adverse chronic effects to aquatic invertebrates at concentrations greater
than 5.6 ng/L (MRID 40452601).
Table 11.
Trichlorfon Toxicity to Freshwater Invertebrates
Species
%Active Ingredient
EC50 (jig/L)
Fulfills
Guidelines?
(I) Acute Toxicity with TGAI
Water flea (S. serr.)
98
0.70
Yes
Water flea (D. pulex)
98
0.18
Yes
Scud (G. lacrustis )
98
40
No
Scud (G. pseudolimneus )
98
32
No
Crayfish
98
7800
No
Stonefly (P. badia)
98
11
No
98
5.3
No
StonefTy (P. calif. )
98
35
No
Stonefly (C. sabulosa)
98
22
No
Stonefly (Isogenus sp.)
98
24
No
Stonefly (A. pacific a)
98
16.5
No
30
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Trichlorfon Toxicity to Freshwater Invertebrates
Species
%Active Ingredient
EC50 (jig/L)
Fulfills
Guidelines?
(ii) Acute Toxicity with Formulated Product
Scud (G. pseudo.)
80
17.0
No
Stonefly (Isogenus sp.)
80 WP
12.0
No
(c) Acute Toxicity to Estuarine and Marine
Animals
Acute toxicity testing on estuarine and marine organisms was required for trichlorfon
based upon the turf use which may cause exposure to those habitats. The acceptable studies
were performed with fish and shrimp (72-3a,c) but an acceptable test for mollusks (72-3b) has
not been submitted. The measurements displayed below indicate that trichlorfon is very
highly toxic to moderately toxic to estuarine and marine animals (MRID 40098001,
40228401).
Table 12.
Acute Toxicity to Marine and Estuarine Animals
Species
%Active Ingredient
LC,n 0lg/L)
Fulfills Guidelines?
Pink shrimp
98
0.36
Yes
Eastern oyster
98
>1.0
No
Spot
98
>1000
No
Atlantic salmon
98
300
Yes
Chronic testing with estuarine and marine organisms is also required because
trichlorfon is expected to be transported to marine and estuarine habitats on a repeated basis
and has acute LC50 values below 1 mg/L. No studies have yet been submitted. An assessment
of chronic risk for marine and estuarine animals is based on MATC values for freshwater fish
and invertebrates.
(3) Terrestrial, Semi-Aquatic and Aquatic Plant Data
Nontarget plant testing is not required to support the currently proposed uses of
trichlorfon.
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b. Ecological Effects Risk Assessment
(1) Exposure to Terrestrial Animals
Birds and mammals may ingest trichlorfon granules directly and may ingest food
(vegetation, seeds, insects) contaminated with trichlorfon residues. The risk assessment is
based on the use of trichlorfon granular formulation on turf, which is the use with greatest
potential exposure to wildlife. The exposure assessment is based on a single application to
turf at the maximum label rate for the granular of 3.75 oz of product per 1000 square feet (i.e.
at a rate of 8.17 lb ai/A or 87.07 mg/ft2 applied as a granular broadcast or foliar spray). [The
granular bait formulation was not evaluated due to a lack of data. However, the registrant has
agreed to voluntarily cancel the lawn uses of the bait formulation, thus eliminating the need
for the bait specific risk assessment.]
The exposure estimate for direct ingestion of granules is 87.07 mg ai/ft2 for birds and
mammals. The exposure estimate for ingestion of trichlorfon residues on feed items is based
on the standard evaluation procedure (USEPA, 1986, 540/9-85-001):
• for short grass (comparable to turf) the EEC is given in mg/L by multiplying the
application rate (in lb ai/A) times 240, i.e. EEC = 8.17 x 240 = 1960.8 ppm; this
represents the worst case scenario for exposure. The value of 240 is the expected
concentration of pesticide on food (in ppm) when applied at a rate of 1 lb ai/A.
• for residues on seeds and insects the EEC is the application rate multiplied by about 12
ppm per lb/A applied, i.e. EEC = 8.17 x 12 » 100 ppm.
Multiple applications are permissible with trichlorfon on turf, but are not directly
addressed in the following terrestrial hazard assessment. The potential for repeated exposure
is taken into consideration when evaluating the overall risk of trichlorfon.
(a) Risk to Birds
Acute Toxicity Findings: Based on acute oral and subacute dietary testing, trichlorfon is
highly toxic to practically non-toxic to birds. LD50 values of 22.4 to 123 mg/kg, based on the
technical material, were obtained representing seven species; LC50 values of 720 to >5000
mg/L were obtained representing four species. An LD50 value of 99 mg/kg was determined
for bobwhite using a formulated product (42.4% active ingredient), indicating moderate
toxicity.
Acute Risk from Ingestion of Granules: Granular pesticides are a significant problem for
birds, which may ingest pesticide granules along with normal grit. Risk quotient values
(RQ=EEC/LD50) range from 1.28 to 21.1, corresponding to LD50 estimates from 22.4 mg/kg to
123 mg/kg, and an EEC of 8.17 lb ai/A (87.07 mg/ft2). For acute risk to birds the Agency
32
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generally accepts an RQ of 0.5 or greater as exceeding the Level of Concern (LOC).
Therefore, the use of granular trichlorfon on turf is expected to result in acute risk to birds.
[This does not include a risk analysis for the bait formulation, see III. C. 1. b.(l) above.]
Acute Risk from Residues on Feed: Acute risk is expected to birds that are exposed to
dietary residues on turf. Based on an LC50 value of 720 ppm (for bobwhite) and an EEC of
1960.8 ppm (for short grass) the RQ is 2.72, which exceeds the acute LOC of 0.5.
Chronic Risk from Residues on Feed: The avian reproduction Lowest Observable Effect
Levels (LOELs) for trichlorfon are 30 ppm for the bobwhite and 78 ppm for the mallard duck.
The EECs from the use of trichlorfon on turf are 1961 ppm for short grass and 100 ppm for
insects and seeds. The risk quotients (RQ = EEC/LOEL) are 65 and 3.3 for bobwhite, and 25
and 1.3 for the mallard. For chronic risk to birds, the Agency generally accepts an RQ of 1.0
or greater as exceeding the Level of Concern. Therefore, chronic hazard to birds is expected
from the turf use of trichlorfon.
(b) Risk to Mammals
Acute and chronic risk to mammals is based on potential ingestion of granules and/or
contaminated food items. [This does not include a risk analysis for the bait formulations, see
Avian risk analysis above for more details.] A rat acute oral study resulted in an LD50 value
of 400 mg/kg, which suggests that mammals are less sensitive to trichlorfon than birds.
Acute Risk from Ingestion of Granules: Based on the LD50 of 400 mg/kg and an EEC 8.17
lb ai/A (87.07 mg/ft2) the risk quotient is 2.13, which is greater than the LOC (0.5).
Acute Risk from Residues on Feed: An LC50 estimate was is determined for this scenario,
as no acute dietary mammalian data were available. An estimate was obtained by dividing the
LD50 by the fraction of body weight that an animal will consume in a day. For a 200 g rat that
consumes 10 g food per day, the LC50 is 8000 mg/L (= 400x200/10). The corresponding RQ
is 0.25 (= 1961/8000) which does not exceed the LOC of 0.5.
Chronic Risk: A 3-generation rat reproduction study resulted in reproductive and maternal
NOELs of 300 mg/L and a LOEL of 1000 mg/L. The EEC for short grass (1961 ppm)
exceeds the LOEL, but the EEC for insect and seeds (100 ppm) does not.
(c) Risk to Nontarget Insects
Trichlorfon is practically non-toxic to honeybees and therefore based on this data, the
Agency does not have a concern for exposed non-target beneficial insects.
33
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(2) Risk to Aquatic Animals
EEC values, risk quotients and LOC's are displayed in the table following; exceeded
levels of concern are indicated by shading. Exposure assessment for aquatic organisms is
based on application to turf at the maximum label rate of 3.75 oz product per 1000 square
feet, or 8.17 lb ai/A. EECs were calculated using the simulation models PRZM 1.0 and
EXAM 2.94.
The values displayed assess risk to marine and estuarine animals based on toxicity
measurements for freshwater animals. There is considerable uncertainty in these findings,
and chronic toxicity measurements are needed for marine/estuarine animals. The
development of the tabled values is described in greater detail subsequently, along with some
discussion of variation among species.
Levels of concern are exceeded for acute risk to freshwater, marine, and estuarine fish
and invertebrates. Chronic levels of concern are exceeded for freshwater invertebrates but
not for freshwater fish.
Table 13.
Level of Concern Determination for Aquatic Animals
Habitat
Invertebrate/
Fish
Acute/
Chronic
Toxic
Concentration
(H2/L Y
EEC(^g/L)
RQ =
(EEC/Toxic
Level)
LOCf
Freshwater
Invertebrates
Acute
0.18
224°
1244
0.58
Chronic
0.0071
54d
7606
1
Fish
Acute
230
224°
0.97
0.58
Chronic
135
24.7e
0.18
1
Estuarine/
Invertebrates
Acute
0.36
224°
622
0.58
Marine
Chronic
0.0071b
54d
7606b
1
Fish
Acute
300
224°
0.75
0.58
Chronic
135b
2A.T
0.18b
1
a EC50, LC50, or MATC (see text), for the most sensitive species tested,
b Toxicity value based on freshwater animals.
c 96-hour EEC
d 21-day EEC
e 60-day EEC
f There is a concern for risk if the RQ is equal to or larger than the LOC.
g LOC value for high risk; LOC = 0.1 for restricted use, 0.05 for endangered species.
34
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(a) Toxicity Summary for Aquatic Organisms
The available toxicity measurements for aquatic organisms are shown in the table
above.
Toxicity tests have been conducted with trichlorfon technical on 12 species of
freshwater fish and 10 species of freshwater invertebrates. For fish, LC50 estimates ranged
from 0.23 mg/L for bluegill sunfish to 110 mg/L for fathead minnow, indicating that
trichlorfon technical ranges from highly toxic to practically non- toxic to freshwater fish. For
invertebrates, EC50's ranged from 0.18 |ig/L for Daphniapulex to 7800 |ig/L for crayfish;
however, ten of eleven studies resulted in EC50 estimates indicating very high toxicity
(ECso<0.1 mg/L).
A freshwater fish early life stage test showed that trichlorfon technical causes adverse
effects to rainbow trout growth and survival at levels greater than 110 |ig/L. A life cycle
study with Daphnia magna showed that growth, survival, and reproduction were impaired
from trichlorfon at levels greater than 5.6 ng/L.
For marine and estuarine species, studies using trichlorfon technical resulted in LC50's
ranging from 0.36 |ig/L for pink shrimp to >1.0 mg/L for spot, indicating very high to
moderate toxicity.
Acute toxicity testing with formulated products (8-80% active ingredient) was
performed with 3 species of fish and 2 species of invertebrates. For fish, the LC50 values
ranged from 0.78 mg/L for rainbow trout to 100 mg/L for bluegill sunfish indicating high to
slight toxicity. For invertebrates tested with an 80% formulation, LC50s of 12 |ig/L for
stonefly and 17 |ig/L for scud resulted, indicating high toxicity.
(b) Aquatic Exposure
Exposure assessment is based on application to turf at the maximum label rate of 3.75
oz product per 1000 square feet, or 8.17 lb ai/A. The resulting estimated environmental
concentrations (EEC's) are displayed in the previous table. The EEC values correspond to
different durations of exposure: initially (immediately following a runoff event) and for
durations of 96 hours, 21 days, and 60 days.
In the exposure scenario, trichlorfon was applied on May 1, June 1, and July 1, to a 10
hectare grass covered field draining into a body of water with no outlet, with surface area 1
hectare and depth 2 meters. Spray drift from ground spray was 1% of applied active
ingredient. The EECs were calculated so that there is an estimated 10% probability of the
EEC being exceeded at the site in a given year, by the concentration averaged over a time
interval of particular duration (96 hrs, 21 days, or 60 days). For example, there is an
35
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estimated 10% probability that the 60 day EEC will be equaled or exceeded in a particular
year by the average concentration over 60 consecutive days, for the use site.
A high exposure scenario was specified in the model using input data from a turf farm
in Columbia County NY, in Major Land Resource Area (MLRA) 144B. Year to year
variation in meteorological variables for MLRA 144B was taken into account by relying on a
record of 36 years of data from weather station W14745 (Concord, NH). The site receives on
average about 93 cm of precipitation each year, of which about 19% becomes runoff. The
expected volume of runoff is greater than that of 90% of turf use sites. The soil is Sharkey
clay. Data for the Sharkey clay was taken from the PRZM database and the 1987 National
Resources Inventory. Soil Conservation Service curve numbers were generated based on the
hydrologic group and the plant cover (Wischmeier and Smith, 1972). Additional details of
the scenario and model parameters are specified in the EFED/EFGWB modelling summary.
(c) Acute Risk to Aquatic Organisms
Acute adverse effects are expected to occur to freshwater fish from the turf use of
trichlorfon. The lowest available LC50 measurement for a freshwater fish is 230 |ig/L for
bluegill sunfish. That value corresponds to a risk quotient of 0.97 which exceeds the LOC.
Risk quotients also exceed the LOC based on rainbow trout, cutthroat trout, and brook trout.
Adverse effects are expected to occur to a variety of freshwater invertebrates from the
turf use of trichlorfon. The lowest EC50 value for freshwater invertebrates (0.18 |ig/L for
water flea) results in a risk quotient of 1244, which greatly exceeds the LOC of 0.5. The
second highest ECS0 value (40 |ig/L for scud) also results in a risk quotient greater than the
LOC. The EC50 value for crayfish (7800 |ig/L) results in a risk quotient below the LOC, but
that species is obviously much less sensitive to trichlorfon than the other species tested.
LOCs are exceeded for marine and estuarine fish and invertebrates. Risk quotients for
estuarine and marine organisms range from 622 (pink shrimp) to 0.75 (Atlantic salmon) and
>0.3 (spot). All species tested, with the exception of spot, result in risk quotients exceeding
the LOC.
(d) Chronic Risk to Aquatic Organisms
The potential for chronic risk to aquatic organisms is determined by comparing the
MATC value (geometric mean of the NOEC and LOEC) to the appropriate EEC (21-day for
invertebrate life cycle and 60-day for fish early life). The 21-day EEC from ground
application is 54 |ig/L, and the 60-day EEC is 24.7 |ig/L. The risk quotient for fish, based on
the early life stage MATC of 135 |ig/L, is 0.18, which does not exceed the LOC of 1.0. The
risk quotient for invertebrates, based on the mean life cycle MATC of 0.0071 |ig/L is 7606 for
ground application, which greatly exceeds the LOC of 1.0.
36
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Based on these results there are chronic risk concerns for aquatic invertebrates
(freshwater, marine, and estuarine). The results do not indicate a concern for chronic risk for
freshwater fish. The results also do not indicate a chronic risk for marine and estuarine fish;
however, that finding is based on toxicity measurements from freshwater animals and so there
is substantial uncertainty regarding that finding. Data are required in order to confirm the risk
assumptions made for marine/estuarine fish.
(3) Risk to Plants
Hazard to nontarget plants (aquatic, semiaquatic, or terrestrial) is not expected from
the use of trichlorfon.
(4) Risk to Endangered Species
Terrestrial: Acute and chronic LOCs are exceeded for non-endangered species (birds and
mammals), and therefore are also exceeded for endangered species.
Aquatic: Acute LOCs are exceeded for non-endangered species (freshwater, estuarine, and
marine fish and invertebrates), and therefore are also exceeded for endangered species. By
the same reasoning, chronic levels of concern are exceeded for aquatic invertebrates
(freshwater, marine, and estuarine). Chronic levels of concern are not exceeded for fish.
2. Environmental Fate
The following categories of information are treated in this section: a review of studies
conducted to fulfill the environmental fate data requirements for registration; qualitative
characterization of environmental fate properties of trichlorfon based on synthesis of
information from studies reviewed; information from detections of trichlorfon and dichlorvos
in ground water. (Dichlorvos is a trichlorfon degradate and also a registered pesticide active
ingredient.)
Aquatic organisms will be exposed to trichlorfon in runoff and/or spray drift from
treated fields. Quantitative assessment of that exposure is summarized in the Ecological
Effects Risk Assessment.
a. Environmental Chemistry, Fate and Transport Data
Hydrolysis: Trichlorfon appears to be stable under acid conditions: the half-life was 31
minutes at pH 9 and 34 hours at pH 7, but was 104 days at pH 5. Degradates identified and
percent of applied radioactivity, at pH 5, 7, and 9 respectively, were DDVP (1.4% to 2.1%;
1.3% to 25.5%; 2.1% to 52.3%), desmethyl DDVP (2.4% to 10.5%; 1.5% to 11.9%; 1.0% to
10.5%), and dichloroacetaldehyde (0.7% to 7.7%; 3.5% to 22.7%; 0%) (MRID 00148974).
37
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Photodegradation in Water: Trichlorfon at 25 mg/L degraded in pH 5 sterile water with a
half-life of 110 days indicating that the compound is stable to photolysis in water. In the dark
control the half-life was 115 days. This corresponds with the 104 day hydrolytic half-life.
Identified degradates included DDVP (1.3 to 5.1%), desmethyl DDVP (3.4 to 8.9%), and
dichloroacetaldehyde (1.1 to 8.0%) (MRID 00148975).
Photodegradation in Soil: Trichlorfon at 65 mg/L did not degrade appreciably when applied
to the surface of a silt loam soil. There was very little difference in measured half-lives
between irradiated and non-irradiated samples: half-life estimates were 13 to 20 days for
irradiated samples and 10 to 13 days for non-irradiated samples. Degradates detected 20 days
after treatment, and percentages of applied radioactivity (for irradiated and non-irradiated
samples, respectively) were desmethyl DDVP (34.9% and 49.3%), DDVP (24.5% and
37.0%)), unextracted residues (6.3% and 8.0%), and volatiles (1.2% and 0.1%).
In another soil photolysis study, half-lives were reported to be 8.8 days for irradiated
soil samples and 10.5 days for non-irradiated soil samples. DM-DDVP comprised 48% to
54.4% of applied radioactivity, DDVP 3.1%> to 9.8%, unextractables 0.2% to 6.4%, and
volatilized compounds 0.1% to 10.9% (MRID 00157859).
Aerobic Soil Metabolism: Measurements of trichlorfon indicated rapid degradation; two
hours after application only 88% of the applied radioactivity remained as the active
ingredient. Small amounts of desmethyl TCF [methyl (2,2,2-trichloro-l-hydroxyethyl)
phosphonate] and DCA (dichloroacetic acid) were formed. Half-life was estimated at 6.4
days (MRID 42243701).
Metabolism of trichlorfon produced three acidic metabolites: DCA, TCA
(trichloroacetic acid), and HDCP (l-hydroxy-2,2-dichlorovinyl phosphate). DCA formed and
decreased rapidly, reaching a maximum concentration of 23% in approximately 3 days and
decreasing to 0% in 14 days or less. TCA reached a maximum concentration of 2% in 7 days
and decreased to 0% in 120 days or less. HDCP reached a maximum concentration of 11% in
approximately 65 days and at the 120 day sampling time represented 21% of applied
radioactivity. Carbon dioxide was approximately 64%. Bound residues increased from 3%
on Day 0% to 10% at Day 7, and remained constant at 10% to 11% for the rest of the study.
Further extraction of the soil-bound residues by acid reflux released less than 5%, which was
not characterized further (MRID 42243701).
In other studies, the half-life estimates ranged from 1 to 27 days depending on the soil
type. In two silt loam soils that were sterilized prior to application of trichlorfon, the half-life
was 20.5 days to over 40 days, compared to 4.5 to 10 days under-nonsterile conditions. This
suggests that microbial activity is responsible for degradation in nonsterile soils. The major
degradate was desmethyl DDVP (MRID 00098625).
38
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Anaerobic Soil Metabolism: Trichlorfon degraded rapidly (half-life 1.8 days) in an
anaerobic sandy loam soil. This rapid degradation following flooding was probably caused
by hydrolysis, and not by anaerobic soil metabolism alone, given that trichlorfon hydrolyses
rapidly. (The hydrolysis study indicates a half-life at environmental pH between 2 hours or
less and 34 hours.) The low Kd values (0.25 to 0.51) support the conclusion that trichlorfon
would partition into the water phase and be degraded by hydrolysis.
Carbon dioxide was 73% of applied radioactivity after 63 days. Minor metabolites
included glyoxylic acid, dichloracetic acid, and DDVP (dimethyl 2,2-dichlorovinyl
phosphate). DDVP was not over 1%, and was not detectable 3 after flooding (MRID
42243701).
Aerobic Aquatic Metabolism: Trichlorfon was applied at 1.0 mg/L to samples of pond
water and incubated for 24 hours. At pH 5.0 trichlorfon did not degrade significantly. At pH
8.5 trichlorfon degraded rapidly to DDVP and could not be detected after 8 hours. DDVP
concentrations peaked at 0.56 mg/L after 8 hours of incubation and declined to 0.39 mg/L
after 24 hours (MRID 40338602).
Leaching and Adsorption/desorption: In column leaching studies, trichlorfon residues
aged for 4 days (i.e., for one half-life) were mobile: over 93% of applied radioactivity was in
the leachate of sand, sandy loam, silt loam, and silty clay loam soil, leached with 25 inches of
water. Kd values for the four soil types ranged from 0.41 to 0.59. About 57% to 96% of the
radioactivity recovered in the leachate represented parent trichlorfon, DDVP was 0.40% to
34%, and desmethyl DDVP was 3.2% to 7% (MRID 40279302).
Laboratory Volatility: Trichlorfon was applied to a sand soil and incubated in a continuous
air-flow apparatus for 14 days. After incubation, 1% of applied radioactivity was trapped in
methanol as volatile organic compounds, 13% was trapped in NaOH as carbon dioxide, and
84% remained in the soil (MRID 40279302).
Terrestrial Field Dissipation: A terrestrial field dissipation study was conducted on four
plots in California. At three plots the reported application rate was not confirmed by analysis
of samples collected immediately after application. No meaningful conclusions can be
reached regarding the dissipation of trichlorfon in those plots because only about 0.73% to
3.4% of the applied trichlorfon was recovered. The fourth plot can be regarded as providing
supplemental information. In that plot 53.1% of the total residues were identified as parent
trichlorfon. The half-life was determined to be less than 0.2 days. No residues of trichlorfon
or DDVP were found below 6 inches depth in any sampling intervals, although irrigation was
applied over the time that residues were detected, i.e. to 7 days after application. At least two
residue-free depths were identified below the depths that contained trichlorfon residues
(MRID 42322501). An acceptable field dissipation must be submitted.
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Confined Crop Accumulation: Trichlorfon was applied at 30 lb ai/A and crops were
planted 30, 120, and 250 days after application. Residues ranged from 0.009 to 0.024 mg/L
for kale, from 0.018 to 0.624 mg/L for red beets, and from 0.005 to 0.52 mg/L for wheat.
Identification of degradates was difficult because of low concentration of residues and poor
extractability of residues in plant samples (MRID 403338602).
Droplet Size Spectrum and Field Drift: Data have not been submitted and are required as
confirmatory data.
b. Environmental Fate Assessment
Synthesis of Reviewed Environmental Fate Studies: Studies submitted to the Agency
provide sufficient information for a preliminary qualitative characterization of environmental
fate properties of trichlorfon.
Potential for contamination of surface and ground water by trichlorfon and trichlorfon
degradates (particularly DDVP) cannot be adequately assessed because acceptable field
dissipation data is not available. Potential to leach is suggested by findings of high mobility
in soil: Kd estimates of 0.25 to 0.50 were obtained for soils with texture varying from sand to
silty clay and organic matter content 0.5% to 5.1%.
Risk of contamination of surface and ground water may be moderated by rapid
degradation of trichlorfon in soil and water. It appears that hydrolysis and aerobic
metabolism are the main routes of dissipation in both soil and water. The major degradate in
both soil and water is DDVP (dimethyl 2,2-dichlorovinyl phosphate), with desmethyl DDVP
also reported as a degradate in soil. DDVP is itself a registered pesticide active ingredient.
Trichlorfon was found to degrade rapidly in non-sterile aerobic soils (half-life
approximately 1 to 27 days) but was stable in a sterile soil (half-life over 40 days). Studies in
pond water and sterile water indicate more rapid degradation at lower pH (higher acidity). In
pond water, trichlorfon degraded rapidly at pH 8.5 and room temperature (99% of applied
active ingredient degraded in 2 hours), but was stable when held at pH 5.0 for 2 hours. In
sterile water trichlorfon hydrolyzed rapidly at pH 7 and 9 (half-life 31 minutes at pH 9 and 34
hours at pH 7) but at pH 5 the half-life was 104 days.
The available data, from field studies that were not completely acceptable, suggested
that trichlorfon and DDVP may have little potential to contaminate ground water because they
degrade rapidly in soil. Acceptable field studies are needed.
Detections and Measurements of Trichlorfon in Ground Water: The EPA Pesticides in
Ground Water Database indicates that trichlorfon has been reported at concentrations 10 |ig/L
and higher in 12 of 179 wells in Georgia. However, these data are not useful for regulatory
purposes because of analytical uncertainties surrounding the detections. There were no
40
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detections of trichlorfon in 280 wells sampled in California, and no detections of DDVP in
188 wells sampled in California, Hawaii, and Indiana.
Exposure to Aquatic Organisms: Aquatic organisms will be exposed to trichlorfon in
runoff and drift from treated sites. The resulting risk is characterized in Ecological Effects
Risk Assessment based on Tier 2 exposure calculations using the PRZM and EXAM models.
IV. RISK MANAGEMENT AND RE REGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregi strati on of products containing trichlorfon. The Agency has completed its review of
these generic data, and has determined that the data are sufficient to support reregi strati on of
all products containing trichlorfon. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregi strati on eligibility of trichlorfon, and
lists the submitted studies that the Agency used to make its determination.
The data identified in Appendix B were sufficient to allow the Agency to assess the
currently supported uses of trichlorfon, and to determine that trichlorfon can be used without
resulting in unreasonable adverse effects to humans and the environment provided certain risk
mitigation measures are implemented. Nonfood uses, except sod farms and domestic lawn
use of the bait formulations, are being supported by the registrant. All food uses are not being
supported. The corresponding food use tolerances will be proposed for revocation, except
those currently established for cattle meat, cattle fat and cattle meat by-products which are
being supported for import purposes. The reregi strati on of particular products is addressed in
Section V of this document.
The Agency made its reregi strati on eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, etc. and the data identified in Appendix B.
Although the Agency has found that most nonfood uses of trichlorfon currently registered are
eligible for reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the registration
of products containing trichlorfon, if new information comes to the Agency's attention or if
the data requirements for registration (or the guidelines for generating such data) change.
41
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1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient trichlorfon, the
Agency has sufficient information on the health effects of trichlorfon and on its potential for
causing adverse effects in fish and wildlife and the environment. Where the potential for
adverse effects was identified, the Agency and the registrant agreed upon risk mitigation
measures. The Agency has determined that all trichlorfon products, labeled for non-food uses
as specified in this Reregi strati on Eligibility Decision, will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, the Agency concludes that products
containing trichlorfon are eligible for reregi strati on if labeling and other changes specified in
this document are implemented. Eligible uses are limited to indoor and outdoor uses on
nonfood and nonfeed sites. The use of trichlorfon on sod farms and the use of trichlorfon bait
formulations on residential lawns have been voluntarily cancelled by the effected registrants.
Also, the use of the bait formulations in indoor residential areas is prohibited unless
prepackaged in child resistant bait stations.
2. Eligible and Ineligible Uses
The Agency has determined that only indoor and outdoor non-food and non-feed uses
of trichlorfon are eligible for reregi strati on. These include golf courses; turf and ornamentals
(except sod and turf farms and also the use of bait formulations on residential lawns); animal
premises and kennels (non-livestock contact areas); mound treatment for ants to non-food and
non-feed areas; nonfood contact areas of food processing plants, grocery markets, commercial
and industrial premises; residential areas (bait formulations are prohibited from indoor
residential use unless housed in prepackaged child resistant bait stations). The terrestrial food
and feed crop uses have been voluntarily cancelled and request for voluntary cancellation has
been received for the dermal livestock treatment. The sod and turf farm use resulted in high
risk exposures for mixers, loaders and applicators and was voluntarily cancelled by the
registrant. Potential exposure to children and pets from the residential uses of the bait
formulations were a concern. The registrant with the residential bait uses on their label has
voluntarily cancelled the residential lawn use and has agreed to limit indoor residential use of
the bait to prepackaged child resistant bait stations. Data are being generated to reassess the
tolerances for cattle products to support their continuing import; all other tolerances will be
proposed for revocation.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for trichlorfon.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
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1. Tolerance Reassessment
The tolerances listed in [40 CFR §180.198] and [40 CFR §186.2325] are for residues
of trichlorfon in/on raw agricultural commodities, animal products, and feed commodities.
Voluntary cancellation of all food/feed uses was finalized in November 1995. The dermal
pour-on cattle treatment is in the process of being cancelled. The Agency is proposing to
revoke all tolerances for trichlorfon except those for cattle meat, cattle fat and cattle meat by-
products. The registrant is not supporting the domestic use of the cattle treatment but will
support the tolerances needed to continue the importation of cattle meat, cattle fat and meat
by-products. In order to reassess these tolerances additional residue data are required and will
be submitted within 24 months. The Agency has determined that the current tolerances of 0.1
ppm are protective of the public health for the estimated three year period of data generation
and review. Tolerances will be reassessed when the additional residue data are available.
This reassessment will be used to determine appropriate levels for tolerances with no U.S.
registration. If the data are not submitted within two years the Agency will propose
revocation of the cattle tolerances.
Table 14. Tolerance Reassessment Summary for Trichlorfon
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comments
Tolerances listed under 40 CFR §180.198
Alfalfa
60
Revoke
Alfalfa, hay
90
Revoke
Artichokes
0.1 (N)
Revoke
Bananas (NMT 0.2 ppm will
be present after the peel is
removed)
2
Revoke
Barley, forage
50
Revoke
Barley, grain
0.1 (N)
Revoke
Barley, straw
1
Revoke
Beans, dried
0.1 (N)
Revoke
Beans, lima (reflecting 0.1
ppm (N) in or on the shelled
beans)
12
Revoke
Beans, lima vine hay
12
Revoke
Beans, lima vines
12
Revoke
Beans, snap
0.1 (N)
Revoke
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Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comments
Beans, vines
1
Revoke
Beets
0.1 (N)
Revoke
Beets, sugar
0.1 (N)
Revoke
Beets, sugar, tops
12
Revoke
Birdsfoot trefoil, hay
90
Revoke
Blueberries
0.1
Revoke
Brussels sprouts
0.1 (N)
Revoke
Cabbage
0.1 (N)
Revoke
Carrots
0.1 (N)
Revoke
Cattle, fat
0.1 (N)
Data to reassess
submitted in 24
months, or
revocation
proposed.
Cattle, mbyp
0.1 (N)
Cattle, meat
0.1 (N)
Cauliflower
0.1 (N)
Revoke
Citrus fruit
0.1 (N)
Revoke
Clover
60
Revoke
Clover, hay
90
Revoke
Collards
0.1 (N)
Revoke
Corn, fodder
30
Revoke
Corn, forage
30
Revoke
Corn, fresh (including sweet
K + CWHR)
0.1 (N)
Revoke
Corn, grain
0.1 (N)
Revoke
Cottonseed
0.1 (N)
Revoke
Cowpeas
0.1 (N)
Revoke
Cowpeas, vines
1
Revoke
Flax, straw
1
Revoke
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Commodity
Current Tolerance
Tolerance
Comments
(ppm)
Reassessment (ppm)
Flaxseed
0.1 (N)
Revoke
Goats, fat
0.1 (N)
Revoke
Goats, mbyp
0.1 (N)
Revoke
Goats, meat
0.1 (N)
Revoke
Grass, pasture
60
Revoke
Grass, pasture, hay
90
Revoke
Grass, range
240
Revoke
Grass, range, hay
240
Revoke
Horses, fat
0.1 (N)
Revoke
Horses, mbyp
0.1 (N)
Revoke
Horses, meat
0.1 (N)
Revoke
Lettuce
0.1 (N)
Revoke
Milk
0.01(N)
Revoke
Oats, forage
50
Revoke
Oats, grain
0.1 (N)
Revoke
Oats, straw
1
Revoke
Peanuts
0.05 (N)
Revoke
Peanuts, vine hay
4
Revoke
Peanuts, vine hulls
4
Revoke
Peppers
0.1 (N)
Revoke
Pumpkins
0.1 (N)
Revoke
Safflower seed
0.1 (N)
Revoke
Sheep, fat
0.1 (N)
Revoke
Sheep, mbyp
0.1 (N)
Revoke
Sheep, meat
0.1 (N)
Revoke
Tomatoes
0.1 (N)
Revoke
Wheat, forage
50
Revoke
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Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comments
Wheat, grain
0.1 (N)
Revoke
Wheat, straw
1
Revoke
Tolerances listed under 40 CFR §180.2325
Dried Citrus Pulp
2.5
Revoke
2. Restricted Use Classification
Trichlorfon is not currently classified as a Restricted Use pesticide and the Agency is
not requiring any change in this classification.
3. Reference Dose and Cancer Classification
Reference Dose: A reference dose of 0.002 mg/kg/day was established based on the results
of a ten year chronic feeding study in monkeys in which the LOEL was 0.2 mg/kg/day. An
uncertainty factor of 100 was used based on the lack of a NOEL and to take into consideration
inter-species extrapolation and intra-species variability.
Cancer Classification: Trichlorfon has been classified as a Group E chemical - no evidence
of carcinogenicity for humans based on available data.
4. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will eliminate the adverse
impacts. The program would require use restrictions to protect endangered and threatened
species at the county level. Consultations with the Fish and Wildlife Service may be
necessary to assess risks to newly listed species or from proposed new uses. In the future, the
Agency plans to publish a description of the Endangered Species Program in the Federal
Register and have available voluntary county-specific bulletins. Because the Agency is
taking this approach for protecting endangered and threatened species, it is not imposing label
modifications at this time through the RED. Rather, any requirements for product use
modifications will occur in the future under the Endangered Species Protection Program.
5. Labeling For Non-Food Uses
In order to maintain use of trichlorfon in animal premises, barns etc., as a non food
use, labels must bear a statement prohibiting use in food or feed handling areas or where
livestock may gain access. Specific label language is found in Section V.
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6. Child Resistant Packaging
In order to maintain use of trichlorfon bait formulations in indoor residential areas, the
bait must be in prepackaged child-resistant bait stations. If the bait is not housed in child-
resistant packaging, the label must clearly state that the product is not for use in indoor
residential areas. Specific language is found in Section V.
7. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices
and State Lead Agencies for pesticide regulation to develop the best spray drift management
practices. The Agency is now requiring interim measures that must be placed on product
labels/labeling as specified in Section V. Once the Spray Drift Task Force completes their
studies, submits data, and the Agency evaluation is completed, there may be further
refinements in spray drift management practices.
8. Ecological Effects
The Agency has identified concerns for avian and aquatic species exposed to
trichlorfon when applied to turf sites. The Agency and the registrant agreed upon mitigation
measures that will greatly reduce the potential exposure to these organisms. These measures
include: prohibition of aerial application, prohibition of residential lawn use with bait
formulations, buffer strips from aquatic habitats, mandatory watering-in that will reduce
potential run-off to aquatic habitats as well as reduce exposure to avian species through
ingestion of granules or vegetative residues.
Aquatic levels of concern were exceeded by a large margin. However, the Agency is
confident that the mitigation efforts that have been established will minimize aquatic
exposure. The mandatory watering-in for turf and golf course uses will cause trichlorfon to
move into the soil, where trichlorfon is most efficacious, and degrades rapidly. The buffer
strips from aquatic habits will minimize any run-off that could occur after the watering-in.
These measures coupled with the drastically reduced acreage (eliminating sod farm and
food/feed uses) will minimize aquatic exposure.
Reproductive concerns for avian species (specifically, impaired egg shell thickness)
exposed to trichlorfon from turf applications have been addressed by consideration of a study
performed by Miles Inc. for the registration of an insecticide with a similar use pattern (MRID
No. 434665-02). The research indicated that species of concern (i.e. mallards, Canada geese
on golf courses and turf farms) apparently would not be exposed to trichlorfon (specifically
insecticides used for grub treatment) during the period of egg formation in the early Spring
months because the efficacious application time of trichlorfon is late Spring to early Summer.
Specific labeling language is found in Section V.
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9. Surface Water Advisory
Since trichlorfon can contaminate surface water through ground spray and run-off, a
surface water advisory is required. Specific language is found in Section V of this document.
10. Occupational/Residential Labeling Rationale/Risk Mitigation
The Worker Protection Standard
Scope of the WPS: The 1992 Worker Protection Standard for Agricultural Pesticides
(WPS) established certain worker-protection requirements (personal protective
equipment, restricted entry intervals, etc.) to be specified on the label of all products
that contain uses within the scope of the WPS. Uses within the scope of the WPS
include all commercial (non-homeowner) and research uses on farms, forests,
nurseries, and greenhouses to produce agricultural plants (including food and feed
crops). Uses within the scope of the WPS also include uses on plants and uses on the
soil or planting medium the plants are (or will be) grown in. At this time some of the
registered uses of trichlorfon are within the scope of the Worker Protection Standard
for Agricultural Pesticides (WPS) and some uses are outside the scope of the WPS.
Those that are outside the scope of the WPS may include the following uses (these are
not trichlorfon specific):
• on livestock or other animals, or in or around animal premises,
• on plants grown for other than commercial or research purposes, which may
include plant inhabitations, home fruit and vegetable gardens, and home
greenhouses,
• on plants that are in ornamental gardens, parks, golf courses, and public or
private lawns and grounds and that are intended only for decorative or
environmental benefit. (However, pesticides used on sod farms are covered by
the WPS),
• in a manner not directly related to the production of agricultural plants,
including, for example, control of pests in manure and garbage dump sites, in
poultry and red-meat packing plants, in inedible product areas of commercial,
industrial, institutional and food processing/preparation/handling/storage.
Compliance With the WPS: Any product whose labeling can be reasonably
interpreted to permit use in the production of an agricultural plant on any farm, forest,
nursery, or greenhouse must comply with the labeling requirements of PR Notice 93-7,
"Labeling Revisions Required by the Worker Protection Standard (WPS)," and PR
Notice 93-11, "Supplemental Guidance for PR Notice 93-7," which reflect the
requirements of EPA's labeling regulations for worker protection statements (40 CFR
part 156, subpart K). These labeling revisions are necessary to implement the Worker
Protection Standard for Agricultural Pesticides (40 CFR part 170) and must be
completed in accordance with, and within the deadlines specified in, PR Notices 93-7
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and 93-11. Unless otherwise specifically directed in this RED, all statements required
by PR Notices 93-7 and 93-11 are to be on the product label exactly as instructed in
those notices.
• After April 21, 1994, except as otherwise provided in PR Notices 93-7 and
93-11, the labeling of all products within the scope of those notices must meet
the requirements of the notices when the products are distributed or sold by the
primary registrant or any supplementally registered distributor.
• After October 23, 1995, except as otherwise provided in PR Notices 93-7 and
93-11, the labeling of all products within the scope of those notices must meet
the requirements of the notices when the products are distributed or sold by any
person.
Personal Protective Equipment/Engineering Controls for Handlers
For each end-use product, PPE requirements for pesticide handlers are set
during reregi strati on in one of two ways:
1. If EPA determines that no regulatory action must be taken as the result of the
acute effects or other adverse effects of an active ingredient, the PPE for
pesticide handlers will be based on the acute toxicity of the end-use product.
For occupational-use products, PPE must be established using the process
described in PR Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active ingredient must be taken
as the result of very high acute toxicity or to certain other adverse effects, such
as allergic effects or delayed effects (cancer, developmental toxicity,
reproductive effects, etc.):
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE requirements that pertain to all or most end-use
products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of the end-use
product.
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product.
Personal protective equipment requirements usually are set by specifying one
or more pre-established PPE units — sets of items that are almost always required
together. For example, if chemical-resistant gloves are required, then long-sleeve
shirts, long pants, socks, and shoes are assumed and are also included in the required
minimum attire. If the requirement is for two layers of body protection (coveralls over
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a long- or short-sleeve shirt and long or short pants), the minimum must also include
(for all handlers) chemical-resistant footwear and chemical-resistant headgear for
overhead exposures and (for mixers, loaders, and persons cleaning equipment)
chemical-resistant aprons.
Occupational-Use Products: EPA has determined that regulatory action regarding
the establishment of active-ingredient-based minimum PPE requirements for
occupational handlers must be taken for trichlorfon. The addition of baseline PPE is
necessary to adequately reduce risk to an acceptable level for three scenarios. (1) To
adequately mitigate risk to mixers and loaders handling soluble powder formulations,
such handlers must wear a single layer of body protection and chemical-resistant
gloves. (2) To adequately mitigate risk to commercial mixers/1 oaders/applicators
handling the bait formulations using a cup or watering can, such handlers must wear a
single layer of body protection and chemical resistant gloves. (3) To adequately
mitigate risk to commercial mixer/loader/applicators handling the granular
formulations using push-type granular spreaders, such handlers must wear a double
layer body protection and chemical-resistant gloves.
The addition of maximum PPE (double layer body protection, chemical-
resistant gloves, and a dust/mist filtering respirator) is insufficient to adequately
mitigate risk to homeowner or commercial mixer/loader/applicators applying granular
formulations using chest-mounted rotary spreaders ("belly-grinders"). No currently
available engineering controls are considered feasible for such a formulation and
application technique. The registrant has proposed to voluntarily prohibit the use of
chest-mounted rotary spreader application equipment.
The addition of maximum PPE is also insufficient to adequately mitigate the
risk to mixers and loaders handling soluble powder formulations to support large-area
(more than 40 acres per day; ie., sod and turf farms) applications. Also, engineering
controls — water soluble packaging — is infeasible for trichlorfon for the soluble
powder formulations. There was no sufficient mitigation for handlers and/or
applicators associated with aerial applications. The registrant has proposed voluntary
cancellation of the sod farm use and will prohibit the aerial application of trichlorfon.
WPS and NonWPS Uses: Since potential handler exposure is similar for WPS and
nonWPS uses, the requirements for active-ingredient-based minimum (baseline) PPE
applies to both WPS and nonWPS occupational uses of trichlorfon (specified in
Section V). These requirements must be followed in the labeling of all applicable
trichlorfon end-use products intended primarily for occupational use.
Homeowner-Use Products: EPA has determined that the risks are unacceptable for
homeowners applying the granular formulation using chest mounted rotary spreader
granular applicators. That risk could be adequately mitigated by requiring the
homeowners to wear chemical-resistant gloves. However, EPA is reluctant to require
50
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personal protective equipment for homeowners, except in special circumstances.
Furthermore, EPA believes the use of chest mounted rotary spreader application
equipment by homeowners is uncommon. Therefore, upon recommendation of EPA
the registrant is voluntarily prohibiting the use of chest mounted rotary spreader
application equipment for granular end-use products intended primarily for
homeowner use. The Agency has concerns for exposure to children and pets from
normal homeowner use of the bait formulations and is therefore requiring that these
products be sold in prepackaged child-resistant bait stations when intended for indoor
use. Also, upon recommendation of the Agency the registrants have agreed to
voluntarily cancel the domestic lawn use of the bait formulations.
EPA is not establishing minimum (baseline) handler PPE for trichlorfon end-
use products that are intended primarily for homeowner use, because the Agency has
determined that the risks for homeowner mixers/1 oaders/applicators (other than chest
mounted rotary spreader application) are acceptable without the addition of PPE.
Post-Application/Entry Restrictions
Occupational-Use Products (WPS Uses)
Restricted-Entry Interval: Under the Worker Protection Standard (WPS), interim
restricted-entry intervals (REI's) for all uses within the scope of the WPS are based on
the acute toxicity of the active ingredient. The toxicity categories of the active
ingredient for acute dermal toxicity, eye irritation potential, and skin irritation potential
are used to determine the interim WPS REI. If one or more of the three acute toxicity
effects are in toxicity category I, the interim WPS REI is established at 48 hours. If
none of the acute toxicity effects are in category I, but one or more of the three is
classified as category II, the interim WPS REI is established at 24 hours. If none of the
three acute toxicity effects are in category I or II, the interim WPS REI is established
at 12 hours. A 48-hour REI is increased to 72 hours when an organophosphate
pesticide is applied outdoors in arid areas. In addition, the WPS specifically retains
two types of REI's established by the Agency prior to the promulgation of the WPS:
(1) product-specific REI's established on the basis of adequate data, and (2) interim
REI's that are longer than those that would be established under the WPS.
During the reregi strati on process, EPA considers all relevant product-specific
information to decide whether there is reason to shorten or lengthen the previously
established REI.
The WPS REI in effect until now was 24 hours. This was an interim REI placed
on trichlorfon products by PR Notice 93-7. EPA notes that the 24-hour interim WPS
REI was established because trichlorfon, at that time, was classified as toxicity
category II for eye irritation potential. Trichlorfon has since been reclassified as a
toxicity category III for eye irritation.
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EPA is retaining the REI of 24 hours for all occupational-use products that
contain trichlorfon and are within the scope of the Worker Protection Standard for
Agricultural Pesticides (WPS). The Agency acknowledges that considering solely the
acute toxicity of trichlorfon an REI of 12 hours may be appropriate. However, in light
of the slow environmental degradation of trichlorfon, and a lack of reentry data, the
Agency will retain the 24 hour REI. The Agency is requiring reentry data for
trichlorfon and will reevaluate the REI when the data are available.
Early-Entry PPE: The WPS establishes very specific restrictions on entry by
workers to areas that remain under a restricted-entry interval, if the entry involves
contact with treated surfaces. Among those restrictions are a prohibition of routine
entry to perform hand labor tasks and a requirement that personal protective
equipment be worn. Under the WPS, these personal protective equipment
requirements for persons who must enter areas that remain under a restricted-entry
interval are based on the acute toxicity category.
During the reregi strati on process, EPA considers all relevant product-specific
information to decide whether there is reason to set personal protective equipment
requirements that differ from those set through the WPS.
The RED requirements for early-entry personal protective equipment are set in
one of two ways:
1. If EPA determines that no regulatory action must be taken as the result of the
acute effects or other adverse effects of an active ingredient, it establishes the
early-entry PPE requirements on the basis of the acute dermal toxicity
category, skin irritation potential category, and eye irritation potential category
of the active ingredient. In any case, the minimum (baseline) early-entry PPE
for all WPS products is coveralls, chemical-resistant gloves, and shoes plus
socks.
2. If EPA determines that regulatory action on an active ingredient must be taken
as the result of very high acute toxicity or to certain other adverse effects, such
as allergic effects or delayed effects (cancer, developmental toxicity,
reproductive effects), it may establish early-entry PPE requirements that are
more stringent than would be established otherwise.
Due to the lack of post-application exposure data, the toxicity concerns (dermal
NOEL of 100), and the high application rates. EPA is establishing PPE for dermal
protection that is more stringent than the PPE that would otherwise be established on
the basis of the acute toxicity category of the active ingredient. Since trichlorfon is
classified as toxicity category III for eye irritation potential, no protective eyewear is
required for early entry.
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WPS Notification Statement: Under the WPS, the labels of some pesticide products
must require employers to notify workers about pesticide-treated areas orally as well
as by posting of the treated areas. The reregi strati on process also may decide that a
product requires this type of "double notification." EPA has determined that double
notification is not required for trichlorfon end-use products.
Occupational-Use Products (NonWPS Uses)
Since EPA has concerns about post-application exposures to persons after
nonWPS occupational uses of trichlorfon, it is establishing entry restrictions for all
nonWPS occupational uses of trichlorfon end-use products. For specific requirements,
refer to Section V of this document.
Homeowner-Use Products
Since EPA has concerns about post-application exposures to persons after
homeowner applications of trichlorfon, it is establishing entry restrictions for all
homeowner uses of trichlorfon end-use products. For specific requirements, refer to
Section V of this document.
11. Skin Sensitization
Trichlorfon is classified as a skin sensitizer, therefore EPA is requiring a cautionary
statement in the "Hazards to Humans and Domestic Animals" section of the Precautionary
Statements on the labeling of all end-use products.
12. Other Labeling Requirements
The Agency is also requiring other use and safety information to be placed on the
labeling of all end-use products containing trichlorfon. For the specific labeling statements,
refer to Section V of this document.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregi strati on of both manufacturing-use and end-use products.
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A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The following data are required as confirmatory:
Occupational Residential Exposure:
• 231 & 232 mixer/1 oader/applicator exposure data are required for residential turfgrass
sites using a hydraulic low pressure handwand (specifically, commercial applicators
using hand held sprayers on residential sites)
• 132-1, 133-3, 133-4 exposure data for post-application entry into greenhouses and on
residential turf
Ecological Effects:
• 72-3(b) Acute Toxicity for Estuarine/Marine Organisms - Mollusk
• 72-4 Aquatic invertebrate life-cycle - Estuarine/marine
Environmental Fate:
• 164-1 Field Dissipation
• 201-1 Droplet Size
• 201-2 Field Drift
Residue Chemistry:
In order to reassess the tolerances for cattle meat, cattle fat, and cattle meat by-
products to support the continued import of cattle products from cattle treated with
trichlorfon, the following residue data are required:
• 171-4(b) Nature of the Residue; livestock metabolism
• 171-4(c) Residue analytical method - animals
• 171-4(e) Storage stability
• 171-4(j) Magnitude of the Residue; meat/milk/poultry/eggs
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP) labeling must
be revised to comply with all current EPA regulations, PR Notices and applicable policies.
The MP labeling must bear the following statement under Directions for Use:
"Only for formulation into an insecticide for the following use(s): (fill blank only
with these uses that are being supported by MP registrant)."
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An MP registrant may, at his/her discretion , add one of the following statements to an
MP label under "Directions for Use" to permit the reformulation of the product for a specific
use or all additional uses supported by a formulator or user groups:
(a) "This product may be used to formulate products for specific use(s) not listed on the
MP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding the support of such use(s)."
(b) "This product may be used to formulate products for any additional use)s) not listed on
the MP label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding the support of such use(s)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made. The
product specific data requirements are listed in Appendix G, the Product Specific Data Call-In
Notice.
Registrants must review previous data submissions to ensure that they meet current
EPA acceptance criteria (Appendix F; Attachment E) and if not, commit to conduct new
studies. If a registrant believes that previously submitted data meet current testing standards,
then study MRID numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain trichlorfon, the
product labeling must be revised to adopt the handler personal protective
equipment/engineering control requirements set forth in this section. Any conflicting
PPE requirements on the current labeling must be removed.
Products Intended Primarily for Occupational Use (WPS and nonWPS)
Minimum (Baseline) PPE/Engineering Control Requirements: At this time there
are no engineering control requirements, such as closed systems, currently required on
labeling for trichlorfon products. EPA is not establishing active-ingredient-based
minimum (baseline) engineering control requirements for trichlorfon end-use products
that are intended primarily for occupational use.
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EPA is establishing minimum (baseline) PPE for some occupational uses of
trichlorfon.
For soluble powder formulations:
Mixers and loaders must wear:
-long-sleeve shirt and long pants,
-chemical-resistant gloves*, and
—shoes plus socks,
Applicators and other handlers (other than mixers and loaders) must wear:
-long-sleeve shirt and long pants,
—shoes plus socks.
For granular formulations:
Applicators and other handlers must wear:
—coveralls over long-sleeve shirt and long pants,
-chemical-resistant gloves*, and
-chemical-resistant footwear.
For readv-to-use bait formulations:
Applicators and other handlers must wear:
-long-sleeve shirt and long pants,
-chemical-resistant gloves*, and
—shoes plus socks.
*For the glove statement, use the statement established for trichlorfon through the
instruction in Supplement Three of PR Notice 93-7.
Determining PPE Requirements for End-use Product Labels: The PPE that would
be established on the basis of the acute toxicity category of the end-use product must
be compared to the active-ingredient-based minimum (baseline) personal protective
equipment specified above. The more protective PPE must be placed on the product
labeling. For guidance on which PPE is considered more protective, see PR Notice
93-7.
Placement in Labeling: The personal protective equipment requirements must be
placed on the end-use product labeling in the location specified in PR Notice 93-7, and
the format and language of the PPE requirements must be the same as is specified in
PR Notice 93-7.
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Products Intended Primarily for Homeowner Use
Minimum (Baseline) PPE Requirements: EPA is not establishing active-ingredient-
based minimum (baseline) handler PPE for trichlorfon end-use products that are
intended primarily for homeowner use.
Determining PPE Requirements for End-Use Product Labels: Any necessary PPE
for each trichlorfon end-use product intended primarily for homeowner use will be
established on the basis of the end-use product's acute toxicity category.
Placement in Labeling: The personal protective equipment requirements, if any,
must be placed on the end-use product labeling immediately following the
precautionary statements in the labeling section "Hazards to Humans (and domestic
animals)."
Entry Restrictions
For sole-active-ingredient end-use products that contain trichlorfon the
product labeling must be revised to adopt the entry restrictions set forth in this section.
Any conflicting entry restrictions on the current labeling must be removed.
Products Intended Primarily for Occupational Use: WPS Uses
Restricted-entry Interval: A 24-hour restricted-entry interval (REI) is required for
uses within the scope of the WPS on all trichlorfon end-use products.
"Exception: if the product is soil-injected or soil-incorporated (including watering-in),
the Worker Protection Standard, under certain circumstances, allows workers to enter
the treated area if there will be no contact with anything that has been treated."
Early-entry Personal Protective Equipment (PPE): The PPE required for early
entry is:
— coveralls over long-sleeve shirt and long pants,
— chemical-resistant gloves,
— shoes plus socks,
Placement in labeling: The REI and the PPE required for early entry must be
inserted into the standardized REI statement required by Supplement Three of PR
Notice 93-7.
Products Intended Primarily for Occupational Use: NonWPS uses
Entry Restrictions: The Agency is establishing the following entry restrictions for
nonWPS occupational uses of trichlorfon end-use products:
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For liquid applications:
"Do not enter or allow others to enter the treated area until sprays have dried."
• For granular applications:
"Do not allow people or pets to enter the treated area (except those involved in
the watering) until the watering-in is complete and the surface is dry."
• For bait applications:
There are no entry restrictions.
Placement in labeling:
If WPS uses are also on label - Follow the instructions in PR Notice 93-7 for
establishing a Non-Agricultural Use Requirements box, and place the appropriate
nonWPS entry restrictions in that box.
If no WPS uses are on the label - Place the appropriate nonWPS entry restrictions in
the Directions for Use, under the heading "Entry Restrictions."
Products Intended Primarily for Homeowner Use
Entry restrictions: The Agency is establishing the following entry restrictions for all
homeowner uses of trichlorfon end-use products:
• For liquid applications:
"Do not allow people or pets to enter the treated area until sprays have
dried."
• For granular applications:
"Do not allow people or pets to enter the treated area (except those
involved in the watering) until the watering-in is complete and the
surface is dry."
Placement in labeling: Place the appropriate entry restrictions in the Directions for
Use, under the heading "Entry Restrictions."
Other Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements be located on all
end-use products containing trichlorfon that are intended primarily for occupational
use:
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Application Restrictions for All Formulations:
• "Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area
during application."
• "Aerial application is prohibited."
Application Restrictions for Granular Formulations Only:
• "Apply with push-type granular spreaders only. Chest-mounted rotary spreader
("belly-grinder") application equipment is prohibited."
User Safety Requirements:
(Registrant: select this if coveralls are required for pesticide handlers on the end-use
product label:)
• Discard clothing or other absorbent materials that have been drenched or
heavily contaminated with this product's concentrate. Do not reuse them.
(Registrant: select this always:)
• "Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables, use detergent and hot water. Keep and
wash PPE separately from other laundry."
User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing."
• "Users should remove PPE immediately after handling this product. Wash the
outside of gloves before removing. As soon as possible, wash thoroughly and
change into clean clothing."
Skin Sensitizer Statement:
• "This product may cause skin sensitization in some people."
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Engineering Controls:
• "When handlers use closed systems, or enclosed cabs in a manner that meets
the requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE requirements
may be reduced or modified as specified in the WPS."
Products Intended Primarily for Home Use
Application Restrictions:
• "Do not apply this product in a way that will contact any person or pet, either
directly or through drift. Keep people and pets out of the area during
application."
• "Do not apply this product using "chest mounted rotary-type spreader"
application equipment."
User Safety Recommendations:
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing."
(Select this only if gloves and/or protective eyewear are required for homeowner
users:)
• "Users should remove protective clothing and equipment immediately
after handling this product. Wash the outside of gloves before
removing. Keep and wash protective clothing and equipment separately
from other laundry."
Skin Sensitizer Statement:
• "This product may cause skin sensitization reactions in some
people."
60
-------
Environmental Hazard Statements
All labels must have standard language, including:
• "Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high water mark."
• "Do not contaminate water by cleaning of equipment or disposal or wastes."
• "Do not apply when turf grass areas are water logged or the soil is saturated
with water (ie. will not irrigate)."
• "Avoid run-off or puddling of irrigation water following application."
Soluble Powders:
• "Do not apply when average wind speeds are greater than 15 mph."
• "Apply product using spray nozzles which produce a coarse droplet size, such
as flood jet nozzles or lawn care gun."
For Golf Course Use:
• "Do not apply within 25 feet of lakes, reservoirs, rivers, permanent streams,
marshes natural ponds, or estuaries."
• "Post-application watering-in is required."
For All Other Turf/lawn Uses:
• "Post-application watering-in is required."
Premise Precautions
All products labeled for use in livestock premise or areas must include the following:
• "Remove animals before using products as a premise spray treatment in barns."
• "Do not treat areas such as drinking cup, mangers, or troughs where livestock
feed."
• "Do not contaminate water, food, feedstuffs, food or feed handling equipment,
or milk or meat handling equipment."
61
-------
"Do not apply bait or spray to areas accessible to animals."
All products labeled for use in indoor residential or commercial
establishments must include:
• "For use in non-food/non-feed areas."
• "Do not contaminate food/feed or food/feed handling equipment."
• "Do not use in the food/feed areas of food/feed handling establishments. Do
not use in edible product areas of food or feed processing plants, restaurants or
other areas where food or feed is commercially prepared for processed. Do not
use in restaurant serving areas while food is exposed."
All bait formulation products that are not housed in child-resistant packaging
must include the following:
• "Not for Indoor Residential Use." and
• "Not for Lawn/Turf Use."
All products labeled for use as a mound treatment for Texas Harvest Ants
must include the following:
• "Apply only by hand-broadcast."
• All products containing the site "area treatment" must be modified to
"nonfood/nonfeed areas."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell trichlorfon
products bearing old labels/labeling for 26 months from the date of issuance of this RED.
Persons other than the registrant may distribute or sell such products for 50 months from the
date of the issuance of this RED. Registrants and persons other than registrants remain
obligated to meet pre-existing Agency imposed label changes and existing stocks
requirements applicable to products they sell or distribute.
62
-------
VI. APPENDICES
63
-------
Intentionally Blank Page
64
-------
Report Run Date: 09/05/95 ) Time 11:42 APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon] LUIS 2.1 ) Page 1
The uses in Appendix A were evaluated for reregistration. These do not include cahnges in application rates, frequency or timing of applications, restricted entry intervals, etc. that
may be mandated in this document.
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))>
The uses in Appendix A were evaluated for reregistration. These do NOT include changes in application rates, deletion of uses, frequency or timing of applications, restricted entry
intervals, etc. that may have been mandated in this document.
FOOD/FEED USES
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
AGRICULTURAL/FARM PREMISES
Bait station. Use code BAB., When B/S
needed., Not on label.
Indoor premise treatment., When needed., B/S
Paintbrush.
Indoor premise treatment., When needed., B/S
Sprayer.
SC/S
B/S
Sprinkle., When needed., Not on label.
ALFALFA
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
NA
NA
NA
NA
Use Group: INDOOR FOOD
.2 lb IK sq.ft
UC
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL FEED CROP
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04, C46
G01 (14)
G01 (14)
H01 (14)
H01 (14)
Bait application., Preplant., Not on
label.
B/S
1 lb A
G01 (14), H01(14)
Band treatment., Foliar., Not on label. B/S
Broadcast., Foliar., Not on label. B/S
Low volume spray (concentrate)
Aircraft.
Foliar., SC/S
NA
NA
NA
1 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
G01 (14)
G01 (14)
G01 (7) ,
, H01(14)
, H01(14)
H01 (7)
Low volume spray (concentrate)
crop., Aircraft.
Spray., Foliar., Ground.
Spray., Foliar., Sprayer.
Spray., Seed crop., Ground.
SC/S
SC/S
SC/S
SC/S
SC/S
SC/S
SC/S
NA
NA
NA
NA
NA
NA
NA
1 lb A
1.5 lb A
1.5 lb A
1 lb A
1 lb A
1 lb A
1.5 lb A
3
NS
NS
1
3
3
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
NS
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
C04, C46, H01(0)
C04, C46, GD2,
H01 (7)
GDI, GD2, H01(7)
G01 (7) , H01 11)
C04, C46, H01(0)
H01 (0)
C04, C46, GD2,
H01 (7)
65
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APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 2
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
ALFALFA (con't)
BARLKIY
Band treatment., Foliar., Not on label.
Broadcast., Foliar., Not on label.
SC/S
B/S
B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
BEANS, DRIED-TYPE
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on B/S
label.
Band treatment., Posttransplant., Not on B/S
label.
Broadcast., Foliar., Not on label. B/S
Broadcast., Postplant., Not on label. B/S
Broadcast., Posttransplant., Not on B/S
label.
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
BEANS, SUCCULENT (LIMA)
Bait application., Foliar., Not on label. B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FEED CROP (con't)
1.5 lb A * NS NS NS NS AN
Use Group: TERRESTRIAL FOOD+FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
1 lb A
1 lb A
1 lb A
1 lb A * NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
NS NS
NS NS
NS AN
1.5 lb A
1.5 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS NS
NS NS
NS NS
NS NS
NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
GDI, GD2, H01(7)
GC1, GF4,
GC1, GF4,
, G01(3),
H01(21)
H01 (21)
H01(21)
, G01(3), H01(21)
GH6, H01
GH6, H01
GH6, H01(14)
GH6, H01
GH6, H01
GH6, H01(14)
GH6, H01
GH6, H01
GH6, H01
H01(14)
66
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APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 3
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
BEANS, SUCCULENT (LIMA) (con't)
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on
label.
B/S
NA
NA
1.6335 lb A
1.6335 lb A
2 NS
2 NS
NS
NS
NS NS
NS NS
NS
NS
H01(30)
H01(30)
Band treatment., Posttransplant., Not on B/S
label.
1.6335 lb A
NS NS
Broadcast., Foliar., Not on label. B/S NA
Broadcast., Postplant., Not on label. B/S NA
Broadcast., Posttransplant., Not on B/S NA
label.
1.6335 lb A
1.6335 lb A
1.6335 lb A
2 NS
2 NS
2 NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
H01(30)
H01(30)
H01(30)
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
NS NS
Spray., Foliar., Ground. SC/S NA
BEANS, SUCCULENT (SNAP)
Bait application., Foliar., Not on label. B/S NA
Bait application., Postplant., Not on B/S NA
label.
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A
1.5 lb A
NS NS
NS NS
NS
NS
NS AN
NS AN
NS
NS
GH6, H01
GH6, H01
Bait application., Preplant., Not on
label.
B/S
1.5 lb A
NS NS
NS AN NS
GH6, H01(14)
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on
label.
B/S
NA
NA
1.6335 lb A
1.6335 lb A
NS NS
NS NS
NS
NS
NS NS
NS NS
NS
NS
GH6, H01
GH6, H01
Band treatment., Posttransplant., Not on B/S
label.
1.6335 lb A
NS NS
GH6, H01(14)
Broadcast., Foliar., Not on label.
B/S
1.6335 lb A
NS NS
GH6, H01(14)
67
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 4
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
BEANS, SUCCULENT (SNAP) (con't)
Broadcast., Postplant., Not on label. B/S
Broadcast., Posttransplant., Not on B/S
label.
NA
NA
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
1.6335 lb A
1.6335 lb A
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS
NS
GH6, H01
GH6, H01
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
1.5 lb A
NS NS
NS AN NS
Spray., Foliar., Ground.
BEEF/RANGE/FEEDER CATTLE (MEAT)
Pour-on., When needed., Cup.
SC/S NA
.002578 lb 100 lb
animal
1.5 lb A * NS NS
Use Group: INDOOR FOOD
NS NS
NS AN NS
BEETS
Band treatment., Foliar., Not on label.
Band treatment., Postplant., Not on
label.
B/S
B/S
NA
NA
Use Group: TERRESTRIAL FOOD CROP
1.6335 lb A
1.6335 lb A
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS
NS
GJ3, H01
GJ3, H01
Band treatment., Posttransplant., Not on B/S
label.
1.6335 lb A
GJ3, H01(26
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S
B/S
B/S
NA
NA
NA
1.6335 lb A
1.6335 lb A
1.6335 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
GJ3, H01
GJ3, H01
GJ3, H01
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
1.5 lb A
NS AN NS
C04, C46,
H01 (28)
Spray., Foliar., Ground.
SC/S
SC/S
NA
NA
1.5 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS
NS
GJ3, H01(28
C04, C46,
H01(28)
SC/S NA
BLUEBERRY
Low volume spray (concentrate)., Bloom., SC/S
Aircraft.
1.5 lb A * NS NS NS
Use Group: TERRESTRIAL FOOD CROP
1.2 lb A * 1 NS NS
NS AN NS
NS NS NS NJ
GJ3, H01(28
68
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 5
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
BLUEBERRY (con't)
Low volume spray (concentrate)
Prebloom., Aircraft.
Spray., Bloom., Ground.
Spray., Prebloom., Ground.
Use Group: TERRESTRIAL FOOD CROP (con't)
SC/S
SC/S
SC/S
SC/S
SC/S
SC/S
SC/S
BRUSSELS SPROUTS
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on
label.
B/S
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on B/S
label.
Band treatment., Posttransplant., Not on B/S
label.
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S
B/S
B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
1 lb A
1.2 lb A
1 lb A
1.2 lb A
1 lb A
1.2 lb A
1 lb A
NS 2/1 yr
NS 2/1 yr
NS 2/1 yr
NS 2/1 yr
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL FOOD CROP
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
1 lb A
1 lb A
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS 7
NS NS
NS NS
NS NS
NS NS
NS AN
NS AN
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS NJ
NS
NS NJ
NS
NS NJ
NS
NS
NS
NS
NS
NS
NS
NS
C04, C46
H01 (45)
C04, C46
H01 (45)
C04, C46
H01(45)
C04, C46
, H01(21)
, H01(21)
, H01(21)
H01(21)
H01(21)
H01(21)
H01(21)
H01(21)
H01(21)
H01(21)
Spray., Foliar., Ground.
SC/S
69
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 6
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
CABBAGE
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Use Group: TERRESTRIAL FOOD CROP
NA
NA
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS
NS
H01(21)
H01(21)
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on
label.
B/S
NA
NA
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS
NS
H01(21)
H01(21)
Band treatment., Posttransplant., Not on B/S
label.
1.089 lb A
Broadcast., Foliar., Not on label. B/S NA
Broadcast., Postplant., Not on label. B/S NA
Broadcast., Posttransplant., Not on B/S NA
label.
1.089 lb A
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
H01(21)
H01(21)
H01(21)
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
NS NS
Spray., Foliar., Ground.
CARROT (INCLUDING TOPS)
SC/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
1 lb A * NS NS NS
Use Group: TERRESTRIAL FOOD CROP
1.5 lb A * NS NS NS
GE3, H01(28
Spray., Foliar., Ground. SC/S
CAULIFLOWER
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
NA
NA
1.5 lb A * NS NS NS
Use Group: TERRESTRIAL FOOD CROP
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS NS
NS AN
NS AN
NS
NS
GE3, H01(28
H01(21)
H01(21)
Band treatment., Foliar., Not on label. B/S
1.089 lb A
70
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 7
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
CAULIFLOWER (con't)
Band treatment., Postplant., Not on
label.
B/S
Band treatment., Posttransplant., Not on B/S
label.
Broadcast., Foliar., Not on label. B/S
Broadcast., Postplant., Not on label. B/S
Broadcast., Posttransplant., Not on B/S
label.
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground.
CLOVER
Low volume spray (concentrate)
Aircraft.
Low volume spray (concentrate)
crop., Aircraft.
Spray., Foliar., Ground.
Spray., Seed crop., Ground.
SC/S
Foliar., SC/S
SC/S
Seed SC/S
SC/S
SC/S
SC/S
SC/S
SC/S
COLLARDS
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FOOD CROP (con't)
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
1 lb A
1.5 lb A
1.5 lb A
1 lb A
1 lb A
1.5 lb A
1.5 lb A
3
NS
NS
1
3
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS AN
Use Group: TERRESTRIAL FEED CROP
NS NS
NS AN
NS AN
NS NS
NS NS
NS AN
Use Group: TERRESTRIAL FOOD CROP
NS AN
NS AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(21)
H01(21)
H01(21)
G01 (7) , H01(7)
C04, C46, H01(0)
C04, C46, GD2,
H01 (7)
GDI, GD2, H01(7)
G01 (7) , H01(7)
C04, C46, H01(0)
C04, C46, GD2,
H01 (7)
GDI, GD2, H01(7)
H01 (28)
H01 (28)
71
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
COLLARDS (con't)
Bait application., Preplant., Not on
label.
Band treatment., Foliar., Not on label.
Band treatment., Postplant., Not on
label.
B/S
B/S
B/S
B/S
Band treatment., Posttransplant., Not on B/S
label.
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S
B/S
B/S
B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
CORN (UNSPECIFIED)
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on B/S
label.
Broadcast., Foliar., Not on label. B/S
Broadcast., Postplant., Not on label. B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground.
CORN, FIELD
Band treatment., Foliar., Ground.
SC/S
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FOOD CROP (con't)
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AN
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(28)
GC1, H01(
H01(28)
H01(28)
H01 (28)
GC1, H01(
H01(28)
H01(28)
H01 (28)
H01(28)
Use Group: TERRESTRIAL FOOD+FEED CROP
1 lb A * 3 NS NS NS NS
C04, C46, H01(0)
72
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 9
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
CORN, FIELD (con't)
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground.
CORN, POP
Band treatment., Foliar., Ground.
SC/S
SC/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground.
CORN, SWEET
Band treatment., Foliar., Ground.
SC/S
SC/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
COTTON (UNSPECIFIED)
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Band treatment., Foliar., Not on label. B/S
Broadcast., Foliar., Not on label. B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground.
SC/S
SC/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
1 lb A * 3 NS NS NS NS
1 lb A * 3 NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1 lb A * 3 NS NS NS NS
1 lb A * 3 NS NS NS NS
1 lb A * 3 NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1 lb A * 3 NS NS NS NS
1 lb A * 3 NS NS NS NS
1 lb A * 3 NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04, C46,
C04, C46,
C04, C46,
C04, C46,
H01 (0)
H01 (0)
C04, C46, H01(0)
C04, C46,
C04, C46,
H01 (0)
H01 (0)
C04, C46, H01(0)
G01 (14)
G01 (14)
H01 (7)
H01 (7)
G01 (14) , H01(7)
G01 (14)
G01 (14)
C04, C46
H01 (7)
C04, C46
H01 (7)
H01 (7)
H01 (7)
. G01(14)
H01 (7)
. G01(14)
SC/S
G01 (14) , H01(7)
73
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 10
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
COTTON (UNSPECIFIED) (con't)
Spray., Foliar., Sprayer. SC/S NA
COWPEA/BLACKEYED PEA
Bait application., Foliar., Not on label. B/S NA
Bait application., Postplant., Not on B/S NA
label.
Bait application., Preplant., Not on
label.
B/S
Band treatment., Foliar., Not on label. B/S NA
Band treatment., Postplant., Not on B/S NA
label.
Band treatment., Posttransplant., Not on B/S NA
label.
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S
B/S
B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
DAIRY CATTLE (LACTATING OR UNSPECIFIED)
Bait application., When needed., Cup. B/S
Enclosed premise treatment., When B/S
needed., Not on label.
Open premise and exterior treatment., B/S
When needed., Not on label.
DAIRY CATTLE (NON-LACTATING)
Pour-on., When needed., Cup. RTU
NA
NA
NA
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
1. 4 lb A * NS NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A
1.5 lb A
1.5 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.6335 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR FOOD
NA .0125 lb IK sq.ft * NS NS
NA .0025 lb IK sq.ft * NS NS
NA .0025 lb IK sq.ft * NS NS
.002513 lb 100 lb
animal
Use Group: INDOOR FOOD
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
NS
NS
NS
NS
NS
NS
NS
NS
G01 (14) , H01(7)
GH6, H01
GH6, H01
GH6, H01(14)
GH6, H01
GH6, H01
GH6, H01(14)
GH6, H01
GH6, H01
GH6, H01
H01(14)
74
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
DAIRY CATTLE (NON-LACTATING) (con't)
RTU
DAIRY FARM MILK STORAGE ROOMS/HOUSES/SHEDS
Bait application., When needed., Cup. B/S
FLAX
Band treatment., Foliar., Not on label. B/S
Broadcast., Foliar., Not on label. B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Bait application., When needed., Not on B/S
label.
Bait station. Use code BAB., When B/S
needed., Not applicable.
Sprinkle., When needed., Not on label. B/S
Void treatment., When needed., Cup. B/S
NA
NA
NA
NA
NA
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS
Bait station. Use code BAB., When
needed., Not applicable.
B/S
i,kttuck:
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Band treatment., Foliar., Not on label. B/S
NA
NA
Use Group: INDOOR FOOD (con't)
.002578 lb 100 lb * NS NS NS NS
animal
Use Group: INDOOR FOOD
.0125 lb IK sq.ft * NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1 lb A
1 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
.0025 lb IK sq.ft
.0125 lb IK sq.ft
UC
.0125 lb IK sq.ft
Use Group: INDOOR FOOD
NS NS
NS
NS
NS
NS
NS
NS
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
1
NS
Use Group: INDOOR FOOD
UC * NS NS
Use Group: TERRESTRIAL FOOD CROP
NS
NS
AN
AN
NS
NS
NS
NS
NS
NS
NS
GC1, GF4, H01(21)
GC1, GF4, H01(21)
G01 (3) , H01(21)
G01 (3) , H01(21)
H01(28
H01(28
GC1, H01(28
75
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
LETTUCE (con't)
Band treatment., Postplant., Not on
label.
B/S
B/S
Band treatment., Posttransplant., Not on B/S
label.
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S
B/S
B/S
B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Spray., Foliar., Ground. SC/S
LIVESTOCK
Outdoor general surface spray., When SC/S
needed., Sprayer.
MANURE
Bait application., When needed., Cup. B/S
Manure treatment. Use site code 40001., B/S
When needed., Not on label.
OATS
Band treatment., Foliar., Not on label. B/S
Broadcast., Foliar., Not on label. B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL FOOD CROP (con't)
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR FOOD
.2 lb IK sq.ft * NS NS
NS
NS
Use Group: TERRESTRIAL FOOD+FEED CROP
.0125 lb IK sq.ft * NS NS NS NS
.0025 lb IK sq.ft * NS NS NS NS
Use Group: TERRESTRIAL FOOD+FEED CROP
Spray., Foliar., Ground.
SC/S
1 lb A
1 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
NS
AN
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(28)
H01(28)
H01 (28)
GC1, H01(
H01(28)
H01(28)
H01 (28)
, H01(28)
C04, C46
GC1, GF4,
GC1, GF4,
, G01(3),
H01(21)
H01 (21)
H01 (21)
G01 (3) , H01(21)
76
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 13
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
PEANUTS (UNSPECIFIED)
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Band treatment., Foliar., Ground. B/S
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Ground. B/S
Band treatment., Posttransplant., Ground. B/S
Use Group: TERRESTRIAL FOOD+FEED CROP
Band treatment., Preharvest., Ground.
Band treatment., Preharvest., Not on
label.
B/S
B/S
Broadcast., Foliar., Aircraft. B/S
Broadcast., Foliar., Ground. B/S
Broadcast., Foliar., Not on label. B/S
Broadcast., Postplant., Aircraft. B/S
Broadcast., Postplant., Ground. B/S
Broadcast., Posttransplant., Aircraft. B/S
Broadcast., Posttransplant., Ground. B/S
Broadcast., Preharvest., Aircraft. B/S
Broadcast., Preharvest., Ground. B/S
Broadcast., Preharvest., Not on label. B/S
PEAS, SOUTHERN
Bait application., Foliar., Not on label. B/S
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
1.5 lb A
1.5 lb A
1.089 lb A
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
1.089 lb A
1.089 lb A
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
H03
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A * 2 NS NS NS NS
GH6, H01(14)
77
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 14
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
PEAS, SOUTHERN (con't)
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Use Group: TERRESTRIAL FOOD+FEED CROP (con't)
GH6, H01(
GH6, H01(
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on
label.
B/S
NA
NA
1.6335 lb A
1.6335 lb A
2 NS
2 NS
NS
NS
NS NS
NS NS
NS
NS
GH6, H01
GH6, H01
Band treatment., Posttransplant., Not on B/S
label.
1.6335 lb A
NS NS
GH6, H01(14)
Broadcast., Foliar., Not on label. B/S NA
Broadcast., Postplant., Not on label. B/S NA
Broadcast., Posttransplant., Not on B/S NA
label.
1.6335 lb A
1.6335 lb A
1.6335 lb A
2 NS
2 NS
2 NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
GH6, H01
GH6, H01
GH6, H01
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
NS AN NS
H01 (14)
Spray., Foliar., Ground. SC/S NA
l:'E PPKIR
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on
label.
B/S
NA
NA
Use Group: TERRESTRIAL FOOD CROP
1.089 lb A
1.089 lb A
NS NS
NS NS
NS
NS
NS NS
NS NS
NS
NS
H01(21)
H01(21)
Band treatment., Posttransplant., Not on B/S
label.
1.089 lb A
NS NS
H01(21)
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S
B/S
B/S
NA
NA
NA
1.089 lb A
1.089 lb A
1.089 lb A
NS NS
NS NS
NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
H01(21)
H01(21)
H01(21)
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
1 lb A
NS AN NS
H01 (21)
78
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 15
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
PEPPER (con't)
Spray., Foliar., Ground.
POULTRY (EGG/MEAT)
Bait application., When needed., Cup.
Enclosed premise treatment., When
needed., Not on label.
SC/S
B/S
B/S
NA
NA
Use Group: TERRESTRIAL FOOD CROP (con't)
1 lb A * NS NS
Use Group: INDOOR FOOD
.0125 lb IK sq.ft * NS NS
.0025 lb IK sq.ft * NS NS
NS
NS
NS
NS
NS
1
NS
NS
Open premise and exterior treatment.,
When needed., Not on label.
B/S
.0025 lb IK sq.ft
NS
NS
PUMPKIN
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
NA
NA
Use Group: TERRESTRIAL FOOD CROP
1.5 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(14)
H01 (14)
Bait application., Preplant., Not on
label.
B/S
Band treatment., Foliar., Not on label. B/S NA
Band treatment., Postplant., Not on B/S NA
label.
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(14)
H01 (14)
Band treatment., Posttransplant., Not on B/S
label.
1.089 lb A
Broadcast., Foliar., Not on label. B/S NA
Broadcast., Postplant., Not on label. B/S NA
Broadcast., Posttransplant., Not on B/S NA
label.
1.089 lb A
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H01(14)
H01(14)
H01 (14)
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
H01(14)
Spray., Foliar., Ground.
SC/S
SC/S
SC/S
NA
NA
NA
1 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04, C46, H01(3)
H01(14)
C04, C46, H01(3)
79
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 16
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
SAFFLOWER (UNSPECIFIED)
Band treatment., Foliar., Not on label. B/S NA
Broadcast., Foliar., Not on label. B/S NA
Low volume spray (concentrate)., Bloom., SC/S NA
Aircraft.
Low volume spray (concentrate).,
Prebloom., Aircraft.
SC/S
Spray., Bloom., Ground. SC/S NA
Spray., Prebloom., Ground. SC/S NA
SOYBEANS (UNSPECIFIED)
Bait application., Foliar., Not on label. B/S NA
Bait application., Postplant., Not on B/S NA
label.
Bait application., Preplant., Not on B/S NA
label.
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
1.5 lb A
NS 2/1 yr
NS 2/1 yr
NS 2/1 yr
NS 2/1 yr
NS 2/1 yr
NS 2/1 yr
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
NS
NS
NS
NS
NS
NS
NS
C14, GC1
C14, GC1
C14, GC1
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
C04, C14,
GI7, H01
C46, G03,
7)
Spray., Foliar., Ground.
SC/S
SC/S
SC/S
C14, GC1,
GI7, H01
C04, C14,
GI7, H01
C14, GC1,
GI7, H01(
GDI, GD2,
7)
C46, G03,
7)
SUGAR BEET
Band treatment., Foliar., Not on label. B/S NA
Broadcast., Foliar., Not on label. B/S NA
Low volume spray (concentrate)., Foliar., SC/S NA
Aircraft.
Use Group: TERRESTRIAL FOOD+FEED CROP
1.5 lb A
1.5 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
H01(14)
H01(14)
H01 (14)
H23 (26
H23 (26
Spray., Foliar., Ground.
SC/S
80
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Min. Restr.
Interv Entry
(days) Interv
[day(s)
Geographic Limitations Use
Allowed Disallowed Limitations
Codes
FOOD/FEED USES (con't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
TOMATO
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
Bait application., Preplant., Not on B/S
label.
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on B/S
label.
Band treatment., Posttransplant., Not on B/S
label.
Broadcast., Foliar., Not on label. B/S
Broadcast., Postplant., Not on label. B/S
Broadcast., Posttransplant., Not on B/S
label.
Use Group: TERRESTRIAL FOOD+FEED CROP
NA
NA
NA
NA
NA
NA
NA
1 lb A
1 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
H01(21)
H01(21)
GC1, H01
GC1, H01
GC1, H01(2^
GC1, H01
GC1, H01
GC1, H01
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
1 lb A
C04, C46, H01(21)
Spray., Foliar., Ground.
SC/S
SC/S
SC/S
NA
NA
NA
1 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS AN
NS
NS
NS
H01(21)
C04, C46,
H01 (21)
WHEAT
Band treatment., Foliar., Not on label. B/S
Broadcast., Foliar., Not on label. B/S
Low volume spray (concentrate)., Foliar., SC/S
Aircraft.
Use Group: TERRESTRIAL FOOD+FEED CROP
NA
NA
NA
1 lb A
1 lb A
1 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS AN
NS
NS
NS
GC1, GF4,
GC1, GF4,
, G01(3),
H01(21)
H01 (21)
H01(21)
Spray., Foliar., Ground.
Spray., Foliar., Sprayer.
SC/S
SC/S
NA
NA
1 lb A
1 lb A
NS
3
NS
NS
NS
NS
NS AN
NS NS
NS
NS
, G01(3)
H01 (21)
H01 (21)
81
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 18
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted
less noted unless noted Max. /crop /year otherwise)/A]
otherwise) otherwise) Dose cycle /crop /year
cycle
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
AGRICULTURAL UNCULTIVATED AREAS
Bait application., When needed., Cup. B/S
Bait station. Use code BAB., When B/S
needed., Not on label.
Broadcast., When needed., Not on label. B/S
Mound treatment., When needed., Cup. B/S
Outdoor general surface spray., When B/S
needed., Paintbrush.
Outdoor general surface spray., When
needed., Sprayer.
Sprinkle., When needed., Not on label.
B/S
SC/S
B/S
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL)
Bait application., When needed., Cup. B/S
Bait application., When needed., Cup. B/S
BATHROOM PREMISES/HARD SURFACES
Bait application., When needed., Cup. B/S
Bait application., When needed., Not on B/S
label.
NA
NA
NA
NA
NA
NA
NA
NA
NA
Use Group: TERRESTRIAL NON-FOOD CROP
.0125 lb IK sq.ft
UC
1.5 lb A
.02 5 lb mound
UC
UC
.2 lb IK sq.ft
UC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
1
NS
AN
1
Use Group: INDOOR NON-FOOD
.0125 lb IK sq.ft * NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
.0125 lb IK sq.ft * NS NS NS NS
Use Group: INDOOR RESIDENTIAL
.0125 lb IK sq.ft * NS NS NS NS
.0025 lb IK sq.ft * NS NS NS NS
NS
1
Sprinkle., When needed., Not on label. B/S NA
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIP. (INDOOR)
B/S NA
UC * NS NS NS
Use Group: INDOOR NON-FOOD
Bait station. Use code BAB., When
needed., Not applicable.
Void treatment., When needed., Cup.
B/S
B/S
NA
UC
UC
.0125 lb IK sq.ft
.0125 lb IK sq.ft
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
82
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
LUIS 2.1 ) Page 19
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
ll'JlI-F'J1 'E1 II1 '1J-FEEE' I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (OUTDOOR)
Use Group: TERRESTRIAL NON-FOOD CROP
Bait application., When needed., Cup. B/S
Bait application., When needed., Not on B/S
label.
NA .0125 lb IK sq.ft * NS NS
NA .0025 lb IK sq.ft * NS NS
NS
NS
NS
NS
NS
1
NS
NS
Mound treatment., When needed., Cup.
Mound treatment., When needed., Not on
label.
B/S
G
B/S
NA
NA
NA
.02 5 lb mound
.02 5 lb mound
.02 5 lb mound
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
NS
NS
NS
Perimeter treatment., Foliar., Shaker
can.
G
.05 lb IK sq.ft
Perimeter treatment., Foliar., Spreader. G NA
Perimeter treatment., When needed., Cup. B/S NA
Perimeter treatment., When needed., Not B/S NA
on label.
.05 lb IK sq.ft
.05 lb IK sq.ft
.05 lb IK sq.ft
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
NS
NS
Perimeter treatment., When needed., G
Shaker can.
Perimeter treatment., When needed., G
Spreader.
Sprinkle., When needed., Not on label. B/S
FOREST PLANTINGS (REFORESTATION PROGRAMS)
Soil treatment., Foliar., Sprayer. SC/S
GOLF COURSE TURF
Broadcast., Foliar., Spreader. G
Spray., Foliar., Ground. SC/S
HORSES (SHOW/RACE/SPECIAL/PONIES)
Bait application., When needed., Cup. B/S
Enclosed premise treatment., When B/S
needed., Not on label.
NA
NA
NA
NA
.062 lb IK sq.ft
.062 lb IK sq.ft
UC
NS
NS
Use Group: FORESTRY
.1875 lb IK sq.ft * NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
.186 lb IK sq.ft * NS NS
.1875 lb IK sq.ft * NS NS
NS
NS
Use Group: INDOOR NON-FOOD
.0125 lb IK sq.ft * NS NS
.0025 lb IK sq.ft * NS NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
1
NS
NS
NS
NS
C04, C46
83
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 20
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATIC
ll'JlI-F'J1 'E1 II1 '1J-FEEE' I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
HORSES (SHOW/RACE/SPECIAL/PONIES) (con't)
Open premise and exterior treatment.,
When needed., Not on label.
B/S
Use Group: INDOOR NON-FOOD (con't)
.0025 lb IK sq.ft
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINARY)
Bait application., When needed., Cup. B/S NA
Indoor premise treatment., When needed., B/S NA
Not on label.
Use Group: INDOOR MEDICAL
.0125 lb IK sq.ft * NS NS NS
.0025 lb IK sq.ft * NS NS NS
NS
NS
NS
1
NS
NS
Open premise and exterior treatment.,
When needed., Not on label.
B/S
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
Bait station. Use code BAB., When
needed., Not applicable.
B/S
Void treatment., When needed., Cup. B/S
HOUSEHOLD/DOMESTIC DWELLINGS OUTDOOR PREMISES
Mound treatment., When needed., Cup. B/S
G
Mound treatment., When needed., Not on
label.
B/S
NA
NA
NA
.0025 lb IK sq.ft
Use Group: INDOOR RESIDENTIAL
UC
NS
NS
NS
.0125 lb IK sq.ft *
.0125 lb IK sq.ft * NS NS NS
Use Group: OUTDOOR RESIDENTIAL
.02 5 lb mound
.02 5 lb mound
.02 5 lb mound
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
AN
AN
NS
NS
NS
Perimeter treatment., Foliar., Shaker
can.
.05 lb IK sq.ft
Perimeter treatment., Foliar., Spreader. G
Perimeter treatment., When needed., Cup. B/S
Perimeter treatment., When needed., Not
on label.
B/S
NA
NA
NA
.05 lb IK sq.ft
.05 lb IK sq.ft
.05 lb IK sq.ft
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AN
NS
NS
NS
NS
NS
Perimeter treatment., When needed.,
Shaker can.
Perimeter treatment., When needed.,
Spreader.
.062 lb IK sq.ft
.062 lb IK sq.ft
84
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APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
LUIS 2.1 ) Page 21
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
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SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
ll'JlI-F'J1 'E1 II1 '1J-FEEE' I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Broadcast., When needed., Not on label. B/S
Mound treatment., When needed., Cup. B/S
ORNAMENTAL AND/OR SHADE TREES
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on B/S
label.
NA
NA
NA
NA
Use Group: TERRESTRIAL NON-FOOD CROP
1.5 lb A * NS NS NS NS NS NS
.025 lb mound * NS NS NS NS AN NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
.0375 lb IK sq.ft * NS NS
.0375 lb IK sq.ft * NS NS
NS
NS
NS NS
NS NS
NS
NS
Band treatment., Posttransplant., Not on B/S
label.
.0375 lb IK sq.ft
NS NS
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
Spray., Foliar., Sprayer.
SC/S
SC/S
NA
NA
UC
UC
NS
NS
NS
NS
NS
NS
NS AN
NS AN
NS
NS
ORNAMENTAL HERBACEOUS PLANTS
Band treatment., Foliar., Not on label.
Band treatment., Postplant., Not on
label.
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
NS
NS
NS NS
NS NS
NS
NS
Band treatment., Posttransplant., Not on B/S
label.
.0375 lb IK sq.ft
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
Drench., Foliar., Not on label.
Drench., Foliar., Sprayer.
SC/S
SC/S
NA
NA
1 lb IK linear ft
1 lb IK linear ft
NS 1/1 yr
NS NS
NS
NS
NS 365
NS 365
NS
NS
85
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 22
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Use
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
ll'JlI-F'J1 'E1 II1 '1J-FEEE' I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
ORNAMENTAL HERBACEOUS PLANTS (con't)
Spray., Foliar., Sprayer.
ORNAMENTAL LAWNS AND TURF
Broadcast., Foliar., Not on label.
SC/S
SC/S
B/S
NA
NA
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL (con't)
UC * NS NS NS NS AN NS
UC * NS NS NS NS AN NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
.0375 lb IK sq.ft
1.5 lb A
NS
NS
NS
NS NS
NS
Broadcast., Foliar., Spreader.
G NA .1875 lb IK sq.ft * NS NS NS NS 7 NS
G NA .186 lb IK sq.ft * NS NS NS NS AN NS
8.1 lb A *
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
G NA .186 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
Broadcast., When needed., Spreader. G
Mound treatment., When needed., Cup. G
Mound treatment., When needed., Not on B/S
label.
NA .1875 lb IK sq.ft * NS NS
NA .025 lb mound * NS NS
NA .025 lb mound * NS NS
NS
NS
NS
NS AN
NS AN
NS AN
NS
NS
NS
Spray., Foliar., Compressed air sprayer. SC/S
Spray., Foliar., Ground. SC/S
Spray., Foliar., Power sprayer. SC/S
Spray., Foliar., Watering can. SC/S
ORNAMENTAL NONFLOWERING PLANTS
Band treatment., Foliar., Not on label. B/S
Band treatment., Postplant., Not on
label.
B/S
NA
NA
NA
NA
NA
NA
4.6 lb A * NS NS
.1875 lb IK sq.ft * NS NS
4.6 lb A * NS NS
4.6 lb A * NS NS
NS
NS
NS
NS
NS 10
NS NS
NS 10
NS 10
NS
NS
NS
NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
.0375 lb IK sq.ft * NS NS
.0375 lb IK sq.ft * NS NS
NS
NS
NS NS
NS NS
NS
NS
C04, C46
Band treatment., Posttransplant., Not on B/S
label.
.0375 lb IK sq.ft
86
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LUIS 2.1 ) Page 23
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Use
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Disallowed Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
ll'JlI-F'J1 'E1 II1 '1J-FEEE' I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
ORNAMENTAL NONFLOWERING PLANTS (con't)
Broadcast., Foliar., Not on label. B/S
Broadcast., Postplant., Not on label. B/S
Broadcast., Posttransplant., Not on B/S
label.
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL (con't)
NA .0375 lb IK sq.ft * NS NS
NA .0375 lb IK sq.ft * NS NS
NA .0375 lb IK sq.ft * NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
ORNAMENTAL WOODY SHRUBS AND VINES
Band treatment., Foliar., Not on label.
Band treatment., Postplant., Not on
label.
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
NS
NS
NS NS
NS NS
NS
NS
Band treatment., Posttransplant., Not on B/S
label.
.0375 lb IK sq.ft
Broadcast., Foliar., Not on label.
Broadcast., Postplant., Not on label.
Broadcast., Posttransplant., Not on
label.
Spray., Foliar., Sprayer.
PATHS/PATIOS
Bait application., When needed., Cup.
Bait application., When needed., Not on
label.
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
B/S NA .0375 lb IK sq.ft * NS NS
SC/S
SC/S
NA
NA
UC
UC
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS AN
NS AN
NS
NS
NS
NS
NS
Use Group: TERRESTRIAL NON-FOOD+OUTDOOR RESIDENTIAL
B/S NA .0125 lb IK sq.ft * NS NS
B/S NA .0025 lb IK sq.ft * NS NS
NS
NS
NS NS
NS 1
NS
NS
Bait station. Use code BAB., When
needed., Not applicable.
Sprinkle., When needed., Not on label.
RECREATION AREA LAWNS
Broadcast., Foliar., Spreader.
B/S
B/S
UC
UC
NS
NS
NS
NS
Use Group: TERRESTRIAL NON-FOOD CROP
.186 lb IK sq.ft * NS NS NS NS AN
87
-------
APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon]
Report Run Date: 09/05/95 ) Time 11:42
PRD Report Date: 04/29/94
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LUIS 2.1 ) Page 24
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
ll'JlI-F'J1 'E1 II1 '1J-FEEE' I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
RECREATIONAL AREAS
Bait application., When needed., Cup.
Bait application., When needed., Not on
label.
Use Group: TERRESTRIAL NON-FOOD CROP
B/S NA .0125 lb IK sq.ft * NS NS
B/S NA .0025 lb IK sq.ft * NS NS
NS
NS
NS
NS
NS
1
NS
NS
Bait station. Use code BAB., When B/S
needed., Not applicable.
Sprinkle., When needed., Not on label. B/S
REFUSE/SOLID WASTE SITES (OUTDOOR)
Bait application., When needed., Cup. B/S
Bait application., When needed., Not on B/S
label.
UC
Use Group: TERRESTRIAL NON-FOOD CROP
NA .0125 lb IK sq.ft * NS NS
NA .0025 lb IK sq.ft * NS NS
NS
NS
NS
NS
NS
1
NS
NS
Bait station. Use code BAB., When B/S
needed., Not applicable.
Outdoor general surface spray., When SC/S
needed., Sprayer.
TOBACCO
Bait application., Foliar., Not on label. B/S
Bait application., Postplant., Not on B/S
label.
NA
NA
UC
.2 lb IK sq.ft
Use Group: TERRESTRIAL NON-FOOD CROP
1.5 lb A
1.5 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
H03
H03
Bait application., Preplant., Not on
label.
B/S
1.5 lb A
H03
Band treatment., Foliar., Ground. SC/S NA
Band treatment., Foliar., Not on label. B/S NA
Band treatment., Postplant., Not on B/S NA
label.
1 lb A
1.089 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04, C46, H01(3)
Band treatment., Posttransplant., Not on B/S
label.
1.089 lb A
Band treatment., Transplant., Ground. SC/S NA
Broadcast., Foliar., Not on label. B/S NA
1 lb A
1.089 lb A
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C04, C46, H01(3)
88
-------
Report Run Date: 09/05/95 ) Time 11:42 APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon] LUIS 2.1 ) Page
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
ll'JlI-F'J1 'E1 II' 'IJ-FEEE1 I :>n't)
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
TOBACCO (con't) Use Group: TERRESTRIAL NON-FOOD CROP (con't)
Broadcast., Postplant., Not on label. B/S NA 1.089 lb A * NS NS NS NS NS NS
Broadcast., Posttransplant., Not on B/S NA 1.08 9 lb A * NS NS NS NS NS NS
label.
Low volume spray (concentrate)., Foliar., SC/S NA 1 lb A * NS NS NS NS AN NS C04, C46, H01(3)
Aircraft.
SC/S NA 1 lb A * NS NS NS NS AN NS H01 (3)
Soil treatment., Plant bed., Sprayer. SC/S NA .005 lb sq.yd * NS NS NS NS NS NS C04, C46, H01(3)
Spray., Foliar., Ground. SC/S NA 1 lb A * NS NS NS NS AN NS C04, C46, H01(3)
SC/S NA 1 lb A * NS NS NS NS AN NS H01(3)
Spray., Plant bed., Ground. SC/S NA .005 lb sq.yd * NS NS NS NS NS NS H01(3)
NOT SPECIFIED
)))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))
EATING ESTABLISHMENTS Use Group: INDOOR FOOD+INDOOR NON-FOOD
Bait station. Use code BAB., When B/S NA UC * NS NS NS NS 1 NS
needed., Not applicable.
B/S NA UC * NS NS NS NS NS NS
.0125 lb IK sq.ft *
Void treatment., When needed., Cup. B/S NA .0125 lb IK sq.ft * NS NS NS NS NS NS
89
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Report Run Date: 09/05/95 ) Time 11:42 APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon] LUIS 2.1 ) Page 26
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless
noted otherwise)
Max. Appl. Rate (AI unless
noted otherwise)
Soil Tex. Max. Dose
Max. # Apps @ Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days)
PRD Report Date
: Minimum dose for a single application to a single site.
: Maximum dose for a single application to a single site.
System calculated. Microbial claims only.
System calculated.
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
0 : Others
FORMULATION CODES
B/S : BAIT/SOLID
G : GRANULAR
RTU : LIQUID-READY TO USE
SC/S : SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to ".0001234"
USE LIMITATIONS CODES
C04 : Proper ventilation required.
C14 : Grown for seed only.
C46 : Do not apply through any type of irrigation system.
F01 : day(s) prefreshening interval.
F05 : Do not apply to lactating animals.
90
-------
Report Run Date: 09/05/95 ) Time 11:42 APPENDIX A ) CASE 0104, [Trichlorfon] Chemical 057901 [Trichlorphon] LUIS 2.1 ) Page 27
PRD Report Date: 04/29/94
4444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444444
USE LIMITATIONS CODES (Cont.)
G01 : day(s) pregrazing interval.
G03 : Do not graze livestock in treated areas.
GC1 : Do not graze treated areas.
GDI : Do not forage or cut green crop or use seed for feed purposes.
GD2 : Chaff and straw from treated areas may be used for feed purposes.
GE3 : Do not use for food or feed.
GF4 : Do not feed straw to livestock.
GH6 : Do not feed treated vines to dairy or meat animals.
GI7 : Do not use seed for food, feed or oil purposes.
GJ3 : Do not use tops as food for humans.
H01 : day(s) preharvest interval.
H03 : Preharvest interval not located on the label.
H23 : day(s) preharvest interval if tops are to be fed to livestock.
S09 : day(s) preslaughter interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
CA : California
KS : Kansas
NC : North Carolina
NJ : New Jersey
91
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Intentionally Blank Page
92
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for
active ingredients within the case Trichlorfon covered by this Reregi strati on Eligibility
Decision Document. It contains generic data requirements that apply to Trichlorfon in all
products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set in the Pesticide Assessment Guidelines, which are available
from the National Technical Information Service, 5285 Port Royal Road, Springfield,
VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use
patterns:
A
Terrestrial food
B
Terrestrial feed
C
Terrestrial non-food
D
Aquatic food
E
Aquatic non-food outdoor
F
Aquatic non-food industrial
G
Aquatic non-food residential
H
Greenhouse food
I
Greenhouse non-food
J
Forestry
K
Residential
L
Indoor food
M
Indoor non-food
N
Indoor medical
0
Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has
been assigned. Refer to the Bibliography appendix for a complete citation of the
study.
93
-------
Intentionally Blank Page
94
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT USE PATTERN CITATION(S)
PRODUCT CHEMISTRY
Product Chemistry for Reg. No. 3125-9
61-1
Chemical Identity
ALL
00152133, 42835201,
44024701
61-2A
Start. Mat. & Mnfg. Process
ALL
00152133,
42835201
61-2B
Formation of Impurities
ALL
42835201
62-1
Preliminary Analysis
ALL
00148973, 42835202,
44027402
62-2
Certification of limits
ALL
00152133,
42835202
62-3
Analytical Method
ALL
00148973,
42835202
63-2
Color
ALL
00152133
63-3
Physical State
ALL
00152133
63-4
Odor
ALL
00152133
63-5
Melting Point
ALL
00152133
63-6
Boiling Point
ALL
N/A
63-7
Density
ALL
00152133, 42835203,
44027403
63-8
Solubility
ALL
00152133
63-9
Vapor Pressure
ALL
00152133,
41535301
63-10
Dissociation Constant
ALL
00152133
63-11
Octanol/Water Partition
ALL
00147436
95
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT
USE PATTERN
CITATION(S)
63-12
pH
ALL
00152133
63-13
Stability
ALL
00152133, 42835203
63-14
Oxidizing/Reducing Action
ALL
00152133
63-15
Flammability
ALL
N/A
63-16
Explodability
ALL
00152133
63-17
Storage stability
ALL
00152133
63-18
Viscosity
ALL
N/A
63-19
Miscibility
ALL
N/A
63-20
Corrosion characteristics
ALL
00152133, 42835203
Product Chemistry for Res. No. 3125-404
61-1
Chemical Identity
ALL
42835207
61-2A
Start. Mat. & Mnfg. Process
ALL
DATA GAP, 44024704
61-2B
Formation of Impurities
ALL
42835207, 44024704
62-1
Preliminary Analysis
ALL
42835208
62-2
Certification of limits
ALL
42835208
62-3
Analytical Method
ALL
42835208, 44024705
63-2
Color
ALL
42835209
63-3
Physical State
ALL
42835209
63-4
Odor
ALL
42835209
96
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT
USE PATTERN
CITATION(S)
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flammability
63-16 Explodability
63-17 Storage stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion characteristics
Product Chemistry for Reg. No. 3125-371
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42835209
N/A
DATA GAP, 44024706
00162307, 42835209
00162307, 42835209, 41535302
00162307
00162307, 42835209
42835209
42835209, 44027406
DATA GAP
N/A
DATA GAP
DATA GAP
DATA GAP
DATA GAP
4285203, 42835209
00158290, 42835204
42835204
97
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT
USE PATTERN
CITATION(S)
61-2B
Formation of Impurities
ALL
42835204
62-1
Preliminary Analysis
ALL
N/A
62-2
Certification of limits
ALL
00158290, 42835205
62-3
Analytical Method
ALL
42835205
63-2
Color
ALL
42835206
63-3
Physical State
ALL
42835206
63-4
Odor
ALL
42835206
63-5
Melting Point
ALL
N/A
63-6
Boiling Point
ALL
N/A
63-7
Density
ALL
42835206
63-8
Solubility
ALL
N/A
63-9
Vapor Pressure
ALL
N/A
63-10
Dissociation Constant
ALL
N/A
63-11
Octanol/Water Partition
ALL
N/A
63-12
pH
ALL
42835206
63-13
Stability
ALL
43139501, 42835206
63-14
Oxidizing/Reducing Action
ALL
N/A
63-15
Flammability
ALL
N/A
63-16
Explodability
ALL
42835206
98
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT
USE PATTERN
CITATION(S)
63-17 Storage stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion characteristics
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-1B Acute Avian Oral - Quail/Duck
TEP
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
71-4A Avian Reproduction - Quail
71-4B Avian Reproduction - Duck
72-1A Fish Toxicity Bluegill
72-1B Fish Toxicity Bluegill - TEP
72-1C Fish Toxicity Rainbow Trout
72-1D Fish Toxicity Rainbow Trout- TEP
72-2A Invertebrate Toxicity
72-2B Invertebrate Toxicity - TEP
72-3A Estuarine/Marine Toxicity - Fish
ALL
ALL
ALL
ALL
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, K
DATA GAP, 42835206
N/A
N/A
DATA GAP
00073683, 0016000
00091969
00034769
00034769
00128682
43119501
43019601
40094602, 40098001
40098001, 00091951
00091881, 00091766
00091766, 00091951, 0091942
40094602, 0065497, 40228401, 40098001
40098001
40228401
99
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT
USE PATTERN
CITATION(S)
72-3B Estuarine/Marine Toxicity -
Mollusk
72-3C Estuarine/Marine Toxicity -
Shrimp
72-4A Early Life Stage Fish
72-4B Life Cycle Invertebrate
141-1 Honey Bee Acute Contact
141-2 Honey Bee Residue on Foliage
141-5 Field Test for Pollinators
TOXICOLOGY
81-1
81-2
81-3
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
C, K
C, K
C, K
C, K
C, K
C, K
C, K
C, I, K, M, O
C, I, K, M, O
C, I, K, M, O
DATA GAP
40098001
42571701
DATA GAP (estuarine), 40452601
00036935
00060628, 05000837
05004412
00152315, 00005494, 00081186
00085923,GS0104070, 00081185
00152315, 00085923, 00081185, GS0104070
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation -
Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-7 Acute Delayed Neurotoxicity - Hen
82-1A 90-Day Feeding - Rodent
C, I, K, M, O
C, I, K, M, O
C, I, K, M, O
C, I, K, M, O
41571302
40306901
40654306
00152139
N/A
100
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT USE PATTERN CITATION(S)
82-1B
90-Day Feeding - Non-rodent
c, I,
K, M,
0
00148091
82-2
21-Day Dermal - Rabbit/Rat
C, I,
K, M,
0
40306901
82-3
90-Day Dermal - Rodent
C, I,
K, M,
0
N/A
82-4
90-Day Inhalation - Rat
C, I,
K, M,
0
N/A
82-5A
90-Day Neurotoxicity - Hen
C, I,
K, M,
0
40351201, 40879301
82-5B
90-Day Neurotoxicity - Mammal
C, I,
K, M,
0
DATA GAP, 43871701
83-1A
Chronic Feeding Toxicity - Rodent
C, I,
K, M,
0
42510301, 41056201, 41973001, 00165011
00152148
83-1B
Chronic Feeding Toxicity -
Non-Rodent
C, I,
K, M,
0
00080593, 40776001
83-2A
Oncogenicity - Rat
C, I,
K, M,
0
42510301, 41056201, 41973001
83-2B
Oncogenicity - Mouse
C, I,
K, M,
0
40782401, 40844301
83-3A
Developmental Toxicity - Rat
C, I,
K, M,
0
00128683, GS0104075, 00063192, 40255601
83-3B
Developmental Toxicity - Rabbit
C, I,
K, M,
0
00128683, GS0104075, 00063192, 41565201
83-4
2-Generation Reproduction - Rat
C, I,
K, M,
0
00128682, 42228301
84-2A
Gene Mutation (Ames Test)
C, I,
K, M,
0
00132949, 00125787, 00028625
84-2B
Structural Chromosomal
Aberration
C, I,
K, M,
0
00123282, 00028625
84-4
Other Genotoxic Effects
C, I,
K, M,
0
00125787, 40277201, 00132949, 0028625
85-1
General Metabolism
C, I,
K, M,
0
40438101
101
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT USE PATTERN CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A
Foliar Residue Dissipation
C, I, K, M, 0
DATA GAP
133-3
Dermal Passive Dosimetry
Exposure
C, I, K, M, 0
DATA GAP
133-4
Inhalation Passive Dosimetry
Exposure
C, I, K, M, 0
DATA GAP
231
Estimation of Dermal Exposure at
Outdoor Sites
C, K
DATA GAP
232
Estimation of Inhalation Exposure
at Outdoor Sites
C, K
DATA GAP
ENVIRONMENTAL FATE
161-1
Hydrolysis
C, I, K
00148974
161-2
Photodegradation - Water
C
00148975
161-3
Photodegradation - Soil
C
00157859
162-1
Aerobic Soil Metabolism
C, I, K
00098625, 42243701
163-1
Leaching/Adsorption/Desorption
C, I, K
40279302, 00029887
163-2
Volatility - Lab
c,i
40279302
164-1
Terrestrial Field Dissipation
C, K
DATA GAP, 00091852, 423222501
165-1
Confined Rotational Crop
C
403338602
201-1
Droplet Size Spectrum
C, K
DATA GAP
202-1
Drift Field Evaluation
C, K
DATA GAP
-------
Data Supporting Guideline Requirements for the Reregistration of Trichlorfon
REQUIREMENT
USE PATTERN
CITATION(S)
RESIDUE CHEMISTRY
171-4B Nature of Residue - Livestock
171-4D Residue Analytical Method -
Animal
171-4E Storage Stability
171-4J Magnitude of Residues -
Meat/Milk/Poultry/Egg
L
L
L
L
00005297, DATA GAP
00091795,00133081, 0091806,
DATA GAP
00091791, 00091807, DATA GAP
00091796, 00091794, 00041262, 00091665
00091807, DATA GAP
103
-------
Intentionally Blank Page
104
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregi strati on Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number." This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
105
-------
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study
within the volume.
106
-------
BIBLIOGRAPHY
MRID
CITATION
00005297 Robbins, W.E.; Hopkins, T.L.; Eddy, G.W. (1956) The metabolism of
P32-labeled Bayer L 13/59 in a cow. Journal of Economic Entomology
49(6):801-806. (Report no. 1635; also In unpublished submission received
Aug 18, 1966 under 7F0612; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:090796-V)
00005494 MacDougall, D. (1962) Acute Toxicity of Some Organophosphorus
Insecticides to Rats. (Unpublished study including letter dated Nov 23, 1962
from D. MacDougall to Dr. Jasper, received Nov 26, 1962 under unknown
admin, no.; prepared by Chemagro Corp., submitted by Bayvet, Shawnee
Mission, Kans.; CDL:109105-A)
00028625 Simmon, V.F. (1979) In vitro Microbiological Mutagenicity and Unscheduled
DAN Syntheses Studies of Eighteen Pesticides: Report No. EPA-600/1-79-041.
Unpublished study including submitter summary, received apr 3, 1980 under
279-2712; prepared by SRI International, submitted by FMC Corp.,
Philadelphia PA; CDL:099350-A.
00029887 Thornton, J.S.; Hurley, J.B.; Obrist, J.J. (1976) Soil Thin-Layer Mobility of
Twenty Four Pesticides (sic) Chemicals: Report No. 51016. (Unpublished
study received Jan. 28, 1980 under 5F1547; submitted by Mobay Chemical
Corp., Pittsburgh, Pa.; CDL: 099216-1)
00034769 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of
Environmental Pollutants to Birds. By U.S. Fish and Wildlife Service,
Patuxent Wildlife Research Center. Washington D.C.: U.S.F.W.S. (Special
Scientific Report- Wildlife No. 191; also in unpublished submission received
Mar 28, 1979 under 3125-236; submitted as report number 334223a by Mobay
Corp., Kansas City, Mo.; CDL: 237905-B.
00036935 Atkins, E.L.; Greywood, E.A.; MacDonald, R.L. (1975) toxicity of Pesticides
and Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By
University of California, Dept. of Entomology. UC/Cooperative Extension
Leaflet 2287; published study.
107
-------
BIBLIOGRAPHY
MRID
CITATION
00041262 Chemagro Corporation (1966) Synopsis of Analytical and Residue Information
on Mist Spray Application of Co-ral-Trichlorfon to Dairy and Beef Cattle.
Summary of studies 090319-Z, 090796-K, 090796-L, 090796-N, 090796-0,
090796-Q through 097096-S and 090796-AC. (Unpublished study received
Aug 18, 1966 under 7F0612; CDL:090796-J)
00060628 Johansen, C.A.; Eves, J. (1965) Bee Poisoning Investigations, 1965: report No.
G-1705; report No. 17338. Unpublished study, including letter dated Jun 12,
1973 from C.A. Johansen to A.D. Cohick, received Mar 27, 1974 under 4F185;
prepared by Washington State University, Dept. of Entomology, submitted by
Chemagro Corp. Kansas City, MO.; CDL:092011-I.
00063192 Staples, R.E.; Kellam, R.G; Haseman, J.K. (1976) Developmental toxicity in
the rat after ingestion of gavage of organophosphate pesticides (Dipterex,
Imidan) during pregnancy. Environmental Health Perspectives
13(Feb):133-140. (Also In unpublished submission received Apr 18, 1978
under 476-1917; submitted by Stauffer Chemical Co., Richmond, Calif.;
CDL:234110-D)
00065495 Pickering, Q.H.; Henderson, C.; Lemke, a.E. (1960) The Toxicity of Organic
Phosphorous Insecticides to Different Species of Warm Water Fishes. U.S.
Public Health Service, R.A. Taft Sanitary Engineering Center, unpublished
study including submitter summary, received Apr 7, 1977 under 3125-183;
submitted as report number 9282 by Mobay Corp. Kansas city, Mo.;
CDL:230908-I.
00065497 Jensen, L.D.; Gaufin, A.R. (1964) Effects of ten organic insecticides on two
species of stonefly naiads. Transactions of the American Fisheries Society
93(l):27-34. (Submitter report no. 14085; unpublished study, including
submitter summary, received Apr 7, 1977 under 3125-183; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:229299-C)
00073683 Schafer, E.W. (1972) the Acute Oral Toxicity of 369 pesticidal, pharmaceutical
and Other Chemicals to Wild Birds. Toxicology and Applied Pharmacology
21:315,316,319. CDL:230908-I.
108
-------
BIBLIOGRAPHY
MRID
CITATION
00080593 Doull, J.; Root, M.; Vesselinovitch, D.; et al. (1962) Chronic Oral Toxicity of
Dylox to Male and Female Dogs: Submitter 8644. (Unpublished study received
on unknown date under 7F0612; prepared by Univ. of Chicago, Depts. of
Pharmacology and Pathology, submitted by Chemagro Corp., Kansas City,
Mo.; CDL:097552-AL)
00081185 Mobay Chemical Corporation (1961) Synopsis of Pharmacology and
Toxicology Information ofNeguvon (Bayer L 13/59, Dipterex, Dylox).
Summary of studies 100895-B through 100895-AE, 100895 AG and
100895-AN. (Unpublished study received Feb 13, 1961 under 3125-77;
CDL:100895-A)
00081186 DuBois, K.P.; Cotter, G.J. (1955) Studies on the toxicity and mechanism of
action of dipterex. American Medical Association Archives of Industrial
Health ll(Jan):53-60. (Submitter #467; also~In~unpublished submission
received Feb 13, 1961 under 312577; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL: 100895-B)
00085923 Edson, E.F.; Noakes, D.N. (1960) The comparative toxicity of six
organophosphorus insecticides in the rat. Toxicology and Applied
Pharmacology 2:523-539. (Submitter 5942; also~In~unpublished submission
received Feb 13, 1961 under 3125-77; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:100895-S)
00091665 Mobay Chemical Corporation (1964) Supplement No. 1 to Brochure Entitled:
Neguvon: Analytical and Residue Information on Backline Application.
Includes method dated Aug 22, 1966. (Compilation; unpublished study
received Mar 3, 1967 under 3125-156; CDL:007101-B)
00091766 Lamb, D.W.; Roney, D.J. (1972) Acute Toxicity of Dylox Technical and Dylox
80% SPA-oil to Fish: Report No. 32807. (Unpublished study received Sep 1,
1972 under 3125-278; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:050510-B)
00091791 Mobay Chemical Corporation (1966) Trichlorfon: Analytical and Residue
Information (Corn). Includes methods dated Jan 30, 1964 and Nov 16, 1964.
(Compilation; unpublished study received May 15, 1967 under 3125-49;
CDL:090792-A)
109
-------
BIBLIOGRAPHY
MRID
CITATION
00091794 Mobay Chemical Corporation (1967) Trichlorfon: Analytical and Residue
Information for Forage Crops, Cowpeas, and Lima Beans. Includes methods
dated Mar 14, 1962; Jan 30, 1964; Aug 16, 1966, and others. (Compilation;
unpublished study received on unknown date under 7F0612; CDL:090793-A;
090794)
00091795 Mobay Chemical Corporation (1964) Neguvon: Analytical and Residue
Information on Backline Application. Includes method dated Sep 24, 1964.
(Compilation; unpublished study received May 15, 1967 under 7F0612;
CDL:090795-A)
00091796 Mobay Chemical Corporation (1966) Neguvon: Residue Information on Cattle
Tissues (Spray). Includes methods dated Nov 27, 1962 and Aug 11, 1966.
(Compilation; unpublished study received May 15, 1967 under 7F0612;
CDL:090795-B)
00091806 Mobay Chemical Corporation (1970) Trichlorfon: Analytical and Residue
Information on Peanuts. Includes methods dated Aug 16, 1966; Aug 22, 1966;
Oct 27, 1966; and others. (Compilation; unpublished study, including rept.
nos. 11560, 12838, 12840..., received Feb 15, 1970 under 0F0969;
CDL:091665-A; 091666)
00091807 Mobay Chemical Corporation (1972) Trichlorfon: Analytical and Residue
Information on Citrus Fruit. Includes methods dated Jan 30, 1964; Jun 12,
1970; Apr 28, 1969; and others. (Unpublished study received Aug 14, 1972
under 2F1242; CDL:091764-A; 091765)
00091852 Olson, T.J. (1968) A Study of DDVP Formation Resulting from Trichlorfon
Treatment of Alkaline Pond Water: Report No. 21808. (Unpublished study
received Sep 19, 1969 under 3125-143; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL:102088-C)
110
-------
BIBLIOGRAPHY
MRID
CITATION
00091881 Henderson, C.; Pickering, Q.H.; Tarzwell, C.M. (1959) The Toxicity of
Organic Phosphorus and Chlorinated Hydrocarbon Insecticides to Fish: Mobay
4276a. (U.S. Public Health Service, Robert A. Taft Sanitary Engineering
Center, Water Supply and Water Pollution Research, Bioassay Application
Studies; unpublished paper presented at the Second Seminar on Biological
Problems in Water Pollution; Apr 21, 1959; Cincinnati, Ohio; unpublished
study; CDL:110547-B)
00091942 McCann, J.A. (1970) Snail Away: Rainbow Trout: Test No. 259. (U.S.
Agricultural Research Service, Pesticides Regulation Div., Animal Biology
Laboratory; unpublished study; CDL:130347-A)
00091951 McCann, J.A. (1969) Neguvon Cattle Insecticide (Trichlorfon): Bluegill.
Prelim, rept. (U.S. Agricultural Research Service, Pesticides Regulation Div.,
Animal Biology Laboratory; unpublished study; CDL:132076-A)
00091969 Lamb, D.W.; Nelson, D.L. (1971) Acute Oral Toxicity of Dylox 4 lb/gal ULV
to Adult Bobwhite Quail: Report No. 29550. (Unpublished study received May
10, 1971 under 3125-210; submitted by Mobay Chemical Corp., Kansas City,
Mo.; CDL: 120463-R)
00092002 Grimble, D.G.; Sykes, R.B., Jr.; Devine, J.M.; et al. (1972) An Evaluation of
the Environmental Impact and Efficacy of an Aerial Application of Trichlorfon
(Dylox) against the Gypsy Moth and Associated Organisms in New York State:
Submitter 32702. (Unpublished study received May 20, 1977 under 3125-210;
prepared by State Univ. of New York—Syracuse, Applied Forestry Research
Institute, submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:230752-T)
00098625 Khasawinah, A.M. (1972) The Fate of Dylox in Soil: Report No. 32365.
(Unpublished study received May 20, 1977 under 3125-210; submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:230752-S)
00123282 Carere, A.; Ortali, V.; Cardamone, G.; et al. (1978) Microbiological
mutagenicity studies of pesticides in vitro. Mutation Research 57:277-286.
(Also In unpublished submission received Dec 9, 1982 under 464-502;
submitted by Dow Chemical U.S.A., Midland, MI; CDL:248984-B)
111
-------
BIBLIOGRAPHY
MRID
CITATION
00125787 Shirasu, Y.; Moriya, M.; Koyashika, R. (1979) Trichlorfon: Mutagenicity Test
on Bacterial Systems: 0Submitter* 69367. (Unpublished study received Feb 9,
1983 under 3125-9; prepared by Institute of Environmental Toxicology,
submitted by Mobay Chemical Corp., Kansas City, MO; CDL:249535-A)
00128682 Loser, E.; Lorke, D. (1969) Bay 15 922: Generation Study on Rats: Submitter:
24855. (Unpublished study received Mar 24, 1981 under 3125-9; prepared by
Farbenfabriken Bayer, AG, W. Ger., submitted by Mobay Chemical Corp.,
Kansas City, MO; CDL: 244915-B)
00128683 Machemer, L.; Lorke, D. (1979) L 13/59 (Trichlorfon): Studies of Embryo-
toxic and Teratogenic Effects on Rats following Oral Administration:
81-T-024; 69298. (Unpublished study received Mar 24, 1981 under 3125-9;
prepared by Bayer AG, W. Ger., submitted by Mobay Chemical Corp., Kansas
City, MO; CDL:244915-C)
00132949 Mortelmans, K.; Riccio, E.; Shepherd, G. (1980) In vitro Detection of Mitotic
Crossing-Over, Mitotic Gene Conversion and Reverse Mutation with S.
Cerevisiae D7 for Seven Pesticides: SRI Project No. LSU-7558-20; Contract
No. 68-02-2947. Final rept. (Unpublished study received Dec 5, 1983 under
239-2471; prepared by SRI International, submitted by Chevron Chemical Co.,
Richmond, CA; CDL:251894-C)
00133081 Mobay Chemical Corp. (1963) Dylox: Analytical and Residue Data (Barley,
Flax, Oats, and Wheat). (Compilation; unpublished study received Jul 18,
1963 under 3125-49; CDL:101742-A)
00147436 Krohn, J. (1983) Letter sent to Hagen dated Jul 14, 1983: Partition coefficient
of trichlorfon and methamidophos: Registration in Egypt. Translation of
Verteilungskoeffizienten von trichlorfon und methamidophos: Registrierung in
Aegypten prepared by Bayer AG, Mobay report 85931. 1 p.
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Dylox in Rats: Project No. DL4R: Report No. 94594. Unpublished study
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40654306 Porter, M.; Craigo, R.; Hartnagel, R. (1987) Dermal Sensitization Evaluation of
Dylox 5% GB in Guinea Pigs: Rept. No. MTD0026. Unpublished Mobay
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Rhesus Monkeys: A Ten Year Study: Study No. 800108. Unpublished study
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Trichlorfon (Dylox) with Rats: Study No. 86-271-02. Unpublished study
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41565201 Clemens, F.; Troup, C.; Hartnagel, R. (1990) Teratology Study in the Rabbit
with Dylox Technical (Trichlorfon): Lab Project Number: MTD0134: 100195.
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41571302 Sheets, L. (1989) Primary Eye Irritation Study with DYLOX 80 T&O (Without
Citric Acid) in Rabbits: Lab Project Number: 89-333-CQ. Unpublished study
prepared by Mobay Corporation. 19 p.
41973001 Christenson, W. (1989) A Combined Chronic Toxicity/Oncogenicity Study of
Technical Grade Trichlorfon (Dylox) with Rats: Supplement: Lab Project
Number: 87-271-02. Unpublished study prepared by Mobay Corp. 1869 p.
42228301 Eigenberg, D. (1991) A Two-Generation Dietary Reproduction Study in Rats
Using Technical Grade Trichlorfon (Dylox): Lab Project Number: 89-672-EA.
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Soil: Lab Project Number: 99640. Unpublished study prepared by Mobay
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42322501 Grace, T.; Cain, K. (1990) Dissipation of Trichlorfon in California Soils: Lab
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Technical Grade Trichlorfon (Dylox) with Rats: Supp. to MRID 41056201:
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42571701 Gagliano, G. (1992) Early Life Stage Toxicity of Dylox Technical to the
Rainbow Trout (Oncorhynchus mykiss) under Flow-through Conditions: Lab
Project Number: DL842201: 103928: Unpublished study prepared by Miles
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42835201 Fontaine, L. (1993) Product Chemistry of Dipterex Technical: Supplemental:
Lab Project Number: MCL0006A: MCL0006B: 605161. Unpublished study
prepared by Miles Inc. 30 p.
42835202 Fontaine, L. (1993) Product Chemistry of Dipterex Technical: Supplemental:
Lab Project Number: 88931: 88935: 93156. Unpublished study prepared by
Miles Inc. 75 p.
42835203 Fontaine, L. (1993) Product Chemistry of Dipterex Technical: Supplemental:
Lab Project Number: 90153: 90155: 91700. Unpublished study prepared by
Miles Inc. 86 p.
42835204 Fontaine, L. (1993) Product Chemistry of Dylox 80 Concentrate:
Supplemental: Lab Project Number: 605161: 501968: 501821. Unpublished
study prepared by Miles Inc. 53 p.
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Supplemental: Lab Project Number: 99697: 103879: 105144. Unpublished
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you
must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements listed in this Notice
and in Attachment 3 (for both generic and product specific data), the
Requirements Status and Registrant's Response Form, (see section III-B); or
3. Why you believe EPA should not require your submission of data in the
manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also included is a list of all
registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
PRO^
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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-In Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions (Form A)
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions (Form B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the
continued use of products containing this active ingredient(s). You have been sent this Notice
because you have product(s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Forms: Attachment 3 (for both generic and product specific data
requirements). Depending on the results of the studies required in this Notice, additional
studies/testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in the Requirements Status and Registrant's Response Forms (Attachment 3) within
the timeframes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (Telephone number:
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160],
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cY2yB^ NOTICES ISSUED
BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-Inrsl or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to
this Notice. The type of Data Call-In you must comply with (Generic or Product Specific) is
specified in item number 3 on the four Data Call-In forms (Attachments 2 and 3).
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Ill-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product
specific data must be submitted to the Agency within 90 days after your receipt of this Notice.
Failure to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for
issuance of NOIS due to failure to comply with this Notice are presented in Section IV-A and
IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a)
voluntary cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy
the generic data requirements imposed by this Notice or (e) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A discussion
of the various options available for satisfying the generic data requirements of this Notice is
contained in Section III-C. A discussion of options relating to requests for data waivers is
contained in Section III-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
(contained in Attachments 2 and 3, respectively).
The Data Call-In Response Forms must be submitted as part of every response to this
Notice. The Requirements Status and Registrant's Response Forms also must be submitted if
you do not qualify for a Generic Data Exemption or are not requesting voluntary cancellation
of your registration(s). Please note that the company's authorized representative is required to
sign the first page of both Data Call-In Response Forms and the Requirements Status and
Registrant's Response Forms (if this form is required) and initial any subsequent pages. The
forms contain separate detailed instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit completed Generic and Product Specific
Data Call-In Response Forms (Attachment 2), indicating your election of this option.
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Voluntary cancellation is item number 5 on both Data Call-In Response FormCsY If you
choose this option, these are the only forms that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b. Use Deletion
You may avoid the requirements of this Notice by eliminating the uses of your product
to which the requirements apply. If you wish to amend your registration to delete uses, you
must submit the Requirements Status and Registrant's Response Form (Attachment 3), a
completed application for amendment, a copy of your proposed amended labeling, and all
other information required for processing the application. Use deletion is option number 7
under item 9 in the instructions for the Requirements Status and Registrant's Response Forms.
You must also complete a Data Call-In Response Form by signing the certification, item
number 8. Application forms for amending registrations may be obtained from the
Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA, by
calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
reguirements, further sale, distribution, or use of your product after one year from the due date
of your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is
exempt from the reguirement to submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from purchased, registered pesticide
products containing the active ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product which would gualify and
continue to gualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To gualify,
all of the following reguirements must be met:
(i). The active ingredient in your registered product must be present solely because of
incorporation of another registered product which contains the subject active
ingredient and is purchased from a source not connected with you;
(ii). Every registrant who is the ultimate source of the active ingredient in your
product subject to this DCI must be in compliance with the reguirements of this Notice
and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement
of Formula" for each of your products to which this Notice applies.
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To apply for the Generic Data Exemption you must submit a completed Data Call-In
Response Form. Attachment 2 and all supporting documentation. The Generic Data
Exemption is item number 6a on the Data Call-In Response Form. If you claim a generic data
exemption you are not required to complete the Requirements Status and Registrant's
Response Form. Generic Data Exemption cannot be selected as an option for responding to
product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons
to provide the Agency with the required data. If the registrant(s) who have committed to
generate and submit the required data fail to take appropriate steps to meet requirements or
are no longer in compliance with this Data Call-In Notice, the Agency will consider that both
they and you are not compliance and will normally initiate proceedings to suspend the
registrations of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will not grant a
time extension for submitting the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this
Notice. These options are discussed in Section III-C.l. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the Requirements Status and Registrant's Response
Form and item 6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy
the generic data requirements), you must submit the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on
the forms marked "GENERIC" in item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l. of this Notice and are
covered by options 8 and 9 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this
Notice or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C.2. A discussion of
options relating to requests for data waivers is contained in Section III-D.2.
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Two forms apply to the product specific data requirements one or both of which must
be used in responding to the Agency, depending upon your response. These forms are the
Data-Call-in Response Form, and the Requirements Status and Registrant's Response Form.
for product specific data (contained in Attachments 2 and 3, respectively). The Data Call-In
Response Form must be submitted as part of every response to this Notice. In addition, one
copy of the Requirements Status and Registrant's Response Form also must be submitted for
each product listed on the Data Call-In Response Form unless the voluntary cancellation
option is selected. Please note that the company's authorized representative is required to sign
the first page of the Data Call-In Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of
your product(s) containing the active ingredient that is the subject of this Notice. If you wish
to voluntarily cancel your product, you must submit a completed Data Call-In Response
Form, indicating your election of this option. Voluntary cancellation is item number 5 on both
the Generic and Product Specific Data Call-In Response Forms. If you choose this
option, you must complete both Data Call-In response forms. These are the only forms that
you are required to complete.
If you choose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of this Notice.
There are various options available to satisfy the product specific data requirements of
this Notice. These options are discussed in Section III-C.2. of this Notice and comprise
options 1 through 6 of item 9 in the instructions for the product specific Requirements Status
and Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product
specific data reguirements for an MUP or EUP as applicable) on the product specific Data
Call-In Response Form. Note that the options available for addressing product specific data
reguirements differ slightly from those options for fulfilling generic data reguirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data reguirements. It is important to ensure that you are using the correct
forms and instructions when completing your response to the Reregi strati on Eligibility
Decision document.
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c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section III-D.2. of this Notice and
are covered by option 7 of item 9 in the instructions for the Requirements Status and
Registrant's Response Form. If you choose this option, you must submit the Data Call-In
Response Form and the Requirements Status and Registrant's Response Form as well as any
other information/data pertaining to the option chosen to address the data requirement. Your
response must be on the forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to
satisfy the generic data requirements (i.e. you select item number 6b), then you must select
one of the six options on the Generic Requirements Status and Registrant's Response Form
related to data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production are
the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency (Citing
an Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency
deadlines and with other Agency requirements as referenced herein and in the attachments.
All data generated and submitted must comply with the Good Laboratory Practice (GLP) rule
(40 CFR Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG)
and be in conformance with the requirements of PR Notice 86-5. In addition, certain studies
require Agency approval of test protocols in advance of study initiation. Those studies for
which a protocol must be submitted have been identified in the Requirements Status and
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Registrant's Response Form and/or footnotes to the form. If you wish to use a protocol which
differs from the options discussed in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to use it. The Agency may
choose to reject a protocol not specified in Section II-C. If the Agency rejects your protocol
you will be notified in writing, however, you should be aware that rejection of a proposed
protocol will not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you
are required to commit to generate or undertake some other means to address that study
requirement, such as making an offer to cost share or agreeing to share in the cost of
developing that study. This 90-day progress report must include the date the study was or
will be initiated and, for studies to be started within 12 months of commitment, the name and
address of the lab oratory (ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year,
interim reports must be submitted at 12 month intervals from the date you are required to
commit to generate or otherwise address the requirement for the study. In addition to the other
information specified in the preceding paragraph, at a minimum, a brief description of current
activity on and the status of the study must be included as well as a full
description of any problems encountered since the last progress report.
The time frames in the Requirements Status and Registrant's Response Form are the
time frames that the Agency is allowing for the submission of completed study reports or
protocols. The noted deadlines run from the date of the receipt of this Notice by the registrant.
If the data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the cost of producing the required
data but will not be submitting the data yourself, you must provide the name of the registrant
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who will be submitting the data. You must also provide EPA with documentary evidence that
an agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or amend an
existing agreement to meet the requirements of this Notice and have been unsuccessful, you
may request EPA (by selecting this option) to exercise its discretion not to suspend your
registration(s), although you do not comply with the data submission requirements of this
Notice. EPA has determined that as a general policy, absent other relevant considerations, it
will not suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept the offer. To qualify for this option,
you must submit documentation to the Agency proving that you have made an offer to
another registrant (who has an obligation to submit data) to share in the burden of developing
that data. You must also submit to the Agency a completed EPA Form 8570-32, Certification
of Offer to Cost Share in the Development of Data, Attachment 7. In addition, you must
demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost-sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the data upon terms to be agreed to
or, failing agreement, to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA of its
election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burden of developing the data. In addition, the other registrant must fulfill
its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant normally will be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit, the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this Notice. You may only
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submit a study that has not been previously submitted to the Agency or previously cited by
anyone. Existing studies are studies which predate issuance of this Notice. Do not use this
option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly Met:
a. You must certify at the time that the existing study is submitted that the raw
data and specimens from the study are available for audit and review and you
must identify where they are available. This must be done in accordance with
the requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR
Part 160. As stated in 40 CFR 160.3 'Raw data' means any laboratory
worksheets, records, memoranda, notes, or exact copies thereof, that are the
result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the exact copy
or exact transcript may be substituted for the original source as raw data. 'Raw
data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data
from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or
analysis."
b. Health and safety studies completed after May 1984 also must also contain all
GLP-required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must certify at the time of
submitting the existing study that such GLP information is available for post
May 1984 studies by including an appropriate statement on or attached to the
study signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the
Guideline relevant to the study provided in the FIFRA Accelerated
Reregi strati on Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or meets
the purpose of the PAG (both available from NTIS). A study not conducted
according to the PAG may be submitted to the Agency for consideration if the
registrant believes that the study clearly meets the purpose of the PAG. The
registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in
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addition to certifying that the purposes of the PAG are met by the study, clearly
articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely
satisfied the purpose of the PAG and that necessary raw data usually are not
available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must
identify any action taken by the Agency on the protocol and must indicate, as part of your
certification, the manner in which all Agency comments, concerns, or issues were addressed
in the final protocol and study.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit
data to upgrade that study. The Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement is not satisfied, you may still
be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to
note that not all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied
or corrected and why the study should be rated as acceptable to EPA. Your submission must
also specify the MRID number(s) of the study which you are attempting to upgrade and must
be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
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The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally, your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria, as well as a certification regarding protocol compliance with Agency
requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study
must have been previously classified by EPA as acceptable, or it must be a study which has
not yet been reviewed by the Agency. Acceptable toxicology studies generally will have been
classified as "core-guideline" or "core-minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all other disciplines the classification
would be "acceptable." With respect to any studies for which you wish to select this option,
you must provide the MRID number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In Response Form that you
agree to satisfy the product specific data requirements (i.e. you select option 7a or 7b), then
you must select one of the six options on the Requirements Status and Registrant's Response
Form related to data production for each data requirement. Your option selection should be
entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for completing
the Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time-frame (Developing
Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an
existing study that has been
submitted but not reviewed by the Agency (Citing an Existing Study)
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Option 1. Developing Data — The requirements for developing product specific data are the
same as those described for generic data (see Section III.C.l, Option 1) except that normally
no protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost
share, the same requirements apply to product specific data as to generic data (see Section
III.C.l, Option 2). However, registrants may only choose this option for acute toxicity data
and certain efficacy data and only if EPA has indicated in the attached data tables that your
product and at least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted
in the agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The same requirements for
generic data (Section III.C.L, Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section III.C.l., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see
Section III.C.l., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C.l., Option 6) apply to this option for product specific data.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form and the
Requirements Status and Registrant's Response Form, and in the generic data requirements
section (III.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice. The first is a request for a
low volume/minor use waiver and the second is a waiver request based on your belief that the
data requirement(s) are not appropriate for your product.
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response
Form. Section 3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of
requiring data for low volume, minor use pesticides. In implementing this provision,
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EPA considers low volume pesticides to be only those active ingredients whose total
production volume for all pesticide registrants is small. In determining whether to grant a low
volume, minor use waiver, the Agency will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of the pesticide, and the exposure
and risk from use of the pesticide. If an active ingredient is used for both high volume and
low volume uses, a low volume exemption will not be approved. If all uses of an active
ingredient are low volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information outlined below. An
exemption will not be granted if any registrant of the active ingredient elects to conduct the
testing. Any registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified for such
waiver. If granted a waiver, a registrant will be required, as a condition of the waiver, to
submit annual sales reports. The Agency will respond to requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the following
information, as applicable to your product(s), as part of your 90-day response to this
Notice:
(i). Total company sales (pounds and dollars) of all registered product(s)
containing the active ingredient. If applicable to the active ingredient, include foreign
sales for those products that are not registered in this country but are applied to sugar
(cane or beet), coffee, bananas, cocoa, and other such crops. Present the above
information by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active
ingredient for each major use site. Present the above information by year for each of
the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient
by year for the past five years. Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to product(s) containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were directly related to the active
ingredient, such as costs of initial registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the
type of waiver sought and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill each of
these data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver
and the estimated cost to you (listed separately for each data requirement and
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associated test) of conducting the testing needed to fulfill each of these data
requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales
(pounds and dollars) of the active ingredient, direct production costs of product(s)
containing the active ingredient (following the parameters in item 2 above), indirect
production costs of product(s) containing the active ingredient (following the
parameters in item 3 above), and costs of data development pertaining to the active
ingredient.
(viii) A description of the importance and unique benefits of the active
ingredient to users. Discuss the use patterns and the effectiveness of the active
ingredient relative to registered alternative chemicals and non-chemical control
strategies. Focus on benefits unique to the active ingredient, providing information that
is as quantitative as possible. If you do not have quantitative data upon which to base
your estimates, then present the reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active ingredient in terms of its
benefits, you should provide information on any of the following factors, as applicable
to your product(s): (a) documentation of the usefulness of the active ingredient in
Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed to its registered alternatives,
(c) information on the breakdown of the active ingredient after use and on its
persistence in the environment, and (d) description of its usefulness against a pest(s) of
public health significance.
Failure to submit sufficient information for the Agency to make a
determination regarding a request for a low volume/minor use waiver will result in
denial of the request for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response
Form. This option may be used if you believe that a particular data requirement should
not apply because the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You also must
submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice are not appropriate to your
product(s), you will not be required to supply the data pursuant to section 3(c)(2)(B). If
EPA determines that the data are required for your product^, vou must choose a
method of meeting the requirements of this Notice within the time frame provided by
this Notice. Within 30 days of your receipt of the Agency's written decision, you must
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submit a revised Requirements Status and Registrant's Response Form indicating the
option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the format required by PR
Notice 86-5). This will be the only opportunity to state the reasons or provide
information in support of your request. If the Agency approves your waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) of FIFRA. If
the Agency denies your waiver request, you must choose an option for meeting the
data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products
and the Agency would grant a waiver only under extraordinary circumstances. You
should also be aware that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted without adequate
supporting rationale will be denied and the original due date will remain in force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address the data requirements (e.g., any required action or
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information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration
concerning joint data development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
i. Inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-In Response Form and a Requirements Status and
Registrant's Response Form.
ii. Fulfill the commitment to develop and submit the data as required by
this Notice; or
iii. Otherwise take appropriate steps to meet the requirements stated in this
Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
grounds for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels
to be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
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2) EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3) EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting (or
raw) data, including, but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to fulfill the submission
requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. You also must explain why an "existing stocks" provision is
necessary, including a statement of the quantity of existing stocks and your estimate of the
time required for their sale, distribution, and use. Unless you meet this burden, the Agency
will not consider any request pertaining to the continued sale, distribution, or use of your
existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due, unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3-year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study
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in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the
information to the Agency. Registrants must notify the Agency of any factual information
they have, from whatever source, including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the environment. This requirement
continues as long as the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
All responses to this Notice must include completed Data Call-In Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms
(Attachment 3), for both (generic and product specific data) and any other documents
required by this Notice, and should be submitted to the contact person(s) identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only
the Generic and Product Specific Data Call-In Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois Rossi, Division Director
Special Review and
Reregi strati on Division
Attachments
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The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status
and Registrant's Response Forms with Instructions
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - List of Registrants Receiving This Notice
6 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
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TRICHLORFON PRODUCT SPECIFIC DATA CALL-IN CHEMICAL STATUS
SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Trichlorfon.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of
data required by this notice, and point of contact for inquiries pertaining to the reregi strati on
of Trichlorfon. This attachment is to be used in conjunction with (1) the Product Specific
Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3)
the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-
Use Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Trichlorfon Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Trichlorfon are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on Trichlorfon are needed for specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are
needed to fully complete the reregi strati on of all eligible Trichlorfon products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Barbara Briscoe at (703) 308-8177.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Barbara Briscoe
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Trichlorfon
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TRICHLORFON GENERIC DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Trichlorfon.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of
Trichlorfon. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Trichlorfon Generic Data Call In (Attachment
F). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for
Trichlorfon are contained in the Requirements Status and Registrant's Response. Attachment
C. The Agency has concluded that additional product chemistry data on Trichlorfon are
needed. These data are needed to fully complete the reregi strati on of all eligible Trichlorfon
products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Dana Lateulere at (703) 308-8044.
All responses to this Notice for the generic data requirements should be submitted to:
Dana Lateulere, Chemical Review Manager
Reregi strati on Branch
Special Review and Reregi strati on Division (7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Trichlorfon
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms"
and are to be used by registrants to respond to generic and product specific Data Call-Ins as
part of EPA's Reregi strati on Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI
letter as part of a RED document you have been sent just the product specific "Data Call-In
Response Forms." Only registrants responsible for generic data have been sent the generic
data response form. The type of Data Call-In (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for
completing these forms are different. Please read these instructions carefully before filling
out the forms.
EPA has developed these forms individually for each registrant, and has preprinted these
forms with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by
the registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork
Reduction Project 2070-0107, Washington, D.C. 20503.
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. ON BOTH FORMS: This item identifies the type of Data Call-In. The date
of issuance is date stamped.
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Item 4. ON BOTH FORMS: This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are also responsible for
informing the Agency of your response regarding any product that you believe
may be covered by this Data Call-In but that is not listed by the Agency in Item
4. You must bring any such apparent omission to the Agency's attention within
the period required for submission of this response form.
Item 5. ON BOTH FORMS: Check this item for each product registration you wish
to cancel voluntarily. If a registration number is listed for a product for which
you previously requested voluntary cancellation, indicate in Item 5 the date of
that request. Since this Data Call-In requires both generic and product specific
data, you must complete item 5 on both Data Call-In response forms. You do
not need to complete any item on the Requirements Status and Registrant's
Response Forms.
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data
Exemption for the chemical listed in Item 2 and used in the subject product.
By electing this exemption, you agree to the terms and conditions of a Generic
Data Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that you
use in your product.
Typically, if you purchase an EPA-registered product from one or more other
producers (who, with respect to the incorporated product, are in compliance
with this and any other outstanding Data Call-In Notice), and incorporate that
product into all your products, you may complete this item for all products
listed on this form. If, however, you produce the active ingredient yourself, or
use any unregistered product (regardless of the fact that some of your sources
are registered), you may not claim a Generic Data Exemption and you may not
select this item.
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is
for generic data as indicated in Item 3 and if you are agreeing to satisfy the
generic data requirements of this Data Call-In. Attach the Requirements Status
and Registrant's Response Form that indicates how you will satisfy those
requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item 7a ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing
use product (MUP) for which you wish to maintain registration, you must agree
to satisfy the data requirements by responding "yes."
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Item 7b.
For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if
your product is identical to another product and you qualify for a data
exemption. You must provide the EPA registration numbers of your source(s);
do not complete the Requirements Status and Registrant's Response form.
Examples of such products include repackaged products and Special Local
Needs (Section 24c) products which are identical to federally registered
products.
If you are requesting a data waiver, answer "yes" here; in addition, on the
"Requirements Status and Registrant's Response" form under Item 9, you must
respond with option 7 (Waiver Request) for each study for which you are
requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
Item 8. ON BOTH FORMS: This certification statement must be signed by an
authorized representative of your company and the person signing must include
his/her title. Additional pages used in your response must be initialled and
dated in the space provided for the certification.
Item 9. ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may
wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For
these cases, please supply all relevant details so that EPA can ensure that its records are correct.
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Instructions For Completing The "Requirements Status and Registrant's Response
Forms" For The Generic and Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Requirements Status
and Registrant's Response Forms" and are to be used by registrants to respond to generic and
product specific Data Call-in's as part of EPA's reregi strati on program under the Federal
Insecticide, Fungicide, and Rodenticide Act. If you are an end-use product registrant only
and have been sent this DCI letter as part of a RED document you have been sent just the
product specific "Requirements Status and Registrant's Response Forms." Only registrants
responsible for generic data have been sent the generic data response forms. The type of
Data Call-In (generic or product specific) is indicated in item number 3 ("Date and Type
of DCI") on each form.
Although the form is the same for both product specific and generic data, instructions
for completing the forms differ slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2) request for a low volume/minor
use waiver. Please read these instructions carefully before filling out the forms.
EPA has developed these forms individually for each registrant, and has preprinted
these forms to include certain information unique to this chemical. DO NOT use these forms
for any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9 must be completed by the
registrant as appropriate. Items 10 through 13 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average
30 minutes per response, including time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect
of this collection of information, including suggestions for reducing this burden, to Chief,
Information Policy Branch, Mail Code 2136, U.S. Environmental Protection Agency, 401 M
St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork
Reduction Project 2070-0107, Washington, D.C. 20503.
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and
address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number,
case name, EPA chemical number and chemical name.
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ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
case number, case name, and the EPA Registration Number of the product for
which the Agency is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is date stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the
type of Data Call-In. The date of issuance is also date stamped. Note the
unique identifier number (ID#) assigned by the Agency. This ID number must
be used in the transmittal document for any data submissions in response to this
Data Call-In Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of
studies required. These guidelines, in addition to the requirements specified in
the Data Call-In Notice, govern the conduct of the required studies. Note that
series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c.
Item 5. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section III of the Data Call-In Notice, 90-day progress reports are required for
all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this
guideline reference number to the Requirements Status and Registrant's
Response Form.
Item 6. ON BOTH FORMS: This item identifies the code associated with the use
pattern of the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use
sites and/or pests indicated. A brief description of each code follows:
A
Terrestrial food
B
Terrestrial feed
C
Terrestrial non-food
D
Aquatic food
E
Aquatic non-food outdoor
F
Aquatic non-food industrial
G
Aquatic non-food residential
H
Greenhouse food
I
Greenhouse non-food crop
J
Forestry
K
Residential
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L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned to the substance
that must be used for testing. A brief description of each code follows:
EUP
End-Use Product
MP
Manufacturing-Use Product
MP/TGAI
Manufacturing-Use Product and Technical Grade Active
Ingredient
PAI
Pure Active Ingredient
PAI/M
Pure Active Ingredient and Metabolites
PAI/PAIRA
Pure Active Indredient or Pute Active
Ingredient Radiolabeled
PAIRA
Pure Active Ingredient Radiolabeled
PAIRA/M
Pure Active Ingredient Radiolabeled and Metabolites
PAIRA/PM
Pure Active Ingredient Radiolabeled and Plant
Metabolites
TEP
Typical End-Use Product
TEP %
Typical End-Use Product, Percent Active Ingredient
Specified
TEP/MET
Typical End-Use Product and Metabolites
TEP/PAI/M
Typical End-Use Product or Pure Active Ingredient and
Metabolites
TGAI
Technical Grade Active Ingredient
TGAI/PAI
Technical Grade Active Ingredient or Pure Active
Ingredient
TGAI/PAIRA
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabeled
TGAI/TEP
Technical Grade Active Ingredient or Typical End-Use
Product
MET
Metabolites
IMP
Impurities
DEGR
Degradates
*
See: guideline comment
Item 8. This item completed by the Agency identifies the time frame allowed for
submission of the study or protocol identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the date of
your receipt of the Data Call-In notice.
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ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the date stamped on the
letter transmitting the Reregi strati on Eligibility Decision document, and not
from the date of receipt. However, your response to the Data Call-In itself is
due 90 days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of
each code follow. The Data Call-In Notice contains a fuller description of each
of these options.
Option 1. ON BOTH FORMS: (Developing Data') I will conduct a new study
and submit it within the time frames specified in item 8 above. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to the conditions for submittal of this
study as outlined in the Data Call-In Notice and that I will provide the
protocols and progress reports required in item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Shared I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to sharing in the cost of developing data
as outlined in the Data Call-In Notice.
However, for Product Specific Data, I understand that this
option is available for acute toxicity or certain efficacy data ONLY if
the Agency indicates in an attachment to this notice that my product is
similar enough to another product to qualify for this option. I certify that
another party in the agreement is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Shared I have made an offer to
enter into an agreement with one or more registrants to develop data
jointly. I am also submitting a completed "Certification of offer to Cost
Share in the Development of Data" form. I am submitting evidence that
I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am including a copy of
my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the
required data; if the required study is not submitted on time, my product
may be subject to suspension. I understand that other terms under
Option 3 in the Data Call-In Notice apply as well.
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However, for Product Specific Data, I understand that this
option is available only for acute toxicity or certain efficacy data and
only if the Agency indicates in an attachment to this Data Call-In Notice
that my product is similar enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data') I will submit an
existing study by the specified due date that has never before been
submitted to EPA. By indicating that I have chosen this option, I certify
that this study meets all the requirements pertaining to the conditions for
submittal of existing data outlined in the Data Call-In Notice and I have
attached the needed supporting information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study^ I will submit by the
specified due date, or will cite data to upgrade a study that EPA has
classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing
existing data to upgrade a study described in the Data Call-In Notice. I
am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I
am citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study^ I am citing an existing study
that has been previously classified by EPA as acceptable, core, core
minimum, or a study that has not yet been reviewed by the Agency. If
reviewed, I am providing the Agency's classification of the study.
However, for Product Specific Data, I am citing another
registrant's study. I understand that this option is available ONLY for
acute toxicity or certain efficacy data and ONLY if the cited study was
conducted on my product, an identical product or a product which the
Agency has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements"
form.
FOR THE GENERIC DATA FORM ONLY: The following three options
(Numbers 7, 8, and 9) are responses that apply only to the "Requirements Status
and Registrant's Response Form" for generic data.
Option 7. (Deleting Uses') I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
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Option 8. (Low Volume/Minor Use Waiver Requesf) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In
Notice and I request a low-volume minor use waiver of the data
requirement. I am attaching a detailed justification to support this
waiver request including, among other things, all information required
to support the request. I understand that, unless modified by the Agency
in writing, the data requirement as stated in the Notice governs.
Option 9. (Request for Waiver of Data') I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data
Call-In Notice and I request a waiver of the data requirement. I am
attaching a rationale explaining why I believe the data requirements do
not apply. I am also submitting a copy of my current labels. (You must
also submit a copy of your Confidential Statement of Formula if not
already on file with EPA). I understand that, unless modified by the
Agency in writing, the data requirement as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7) is a
response that applies to the "Requirements Status and Registrant's Response
Form" for product specific data.
Option 7. (Waiver Requesf) I request a waiver for this study because it is
inappropriate for my product. I am attaching a complete justification for
this request, including technical reasons, data and references to relevant
EPA regulations, guidelines or policies. [Note: any supplemental data
must be submitted in the format required by P.R. Notice 86-5], I
understand that this is my only opportunity to state the reasons or
provide information in support of my request. If the Agency approves
my waiver request, I will not be required to supply the data pursuant to
Section 3(c) (2) (B) of FIFRA. If the Agency denies my waiver request,
I must choose a method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying the option chosen. I also
understand that the deadline for submission of data as specified by the
original Data Call-In notice will not change.
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative
of your company. The person signing must include his/her title, and must initial
and date all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
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Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you
may wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this
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EPA'S BATCHING OF TRICHLORFON PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR RE REGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing the active ingredient
trichlorfon, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and
inert ingredients (identity, percent composition and biological activity), type of formulation
(e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g.,
signal word, use classification, precautionary labeling, etc.). Note that the Agency is not
describing batched products as "substantially similar" since some products within a batch may
not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the
right to require, at any time, acute toxicity data for an individual product should the need
arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered by EPA to be similar for
acute toxicity, and the formulation has not been significantly altered since submission and
acceptance of the acute toxicity data. Regardless of whether new data is generated or existing
data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the
registrant must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must
follow the directions given in the Data Call-In Notice and its attachments appended to the
RED. The DCI Notice contains two response forms which are to be completed and submitted
to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks
whether the registrant will meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the product specific data required for
each product, including the standard six acute toxicity tests. A registrant who wishes to
participate in a batch must decide whether he/she will provide the data or depend on someone
else to do so. If a registrant supplies the data to support a batch of products, he/she must
select one of the following options: Developing Data (Option 1), Submitting an Existing
Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study
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(Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If
a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.
However, a registrant should know that choosing not to participate in a batch does not
preclude other registrants in the batch from citing his/her studies and offering to cost share
(Option 3) those studies.
There are 27 active products registered with the active ingredient trichlorfon, dimethyl
(2,2,2-trichloro-l-hydroxyethyl)phosphonate. Of these, the three manufactured by Bayer
(manufacturer number 11556) are being considered for withdrawal by the producer. Presently
these are still in the batching process, and will not be withdrawn until they are removed from
the active list.
The first batch are technicals, with no added inerts. These will not need testing as the
RED includes validated acute toxicity information on the pure substance.
Batch No.
Epa Reg. No.
% of Trichlorfon
Formulation Type
1
3125-9
98
Solid
3125-404
97
Solid
11556-30
98
Solid
The products in Batch #2 have the smallest percentage of trichlorfon and similar inerts.
It is possible to bridge from Batch #3 and cite data with the exception of an eye irritation
study.
Batch No.
Epa Reg. No.
% of Trichlorfon
Formulation Type
2
3125-7
1
Solid
3125-151
1
Solid
There is valid information on 3125-76, with the exception of acute inhalation toxicity
study, which may be used on all products for Batch #3.
Batch No.
Epa Reg. No.
% of Trichlorfon
Formulation Type
3
655-790
5.0
Solid
655-791
5.0
Solid
3125-76
5.0
Solid
3125-400
6.2
Solid
158
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Batch No.
Epa Reg. No.
% of Trichlorfon
Formulation Type
3
3125-405
5.0
Solid
3125-406
6.2
Solid
8660-71
6.2
Solid
9198-100
5.0
Solid
9198-110
6.2
Solid
10404-55
5.0
Solid
10401-64
6.2
Solid
32802-29
6.2
Solid
Batch No.
Epa Reg. No.
% of Trichlorfon
Formulation Type
4
829-203
5
Solid
19713-220
5
Solid
PRS waived acute toxicity data on products 3125-184 and 371, and used data on the
technical for toxicity grading with the addition of an eye irritation study. This approach may
be used for products in Batch #5.
Batch No.
Epa Reg. No.
% of Trichlorfon
Formulation Type
5
3125-184
80
Solid
3125-371
80
Solid
3125-449
80
Solid
34704-308
80
Solid
45639-123
80
Solid
The table below shows products which were not batched because of significant
differences in inert ingredients.
159
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Epa Reg. No.
% of Trichlorfon
Formulation Type
10370-186
5
Solid
11556-32
8
Liquid
11556-109
8
Liquid
160
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The following is a list of available documents for Trichlorfon that my further assist
you in responding to this Reregi strati on Eligibility Decision document. These documents
may be obtained by the following methods:
Electronic File format:
Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader.
Electronic copies can be downloaded from the Pesticide Special Review and Reregi strati on
Information System at 703-308-7224. They also are available on the Internet on EPA's
gopher server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using WWW (World
Wide Web) on WWW.EPA.GOV., or contact Barbara Briscoe at (703)-308-8177.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Trichlorfon.
The following documents are part of the Administrative Record for Trichlorfon and
may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may
be obtained by contacting the person listed on the Chemical Status Sheet of this RED
document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
161
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162
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Attachment 1. List of All Registrants Sent This Data Call-In (insert) Notice
163
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164
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\
^tosr%
Sie
K it/
PRO^
%
United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any othdr
aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy
Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office o:
Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below:
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the
Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of
developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included
an
an offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firms on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made
on this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false <
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
165
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166
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
PRCS#'
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing th
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with section
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration
or reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
167
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Intentionally Blank Page
168
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible,
signed copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided.
d. All applicable information which is on the product specific data submission
must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
all common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if
the proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
169
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Intentionally Blank Page
170
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Confidential Business Information: Does Not Contain National Securit
f Information (E. 0. 12065) Form Approved. OMB No. 2070-0060. Approval Expires 2/28/94!
United States Environmental Protection Agency
Office of Pesticide Programs (TS-767)
P OA Washington, DC 20460
EI r r\ Confidential Statement of Formula
CH Basic Formulation
~ Alternate Formulation
B.
Page of
See Instructions on Back
1. Name
snd Address of Applicant/Registrant (Include ZIP Code)
2. Name and Address of Producer (Include ZIP Code)
3. Product
Name
4. Registration No./File Symbol
5. EPA Product Mgr/Team No.
6. Country Where Formulated
7. Pounds/Gal or Bulk Density
8. pH
9. Flash Point/Flame Extension
EPA USE
ONLY
10. Components in Formulation (List as actually introduced
into the formulation. Give commonly accepted chemical
name, trade name, and CAS numberJ
11. Supplier Name & Address
12. EPA Reg. No.
13. Each Component
in Formulation
a. Amount b. %byWeighi
14. Certified Limits
% by Weight
a Upper Limn b Lower Limit
15 Purpose in
Formulation
16 Typed Name of Approving Official
1 7. Total Weight
100%
18. Signature of Approving Official
19. Title 20. Phone No. /Include Area Code)
21 Date
EPA Form 8570-4 (Rev. 12-90) Previous editions are obsolete. If you can photocopy this, please submit an additional copy. White- EPA File Copy (original) Yellow- Applicant copy
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Intentionally Blank Page
172
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