vvEPA
United States
Environmental Protection
Agency
Office of Prevention, Pesticides EPA 738-R-95-033
And Toxic Substances July 1996
(7508W)
Re registration
Eligibility Decision (RED)
Prometryn
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United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances August
(7508W)
EPA-738-R-95-028
July 1996
R.E.D. FACTS
PROMETRYN
Pesticide
Reregistration
Use Profile
All pesticides sold or used in the United States must be registered by
EPA, 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 years ago be reregistered to ensure that they meet
today's more stringent standards:
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision Document, or
RED. This fact sheet summarizes the information in the RED document for
reregistration case ,0467, prometryn.
Prometryn is a substituted thiomethly triazine herbicide registered for
the control of several annual grasses and broadleaf weeds in terrestrial food
and feed crops cotton, celery, pigeon peas and dill. Prometryn!s mechanism
of action inhibits the electron transport in target broadleaves and grasses.
Prometryn was first registered in 1964 by Ciba Crop Protection. Prometryn
is also manufactured by the Verolit Chemical Manufacturer, Ltd.
Prometryn's major use sites are cotton and celery.
Other names for prometryn are Prometryne, Caparol, Gesagard,
Primatol Q, and Prometex. Prometryn is formulated as a single active
ingredient in wettable powder, crystalline, and flowable concentrate. -
Prometryn is also formulated in a multiple active ingredient product which
combines a flowable concentrate with monosodium methanearsonate.
Currently there are 17 registered products (includes two Special Local Need
registrations) that contain from 8 to 97 percent prometryn. There are no
homeowner use products registered.
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Regulatory Prometryn was first registered in the United States in 1964 as a
History herbicide for the control of weeds in cotton, celery, pigeon peas, and dill. A
Registration Standard was issued in March 1987 (NTIS# PB87-184826),
and required product and residue chemistry, toxicology, fish and wildlife,
plant protection, and environmental fate data. Additionally, the Special
Review and Reregistration Division issued two Data Call-Ins, one
September 30, 1991, requesting Tier m non-target phytotoxicity field
studies and Spray Drift information, and the second, September 2, 1992,
requesting hexachlorobenzene (HCB) and penta-chlorobenzene (PCB) data
to determine the potential presence of the impurities in technical prdmetryn.
Lacking appropriate guidance for conducting Tier HL testing and because of
our new policy, the Agency has decided to assess risk and make
reregistration decisions based on Tier n laboratory data. Therefore, the
Agency placed Tier HI study requirements on reserve. The Reregistration
Eligibility Decision document reflects the reassessment of the data
submitted in response to the Registration Standard and both Data Call-ins.
Human Health
Assessment
Toxicity
In studies using laboratory animals, prometryn technical has been
shown to be slightly to practically non-toxic for oral, dermal, inhalation and
has been placed in Tox Category HE (next to lowest in the four categories)
for these. Additionally, pertaining to acute eye and dermal irritation,
prometryn technical is considered to be slight to practically nqn toxic,
respectively and has been categorized as being in Categories HE and IV for
these. Prometryn is not considered a sentizer.
In a subchronic 28-day feeding study using rats showed that
macroscopic and microscopic pathological findings appeared in the high
dose animals, and were limited to the G.I. tract along with clinical signs and
marked decreases in body weights were also seen in these animals. In a 21-
day dermal toxicity study with rabbits, no locator systemic toxicity was
observed at the highest dose levels (1000 mg/kg/day).
In three chronic toxicity/carcinogenicity studies with mice, rats and
dogs showed that prometryn was not oncogenic. Prometryn was classified
as a Group E Carcinogen (no evidence of human carcinogenic potential)
because prometryn did not alter the spontaneous tumor profile for the
strains of mice and rats tested. The dog study, however, was not considered
because, even though there were some effects, under the conditions of the
study, the effects were not oncogenic.
A developmental toxicity study with rats showed the highest dose
level caused maternal and developmental toxicity. In another study also
conducted with rabbits resulted in effects at the highest dose level,
including increased abortions and decrease in body weight parameters.
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- A 2-generation reproductive study with rats showed effects at the
highest dose level including decrease in body weight and corresponding
food consumption. Nevertheless, the statistically significant decrease in
pup body weight (also at the high dose level) was considered to be
lexicologically significant because of its potential negative impact on post-
natally developing systems such as the neuro- and immune systems.
In four mutagenicity studies (ames samonella test, chromosomal
aberration, bacterial DNA repair, and unscheduled DNA synthesis test)
prometryn was found to be negative.
A series of (radiolabeled) general metabolism studies with rats
showed the greatest distribution of prometryn first in the blood followed by
the spleen and then in the lungs.
Dietary Exposure
People may be exposed to residues of prometryn through the diet.
Tolerances or maximum residue limits have been established for a variety
of crop and animal commodities (see 40 CFR 180.222(a) and (b)).
Food and Feed additive tolerances are established for residues of
prometryn in or on the following raw agricultural commodities: celery (0.5
ppm); corn fodder (field, pop, and sweet, 0.25 ppm); corn forage (field,
pop, and sweet, 0.25 ppm); fresh corn (sweet K +CWHR, 0.25 ppm); corn
grain (0.25 ppm); cotton[forage](l ppm); cottonseed (0.25 ppm); and
pigeon peas (0.25 ppm). A tolerance with regional registration is
established in or on dill (0.03 ppm). J
The Agency has determined that a risk assessment for the uses of
prometryn can be conducted using tolerance-level residues of prometryn,
per se in cottonseed,, pigeon peas, celery and dilL
The Agency has assessed the dietary risk posed by prometryn
considering tolerance level residues to calculate the Theoretical Maximum
Contribution (TMRC) for the overall US population and 22 subgroups. No
refinements using anticipated residues or percent crop treated were applied.
Two analysis were conducted, one included the commodity (corn) for
which revocation of tolerance is recommended and the other did not include
the proposed revocation of tolerances on corn. Both chronic analyses
indicated a negligible chronic dietary risk from the use of prometryn.
The RfD was determined to be 0.04 mg/kg/day based on a NOEL of
3.75 mg/ kg/day from a chronic toxicity study in dogs. The LEL was '
determined to be 3.75 mg/kg/day based on bone marrow atrophy and
degenerative changes in the liver and kidneys. An uncertainty factor of 100
was used to account for inter- and intra- species variability.
An acute dietary analysis has been recommended. The endpoint for
acute dietary risk assessment is the NOEL of 12 mg/kg/day from a rabbit
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developmental study, while the LEL was based on increased resorptions,
abortion and significant changes in other reproductive parameters at
72 mg/kg body weight/day.
Occupational Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to prometryn during and after application in
agricultural settings. There are no data to evaluate post-application
exposure because post-application data were not required in the
Registration Standard and subsequent DCI's, because at the time no
toxicological criteria had been triggered. There are no residential uses for
prometryn and no exposure risk is expected to homeowners.
There are toxicological endpoints of concern for prometryn. The
.endpoint for both short-term and intermediate-term occupational exposure
is a NOEL of 12 mg/kg/day taken from a rabbit developmental study
indicating increased resorption, abortion, and significant changes in other
reproductive parameters at the LEL. The LEL is 72 mg/kg/day and the
Agency deemed a 15% factor appropriate for estimating dermal exposure.
Although no dermal absorption study with prometryn was ever
conducted, the Agency determined that a 7% absorption value is a
reasonable upper limit for dermal absorption. The 7% is based on a
comparison between an oral rabbit developmental study and a 21-day
dermal rabbit study. However, uncertainties and concerns exist regarding
the use of 7% in conducting the risk assessment because the parameters
typically measured in a 21-day dermal study are not extensive (i.e., no
clinical chemistries) and the effects observed including increased abortion
and increased post-implantation loss in the developmental study are
significant. Thus, the Agency has decided to use a more protective
absorption rate of 15%.
The Agency has determined that there is an exposure potential for
handlers during the usual use-patterns associated with prometryn.
Exposures to mixers, loaders and applicators are likely when liquid (used in
aerial application) and wettable powder (used in aerial and groundboom
applications) formulations are used. In the same manner, the Agency has
determined that there is a potential for exposure to persons entering treated
sites after application is complete with special concern for lay-by
applications to celery, since such applications can be made over the crop
and celery is often thinned by hand.
Human Risk Assessment
To mitigate the risks posed to handlers, the Agency is requiring that
all wettable powder formulations be encased in soluble packets. To
mitigate the risks associated with mixing and loading liquid formulations to
support aerial applications, the Agency is, requiring minimum (baseline)
PPE of a chemical resistent apron and a respirator equipped with a dust/mist
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Environmental
Assessment
filter. Additionally, to protect field workers, the Agency is requiring a 24-
hour REI for uses on celery and a 12-hour REI for all other uses. The
Agency is also requiring interim spray drift advisory measures be placed on
all labels, and is requiring a confirmatory post-application/ reentry study for
celery to assess the impact posed to reentry workers.
Environmental Fate
The laboratory mobility data for prometryn indicate that prometryn
has the potential to leach into ground water and will be most mobile in
sandy, alkaline soils which contain little organic matter or clay. Prometryn
was detected in ground water from an irrigation well in California.
However, in California, Arizona and New Mexico, prometryn labels
instruct potential users not to apply the product to sand or loamy sand soils.
Also, prometryn was not detected in ground water during a retrospective
ground-water monitoring study performed by the registrant in Missouri, at a
site which was underlain by sandy loams arid loamy sands.
Ecological Effects
Because prometryn is registered for the control of weeds in terrestrial
feed and food crops; cotton, celery, pigeon peas and dill, it is expected that
.exposure to nontarget organisms can result from direct applications, spray
drift, and runoff from treated areas. Studies indicate that prometryn poses
an acute risk to nonendagered and endangered terrestrial and aquatic plants,
a chronic risk to birds, and an acute risk to endangered small mammals.
Prometryn is currently not classified as a restricted use pesticide.
Although the restricted use risk quotients are at the threshold for small
mammals, fresh water invertebrates and estuarine/marine organisms, the
Agency has determined that the numbers do not warrant the chemicaT.s
reclassification at this time.
Ecological Effects Risk Assessment
The Agency is requiring labelling prohibiting the use of prometryn on
sand and sandy loam soils. However, in light of the registrant's stewardship
and the data-in-house, the Agency has determined that ground water and
surface water label advisories are not necessary at this time.
All of the ecological effects data required are fulfilled with the
exception of an avian reproduction (upland gamebird) study and a fish early
life stage study. These studies are needed to fully assess prometryn's risk
assessment to birds and fish.
In order that the use of prometryn will not endanger sensitive
terrestrial and aquatic plant species and to reduce potential risks, the
Agency is requiring all products to carry environmental hazard labeling.
Additionally, in the future, when the Agency implements the Endangered
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Additional Data
Required
o
o
o
Guideline 132-l(a)
Guideline 132-l(b)
Guideline 133-3
o Guideline 165-2
Species Protection Program, limitations may be imposed on the use of
prometryn to protect threatened and endangered species.
The Agency is requiring the following generic data for prometryn to
confirm its regulatory assessment and conclusions:
o Guideline 7 l-4(a) Avian reproduction (upland gamebird)
Guideline 72-4(a) Fish early life-stage
Guideline 85-2 Dermal absorption
A confirmatory post-application/reentry study for celery. The study
shall consist of:
Foliar dislodgeable residue dissipation,
Soil residue dissipation, and
Dermal exposure to be conducted
concurrently.
Limited field rotational crop study (for leafy
vegetables).
Additionally, the Agency is requiring product-specific data including
product chemistry and acute toxicity studies, revised Confidential
Statements of Formula (CSFs), and revised labeling for reregistration.
Product Labeling The labels of all registered pesticide products containing prometryn must
comply with the Agency's current pesticide labeling requirement and with
the additional requirements summarized below.
Worker Protection Requirements
Personal Protective Equipment (PPE) Requirements
For Occupational Use
The minimum (baseline) PPE for all prometryn occupational handlers
of prometryn end-use products is:
"Applicators and other handlers must wear:
— long sleeve shirt and long pants,
— Chemical resistant gloves,.and
— Shoes plus socks."
For the liquid-formulation end-use products that contain instructions for
aerial applications, the Agency is requiring the following additional
minimum (Baseline) PPE for mixers and loaders supporting aerial
application:
"In addition, mixers and loaders supporting aerial applications must wear:
— Chemical resistant apron, and
— Respirator (a dust/mist filtering respirator (MSHA/NIOSH
approval numb er prefix TC -21C)).
Changes Required
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Entry Restictions
For Occupational-Use
A 24-hour restricted entry interval (REI) is required for celery and a
12-hour (REI) is required for all other uses. The PPE required for early
entry is:
—Coveralls over long-sleeve shirt and long pants,
—Chemical-resistant gloves,
—Shoes plus socks.
Other Labeling Requirements
For Occupational Use: • .
"Do not apply this product in a way that will make contact with
workers or other persons, either directly or through drift. Only
protected handlers may be in the area during application."
Engeneering Controls:
"When handlers use closed systems* (including water-soluble packets),
enclosed cabs, or aircraft in a manner that meets the requirements listd
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."
User Safety Requirements:
"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."
Soil Incorporation Statement
Registrants may add the following statement to their labeling in the
Agricultural Use Requirements box immediately following the restricted
entry interval:
"Exception: If the product is soil-incorporated, 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."
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Environmental Hazard:
For all prometryri end-use products, use this precautionary statement:
"Do not apply directly to. water or to areas where the
surface water is present or to intertidal areas below the
mean high water mark. Do not contaminate water when
disposing of equipment washwater or rinsate. Drift and
runoff may be hazardous to aquatic organisms in
neighboring areas. Do not apply where runoff is likely to
occur. Do not apply v/hen weather conditions favor drift
from treated areas."
Rotational Crops:
Labels must specify a plant-back-interval (FBI) of 8 months for
rotational crops.
Spray Drift Label Advisory:
For prometryn products that can be applied aerially, the following
statement must be placed on each label:
"Avoiding spray drift at the application site is the responsibility
of the applicator. The interaction of many equipment-and-
weather-related factors determine the potential for spray drift.
The applicator arid the grower are responsible for considering all
these factors when making spraying decisions."
The following drift management requirements must be followed to
avoid off-target drift movement from aerial applications to agricultural
crops. These requirements do not apply to forestry applications, public
health uses or to applications dry formulations:
1. "The distance of the outer most nozzles on the boom must not
exceed 3/4 the lenght of the wingspan or rotor."
2. "Nozzles must always point backward parallel with the air
stream and never be pointed downwards mure than 45
degrees."
Where states have more stringent regulations, they should be
observed.
The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory Information.
The following aerial drift reduction advisory information must be contained
in the product labeling:
[This section is advisory in nature and does not supersede the mandatory
label requirements.]
Information on droplet size
The most effective'way to reduce drift potential is to apply large
droplets. The best drift management strategy is to apply the largest
droplets that provide sufficient coverage and control. Applying larger
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droplets reduces drift potential, but will not prevent drift if applications are
made improperly, or under unfavorable environmental conditions (see
Wind, Temperature and Humidity, and Temperature Inversions).
Controlling Droplet Size
• Volume - Use high flow rae nozzles to apply the highest practical
spray volume. Nozzles with higher rated flows produce larger droplets.
• Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets.
When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure.
• Number of nozzles - Use the minimum number of nozzles that
provide uniform coverage.
• Nozzle orientation - Orienting nozzles so that the spray is released
parallel to the airstream produces larger droplets than other
orientations and is the recommended practice. Significant deflection
from horizontal will reduce droplet size and increase drift potential.
• Nozzle type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce larger
droplets. Consider using low-drift nozzles. Solid stream nozzles oriented
straight back produce the largest droplets and the lowest drift. :
Boom Length
For some use patterns, reducing the efffective boom length to less
than 3/4 of the wingspan or rotor length may further reduce drift without
reducing swath width. '
Application Height
Applications should not be made at a height greater than 10 feet
above the top of the largest plants unless a greater height is required for
aircraft safety. Making applications at the lowest height that is safe
reduces exposure of droplets to evaporation and wind.
Swath Adjustment
When applications are made with a crosswind, the swath will be
displaced downward. Therefore, on the up and downwind edges of the
field, the applicator must compensate for this displacement by adjusting the
path of the aircraft upwind. Swath adjustment distance should increase,
with increasing drift potential (higher wind, smaller drops, etc.).
Wind
Drift potential is lowest between wind speeds of 2-10 mph. However,
many factors, including droplet size and equipment type determine drift
potential at any given speed. Application should be avoided below 2 mph
due to variable wind direction and high inversion potential. NOTE: Local
terrain can influence wind patterns. Every applicator should be familiar
with local wind patterns and how they affect spray drift.
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Regulatory
Conclusion
For More
Information
Temperature and Humidity
When making applications in low relative humidity, set up equipment
to produce larger droplets to compensate for evaporation. Droplet
- evaporation is most severe when conditions are both hot and dry,
Temperature Inversions
Applications should not occur during a temperature inversion because
drift potential is high. Temperature inversions restrict vertical air mixing,
which causes small suspended droplets to remain in a concentrated cloud.
This cloud can move in unpredictable directions due to the light variable
winds common during inversions. Temperature inversions are
characterized by increasing temperatures with altitude and are common on
nights with limited cloud cover and light to no wind. They begin to form
as the sun sets and often continue into the morning. Their presence can be
indicated by ground fog; however, if fog is not present, inversions can also
be identified by the movement of smoke from a ground source or an
aircraft smoke generator. Smoke that layers and moves laterally in a
concentrated cloud (under low wind conditions) indicates an inversion,
while smoke that moves upward and rapidly dissipates indicates good
vertical air mixing.
Sensitive Areas
The pesticide should only be applied when the potential for drift to
adjacent sensitive areas (e.g. residential areas, bodies of water, known
habitat for threatened or endangered species, non-target crops) is minimal
(e.g. when wind is blowing away from the sensitive areas).
The use of currently registered products containing prometryn in
accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of these
products abiding to the requirements imposed in the RED document are
eligible for reregistration.
Prometryn products will be reregistered once the required product
specific data, revised Confidential Statements of Formula, and revised
labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision Document (RED) for prometryn 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 or to submit written comments, please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field
Operations Division (H-7506C), Office of Pesticide Programs (OPP),
US EPA, Washington, DC 20460. Telephone 703-305-5805.
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Following the comment period, the prometryn RED 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 prometryn or about EPA's pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8000. For information about reregistration of
individual products containing prometryn, please contact Robert Taylor,
Product Manager, Registration Division (H-7505C), OPP, US EPA,
Washington, DC 20460, telephone 703-305-6800.
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MIM^/
:«X
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
AUG 1 5 1996
Dear Registrant:
I am pleased to announce that the Environmental Protection
Agency has completed its reregistration eligibility review and
decisions on the pesticide chemical case prometryn. The enclosed
Rereaistration 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 reregistration. The RED
includes the data and labeling requirements for products for
reregistration.
To assist you with a proper response, read the enclosed
document entitled "Summary of Instructions for Responding to the
R^D." 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 receipt of this
letter. The second set of required responses is due 8 months
from the date of this letter. Complete and timely responses will
avoid the Agency taking the enforcement action of suspension
against your products .
If you have questions on the product specific data
requirements or wish to meet with the Agency, please contact the
Special Review and Reregistration Division representative Jean
Holmes at (703) 308-8008. Address any questions on generic data
to the Special Review and Reregistration Division representative,
Mario Fiol at (703) 308-8049. .
Sincerely you
Division
Enclosures
Lois A. Rossa, Director
Special Review
and Reregistration
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED1
1. DATA CALL-IN (PCD OR "90-DAY RESPONSE"-IF generic data are required for
reregistration, aDCI 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. TEVCE EXTENSIONS AND DATA WAIVER REOTJESTS-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 REREGISTRATION 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 Registrationln 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 cite the data for the five
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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-DAYl AND
APPLICATIONS FOR REREGISTRATION (S-MQNTH RESPONSES*
By 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
By express:
i 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 reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
PROMETRYN
0
LIST A
CASE 0467
' ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
PROMETRYNREREGISTRATION ELIGIBILITY DECISION TEAM . . .. . i
EXECUTIVE SUMMARY '..._, v
I. INTRODUCTION . .. . 1
H. CASE OVERVIEW . ,:.'.. . 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Regulatory History/Data Requirements 5
HI. SCIENCE ASSESSMENT ....'.....'. ....... 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment .-. 6
N ' a. Acute and Subchronic Toxicity : 6
b. Subchronic Toxicity . . 7
c. Chronic Toxicity/Carcinogenicity 7
« d. Developmental Toxicity .9
e. Reproductive Toxicity 9
f. Mutagenicity , '. 10
g. Metabolism ..:...... 10
h. Additional Toxicicity Endpoints 11
i. Dermal Absorption 11
2. Exposure Assessment 12
a. Dietary Exposure 12
b. Occupational Exposure 19
3. Risk Characterization 22
a. Chronic Dietary Risk . . ... . . 22
b. Acute Dietary Risk 23
c. Occupational Risk 23
C. Environmental Assessment 26
' ' i. Ecological Toxicity Data 26
- a. Toxicity to Terrestrial Animals 26
(1) Birds, Acute and Subacute 26
(2) Birds, Chronic . . . ... 26
. (3) Mammals . .. 27
(4) Insects 27
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b. Toxicity to Aquatic Animals 28
(1) Freshwater Fish .... 28
(2) Freshwater Invertebrates 29
(3) Estuarine and Marine Animals 29
c. Toxicity to plants 30
(1) Terrestrial 30
(2) Aquatic 30
2. Environmental Fate 31
a. Environmental Fate Assessment 31
b. Environmental Chemistry, Fate and Transport 33
c. Water Resources 37
3. Exposure and Risk Characterization 39
a. Ecological Exposure and Risk Characterization 39
b. Exposure and Risk to Non-target Terrestrial 41
(1) Exposure and Risk to Non-Target Aquatic Animals 42
(2) Exposure and Risk to Non-Target Plants 44
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 45
A. Determination of Eligibility .. '. 45
1. Eligibility Decision 46
2. Eligible and Ineligible Uses 1 .46
B. Regulatory Position , 46
1. Tolerance Reassessment ... 46
2. Restricted Use Classification 48
3. Reference Dose - - 48
4. Endangered Species Statement 49
5. Worker Protection Requirements 49
6. Spray Drift Advisory 53
7. Groundwater and Surface Water Advisories 53
8. Rotational Crops Intervals 54
9. Environmental Hazard '. -54
V. ACTIONS REQUIRED BY REGISTRANTS 54
A. Manufacturing-Use Products 54
1. Additional Generic Data Requirements . . 54
2. Labeling Requirements for Manufacturing-Use Products ...... 55
B. End-Use Products 55
1. Additional Product-Specific Requirements 55
2. Labeling Requirements for End-Use Products 56
a. Occupational Labeling 56
b. Other Labeling Requirements . 59
C. Homeowner Limitation Statement : 62
D. Existing Stocks .62
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VL APPENDICES .65
APPENDIX A. Table of Use Patterns Subject to Registration .67
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 80
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of prometryn 92
APPENDIX D. Combined Generic and Product Specific Data Call-In ... 110
- Attachment 1. Chemical Status Sheets ..... 131
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructionsl33
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions . 137
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration ..-..'.'....'..... 145
Attachment 5. List of AH Registrants Sent This Data Call-In (insert)
Notice 148
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions .... 149
APPENDIX E. List of Available Related Documents . 156
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PROMETRYN REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
EricMaurer
Jim Saulmon
Gabe Patrick
Environmental Fate and Effects Division
Renee Costello
Sharlene Matten
Kathryn Valente-Montague
David Edelstein
Kevin Costello
John Jordan
Health Effects Division
John C. Redden
Karen Whitby
Elizabeth Doyle
Myron Ottley
Christina Swartz
Jeff Evans
Registration Division •
Robert Taylor
Karen Hicks
Ian Blackwell
Economic Analysis Branch
Biological Analysis Branch
LUIS
Science Analysis & Coordination Branch
Science Analysis & Coordination Branch
Ecological Effects Branch
Environmental Fate & Groundwater Branch
Environmental Fate & Groundwater Branch
Environmental Fate and Groundwater Branch
Risk Characterization & Assessment Branch
Risk Characterization & Assessment Branch
Science Analysis Branch
Toxicology Branch I
Reregistration Support Chemistry Branch
Occupational & Residential ExposureBranch
Fungicide-Herbicide Branch
Fungicide-Herbicide Branch
Registration Support Branch
Special Review and Reregistration Division
Walter Waldrop
Linda Propst
Mario Fiol
Reregistration Branch
Reregistration Branch
Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent , ,
ai. . 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 . ,
FDA Food and Drug Administration
FEFRA , 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.
HOT . 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 „ ; '
' LOG 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
Hg/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 ' ••
NOEC No effect concentration
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
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*J 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
SLN Special Local Need (Registrations Under Section 24 (c) of FDFRA)
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.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
Background
v • • '•'.''
This Reregistration Eligibility Decision document (RED) addresses the reregistration
eligibility of the pesticide prometryn, 2,4-bis (isopropylamino)-6-methylthio-s-triazine.
Prometryn is a substituted thiomethyl triazine herbicide registered for the control of
. several annual grasses and broadleaf weeds in the terrestrial food and feed crops cotton,
celery, pigeon peas and dill. Prometryn was first registered in 1964 by Ciba Crop Protection.
Prometryn is also manufactured by the Verolit Chemical Manufacturer, Ltd. Prometryn's
major use sites are cotton and celery.
A Registration Standard for prometryn was issued in March 1987. Since then, two
Data Call-ins (DCI) have been issued. The first DCI, issued in September 1991, required
phytotoxicity studies and spray drift data. The second DCI, issued in September 1992,
required data concerning hexachlorobenzene (HCB) and pentachlorobenzene (PCB) in
technical prometryn. The Agency has now completed its review of the prometryn target data
base including data submitted in response to the 1987 Standard and the DCIs.
Reregistration Eligibility
The Agency has determined that all uses of prometryn as currently registered will not
cause unreasonable risk to humans or the environment and all uses are eligible for
reregistration. However, the Agency is requiring two ecological effects studies, a post-
application reentry exposure study for celery, a dermal absorption/penetration study and a
limited field rotational crop study as confirmatory data.
Health Effects
Prometryn was classified by the Agency's Office of Pesticide Program's
Carcinogenecity Peer Review Committee as a Group E Carcinogen (no evidence of human
carcinogenic potential). A RfD has been set at 0.04 mg/kg/day based on a NOEL of
3.75 mg/kg/day from a chronic toxicity study in dogs with an uncertainty factor of 100 to
account for inter- and intra-species variability.
An acute dietary analysis was conducted using a NOEL of 12 mg/kg body weight/day
from a rabbit developmental toxicity study. The LEL was based on increased resorptioris,
abortions and significant changes in other reproductive parameters at 72 mg/kg body
weight/day. MOE's calculated for both the average and highest exposed individuals are
greater than 100, indicating that acute dietary exposure from the use of prometryn on food
poses only a minor risk.
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The residue chemistry data base for prometryn is adequate. Tolerances are established
for residues of prometryn in or on agricultural commodities and are listed under 40 CFR
180.222. Revised or new tolerances are needed for cotton, cotton gin byproducts and for
rotational small grains (forage, straw and hay).
Prometryn residues do not concentrate in any cottonseed processed commodities.
Therefore, no food/feed additive tolerances are required for cottonseed processing
commodities other than grain byproducts.-
Occupational Exposure/Risk Assessment
A NOEL of 12 mg/kg/day from a rabbit developmental study together with a 15%
dermal absorption factor was used to assess both short and intermediate term occupational
exposure. This is the same NOEL used to assess the acute dietary analysis.
The Agency has determined that there is an exposure potential for handlers (mixers,
loaders, applicators) using prometryn. Data from-the most recent version of the Pesticide
Handlers Exposure Database were used to estimate daily exposures to mixers/loaders/
applicators.
The Agency also determined that there is a potential for exposure to prometryn to
persons entering treated sites after application is complete. For many uses of prometryn, the
potential for post-application exposure exists when the task being performed either disturbs
the soil sub-surface or the person comes into contact with the area to which the spray was
directed (soil incorporation and lay-by treatments, respectively).
The Worker Protection Standard for Agricultural Pesticides - 40 CFR Parts 156 and
170 — established an interim restricted-entry interval (REI) of 12-hours. However, the
Agency is establishing a 24-hour REI for uses on celery and a 12-hour REI for all other uses
within the scope of the Worker Protection Standard for Agricultural Pesticides. The basis for
the 24-hour REI on celery is that prometryn has a toxicological endpoint of concern for
•systemic toxicity for short-term and intermediate exposures, no post-application exposure data
are available, and hand-labor tasks (hand-thinning) are associated with the timing of the
celery use. Furthermore, the Agency is also requiring additional labeling statements
regarding user safely to be located on all end-use products containing prometryn that are
intended primarily for occupational use.
Additionally, in order to alleviate the concerns to handlers, the technical registrant has
agreed to formulate wettable powder in water soluble packets. This requirement should
adequately mitigate the risks associated with mixing and loading of wettable powder
formulations. To mitigate the risks associated with mixing and loading liquid formulations to
support aerial applications, the Agency is requiring minimum (baseline) PPE of a chemical-
resistant apron and a respirator equipped with a dust/mist filter.
VI
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Environmental Fate and Ecological Effects
The Agency has reviewed all of the ecological effects and environmental fate data for
prometryn. All of the ecological effects data required to complete a risk assessment for the
reregistration of prometryn are fulfilled with the exception of an avian reproduction (upland
gamebird) study and a fish early life stage study. These studies are needed to fully assess
prometryn's risk assessment to birds and fish and both studies are considered confirmatory.
Prometryn poses an acute risk to nonendangered and endangered terrestrial and aquatic
plants, a chronic risk to birds, and an acute risk to endangered small mammals. Li order to •
reduce the potential risks, the Agency is requiring products to carry environmental hazard
labeling.
All environmental fate data required to complete an environmental fate assessment for
the reregistration of prometryn are fulfilled. The laboratory mobility data for prometryn
indicate that prometryn has the potential to leach into ground water and will be most mobile
in sandy, alkaline soils which contain little organic matter or clay. Prometryn was detected in
ground water from an irrigation well in California. However, in California, Arizona and New
Mexico, prometryn labels instruct potential users not to apply the product to sand or loamy
sand soils. Prometryn was not detected in ground water during a retrospective ground-water
monitoring study performed by the registrant in Missouri, at a site which was underlain by
sandy loams and loamy sands. In light of the registrant's stewardship and the data in-house,
the Agency has determined that ground water and surface water label advisories are not
necessary at this time. The use of prometryn is prohibited on sand and sandy loam soils.
Before reregistering the products containing prometryn, 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 registration and acute toxiciry testing. 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 other active
ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
vn
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INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
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 reregistration.
f .—
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration 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.
•' t -
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of prometryn. The document consists of six sections. Section I is the
introduction. Section II describes prometryn, its uses, data requirements and regulatory
history. Section m discusses the human health and environmental assessment based on the
data available to the Agency. Section IV presents the reregistration decision for prometryn.
Section V discusses the reregistration requirements for prometryn. Finally, Section VI is the
Appendices which support this Reregistration Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration Eligibility
Decision:
Common Name: Prometryn
Chemical Name: [2,4-bis (isopropylamino)-6-methylthio-s-triazine]
N
N
CH,
CH,
^
Empirical Formula:
Molecular Weight:
CAS Registry No.:
Shaughnessy No.:
Basic Manufacturers:
C10H19N5S
241.37
7287-19-6
080805
Ciba Crop Protection and
Verolit Chemical Manufacturers, Ltd.
Technical prometryn is a white crystalline solid with a melting point of 118-120°C.
Prometryn is soluble at 20°C in water at 33 ppm and is readily soluble (10-30 g/100 mL) in
the following organic solvents: acetone, dichloromethane, methanol, octanol, and toluene.
The vapor pressure for prometryn is low, 1.0-x. 10"6 mm Hg at 20°C.
B. Use Profile
The following information is on the currently registered uses of prometryn with an
overview of use sites and application methods. A detailed table of prometryn uses can be
found in Appendix A.
Type of Pesticide: a substituted thiomethyl triazine herbicide
Other Names: Prometryne, Caparol, Gesagard, Primatol Q, Prometrex
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Mechamism of Action: inhibits electron transport
Use Groups and Sites -
TERRESTRIAL FOOD CROP: celery, dill, pigeon peas
TERRESTRIAL FOOD + FEED CROP: cotton (unspecified), pigeon peas
Target Plants:
broadleaves: black nightshade, cocklebur, coffeeweed, dock, Florida pusley,
ground-cherry, henbit, lambsquarters, mallow, morningglory, mustard,
pigweed, prairie sunflower, prickly sida, purslane, ragweed, rough blackfoot,
smartweed, spurred anoda
grasses: barnyardgrass, crabgrass, foxtail; goosegrass, junglerice, panicum,
sandbur, signalgrass, wild oat •
Formulation Types Registered:
Single Active Ingredient (AD Products
Wettable powder - 80%
Crystalline - 97%
Flowable concentrate — 44 to 45.41%
Formulation not identified/solid — 95%
Multiple Active Ingredient Product
Flowable concentrate — 8.4% + monosodium methanearsonate
(MSMA) •
Method and Rates of Application:
Wettable powder
Apply to celery at planting, pre- or postemergence, postplant,
ppsttransplant, or seed bed as broadcast by sprayer at 0.8 to
3.21bAI/acre.
Apply to dill at preemergence or postemergence as broadcast with
sprayer at 1.6 IbAI/acre.
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Apply to pigeon peas at preemergence as broadcast with sprayer at 2.0
to 2.8 Ib Al/acre.
Apply to cotton at planting, fall, lay-by, plant bed, postemergence,
postplant, preemergence, seedbed, or winter as broadcast with sprayer at
.64 to 2.8 Ib AI/A; or, at fall as broadcast by airplane at .8 Ib AI/A; or, at
preplant as soil incorporated treatment by aircraft or sprayer at
2.4 Ib Al/acre.
Flowable concentrate
Apply to celery at planting, preemergence, postemergence, postplant,
posttransplant, or seed bed as broadcast by sprayer at .8 to
3.2 Ib AI/A [4.0 Ib AI/A for Hawaii].
Apply to cotton at planting, fall, lay-by, postemergence, postplant,
preemergence, seedbed, or winter as broadcast by sprayer at .5 to
2.8 Ib AI/A; [3.5 Ib AI/A for Sharkey clay (Arkansas only) and for silt
and clay loam in Mississippi River Delta in Mississippi] or, apply to
cotton at planting, fall, lay-by, postplant, preemergence, seedbed, or
winter as broadcast by aircraft at .8 to 2.8 Ib AI/A; or apply to cotton at
postemergence by low pressure ground equipment, shielded application,
or sprayer as directed spray at .5 Ib AI/A; or, at postemergence as
directed spray by sprayer at .65 Ib AI/A; or, at preplant as soil
incorporated treatment by aircraft or sprayer at 1.6 to 2.4 Ib AI/A.
Apply to pigeon peas at planting, postplant, or preemergence as
broadcast by aircraft or sprayer at 2 to 3 Ib AI/A.
Use Practice Limitations:
Do not apply through any type of irrigation system. Do not feed treated
foliage to livestock or graze treated areas. Please refer to Appendix A
for more information.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
prometryn.. These estimates are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop)
basis, reflect annual fluctuations in use patterns as well as the variability in using data
from various information sources.
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Percent of Various U.S. Crops Treated with Prometrvn 1990 - 199?
Site/1
Celery
Cotton
Other
Total
Acres Grown/2 (000)
36
13,230
N/A
Acres Treated (000)
20-30
1,800-2,800
40-50
1,865-2,850
• Percent Crop Treated
56-83
14-21
N/A
Pounds AI Applied
15-25
1,100-1,800
20 - 25
1 135- 1 850
i - oiic iaeniir.ica.Tion Daseu on KKHN
2 - 1990-1993 average (USDA/NASS).
Note: There is no known usage on pigeon peas and there are no data available for dill.
D. Regulatory History/Data Requirements
Prometryn was registered in the United States in 1964 for use as a herbicide for the
control of weeds in cotton, celery, pigeon peas, and dill. A Registration Standard was issued
in March 1987 (PB87-184826), and required product and residue chemistry, toxicology, fish
and wildlife, plant protection and environmental fate data. The Special Review and '
Reregistration Division issued two Data Call-Ins, one September 30, 1991, requesting Tier 3
non-target phytotoxicity field studies and Spray Drift information, and the second,
September 2,1992, requesting hexachlorobenzene (HCB) and penta-chlorobenzene (PCB)
data in technical prometryn to determine the potential presence of these impurities, Since
then, the registrant has submitted adequate information addressing the PCB and HCB
deficiencies. Lacking appropriate guidance for conducting Tier m testing and because of our
new policy, the Agency has decided to assess risk and make reregistration decisions based on
Tier H lab data. Consequently the Agency has placed Tier IH study requirements on reserve.
This Reregistration Eligibility Decision document reflects the reassessment of the data
submitted in response to the Registration Standard and to the Data Call-Ins.
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
The physical and chemical properties of prometryn are as follows:
o Prometryn Technical
Color: white
Physical State: a crystalline solid
Odor: odorless or very faint
Melting Point: 118-120° C
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r
Specific Gravity: 1-16 g/ml @20° C
Solubility: 33 ppm in water at 20° C and is readily soluble
(10-30 g/100 ml) in the following organic solvents: acetone,
dichloromethane, methanol, octanol and toluene.
Vapor Pressure: 1.0 x 10'6 mm Hg at 20° C
- pH: 6.7 @ 20° C (saturated solution)
Stability: stable in neutral and slightly acidic or alkaline media; hydrolyzed
by alkali and mineral acids at elevated temperatures.
There are two prometryn manufacturing-use products (MPs); the Ciba Crop Protection
97% T (EPA Registration Number 100-542) and the Verolit Chemical Manufacturers, Ltd.
95% T (EPA Registration Number 46386-2).
The product chemistry data base for prometryn is adequate to support the reregistration
eligibility decision of prometryn. However, there are several product chemistry requirements
not fully satisfied. References for all studies submitted in support of the product chemistry
data requirements are listed in Appendix B of this document.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological database for prometryn is adequate and will support reregistration
eligibility for current uses. The laboratory animal data consists of the following:
a. Acute and Subchronic Toxicity
Acute Toxicity: The following table summarizes the results of acute toxicity studies
on prometryn and the toxicity categories for the different routes of administration. Data
pertaining to acute eye and dermal irritation and dermal sensitization are not required to
support the reregistration of the technical grade active ingredient (TGAI). These data are
presented for informational purposes:
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3,000 ppm (0, 1.42, 2, 142, 429 mg/kg/day) for 102 weeks and observed for signs of toxicity
including oncogen!city. (MRID 40466201) " .
Mean body weight gain in the high-dose females was lower than those of controls
during the first 48 weeks of the study (statistically significant(p<0.05)). There was no
significant effect of dosing on clinical signs, mortality, gross pathology or histopathology. No
effects were observed in males. The NOEL was 1,000 ppm for females. The LOEL was
3,000 ppm for females based on decreased body weight gain.
Although significant toxicity was observed only in females, the RfD committee
(July 26, 1994) considered the study adequate since 1) levels were close to one-half the limit
dose in mice; 2) no effects were noted in the study to warrant repeating the.study at higher
dose levels; 3) all tumors noted with other members of the s-triazine class were mainly in rats
and not mice. Prometryn was not ohcogenic under the conditions of.the study.
Prometryn technical was fed to male and female Sprague-Dawley rats for 104 weeks at
dietary levels of 0, 10, 100, 750 or 1500 ppm (males: 0, 0.38, 3.90, 29.45 or 60.88 mg/kg/day,
respectively; females: 0, 0.49, 4.91, 37.25, or 80.62 mg/kg/day, respectively.) .(MRID
41901201)
Decreased body weight and body weight gain were observed in high-dose males and
females during the first and second year of treatment. Transient decreases (weeks 1 and 2) in
food consumption in both sexes at the high dose and in males at the mid-dose, were attributed
to decreased palatability of the diet. An increase in the incidence of renal lesions (mineralized
concretions) in high dose males was noted. The LOEL in males and females was 1500 ppm,
and the NOEL 750 ppm. Prometryn was not oncogenic under the conditions of the study.
Groups of 3 male and 3 female beagle dogs (4-8 months old) were dosed in the diet
for 106 weeks with prometryn SOW (80% wettable powder) as active ingredient
concentrations of 0, 15, 150, or 1500 ppm (0.0, 0.375, 3.75, or 37.50 mg/kg/day).
(MRID 00042794). .
No clinical signs or effects on body weight were observed. No changes in clinical
pathology or urinalysis parameters were observed. All of the high-dose males showed slight
to moderate renal tubular degeneration, including degeneration of the loops of Henle, cortical
congestion, thickening of capsular basement membranes, and hypercellularity of the
glomeruli. Slight bone marrow atrophy was observed in 2 of 3 high-dose males, and 1 of 3
males had a congested liver. The NOEL was 3.75 mg/kg/day a.L, and the LOEL was
37.5 mg/kg/day based on degenerative hepatic changes, renal tubule degeneration, and bone
marrow atrophy.
The Agency's Office of Pesticide Programs RfD Committee classified prometryn as a
Group E Carcinogen (no evidence of human carcinogenic potential) on May 19, 1994,
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because prometryn did not alter the spontaneous tumor profile for the strains of rats and mice
tested.
d. Developmental Toxicity
In a developmental rat toxicity study, prometryn technical was administered by gavage
to groups of 26 pregnant Sprague-Dawley rats at levels of 0, 10, 50 or 250 mg/kg/day during
gestational days 6 to 15. A compound-related increased incidence of clinical signs was noted
at 250 mg/kg, as was decreased body weight, body weight gain and food consumption during
the dosing period. Body weight was also significantly decreased (p<0.05) at 50 mg/kg/day,
but the decrease was minimal, <5%, and therefore not of concern. The maternal NOEL was •
50 mg/kg/day, the LOEL was 250 mg/kg/day, based on salivation and decreases in body
weight and food consumption. At 250 mg/kg/day, fetal body weight was significantly
decreased and incomplete ossification in the sternebrae and metacarpals was observed
(p<0.05). No significant effects were noted at 50 mg/kg/day. The developmental NOEL was
50 mg/kg/day, the LOEL was 250 mg/kg/day. (MRTD 40457517)
In a developmental toxicity study, prometryn technical was administered by gavage to
pregnant New Zealand White rabbits at 0, 2, 12, or 72 mg/kg/day during days 6 thru 19.
Decreased food consumption (10-36%) was observed in high-dose animals, but a
corresponding decrease in body weight parameters was not observed. A slight, not significant
increase in abortions was observed. No other toxicity was observed. The maternal NOEL
was 12 mg/kg/day, the LOEL was 72 mg/kg/day based on decreased food consumption. The
HDT was observed to have a decreased number of live litters and live fetuses due to increased
late resorption and abortion. It cannot be determined whether the abortions were a
consequence of maternal toxicity. The developmental NOEL was 12 mg/kg/day, the LOEL
was 72 mg/kg/day based on increased fetal resorptions. (MRID 00157995)
e. Reproductive Toxicity
In a two-generation reproductive toxicity study, prometryn technical was administered
in the diet to groups of 30 male and 30 female Sprague-Dawley rats at levels of 0, 10 ppm
(0.6 mg/kg/day in males, 0.7 mg/kg/day in females), 750 ppm (47.8 mg/kg/day in males,
53.6 mg/kg/day in females) or 1500 ppm (96.7 mg/kg/day in males, 105.6 mg/kg/day in
females). (MRID 41445101)
Body weight gain in FO males decreased significantly at 1500 ppm (11-40%) and
750 ppm (11-18%). Body weight gain decreased in FO females by up to 50% at 1500 ppm
and 750 ppm. Similar changes in body weight gain were seen in Fl males. Corresponding
decreases in food consumption were also observed. The parental systemic toxicity NOEL
was 10 ppm; the LOEL was 750 ppm, based on decreased food consumption, body weight
and body weight gain.
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Statistically significant decreases in Fl pup body weights were observed at 1500 and
750 ppm (up to 12%) during lactation. A similar, though less marked, profile was seen in F2
generation pups. While actual weight loss was small (5 - 12%), and may be artifactual to
maternal weight losses, it is considered of toxicological significance because of its potential
negative impact on postnatally developing systems such as the neuro- and immune systems.
The reproductive NOEL was 10 ppm (0.65 mg/kg/day); and, based on decreased pup weight,
the LOEL was 750 ppm («50 mg/kg/day).
- f. Mutagenicity
In an Ames salmonella test, prometryn was negative for gene mutation up to cytotoxic
solubility limits (1000-2000 ug/plate). (MRID 40457518)
In a chromosomal aberration in vivo Chinese hamster bone marrow test,.prometryn
was negative for nuclear anomalies (micronuclei) when animals were dosed orally up to
5000 mg/kg. (MRTD 40466203)"
Prometryn was negative for bacterial DNA repair and gene mutation up to
precipitating levels (1000//g/plate). (MRID 40457519)
In an unscheduled DNA synthesis test, prometryn was negative (measured as UDS) in
rat hepatocytes cultured m vitro up to cytotdxic levels 156.25 /ig/ml). (MRID 40457522)
g. Metabolism
In a series of general metabolism studies, three groups of Crl:CD BR rats (5 males,
5 females per group) were given a single oral dose of 14C-prometryn. Group 1 received
0.46-0.47 mg/kg. Group 2 received 467 mg/kg (average). Group 3 received 0.5 mg/kg
unlabeled prometryn daily for 14 days, followed by 0.46 mg/kg 14C-prometryn on day 15. An
additional group, Group 4, was used for metabolite isolation and identification purposes and
received 540 mg/kg 14C-prometryn. (MRID 41255901)
Data frpm these studies indicate that the distribution of prometryn is greatest in the
blood, followed by the spleen, and finally in the lungs (the three highest tissues measured).
Distribution is not dosage-dependant. It is extensively metabolized with <2% of recovered
14C radioactivity representing the parent compound. Twenty-eight metabolites were identified
in the urine, and 28 in the feces. Ten metabolites were identified in both urine and feces.
Prometryn is excreted predominantly in the urine and feces, with slightly higher
concentrations in the urine. The 7-day recovery of 14C radioactivity averaged 95% for all
dosing groups. _ -
10
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h. Additional Toxicicity Endpoints
The RfD has been set at 0.04 mg/kg/day by the Office of Pesticide Programs RfD/Peer
Review Committee based on a NOEL of 3.75 mg/kg/day in a chronic toxicity study in dogs.
The LEL was 37.5 mg/kg/day based on bone marrow atrophy and degenerative changes in the
liver and kidneys. An uncertainly factor of 100 was used to account for inter- and intra-
species variability. -
An acute dietary analysis has been recommended in the Toxicology Endpoint
Selection Document. The endpoint for acute dietary risk assessment is the NOEL of
12 mg/kg body weight/day from a rabbit developmental toxicity study. The LEL was based
on increased resorptions, abortion and significant changes in other reproductive parameters at
72 mg/kg body weight/day.
A NOEL of 12 mg/kg/day from a rabbit developmental study was used to assess both
short and intermediate term occupational and residential exposure. (MRID 00157995)
i. Dermal Absorption
The Agency has determined that a dermal absorption value of 15°/o should be used for
risk assessment purposes. This value is based on an interpretation of data from two
toxicology studies (an oral developmental study and a 21 day dermal study) in which rabbits
were used as the test species.
In the developmental toxicity study in rabbits, the maternal and fetal NOEL were
determined to be 12 mg/kg/day; the LEL = 72 mg/kg/day. These effects included
significantly decreased food consumption, increased resorption (113%), and increased post-
implantation loss (130%). There was a corresponding decrease in the number of viable litters
(-35%) and live fetuses (-15%). These or other effects were not observed at lower doses.
(MRID No. 00157995)
In the 21-day dermal study in rabbits, no signs of systemic or local toxicity were
observed. A dermal NOEL was determined to be > 1000 mg/kg/day. (MRID 40573702)
Although no dermal absorption study with prometryn was ever conducted, the Agency
has concluded that a 7% absorption factor is a reasonable upper limit for dermal absorption.
The 7% is based on a comparison between an oral rabbit developmental study and a 21-day
dermal rabbit study. Uncertainties and concerns regarding the use of 7% in conducting the
risk assessment exist because the parameters typically measured in a 21-day dermal study are
not extensive (i.e., no clinical chemistries) and the effects observed in the developmental
study are significant including increased abortion and increased post-implantation loss.
Therefore, the Agency is using a more protective absorption rate of 15% with the stipulation
that a dermal absorption study be conducted as confirmatory data.
11
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2. Exposure Assessment
• a. Dietary Exposure
The residue chemistry data base for prometryn is adequate and will support
reregistration as a food use pesticide. Prometryn is registered for food/feed use on celery,
cotton, dill, and pigeon peas. ,
The-residue of concern (i.e. that which should be included in the tolerance expression)
is prometryn, per se. Magnitude of the residue data are available for dill, pigeon peas,
cottonseed, and celery. An adequate processing study has been submitted for cottonseed, and
demonstrates that residues of prometryn do not concentrate in any cottonseed processed
commodities. Acceptable storage stability studies are available to support the established
tolerances, provided that storage stability issues are adequately resolved for the celery and
cottonseed studies reviewed.
The qualitative nature of the residue in animals is adequately understood; the residue
of concern in animals is prometryn, per se. Since there are.no residues of prometryn per se in
poultry feed items, no tolerances are required for poultry meat and eggs. Based on the
maximum theoretical dietary burden for prometryn per se for ruminants and on data from the
ruminant metabolism study, the Agency has concluded that residues of prometryn per se in
meat and milk may be classified under Category 3 of 40 CFR §180.6(a), (i.e., there is no
reasonable expectation of detectable residues). Therefore, a ruminant feeding study is not
required, and tolerances for residues in meat and milk are not required.
The Agency concludes that a risk assessment for the uses of prometryn can be
conducted using tolerance-level residues of prometryn, per se in cottonseed, pigeon peas,
celery and dill.
Tolerances are established for residues of prometryn in or on the following raw
agricultural commodities: celery (0.5 ppm); corn fodder (field, pop, and sweet, 0.25 ppm);
corn forage (field, pop, and sweet, 0.25 ppm); fresh corn (sweet K + CWHR, 0.25 ppm); corn
grain (0.25 ppm); cotton [forage] (1 ppm); cottonseed (0.25 ppm); and pigeon peas
(0.25 ppm). A tolerance with regional registration is established in or on dill (0.03 ppm)
[40 CFR §180.222 (a) and (b)]. No tolerances are needed for residues of prometryn in animal
commodities and no food/feed additive tolerances need to be established under
40 CFR §185 and §186.
(1) Guideline 165-1: Confined Rotational Crops
The nature of the residue in rotational crops is adequately understood. The
metabolism of prometryn in rotational crops is similar to that, of the primary crops and
involves dealkylation, oxidation, hydroxylation, deamination, and conjugation.
12
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(2) Guideline 165-2: Field Rotational Crops
Requirements are fulfilled for magnitude of the residue data in rotational root crops
and in forage and straw of rotational small grains (wheat and barley). Adequate limited field
trial data have been submitted for rotational root crops, provided the registrant amends its
labels to specify an 8-month Plant Back Interval (FBI) for rotational root crops. Adequate
extensive field trial data have been submitted depicting residues of prometryn in forage and
straw of rotational wheat and barley. A sufficient number of field trials were conducted in
representative geographic regions at maximum label rates.
The available data support the registrant's suggested tolerance of 0.3 ppm for residues
of prometryn per se in forage and straw of rotational small grains planted after prometryn-
treated cotton, with a 3-month FBI. The data also indicated that tolerances are not required
for residues in rotational small grains and processed grain fractions. Additional data are
required depicting prometryn per se residues in hay from rotational wheat and barley;
however, these data will not be required, provided the registrant has no objection to a
tolerance of 1.0 ppm in or on hay of rotational small grains. This tolerance was calculated
based on the suggested tolerance in forage and a dry-matter conversion.
Additional rotational crop field trial data are required for leafy vegetables, since
residues of prometryn per se were detected at up to 0.03 ppm in lettuce rotated at the longest
FBI (8-9 months) in the limited field trial. The registrant must either conduct extensive field
trials with representative leafy vegetables at an 8-month FBI, or an additional limited field
trial with lettuce that includes a 12-month FBI. If no residues of prometryn per se are present
in lettuce at a 12-month FBI (< .01), then a label restriction specifying a 12-month FBI will be
adequate and no further data will be required. In the interim, the Agency will require that
registered labels be amended to specify a 12-month FBI for rotational leafy vegetables.
(3) Guideline 171-3: Directions for Use
Use directions for prometryn on cotton prohibit grazing in treated areas and the
feeding of treated forage to livestock. However, cotton forage is no longer considered to be a
significant livestock feed item, and cotton gin by-products (gin trash), considered to be a feed
item in beef and dairy cattle diets, are not under control of the grower. Consequently, a label
restriction against the feeding of treated cotton material is no longer appropriate. The
registrant should submit amended labeling deleting this restriction. Label directions for
cotton do not list specific plantback intervals (PBIs) for crops rotated with treated cotton; the
registrant should submit revised labels specifying the allowed plant back intervals, (refer to
the discussion under Guideline 165T2, Field Rotational Crops).
13
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(4) Guideline 171-4(a): Plant Metabolism
* ' • " .' t 'V
The qualitative nature of the residue in plants is adequately understood based on
acceptable cotton and celery metabolism studies. Results of the cotton and celery metabolism
studies support the registrant's proposed metabolic pathways involving N-dealkylation and
hydrolysis of prometryn. Prometryn is absorbed by the roots arid is translocated to the
foliage, but does not appear to be translocated from older shoots to new shoot growth.
The residue of concern in plants consists of the parent, prometryri/?er se, which is the
currently regulated residue.
The Agency notes that if other major uses are registered in the future, additional
metabolism studies will be required, and regulation (i.e., inclusion in the tolerance expression)
of residues in addition to the parent may be required. (MRIDs 41293301, 41711301,
41711302)
(5) Guideline 171-4(b): Animal Metabolism
The nature of the residue in animals is adequately understood, based on acceptable
poultry and ruminant metabolism studies. As in plants, the residue of concern (and that which
should be regulated) in animals is the parent, prometryn per se. The major portion of the
terminal residues in milk, muscle, and liver of poultry and goats, goat kidney, poultry fat and
eggs are comprised of the N-acetyl cysteine conjugate of GS-11354, the cysteine conjugate of
GS-113 54, melamine, GS-17794, the N-acetyl cysteine conjugate of prometryn and
GS-26831. The metabolism of prometryn in animals involves N-dealkylation along with
hydrolysis and/or amino acid conjugation. (MRIDs 41293302, 41293303)
(6) Guideline 171-4(c) and (d): Residue Analytical
Methods - Plants/Animals
Two enforcement methods are published in PAM, Vol. n, neither of which has
undergone Agency validation. Method A is a spectrophotometric method that includes a
reference for GC determination for specific triazine compounds. Method A is unsuitable as
an enforcement method because it is not specific for prometryn. Method B is a GC method
using a microcoulometric sulfur detection system that determines residues of prometryn,
atrazine, and simazine in milk. For purposes of reregistration, adequate analytical
methodology is available for determining residues of prometryn in plant commodities. A
-registrant developed GC method, (Method AG-559), using a flame photometric detector in the
sulfur mode (FPD/S) has undergone a successful independent laboratory validation.
1 '
The Agency has determined that Method AG-559 would be acceptable for
enforcement purposes, pending completion of a successful Agency method validation trial.
Now that the nature of the residue in plants is adequately understood and the residue to be
regulated is prometryn per se, Method AG-559 will undergo an Agency method validation
14
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trial. Method AG-559 has undergone radiovalidation using samples from the celery
metabolism study; however, these samples contained no detectable residues of prometryn. An
additional radiovalidation of Method AG-559 has been requested using samples from the
most recent cotton metabolism study.. No tolerances are needed for prometryn residues in
animal commodities, therefore, enforcement analytical methods for residues in animals are
not presently required.
Adequate GC data collection methods are available for prometryn and the metabolites
GS-11354andGS-26831. Method AG-559 is the most recent of these methods. Residue
data submitted for tolerance reassessment were collected using either a spectrophotometric
method (Method A) or GC methods using microcoulometric, thermionic, or FPD/S detectors.
The registrant provided adequate method validation data to verify the suitability of these
methods for data collection.
The FDA PESTDATA database indicates that prometryn is completely recovered
(>80%) using multiresidue method PAM, Vol. I Section 302 and partially recovered
(50-80%) using Sections 303 and 304, with the recovery varying depending upon the choice
of Florisil system used.
(7) Guideline 171-4(e): Storage Stability
The requirements for storage stability data are not fully satisfied for reregistration.
Information regarding sample storage intervals and conditions is needed for celery and
cottonseed samples from submitted studies. If the registrant submits information indicating
that the storage intervals for celery or cottonseed samples from the studies previously
submitted exceeded 37 months, or if storage conditions differed from those represented in the
storage stability data, the Agency may require additional storage stability data or new residue
field trials. ,
Storage stability studies have been conducted using fortified control samples of celery,
cottonseed, fresh and dried parsley, and pigeon peas. Residues of prometryn and its
metabolites GS-11354 and GS-26831 are stable in cottonseed and celery samples stored
frozen at -20 °C for up to 37 months, and in fresh and dried parsley samples stored frozen for
up to 21.7 months. Residues of prometryn per se are stable in pigeon peas stored at
-12 °C for up to 42 days. Storage stability data on celery and parsley (tolerance petition
pending) are adequate to support dill.
(8) Guideline 171-4(k): Magnitude of the Residue in
Plants
The reregistration requirements for magnitude of the residue in plants are fulfilled for
the following commodities: dill, parsley and pigeon peas. Adequate field trial data depicting
residues of prometryn following applications made according to the maximum registered use
15
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patterns have been submitted for these commodities. Geographic representation is adequate
and a sufficient number qf trials reflecting representative formulation classes were conducted.
Provided that the storage conditions and intervals incurred during celery and cotton field trials
are supported by the available storage stability data, reregistration requirements for magnitude
of the residue in plants will also be fulfilled for celery and cottonseed.
Additional residue data are not required for pigeon pea vines and hay and cotton
forage) at this time. The Agency feels that label restrictions prohibiting the feeding of pigeon
pea forage and hay to livestock are practical and thus may remain on registered labels and
cotton forage is no longer considered a significant feed item.
The March 1987 Prometryn Reregistration Standard Guidance Document required
additional residue data to support uses on corn; however in June 1987, the registrant canceled
its labeled uses on corn. A summary of the available data and reregistration status is
presented below for each commodity.
Leafy Vegetables Group (except Brassica Vegetables)
Celery: Acceptable residue data are available. However, for purposes of
reregistration, information on sample storage conditions and intervals are required. If sample
storage intervals exceeded 37 months, or if storage conditions differed from those in the
•supporting storage stability studies, additional storage stability data or new residue field trials
may be required. (MRIDs 00034043, 000935529, 00093548)
Residues of prometryn -were <0.04-0.35 in celery samples harvested 51-158 days
following seedbed, preemergence, postemergence, and/or posttransplant applications of
prometryn (WP) at 1-16 Ib ai/A (0.3X-5X). Prometryn residues were O.02-0.19 ppm in
celery samples harvested 37-70 days following a single postplant application of prometryn
(EC) at 3.2-6.4 Ib ai/A (1X-2X). In studies using the EC formulation, celery samples were
analyzed for residues of GS-11354 and GS-26831, which were each <0.02 ppm in all
samples. The available data support the established 0.5 ppm tolerance for residues of
prometryn per se in or on celery.
Legume Vegetables (Succulent or Dried) Group
Pigeon peas; Acceptable data are available to support tolerances in or on pigeon peas.
Residues of prometryn per se were <0.2 ppm (nondetectable) in pigeon peas and pigeon pea
pods harvested 132 days after a single preemergence application of prometryn (80% WP) at
3.2 Ib ai/A (1.1X) using ground equipment. Residues of prometryn resulting from a 6.4 Ib
ai/A (2.2X) preemergence application were <0.2 ppm in pigeon peas (without pods) and
0.28-0.40 ppm in pigeon pea pods. The available data support the established 0.25 ppm
tolerance for residues of prometryn per se in pigeon peas.
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Foliage of Legume Vegetables Group
Pigeon pea forage and hay: Residue data on pigeon pea forage and hay are not
required at this time and, therefore, the restrictions prohibiting the grazing or feeding of
treated pigeon peas forage or hay to livestock should remain on registered product labels.
Herbs and Spices Group
Dillt Prometryn is registered on dill grown in California with a regional tolerance of
0.3 ppm. The registered use reflects a single preemergent or postemergence application of
prometryn at 1.6 Ib ai/A in a minimum of 20 gal/A with a PHI of 48 days. The available data
support the established 0.3 ppm tolerance for residues of prometryn per se in fresh and dried
dill grown in California.
Miscellaneous Commodities
Cotton: Acceptable residue data are available to support the 0.25 ppm tolerance for
residues of prometryn per se in or on cottonseed and cotton forage. However, information
must be submitted regarding sample storage conditions and intervals for all samples from the
reviewed studies. If sample storage intervals exceeded 37 months, or if storage conditions
differed from those used in supporting storage stability studies, additional storage stability
data or new field trials may be required. (MRIDs 00027329, 00027330, 00093531,
00125011).
Residues of prometryn in 86 cottonseed samples were nondetectable (<0.04 ppm) and
0.04-0.06 ppm in 13 other samples collected 26-231 days following preemergence,
postemergence, and/or lay-by soil applications (one to five) of prometryn (WP) at
0.8-9.0 Ib ai/A (0.13X-1.5X). Residues of prometryn were <0.04 - 0.84 ppm in 80 cotton
forage, foliage, and whole plant samples harvested 20-122 days following one to five
preemergence, postemergence, and/or lay-by soil applications of prometryn at
0.25-9.0 Ib ai/A (0.04X-1.5X). Residues of prometryn per se were 1.1 ppm in a single forage
sample following five applications of prometryn totaling 6.15 Ib ai/A (~1X). In addition,
residues of the metabolites GS-11354 and GS-26831 were nondetectable (<0.1 ppm) in or on
cotton forage. No residue data are available for cotton gin by-products (gin trash).
The available residue data support the established tolerances of 1.0 ppm for residues of
prometryn per se in or on cottonseed and cotton forage, respectively. However, since cotton
forage is no longer considered to be a significant animal feed item, the 1.0 ppm tolerance for
prometryn residues on cotton forage will be proposed for revocation.
Although data on cotton gin trash are not available, based on the available residue data
for cotton forage and data from the cotton metabolism studies, the Agency will use an
estimated 1.0 ppm residue for cotton gin trash for purposes of a risk assessment. Metabolism
17
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data for cotton plants indicated that the TRRs (total radioactive residue) in plants treated at
0.8X were 0.38 ppm in mature stalks, 0:34 ppm in ginned seed, 0.29 ppm in empty bolls, and
0.27 ppm in ginned fiber all of which are components of gin trash. The registrant must either
propose a 1.0 ppm tolerance or submit the required studies.
(9) Guideline 171-4(1): Magnitude of the Residue in
Processed Food/Feed
The reregistration requirements for magnitude of the residue in processed food/feed
commodities are fulfilled for cottonseed. A summary of the available processing data is
presented below.
Cottonseed; Acceptable cottonseed processing studies have been submitted.
Residues of prometryn were nondetectable (<0.04 or <0.1 ppm) in 19 samples each of meal,
crude oil, and refined oil processed from seed bearing residues of O.04-0.07 ppm. Residue's
of prometryn were 0.06-0.08 ppm in four hull samples derived from seeds having residues of
<0.04 ppm; however, residues were <0.04 ppm (non-detectable) in 15 hull samples derived
from seeds of plants treated multiple times and at exaggerated rates. Prometryn residues do
not concentrate in any cottonseed processed commodities. Therefore, no food or feed
additive tolerances are required for the processed commodities of cottonseed.
(10) Guideline 171-4(j): Magnitude of the Residue in
Meat, Milk, Poultry and Eggs
There are no existing tolerances established for prometryn residues in eggs, milk,
animal fat, meat, and meat byproducts. Animal feeding studies were not required because
detectable residues of prometryn and its triazine-containing analogs were not expected in
meat, milk, or eggs. This conclusion was based on (1) maximum theoretical dietary burdens
of 0.11-0.15 ppm for dairy and beef cattle, 0.04 ppm for poultry, and 0.05 ppm for swine
calculated from the 0.25 ppm tolerance on cottonseed and the percent of cotton feed items in
the animals' diets; (2) the levels of prometryn fed to the animals in the ruminant (50 ppm) and
poultry (83 ppm) metabolism studies; and, (3) the TRR levels in milk, egg, and tissue samples
from the metabolism studies.
The Agency has recalculated the maximum theoretical dietary burden of prometryn to
be 0.755 ppm for dairy cattle and 0.577 ppm for beef cattle. The information used to
calculate these theoretical dietary burdens included the percentage dry matter (% DM) in each
feed item; the percentage of each feed item in the respective ruminant diets; and maximum
residues in the feed items based on established tolerances for cottonseed, an estimate of
maximum residues in cotton gin trash, and proposed tolerances for rotational small grains
(barley and wheat) forage, hay, and straw. ,
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Based on this reassessment of the theoretical dietary burden of ruminants for
prometryn and on residues found in goat tissues in a ruminant metabolism study, the Agency
concludes that residues of prometryn per se in meat and milk can be classified under Category
3 of 40 CFR §180.6(a). That is, there is no reasonable expectation of finite residues in meat
and milk. No tolerances are required, and therefore a ruminant feeding study need not be
submitted. .
Because there are no residues of prometryn in or on poultry feed items, a feeding study
is not required at this time for poultry and no tolerances are required for poultry meat and
eggs. '
b. Occupational Exposure
The acute toxicological database indicates that prometryn is in toxicity category IE for
acute oral, dermal, inhalation and eye irritation, and in toxicity category IV for dermal
irritation. Prometryn is not a skin sensitizer. The vapor pressure for prometryn is low,
1.0xlO-6mmHgat20°C. .
There are toxicological endpoints of concern for prometryn. The endpoint for both
short-term and intermediate-term occupational exposure is a NOEL of 12 mg/kg/day taken
from a rabbit developmental study indicating increased resorption, abortion, and significant
changes in other reproductive parameters at the LEL. The LEL is 72 mg/kg/day and as
discussed in Section m(B)(l)(i) "Dermal Absorption," the Agency has deemed a 15% factor
appropriate for estimating dermal exposure.
. Summary of Potential Occupational Exposure
o For Handlers (Mixers, Loaders, Applicators, etc.) Exposures
The Agency has determined that there is an exposure potential for handlers (mixers,
loaders, applicators) during the usual use-patterns associated with prometryn. Exposures to
mixers, loaders and applicators are likely when liquid (used in aerial application) and wettable
powder (used in aerial and groundboom applications) formulations are used.
Mixer/loader/applicator (M/L/A) exposure data for prometryn were not required in the
Registration Standard or subsequent DCI's, because the toxicological criteria had not been
triggered. To address the recently identified toxicological endpoint, surrogate mixer/loader
and applicator data available in the latest release of the Pesticide Handlers Exposure Database
(PHED, ver 1.1) were used to estimate daily exposures for handlers. Handler exposure
includes mixer/loaders, applicators, and flaggers exposed during applications of prometryn
formulated as wettable powders, liquid formulations, or enclosed in a water soluble papkets.
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The mixer/loader exposure scenarios identified for prometryn are (1) wettable powders
for aerial applications; (2) wettable powders for groundboom applications; (3) water soluble
packets for aerial application; (4) closed mixing/loading for groundboom application; (5)
liquid - closed mixing/loading used for aerial application; (6) liquid - closed mixing/loading
for groundboom application; (7) liquid-open-pour aerial application; and (8) liquid-open-pour
groundboom application.
The handler daily dermal exposures (DDE) (mg/kg/day) are calculated using the
following formula:
Daily Dermal Dose (DDD)= Unit exposure fmg/lb ai) x amt. ai/acre x acres treated/day x % absorbed
, ' • 60 kg body weight
The Agency considered the following scenarios as applicable for the use of prometryn:
Open bag - wettable powder formulation:
o Aerial application
0.1737 mg/lb a! x 0.8 to 3.2 Ib/A x 350 acres x 15% -
60kg
0.12 to 0.49 mg/kg/day
o Groundboom application
0.1737 mg/lb ai x 0.8 to 3.2 Ib/A x 1,00 acres x 15%
I . ' 60kg
= 0.12 to 0.14 mg/kg/day
Water Soluble Packet - wettable powder formulation;
o Aerial application
0.01 mg/lb ai x 0.8 to 3.2 Ib/Ax 350 acres x 15%
60kg
.. = 0.007 to 0.03 mg/kg/day
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Closed Mixing/Loading;
o Groundboom application
0.01 mg/lb ai x 0.8 to 3.2 Ib/A x 100 acres x 15%
60 kg
= 0.0002 to 0.008 mg/kg/day
Liquid - Closed mixing/loading:
o Aerial application
0.0086 mg/lb ai x 0.8 to 3.2 Ib/A x 350 acres x 15%
60kg
= 0.006 to 0.024 mg/kg/day
o Groundboom application
0.0086 mg/lb ai x 0.8 to 3.2 Ib/A x 100 acres x 15%
60kg
= 0.002 to 0.007 mg/kg/day
Liquid - open pour;
o Aerial application
0.0425 mg/lb ai x 0.8 to 3.2 Ib/A x 350 acres x 15%
60kg
= 0.03 to 0.119 mg/kg/day
o Groundboom application
0.0425 mg/lb ai x 0.8 to 3.2 Ib/A x 100 acres x 15%
60kg
= 0.009 to 0.034 mg/kg/day
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Unit exposure changes were also used to estimate inhalation exposure and for the
application of prometryn by groundboom equipment. The exposure scenarios are presented
in Table 1 (of this section) along with the corresponding exposure assessment. The data have
been normalized to simulate workers wearing long pants, long-sleeve shirts, and chemical-
resistant gloves. Shoes and socks are assumed. Additional assumptions include a maximum
of 100 acres treated per day for groundboom applications and 350 acres treated per day for
aerial applications. The handler body weight is assumed to be 60 kg. Fifteen percent dermal
absorption was used for estimating dermal exposure.
i . ,
0 Post-Application Exposures
There are currently no data to evaluate post-application exposure to field residues of
prometryn. Post-application exposure data were not required in the Registration Standard or
subsequent DCI's, because, at that time, no lexicological criteria had been triggered for
prometryn^ More recently, the toxicological criteria have been triggered.
' • ' ' ' , '
The Agency has determined that there is a potential for exposure to persons entering
treated sites after application is complete. For many uses of prometryn, the potential for post-
application exposure is diminished because the herbicide is incorporated into the soil after it is
applied. If prometryn is appropriately incorporated, post-application exposures should be
limited to those situations where the task being performed disturbs the soil sub-surface. When
lay-by treatments are made, they are applied as directed sprays. If such applications are made
correctly, post-application exposures should be limited to those situations where the task
being performed involves contact with the area to which the spray was directed. There may
possibly be more potential for post-application exposure to prometryn following lay-by
applications to celery, since such applications can be made over the crop and celery is often
thinned by hand.
3. Risk Characterization
a. Chronic Dietary Risk
The DRES chronic analysis used tolerance level residues to calculate the Theoretical
Maximum Residue Contribution (TMRC) for the overall U.S. population and 22 population
subgroups. No refinements using anticipated residues or percent crop treated were applied to
these analyses. Furthermore, this analysis also includes commodities for which revocation of
tolerance is recommended.
The TMRC (mg/kg/day) and %RfD for the general US population is
0.00018 mg/kg/day (0.45% of RfD), while the TRMC for non-nursing infants and children
(1-6 years), the DRES subgroups most highly exposed, is 0.000360 mg/kg/day (0 90% RfD)
and 0.000406 mg/kg/day (1.02% RfD), respectively.
'22
-------
A second chronic analysis was conducted not including the proposed revocation of
tolerances on corn. The TRMC (mg/kg/day) and %RfD for the US population is
0.000036 mg/kg/day (0.09% RfD), while for females 13+ years, nursing, and children
(1-6 years), the DRES subgroups most highly exposed, is 0.000047 mg/kg/day (0.12% RfD),
and 0.000049 mg/kg/day (0.12% RfD), respectively.
Both chronic analyses suggest a negligible chronic dietary risk from the use of
prometryn.
b. Acute Dietary Risk
The DRES acute exposure analysis evaluates individual consumption as reported by
respondents in the USDA 77-78 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 prometryn in the commodity
supply. Since the toxicological effect to which the high end exposure is compared is a
developmental endpoint (increased resorptions and abortions, and significant changes in other
reproductive parameters), these analyses considered only females (13+ years).
\
In the analysis, tolerance level residues were used to calculate the exposure of the
average and highest exposed individual and compared to the NOEL of 12 mg/kg body
weight/day. MOEs calculated for both the average and highest exposed individuals are
greater than 100, indicating that acute dietary exposure from the use of prometryn on food
poses only a minor risk.
c. Occupational Risk
The toxicological endpoint of concern for occupational exposure is systemic toxicity
resulting from short-term (one day to one week) and intermediate-term (one week to several
months) exposure. A NOEL of 12 mg/kg/day was used to estimate MOEs, based on systemic
toxicity from a rabbit developmental study. A dermal absorption rate of 15 percent was
assumed.
Margins of exposure (MOEs) were calculated using the following formula:
Intermediate Length Exposure MOE =
12 mg/kg/dav
Maximum Daily Exposure
23
-------
(1) Risk to Handlers (Mixers, Loaders, Applicators, etc)
Margins of exposure (MOEs) for occupational exposure were calculated for handlers
using the NOEL (12 mg/kg/day) for short-term and intermediate exposure. The calculated
MQE's are presented in Table 1 of this section.
' • ; ' l
MOEs for mixers and loaders are higher than 100 for all scenarios, with the exception
of three mixer/loader scenarios. There was an increase in inhalation exposure in the unit
exposure for wettable powders. Margins of exposure (MOE) are at levels the Agency
considers to be of concern without a respirator for the following exposure scenarios: mixing
and loading wettable powder formulations to support aerial application at both
0.8 and 3.2 Ib ai/A, and to support groundboom application at 3.2 Ib ai/A; and mixing and
loading (open-pour) liquid formulations to support aerial application at 3.2 Ib ai/A.
Exposures for the above listed scenarios of concern were also calculated assuming that
a dust/mist filter (dust mask (TC-21C) with an 80% protection factor is worn during the above
exposure scenarios of concern. The following MOE's result:
for mixing/loading wettable powder to support aerial application at 3.2 Ib ai/A,
[the MOE = 24], at 0.8 Ib ai/A [MOE = 100];
for mixing/loading wettable powder formulations to support groundbobm
applications at 3.2 Ib ai/A [the MOE = 83];
for mixing/loading (open-pour) liquid formulations to support aerial application
at 3.2 Ib ai/A [theMOE = 98].
For flaggers, MOEs range from 231 to 923, based on the amount of active ingredient
to which the flagger is exposed. For aerial and ground-boom applicators, MOEs are 600 to
3000 and 800 to 3000, respectively. The MOEs are presented in a range because the amount
of active ingredient applied per acre is dependent on soil type.
(2) Risk from Post-Application Exposures
There are no data currently available to estimate risks resulting from post-application
exposures to residues of prometryn. The Agency has determined that, since there are
identified toxicological end-points of concern and entry to treated areas should not be
permitted immediately following application. These entry restrictions will remain in effect
until the additional reentry data or information are submitted and the post application
restrictions can be reevaluated.
24
-------
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C. Environmental Assessment
, t ' . • •
1. Ecological Toxicity Data
The Agency has adequate data to assess the hazard of prometryn to nontarget
terrestrial and aquatic organisms; however, some data requirements are considered as
confirmatory information: 71-4(a) avian reproduction (upland gamebird) and 72-4(a) fish
early life-stage. ' . :
a. Toxicity to Terrestrial Animals
'
(1) Birds, Acute and Subacute
In order to establish the toxicity of prometryn to birds, the following tests are required
using the technical grade material: one avian single-dose oral (LD50) study on one species
(preferably mallard or bob white quail); two subacute dietary studies (LC50) on one species of
waterfowl (preferably the mallard duck) and one species of upland game bird (preferably
bobwhite quail or ring-necked pheasant).
Species
Mallard Duck
%A.I.
98.8
>
"y' ' - Avia«A«ateOTaJTvsicity Findings
LD,» raj/kg
>4640 nig/kg
MRIDNo.
00082966
Torichy Category
Practically nontoxic
Fulfills Guideline Requirement
Yes
* * "Awrais SHtocafe Meterj T»»c#y Finatags
Species
Northern Bobwhite Quail
Mallard Duck
% A.I.
98.1
80.7
LC« ppm
>5000
42,766
MRIDNo.
404575-02
00070686
Toxicity Category
Practically nontoxic
Practically nontoxic
ssss
Fulfills Guideline Requirement
Yes
Yes :
These results indicate that prometryn is practically, nontoxic to avian species on an
acute oral and subacute dietary basis. The guideline requirements are fulfilled.
(MRIDs 00082966, 40457502, and 00070686)
(2) Birds, Chronic
Avian reproduction studies are required when birds may be exposed repeatedly or
continuously through persistence, bioaccumulation, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. Present product labeling of prometryn allows
more than one application of the end-use product per growing season, and the terrestrial
field-dissipation half-lives indicate that it is persistent for greater than 4 days.
26
-------
: _ - r
Species
Northern
Bobwhite
Mallard Duck
% A.I.
98.1
98.1
< ••,",$
s , \
NOEL ppm
250
500
""" - Avian Keprodntiion landings
LOEL ppm
500
1000
Endpolnts affected
Egg production,
hatchling weight and
number of 14-day
survivors
Egg production
,
MRIDNo.
410359-02
410359-01
, ; , ' | s ' :
Fulfills Guideline
Requirement
No
Yes
The northern bobwhite reproductive study indicates that prometryn can cause
reductions in egg production, hatchling weight and number of 14-day survivors at levels
greater than 250 ppm; the mallard duck reproductive study indicates that prometryn can cause
reductions in egg production at levels greater than 500 ppm.
The guideline requirements are not fulfilled; the northern bobwhite study is
unacceptable and must be repeated due to high control mortality (25%). In addition, there are
questions regarding the adequacy of the study design to address concerns with this class of
triazine herbicides as endocrine disrupters. This is especially valuable for performing an
accurate risk assessment, as the bobwhite quail appears to be more sensitive to prometryn
than the mallard duck. Therefore, the toxicity values for the bobwhite quail cannot be used in
a risk assessment. Although the mallard study is acceptable, a confirmatory bobwhite study is
recommended to accurately assess the chronic avian risk.
(3)
Mammals
Wild mammal testing is required on a case-by-case basis, depending on the results of
the lower tier studies such as acute and subacute testing, intended use pattern, and pertinent
environmental fate characteristics. In most cases, however, an acute oral LD50 is used to
.estimate toxicity to mammals. This LDSO is reported below.
- - •• ",«« Mairro^an Acute braJTo^^ Findings; " ' ',
Species
Rat (small mammal surrogate)
LDOT mg/kg
1802
MRID#
060314
Toxicity Category
m
The available data indicates that prometryn is slightly toxic to small mammals on an
acute oral basis. (MRID 00060314) ' :
(4) Insects
A honey bee acute contact LD50 study is required if the use will result in honey bee
exposure.
27
-------
, -- - "
Species
Honey Bee
-
«*.
TGAI
** f f $Con-tft££e£Iii!
LD5, ^ig a.i./bee
>96.7
ert A««ie Contact foxtrfty lindiags
MRIDNo.
425285-01
Toxicity Category
Practically Non-toxic
Fulfills Guideline Requirement
Yes '
There is sufficient information to characterize prometryn as practically non-toxic to
bees. The guideline requirement is fulfilled. (MRID 42528501)
* ' "*
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of a pesticide to freshwater fish, the minimum data
required on the technical grade of the active ingredient are two freshwater fish toxicity
studies. One study should use a coldwater species (preferably the rainbow trout), and the
other should use a warmwater species (preferably the bluegill sunfish).
''. "" '/. "V "£", , ' J&^liw«terK*A * J&ei^wis^FisfeCatronic'r«sdfe»yKHaiHgs " "
Species
Fathead minnow
% A.I.
98.1
NOEC
800 ppb
LOEC
1390 ppb
MRD>#
405737-20
Fulfills Guideline Requirements
No
The freshwater fish chronic test study does not satisfy guideline requirements and thus,
cannot be used in risk assessments. The guideline requirement is not fulfilled. The study is
unacceptable due to the relative standard deviation (RSD) for fish weights in the solvent
control being 80.5%. A test is unacceptable if any control RSD is greater than 40%. A
confirmatory fish early life-stage is required in order to fully assess the chronic toxicity of
prometryn to fish.
28
-------
(2) Freshwater Invertebrates
The minimum testing required to assess the hazard of a pesticide to freshwater
invertebrates is a freshwater aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges.
1"- ">," "~v- ^FE^waterlavS!^»rateA««telloxfel{yJEui)Hns'B '"
Species
Daphnia magna
%A.I.
98.9
EC,, ppm a.i.
18.59
MRIDNo.
00070146
Toxicity Category
Slightly toxic
Fulfills guideline requirement
Yes
There is sufficient information to characterize prometryn as slightly toxic to aquatic
invertebrates on an acute basis. The guideline requirement is fulfilled. (MRID 00070146)
3te^hwat«rin.v«Eteirate Cfcronis Toxlclfr JFIroJinss "•"•'>, ^
Species
Daphnia magna
%AJL
98.1
NOEC ppm
1.0
LOEC ppm
2.0
MRIDNo.
405737-20
Toxicity Category
Moderately toxic
Fulfills guideline requirement
Yes
The data indicate that prometryn is moderately toxic to invertebrates on a chronic
basis. The guideline requirement is fulfilled. (MRID 40573720)
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine/marine organisms is required when an end-use
product is intended for direct application to the estuarine/marine environment or is expected
to reach this environment in significant concentrations. The terrestrial food use of prometryn
on cotton and celery may result in exposure to the estuarine environment.
The requirements under this category include a 96-hour LC50 for an estuarine fish, a
96-hour LCSO for shrimp, and either a 48-hour embryo-larvae study or a 96-hour shell
deposition study with oysters.
Species
Eastern oyster
Mysid
Sheepshead minnow
^ *"•
%A.I.
99
98.1
98.1
v
LCjj/EC,. ppm a.i
>!
1.7
5.1
ferine Acufe To
MRIDNo.
402284-01
405737-18
405737-17
xJciiiv l^Jn.d&u's
Toxicity Category
Moderately toxic
Moderately toxic
Moderately toxic
, ..
Fulfills guideline requirement
Supplemental
Yes
Yes
29
-------
There is sufficient information to characterize prometryn as moderately toxic to
marine/estuarine fish and invertebrates. The guideline requirement is fulfilled.
(MRIDs 40228401, 40573717 and 40573718)
c. Toxicity to plants
" (I) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative vigor) is required for
herbicides which have terrestrial or aquatic food or non-food (except residential) use patterns
and under any of the following conditions: 1) the vapor pressure of the TGAI is equal to or
greater than 1.0 x 10 "5 mm at 25°C and the TEP is not incorporated immediately after
application; 2) the TEP is applied aerially, by forced air, air blast or through sprinkler
irrigation; and, 3) endangered or threatened plant species are associated with the site of
application. Terrestrial plant testing is also required for all pesticides which carry
phytotoxicity warnings on their labels.
Jft»
Test (most sensitive species)
Seedling emergence— monocot (Oat)
Seedling emergence— dicot (cabbage)
Vegetative vigbr—monocot (onion)
Vegetative vigor— dicot (cucumber)
itarget Terrestrial Jla
%A.L
98.1
98.1
98.1
98.1
ntTosMty Findings
EC,.lbsa.t/A
0.07
0.014
0.161
0.006
*•
MRIDNo.
410359-04
410359-04
410359-03
410359-03
,
Status
Core
Core
Core
Core
These data indicate that prometryn is toxic to terrestrial plant species at levels
. significantly below the maximum label rate of 3.2 Ibs a.i./A. The guideline requirements
(123-la and 123-lb) are fulfilled. (MRIDs 41035903 and 41035904)
(2) Aquatic
Tier n aquatic plant testing is required for an herbicide applied to terrestrial or. aquatic
food or non-food (except residential), or for any pesticide when the label carries a
phytotoxicity warning. The following species should be tested: Selenastrum capricornutum,
Lemna gibba, Skeletonema costatum, -Anabaenaflos-aquae, and a freshwater diatom. (For
cases of testing based on label phytotoxicity warnings, only Lemna gibba and Selenastrum
capricornutum testing is required).
30
-------
•. "•* 2 , > •• "* f ••'"'"
Species
Navicula pelliculosa (Freshwater diatom)
Lemna gibba
Selenastmm capricomutum
Skeletonema costatum
Anabaena floi-aquae
% A.I.
98.1
98.1
98.1
98.1
98.1
EC,, ppb
1.0 ppb
11.8 ppb
12.0 ppb
7.6 ppb
40.1 ppb
MRIDNo.
426202-01
425209-01
425209-03
426202-02
405209-02
Status
Core
.Core
Core
Core
Core
These findings indicate prometryn is very highly toxic to aquatic plant species. The
guideline requirements are fulfilled. (MRIDs 42620201, 42520901, 42520902, 42620202 and
42520903)
2.
Environmental Fate
a.
Environmental Fate Assessment
Prometryn has the potential to leach to ground water and move offsite into surface
water.
Although the individual data submissions on prometryn and its degradates appear to be
scientifically sound, the environmental fate of prometryn remains somewhat uncertain
because the studies yield contradictory results that have not been reconciled. Batch
equilibrium data and published literature suggest that prometryn and its degradates are very
mobile in sandy soils with low organic matter and clay. However, .prometryn was not
observed to leach below 18 inches in the field. Rapid dissipation was observed in the
terrestrial field dissipation studies carried out in Texas.
According to laboratory data, prometryn is a persistent chemical. It resists abiotic
hydrolysis, direct photolysis, and biodegradation under anaerobic conditions. Its half-life
under aerobic conditions is in excess of 270 days.
The following prometryn degradates have been identified: 2,4-bis(isopropylamino)-
6-hydroxy-s-triazine (GS-11526), and 2-amino-4-isopropylamino-6-methylthio-s-triazine
(GS-11354). Field studies appear to confirm that the degradate GS-11526 is mobile in soils
with low to moderate clay contents. Results from the small-scale ground water studies and
the laboratory mobility data, taken as a whole, suggest prometryn is moderately mobile in
sandy soils with low organic matter and clay. Prometryn parent does not appear to leach
beyond 12 to 18 inches, but GS-11526 was found at all depths down to 24 to 26 inches.
Mobility data for parent prometryn is inconclusive. Batch equilibrium studies indicate
that prometryn is mobile in agricultural sand, loamy sand, silt loam, and silty clay loam soils.
31
-------
Prometryn sorption was most strongly correlated to the soil's cation exchange capacity, which
is derived primarily from the soil's clay and organic matter content. This is confirmed in
published literature [Rao and Davidson, 1982] where batch equilibrium results from 38 soils
suggest that prometryn sorption is correlated to both CEC and soil organic matter. Although
the Koc values in the submitted batch equilibrium data suggest that prometryn does not bind
strongly to organic matter, the larger Rao and Davidson data set suggests that organic matter
plays a major role in prometryn adsorption. KD and Koc values in the Rao and Davidson study
tended to be higher than in the study submitted to the Agency, suggesting that prometryn
would only-be mobile in sandy soils low in both clay and organic matter. A submitted
column leaching study also suggested that unaged prometryn was immobile in a low organic
matter sandy loam soil, but these results have not been satisfactorily explained. The studies of
Senesi and Testini (1982, 1984) have indicated that s-triazines, including prometryn, are
capable of binding to humic acids ionically through a proton donation process, but can also
bind covalently through an electron donation process to humic acid molecules with a
decreased capacity to form ionic and hydrogen bonds. According to the Herbicide Handbook
(1979), acid soils will bind prometryn more efficiently than neutral or basic soils, but this was
not consistently confirmed in the results reported by Rao and Davidson. Prometryn does not
volatilize from soil.
Batch equilibrium studies indicate that prometryn degradates are mobile in agricultural
sand, loamy sand, silt loam, and silty clay loam soils. These degradates are unlikely to
volatilize from soil.
- Prometryn dissipated more quickly in the field than in the lab, with calculated ,
half-lives of 14-to-103 days. Prometryn dissipated with a calculated first-order half-life of
71 days in an uncropped California sandy loam with 0.9% organic matter, and 103 days in the
California sandy loam under cotton. In a Texas silt loam with 2.1% organic matter,
prometryn dissipation appeared to be either biphasic or higher order, with a period of rapid
early dissipation (estimated first half-life = 14-to-30 days) followed by an extended presence
at low concentrations in the soil. The cause of this rapid early phase dissipation is
unexplained, but may be due to an unidentified physical dissipation process (i.e., loss of
surface soil due to wind-blown dust in the bareground plot, plant uptake or volatilization
from plant surfaces in the cropped plot, leaching via preferential flow pathways in either plot);
none of these potential routes of dissipation has been evaluated. .
As expected, prometryn was more mobile in the coarse, low organic matter California
soil, with low concentrations found at depths up to 18 inches. In Texas, no prometryn was
detected below 12 inches, and little was detected below 6 inches. In both Texas and
California, GS-11526, the primary degradate, appeared to be mobile, moving through the soil
profile at concentrations near the limit of quantitation (0.010 ppm). The secondary degradate,
GS-11354, does not appear to be mobile and is found only at low concentrations. The pattern
.'of degradate formation and decline suggests that prometryn dissipation may be due to a
combination of 1) slow biodegradation with degradate leaching, 2) binding to clay arid
32
-------
organic matter, and 3) leaching or runoff of the parent compound. While dissipation through
irreversible adsorption is questionable for this chemical, with a maximum reported Kads of
3.18 in a silty clay loam soil, soil binding did occur in the aerobic soil metabolism study, and
may depend upon whether prometryn, GS-11354 and GS-11526' can react with soil
components or degrade before leaching can occur.
Graphical analysis of GS-11526 detections below 15 cm indicates that such detections
may not have been random experimental error, as suggested by study authors. These
detections demonstrate a pattern consistent with the leaching of very low concentrations of
GS-11526, while deep detections of prometryn and GS-11354 appear to be random
experimental error. Reviewer-developed graphs of GS-11526 concentration vs. depth of
detection of GS-11526 in the four field dissipation studies are attached. The graphs suggest
that, at least in some cases, a decline in GS-11526 concentration in the surface layer may be
accompanied by an increase in GS-11526 concentration at greater depth, followed by slow
dissipation of the degradate.
Prometryn does not bioaccumulate in fish.
b. Environmental Chemistry, Fate and Transport
(1) Degradation
(a) Hydrolysis
A study of prometryn hydrolysis at 1.5 ppm showed that prometryn did not hydrolyze
in sterile aqueous buffer solutions (pH 5, 7 and 9) incubated 30 days in the dark at
25 ± 1°C. This study satisfies the hydrolysis data requirement. (MRJDD 40573704)
(b) Fhotodegradation in water (Guideline 161-2)
A study of photolysis of prometryn at 1.74 ppm in sterile aqueous buffered solution at
pH 7 found that prometryn was relatively stable to direct photolysis when irradiated with
natural sunlight for 30 days. Prometryn comprised 95.91% of the recovered radioactivity in
the irradiated solution and 100% in the dark controls. This study satisfies the photolysis in
water data requirement. (MRID 40573705)
(c) Photodegradation in soil (Guideline 161-3)
A study of prometryn photolysis on soil at 53 ppm showed that prometryn was
relatively stable on a sandy loam soil irradiated with natural sunlight for 30 days. Prometryn
comprised an average of 96.55% of the extractable radioactivity in the irradiated soil and
100% in the dark control. This study satisfies the photodegradation on soil data requirement.
(MRID 40573706)
33
-------
(d) Aerobic soil metabolism (Guideline 162-1)
The acceptable aerobic metabolism study of prometryn indicates that prometryn has
two primary degradates: GS-11526, 26.2% of the applied at 360 days post-treatment and
GS-11354, 1.1% of the applied at30 days post-treatment.
Non-extractable residues increased with time and reached 30.8% of the applied, while
volatiles remained less than 0.5% of the applied. The study indicates an aerobic half-life of
approximately 270 days. This study satisfies the aerobic soil metabolism data requirement
(MRID 00148338)
(e) Anaerobic soil metabolism (Guideline 162-2)
Prometryn at 10.6 ppm did not degrade under anaerobic conditions on sandy loam soil
that was incubated in the dark at 25 ± 1°C for 71 days, the treated soil was aged aerobically
for 30 days prior to the introduction of anaerobic conditions. At 71 days post-flooding (102
days post-treatment), prometryn comprised an average of 86.3% of the applied radioactivity
(98.6% of the extractable radioactivity) in the flooded soil plus floodwater. No residues other
than prometryn were isolated from the soil extracts or floodwater. The anaerobic soil
metabolism data requirement has been satisfied. (MRID 41155901)
(2) Mobility
(a) Leaching and adsorption/desorption
(Guideline 163-1)
Mobilitv/Adsorption/Desorption: Batch equilibrium studies were carried out on
prometryn and two degradates GS-11354 and GS-11526 in agricultural sand, loamy sand, silt
loam and silty clay loam soils. Li MRID 41875901, prometryn was very mobile, with
Freundlich Kads values of 0.86-3.18 and K^ values of 117-448. This study may be upgraded
if this result can be reconciled with the column leaching study (MRTD 40573713) which
shows prometryn to be relatively immobile in soil. GS-11354 was also very mobile, with
Freundlich Kads values of 0.63-1.43. GS-11526 was very mobile in agricultural sand,
loamy sand, silt loam, and mobile in silty clay loam, with Freundlich Kads values of
0.65-7.10. (MRIDs 41875902, 41875903)
Mobility (column leaching^: Two supplements to a column leaching study of
prometryn aged in sandy loam (MRID 40573713) were submitted. The study suggests that
prometryn is immobile in sandy loam (0.7% organic matter). The registrant did not reconcile
the results of the column study with the results of the batch equilibrium study, as required
when the study was reviewed. No conclusions may be drawn from this study about the
mobility of the degradates, due to negligible degradation of prometryn under the conditions of
the experiment. (MRIDs 41875904 and 41875905)
34
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(b) Laboratory volatility (Guideline 163-2)
Prometryn at 9.7 ppm exhibited minimal volatilization from sandy soil that was
incubated for 30 days in the dark at 25 ± 0.2°C under continuous airflow (150 mL/minute).
After 30 days of incubation, only 0.99% of the applied radioactivity had volatilized on
average, of which more than 99% was prometryn; the remainder of the radioactivity remained
associated with the soil. The laboratory volatility data requirement has been satisfied.
(MRTD 41875906)
(3) Accumulation
(a) Accumulation in fish (Guideline 165-4)
Prometryn residues did not accumulate to a significant degree in bluegill sunfish
continuously exposed to prometryn at 0.05 ppm for 28 days in a flow through system. The
maximum mean bioconcentration factors were 54x for edible tissues, 13 Ox for non-edible
tissues, and 85x for the whole fish. These values are lower than might be expected
considering the high octanol/water coefficient of prometryn (log Kow = 3.46). While the study
did not fully characterize unknowns, the low degree of bioconcentration of this chemical is
sufficient to suggest that prometryn does not bioaccumulate in fish. The data requirement for
fish bioaccumulation is satisfied. (MRIDs 41027701 and 40573715)
(4) Field Dissipation
(a) Terrestrial field dissipation (Guideline 164-1)
California Terrestrial Field Dissipation Studies. Prometryn degraded with a half-life of
103 days (in the 0-15 cm depth) in sandy loam soil (70.2% sand, 17.8% silt, 12.0% clay,
0.9% organic matter, pH 7.4, CEC 8.4 meq/100 g) on cotton in California. The site received
five weekly applications of prometryn (4 Ibs a.i./gal EC) at 0.7-to-3.1 Ibs a.i./A/application
(total nominal application 7.8 Ibs a.i./A). Prometryn was generally not detected below the
45-cm depth. The degradate GS-11526 was detected (0.322 ppm) in the 0-15 cm depth. It
was detected at low concentrations (<0.02 ppm) at soil depth as deep as 120-cm throughout
the study period. The degradate GS-11354 was present at 0.053 ppm in the 0-15 cm depth. It
was not detected at depth > 15-cm. The data requirement for a terrestrial field dissipation
study has been satisfied. (MRID 41546401)
Supplemental Study to MRID 41546401: (Terrestrial Field Dissipation; Cotton;
California) At 654 days post treatment, prometryn residues were found at low levels
(0.010-0.015 ppm) in the upper six inches of a cotton field in a California sandy loam.
Degradate residues (GS-11526) were found at low levels (O.010 ppm) from 6-12 inches.
Neither prometryn nor its degradate were found below the twelve inch depth. Samples were
taken to a depth of forty-eight inches. In the original study, the registrant calculated the
35
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initial half-life of prometryn as 103 days. Dissipation appears to slow with reduced
prometryn concentration in the soil. (MRID 42253903)
Prometryn degraded with a half-life of 71 days (in the 0-15 cm depth) in bareground
sandy loam soil (70.2% sand, 17.8% silt, 12.0% clay, 0.9% organic matter, pH 7.4,
CEC 8.4 meq/100 g) in California. The site received a single application of prometryn
(4 Ibs a.i./gal EC) at a nominal application rate of 6.52 Ibs a.i./A. Prometryn was generally
not detected below the 45-cm depth. The degradate GS-11526 was detected (0.408 ppm) in
the O-to-15-cm depth. The degradate GS-11354 was present at 0.025 ppm in the 0-15 cm
depth. It was not detected at depths greater man 15-cm. The data requirement for a terrestrial
field dissipation study has been satisfied. (MRID 41546402)
Supplemental Study to MRID 41546402: (Terrestrial Field Dissipation; Bare Ground;
California) At 654 days post treatment, prometryn residues were found at low levels (less
than 0.010-to-0.013 ppm) in the upper six inches of a bareground plot in a California sandy
loam. No degradate residues were found, nor was prometryn found below the six inch depth.
Samples were taken to a depth of forty-eight inches. In the original study, the registrant
calculated the initial half-life of prometryn as 71 days. Dissipation appears to slow with
reduced prometryn concentration in the soil. (MRID 42253904)
Texas Terrestrial Field Dissipation Studies. Prometryn degraded with an observed
half-life of 14-to-30 days (in the O-to-6 inch depth) in silt loam soil (18% sand, 64% silt,
18% clay, 2.1% organic mater, pH 7.7, CEC 13.4 meq/lOOg) on cotton in Texas. The site
received five weekly applications of prometryn (4 Ibs a.i./gal EC) at 0.53-to-3.1 Ibs
a.i./A/application (total nominal application 6.03 Ibs a.i./A). Prometryn was not detected
below the 12-inch depth. The degradate GS-11526 was detected (0.473 ppm) in the O-to-6
inch depth, as well as the 24-36 inch depth. The degradate GS-11354 was present at 0.06553
ppm in the 0-6 inch depth. It was not detected at depths greater than 6 inches. The data
requirement for a terrestrial field dissipation study has been satisfied. (MRID 41546403)
Supplemental Study to MRID 41546403: (Terrestrial Field Dissipation; Cotton, Texas)
At 668 days post treatment, prometryn residues were found at low levels (less than 0.010-to-
0.021 ppm) in the upper six inches of a cotton field in a Texas silt loam. No degradate
residues were found, nor was prometryn found below the six inch depth, although samples
were taken to forty-eight inches. Prometryn dissipation appears to be either biphasic or
higher-order, with a period of more rapid early dissipation followed by an extended presence
at low concentrations in the soil. Linear interpretation of the data indicated a half-life of
86 days; however, prometryn was more than 80% dissipated at 60 days.
(MRID 42253901) , '
.'',*. ' '' ' ' '
Prometryn degraded with an observed half-life of 14 days (in the O-to-6 inch depth) in
bareground silt loam soil (18% sand, 64% silt, 18% clay, 2.1% organic matter, pH 7.7,
CEC 13.4 meq/lOOg) in Texas. The site received a single application of prometryn
36
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(4 Ibs a.i./gal EC) at a nominal application rate of 7.0 Ibs a.i./A. Prometryn was detected to the
12 inch depth. The degradate GS-11526 was detected (0.735 ppm) in the O-to-6 inch depth,
as well as at depths of up to 36 inches (0.013-to-0.02 ppm). The degradate GS-11354 was
present at 0.041 ppm in the O-to-6 inch depth. It was not detected at depths greater than
6 inches. The data requirement for a terrestrial field dissipation study has been satisfied.
(MRID 41546404)
Supplemental Study to MRID 41546404: (Terrestrial Field Dissipation; Bare Ground;
Texas) At 668 days post treatment, residues of prometryn (0.013-to-0.015 ppm) and its
primary degradate, GS-11526 (<0.010-to-0.024 ppm) were found in the upper six inches of a
bare ground plot in a Texas silt loam. No residues were found below the six inch depth at
concentrations greater than or equal to .010 ppm. Prometryn dissipation appears to be either
biphasic or higher order, with a period of rapid early dissipation followed by an extended
presence at low concentrations in the soil. Linear interpretation of the data indicated a half-
life of 70 days, even though prometryn was almost 90% dissipated at 60 days.
(MRID 42253902)
(b) Long-term field dissipation (Guideline 164-5)
This study is deferred pending review of a small-scale retrospective groundwater study
by the Agency's Groundwater section.
(5) Spray drift
(a) Droplet size spectrum (Guideline 201-1)
This study is being conducted by the Industry Spray Drift Task Force.
(b) Droplet size evaluation (Guideline 202-1)
This study is being held in reserve pending the work currently being conducted by
industry's Spray Drift Task Force.
c. Water Resources
(a)
Ground water
The mobility data, taken as a whole, suggest that prometryn will be most mobile in
sandy, alkaline soils which contain little organic matter or clay. Therefore, the use of
prometryn on. celery is likely to pose little risk to ground water, not only because it is a minor
use, but also because celery is generally grown in soils with high organic matter contents.
The use on dill or pigeon peas may not pose a threat to ground water either, as the labels warn
that use on sand or loamy sand soils might injure the crop.
37
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However, the use of prometryn on cotton presents a potential threat to groundwater in
certain use areas. In California, Arizona and New Mexico, prometryn labels instruct
potential users not to apply the product to sand or loamy sand soils, reducing the risk of
ground-water contamination. However, prometryn may be more likely to reach ground water
if used on cotton in sand or loamy sand soils in the mid-South and Southeast, such as those
found in the Atlantic Coastal Plain. Although soils in this region tend to be acid, their
porosity and lack of organic matter combined with occasional heavy rainfall make them
susceptible to prometryn leaching. Available records show that little or no prometryn is now
used in the-Carolinas and Georgia.
The registrant completed two small-scale retrospective ground-water studies for
prometryn on cotton in 1989. The studies, which evaluated the effects of long-term use of the
chemical, were conducted on fields in the San Joaquin Valley of California and in Mississippi
that were underlain by sandy loam and loam soils. Parent prometryn and degradate
GS-11354 were not detected in limited sampling of the ground-water of either site, with the
exception of a single sub-part-per-billion detection of prometryn in the irrigation source water
of the California site. The degradate GS-11526 was detected three times at the California site
only, at a maximum concentration of 0.61 ppb.
The root-zone leaching screening model PATRIOT was used to roughly compare the
relative leaching potential of prometryn and several other triazine pesticides. The simulation
was run for the Cajon soil series of Tulare County, California, using 10 years of historical
rainfall data from Bakersfield (actual field conditions would require more intensive irrigation
to support the crop). Under this scenario, PATRIOT predicted that the average annual
leaching of prometryn would be less than that of atrazine and propazine, but greater than that
of simazine and cyanazine. Comparison of prometryn to other cotton herbicides, using the
ranking method GUS (Gustafson, 1989), indicates that prometryn might have a leaching
potential greater than that of several other cotton herbicides, such as norflurazon, cyanazine,
and others. The ranking of prometryn was similar to that of diuron, and only less than the
rankings of pyrithiobac-sodium and fluometuron.
. ... i , ^
;.'.',•' ,' ' ' ;
(b) Surface water
Substantial amounts, of prometryn could be available for runoff to surface waters for
several months post-application. This will be especially true in areas where runoff is most
likely, for example, sloping silly or clay soils which are subject to occasional intense rainfall.
Although prometryn runoff may occur in any area meeting this description, records indicate
that there is an area of relatively heavy prometryn use in northeastern Louisiana, northwestern
Mississippi and southeastern Arkansas. As this area is on the banks of the Mississippi River,
it appears likely that there will be significant overland flow in most years, and that prometryn
could be carried to surface water in this flow. The combination of runoff and heavy
prometryn use give this area's unique potential for surface water contamination with
prometryn.
38
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The low to moderate soil/water partitioning of prometryn (Kads of 0.86 to 3.18; Kocs of
120 to 450) indicates that most of prometryn runoff may generally occur via dissolution in
runoff water as opposed to adsorption to eroding soil. Its resistance to hydrolysis, direct
photolysis in water, and anaerobic soil metabolism combined with only a very moderate
susceptibility to aerobic soil metabolism and a low volatilization potential should make it
somewhat persistent in surface waters. Based upon its low to moderate soil/water and
sediment/water partitioning, most of any prometryn in surface water will probably be
dissolved in the water column instead of adsorbed to suspended and bottom sediment. The
reported BGFs for prometryn (54X to 130X) indicate that its potential for bioaccumulation is
low.
The 2 major atrazine degradates of prometryn in the aerobic soil metabolism study
(GS-11526 and GS-113 54) appear to be at least as mobile and in some cases more mobile
than prometryn. Consequently they will probably runoff primarily via dissolution in runoff
water and will probably exist in surface waters primarily dissolved in the water column. The
occurrence of the GS-11526 degradate at 26.2% of applied at the end of the aerobic soil
metabolism study suggests that it may be somewhat persistent and therefore available for
runoff for a substantial period. , . "
In a 1989 reconnaissance study, the USGS (Goolsby and Thurman, 1991) collected
samples from numerous locations throughout 10 states in the midwestern corn belt and
analyzed them for several herbicides including prometryn. Prometryn was not detected at a
detection limit of 0.05 //g/L in pre-application samples collected from 55 sites, in post-
application samples collected from 129 sites, and in fall samples collected from 142 sites.
Prometryn is not currently regulated under the Safe Drinking Water Act (SDWA).
Therefore no MCL has been established for it and water supply systems are not required to
sample and analyze for it. In addition, no drinking water health advisories have been
established for prometryn. However, the low to moderate soil/water partitioning of prometryn
suggests that it would not be effectively removed by the great majority of surface water
supply systems which employ only primary treatment processes.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RC» and the Level of Concern (LOO: The Levels of
Concern are criteria used to indicate potential risk to nontarget organisms. The criteria
indicate that a chemical, when used as directed, has the potential to cause undesirable effects
on nontarget organisms: There are two general categories of LOG (acute and chronic) for
each of the four nontarget faunal groups and one category (acute) for each of two nontarget
floral groups. In order to determine if an LOG has been exceeded, a risk quotient must be
derived and compared to the LOC's. A risk quotient is calculated by dividing an appropriate
39
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exposure estimate, e.g. the estimated environmental concentration, (EEC) by an appropriate
toxicity test effect level, e.g. the LCS0.
The acute effect levels typically are: . :
- EC2S (terrestrial plants),
- EC50 (aquatic plants and invertebrates),
- LC50 (fish and birds), and .
- - LDSO (birds and mammals)
The chronic test results are the: -
o NOEC for avian and mammal reproduction studies, and either the NOEC for
chronic aquatic studies, or the Maximum Allowable Toxicant Concentration
MATC), the geometric mean of the NOEC and the LOEC for chronic aquatic
studies.
When the risk quotient exceeds the LOG for a particular category, risk to that
particular category is presumed to exist. Risk presumptions are presented along with the
corresponding LOC's.
Levels of Concern CLOO and associated Risk Presumntion
o Mammals, Birds
IF THE
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
o Fish, Aquatic invertebrates
acute RQ>
acute RQ>
acute RQ>
chronic RQ>
o Plants
IF THE
RQ>
RQ>
LOG PRESUMPTION
0.5 High acute risk
0.2 Risk that may be mitigated through restricted
use
0.1 Endangered species may be affected acutely
1.0 Chronic risk (nonendangered and endangered
species may be affected chronically),
LOG PRESUMPTION
0.5 High acute risk
0.1 Risk that may be mitigated through restricted
use
0.05 Endangered species may be affected acutely
1.0 Chronic risk (nonendangered and endangered
species may be affected chronically)
LOG PRESUMPTION
1.0 Highrisk '
1.0 Endangered plants may be affected
Currently, no separate criteria for restricted use or chronic effects for plants exist.
40
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b. Exposure and Risk to Non-target Terrestrial Animals
(a) Birds
Residues found on dietary food items following prometryn application may be
compared to LCSO values to predict hazard. The maximum concentration of residues of
prometryn which may be expected to occur on selected avian or mammalian dietary food
items following a single foliar application at different application rates is provided in the table
below:
<
Reslc
Use Sites - Celery,
cotton, dill, pigeon
PeaS
Range Grasses (short)
Range Grass (long)
Fruit/Vegetable Leaves
(other than legumes)
Forage Legumes and
Insects
Seeds
Fruits
foeifctt Avian SBM* MEaavroatias Dietary «o«id Items IB f&U
Application rates (3.2lb a.i./A)
with maximum of 4.0 Ib a.i./A, on
celery in Hawaii
768 ppm maximum;
(960 ppm maximum in Hawaii)
352 ppm maximum;
(440 ppm maximum in Hawaii)
400 ppm maximum;
(500 ppm maximum in Hawaii)
186 ppm maximum;
(232 ppm maximum in Hawaii)
38 ppm maximum;
(48 ppm maximum, in Hawaii)
22 ppm maximum;
(28 ppm maximum in Hawaii)
AVIAN RQs
acute: bobwhite= 0.15 (0.2 Hawaii)
mallard= 0.02 (0.02 Hawaii)
chronic: mallard= 1.5 (1.9 Hawaii)
acute: bobwhite= 0.1 (0.1 Hawaii)
mallard= 0.01 (0.1 Hawaii)
chronic: mallard=0.7 (0.9 Hawaii)
acute: bobwhite= 0.08 (0.1 Hawaii)
mallard= 0.01 (0.01 Hawaii)
chronic: mallard= 0.8 (1.0 Hawaii)
acute: bobwhite= 0.04 (0.05 Hawaii)
mallard= 0.00 (0.00 Hawaii)
chronic: mallard= 0.4 (0.5 Hawaii)
acute: bobwhite: 0.01 (0.01 Hawaii)
mallard= 0.00 (0.00 Hawaii)
chronic: mallard= 0.18 (0.1 Hawaii)
acute: bobwhite: 0.00 (0.00 Hawaii)
mallard= 0.00 (0.00 Hawaii)
chronic: mallard= 0.04 (0.06 Hawaii)
Acute adverse effects to birds are not expected from the use of prometryn at maximum
application rates. However, prometryn poses a chronic risk to birds. The chronic LOG
(LOG = 1) was exceeded for birds feeding on short grasses and fruit/vegetable leaves for
celery use in Hawaii (RQ = 1.5, 1.9 for short grasses and RQ = 1.0 for fruit/vegetable leaves).
It is likely that these risk quotients would be even higher for the northern bobwhite which
appear to be more sensitive to prometryn than the mallard. At this time, a thorough
assessment of the chronic effects of prometryn on avian species cannot be completed. In
order to confirm the chronic assessment and decrease the uncertainty, a valid northern
bobwhite study (Guideline 72-4(a)) is required. These additional data are considered
confirmatory based on what is already known about prometryn.
41
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(b) Mammals
Small mammal exposure is addressed using acute oral LDSO values converted to
estimate a LCSO value for dietary exposure, unless acceptable longer-term feeding data are
available. A 28-day mouse feeding study was available for prometryn; therefore, the results
of this study (NOEL = 3000 ppm) were used to calculate the risk quotient.
'
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(a) Freshwater fish
,JRIsk Quofients (RQ> for Freshwater Fish ,
Crop/application rate (#)
Celery/3.2 lba.i./A(l)
Cotton/2.8 lba.i./A(l)
Cotton/2.8 lba.i./A (2)
Species
Bluegill
Rainbow trout
Bluegill
Rainbow trout
Bluegill
Rainbow trout
Acute RQ (96-hr)
0.02
0.09
0.02
0.06
0.03
0.09
As indicated in the above estimated residue table, the high risk and restricted use acute
LOCs for freshwater fish have not been exceeded for the maximum application rate.
However, the endangered species LOC for freshwater fish has been exceeded. At this time, a
thorough assessment of the chronic effects of prometryn on fish cannot be completed. The
submitted fish early life-stage study is 'invalid1 based on several discrepancies, not the least of
which is the Relative Standard Deviation (RSD) factor being over twice that which is
currently acceptable. In order to complete a chronic assessment, a valid fish early life-stage
(Guideline 72-4(a)) is required. Because prometryn displays slight to moderate toxicity to
aquatic organisms, this additional fish early life-stage data would be considered confirmatory.
(b) Freshwater Invertebrates .
*,?-"', - ' '- « "•"• - - ' ' .A/,,,f.. ,*y'p~ - * ;-
,.-.,. JRtskjQtafttients (JftQ) for Freshwater Invertebrates
Crop/application rate (#)
Celery/ground 3.2 Ib a.i7A (1)
Cotton/ground 2.8 Ib a.i7A (1)
Cotton/aerial 2.8 Ib a.iVA (1)
Species
Daphnia magna
Daphnia magna
Daphnia magna
Acute RQ (96-hr)
0.01
0.01
0.012
Chronic RQ (21-day)
0.24
0.25
0.17
As indicated in the above estimated residue table, the freshwater invertebrate acute
high risk, restricted use and endangered species LOCs have not been exceeded at any
application rates. Therefore, freshwater aquatic invertebrates are not likely to be acutely
affected by the use of prometryn. Also, the freshwater invertebrate chronic LOC
(LOC = 1) has not been exceeded by any of the application rates. Chronic adverse effects to
freshwater invertebrates are not expected to occur from the use of prometryn.
43
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(c) Estuarine and Marine Animals
" ' , ~ s «s, "-' 'BfekQwi
.Crop/application rate (#)
Celery/ground 3.2 Ib a.i./A (1)
Cotton/grotuid 2.8 Ib a.i./A (1)
Cotton/aerial 2.8 Ib a.i./A (1)
% i
Species
Sheepshead minnow
Oyster
Mysid
Sheepshead minnow
Oyster
Mysid
Sheepshead minnow
Oyster L
Mysid
rEBHiams
Acute RQ (96-hr)
0.05 ,
0.26
0.15
0.05
0.27
0.15
0.04
0.18
0.10
As indicated in the above estimated residue table, the high risk acute LOG for
marine/estuarine fish and invertebrates has not been exceeded. The restricted use LOG for
marine/estuarine invertebrates (molluscs) has been exceeded for all three application
rates/methods. This LOG also applies to freshwater mollusc species, such as clams and
mussels. The endangered species LOG for all invertebrates has been exceeded for all rates
and methods and for fish for ground application. This indicates that the use of prometryn may
cause adverse effects to endangered marine/estuarine fish and invertebrates. Prometryn use
may also cause adverse effects to freshwater and marine mollusc species.
(2) Exposure and Risk to Non-Target Plants
• ' , ' ' '
(a) Terrestrial and Semi-aquatic
Application rate (#)
3.21ba.i./A
Species
Monocot - emergence
Dicot - emergence
Monocot - vigor
Dicot - vigor
RQ
45.7
228.6
19.9
533.3
Adverse effects are expected to occur to non-target terrestrial plants, including any
endangered species, from the use of prometryn at current label rates.
44
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(b) Aquatic
Species
Navtcula pelliculosa
Lemna gibba
Selenastrum capricornutum
Skeletonema costatum
Anabaena flos-aquae
RQ from ground application, 3.2 Ib
a.i,/A (GENEEC EEC = 57.5 ppb at 96
hours)
57.5
4.9
4.8
9.6
1.4
RQ from aerial application, 3.2 Ib
a,i./A (GENEEC EEC = 61.1 ppb at .
96 hours)
61.1
5.2
5.1
8.0
1.5
Adverse effects are expected to occur to aquatic plants from the use of prometryn.
IV. RISK MANAGEMENT AND REREGISTRATION 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 reregistration. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing prometryn. The Agency has completed its review of
these generic data, and has determined that the data are sufficient to support reregistration of
all products containing prometryn. Appendix B identifies the generic data requirements that
the Agency reviewed as part of its determination of reregistration eligibility of prometryn, and
lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of prometryn and to determine that prometryn can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing prometryn as the active ingredient, labeled and used as specified
in this document, are eligible for reregistration. The reregistration of particular products is
addressed in Section V of this document. ,
The Agency made its reregistration 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 all uses of prometryn 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 prometryn,
if new information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
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1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient prometryn, the
Agency has sufficient information on the health effects of prometryn and on its potential for
causing adverse effects in fish and wildlife and the environment. The Agency has determined
that prometryn products, labeled and used as specified in this Reregistration Eligibility
Decision dpcument, will not pose unreasonable risks or adverse effects to humans or the
environment. Therefore, the Agency concludes that products containing prometryn for all
uses are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all of the registered uses of prometryn on celery,
pigeon peas, cotton, and dill are eligible for reregistration.
f \ •' *
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for prometryn.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document. The Agency has determined that all uses are eligible for reregistration.
1.
Tolerance Reassessment
Tolerances Listed Under 40 CFR S180.222fa>>
The tolerances listed in 40 CFR §180.222(a) are for residues of prometryn per se.
Adequate data are available to support the established tolerances in cottonseed, celery and
pigeon peas, pending submission of additional storage stability information for cottonseed and
celery.
No tolerances for residues of prometryn in milk, eggs, animal fat, meat, and meat
byproducts have been established, and none are recommended at this time. A summary of the
prometryn tolerance reassessment and modifications in commodity definitions are presented
in Table 1 of this section.
New Tolerances Needed Under 40 CFR S180.222Ca>)
Provided that the registrant has no objection to a tolerance of 1.0 ppm in or on cotton
gin by products (cotton gin trash), no additional data are required. The registrant must
propose a tolerance for residues in this commodity.
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Tolerances Listed Under 40 CFR SI80.222031
The tolerance listed in 40 CFR §180.222(b) is for a regional registration as defined in
180.1(n) for residues of prometryn per se in dill. Adequate data are available to support the
established tolerance.
New Tolerances Needed Under 40 CFR S180.222(c)
Based on residue data from extensive rotational field studies, tolerances will be
required for the inadvertent residue of prometryn per se in rotational crops. These tolerances
should be listed in 40 CFR §180.222(c). Available data support the suggested tolerances of
0.3 ppm for residues of prometryn per se in the forage and straw of rotational small grains.
The registrant must propose tolerances of 0.3 ppm for residues of prometryn in the forage and
straw of rotational small grains. The Agency will not require extensive field trials to
determine appropriate tolerances for residues in the hay of rotational small grains, provided
the registrant has no objection to proposing a tolerance of 1.0 ppm in rotational small grain
hay.
Table 1. Tolerance Reassessment Summary for Prometryn
Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correct
Commodity Definition
Tolerances listed under 40 CFR 180.222(a):
Celery
Com, field (forage and fodder)
Com, sweet (forage and fodder)
Com, pop (forage and fodder)
Corn, fresh. (Inc. sweet, K+CWHR)
Com, grain
Cotton, forage
Cottonseed
Pigeon peas
0.5
0.25
1.0
0.25
0.25
0.5
Revoke
Revoke
0.25
0.25
Tolerances for residues in
com commodities will be
proposed for revocation,
since use sites for com
have been removed from
all product labels.
The tolerance should be
revoked since cotton
forage is no longer
considered to be a
significant feed item.
Cotton, undelinted seed
Pigeon pea, seed
Tolerance listed under 40 CFR 180.222(b):
Dill
0.3
0.3 1 Regional Registration
New Tolerance Required under 40 CFR §180.222(a):
Cotton, gin byproducts
None
1.0 b
Tolerance to be proposed
by registrant for cotton,
gin by products (gin
trash)
47
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Commodity
Current Tolerance
(ppm)
Tolerance
Reassessment (ppm)
Comment/Correcf
Commodity Definition
New Tolerances Required under 40 CFR §180.222(c):
Small grains, forage and straw
Small grains, hay
None
None
0.3
1.0
The registrant must
propose tolerances for the
inadvertent residues of
prometryn j per se,in.
forage and straw of small
grains rotated with cotton.
The registrant must
propose a tolerance for
inadvertant residues of
prometryn/jerse, in hay or
submit additional data.
a the 1.0 ppm tolerance was .calculated based on the proposed tolerances in or on forage and a dry-matter
conversion. Provided the registrant has no objection to a 1.0 ppm tolerance^ residue data will not be
required.
b " The 1.0 ppm tolerance was calculated based on residues in rotational small grain hay and dry matter
: . conversion. The registratat must propose the suggested tolerance of 1.0 ppm, or submit the additional
required data. ' .
Codex Harmonization .
No maximum residue limits (MRLs) for prometryn have been established by Codex
for any agricultural commodity. Therefore, no compatibility questions exist with respect to
U.S. tolerances.
2* Restricted Use Classification
Prometryn is not currently classified as a restricted use pesticide. Although the
restricted use risk quotients are at the threshold for small mammals, fresh water invertebrates
and estuarine/marine organisms (oysters and mysid shrimp), the Agency has determined that
the numbers do not warrant the chemical's reclassificatibn at this time.
3.
Reference Dose
The RfD has been set at 0.04 mg/kg/day by the Office of Pesticide Program's RfD/Peer
Review Committee, based upon a NOEL of 3.75 mg/kg/day in a chronic toxicity study in
dogs. The LEL was 37.5 mg/kg/day based on bone marrow atrophy and degenerative
changes in the liver and kidneys. An uncertainty factor of 100 was used to account for inter-
and infra-species variability.
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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 in the Federal Register a description of the program and have
available 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
this RED document. Rather, any requirements for product use modifications will occur in the
future under the Endangered Species Protection Program.
5. Worker Protection Requirements
a. Occupational/Residential Labeling Rationale/Risk Mitigation
(1). Compliance with Worker Protection
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, feed, and fiber plants, trees, turf grass, flowers, shrubs, ornamentals, and
seedlings). Uses within scope include not only uses on plants, but also uses on the soil or
planting medium the plants are (or will be) grown in.
At this time all of the registered uses of prometryn are within the scope of the Worker
Protection Standard (WPS).
Any product whose labeling reasonably permits 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 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.
49
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After April 21, 1994, except as otherwise provided in PR Notices 93-7 and 93-11, all
products within the scope of those notices must bear WPS PR Notice complying labeling
when they 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,
all products within the scope of those notices must bear WPS PR Notice complying labeling
when they are distributed or sold by any person.
Personal Protective Equipment (PPE) and Engineering Controls for Handlers (Mixer/
Loader/Applicators)
Occupational-Use Products (WPS and NpnWPS Uses)
To the Agency's knowledge, at this time all of the registered uses of prometryn are
within the scope of the Worker Protection Standard (WPS)!
For each end-use product, PPE requirements for pesticide handlers will be set during
reregistration in one of two ways:
'
1. If the Agency has no special concerns about the acute 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 will
be established using the process described in PR Notice 93-7 or more recent
Agency guidelines.
2. If the Agency has special concerns about an active ingredient due to 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 document for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE requirements that pertain
to all or most occupational 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 each end-use
. product.
• The more stringent choice for each type of PPE (Le., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the
end-use product
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There are special toxicological concerns about prometryn that warrant the
establishment of active-ingredient-based minimum engineering-control and PPE requirements
for certain handlers of certain formulations. The MOE's were calculated as being
unacceptable for (1) occupational mixers/loaders who are supporting ground and aerial
application of using wettable powder formulations, and (2) occupational mixers/loaders who
are supporting aerial application using liquid formulations. The risks associated with mixing
and loading wettable powder formulations cannot be adequately mitigated with the use of
personal protective equipment. Therefore, the Agency is requiring that wettable powder .
formulations be formulated O1SJLY as water-soluble packets. This mandatory engineering-
control requirement should adequately mitigate the risks associated with mixing and loading
wettable powder formulations. To mitigate the risks associated with mixing and loading
liquid formulations to support aerial applications, the Agency is requiring minimum (baseline)
PPE of chemical-resistant apron and a respirator equipped with a dust/mist filter in addition to
the PPE required for other handlers of prometryn. The MOE's were calculated as being
acceptable for applicators and flaggers for all formulations. Since the exposure studies used
to calculate these risks included the use of chemical-resistant gloves, long-sleeve shirts, long
pants, shoes, and socks, these PPE and work clothing will be required for all handlers of
prometryn.
Handler PPE for Homeowner-Use Products
There are no registered products containing prometryn that are intended for
homeowner use.
Post-Application/Entrv Restrictions
Occupational-Use Products (WPS Uses)
To the Agency's knowledge, at this time all registered uses of prometryn are within the
scope of the Worker Protection Standard (WPS).
Restricted-Entry Interval: Under the Worker Protection Standard (WPS), interim
restricted entry intervals (REI) for all uses within the scope of the WPS are established on the
basis of 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 n, the
interim WPS REI is established at 24 hours. If none of the three acute toxicity effects are in
category I or n, 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
51
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promulgation of the WPS: product-specific REI's established on the basis of adequate data
and interim REI's that are longer than those that wOuld'be established under the WPS.
For occupational end-use products containing prometryn as an active ingredient, the
Agency is establishing a 24-hour REI for celery and a 12-hour REI for all other uses of the
product. The basis for this requirement is that prometryn has a toxicological endpoint of
concern for systemic toxicity for short-term and intermediate exposures and no post-
application exposure data are available.
The Agency notes that the WPS places very specific restrictions on entry during
restricted-entry intervals when that entry involves contact with treated surfaces. The Agency
believes that these existing WPS protections are sufficient to mitigate post-application
exposures of workers who contact surfaces treated with prometryn.
The WPS interim REI in effe,ct until now was 12 hours. The WPS interim REI was
established through labeling modifications specified in PR Notice 93-7, which implemented
the labeling requirements of the 1992 Worker Protection Standard for Agricultural Pesticides.
For those uses of prometryn that are incorporated into the soil, the Agency notes that if
prometryn has been correctly incorporated, the WPS permits workers to enter the treated area
during the restricted-entry interval without personal protective equipment or any other
resfriction if they are performing tasks that do not involve contact with the soil subsurface.
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 or routine entry to perform
hand labor tasks and requirement that personal protective equipment to be worn.
Personal protective equipment requirements for persons who must enter areas that
remain under a restricted-entry interval are based on the toxicity concerns about the
active ingredient. The requirements are set in one of two ways.
1. If the Agency has no special concerns about the acute or other adverse effects
of an active ingredient, it establishes the early-entry PPE requirements based on
the.acute dermal toxicity, skin irritation potential, and eye irritation potential of
the active ingredient.
2. If the Agency has special concerns about an active ingredient due to very high
acute toxicity or to certain other adverse effects, such as allergic effects, cancer,
development toxicity, or reproductive effects, it may establish early-entry PPE
requirements that are more stringent than would be established otherwise.
There are no special concerns about prometryn since the MOEs for most handlers are
acceptable with the use of long-sleeve shirt, long pants, shoes socks, and chemical-resistant
52
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gloves. Therefore, for early entry following applications of prometryn, the Agency is
establishing PPE for dermal protection based on the acute toxicity of the active Ingredient.
Since prometryn is classified as category HI for eye irritation potential, protective eyewear is
not required.
Occupational Use Products (nonWPS Uses)
To the Agency's knowledge, at this time there are no registered uses of prometryn
outside the-scope of the Worker Protection Standard.
Homeowner-Use Products
There are no registered products containing prometryn that are intended for
homeowner use. The Agency is requiring labeling statements to assure that such products are
not sold or used by homeowners.
Additional Labeling Requirements
The Agency is requiring additional labeling statements to be located on all end-use
products containing prometryn that are primarily for occupational use. For the specific
labeling statements, refer to Section V of this document.
6. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, Agency 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.
7.
Groundwater and Surface Water Advisories
The laboratory mobility data for prometryn, taken as a whole, suggest that prometryn
will be most mobile in sandy, alkaline soils which contain little organic matter or clay. In
California, Arizona and New Mexico, prometryn labels instruct potential users not to apply
the product to sand or loamy sand soils. Prometryn was not detected in ground water during a
retrospective ground-water monitoring study performed by the registrant in Missouri, at a site
which was underlain by sandy loams and loamy sands. In light of the registrant's stewardship
in conducting numerous groundwater studies and the data in-house, the Agency has
determined that groundwater and surface water label advisories are not necessary at this time.
However, the Agency will require labelling prohibiting the use of prometryn on sand and
sandy loam soils in certain areas of the country.
53
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8. Rotational Crops Intervals
The following requirements (labeling and submission of data) are being imposed for
rotational crops (rotational leafy vegetables, rotational small grains, and rotational root crops):
o For Rotational Leafy Vegetables:
Data are required. The registrant must conduct an additional limited
- field trial which includes a 12-month FBI. If residues of prometryn, per se in
rotational leafy vegetables rotated at 12 months are <0.01 ppm, then no
additional data will be required, and amended labels specifying a 12-month FBI
must be submitted. Extensive rotational crop field trials are required if shorter
PBIs are desired.
o For Rotational Small Grains:
The available data suggest that rotational crop tolerances of 0.3 ppm are
required for residues of prometryn, per se in forage and straw of rotational
small grains. These tolerances must be accompanied by amended labels
stipulating a 3-month FBI for rotational small grains.
No additional data are required depicting residues in rotational small
grain hay, provided the registrant proposes a tolerance of 1.0 ppm in hay of
rotational small grains.
9.
Environmental Hazard
The Agency is requiring labeling to ensure that prometryn use will not endanger
sensitive terrestrial and aquatic plant species. Refer to Section V of this document.
V; ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
»
The generic data base supporting the reregistration of prometryn for the above eligible
uses has been reviewed and determined to be substantially complete for all uses. The
following additional confirmatory data are needed to fulfill the guideline requirements for the
studies listed below:
54
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o Guideline 71-4(a)
o Guideline 72-4(a)
o , Guideline 85-2
o A confirmatory post-appl
shall consist of:
Guideline 132-l(a)
Guideline 132-l(b)
Guideline 133-3
o - Guideline 165-2
Avian reproduction (upland gamebird)
Fish early life-stage
Dermal absorption
ication/reentry exposure study for celery. The study
Foliar dislodgeable residue dissipation,
Soil residue dissipation, and
Dermal exposure to be conducted concurrently
Limited field rotational crop study (for leafy
vegetables)
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 a herbicide for the following use(s):
(fill blank only with those uses that are being supported by MP registrant)."
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 use group:
(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 the
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 the U.S. EPA submission requirements regarding the support of such
use(s)."
B. End-Use Products
1. Additional Product-Specific Requirements
i
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 D, the Product Specific Data Call-in
Notice.
55
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Registrants must review previous data submissions to ensure that they meet current the
Agency's acceptance criteria and if not, commit to conducthew studies. If a registrant
believes that previously submitted data meet current testing standards, then study MRTD
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
, - a. Occupational Labeling
(1) Personal Protective Equipment Requirements for
Pesticide Handlers (mixers, loaders, applicators, etc);
Sole-active-ingredient end-use products that contain prometryn must be revised to
adopt the handler personal protective equipment requirements set forth in this section. Any
conflicting PPE requirements on their current labeling must be removed.
Multiple-active-ingredient end-use products that contain prometryn must compare
the handler personal protective equipment requirements set forth in this section to the PPE
requirements on their current labeling and retain the more protective. For guidance on which
PPE is considered more protective, see PR Notice 93-7.
• Handler PPE for Occupational-Use Products (products NOT intended
primarily for home use — (see tests in PR Notice 93-7 and 93-11):
Minimum (Baseline) Personal Protective Equipment Requirements: All of the
registered uses of prometryn are within the scope of the Worker Protection Standard
for Agricultural Pesticides (WPS). The minimum (baseline) PPE for occupational
handlers of prometryn end-use products is:
"Applicators and other handlers must wear:
—long sleeve shirt and long pants,
—Chemical resistant gloves (see instructions * below), and
—Shoes plus socks
* The glove statement for prometryn is the statement established through the
instructions in Supplement Three of PR Notice 93-7."
i' - , .'••'' ' ••'';•••
In addition, on the liquid-formulation end-use products that contain instructions for
aerial applications, the Agency is requiring the following additional minimum (baseline) PPE
for mixers and loaders supporting aerial applications:
56
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"In addition, mixers and loaders supporting aerial applications must wear:
—Chemical-resistant apron, and
—Respirator (see instructions ** below)
** The following type of respirator is appropriate to mitigate prometryn inhalation
concerns: "A dust/mist filtering respirator (MSHA/NIOSH approval number prefix
TC-21C)."
Actual End-Use Product Personal Protective Equipment Requirements: The PPE that
would otherwise be established based on the acute toxicity of each end-use product
must be compared to the minimum (baseline) personal protective equipment, if any,
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 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:
To assure that such products are not sold to or used by homeowners the following
labeling statement will be required: "For agricultural or commercial use only. Not for use by
homeowners."
(2) Entry Restrictions; Labeling
Sole-active-ingredient end-use products that contain prometryn must be revised to
adopt the entry restrictions set forth in this section. Any conflicting entry restrictions
on their current labeling must be removed.
Multiple-active-ingredient end-use products that contain prometryn must compare
the entry restrictions set forth in this section to the entry restrictions on their current
labeling and retain the more protective. A specific time-period in hours or days is
considered more protective than "sprays have dried" or "dusts have settled."
(3) Occupational-Use Products (Products NOT Intended
Primarily For Homeowner Use):
-Uses Within the Scope of the WPS:
Restricted-Entry Interval: A 24-hour restricted entry interval (REI) is required for
celery and a 12 hour REI is required for all other uses. This REI must be inserted into
the standardized REI statement required by Supplement Three of PR Notice 93-7.
57
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Early-Entry Personal Protective Equipment (PPE): The PPE required for early entry
following applications of prometryn is:
—Coveralls over long-sleeve shirt and long pants,
—Chemical-resistant gloves,
—Shoes plus socks.
Placement in Labeling: The PPE required for early entry must be inserted into the
standardized early entry PPE statement required by Supplement Three of PR Notice
93-7.
—Uses Not Within the Scope of the WPS: All of the registered uses of prometryn are
within the scope of the Worker Protection Standard for Agricultural Pesticides (WPS).
(4) Other Occupational Labeling Requirements
The Agency is requiring the following labeling statements to be located on all end-use
products containing prometryn that are intended primarily for occupational use:
Application Restrictions:
"Do not apply this product in a way that will make contact with workers or other
persons, either directly or through drift. Only protected handlers may be in the area
during application."
Engineering Controls:
x ' ,'••••
"When handlers use closed systems (including water-soluble packets), enclosed cabs,
or aircraft 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."
User Safety Requirements:
"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."
58
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• "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."
Soil Incorporation Statement:
Registrants may add the following statement to their labeling in the
Agricultural Use Requirements box immediately following the restricted entry interval:
"Exception: If the product is soil-incorporated, 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."
b. Other Labeling Requirements
The Agency is requiring the following statements to be located on all prometryn end-
use product labeling:
(1) Environmental Hazard Labeling
"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 when
disposing of equipment washwater or rinsate. Drift and runoff may be hazardous to
aquatic organisms in neighboring areas. Do not apply where runoff is likely to occur.
Do not apply when weather conditions favor drift from treated areas."
(2) Rotational Crops
For Rotational Root Crops:
Labels must specify a Plant back interval (FBI) of 8 months for rotational root
crops.
(3) Spray Drift Labeling
The following language must be placed on each product label that can be applied
aerially:
/
"Avoiding spray drift at the application site is the responsibility of the
applicator. The interaction of many equipment-and-weather-related factors
59
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determine the potential for spray drift. The applicator and the grower are
responsible for considering all these factors when making decisions regarding
spraying." .
The following drift management requirements must be followed to avoid off-target
drift movement from aerial applications to agricultural field crops. These requirements
do not apply to forestry applications, public health uses or to applications using dry
formulations. . .
1. "The. distance of the outer most nozzles on the boom must not exceed 3/4 the
length of the wingspan or rotor."
2. "Nozzles must always point backward parallel with the air stream and never be
, , pointed downwards more than 45 degrees."
More stringent regulations should be observed in the states requiring them.
The applicator should be familiar with and take into account the information covered
in the Aerial Drift Reduction Advisory Information.
The following aerial drift reduction advisory information must be contained in the
product labeling:
[This section is advisory in nature and does not supersede the mandatory label
requirements.]
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to apply large droplets. The
best drift management strategy is to apply the largest droplets that provide
sufficient coverage and control. Applying larger droplets reduces drift
potential, but will not prevent drift if applications are made improperly, or
under unfavorable environmental conditions (see Wind, Temperature and
Humidity, and Temperature Inversions).
CONTROLLING DROPLET SIZE
• Volume - Use high flow rate nozzles to apply the highest practical spray
volume. Nozzles with higher rated flows produce larger droplets.
• Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger droplets.
60
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When higher flow rates are needed, use higher flow rate nozzles instead of
increasing pressure. •
• Number of nozzles - Use the minimum number of nozzles that provide
uniform coverage.
• Nozzle Orientation - Orienting nozzles so that the spray is released
parallel to the airstream produces larger droplets than other orientations and is
the recommended practice. Significant deflection from horizontal will reduce
droplet size and increase drift potential.
• Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce larger
droplets. Consider using low-drift nozzles. Solid stream nozzles oriented
straight back produce the largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective boom length to less than 3/4 of
the wingspan or rotor length may further reduce drift without reducing swath
width.
APPLICATION HEIGHT
Applications should not be made at a height greater than 10 feet above the top
of the largest plants unless a greater height is required for aircraft safety.
Making applications at the lowest height that is safe reduces exposure of
droplets to evaporation and wind.
SWATH AD JUSTMENT
When applications are made with a crosswind, the swath will be displaced
downward. Therefore, on the up and downwind edges of the field, the
applicator must compensate for this displacement by adjusting the path of the
aircraft upwind. Swath adjustment distance should increase, with increasing
drift potential (higher wind, smaller drops, etc.)
WIND
Drift potential is lowest between wind speeds of 2-10 mph. However, many
factors, including droplet size and equipment type determine drift potential at
any given speed. Application should be avoided below 2 mph due to variable
wind direction and high inversion potential. NOTE: Local terrain can
61
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influence wind patterns. Every applicator should be familiar with local wind
patterns and how they affect spray drift.
TEMPERATURE AND HUMIDITY
When making applications in low relative humidity, set up equipment to
produce larger droplets to compensate for evaporation. Droplet evaporation is
most severe when conditions are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a temperature inversion because drift
potential is high. Temperature inversions restrict vertical air mixing, which
causes small suspended droplets to remain in a concentrated cloud. This cloud
can move in unpredictable directions due to the light variable winds common
during inversions. Temperature inversions are characterized by increasing
temperatures with altitude and are common on nights with limited cloud cover
and light to no wind. They begin to form as the sun sets and often continue
into the morning. Their presence can be indicated by ground fog; however, if
fog is not present, inversions can also be identified by the movement of smoke
from a ground source or an aircraft smoke generator. Smoke that layers and
, moves laterally in a concentrated cloud (under Tow wind conditions) indicates
, an inversion, while smoke that moves upward and rapidly dissipates indicates
good vertical air mixing.
: ' ' I . "
SENSITIVE AREAS
The pesticide should only be applied when the potential for drift to adj acent
sensitive areas (e.g. residential areas, bodies of water, known habitat for
threatened or endangered species, non-target crops) is minimal (e.g. when wind
is blowing away from the sensitive areas).
, C. Homeowner Limitation Statement
The following statement must be added to all end-use products: "For agricultural or
commercial use only; not for use by homeowners."
N ' , . i
D. Existing Stocks
Registrants may generally distribute and sell products'bearing old labels/labeling for
26 months from the date of the issuance of this Reregistration 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
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-------
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 prometryn 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.
63
-------
-------
VI. APPENDICES
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case prometryn covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to prometryn 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 R.oyal 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
O 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.
80
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GUIDE TO APPENDIX C
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 Reregistration 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.
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.
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.
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
92
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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. .
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.
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.
93
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BIBLIOGRAPHY
MRID
CITATION
00023213 Muller, P.W.; Payot, P.H, (1966) Fate of 14C-Labelled Triazine herbicides in
plants. Pages 61-70,~In~Isotopes Weed Research: Proceedings of IAEA
Symposium; 1965-66, Vienna, Austria. N.P. (Also~In~unpublished
submission received Jul 1, 1971 under unknown admin, no.; submitted by Shell
Chemical Co., Washington, D.C.; CDL:221995-R)
00023280 Mattson, A.M.; Solga, J. (1966) The Determination of Atrazine, Simazine and
Prometryne in Cow's Milk by Gas Chromatography. Method dated Nov 11,
1966. (Unpublished study received Jul 15, 1968 under 7F5034; submitted by
Geigy Chemical Co., Ardsley, N.Y.; CDL:092912-A).
00023963 Burkhard, N. (1976) Project Report 17/76: Hydrolysis of 2-Chloroand
2-Methylthio-4,6-bis-(alkylamino)-s-triazines under Laboratory Conditions.
(Unpublished study received Apr 27, 1977 under 100-588; prepared by
Ciba-Geigy, Ltd., submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:229641-A) '
00024378 Best, J.A.; Weber, J.B.; Monaco, T.J. (1975) Influence of soil pH on Triazine
availability to plants. Weed Science 23(5): 378-382. (Also-rln-unpublished
submission received Jul 19, 1978 under 201-403; submitted by Shell Chemical
Co., Washington, D.C.; CDL:234470-AD)
00024668 Ross, J.; Balu, K.; Maher, J. (1976) Laboratory Report: ProjectNo. 101904.
(Unpublished study received Dec 29, 1976 under 6E1725; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 095644-B)
00024696 Richardson, C.; Nalewaja, J.D.; Buchholtz, K.P.; et al. (1964)
Atrazine/Prometryne Residues—Corn: AG-A 540. (Unpublished study
including AG-A 565, AG-A 586, AG-A 644..., received May 26, 1967 under
100-492; prepared in cooperation with North Dakota State Univ., Dept. of
Agronomy and others, submitted by CibaGeigy Corp., Greensboro, N.C.;
CDL:000510-B) "
00027329 Holstun, J.T., Jr.; Frans, R.E.; Hazlewood, B.P.; et al. (1969) Summary of
Cotton Residue Data. (Unpublished study received Nov 27, 1970 under
100-471; prepared in cooperation with U.S. Agricultural Research Service,
Crops Research Div., Delta Branch Experiment Station and others, submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000464-B)
94
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BIBLIOGRAPHY
MRID
CITATION
00027330
00034043
00042794
00055672
00056556
00060314
00060316
00060647
Gemma, A. (1970) Determination of Prometryne, G-11354, and GS26831
Residues in Cotton and Soybeans by Gas Chromatography. Method No.
AG-150 dated Oct29, 1970. (Unpublished study received Dec 12, 1970 under
100-471; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:000464-C)
Motko, L.; Alamo, A.; Agamalian, H. (1966) Residue Data Summary,
(Unpublished study received Dec 11, 1972 under 100-471; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:000468-C)
Woodard, M.W.; Cockrell, K.O.; Lobdell, B.I; et al. (1965) Prometryne Safety
Evaluation by Oral Administration to Rats for 104 Weeks arid to Dogs for 106
Weeks. (Unpublished study received Oct 7, 1977 under 100-566; prepared by
Woodard Research Corp., submitted by Ciba-Geigy Corp., Greensboro N C •
CDL:231965-C)
Ciba-Geigy Chemical Corporation (1971) Metabolism of s-Triazine Herbicides.
(Unpublished study including letter dated Dec 29, 1971 from J.R Forsythe to
Harold G. Alford, received Dec 29, 1971 under 100-437; CDL:231915-A)
Ciba-Geigy Corporation (1975) Residue Data-Tolban in Cotton. (Compilation;
unpublished study received Apr 29, 1976 under 100523; CDL:224722-A)
, , . - ' • ., ' f . •
Kapp, R.W. (1975) Final Report: Acute Oral Toxicity Study in Rats: Project
No. M915-106. (Unpublished study received Dec 19, 1977 under 33660-5;
prepared by Hazleton Laboratories America, Inc., submitted by Industria
Prodotti Chimici, S.pA., Novate Milanese, Italy; CDL:232506-A)
Kapp, R.W. (1975) Final Report: Primary Skin Irritation Study in Rabbits:
Project No. 915-105. (Unpublished study received Dec 19, 1977 under
33660-5; prepared by Hazleton Laboratories America, Inc., submitted by
Industria Prodotti Chimici, S.p.A, Novate Milanese, Italy; CDL:232506-C)
Sachsse, K.; Bathe, R. (1976) Acute Dermal LDs50- in the Rat of Technical G
34161: Project No. Siss 5662. (Unpublished study received Dec 29, 1977
under 100-542; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by .
Ciba-Geigy Corp., Greensboro, N.C.; CDL:232550-H)
95
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BIBLIOGRAPHY
MRID
CITATION
00065048 Ciba-Geigy Corporation (1981) Residue Tests with Cotton. (Compilation;
unpublished study received Apr 28, 1981 under 100-597; CDL:070049-B)
00070146 " Vilkas, A.G. (1977) Acute Toxicity of Prometryn-FL-761355 to the Water
Flea (Daphnia magnaStraus): UCES Proj. # 11506-04-04. (Unpublished study
received Dec 29, 1977 under 100-542; prepared by Union Carbide Corp.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:232551-D)
00070686 Beliles, R.P.; Scott, W.; Knott, W. (1965) Prometryne: Safety Evaluation on
Fish and Wildlife (Bobwhite Quail, Mallard Ducks, Rainbow Trout, Sunfish,
Goldfish). (Unpublished study received Dec 29, 1977 under 100-542; prepared
by Woodard Research Corp., submitted by Ciba-Geigy Corp., Greensboro,
N.C.;CDL:232551-B)
00082966 Fink, R.; Beavers, J.B.; Brown, R. (1977) Final Report: Acute Oral
LD50~Mallard Duck: Project No. 108-131. (Unpublished study received Dec
29,1977 under 100-542; prepared by Wildlife International Ltd. and
Washington College, submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:232551-C)
00093530 Geigy Chemical Company (1964) Analyses for Prometryne Residues in Corn.
(Compilation; unpublished study, including AG-A nos. 492, 622, 645...,
received Oct 8, 1966 under 7F0559; CDL: 090699-B)
00093 531 Geigy Chemical Company (1966) Analyses for Prometryne Residues in Cotton.
(Compilation; unpublished study, including AG-A nos. 310, 315, 316...,
received Oct 8, 1966 under 7F0559; CDL: 090699-C)
00093535 Geigy Chemical Company (1966) Determination of Prometryne and
Hydroxy-propazine in Milk of Dairy Cows Fed Prometryne in Rations.
Includes method dated Nov 10, 1966. (Compilation; unpublished study,
including AG-A 970, received on unknown date under 7F0559;
CDL-.090699-I)
00093536 Mattson, AM.; Solga, J.; Motko, L. (1966) Determination of Residues in Body
Tissues of Sheep and Cattle Receiving Prometryne in the Diet. (Unpublished
study, including AG-A 969, received on unknown date under 7F0559;
submitted by Geigy Chemical Co., Ardsley, N.Y.; CDL:090699-J)
96
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BIBLIOGRAPHY
MRID
CITATION
00093542
00093546
00093548
00105780
00106358
00106481
00106829
00115783
00121155
Colby, S.R.; Harris, C.I. (1965) Atrazine-prometryne Combinations: Herbicidal
Activity, Fate in Corn, and Soil Persistence. (Unpublished study received Apr
14, 1967 under 7F0525; prepared by Univ. of Maryland, Agronomy Dept in
cooperation with U.S. Agricultural Research Service, Crops Research Div.,
submitted by Geigy Agricultural Chemicals, Yonkers, N.Y.; CDL:090703-B)
Geigy Chemical Company (1964) Analyses for Prometryne Residues in Celery.
(Compilation; unpublished study, including AG-A nos. 352, 424, 598...,
received Jan 12, 1965 under 7F0559; CDL: 090701-E)
Geigy Chemical Company (1964) Analyses for Prometryne Residues in
Cabbage and Celery. (Compilation; unpublished study, including AG-A nos.
680 and 598, received Dec 1, 1964 under 7F0559; CDL: 090702-C)
Blanco Product Co. (1977) Treflan EC Plus Caparol SOW Tank-mix Preplant
Soil Incorporated on Cotton in California, Arizona, New Mexico and Texas.
(Compilation; unpublished study received Aug 2, 1977 under 1471-35-
CDL:230951-A)
United States Borax Research Corp. (1977) Residues of Cobex (Dinitramine)
Caparol (Prometryn) in Cotton. (Compilation; unpublished study received Aug
11, 1977 under 7F1997; CDL: 096307-B) -
1 ' ' • '
Ciba-Geigy Corp. (1975) Sequential and Tank Mix Applications of Tolban 4E
Plus Caparol SOW and Tolban Plus Cotoran 80WP in Cotton: Residue Data:
GAAC-75006. (Compilation; unpublished study received Apr 29 1976 under
100-523; CDL:225279-A)
American Cyanamid Co. (1978) Residues of Prowl Herbicide. (Compilation;
unpublished study received Aug 14, 1979 under 241-243; CDL'238944-B-
241020)
Ciba-Geigy Corp. (1971) Study: Prometryne Residue in Selected Crops.
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00125013 Whitenberg, D. (1962?) Metabolism of Prometryne by Cotton Plants.
(Unpublished study received Dec 3, 1963 under unknown admin, no.; prepared
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00125015 Interregional Research Project No. 4 (1979) Prometryn Residue Tolerance
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9E2261; CDL:240975-A)
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40457515
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40457518
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100
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41842502 Fleischmann, T. (1991) Prometryn: Addendum I to (.. .) Uptake and
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Texas: A Supplement: Lab Project Number: 1641-88-71-16-11B-13: 8808A.
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42253904 Fleming, P. (1992) Caparol 4L Field Dissipation Terrestrial on Bare Ground in
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T-1268. Unpublished study prepared by Product Safety Labs. 31 p.
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~ Metabolites in Cottonseed and Celery under Freezer Storage Conditions for
Two Years: Lab Project Number: ABR-92015. Unpublished study prepared by
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Laemna gibba G3: Lab Project Number: B267-577-4. Unpublished study
prepared by Malcolm Pirnie, Inc. 36 p.
42520902 Hughes, J.; Alexander, M. (1992) The Toxicity of Prometryn Technical to
Anabaena flos-aquae: Lab Project Number: B267-577-1. Unpublished study
prepared by Malcolm Pirnie, Inc. 38 p.
42520903 Hughes, J. (1987) The Toxicity of Prometryn Technical to Slenastrum
Capricornutum: Lab Project Number: 0267-38-1100-1. Unpublished study
prepared by Malcolm Pirnie, Inc. 73 p.
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Ingredients, Description of Beginning Materials and Manufacturing Process,
and Discussion on the Formation of Impurities: Lab Project Number: 92-4.
Unpublished study prepared by Agan Chemical Manufacturers, Ltd. 72 p.
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Prometrex (Vapor Pressure, Stability, and Corrosion Characteristics): Lab
Project No. 6443-100. Unpublished study prepared by Hazleton Wisconsin,
Inc. 55 p.
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Proj ect Number: 76. Unpublished study prepared by Analyst Ltd. 29 p.
i. • / ' . . •
42579104 Pesselman, R. (1992) Storage Stability of Prometrex: Interim Report: Lab
Proj ect Number: 6443-101. Unpublished study prepared by Hazleton
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Methods to Verify Certified Limits of Six Lots of Prometrex Technical: Lab
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Metabolites GS-11354 and GS-26831 in Cotton and Rotational Wheat and
Barley Following Application of Caparol 4L: Lab Project Number:
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109
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
AUG ! 5 1996
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MATT,
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 m 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 TH-B); or
3. Why you believe EPA should not require your submission of data in the
manner specified by this Notice (see section ITJ-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 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FTJFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
110
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information is authorized under the Paperwork Reduction Act by OMB Approval No.
2070-0107 and 2070-0057 (expiration date 3-31-96). ,
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
Section n .
Section HI
Section IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this Notice
Registrants' Obligation to Report Possible Unreasonable Adverse
Effects
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 Reregistration
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
revaluation 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 n. DATA REQUIRED BY THIS NOTICE
/ • . i '
n-A. DATA REQUIRED
r '
" 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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n-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.
n-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, Va22161 (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].
n-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcV2XB) 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-InfsX 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 HI.
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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m-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.
m-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 ffl-C. A discussion of options relating to requests for data waiversis
contained in Section ni-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 registrations). 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
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Data Call-In Response Forms (Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-In Response Formes! 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
requirements, 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 requirement 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 qualify and
continue to qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify,
all of the following requirements 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 requirements of this Notice
and must remain in compliance; and
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(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.
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 ffi-C.1. 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 ffl-D. 1. 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) requesta data waiver(s).
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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 EI-C.2. A discussion of
options relating to requests for data waivers is contained in Section IH-D.2.
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 ni-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 requirements 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
requirements differ slightly from those options for fulfilling generic data requirements.
Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements. It is important to ensure that you are using the correct
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forms and. instructions when completing your response to the Reregistration Eligibility
Decision document.
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.
ni-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 CFRPart 160), be conducted according to the Pesticide Assessment Guidelines (PAG)
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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
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 n-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.
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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
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
registrations), 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.
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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
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 data1 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
Reregistration 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
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according to the PAG may be submitted to the Agency for consideration if the
registrant believes mat 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
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.
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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.
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 wrth 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
Forni 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)
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(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 — The requirements for developing product specific data are the
same as those described for generic data (see Section IH.C.l, Option i) 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
m.C. 1, 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 arid 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. ,
acute
Option 3. Offer to Share in the Cost of Data Development -The same requirements for
generic data (Section ffl.C.I., Option 3) apply to this option. This option only applies to
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 IH.C.1., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see
Section m.C.1., Option 5) apply to this option for product specific data.
V
Option 6. Citing Existing Studies ~ The same requirements described for generic data (see
Section m.C.I., 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 (ULC.l.), as appropriate.
m-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 requirements) are not appropriate for your product.
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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
requiririg data for low volume, minor use pesticides. In implementing this provision,
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 produces), 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 arid marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and
equipment) charged to produces) 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
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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
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 produces) 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 produces) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
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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 produces! 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
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 y^waiver request,
you will not be required to supply the data pursuant to section 3(c)(2)(B) ol JMtKA. Ji
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 Response Form. Product specific data requirements for product
chemistry, acute toxiciry 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 TNTENT TO SUSPEND
The Agency may issue aNotice 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.
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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
. 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 j oint 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 IH-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.
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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.
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.
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If you request a voluntary cancellation of your produces) 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
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.
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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
Reregistration Division
Attachments
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 Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7- Confidential Statement of Formula. Cost Share and Data Compensation Forms
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PROMETRYN DATA CALE-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have product(s)
containing prometryn.
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 reregistration of
prometryn. 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 prometryn 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 prometryn are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on prometryn 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 reregistration of all eligible prometryn products.
INQUIRIES AND RESPONSES TO THIS NOTICE
r1—
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Jean Holmes at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Jean Holmes
Chemical Review Manager Team 81
. Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC. 20460
RE: prometryn .
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PROMETRYN DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing prometryn.
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 reregistration of prometryn.
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
Registrants 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 prometryn 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 prometryn
are contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional product chemistry data on prometryn are needed. These data are
needed to fully complete the reregistration of all eligible prometryn products.
INQUIRIES AMD RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Mario F. Fiol at (703) 308-8049.
All responsades to this Notice for the generic data requirements should be submitted to:
* >'"''''..
Mario F. Fiol, Chemical Review Manager
Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: prometryn
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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 Reregistration 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 and recordkeeping burden for this collection of information is
estimated to average 75 minutes per response annually. Burden means the total time, effort,
or financial resources expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to respond to a collection
of information; search data sources; complete and review the collection of information; and
transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number. .
Send comments on the Agency's need for this information, the accuracy of the
provided burden estimates, and any suggested methods for minimizing respondent burden,
including through the use of automated collection techniques to the Director, OPPE
Regulatory Information Division, U.S. Environmental Protection Agency (2136), 401 M St.,
S.W., Washington, D.C. 20460. Include the OMB control number in any correspondence.
Do not send the completed/orm to this address.
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DESTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
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.
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
134
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are registered), you may not claim a Generic Data Exemption and you may not
j 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
f — • - cr" "—' f ' _ " ••
requirements.
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
ItemVa. 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."
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.
135
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
ItemS. 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.
i '
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 mis
product. For these cases, please supply all relevant details so that EPA can ensure that its records are correct
136
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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
i . •
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 reregistration 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 and recordkeeping burden for this collection of information is
estimated to average 30 minutes per response annually. Burden means the total time, effort,
or financial resources expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to respond to a collection
of information; search data sources; complete and review the collection of information; and
transmit or otherwise disclose the information. An agency may not conductor sponsor, and a
person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number.
Send comments on the Agency's need for this information, the accuracy of the
provided burden estimates, and any suggested methods for minimizing respondent burden,
137
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including through the use of automated collection techniques to the Director, OPPE
Regulatory Information Division, U.S. Environmental Protection Agency (2136), 401 M St.,
S.W., Washington, D.C. 20460. Include the OMB control number in any correspondence.
Do not send the completed^?77K to this address.
138
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
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. /
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.
Item3. 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, Subpartc.
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 in 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.
139
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
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
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
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade Active
Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
140
-------
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
t '
TGAI/TEP
MET
IMP
DEGR
Typical End-Use Product or Pure Active Ingredient and
Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient
Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
Technical Grade Active Ingredient or Typical End-Use
Product
Metabolites .
Impurities
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.
1 - * .„.-,'••'
ON THE GENERIC DATA FORM: The time frame runs from the date of
•your receipt of the Data Call-In notice.
? /. .,--•. , ''
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 Reregistration 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!. 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 Share) 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.
141
-------
However, for Product Specific Data, I understand that this
option is available for acute tbxicity 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.
Options. 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.
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: CSubmittine 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 Studv> 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 Studv^ I am citing an existing study
that has been previously classified by EPA as acceptable, core, core
142
-------
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.
Option 8. (Low Volume/Minor Use Waiver Request) 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
hot 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.
143
-------
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 Request) 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.
I'
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.
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
144
-------
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THE EPA'S BATCHING OF PRODUCTS CONTAINING PROMETRYN AS THE ACTIVE
INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products, containing the active ingredient
Prometryn (2,4-Bis(isopropylamino)-(methylthio)-s-triazine), the Agency has batched
products that can be considered similar in terms 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., liquid, powder, aerosol,
granular, etc.), and labeling (e.g., signal word, 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 if the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by the 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 it's 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 that 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
145
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Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study
(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.
Table 1 displays the batches for the active ingredient Prometryn. Although reg. no.
34707-692 is placed into batch #3, the registrant must cite or submit an acute inhalation
toxicity study conducted on 34704-692 to support this product.
'i
Table 1.
Batch No.
1
2
3
Registration Number
100-542
46386-2
100-757
66222-14
100-620
1812-274
9779-297
10163-94
34704-69.2
66222-15
AZ89001900
Percent Active Ingredient
prometryn ... 97.0%
prometryn ... 95.0%
prometryn ... 80.0%
prometryn ... 80.0%
prometryn ... 44.4%
prometryn ... 45.41%
prometryn ... 44.4%
prometryn ... 44.4%
prometryn ... 44.4%
prometryn ... 44.0%
prometryn ... 44.4%
Form
powder
powder
powder
powder
liquid
liquid
liquid
liquid
liquid
liquid
liquid
Table 2 lists the products the Agency was unable to batch. This product was
considered not to be similar to other products for purposes of acute toxicity or the Agency
lacked sufficient information for decision making. The registrants of these products are
responsible for meeting the acute toxicity data requirements for these products.
146
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Table 2
EPA Reg. No.
100-495
1812-349
9779-3.17
CA9100020
Active Ingredient
prometryn • ... 8.4%
monosodium acid methanearsonate ... 33.6%
prometryn ... 80.0%
prometryn ... 8.4%
monosodium acid methanearsonate ... 33.6%
unknown
Formulation Type
liquid
powder
liquid
unknown
147
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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.
, ,' . • f
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. .
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151
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United States Environmental Protection Agency
f^ FT%JV Washington, DC 20460
feMtfr^r^LA CERTIFICATION OF OFFER TO COST
\^|M| M\ SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-01 OS
2070-0057
Approval Explras 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 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 PM-223. 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
Product Name
EPA Reg- No.
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
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 firm(s) on the following
date(s):
Nama of Firm(s)
Certification;
Date of Offer
certify that I am duly authorized to represent the company named above, and that the statements that 1 have made on
this form and all attachments therein are true, accurate, and complete. 1 acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Rapr**tntaliv*
Dal*
Nam* and TIU« (Ptease Typ« or Print)
F.PA Form 8570-32 (S/91) Replaces EPA Form 8580, which Is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2O70-OW7,
2070-0057
Approval Expires
3-31-96
ublic reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
viewing instructions searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
llection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
eluding suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
gency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
070-0106), Washington, DC 20503.
ease fill in blanks below.
ompanyName ,
- ' /
roductName
' - ' '.'•'','.•
Company- Number
EPA Reg. No.
Certify that:
For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
:IFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
ata submitter to cite that study.
That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
riqinal data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
ompany(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
squirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
t ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
tequirements Status and Registrants' Response Form,"
That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
sregistration under FIFRA.
ignature
Date
lame and Title (Please Type or Print)
fcENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
Registration of my products, to the extent required by FIFRA section 3(c)(1)(F) and3(c)(2)(D).
Ignature
Date
lame and Title (Please Type or Print)
iForm 8570-31 (4-96)
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APPENDIX E - LIST OF AVAILABLE RELATED DOCUMENTS
The following is a list of available documents for prometryn that may further assist you in
responding to this Reregistration 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 Reregistration 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 Jean Holmes at (703)-308-8008.
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 prometryn.
The following documents are part of the Administrative Record for prometryn 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
156
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