United States Prevention, Pesticides EPA 738-R-00-006
Environmental Protection And Toxic Substances August 2000
Agency (7508C)
Interim Reregistration
E|jgibj|ity Decision (IRED)
Profenofos
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UNITED ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C.,
OFFICE OF
PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES
MEMORANDUM
DATE: July 31,2006
SUBJECT: Finalization of Interim Reregi strati on Eligibility Decisions (IREDs) and Interim
Tolerance Reassessment and Risk Management Decisions (TREDs) for the
Organophosphate Pesticides, and Completion of the Tolerance Reassessment and
Reregi strati on Eligibility Process for the Organophosphate Pesticides
FROM: Debra Edwards, Director
Special Review and Reregi strati on Division
Office of Pesticide Programs
TO: Jim Jones, Director
Office of Pesticide Programs
As you know, EPA has completed its assessment of the cumulative risks from the
Organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of
1996. In addition, the individual OPs have also been subject to review through the individual-
chemical review process. The Agency's review of individual OPs has resulted in the issuance of
Interim Reregi strati on Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance
Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregi strati on
Eligibility Decision (RED) for one OP, malathion.l These 31 OPs are listed in Appendix A.
EPA has concluded, after completing its assessment of the cumulative risks associated
with exposures to all of the OPs, that:
(1) the pesticides covered by the IREDs that were pending the results of the OP
cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and
Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion,
rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative
assessment.
Page 1 of 3
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(2) the pesticide tolerances covered by the IREDs and TREDs that were pending the
results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under
Section 408(b)(2) of the FFDCA.
Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance
reassessment and FIFRA reregi strati on, other than product-specific reregi strati on.
The Special Review and Reregi strati on Division will be issuing data call-in notices for
confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in
the OP cumulative assessment. The specific studies that will be required are:
- 28-day repeated-dose toxicity study with methidathion oxon; and
- Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone
in both source water (at the intake) and treated water for five community water
systems in Palm Beach County, Florida and two near Lake Okechobee, Florida.
The cumulative risk assessment and supporting documents are available on the Agency's website
at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618).
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Attachment A:
Organophosphates included in the OP Cumulative Assessment
Chemical
Acephate
Azinphos-methyl (AZM)
Bensulide
Cadusafos
Chlorethoxyphos
Chlorpyrifos
Coumaphos
DDVP (Dichlorvos)
Diazinon
Dicrotophos
Dimethoate
Disulfoton
Ethoprop
Fenitrothion
Malathion
Methamidophos
Methidathion
Methyl Parathion
Naled
Oxydemeton-methyl
Phorate
Phosalone
Phosmet
Phostebupirim
Pirimiphos-methyl
Profenofos
Propetamphos
Terbufos
Tetrachlorvinphos
Tribufos
Trichlorfon
Decision Document
IRED
IRED
IRED
TRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
RED
IRED
IRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
IRED
IRED
IRED
IRED
TRED
IRED
TRED
Status
IRED completed 9/2001
IRED completed 10/2001
IRED completed 9/2000
TRED completed 9/2000
TRED completed 9/2000
IRED completed 9/2001
TRED completed 2/2000
IRED completed 6/2006
IRED completed 7/2002
IRED completed 4/2002
IRED completed 6/2006
IRED completed 3/2002
IRED completed 9/2001
IRED addendum completed 2/2006
TRED completed 10/2000
RED completed 8/2006
IRED completed 4/2002
IRED completed 4/2002
IRED completed 5/2003
IRED completed 1/2002
IRED completed 8/2002
IRED completed 3/2001
TRED completed 1/2001
IRED completed 10/2001
TRED completed 12/2000
IRED completed 6/2001
IRED completed 9/2000
IRED completed 12/2000
IRED completed 9/2001
TRED completed 12/2002
IRED completed 12/2000
TRED completed 9/2001
Page 3 of 3
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-**~ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or
the Agency) has completed its review of the available data, as well as the public comments received on
the preliminary and revised risk assessments), for the organophosphate (OP) pesticide profenofos. In
reaching this decision point on profenofos, EPA has employed a pilot public participation process
developed by the Tolerance Reassessment Advisory Committee (TRAC) to increase public
involvement and improve the transparency of the reregistation and tolerance reassessment processes.
The Agency successfully implemented the six phase pilot process during its review of
profenofos. The pilot public participation process afforded multiple opportunities for public comment
on the Agency's risk assessments, including a Technical Briefing presentation to the general public on
June 16, 1999. The final formal comment period, which closed on August 16, 1999, invited interested
parties to participate and provide suggestions on ways the Agency might mitigate the estimated risks
presented in the revised risk assessments.
After reviewing the comments received during the public comment periods and reviewing the
available data received from the registrant and other sources, a number of risk mitigation measures
were identified that the Agency believes are necessary to address the human health and environmental
risks associated with the current use of profenofos. EPA is now publishing its interim reregistation
eligibility and risk management decision for the current uses of profenofos and the associated human
health and environmental risks. The tolerance reassessment decision for profenofos will be finalized
once the cumulative assessment for all of the organophosphate pesticides is complete. The Agency's
decision on the individual chemical profenofos can be found in the attached document entitled, "Interim
Reregistation Eligibility Decision for Profenofos.
A Notice of Availability for this interim Reregistation Eligibility Decision for Profenofos is
published in the Federal Register. To obtain a copy of the interim RED document, please contact the
Pesticide Docket, Public Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone (703)
305-5805. Electronic copies of the interim RED and all supporting documents are available on the
Internet. See http://www.epa.gov/oppsrrdl/op/.
The interim RED is based on the updated technical information found in the profenofos public
docket. The docket not only includes background information and comments on the Agency's
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preliminary risk assessments, it also now includes the Agency's revised risk assessments for profenofos
(revised as of June 16, 1999 and updated in March 2000), teleconference notes, and documents
summarizing the Agency's Response to Comments. The Response to Comments document addresses
corrections to the preliminary risk assessments submitted by chemical registrants, as well as responds to
comments submitted by the general public and stakeholders during the comment period on the risk
assessment. The docket will also include comments on the revised risk assessment, and any risk
mitigation proposals submitted during Phase 5.
This document and the process used to develop it are the result of a pilot process to facilitate
greater public involvement and participation in the reregistration and/or tolerance reassessment
decisions for these pesticides. As part of the Agency's effort to involve the public in the implementation
of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to
maintain open public dockets on the organophosphate pesticides and to engage the public in the
reregistration and tolerance reassessment processes for these chemicals. This open process follows the
guidance developed by the (TRAC), a large multi-stakeholder advisory body which advised the
Agency on implementing the new provisions of the FQPA. The reregistration and tolerance
reassessment reviews for the organophosphate pesticides are following this pilot process.
Please note that the profenofos risk assessment and the attached interim RED concern only this
particular organophosphate. This interim RED is the Agency's final reregistration decision except for
the decision on tolerance reassessment. Because the FQPA directs the Agency to consider available
information on the basis of cumulative risk from substances sharing a common mechanism of toxicity,
such as the toxicity expressed by the organophosphates through a common biochemical interaction with
cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire
organophosphate class of chemicals after completing the risk assessments for the individual
organophosphates. The Agency is working towards completion of a methodology to assess cumulative
risk and the individual risk assessments for each organophosphate are likely to be necessary elements
of any cumulative assessment. The Agency has decided to move forward with individual assessments
and to identify mitigation measures necessary to address those human health and environmental risks
that have already been attributed to current uses of profenofos. The Agency will issue the final
tolerance reassessment decision for profenofos once the cumulative assessment for all of the
organophosphates is complete.
End-use product labels must be revised by the manufacturer to adopt the changes set forth in
Section IV. of this document. Instructions for registrants on submitting revised labeling and the time
frame established to do so can be found in Section V of this document.
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If you have questions on this document or the proposed label changes, please contact the
Special Review and Reregistration Division representative, Carmelita White at (703) 308-7038.
Lois A. Rossi, Director
Special Review and
Reregistration Division
Enclosure
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Interim Reregistration Eligibility
Decision
for
Profenofos
Case No. 2540
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TABLE OF CONTENTS
Profenofos Team i
Glossary of Terms and Abbreviations iii
Executive Summary 1
I. Introduction 5
II. Chemical Overview 7
A. Regulatory History 7
B. Chemical Identification 7
C. Use Profile 8
D. Estimated Usage of Pesticide 9
III. Summary of Profenofos Risk Assessment 9
A. Human Health Risk Assessment 10
1. Dietary Risk (food) 11
a. Dietary Risk from Food (Acute) 12
b. Dietary Risk from Food (Chronic) 13
2. Dietary Risk (Drinking Water) 13
a. Surface Water 14
b. Ground Water 14
c. Drinking Water Levels of Comparison 14
B. Residential Risk 15
C. Aggregate Risk 15
D. Occupational Risk 15
E. Environmental Risk Assessment 19
1. Environmental Fate and Transport 19
2. Ecological Risk Assessment Analysis 20
a. Nontarget Terrestrial Animal Risk 20
b. Nontarget Aquatic Animal Risk 21
F. Assessment of the Use of Profenofos 22
1. Use Patterns 22
2. Alternatives 23
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IV. Interim Risk Management Reregistration Eligibility Decision 24
A. Interim Determination of Reregistration Eligibility 24
1. Summary of Phase 5 Comments and Responses 26
2. Basis for Interim Eligibility Determination 26
B. Tolerance Summary 27
C. Endocrine Disrupter Effects 28
D. Regulatory Position 29
E. Human Health Risk Mitigation 31
1. Mitigation Measures 31
a. Dietary (food) 31
b. Dietary (water) 31
c. Residential and Other Non-Occupational Risks 32
d. Aggregate (food and water) 32
e. Occupational Risk Mitigation 32
F. Ecological Risk Mitigation 36
1. Aquatic Animals 36
2. Nontarget Terrestrial Organisms 37
3. Mitigation Measures 37
a. Aquatic animals 37
b. Birds and Mammals 38
c. Additional Measures 38
4. Other Options Considered 39
5. Other Labeling Requirements 39
a. Endangered Species Statement 39
b. Spray Drift Management 39
V. What Registrant Must Do 40
A. Manufacturing-Use Products 40
1. Additional Generic Data Requirements 40
2. Labeling Requirements for Manufacturing-Use Products 40
B. End-Use Products 41
1. Additional Product-Specific Data Requirements 41
2. Labeling Requirements for End-Use Products 41
C. Existing Stocks 41
D. Required Labeling Changes Summary Table 43
VI. Related Documents and How to Access Them 50
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VII. APPENDICES 51
A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION 53
B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES
USED TO MAKE THE REREGISTRATION DECISION 55
C. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY) 65
D. GENERIC DATA CALL-IN 83
E. PRODUCT SPECIFIC DATA CALL-IN 89
F. LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN 95
G. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 97
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Profenofos Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Richard Griffin
Alan Nielsen
Pauline Wagner
Environmental Fate (Drinking Water and Ecological^ Risk Assessment
Nelson Thurman
Dana Spatz
Use and Usage Analysis
Neil Anderson
Timothy Kiely
Registration Support
Marilyn Mautz
Risk Management
Carmelita White
Michael McDavit
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Glossary of Terms and Abbreviations
ADI Acceptable Daily Intake. A now defunct term for reference dose (RiD).
AE Acid Equivalent
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
ORES 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, noncarcinogenic health effects are not anticipated to occur.
DWLOC Drinking Water Level of Comparison
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial
ecosystem.
EPA U.S. Environmental Protection Agency
EUP End-Use Product
FAO Food and Agriculture Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory. 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.
LEL Lowest Effect Level
LOC Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
LOAEL Lowest Observed Adverse 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.
|ig/g Micrograms Per Gram
ug/L Micrograms Per Liter
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Glossary of Terms and Abbreviations
mg/L Milligrams Per Liter
MOE Margin of Exposure
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
N/A Not Applicable
NRCS Natural Resource Conservation Service
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa Pascal, the pressure exerted by a force of one newton acting on an area of one square meter
PAD Population Adjusted Dose
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Database
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q!* 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
RiD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 © of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions
UF Uncertainty Factor
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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Executive Summary
EPA has completed its review of public comments on the revised risk assessments and is
issuing its risk management decisions for profenofos. The decisions outlined in this document do not
include the final tolerance reassessment decision for profenofos. However, some tolerance actions will
be undertaken prior to completion of the final tolerance reassessment. One tolerance will be modified
and nine other tolerances will be revoked. The final tolerance reassessment decision for this chemical
will be issued once the cumulative assessment for all of the organophosphates is complete. The Agency
may need to pursue further risk management measures for profenofos once the cumulative assessment
is finalized.
The revised risk assessments are based on review of the required target data base supporting
the use patterns of currently registered products and new information received. The Agency invited
stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before the
Agency issued this risk mitigation decision on profenofos. After considering the revised risks, as well as
consultation with Novartis Crop Protection, Inc., the technical registrant of profenofos, and comments
and mitigation suggestions from other interested parties including the National Cotton Council, National
Alliance of Independent Crop Consultants, and several certified crop advisors, EPA developed its risk
management decision for uses of profenofos that pose risks of concern. This document details these
activities and discusses the actions necessary to reduce the risks identified in the risk assessment for the
purpose of reregistration.
Profenofos is an organophosphate insecticide/miticide used solely on cotton. It was first
registered in the United States in 1982. There are about 775,000 pounds (Ibs.) active ingredient (ai)
applied to cotton each year. Profenofos, a "restricted use" pesticide, is used to control tobacco
budworm, cotton bollworm, armyworm, cotton aphid, whiteflies, spider mites, plant bugs, and
fleahoppers. An estimated 85% of all profenofos is used for the control of lepidopteran species (the
worm complex) at varying rates. About 30% of this use is aimed at controlling the worm complex at
the current maximum label rate of 1 Ib. ai/Acre. Other pests are usually controlled at lower rates.
Human Health Risk
The profenofos risk assessments are based on its potential to cause cholinesterase inhibition.
The Agency's human health risk assessment for profenofos indicates that there are no concerns for
dietary risk from food and water. Dietary risks (food) do not exceed 8% of the acute PAD while
chronic risks (food) do not exceed 20% of the chronic PAD. Neither acute nor chronic drinking water
risk exceed the Agency's level of concern based on a drinking water level of comparison assessment
(DWLOC). Because there are no residential uses of profenofos, aggregate risk is based only on
dietary (food and water) exposures. In short, aggregate risk does not exceed the Agency's level of
concern.
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The human health risk assessment for profenofos indicates that there are concerns for
occupational mixers/loaders and applicators and Saggers involved in groundboom and aerial
applications and for reentry personnel following application. Margins of Exposure (MOE) of less than
100 for dermal and less than 300 for inhalation are of concern for occupational exposures. All
inhalation exposure MOEs greatly exceed 300 and therefore do not contribute appreciably to
occupational risks. Two of five occupational dermal handler scenarios produce MOEs less than 100
even when assuming the use of engineering controls (closed systems for mixer/loaders for aerial
application, and enclosed cockpits for aerial applicators). The MOEs for aerial mixers/loaders and
applicators were 23 and 40, respectively, even with the use of engineering controls for short and
intermediate term dermal exposure. MOEs for mixers/loaders and applicators involved in groundboom
applications and for flaggers supporting aerial applications ranged from 101 to over 1,000 and,
therefore, do not exceed the Agency's level of concern.
Postapplication worker risk estimates were calculated from registrant submitted studies on
dislodgeable foliar residue dissipation and scout and hoer monitoring exposure. The studies measured
both inhalation and dermal exposure. Using these data, the Agency calculates that under the present
assumptions and use rates, the restricted entry interval (REI) for workers who reenter treated fields to
perform routine hand labor activities should be 48 hours, and 72 hours in arid regions that receive less
than 25" of annual rainfall. Certified crop advisors and their employees currently have an exemption
from the WPS requirements. The Agency is concerned that crop advisors performing scouting
activities could be at risk when spending extended periods in treated cotton fields during the REI. The
Agency is requiring an advisory on the label to alert handlers of the protective measures that should be
taken when reentering treated fields to perform scouting and hoeing tasks to minimize risks.
Environmental Fate and Ecological Risk
In addition to considering the human health effects associated with exposure to profenofos, the
Agency assessed the environmental fate and ecological risks that could result from the use of
profenofos on cotton. Available environmental fate studies show that profenofos is not persistent in
neutral and alkaline soils. Profenofos breaks down rapidly in aerobic and anaerobic conditions and
dissipates in neutral to alkaline soils with a half-life of several days. Acidic conditions typical of the
areas where most profenofos use occurs favor a slower breakdown. Although not highly mobile,
profenofos may reach surface waters through spray drift or runoff.
Data were available to assess the hazard profenofos poses to nontarget terrestrial and aquatic
organisms. Profenofos is moderately to highly toxic to birds, moderately toxic to small mammals, highly
toxic to bees, and highly to very highly toxic to fish and aquatic invertebrates. Thirteen separate fish kill
incidents were reported to the Agency between 1994 and 1996 in which profenofos was implicated as
the probable to highly probable cause. The kills were generally attributable to runoff, although spray
drift during application killed several hundred fish in one incident. These incident reports support the
results of the Agency's comparison of estimated environmental concentrations to affect levels in fish and
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suggest fish may be at significant risk. Unlike fish, incident reports are not normally collected for
aquatic invertebrates; however, the ecological assessment suggests profenofos will pose an even greater
hazard for aquatic invertebrates than for fish.
Risk Mitigation
The registrant has agreed to immediately modify the profenofos label to address human health
and ecological risks. For occupational risks, the label will be modified to: (1) reduce the maximum
application rate to 0.75 Ib. ai/A; (2) allow a 1 Ib. ai/A rate for use only on lepidopteran pests up to
twice per season; (3) require closed mixing/loading systems and enclosed cockpits and cabs; and (4)
prohibit pilots from mixing and loading on the same day of application. While these measures will not
reduce the risks to below the Agency's level of concern based on the current risk assessment, the
Agency believes these measures will significantly reduce exposure.
As indicated above, the Agency is requiring changes to the profenofos label to address worker
risk from aerial application where large quantities of the chemical are handled. Mixer, loader and
applicator risks are not of concern for groundboom applications given the smaller number of acres
treated and amount of pesticide handled once closed systems are employed. For aerial application, the
registrant has agreed to only market the product in an advanced mixing/loading system and allow
application using enclosed cockpits beginning with the 2001 growing season. The seasonal maximum
application rate is being reduced from 6 to 5 Ibs ai/A/season. Application at the 1 Ib ai/A rate will be
limited to twice per year and may be used only for severe lepidopteran infestations. Use under all other
conditions will be limited to 0.75 Ibs ai/A/application. Information reported by USDA indicates that
growers frequently use even lower application rates generally ranging from 0.46 to 0.62 Ib ai/A and
have used rates as low as 0.25 Ib ai/A. At this lowest application rate, risks are not of concern based
on the current assessment.
The registrant is undertaking an exposure study using the advanced mixing/loading system that
will be commercially available next year. This advanced system is expected to perform better than the
older closed mixing/loading systems currently reflected in the PHED database. Use of this improved
system and the aforementioned risk mitigation measures are expected to confirm the Agency's belief
that actual exposures and concomitant risks are not of concern.
To address risk to aquatic animals, the registrant has agreed to require a 300' buffer zone
around water bodies for aerial applications and a 100' buffer zone around water bodies for
groundboom applications. Although the mitigation measures focus on minimizing risk to fish, the
Agency believes they will have a secondary benefit in mitigating risks to nontarget aquatic invertebrates
and may mitigate some risks to terrestrial species. The Agency is also requiring the registrant to reduce
the application rate which should also reduce exposure.
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The decisions in this document are specific to profenofos; a cumulative risk assessment of all
organophosphate pesticides has not been completed. The cumulative assessment may result in further
risk mitigation measures for profenofos.
The Agency is issuing this Interim Reregistration Eligibility Document (IRED) for profenofos, as
announced in a Notice of Availability published in the Federal Register. This interim RED document
includes guidance and time frames for making label changes for products containing profenofos. This
document is not the final reregistration eligibility decision because the Agency has not completed the
final tolerance reassessment. The IRED outlines the risks of profenofos (when considering profenofos
individually) and provides the necessary label modifications which must be implemented to make any
future eligibility findings.
Note that there is no comment period for this document, and that the time frames for
compliance with the necessary changes outlined in this document are shorter than those given in
previous REDs. As part of the process discussed by the TRAC, which sought to open up the process
to interested parties, the Agency's risk assessments for profenofos have already been subject to
numerous public comment periods, and a further comment period for profenofos was deemed
unnecessary. The Phase 6 of the pilot process did not include a public comment period; however, for
some chemicals, the Agency may provide for another comment period, depending on the content of the
risk management decision. With regard to complying with the requirements in this document, the
Agency has shortened this time period so that the risks identified herein are mitigated as quickly as
possible. Neither the tolerance reassessment nor the reregistration eligibility decision for profenofos can
be considered final, however, until the cumulative risk assessment for all organophosphate pesticides is
complete. The cumulative assessment may result in further risk mitigation measures for profenofos.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S. Environmental
Protection Agency (hereafter referred to as "the Agency") to determine whether a pesticide containing
such active ingredient is eligible for reregistration. Thus, reregistration involves a thorough review of the
scientific database 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.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
This Act amends FIFRA to require tolerance reassessment during reregistration. FQPA also amends
the Federal Food, Drug and Cosmetic Act (FFDCA), to require a safety finding in tolerance
reassessment based on factors including an assessment of cumulative effects of chemicals with a
common mechanism of toxicity. Profenofos belongs to a group of pesticides called organophosphates
which share a common mechanism of toxicity. They all affect the nervous system by inhibiting
cholinesterase. Therefore, tolerance reassessment requires that the Agency consider, among other
things, the cumulative effects of exposures to all organophosphates.
This document presents the Agency's revised human health and ecological risk assessments; its
progress toward tolerance reassessment; and the interim reregistration eligibility decision for profenofos.
It is intended to be only the first phase in the reregistration process for profenofos. The Agency will
eventually proceed with its assessment of the cumulative risk of the OP pesticides.
The implementation of FQPA has required the Agency to revisit some of its existing policies
relating to the determination and regulation of dietary risk, and has also raised a number of new issues
for which policies need to be established. These issues were developed and refined through
collaboration between the Agency and the Tolerance Reassessment Advisory Committee (TRAC),
which is composed of representatives from industry, environmental groups, and other interested parties.
The TRAC identified the following science policy issues it believed were key to the implementation of
FQPA and tolerance reassessment:
Applying the FQPA 10-Fold Safety Factor
• Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments
How to Interpret "No Detectable Residues" in Dietary Exposure Assessments
• Refining Dietary (Food) Exposure Estimates
• Refining Dietary (Drinking Water) Exposure Estimates
Assessing Residential Exposure
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Aggregating Exposure from all Non-Occupational Sources
How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with
a Common Mechanism of Toxicity
• Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates
• Whether and How to Use Data Derived from Human Studies
The process developed by the TRAC calls for the Agency to provide one or more documents
for public comment on each of the policy issues described above. Each of these issues is evolving and
in a different stage of refinement. Some issue papers have already been published for comment in the
Federal Register and others will be published shortly.
In addition to the policy issues that resulted from the TRAC process, the Agency published in
the Federal Register on Augustl2, 1999, a draft Pesticide Registration Notice that presents EPA's
proposed approach for managing risk from organophosphate pesticides to occupational users. This
notice describes the Agency's baseline approach to managing risks to handlers and workers of
organophosphate pesticides. Generally, basic protective measures such as closed mixing and loading
systems, enclosed cab equipment, or protective clothing, as well as increased reentry intervals are
needed for most uses where current risk assessments indicate a risk and such protective measures are
feasible. The draft guidance policy also states that the Agency will assess each pesticide individually,
and based upon the risk assessment, determine the need for specific measures tailored to the potential
risks of the chemical. The measures included in this interim RED are consistent with that draft Pesticide
Registration Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistration tolerance reassessment as well as descriptions of the process developed by TRAC for
public comment on science policy issues for the organophosphate pesticide and the worker risk
management PR Notice. Section n provides a profile of the use and usage of profenofos. Section m
gives a summary of the revised human health and environmental effects risk assessments resulting from
public comments and other information. Section IV discusses the Agency's interim decision regarding
measures necessary for the interim reregistration eligibility and risk management decisions. Section V
summarizes label changes needed to meet the Agency's interim reregistration eligibility decision set forth
in Section IV. Finally, the Appendices list Data Call-in (DCI) information, related documents and how
to access them. The revised risk assessments [and addenda] are not included in this document, but are
available on the Agency's web page (www.epa.gov/oppsrrdl/op), and in the Public Docket.
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II. Chemical Overview
A. Regulatory History
Profenofos was first registered by the Agency in 1982 for use as an insecticide/miticide. This
interim reregistration eligibility review is the Agency's first reevaluation of profenofos since its initial
registration in 1982. A Registration Standard was not issued for profenofos, nor was profenofos ever
the subject of a Special Review.
B.
Chemical Identification
Profenofos:
o
O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl phosphorothioate
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Molecular Weight:
Profenofos
O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl
phosphorothioate
Organophosphate
41198-08-7
111401
CnH15O3PSBrCl
373.65 g/mole
Trade and Other Names: Curacron 8E, CGA-15324
Basic Manufacturer:
Novartis Crop Protection, Inc.
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Technical profenofos is a pale yellow liquid with a boiling point of 100°C (1.8 Pa) and a density
of 1.46 g/cm3 at 20°C. Pure profenofos is an amber-colored oily liquid with a boiling point of 110°C
(0.13 Pa). Profenofos has limited solubility in water (20 ppm), but is completely soluble in organic
solvents (ethanol, acetone, toluene, n-octanol, and n-hexane) at 25°C. (See "Human Health Risk
Assessment, Profenofos, June 16, 1999".)
C. Use Profile
The following information is based on the currently registered use of profenofos.
Type of Pesticide: Insecticide/miticide
Summary of Use:
Sites: Terrestrial food and feed crop - cotton.
Food: Cottonseed is processed into cottonseed oil; meal and gin trash are
used as ruminant feed.
Residential: No residential uses.
Other Nonfood: None. Registered for use on cotton only.
Target Pests: Profenofos is used to control tobacco budworm, cotton bollworm,
armyworms (fall, beet), cotton aphid, spider mites, plant bugs,
fleahoppers, and whiteflies.
Formulation Types:
Registered: Novartis Crop Protection, Inc., has registered a technical grade (89%
ai) and an emulsifiable concentrate (73% ai).
Method and Rates of Application:
Equipment - Aircraft (fixed wing and helicopter) and groundboom.
Method and Rate - Foliar spray applied at up to 1.0 Ib ai/A (maximum)
Timing - From planting through defoliation; six treatments per season
(maximum).
-------
Trend - According to USDA's National Agricultural Statistics Service and other
sources, profenofos use has declined markedly over the last five years.
USDA reports that growers are using lower rates (0.46 to 0.62 Ib ai/A)
and applying the pesticide less frequently (about twice per year).
Use Classification: Profenofos is a restricted use pesticide.
D. Estimated Usage of Pesticide
Based on information available to the Agency and from consultation with the USDA, the
Agency estimates that on average approximately 775,000 pounds of profenofos are applied to an
estimated average of 5% of the approximately 13,818,000 acres of cotton grown in the US per year.
The Agency estimates the maximum percent cotton treated to be about 10%. Although some
profenofos is used in nearly every state where cotton is grown, approximately 80% of the yearly use of
profenofos is in the mid-South states of Arkansas, Georgia, Texas, Louisiana, and Mississippi.
III. Summary of Profenofos Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide profenofos, as fully presented in the documents, "Human
Health Risk Assessment, Profenofos, June 16, 1999," and "Reregistration Eligibility Decision
Environmental Risk Assessment for Profenofos, June 16, 1999." The purpose of this summary is to
assist the reader by identifying the key features, findings and conclusions reached in these risk
assessments.
Using relevant data submitted under section 4(g)(2)(A) of FIFRA, published scientific literature,
and available surrogate data, the Agency assessed the human health and ecological risks associated
with using profenofos on cotton. For more detail, see "Human Health Risk Assessment, Profenofos,
June 16, 1999," and "Reregistration Eligibility Decision Environmental Risk Assessment for Profenofos,
June 16, 1999," The endpoint of concern is cholinesterase inhibition as measured in plasma, red blood
cells, and brain following exposure to profenofos. The Agency calculated human health risks from
food, water, and occupational exposures. Potential dietary (food) exposure to profenofos residues may
occur through the consumption of cottonseed oil, milk, meat and meat by-products, and through
drinking water. There are no residential, recreational, or other non-occupational sources of exposure
to profenofos. Therefore, in quantifying aggregate risks, the Agency only considered exposures from
food and drinking water. The results of the individual food and drinking water analysis indicate that
dietary risk is not of concern for profenofos (as stated previously this assessment considers profenofos
alone and does not consider cumulative risks).
The occupational risk assessment for profenofos considered exposures that could result from
aerial and groundboom application methods based on maximum application rates. Postapplication data
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were submitted by the registrant and were considered by the Agency in its postapplication risk
assessment. The results of the occupational risk assessment indicate that risks for both handlers and
postapplication workers are a concern.
The Agency considered the toxicity and environmental fate characteristics of profenofos in its
assessment of the potential adverse effects on nontarget aquatic and terrestrial organisms. Using
exposure estimates derived from environmental fate studies that were conducted under conditions that
favor rapid dissipation of profenofos, the Agency identified potential risks to nontarget species,
particularly aquatic organisms. Additional information on reported fish kill incidents that identified
profenofos as the probable cause confirm that the use of profenofos under typical use conditions can
pose adverse risk to aquatic organisms.
These risk assessments for profenofos were presented at a June 16, 1999, Technical Briefing,
which was followed by an opportunity for public comment on risk management for this pesticide. The
risk assessments presented here form the basis of the Agency's risk management decision for
profenofos only; the Agency must complete a cumulative assessment of the risks of all organophosphate
pesticides before any final decisions can be made.
A. Human Health Risk Assessment
The Agency issued its preliminary risk assessment for profenofos in August 1998 (Phase 3 of
the TRAC process). Since that time, the preliminary risk assessment has been revised to address
stakeholder comments and refined to the extent practicable using currently available information. These
updates or refinements include:
- Refined the dietary risk assessment using DEEM (an updated exposure model).
(Previous assessment was based on DRES to assess the dietary risk.)
- Reevaluated the postapplication risks to determine reentry requirements.
- Calculated DWLOCs.
- Compared the estimates of profenofos levels in drinking water to the DWLOC estimates.
The following table summarizes the lexicological endpoints selected by the Agency to assess
human health risks for profenofos:
10
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Table 1. Summary of Toxicological Endpoints for Profenofos
TYPE OF EXPOSURE
(duration and route)
ENDPOINT AND DOSE
STUDY
Acute Dietary (one day)
aPAD of 0.005 mg/kg /day [NOEL 0.5
mg/kg/day inhibition of cholinesterase
activities in plasma (males) and RBC's
(females)]. UF: 100
Non-guideline acute single-dose oral
toxicity study in rats (MRID
43213302).
Chronic Dietary
cPAD of 0.00005 mg/kg/day [NOEL 0.005
mg/kg/day / inhibition of cholinesterase
activity in plasma and RBC's]. UF: 100
Six-month dog study (MRID
00081687).
Short-Term Occupational (one to
seven days)
Intermediate-Term Occupational
(one week to several months)
NOEL of 1.0 mg/kg/day [NOEL for
significant decreases in cholinesterase
activities in RBC's, plasma, and brain]. UF:
100
21-day dermal toxicity study in
rabbit (MRID 41644501).
Inhalation (any duration)
LOEL of 9.7 mg/kg/day. Dose calculated for
route-to-route extrapolation based on the
LOEL of 0.068 mg/L, which inhibited brain,
RBC, and plasma cholinesterase activities].
UF: 300
21-day inhalation toxicity study in
rat (MRID 00082079).
1. Dietary Risk (food)
Dietary Exposure Assumptions
The Agency's dietary risk assessment for profenofos uses the Dietary Exposure Evaluation
Model (DEEM™), which incorporates consumption data generated from the U.S. Department of
Agriculture's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-1992. Acute dietary
risk is calculated considering maximum, or high end, single day exposure to pesticide residues in food.
Chronic dietary risk is calculated by using the average consumption values for food and average residue
values for those foods over a 70-year life time. The Agency uses the estimated maximum percent crop
treated for acute risk and the average estimated percent crop treated for chronic risk. The no-
observed-effect-level (NOEL) and uncertainty factors (UF) are used to establish the "allowable"
exposures to a pesticide, which is referred to as the reference dose (RfD). The RfD is divided by the
FQPA Safety Factor, which results in the Population Adjusted Dose (PAD). The FQPA safety factor
is intended to provide up to an additional 10-fold factor to safeguard against a special sensitivity in
infants and children to specific pesticide residues in food or to account for an incomplete database. The
PAD is the value used for regulatory decisions rather than the RfD following FQPA considerations.
Estimated acute and chronic dietary exposures to profenofos result in risk estimates that are
significantly below the Agency's level of concern using reassessed tolerances, and incorporating
anticipated residues and percent crop treated. For the acute dietary risk assessment, the entire
11
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distribution for each food item of single day food consumption was combined with a single residue level
to obtain a distribution of exposure. For the chronic dietary risk assessment, the three-day average
consumption for the U.S. and sub-populations was combined with average residues in commodities to
determine average exposure. Limited monitoring data have been generated for profenofos by the
USDA Pesticide Data Program (PDF) and the U.S. Food and Drug Administration (FDA).
FOPA Safety Factor
The FQPA Safety Factor was reduced to IX. The reduction was based on the completeness
of the toxicity and exposure databases, and on the assessment of the following studies: (1) a
developmental toxicity study in rats; (2) a supplemental developmental study in rabbits; (3) a two-
generation reproduction study in rats; (4) an acute delayed neurotoxicity study in hens (and two
supplementary studies); (5) an acute neurotoxicity study in rats; and (6) a subchronic neurotoxicity
study in rats.
Based on these data, the Agency concluded that the additional 10X FQPA Safety Factor to
account for enhanced sensitivity of infants and children, as required by FQPA, should be reduced to
IX since there was no indication of increased sensitivity to young animals following pre-and/or post-
natal exposure to profenofos. Specifically, there was no evidence of increased susceptibility of rat or
rabbit fetuses following in utero exposure in prenatal developmental toxicity studies, 2) no offspring
toxicity was seen at the highest dose tested in the two-generation reproduction toxicity study and there
was no evidence of abnormalities in the development of the fetal nervous system in these studies and 3)
adequate data and modeling outputs are available to satisfactorily assess dietary exposure and to
provide a screening level drinking water exposure assessment. The Agency believes that the
assumptions and models used in the assessments do not underestimate the potential risk for infants and
children. Therefore, the additional 10X factor as required by FQPA was reduced to IX.
a. Dietary Risk from Food (Acute)
As previously stated, the acute dietary risk (food) of profenofos does not exceed the Agency's
level of concern (i.e., less than 100% of the acute PAD is utilized). The endpoint is cholinesterase
inhibition in plasma and red blood cells from a single-dose oral toxicity rat study with a NOEL of 0.5
mg/kg (MRID 43213302). The Agency applied the conventional uncertainty factor (UF) of 100 to
account for both interspecies extrapolation (10X) and intraspecies variability (10X). The 10X FQPA
safety factor was reduced to IX (removed). The acute dietary assessment is based on cholinesterase
inhibition observed in an acute oral toxicity study in rats with a NOEL of 0.5 mg/kg/day (MRID
43213302). An uncertainty factor of 100 was applied to account for interspecies extrapolation (10X)
and intraspecies variability (10X).
As a result, the acute PAD is calculated to be 0.005 mg/kg/day. The Agency conducted a
deterministic analysis which resulted in a dietary exposure <8% of the aPAD at the 95th exposure
12
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percentile for the most highly exposed subpopulation (children 1-6 years). No additional data were
available for the Agency to further refine the risk assessment. The results of field trials indicate residue
on cotton seed was below the level of detection. In contrast, gin trash residues contained substantial
residues. Therefore, a tolerance must be established. The acute dietary risk assessment was based on
residue values of 1A the limit of quantitation (LOQ) for cottonseed oil, milk, meat and meat byproducts,
and the Agency's estimate of maximum percent crop treated (10%).
b. Dietary Risk from Food (Chronic)
The chronic dietary risk assessment is based on cholinesterase inhibition in plasma and red
blood cells from a six-month dog feeding study with a NOEL of 0.005 mg/kg (MRID 00081687). As
above, the Agency applied an UF of 100 for both interspecies extrapolation (10X) and intraspecies
variability (10X). The FQPA 10X safety factor was reduced to IX (removed) as in the acute dietary
assessment. Therefore, the cPAD is calculated to be 0.00005 mg/kg/day. For the most highly
exposed subgroup, children (1-6 years), less than 20% of the cPAD is utilized.
The chronic dietary risk assessment was conducted using a 5% weighted average crop treated
estimate and anticipated residue values based on one-half the limit of quantitation for cottonseed oil,
milk, meat and meat byproducts. This approach allows the Agency to put emphasis on the most recent
data, which results in a more accurate account of the current use patterns. The chronic dietary risk
(food) of profenofos does not exceed the Agency's level of risk concern (i.e., less than 100% chronic
PAD is utilized).
2. Dietary Risk (Drinking Water)
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. The Agency considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or actual monitoring data, if available. The Agency did not have
representative drinking water monitoring data available for profenofos; therefore, the surface and
ground water assessments were based on modeling predictions. Based on laboratory studies and
limited field data, the Agency assessed the potential of profenofos to reach surface- or ground-water
sources of drinking water (see Section E, Environmental Risk Assessment, June 16, 1999, for details).
The Agency performed surface and groundwater modeling to estimate drinking water
concentrations, which were then compared to the Drinking Water Level of Comparison (DWLOC).
The GENEEC and PRZM-EXAMS models were used to estimate surface water concentrations, and
SCI-GROW was used to estimate groundwater concentrations. All of these are considered to be
screening models, with the PRZM-EXAMS, model being somewhat more refined than the other two.
The models are discussed below.
13
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a. Surface Water
Tier IIPRZM-EXAMS modeling provides upper-bound predictions of profenofos
concentrations in surface water. This model is based on more refined data and less conservative
assumptions than the GENEEC model. The modeling was performed assuming profenofos was applied
at the maximum label rate of 1 Ib ai/A, 6 times per season to a cotton site in Mississippi, a major
cotton-growing state. Based on the modeling, concentrations of profenofos in surface water are not
likely to exceed 6 ppb profenofos equivalents for peak (acute) exposure and 0.1 ppb profenofos
equivalents for mean (chronic) exposure. Profenofos concentrations in water were measured in eleven
of the thirteen fish kill incidents reported between 1994 and 1996. Although the surface water
concentrations were generally below the modeled estimates, actual measured concentrations ranged
from a low of 0.08 ppb to 36.4 ppb.
b. Ground Water
Profenofos is not expected to leach to ground water based on limited laboratory mobility data.
The SCI-GROW model was used to estimate ground water concentrations using the same site, soil,
and application rate input data used for PRZM/EXAMS. The model resulted in a screening-level
concentration of 0.03 ppb. The Agency also has limited data from wells monitored in Texas that show
no detection. However, these data were not of sufficient quantity or representative of profenofos use
under various geographical conditions to be used for risk assessment.
c. Drinking Water Levels of Comparison
To determine the maximum allowable contribution of water containing pesticide residues
permitted in the diet, the Agency first looks at how much of the overall allowable risk is contributed by
food and then determines a drinking water level of comparison (DWLOC) to ascertain whether
modeled levels exceed this value. The Agency uses the DWLOC as a surrogate to capture risk
associated with exposure from pesticides in drinking water. As mentioned above, the Agency modeled
the drinking water exposure values because of limited monitoring data. The Agency compared the
DWLOCs and the estimated concentrations of profenofos in surface water and ground water generated
by modeling with PRZM/EXAMS and SCI-GROW, respectively.
As seen in the table below, neither surface water or ground water modeled concentrations for
profenofos exceed the DWLOC for acute or chronic exposures. Consequently, the Agency has no
concern for exposure to profenofos in drinking water.
14
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Table 2. Drinking Water Level of Comparison and Modeled concentrations
Population
Subgroup
PAD
(mg/kg/day)
Food
Exposure
(mg/kg/day)
Water
Exposure
(mg/kg/day)
DWLOC
(Mg/L)
PRZM-
EXAM
(Mg/L)
EECs
SCI-
GROW
(Mg/L)
EECs
Acute Exposure
Adult Male
Adult Female
Infants <1 yr
Children 1-6
Children 7-12
0.005
0.005
0.005
0.005
0.005
0.000114
0.000108
0.000394
0.000400
0.000237
0.004886
0.004892
0.004606
0.0046
0.004763
171
146
46
46
48
6
6
6
6
6
0.03
0.03
0.03
0.03
0.03
Chronic Exposure
Adult Male
Adult Female
Infants <1 yr
Children 1-6
Children 7-12
0.00005
0.00005
0.00005
0.00005
0.00005
0.000003
0.000003
0.000004
0.000009
0.000005
0.000047
0.000047
0.000046
0.000041
0.000045
2
1.41
0.46
0.41
1.57
0.1
0.1
0.1
0.1
0.1
0.03
0.03
0.03
0.03
0.03
B.
Residential Risk
There are no residential uses of profenofos. It is registered as a restricted use pesticide for use
only on cotton.
C. Aggregate Risk
Aggregate risk considers combined exposures from food, drinking water, and non-occupational
uses of a pesticide. As stated previously, there are no residential or other non-occupational (e.g., use
on a golf course) uses of profenofos to consider in an acute or chronic aggregate assessment.
Therefore, as discussed above, acute and chronic drinking water levels of comparison (DWLOCs)
were calculated and compared to estimated environmental concentrations (EECs) that were generated
using the PRZM-EXAMS model for surface water and the SCI-GROW model for ground water
sources of drinking water. The EECs for surface and ground water were less than the acute and
chronic DWLOCs indicating that aggregate risk is less than the level of concern, based on current use.
D. Occupational Risk
The Agency considers the tasks (e.g., mixing/loading, applying); pesticide formulation (e.g.,
liquid, granular); application method (e.g., aerial, groundboom); application rate and similar activities in
assessing occupational exposure. The Agency considers both direct and indirect or secondary
15
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exposure and risks that may result from the use of the pesticide, such as handlers not directly involved
in mixing/loading or applying the chemical. The Agency also reviews any incident data that may be
available and applicable.
The Pesticide Handlers Exposure Database (PHED) was used to estimate occupational
exposure. PHED is a comprehensive generic/surrogate exposure database containing a large number
of measured values of dermal and inhalation exposures for pesticide workers (e.g., mixers, loaders, and
applicators) involved in the handling or application of pesticides. The database currently contains data
for over 2000 monitored exposure events.
The Agency's first step in performing a handler exposure assessment is to complete a baseline
exposure assessment. The baseline scenario generally represents a handler wearing long pants, a long-
sleeved shirt, shoes and socks. If the level of concern is met or exceeded, then additional protective
measures, such as PPE (personal protective equipment) and engineering controls, are used to
recalculate the Margin of Exposure (MOE) until exposure is sufficiently reduced. A MOE is a measure
of how close the handlers' exposure comes to the No-Observed-Effect- Level (NOEL) taken from
animal studies. The Agency uses the MOE as an expression of risk. The levels of protection used as
the basis for calculating exposure from profenofos activities include:
• Baseline: Long-sleeved shirt and long pants and socks and shoes (no respiratory protection).
• Maximum available PPE: Baseline scenario + coveralls and chemical resistant gloves.
• Engineering controls: Closed cab, enclosed cockpit or closed loading system.
The current label requires the following PPE for "applicators and other handlers": coveralls
over short-sleeved shirt and short pants, chemical-resistant gloves, chemical-resistant footwear plus
socks, protective eyewear, and chemical-resistant apron when cleaning equipment, mixing, or loading.
In addition to factors captured in PHED, the toxicity of a chemical is integral to assessing risk to
handlers. The endpoints (i.e., NOEL) and uncertainty factors used in the assessment of risk to
occupational and post-application handlers are summarized below.
Mixer/Loader and Applicator Risk
Inhalation and dermal exposure to profenofos can result from occupational use. The Agency
assessed dermal and inhalation risks for mixers/loaders and applicators during aerial and groundboom
applications and for flaggers during aerial application. Profenofos is not expected to be used on a
continuous long-term basis (greater than 6-months a year) resulting in chronic exposure. Therefore,
only short- (1-7 days) and intermediate- (one week-several months) term occupational risk
assessments were conducted.
16
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For profenofos, the Agency assessed dermal exposures using a NOEL from a 21-day dermal
toxicity study in the rabbit. This study serves as the endpoint for both short-term and intermediate-term
exposures. Significant decreases in cholinesterase activity in red blood cells, plasma, and brain were
observed. A NOEL of 1.0 mg/kg/day was established and the LOEL was 10 mg/kg/day (MRID
41644501). An uncertainty factor of 100 was applied to account for interspecies extrapolation (10X)
and intraspecies variability. MOEs that are greater than 100 do not exceed the Agency's level of
concern.
The risk assessment for inhalation short-term and intermediate term exposure is based on a 21-
day inhalation toxicity study in the rat (MRID 00082079). Brain, red blood cell, and plasma
cholinesterase activities were significantly depressed at the lowest dose tested, 0.068 mg/L. In order to
quantify inhalation risk, the Agency converted the inhalation endpoint to an oral dose equivalent of 9.7
mg/kg/day, because of the need to calculate dermal and inhalation risks together. A NOEL for
cholinesterase inhibition was not established. The Agency applied an UF of 300 for the inhalation risks
to account for interspecies extrapolation (10X), intraspecies variability (10X), and the use of a LOEL
(3X) rather than a NOEL for short and intermediate term risk estimates. An inhalation MOE that is
greater than 300 is above the Agency's level of concern.
In reviewing the use patterns of profenofos, the Agency identified four major exposure
scenarios: (1) mixing/loading liquid formulations for aerial and groundboom equipment; (2) aerial
application (3) groundboom application; and (4) flagging during aerial spray applications. Absent
chemical specific data, the Agency assessed the aerial and ground scenarios using surrogate data from
PHED version 1.1. The Agency also assumed that an applicator applies profenofos to 350 acres/day
(aerial) and 80 acres/day (groundboom) at the maximum label rate of 1 Ib ai/acre. Mixing/loading and
application are assumed to be performed by different individuals.
The results of these assessments indicate that dermal exposure is a significant source of
exposure and that inhalation exposure does not contribute measurably to overall exposure. The dermal
exposure component resulted in MOEs <100 for aerial mixers/loaders (MOE 23) and aerial
applicators (MOE 40), based on exposure estimates assuming the use of engineering controls (i.e.,
closed mixing/loading systems and enclosed cockpits). The MOE for aerial flaggers was 1000 when
assuming the use of engineering controls (enclosed cabs). If engineering controls are used, the MOE
for groundboom mixers/loaders is 101 and for groundboom applicators the MOE is 180. The Agency
continues to be concerned about mixer/loaders and applicators involved in aerial spray operations even
after considering the use of engineering controls. Reducing the aerial application rate to 0.75 Ib. ai/A
results in increased MOEs for aerial mixers/loaders (MOE 29) and aerial applicators (MOE 50).
The Agency assumed 350 acres per day as a representative treatment day for handlers
supporting cotton treatment, rather than using the 1200 default maximum treatment value. Based on
information provided by the registrant and the use practices associated with profenofos, the Agency
considers 350 acres to be a reasonable assumption. In the case of profenofos, the Agency believes
that the conventional maximum default values, which expresses the total cotton acreage per day under
17
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ideal weather conditions, would overestimate exposure. Typically, profenofos would not be applied at
the maximum rate to the entire cotton acreage on a given farm. Entire fields may not need to be treatec
because pest pressure is often localized.
Postapplication Risk
The Agency also assessed risks to postapplication workers. Postapplication workers who
enter previously treated fields may be exposed to profenofos because their skin contacts treated
surfaces. Exposures are directly related to the kind of tasks performed. The Agency examines the
amount of pesticide residue found on the workers over time from various studies. The Agency
evaluates this information to determine the number of hours/days following application that must elapse
before the pesticide residues dissipate to a level where worker MOEs equal or exceed 100 while
wearing baseline attire. Baseline attire is defined as long-sleeved shirt, long pants, shoes and socks.
Based on the results of the postapplication worker assessment, the Agency decides whether to establish
early entry restrictions for worker reentry into treated fields for nonroutine hand labor activities using a
specified set of PPE or to prohibit entry for a period of time.
For profenofos, the Agency also reviewed dislodgeable foliar residue (DFR) studies (MRID
428513-04 and 428513-03) and postapplication worker exposure studies (MRID 428513-02) that
were conducted at several sites in various states. These studies measured the average dislodgeable
foliar residues and postapplication exposure to workers during scouting and hoeing activities. The
results of these studies showed that the major exposure was from the dermal route and exposure via the
inhalation route is not a concern. Using the data from these studies, the Agency determined that the
MOEs for dermal risks were above the level of concern (MOE greater than 100) at days two to three
following pesticide application. These data support the current reentry interval (REI) of 48 to 72 hours
(for non-arid conditions). Table 3 below summarizes the MOEs for scouts and hoers who may enter
fields treated with profenofos. As shown in the table, dermal risk for both scouts and hoers for a
period of time (48-72 hrs) after treatment exceed the Agency's level of concern.
Table 3. Risks for Cotton Scouting and Hoeing in Profenofos-Treated Fields
Margins of Exposure (MOEs)*
Cotton Scouting
Days
after
treatment
0
1
2
3
North Carolina &
South Carolina (avg
of 3 sites)
15
43
200
not needed
Texas
9
48
140
not
needed
California
13
40
78
110
Cotton Hoeing
North Carolina &
South Carolina (avg
of 3 sites)
38
110
not needed
not needed
Texas
22
120
not
needed
not
needed
California
32
99
195
not needed
*MOE = NOEL •*• Calculated Average Daily Dermal Dose; where the NOEL = 1 mg/kg/day and the Calculated Average Daily Dermal
Dose = DFR ([jg/cm2) x TC (cm2/hr) x conversion factor (1 mg/1,000 |jg) x exposure time (8 hrs) •*• body weight (70 kg). See
table 1 in amended postapplication risk assessment dated August 13, 1999, in docket.
18
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Human Incident Reports
The Agency reviewed the Incident Data System (IDS) to determine whether profenofos cases
had been reported. The database contains over 17,000 pesticide-related reports of incidents involving
adverse effects to humans and approximately 9,000 reports involving domestic animals since 1992. Of
the reported incidents, profenofos was identified in only seven human cases with minor symptoms and
one lawsuit alleging death.
The Agency also reviewed the Poison Control Center's data which compiles data reported
from 1985 through 1992. This database covered 28 organophosphate and carbamate chemicals.
Additional data on all pesticide exposures were obtained for the years 1993-1996. Most of the
national Poison Control Centers (PCCs) participate in a national data collection system, the Toxic
Exposure Surveillance System, which obtains data from about 70 centers at hospitals and universities.
There were only three occupational cases and four non-occupational cases involving exposure to
profenofos alone reported from 1985 through!992. Two occupational and six non-occupational cases
were reported for profenofos from 1993 through 1996. Non-occupational cases are likely to involve
bystanders or workers exposed to spray drift. Profenofos had a lower ratio of symptomatic cases
reported per pounds used than did other organophosphate or carbamate insecticides.
E. Environmental Risk Assessment
1. Environmental Fate and Transport
Available environmental fate studies show that profenofos is not persistent, particularly in
neutral and alkaline soils. Hydrolysis is the major route of dissipation in neutral to alkaline
environments. Photolysis is not a major pathway while biotic processes — aerobic and anaerobic
metabolism - become important after the initial hydrolysis. Profenofos metabolizes rapidly in aerobic
and anaerobic conditions and dissipates in neutral to alkaline soils with a half-life of several days. Little
data exists for acid soils, although it can be inferred that profenofos dissipates at a slower rate. One of
the major degradates, 4-bromo-2-chlorophenol, is persistent in the environment while the fate of
another degradate, O-ethyl-S-propyl phosphorthioate, is not well known. Profenofos is not highly
mobile and is not expected to leach to ground water under normal use. Because field dissipation
studies were conducted under conditions that resulted in a moisture deficit, the leaching potential could
not be reliably assessed in the studies. The mobility and leaching potential of the degradates is
unknown. The chemical may reach surface waters through spray drift or runoff.
The available environmental fate database is relatively complete but contains substantial gaps
related to profenofos' degradates. However, the Agency does not expect the degradates to pose any
lexicological concerns. While the guideline requirements have been met, our understanding of the fate
of profenofos is confined primarily to neutral and alkaline environments (which are more prevalent in the
Southwest and Western cotton-growing regions). The fate of profenofos under acidic conditions
19
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(common to the Southeast and Md South regions) is not well understood. (See Reregistration
Eligibility Decision Environmental Risk Assessment for Profenofos, June 16, 1999, for a detailed
discussion.)
2. Ecological Risk Assessment Analysis
The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity
studies to estimated environmental concentrations based on environmental fate characteristics, pesticide
use, and/or monitoring data. To evaluate the potential risk to nontarget organisms from the use of
profenofos products, the Agency calculates a Risk Quotient (RQ), which is the ratio of the estimated
exposure concentration to the toxicity endpoint values, such as a LD50 or LC50. These RQ values
represent the level of concern the particular pesticide and/or use may pose for nontarget organisms.
Use, toxicity, fate, and exposure are combined to characterize the risk as well as the level of certainty
and uncertainty in the assessment.
For profenofos, laboratory data showed that it is highly to very highly toxic to fish and aquatic
invertebrates. The Agency also assessed fish kill incident reports and testing to determine potential risk
to aquatic species.
The acute toxicity data for nonterrestrial animals showed moderate toxicity using a single-dose
oral study on mallard ducks. Subacute studies on mallard duck and northern bobwhite quail showed
slight to high toxicity to these species, respectively (MRID 43107302). A chronic toxicity study for
avian species showed that profenofos significantly affects egg production due to parental toxicity
(MRID 92148004 and 92148006). The results of acute and subacute studies on small mammals
indicated that profenofos is moderately toxic (MRID 00105226 and 001052281). Profenofos is highly
toxic to honey bees (MRID 41627308).
a. Nontarget Terrestrial Animal Risk
The Agency has adequate data to assess the hazard of profenofos to nontarget terrestrial
organisms. On an acute basis, profenofos is moderately to highly toxic to birds, moderately toxic to
small mammals, and highly toxic to bees.
Results of acute toxicity studies do not represent all species of bird, mammal, or aquatic
organisms. Only one or two surrogate species for birds are used to represent all bird (680+) species in
the United States. For mammals, acute studies are usually limited to a Norway rat or house mouse.
Neither reptiles nor amphibians are tested. The assessment of risk or hazard makes the assumption that
avian and reptilian toxicity are similar. The results of these studies indicate that profenofos is more toxic
to some bird species (MRID 416273-01) than others. Also, avian reproduction studies showed the
profenofos affects egg production due to parental toxicity (MRID 92148004, 92148006).
20
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A single application of profenofos at maximum label rates poses some acute and chronic risk to
birds (acute RQs range from .21- 4.21 and chronic RQs range from 1.2 - 24) and small mammals
(acute RQs range from 0.01 - 0.76). Since profenofos can be applied up to 6 times per season (at the
maximum label rate), profenofos levels in the environment and on avian and mammalian food and feed
items from its use could be as much as 2 times higher than those associated with a single application.
b. Nontarget Aquatic Animal Risk
Toxicity data for profenofos show that the chemical is highly to very highly toxic to fish and
aquatic invertebrates. In calculating toxicity to nontarget aquatic animals, the Agency typically uses one
or two surrogate species to represent all freshwater fish (2000+) species in the United States.
Estuarine/marine testing is usually limited to a crustacean, a mollusk, and a fish. The assessment of risk
or hazard assumes that fish and amphibian toxicity are similar.
Since profenofos can be applied up to 6 times per season (at the maximum application rate),
the Agency assumed this frequency and rate of application in conducting its aquatic risk assessment,
and, assumed that the compound would degrade fairly rapidly between applications. The resulting
acute RQs range between 0.24 and 0.77 for fish, between 2.5 - 6.4 for aquatic invertebrates, and the
RQ is 0.02 for shellfish. The chronic RQ for fish is 0.58; the chronic RQ for aquatic invertebrates is
between 5.2 and 5.8. This suggests that the use of profenofos poses some acute risk to fish and
aquatic invertebrates and some chronic risk to aquatic invertebrates. The magnitude of the actual risks
posed to aquatic species may be somewhat greater in certain locations (e.g., the Southeast and Mid-
South cotton growing regions) than is suggested by these RQs. This is because in certain surface water
systems (i.e., systems which are more acidic), profenofos will not degrade as rapidly as was assumed in
the calculation of the above RQs. In fact, there have been 13 documented, significant fish kill incidents
between 1994 and 1996 attributed to profenofos use in Louisiana and Mississippi. These fish kills
were generally attributed to runoff of profenofos - suggesting that the Agency's aquatic risk assessment
and acute RQs accurately reflect the fact that the use of this compound poses some acute risk to fish.
As noted earlier, the Agency estimated acute profenofos concentrations in surface water using
modeling (6 ppb for peak). The profenofos concentrations reportedly found in surface water
associated with the fish kill incidents were generally below the modeled acute peak concentration. The
measured concentration levels of profenofos ranged from 0.08 ppb - 36.4 ppb in surface water where
the fish kill incidents occurred.
In the majority of the incidents, water samples were taken and analyzed for profenofos. While
measured concentrations were below the fish LC50, initial profenofos concentrations were likely higher
prior to dilution in the water bodies and dissipation prior to sampling (post incident). Profenofos was
detected in fish tissue in the four incidents in which it was analyzed. Profenofos was the only pesticide
detected in 3 incidents. Of the remaining 10 incidents, methyl parathion and atrazine and/or cyanazine
21
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were believed to be a co-contributor in two separate incidents, while other pesticides were considered
unlikely contributors due to the toxicity, concentration, or lack of detection in fish tissues.
The Agency considers these reports reliable because samples collected by States and analyzed
by universities confirmed the presence of profenofos in either fish tissues or water. Records indicate the
Curacron 8E product used at the time of these incidents had the label statement prohibiting aerial
application "within 300 feet upwind of impounded water" and that label directions and precautions
were followed by certified applicators. None of the reported incidents were attributed to misuse.
Therefore, the Agency has concern for the acute risks posed to freshwater and marine/estuarine fish
from the labeled use of profenofos.
The Agency assessed the results from an early fish life cycle study (MRID 92148014) to
establish the chronic toxicity of profenofos. The results indicate that profenofos is very highly toxic on a
chronic basis. However, the Agency needs more data to adequately assess the chronic risk for aquatic
animals. Additional data are needed because the estimated environmental concentration (EEC) (5.9
ppb) is equal to or greater than one-tenth of the NOEC (2.0 ppb) in the early fish life cycle study and
studies from other organisms indicate that the reproductive
physiology offish may be affected which could adversely impact the ecological system. The full fish life
cycle study is needed for the Agency to confirm the chronic risks to aquatic life.
F. Assessment of the Use of Profenofos
1. Use Patterns
On average, approximately 775,000 pounds of profenofos are applied to 5% of the estimated
13.8 million acres of cotton grown annually in the United States. Profenofos is used in three regions:
the South (AL, AR, FL, GA, LA, MS, MO, SC, and TN), Southwest (NM, OK, TX), and the Far
West (AZ, CA). Almost 90% of the estimated profenofos use occurs in the Southern region.
However, profenofos accounts for only 6% of the total insecticide use on cotton in this region. Use of
profenofos in the Far West and Southwest accounts for less than 5% of the total insecticide use in those
regions on cotton. (EPA proprietary data, 1995-1997) Application rates vary by pest species and
infestation level, but typical application rates range from 0.125 to 0.5 Ib. a.i. per acre early season to
0.25 to 1.0 Ib a.i. per acre mid-to-late season.
The primary and most critical targeted pests of profenofos applications are the worm complex:
tobacco budworm, cotton bollworm, and fall and beet armyworms. It is estimated that greater than
50% of all insecticide treatments applied to cotton are targeted at worm complex pests. The worm
complex attacks developing bolls directly impacting yield and quality of the cotton. Yield losses
attributable to this complex can be as high as 90% in untreated cotton fields (Crop Profile for Cotton in
North Carolina, 1999, USDA/OPMP). Profenofos also has usage targeted at the cotton aphid, spider
22
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mites, plant bugs, leafhoppers, and whiteflies, which all occur at varying levels in the different cotton
production regions. Profenofos use, as a percent of the total insecticide use on each pest, is estimated
to be 10% or less for all six pest groups. An estimated 85% of all profenofos usage is for the control of
the worm complex. Profenofos is not used for boll weevil control or as a component of any eradication
program, but is currently an important component of a systems approach to control the targeted pests.
Profenofos is one of only a few registered pesticides that has both larvicidal and ovicidal activity
on the worm complex. This is important because worm pressure often increases dramatically towards
the end of the growing season with an associated increase in the amount of egg laying. This is one
reason profenofos usage is highest from mid-to-late season. Ovicidal activity is important against the
worm complex because of the intense pest pressure that can build very quickly late in the season. With
activity against both stages of the worm complex, profenofos continues to be an important component
of a systems approach to the control of these important pests. Growers typically vary the application
rate as a function of pest pressure. Although the worm complex is the most targeted pest, early season
applications are usually at rates below the maximum label rate.
2. Alternatives
When the Agency reviews alternatives to a pesticide, it considers efficacy against target pests,
costs, ease of use, potential resistance development to the pesticide, impacts on existing integrated pest
management (IPM) programs, and several other characteristics. The Agency recognizes that there are
several alternatives potentially available to control the pests targeted by profenofos on cotton (see,
"Analysis of the Use of Profenofos Insecticide (Curacron 8E) on Cotton", November 2, 1999);
however, none are exact replacements.
One of the newer and more novel alternatives is Bt cotton (cotton containing the Bt gene
(Bacillus thuringiemis) (Bollgard™), a Monsanto Corp. product, which was introduced for
commercial use in 1996. Bt cotton provides excellent control of pink bollworm and tobacco budworm,
moderate control of bollworm, and some control of armyworms. Other potential alternatives include
synthetic pyrethroids (lambda-cyhalothrin, zetamethrin, cypermethrin, cyfluthrin, esvenfalerate, and
tralomethrin) and other organophosphates and carbamates. There are several recently registered
insecticides (i.e, spinosad, tebufenozide, and pymetrozine) for use on cotton and several more under
review. Some of these pesticides, used in combination with other existing control techniques (Bt
cotton, pyrethroids, other OPs, and carbamates), may achieve efficacious control for the pests targeted
by profenofos.
The Agency also considers the cost of potential alternatives when evaluating how appropriate
substitute pest control measures are to an existing technique, in this case profenofos. Several of the
potential alternatives identified (the synthetic pyrethroids, the organophosphates, and the carbamates -
except aldicarb) are estimated to cost the same or less than profenofos per acre. Although Bt cotton
may be more expensive to produce and growers also pay a premium (technology fee) on the seed (that
23
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makes the overall cost of the seed substantially more than non-Bt cotton seed), the costs are offset by
the reduced amount of treatments needed and the potential increase in yield (Crop Profile for Cotton in
Texas, 1999, USDA/OPMP). However, Bt cotton and the other alternatives are not used alone
because of the potential for target pests to build up resistance to the pesticide.
Profenofos is an important component of current resistance management strategies. Its efficacy
in controlling high worm complex infestation periods is consistent with the interim reregistration eligibility
decision and risk management decisions stated below.
IV. Interim Risk Management Reregistration Eligibility Decision
A. Interim Determination of Reregistration 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 an active ingredient are eligible for
reregistration. For profenofos, the Agency assessed the dietary, ecological and occupational risks
associated with its use on cotton. There are no residential uses. The Agency has determined that the
organophosphates share a common mechanism of toxicity, the inhibition of cholinesterase levels. As
required by FQPA, a cumulative assessment will need to be conducted to evaluate the risk from food,
water and non-occupational exposure resulting from all uses of OPs. Currently, the Agency is
developing the methodology needed to conduct such an assessment with guidance/advise provided by
the Science Advisory Panel. Consequently, the risks and decisions presented in this document are only
for profenofos.
For the individual assessment of profenofos, the Agency considered (1) dietary, occupational,
and ecological risks, (2) the availability of efficacious alternatives, (3) scope of use, and (4) human and
wildlife incident data. The Agency previously identified and required the submission of generic (i.e.,
active ingredient specific) data to support reregistration of products containing profenofos as an active
ingredient.
The Agency has completed its review of these generic data (Appendix B identifies the generic
data the Agency reviewed as part of its interim determination of reregistration eligibility of profenofos).
During this review, the Agency determined that MOEs for handlers involved in aerial applications
(mixers/loaders and pilots) exceed the Agency's level of concern even after engineering controls are
considered. As discussed in Section IV.D., the Agency believes these risks could be overstated.
Additionally, the Agency believes that chemical-specific data from field studies would more accurately
reflect the actual exposure to profenofos during aerial application than currently estimated using
surrogate data. The Agency is, therefore, calling in confirmatory chemical-specific exposure data on
aerial mixers/loaders and applicators in order to refine the occupational risk assessment. The Data-
Call-in (DCI) will require a handler dermal exposure study (using engineering controls). This chemical-
specific exposure study should be conducted using an advanced closed mixing and loading system that
24
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is not currently represented in the PHED database. The Agency expects that this study will more
accurately reflect actual exposure and that the associated risk will likely be of less concern than
currently projected using PHED. (As described in Section IV, the registrant has agreed to manufacture
profenofos in a particular performance-based, closed mixing and loading system.) Once the handler
dermal exposure study is received and reviewed, the Agency may refine the risk assessment based on
the findings. If the results of the study are not consistent with the Agency's expectations, the Agency
may reconsider this reregistration decision.
As a result of its assessment of the risks of profenofos alone, EPA has determined that certain
uses of profenofos, unless amended as set forth in this document, may present risks inconsistent with
FIFRA. Accordingly, EPA may commence cancellation proceedings unless the registrant agrees to
label changes implementing the risk reduction measures discussed in this reregistration eligibility
decision. At the time that a cumulative assessment is conducted, the Agency will address any
outstanding risk concerns. The Agency also expects that new data from the pending exposure study
will result in MOEs below the Agency's level of concern. Also, because this is an interim RED, the
Agency may take further actions, if warranted, to finalize the reregistration eligibility decision for
profenofos after assessing the results of the exposure study or the cumulative risk of the
organophosphate class. Such an incremental approach to the reregistration process is consistent with
the Agency's goal of improving the transparency of the reregistration and tolerance reassessment
processes. By evaluating each organophosphate in turn and identifying appropriate risk reduction
measures, the Agency is addressing the risks from the organophosphates in as timely a manner as
possible.
The Agency therefore finds, based on the results of the risk assessments and the expected
timely receipt of confirmatory exposure data, that products containing profenofos as an active ingredient
are eligible for reregistration as long as the registrant fulfills the label modifications and the data
requirements outlined in this document. As stated previously, this reregistration eligibility decision does
not include the cumulative assessment with other organophosphates.
Because the Agency has not completed the cumulative risk assessment for the
organophosphates, this reregistration eligibility decision does not fully satisfy the tolerance reassessment
requirement called for by the Food Quality Protection Act (FQPA). When the Agency has completed
the cumulative assessment, profenofos' tolerances will be reassessed. At that time, the Agency will
reassess profenofos along with the other organophosphate pesticides to complete the FQPA
requirements and make a final reregistration determination. By publishing this reregistration eligibility
decision and requiring risk mitigation now for the individual chemical profenofos, the Agency is not
deferring or postponing FQPA requirements. Rather, EPA is taking steps to assure that uses which
exceed FIFRA's unreasonable risk standard do not remain on the label indefinitely, pending completion
of assessment required under the FQPA. This decision does not preclude the Agency from making the
further determinations and tolerance-related rulemakings that may be required on this pesticide or any
other in the future.
25
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1. Summary of Phase 5 Comments and Responses
A 60-day public comment period for the revised risk assessments was initiated on June 16,
1999. The Agency invited the public to submit risk mitigation recommendations at the technical briefing
held on June 16, 1999, and in a FR notice (64 FR 32229, dated June 16, 1999) which opened the
public docket. No comments or risk mitigation options were submitted to the Agency during the public
comment period.
2. Basis for Interim Eligibility Determination
This interim decision presents the Agency's current position on reregistration eligibility of
pesticides containing the active ingredient profenofos. An incremental approach to the reregistration
process (assessing available information and making risk mitigation decisions on the specific chemical
prior to a cumulative assessment) is consistent with the Agency's goal of improving the transparency of
the reregistration and tolerance reassessment processes. By initially evaluating each organophosphate
one at a time and taking appropriate risk reduction measures on that basis, the Agency is addressing the
risks of the organophosphates in as timely a manner as possible. Jf the Agency receives any additional
information that calls the basic findings of this assessment into question, this decision may be modified.
"Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this organophosphate. The assessment was for this individual organophosphate, and does not attempt
to fully reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate
food tolerances on the basis of cumulative risk from substances sharing a common mechanism of
toxicity, such as the toxicity expressed by the organophosphates through a common biochemical
interaction with the cholinesterase enzyme. The Agency will evaluate the cumulative risk posed by the
entire class of organophosphates once the methodology is developed and the policy concerning
cumulative assessments is resolved.
EPA has determined that risk from exposure to profenofos is within its own "risk cup." In other
words, if profenofos did not share a common mechanism of toxicity with other chemicals, EPA would
be able to conclude today that the tolerances for profenofos meet the FQPA safety standards. In
reaching this determination EPA has considered the available information on the special sensitivity of
infants and children, as well as the chronic and acute food exposure. An aggregate assessment was
conducted for exposures through food and drinking water (there were no residential uses). Results of
this aggregate assessment indicate that the human health risks from these combined exposures are
considered to be within acceptable levels; that is, combined risks from all exposures to profenofos "fit"
within the individual risk cup. Therefore, the profenofos tolerances remain in effect and unchanged until
a full reassessment of the cumulative risk from all organophosphates is completed.
26
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B. Tolerance Summary
In the individual assessment, tolerances for residues of profenofos in/on plant commodities [40
CFR §180.241] are presently expressed in terms of profenofos and its metabolites converted to 4-
bromo-2-chlorophenol and calculated as profenofos. The Agency has concluded that profenofos^er
se is the compound of lexicological concern. The tolerance expression will be revised to reflect that
profenofos per se is the only regulated residue. Sufficient field trial data reflecting the maximum
registered use patterns are available to reassess the established tolerance for cottonseed; data indicate
that the existing cottonseed tolerance should be lowered from 3.0 ppm to 2.0 ppm.
Ruminant metabolism and feeding studies indicate that the established tolerances for the fat,
meat, and meat byproducts of cattle, goats, horses, and sheep (0.05 ppm), and for milk (0.01 ppm) are
adequate. Poultry metabolism and feeding studies indicate that there is presently no need for tolerances
for residues of profenofos per se in poultry tissues and eggs; the established tolerances should be
revoked. The Agency is revoking the tolerance for hogs based on feeding studies.
Tolerances To Be Proposed Under 40 CFR 180.404
A tolerance for cotton gin byproducts is needed. The registrant should submit a petition to
establish a new tolerance for cotton gin byproducts at 55 ppm.
Tolerances Listed Under 40 CFR 186.4975
Based on the results of an acceptable cottonseed processing study and the revision to the
tolerance expression, the established feed additive tolerance for cottonseed hulls should be revoked.
The Agency no longer recognizes soapstock as a significant feed item. The established feed additive
tolerance should be revoked. A tolerance summary of profenofos' tolerance reassessments is
presented in Table 4.
Table 4. Tolerance Summary for Profenofos
COMMODITY
CURRENT TOLERANCE
(ppm)"
TOLERANCE
REASSESSMENT (ppm)b*
COMMENT/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR 180.404:
Cattle, fat
Cattle, mbyp
Cattle, meat
Cottonseed
Eggs
Goats, fat
0.05
0.05
0.05
3.0
0.05
0.05
0.05
0.05
0.05
2.0
Revoke
0.05
Field trial data suggest that the established tolerance
for cottonseed should be lowered.
[Cotton, undelinted seed]
Poultry metabolism and feeding studies indicate that
tolerances are not needed for poultry commodities.
[Category 40 CFR 180.6(a)(3)]
27
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COMMODITY
Goats, mbyp
Goats, meat
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, mbyp
Horses, meat
Milk
Poultry, fat
Poultry, mbyp
Poultry, meat
Sheep, fat
Sheep, mbyp
Sheep, meat
CURRENT TOLERANCE
(ppm)'
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.01
0.05
0.05
0.05
0.05
0.05
0.05
TOLERANCE
REASSESSMENT (ppm)b*
0.05
0.05
Revoke
Revoke
Revoke
0.05
0.05
0.05
0.01
Revoke
Revoke
Revoke
0.05
0.05
0.05
COMMENT/
[Correct Commodity Definition]
Feeding studies indicate that tolerances are not
needed for hog commodities. [Category 40 CFR
180.6(a)(3)]
Poultry metabolism and feeding studies indicate that
tolerances are not needed for poultry commodities.
[Category 40 CFR 180.6(a)(3)]
Tolerances To Be Proposed Under 40 CFR 180.404:
Cotton, gin
byproducts
None
55.0
New RAC according to the 860 Residue Chemistry
Guidelines, 860.1000, Table 1 (August 1996).
Tolerances Previously Listed Under 40 CFR 186.4975:
Cottonseed hulls
Soapstock
6.0
15.0
Revoke
Revoke
Not warranted based on the results of an acceptable
cottonseed processing study and the revision to the
tolerance expression.
No longer considered a feed item by the Agency
(860 Residue Chemistry Guidelines, 860.1000, Table
1; August 1996).
* The term "reassessment" here is not meant to imply that the tolerance has been reassessed as required by FQPA, since this tolerance
may be reassessed only upon completion of the cumulative risk assessment of all organophosphates, as required by this law. Rather, it
provides a tolerance level for this single chemical, if no cumulative assessment was required, that is supported by all of the submitted
residue data.
The Agency will commence proceedings to revoke, modify the existing tolerances, and correct
commodity definitions. The establishment of a new tolerance will be deferred, pending the outcome of
the cumulative assessment.
C. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have an
effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate." Following recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
28
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include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and FFDCA
authority to require wildlife evaluations to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans. As the science develops and resources allow, screening of
additional hormone systems may be added to the Endocrine Disrupter Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the EDSP
have been developed, profenofos may be subject to additional screening and/or testing to better
characterize effects related to endocrine disruption.
D. Regulatory Position
Section IV.D-F outlines the specific risk mitigation measures established in this decision
document. Where labeling revisions are necessary, specific language is set forth in the summary tables
of Section V. The Agency believes the measures identified in this document will adequately mitigate the
risks associated with the use of profenofos. In particular, the Agency has determined the measures
discussed below will reduce risks to mixers/loaders and applicators involved in groundboom and aerial
applications, Saggers supporting aerial applications, postapplication handlers and workers, and mitigate
exposure to nontarget organisms. The registrant has agreed to amend the label incorporating all the
changes by the 2001 growing season.
The Agency has determined that profenofos must be used in closed systems to mitigate handler
and worker risks. Requiring closed systems resolves much of the worker risks associated with both
groundboom and aerial application. (Aerial application usually involves handling larger quantities of the
chemical than groundboom application, resulting in higher risk). The registrant has agreed to market the
product only in an advanced mixing/loading system. Enclosed cockpits must also be used for aerial
application. When closed loading systems are employed, mixer/loader and applicator risks are not of
concern for groundboom applications (given the smaller number of acres treated and the amount of
pesticide handled). Using enclosed cabs, restricted entry intervals and appropriate personal protective
equipment the risks to Saggers supporting aerial applications and the risk to postapplication workers
and handlers are also not of concern.
Although the current risk assessment indicates a concern for handlers involved in aerial
applications, the Agency believes that such risks do not raise a concern when all of the uncertainties and
mitigation measures outlined in this document are considered. To confirm this position, the Agency is
requiring the registrant to undertake an exposure study using the advanced mixing/loading technology
that will be marketed next year. This advanced system is expected to perform better than the older
closed mixing/loading systems currently reflected in the PFffiD database. The Agency believes that the
exposure study will confirm that the refined MOE's are actually much higher than the current estimates
using surrogate data Therefore, actual occupational exposures are expected to be less. The Agency
also recognizes that there is uncertainty in the endpoint used for the occupational risk estimates. There
is a 10-fold range between the NOEL observed in the rabbit 21-day dermal toxicity study and the
29
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LOEL. If this study were repeated, a higher NOEL might be identified indicating actual toxicity is less
than the Agency's current assessment suggests. The use of this improved system combined with the
label amendments are expected to confirm the Agency's belief that actual exposures and concomitant
risk are not of concern when profenofos is used as specified in this interim reregistration decision
document.
To further reduce potential exposure, the Agency is requiring a reduction in the seasonal
maximum application rate from 6 to 5 Ibs ai/A/season. Application at the 1 Ib ai/A rate will be limited
to twice per year and may be used only for severe lepidopteran infestations. Use under all other
conditions will be limited to 0.75 Ibs ai/A/application. Information reported by USDA indicates that
growers frequently use even lower application rates generally ranging from 0.46 to 0.62 Ib ai/A and
have used rates as low as 0.25 Ib ai/A. At this lowest application rate, occupational risks are not of
concern based on the current assessment.
The Agency is requiring an advisory notice be added to the label to inform crop advisors of the
potential risks to workers who reenter the field immediately after application. In particular, this
information can assist certified crop advisors [as defined by the Worker Protection Standard (WPS)]
who are exempt from the Agency's WPS requirements and allows them to determine the level of
protection that should be required for themselves and their employees during scouting activities.
Postapplication residue data indicate worker risks are of concern when cotton is harvested by
hand. Mechanical harvesting equipment significantly limits potential handler/harvester exposure.
Discussions with stakeholders indicate that virtually all harvesting is currently done mechanically. The
Agency is therefore requiring that "mechanical only" harvesting be allowed for profenofos.
To reduce the risks to aquatic animals and other nontargeted terrestrial organisms, the Agency
is requiring the use of buffer zones and vegetative strips and a continuation of the registrant's
stewardship programs. These measures, coupled with the rate changes, are expected to adequately
reduce ecological risk of profenofos.
Profenofos occupies a critical pest control niche for cotton growers in controlling lepidopteran
pests as stated earlier. The Agency has determined that the availability of profenofos is most critical
during severe pest pressure. In considering the potential alternatives, the Agency considered the
potential for pesticide resistance. The alternatives are used in combination with other pesticides,
including profenofos, as part of a resistance management strategy to maintain their viability as
efficacious materials for the control of the worm complex and several other target pests that profenofos
controls. Therefore, profenofos remains an important pest control tool.
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E. Human Health Risk Mitigation
The Agency has determined that the dietary aggregate exposure (food and water) is less than
the Agency's level of concern. However, risks to certain occupational workers and handlers is of
concern.
The Agency has also determined engineering controls are warranted to reduce short and
intermediate term occupational exposures. Additionally, the registrant has initiated a mammalian
pharmacokinetics study in preparation of a mixer/loader and applicator exposure study that may refine
the occupational exposure assessment.
1. Mitigation Measures
Dietary risk from food and water sources is less than the level of concern determined by the
Agency.
a. Dietary (food)
(i.) Acute
The acute dietary exposure estimate is below the Agency's level of concern for the general U.S.
population and all population subgroups. Infants and Children (1-6 years) are exposed to profenofos
at a level less than or equal to 8% of the aPAD (0.005 mg/kg/day) at the 95th exposure percentile. No
additional mitigation for acute dietary food risk is needed.
(ii.) Chronic
The chronic dietary risk estimate is below the Agency's level of concern for the general
population and all population subgroups. The risk is estimated to be less than 20% of the cPAD for all
population subgroups including Infants and Children (1-6 years). No additional mitigation for chronic
dietary food risks is needed.
b. Dietary (water)
The Agency's upper bound estimates of acute and chronic drinking water exposure are less
than the corresponding DWLOC. Therefore, risks from surface and ground water did not exceed the
Agency's level of concern. No mitigation for acute or chronic drinking water risks is required.
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c. Residential and Other Non-Occupational Risks
There are no residential or other non-occupational uses of profenofos. Therefore, no mitigation
is required.
d. Aggregate (food and water)
For profenofos the aggregate risk is limited to food and water because there are no residential
uses. The risk estimates presented do not exceed the Agency's level of concern for the most highly
exposed subpopulation, children and infants. No mitigation is required since the aggregate risks are
below the Agency's level of concern.
e. Occupational Risk Mitigation
Based on the Agency's revised occupational risk assessment, handlers of profenofos are
exposed (dermally) at a level of risk concern. Estimated MOEs for inhalation exposure are well over
the target MOE of 300 for all exposure scenarios and do not contribute significantly to the overall risk.
Therefore, inhalation risks are not a significant issue for reregistration. Absent dermal risk mitigation
measures such as the use of engineering controls, the Agency finds that mixers/loaders and applicators
supporting groundboom or aerial applications are subject to risks currently exceeding the Agency's
level of concern. To address these exposure concerns, the registrant is proposing to revise the
profenofos registration product labeling as specified below. The current label requires the use of
coveralls over short-sleeved shirt and short pants, chemical-resistant gloves, and chemical resistant
footwear plus socks. The current label also allows up to 6 applications per season at a rate of 1 Ib
ai/acre. The registrant is prepared to immediately implement the following measures:
• Produce product only in enclosed transfer system container starting with the year 2001 growing
season.
Stipulate the use of enclosed cabs and cockpits for groundboom applicators and flaggers, and
aerial applicators, respectively.
Conduct handler dermal exposure study (with engineering controls).
• Reduce the maximum application rate to 0.75 Ib ai/acre for all applications, except applications
to control lepidopteran pests.
Limit use of the maximum application rate of 1 Ib ai/A to twice per season and allow the
maximum rate only for lepidopteran pests (worm complex, such as caterpillars, etc).
• Prohibit pilots from mixing or loading on the same day.
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(i.) Mixers/Loaders
Groundboom: The MOE for mixer/loaders supporting groundboom applications is 101 if
engineering controls (i.e., closed mixing/loading systems) are used. Therefore, the Agency is requiring
mixers/loaders supporting groundboom applications to use closed mixing/loading systems.
Aerial: The MOE for mixer/loaders supporting aerial applications is 23 if engineering controls
(i.e., closed mixing loading system) are used.
As mentioned above, the registrant has agreed to modify the profenofos label immediately,
mandating the use of closed mixing/loading systems. The Agency is requiring the registrant to
manufacture profenofos in a closed/loading container system. The system must be used to mix/load and
enclose the pesticide in a manner to prevent it from contacting handlers. At the connection point, a dry
disconnector or dry coupler with not more than 2 ml drippage per disconnect must be installed to
ensure worker exposures do not exceed estimated levels. Because closed systems have been
commercially available for profenofos users for some time, the Agency does not anticipate that cotton
growers or commercial applicators will face difficulties in fully converting to such a use requirement.
The registrant is planning to conduct a biomonitoring study to better determine the level of
exposure associated with using the enclosed cockpits and closed mixing/loading systems at the
maximum label rate of 1 Ib ai/A for handlers (pilots and mixer/loaders) involved in aerial spray
applications. At this time the registrant is working on the metabolism study in the monkey to determine
the pharmacokinetics. This biomonitoring study may be substituted for a passive dosimetry study,
assuming the pharmacokinetics of profenofos are well understood and the study is acceptable.
Furthermore, when considering the recent use trend for profenofos, many mixers/loaders are
actually not exposed to profenofos at the levels estimated by the Agency. Use data from 1995-1997
reveal that only about 30% of profenofos applications were at the maximum application rate of 1 Ib
ai/A. The balance of applications were at rates equal to or less than 0.75 Ib ai/A. According to the
National Cotton Council, applications made early in the growing season may be as low as 0.25 Ib ai/A.
This is reportedly a practice common in many profenofos use areas in recent years. When considering
the Agency's current risk assessment, the mixers and loaders who work with profenofos at the lowest
rates are exposed at levels that are of less concern. It is only the handlers who work with the chemical
at the highest rates that have MOEs of the greatest concern to the Agency. Limiting the highest rate to
two times per season serves to reduce and limit the potential frequency of such exposures. The Agency
further expects that the remaining applications will be made at rates less than 0.75 Ib ai/A. Based on
information from the USD A, the National Cotton Council, and a review of available marketing
information, the Agency believes that these measures will reduce the potential for exposure in a
meaningful way.
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(ii.) Applicators and Flaggers
Similar to the mixer/loader measures discussed in the previous section, the registrant is also
modifying the profenofos label to address risks associated with dermal exposure to applicators and
flaggers using profenofos. When using engineering controls as discussed in Section m, the MOEs are
as follows: groundboom applicators, 180; aerial applicators, 40; and aerial flaggers, 1000. Therefore,
the registrant has agreed to require the use of enclosed tractor cabs and enclosed cockpits, which are
widely available for profenofos users. Mechanical flaggers may also be used. A compliant enclosed
cab/cockpit has a nonporous barrier that completely surrounds the occupants of the cab and prevents
dermal contact with the pesticide outside of the cab/cockpit. Such new use requirements should not
pose any difficulty for cotton growers and commercial applicators because such measures are routinely
used (verbal communication with National Cotton Council, 1999).
With the use of enclosed cabs, groundboom applicator and flagger risks are significantly
reduced and are not of concern to the Agency. However, the aerial applicator risk is not reduced
below the Agency's level of concern at the higher use rates. As stated previously, the Agency believes
the proposed interim risk mitigation measures being implemented by the registrant immediately are
appropriate and consistent with Agency goals for interim reregistration of the organophosphates. For
profenofos, reduction in the seasonal and single application rates, the use of closed systems, and
information on decreasing use trends all support the Agency's decision to proceed with the interim
reregistration. However, if the results of the worker exposure study show that these measures are not
as effective as anticipated, the Agency may revisit this decision. Meanwhile, the Agency is prohibiting
pilots from participating in mixing/loading operations on the same day of application. The Agency
believes this measure, coupled with the adoption of closed systems and the modified application rate,
will reduce exposure levels to aerial applicators.
The Agency is also concerned about applicators/Saggers that must enter or exit contaminated
cabs in a treated area. A chemical resistant apron or coveralls, and chemical resistant gloves must be
available for flaggers or applicators to use when exiting a cab in the treated area.
(iii.) Other Handlers
In addition to mixers, loaders and applicators, the Agency is concerned about potential
exposure to other handlers who participate in tasks where engineering controls are not feasible or may
fail (e.g., cleaning, adjusting or repairing equipment; disposing of containers; opening or closing hoses;
or cleaning up spills). Secondary exposure and risks may result from profenofos residues that may
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remain on the equipment or in the use area. The PPE necessary to protect these handlers include the
following:
• double layer of clothing (e.g., coveralls worn over long sleeve shirt and long pants)
chemical resistant gloves
• socks and chemical resistant footwear
chemical resistant apron (for use by handlers when cleaning equipment).
(iv.) Postapplication Workers and Handlers
The Agency is also concerned about postapplication exposure and risks to workers performing
routine tasks such as hoeing, scouting, or the like in the treated area. The Agency estimated
postapplication risks to such individuals from two foliar dissipation studies (MRID 428513-04 and
428513-03) and a worker reentry study that also included a dislodgeable foliar residue (DFR) study
(MRID 428513-02).
The DFRs were based on using six applications at the 1 Ib ai/A maximum labeled rate. The
maximum application rate for profenofos may not be used in all cases and may overestimate risks in
instances when a lower application rate is used. However, pest pressures could warrant more than one
application at the maximum rate; therefore, the Agency believes the existing data appropriately
measures the highest potential dermal exposure. These studies allow the Agency to develop mitigation
that is protective for all potential use scenarios. In this case, the mitigation measures are consistent with
the requirements outlined under the WPS.
Based on the results of DFR studies that included scouting activities (see Table 3), the Agency
is identifying entry restrictions to protect workers that need to reenter a treated field. The Agency is
also concerned about the potential risks associated with scouting activities. Generally, scouts work
under the supervision of crop advisors. Crop advisors that have been certified or licensed as required
in the WPS and employees that work under their direct supervision are exempt from some reentry
requirements. Certified crop advisors are authorized to determine the personal protection measures
deemed necessary to protect the health of the scouts under their direct supervision.
The Agency believes the requirements discussed below are necessary to protect
postapplication workers and scouts. These requirements do not apply to certified crop advisors and
persons under their direct supervision at this time. The Agency is including an advisory notice on the
label to assist certified crop advisors with determining the proper level of protection that should be
required for scouting tasks.
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Early Entry Workers (as defined by WPS^: Early-entry personnel must use protective
equipment of coveralls; chemical-resistant gloves and shoes and socks. Early-entry personnel
in non-arid (areas receiving at least 25" annual rainfall) areas should follow the above
requirements for 48-hours after treatment and in arid areas should follow the above
requirements for 72-hours after treatment.
• Double notification is required in accordance with WPS due to high dermal toxicity.
• Employees not under the direct supervision of certified crop advisors: Same as early entry
workers and handlers per WPS.
• Only mechanical harvesting is allowed.
Postapplication-certified crop advisors and their employees. As mentioned in section IV.D.,
certified crop advisors and their employees are generally exempt from WPS provisions that address
postapplication risks. However, for profenofos, the Agency reviewed field studies submitted by the
registrant that indicate potential risks to scouts reentering treated fields. The Agency is committed to
providing information and appropriate guidance to the regulated community. Therefore, the Agency is
recommending that (1) associations representing certified crop advisors voluntarily inform scouts of the
potential risks and the need to be protected during the REI; and (2) the following statement must be
placed on the label:
ADVISORY TO CERTIFIED CROP ADVISORS: Users should inform Certified Crop
Advisors [as defined by the Worker Protection Standard (WPS)] that people engaged in scouting
activities should wear coveralls, shoes and socks, and chemical resistant gloves made of any
waterproof material when entering treated areas during the first 48 hours following application (72
hours in areas where the average rainfall is less than 25 inches per year).
F. Ecological Risk Mitigation
1. Aquatic Animals
Some risk quotients for fish and aquatic invertebrate exceed the Agency's level of concern.
RQs range from 0.02-6.4 compared to an acceptable RQ of 0.5. The registrant submitted studies on
the mobility, hydrolysis, adsorption/desorption, and volatility of profenofos and its degradates in alkaline
or neutral soils. Similar data for acidic conditions was not available, therefore, the Agency is not able to
fully assess how profenofos acts under all soil conditions. However, the Agency also assessed several
fish kill incident reports which did indicate that profenofos was either one of the potential pesticides or
the only pesticide implicated in the fish kills. No reports of misuse were associated with any of the fish
kill incidents.
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Relying upon these fish kill incident reports, the Agency concludes that such incidents were
attributable to profenofos use in accordance with the current label requirements. Although the incident
reports did not identify site-specific conditions that may have contributed to the fish kills, an evaluation
of the incident data and the fate profile suggests that the risk posed to fish from profenofos use is likely
to be greater in regions that are susceptible to runoff with neutral to acidic soil conditions. This is more
of a concern in the Mid-south and Southeast cotton region than in the Southwest or Texas.
2. Nontarget Terrestrial Organisms
Profenofos is highly toxic to bees, birds, and small mammals based on test results. The RQ
values ranged from 0.53-0.76 for terrestrial animals (exceeding the acute risk level of concern of 0.5 or
greater). Endangered species levels of concern are exceeded for birds and small mammals from the
use of a single application at the maximum rate.
3. Mitigation Measures
a. Aquatic animals
To protect nontarget aquatic animals and reduce risk to nonterrestrial animals:
• Expand all aerial application buffer restrictions to 300 feet for all water bodies (or aquatic
habitats) irrespective of wind conditions. (Implementing buffer zones would not limit the ability
to plant, but rather restricts the application of the pesticide in the buffer areas.) Under the
current label, the 300-foot buffer pertains only to impounded waters upwind of application.
Most of the reported fish kill incidents occurred in nonimpounded water bodies.
• Use vegetative buffer strips as a means of protecting water bodies from runoff. The
adsorption/desorption characteristics of profenofos suggest that vegetated buffers should be
effective at preventing the movement of profenofos into nearby waters. The label should state
that buffer width determination should be made in consultation with the local USDA and
Natural Resource Conservation Service (NRCS) officials, taking into account the adsorption
characteristics of profenofos. The Agency also believes the requirement for vegetative buffer
strips will not pose a significant hardship on cotton-growers, because the synthetic pyrethroids
which are used on cotton already require vegetative buffers.
• Prohibit application of profenofos in saturated soils. Do not treat while precipitation is
occurring, or while conditions favor runoff from the treated area.
• Require 100 foot buffer zone for all waters for groundboom application irrespective of wind
direction.
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b. Birds and Mammals
Although RQs are exceeded for birds and small mammals, the Agency expects the other
proposed mitigation measures will result in lower exposure for terrestrial animals. The proposed
measures will reduce drift potential to off-field habitats and, thus, reduce exposure via food sources at
and beyond the edge of the field. Also, the reduction in the application rate to mitigate worker risks
should reduce the amount of pesticide applied and would have the effect of reducing the level of
exposure. The Agency typically receives fewer incident reports for terrestrial organisms unless the
exposure involves immediate mortality to large numbers of birds. Such incidents are not usually
observed or reported. Should additional information come to the Agency's attention indicating birds or
small animals are being adversely impacted, the Agency will take appropriate action at that time.
c. Additional Measures
Even though educational programs are not labeling measures, the registrant supports two
voluntary educational programs that are available to growers and provide valuable information on the
use of profenofos and potential hazards. The Delta program provides information to growers in
Mississippi on a case-by-case basis on what best management practices to implement to avoid runoff
into surface waters. The other program known as the Stewardship program is a website sponsored by
the National Cotton Council that provides information on how to use profenofos to minimize
environmental impacts. The information is important because it includes advice on ways to minimize
risks to aquatic life and to avoid future fish kills. The registrant has agreed to expand the Stewardship
program and outreach efforts to ensure that all growers are aware of the requirements and the potential
impacts of profenofos on aquatic animals. The expansion will require the registrant to take the following
steps:
• At routine grower meetings, provide relevant information on ways to minimize runoff or drift,
thereby minimizing the potential for fish kill incidents.
Link the company website to the Cotton Council website for the Stewardship program.
• Include information on the label concerning the website (URL address, information on use
practices).
• Coordinate with state agencies, universities and special interest groups to provide outreach
programs. Periodically (annually) evaluate the website use to determine the number of users
that are accessing the information as a gauge of its utility.
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4. Other Options Considered
The Agency requested the public to submit any mitigation proposals or comments to address
the potential ecological/environmental risks for profenofos at the technical briefing held on June 16,
1999,( 64 FR 32229). None were received.
5. Other Labeling Requirements
a. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection
Program") to identify all pesticides whose use may cause adverse impacts on endangered and
threatened species and to implement mitigation measures that will eliminate the adverse impacts. The
program would require use restrictions to protect endangered and threatened species at the county
level. Consultations with the Fish and Wildlife Service may be necessary to assess risks to newly listed
species or from proposed new uses. In the future, the Agency plans to publish a description of the
Endangered Species Program in the Federal Register and have available voluntary county-specific
bulletins. Because the Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through the RED.
In the future, the Agency plans to publish a description of the Endangered Species Program in
the Federal Register. EPA is in the process of developing county-specific bulletins that specify
measures to protect endangered and threatened species. Although bulletins have not yet been
developed for all counties where they will be needed, EPA has completed and distributed over 300
county bulletins.
b. Spray Drift Management
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and
State Lead Agencies for pesticide regulation and other parties to develop the best spray drift
management practices. The Agency is now requiring interim mitigation measures for aerial applications
that must be placed on product labels/labeling as specified in section V of this document. The Agency
has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a
membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the
data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard
airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further
refinements in spray drift management practices to reduce off-target drift and risks associated with
aerial as well as other application types where appropriate. In the interim, the following spray drift
related language is required on product labels that are applied outdoors in liquid sprays (except
mosquito adulticides), regardless of application method:
"Do not allow this product to drift"
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V. What Registrant Must Do
This section specifies the data requirements, responses and labeling changes 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 profenofos for the eligible uses has been
reviewed and determined to be substantially complete. Based on a need to further refine the
occupational and ecological risk assessments, the Agency is requiring the following additional data.
Product Use Information. (Guideline 875.1700)
• Dermal Exposure Outdoor. (Guideline 875.1100)
• Full Fish Life Cycle Study for freshwater fish (Guideline 72-5)
The above studies will be used as confirmatory data. If the Agency finds that new studies
identify additional risks of concern, the Agency will reconsider the measures established in this Interim
RED. The Agency will issue a Data Call-In (DCI) requiring these studies.
Also, a Data Call-in Notice (DCI) was recently sent to registrants of organophosphate
pesticides currently registered under FIFRA (August 6, 1999 64FR42945-42947, August 18
64FR44922-44923). DCI requirements included acute, subchronic, and developmental neurotoxicity
studies; due dates are 9/2001. Registrant responses are under review.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MUP) labeling must be
revised to comply with all current Agency regulations, PR Notices and applicable policies. The MUP
labeling must bear the labeling contained in the table at the end of this section.
All registrants must submit applications for amended registration. This application should
include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with all
required label amendments outlined in Table 5 of this document incorporated, and a description on the
application, such as, "Responding to Interim Reregistration Eligibility Decision" document. All amended
labels must be submitted within 90 days of receipt of this document. The Registration Division contact
for profenofos is Ms. Marilyn Mautz. Her phone number is (703) 308-6785.
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B. End-Use Products
To remain in compliance with FIFRA, end-use product (EUP) labeling must be in compliance
with all current Agency regulations, PR Notices and applicable policies.
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current Agency acceptance criteria and if not,
commit to conduct new studies. If a registrant believes that previously submitted data meet current
testing standards, then study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
Label changes are necessary to implement mitigation measures outlined in Section IV above.
These changes include reduction in application rates, except for lepidopteran pests; additional
engineering controls or Personal Protective Equipment; mechanical harvesting requirements; retain the
restricted-use classification and add a notation that the classification is due to high toxicity. Specific
language to implement these changes is specified in table 5 below. Registrants must submit applications
for amended registration. This application should include the following items: EPA application form
8570-1 (filled in), five copies of the draft label with all required label amendments outlined in Table 5 of
this document incorporated, and a description on the application, such as, "Responding to Interim
Reregistration Eligibility Decision" document. All amended labels must be submitted within 90 days of
receipt of this document. The Registration Division contact for profenofos is Ms. Marilyn Mautz. Her
phone number is (703) 308-6785.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 12 months
from the date of the issuance of this Interim Reregistration Eligibility Decision document. Persons other
than the registrant may generally distribute or sell such products for 24 months from the date of the
issuance of this interim RED. However, existing stocks time frames will be established case-by-case,
depending on the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register. Volume 56, No.
123, June 26, 1991.
The Agency has determined that the registrant may distribute and sell profenofos products
bearing old labels/labeling for 12 months from the date of issuance of this interim IRED. Persons other
than the registrant may distribute or sell such products for 24 months from the date of the issuance of
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this IRED. Registrants and persons other than the registrant remain obligated to meet pre-existing
Agency imposed label changes and existing stocks requirements applicable to products they sell or
distribute.
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D. Required Labeling Changes Summary Table
A summary of the required label changes for profenofos is shown in Table 5.
Table 5: Summary of RED Labeling Requirements for Profenofos
Description
Required Labeling
Placement on Label
Manufacturing Use Products
Formulation
Instructions required
on all MUPs
One of these
statements may be
added to a label to
allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user
group.
Environmental
Hazards Statements
"Only for formulation into an insecticide/miticide for use on cotton."
'This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of such use(s)."
'This product may be used to formulate products for any additional use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements regarding support of such use(s)."
"Environmental Hazards"
"This chemical is toxic to terrestrial and aquatic plants, fish and aquatic invertebrates. Do not discharge effluent containing this product
into lakes, streams, ponds estuaries, oceans or other waters unless in accordance with the requirements of a National Pollutant Discharge
Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge
effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance
contact your state Water Board or Regional Office of the EPA."
Directions for Use
Precautionary
Statements under
Environmental Hazards.
Buffer zones also must
appear in directions for
use.
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Description
Restricted Use
Pesticide
IRED PPE
Requirements
User Safety
Requirements
Required Labeling
End Use Products Intended for Occupational Use (WPS)
"RESTRICTED USE PESTICIDE". "For retail sale to and use only by certified applicators or persons under their direct supervision, and
only for those uses covered by the certified applicator's certification.
Due to hiah toxicitv.
Personal Protective Equipment
"Some materials that are chemical resistant to this product are (registrant inserts correct material as per supplement 3 of PR notice 93-7).
If you want more options, follow the instructions for category [registrant inserts A, B, C, D, E, F, G, or H] on an EPA chemical-resistant
category selection chart."
Mixers, loaders, applicators, flaggers, and other handlers using engineering controls (see requirements below) must wear:
- long-sleeve shirt and long pants,
- shoes plus socks
- chemical resistant gloves and chemical resistant-apron when mixing and loading."
"Handlers for which use of an engineering control is not possible and engaged in activities, such as cleaning up a spill or leak and
cleaning or repairing contaminated equipment must wear:
~ coverall over long-sleeve shirt and long pants,
— chemical-resistant gloves (registrant inserts correct glove types)
~ chemical-resistant footwear plus socks
~ chemical-resistant apron,
NOTE: The PPE that would otherwise be established based on the acute toxicitv of each end-use product must be compared to the
minimum personal protective equipment, specified above. The more protective PPE must be placed on the product labeling. Fro
guidance on which PPE is considered more protective, see PR Notice 93-7.
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot
water. Keep and wash PPE separately from other laundry."
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated with this product's concentrate. Do not
reuse them."
Placement on Label
Top of Front Panel
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
reauirements
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Description
Required Labeling
Placement on Label
Engineering Controls
"Engineering Controls"
"Mixers and loaders must use a mechanical transfer system that meets the requirements listed in the Worker Protection Standard (WPS)
for agricultural pesticides [40 CFR 170.240(d)(4)] for providing dermal protection. The system must be capable of removing the pesticide
from the shipping container and transferring it into mixing tanks and/or application equipment. At any disconnect point, the system must
be equipped with a dry disconnect or dry couple shut-off device that is warranted by the manufacturer to minimize drippage to not more
than 2 ml. per disconnect point."
"Persons using a closed system that operates under pressure shall wear protective eyewear."
"Pilots must:
— use an enclosed cockpit that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d)(6)];
"Ground-equipment applicators and flaggers must use an enclosed cab that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(5)]."
"All mixers, loaders, applicators, and flaggers must wear the personal protective equipment specified above for the task they are
performing and all (except aerial applicators) must be provided and must have immediately available for use in an emergency, such as a
spill, equipment failure or if exiting a cab in a treated area, the PPE specified above for handlers not using engineering controls."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
following PPE and User
Safety Requirements.)
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE 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."
"ADVISORY TO CERTIFIED CROP ADVISORS: Users should inform Certified Crop Advisors [as defined by the Worker Protection
Standard (WPS)] that people engaged in scouting activities should wear coveralls, shoes and socks, and chemical resistant gloves made of
any waterproof material when entering treated areas during the first 48 hours following application (72 hours in areas where the average
rainfall is less than 25 inches per year).
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
(Must be placed in a
box.)
(Immediately following
Engineering Controls)
45
-------
Description
Required Labeling
Placement on Label
Environmental
Hazards
"Environmental Hazards:
Due to the hazard to endangered fish, the application of this product is prohibited in Reeves County, TX and within one mile of the
Dexter National Fish Hatchery in NM. This pesticide is acutely toxic to fish and wildlife. Do not apply to saturated soil and do not treat
while precipitation is occurring, or while conditions favor runoff from the treated area due to the potential for surface water runoff mat
may cause fish kills. Use with care when applying to areas frequented by wildlife or adjacent to any body of water. For terrestrial uses, do
not apply directly to water, or to area where surface water is present, or to intertidal areas below the mean high water mark. Do not
apply with aircraft within 300 ft. of any waterbody including impounded waters, rivers, streams, lakes, oceans. Do not apply with aircraft
when wind speed is greater than 10 mph. Do not apply with groundboom equipment within 100 ft. of any waterbody including impounded
waters, rivers, streams, lakes, oceans. Use vegetative buffers Apply this pesticide only as specified on this label. Do not contaminate water
when cleaning equipment or disposing of equipment washwaters."
This product is highly toxic to bees exposed to direct treatment or residues on crops or weeds. Do not apply this product or allow it to
drift to crops or weeds on which bees are foraging. Additional information may be obtained from your Cooperative Agricultural
Extension Service.
Precautionary
Statements under
Environmental Hazards
Buffer zones should be
reported in Directions
For Use.
Restricted-Entry
Interval
"Do not enter or allow workers to enter into treated areas during the restricted entry interval (REI) of 48 hours."
"The REI is 72 hours in areas where average rainfall is less than 25 inches a year."
Directions for Use,
Agricultural Use
Requirements Box
Personal protective
equipment required
for early entry
"PPE required for early entry to treated areas mat is permitted under the Worker Protection Standard and mat involves contact with
anything mat has been treated, such as plants, soil, or water is:
- Coveralls
- Chemical-resistant gloves made of any waterproof material.
- Shoes and socks.
Use of protective eyewear will be retained as on the current label for the end-use product.
"Notify workers of the application by warning them orally and by posting warning signs at entrances to treated areas"
General Application
Restrictions
"Do not apply this product in a way mat will contact workers or other persons, either directly or through drift. Only protected handlers
may be in the area during application."For any requirements specific to your State or tribe, consult the agency responsible for pesticide
regulation.
"Cotton treated with mis product must be mechanically harvested. Hand harvesting is prohibited." "Pilots are prohibited from
participating in mixing or loading on the day of application."
"Do not allow this product to drift."
Directions for Use
immediately preceding
the Agricultural Use
Requirements box.
Buffer Zone
Restrictions
Do not apply with aircraft within 300 ft. of any waterbody including impounded waters, rivers, streams, lakes, oceans. Do not apply with
aircraft when wind speed is greater than 10 mph. Do not apply with groundboom equipment within 100 ft. of any waterbody including
impounded waters, rivers, streams, lakes, oceans. Apply this pesticide only as specified on this label. Do not contaminate water when
cleaning equipment or disposing of equipment washwaters
Directions For use
Aerial Spray Drift
Label Language
"Aerial Spray Drift Management"
"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 and the grower are responsible for considering all these factors
when making decisions."
Directions for Use
46
-------
Description
Required Labeling
'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.
l.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.
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."
Placement on Label
Continued...
Aerial Spray Drift
Label Language
Directions for Use
Continued...
Aerial Spray Drift
Label Language
"Aerial Drift Reduction Advisory"
'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)."
Directions for Use
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals that can
be applied aerially)
"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. 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."
Directions for Use
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals applied
aerially)
"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."
Directions for Use
47
-------
Description
Required Labeling
Placement on Label
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals that can
be applied aerially)
"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."
Directions for Use
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals that can
be applied aerially)
"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.)"
Directions for Use
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals that can
be applied aerially)
"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."
Directions for Use
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals that can
be applied aerially)
"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."
Directions for Use
Continued...
Aerial Spray Drift
Label Language
(*only required for
chemicals that can
be applied aerially)
"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."
Directions for Use
Continued...
Aerial Spray Drift
Label Language
"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)."
Directions for Use
48
-------
Description
Required Labeling
Placement on Label
Other Applications
Restrictions.
Maximum 5 Ib ai/A per season:
- 0.75 Ib ai/A or less per application.
- For lepidopteran pests only, you may use 1.0 Ib ai/A/ maximum 2x per season.
For information on use practices refer to the Cotton Council website: http://www.carefulbynature.org.
Directions for Use under
General Precautions and
Restriction or
Application Instructions.
49
-------
VI. Related Documents and How to Access Them
This interim Reregistration Eligibility Decision is supported by documents that are presently
maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays
from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of
September 10, 1998. Sixty days later the first public comment period closed. The EPA then
considered comments, revised the risk assessment, and added the formal "Response to Comments"
document and the revised risk assessment to the docket on June 16, 1999.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the Internet at the following site: 'http://www.epa.gov/opp/op."
The following documents were considered in the risk management assessment and proposal.
Revised HED Assessment
Revised EFED Assessment
Response to Comments (chemical specific)
Response to Generic Comments
Registrant Meeting Minutes
50
-------
VH. APPENDICES
51
-------
52
-------
Appendk A. TABLE OF USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Cotton
At-plant, through
defoliation
Foliar Spray
Groundboom
Aerial
Formulation
[EPA Reg.
No.]
8 Ib/gal EC
[100-669]
Max. Single
App. Rate
(Ib ai/A)
1*
Max. No. of
Apps.
5*
Min.
Retreatment
Interval
None
Restrictions/Comments
Restricted use Chemical. Not for residential use, or
other nonoccupational uses. "Mechanical
Harvesting Only"; requires use of closed systems.
Do not allow to drift.
EC, emulsiliable concentrate
' 0.75 Ib ai/A or less per application; 1.0 Ib ai/A 2x per season for lepidopteran allowed. Maximum 5 Ib ai/A per season.
53
-------
54
-------
Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES
USED TO MAKE THE REREGISTRATION DECISION
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active
ingredients within the case EPTC covered by this RED. It contains generic data requirements that
apply EPTC in all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in the following formats:
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 Guidance, which are available from
the National technical Information Service, 5285 Port Royal Road, Springfield, VA
22161 (703)487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use
patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MIRD) 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.
55
-------
56
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
875.1700
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7860
830.7950
REQUIREMENT
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
Product Use Information
Product Identity and Disclosure of
Ingredients
Start. Mat. & Mfg. Process
Formation of Impurities
Preliminary Analysis
Certification of Ingredient Limits
Analytical Methods to Verify the Certified
Limits
Color
Physical State
Odor
Melting Point
Boiling Point
Density, Bulk Density or Specific Gravity
Solubility
Vapor Pressure
USE
PATTERN
All
All
All
All
All
All
All
All
All
All
N/A
All
All
All
All
CITATION(S)
Data Gap
40445001, 43665301
40445001, 43665301
40445001, 43665301
40445002, 43665302
40445002
40445002, 43665302
42030301
42030301
42030301
N/A
42030301, 42731401
42030301, 42731401
42030301, 42731401
42030301
57
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
830.7370
830.7550
830.7000
830.6313
REQUIREMENT
63-10
63-11
63-12
63-13
Dissociation Constant
Octanol/Water Partition Coefficient
Ph
Stability
USE
PATTERN
All
All
All
All
CITATION(S)
42030301, 42731401
40445003, 42854201
42030301, 42731401
40445003, 42854201, 42968701
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
850.1075
850.1010
850.1025
850.1025
71-1A
71-2A
71-2B
71-4
71-4B
72-1B
72-1C
72-2A
72-3A
72-3B
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Avian Reproduction
Reproduction toxicity - Mammal
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Acute Toxicity - Pinfish,
Mysid
Estuarine/Marine Acute Toxicity - Mollusk
41627301,
43107301
43107302
92148004, 92148006
00105226, 00105228
92148008
92148009
41627304, 41614807
92148010, Ace. 24621
92148011
58
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
850.1035
850.1400
850.1300
850.1500
850.4225
850.4230
850.4250
850.4250
885.4380
REQUIREMENT
72-3C
72-4
72-4B
72-5
123-1A
123-1B
123-2
154a-24
Estuarine/Marine Acute Toxicity - Pink
Shrimp
Fish Early Life Stage Toxicity - Fathead
Minnow
Aquatic Invertebrate Life Cycle Toxicity -
Daphnia Magna
Full Fish Life Cycle
Seed Germination/Seedling Emergence
Vegetative Vigor
Aquatic Plant Growth
Nontarget - Honey Bee Test Tier 1
USE
PATTERN
CITATION(S)
92148012
92148014
92148013
Data Gap
41627305
44735901
42265101, 42265102, 42265103,
42265104, 42265105
41627308
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
81-1
81-2
81-3
81-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
41714801 , 43213302
00109427, 00105231
00109428
00109429
59
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
870.2500
870.2600
870.6100
870.3100
870.3150
870.3200
870.3465
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
REQUIREMENT
81-5
81-6
81-7
82-1A
82-1B
82-2
82-4
82-5B
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
83-5
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation - Rat
90-Day Neurotoxicity - Mammal
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Chronic Toxicity/Carcinogenicity - Mice/Rat
USE
PATTERN
CITATION(S)
41714802
00109431
00126485, 00082083, 00082085
00105255, 00105226, 00105228
00105228
41644501
00143576
42939801, 42939802
00081685
00081687, 00108016
00081685
40033301
40033201
43211308, 43213309
00082901, 00081685
60
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
870.6300
885.3650
870.5250
870.5375
870.7485
REQUIREMENT
83-6
152a-30
84-2A
84-2B
84-4
85-1
Developmental Neurotoxicity
Reproductive Toxicity - Rats
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
USE
PATTERN
CITATION(S)
00045031
43213308, 43213309
41866901
41945103
41945102, 41945101
42334301
OCCUPATIONAL EXPOSURE
875.2100
875.2200
875.2400
875.1100
875.2500
132-1A
132-1B
133-3
875.1100
133-4
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry Exposure
Dermal Exposure Outdoor
Inhalation Passive Dosimetry Exposure
42851302, 42851303, 42851304
Waived
Reserved
Data Gap
00082079
ENVIRONMENTAL FATE
835.2120
835.2240
160-5
161-1
161-2
Chemical Identity
Hydrolysis
Photodegradation - Water
41627309, 41939001
41879901, 41939002
61
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
835.2410
835.4100
835.4200
835.4400
835.1230
835.1410
835.6100
REQUIREMENT
161-3
162-1
162-2
162-3
163-1
163-2
164-1
165-4
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Volatility - Lab
Terrestrial Field Dissipation
Bioaccumulation in Fish
USE
PATTERN
CITATION(S)
41627310
42334302
42334303
42218101
41627311
41905001
42851301, 42900901
00085952, 92148059
RESIDUE CHEMISTRY
860.1300
860.1340
171-4A
171-4B
171-4C
171-4D
171-4E
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - Animals
Storage Stability
00045036, 00045037, 43186801
00046063, 00046064, 00046085,
00048056, 43301901, 43301902
00086645, 00105244, 43203501
00105243,3354801
42535202, 42928401-42928409, 43430101
62
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Profenofos
860.1500
860.1520
860.1480
860.1480
860.1400
860.1850
860.1900
REQUIREMENT
171-4K
171-4 (1)
171-40)
171-40)
171-4 (f)
171-4 (g)
165-1
165-2
Crop Field Trials - Cottonseed and gin
byproducts
Magnitude of the Residues in Processed
Food/Feed
Magnitude of the Residue in Meat, Milk,
Poultry, and Eggs:
Milk and the Fat, Meat, and Meat
Byproducts of Cattle, Goats, Hogs, Horses,
and Sheep
Magnitude of the Residue in Meat, Milk,
Poultry, and Eggs
Eggs and the Fat, Meat, and Meat
Byproducts of Poultry
Nature and Magnitude of
the Residue in Water
Nature and Magnitude of
the Residue in Fish
Rotational Crops (Confined)
Rotational Crops (Field)
USE
PATTERN
N/A
N/A
Reserved
CITATION(S)
00045035, 00045038, 00046060,
00105217, 00106649, 42535201,
92148055
00046060, 00105217, 00106649,
92148057
00046061, 00046062, 00046065,
00046067, 00048057, 00105217,
00106649, 92148050-92148051
00046061, 00046063, 00046064,
00046067, 00048056, 00105217,
00106649, 92148052-92148053
N/A
N/A
00086647, 00086650
N/A
These data are required to support a preharvest interval of less than 30 days for tomatoes. To support a plantback harvest interval of less
than 4 months, upgraded confined rotational studies or limited field studies (to include seeking metabolites of potential lexicological concern and
the parent) must be submitted for all crops, including tomatoes and sugar beets.
63
-------
64
-------
Appendk C. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION
(BIBLIOGRAPHY)
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
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.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The
Agency has also attempted to unite basic documents and commentaries upon them, treating
them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should
be used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the
review may be preceded by a nine character temporary identifier. These entries are listed after
all MRID entries. This temporary identifying number is also to be used whenever specific
reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA, by
a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for certain
special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
65
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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 the date from the
evidence contained in the document. When the date appears as (1999), the Agency
was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
66
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00045301 Fritz, H. (1974) Reproductive Study-Technical CGA 15324: Rat: Segment H (Test for
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study received Mr 4, 1977 under 100-EX-53; prepared by Ciba-Geigy, Ltd.,
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00045035 Houseworth, L.D.; Tweedy, E.G. (1977) Residues of Curacron(R) and Guthion in or
on Cottonseed Resulting from Tank Mix Applications to Cotton: Summary: Report No.
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14C-CGA-15324 Sprayed on Cotton and the Degradation of this Compound in Soil:
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00045037 Simoneaux, B.J.; Thomas, R.D.; Cassidy, I.E. (1976) The Metabolism of
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No. 3513. (Compilation; unpublished study including AG-A nos. 3596 A,
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00046061 Seim, V.W. (1975) Residue Report: Corn Oil: AG-A No. 3883 I, II, HI.
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00046063 Seim, V. (1976) Residue Report: Eggs: AG-A No. 3895 m,IV. (Unpublished study
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00046064 Seim, V. (1976) Residue Report: Chicken Breast, Thigh, Liver, Fat: AG-A No. 3896
m,IV,V. (Unpublished study received Nov 19,1976, under 100-EX-53; submitted by
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00046065 Seim, V. (1976) Residue Report: Blood, Loin, Perirenal Fat, Omental Fat, Liver,
Kidney, Round Steak: AG-A No. 3915 I,II,m. (Unpublished study received Nov 19,
1976 under 100-EX-53; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
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00046067 Smith, J.W.; Kahrs, RA. (1976) Stability of CGA-15324 and Its Metabolites in
Frozen Storage: Report No. GAAC-76034. (Unpublished study received Nov 19,
1976 under 100-EX-53; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:095614-I)
00046085 Thomas, R.D.; Cassidy, I.E. (1976) Metabolism and Balance Study of
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(Unpublished study received Nov 18, 1976 under 100-EX-53; submitted by
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00048056 Seim, V.W. (1975) Biological Report for the Residue Study of CGA-15324 in Poultry
and Eggs: Report No. BIOL-2. (Unpublished study received Nov 18, 1976 under
100-EX-53; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095615-O)
00048057 Seim, V.W. (1976) Biological Report for CGA-15324 Residue Test in Lactating
Cows: Report No. BIOL-3. (Unpublished study including published data, received
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Animal Hospital, submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:095615-P)
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rept. (Unpublished study received Aug 20, 1981 under 100-598; prepared by
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N.C.; CDL:245709-B; 245710; 245715)
00081687 Gfeller, W.; Kobel, W.; Schaeppi, U. (1981) CGA 15'324 Techn.: 6-month Toxicity
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under 100-598; prepared by Ciba-Geigy Ltd., Switzerland, submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL:245719-A; 245720; 245721)
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00082085 Reinart, D.; Fletcher, D.; Arceo, R.J.; et al. (1978) Report to Ciba-Geigy Corporation:
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8580-11187. (Unpublished study, including letter dated Feb 5, 1979 from J.F. Ellis to
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Technical in Albino Mice: Project No. 483-133. (Unpublished study received Feb 14,
1979 under 100-598; submitted by Ciba-Geigy Corp., Greensboro, N.C.;
CDL:097800-A)
00085952 Cargile, N.L.; Cassidy, I.E. (1977) The Metabolism of [Phenyl]-14C-CGA-15324 in
Bluegill Fish; M12-130-4F: Report No. ABR-77076. (Unpublished study received
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CDL:246216-E)
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00086645 Kahrs, R.A.; Smith, J.W.; Ross, J.A. (1978) Gas Chromatographic Method for
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Method no. AG-322 dated Feb 17, 1978. (Unpublished study received Nov 6, 1981
under 100-598; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:246218-H)
00086647 Simoneaux, B.; Cassidy, I.E. (1977) Uptake of the Soil Metabolites of
[Phenyl]-144C-CGA-15324 by Rotation Soybeans: Report No. ABR-77005.
(Unpublished study received Nov 6, 1981 under 100-598; submitted by Ciba-Geigy
Corp., Greensboro, N.C.; CDL: 246218-K)
00086650 Simoneaux, B.; Cassidy, I.E. (1978) Uptake of [Phenyl]-14C-CGA-15324 and Its
Soil Metabolites by Cotton Grown in a Field Plot in Preparation for Rotation Crops:
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00105217 Ciba-Geigy Corp. (1978) The Results of Tests on the Amount of Residues Remaining
Including a Description of the Analytical Methods Used: [Curacron]. (Compilation;
unpublished study received Mar 3, 1978 under 100-598; CDL:096851-A; 096852;
096853; 096854; 096855)
00105226 Bathe, R. (1974) Acute Oral LD50 of Technical CGA-15324 in the Mouse: Proj ect
No. Siss 3647. (Unpublished study received Feb 14, 1979 under 100-598; prepared
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00105228 Sachsse, K. (1973) Acute Oral LD50 of Technical CGA-15324 in the Rabbit: Project
No. Siss 2850. (Unpublished study received Feb 14, 1979 under 100-598; prepared
by Ciba-Geigy, Ltd., Switz., submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:
097794-H)
00105231 Bathe, R. (1973) Acute Dermal LD50 of Technical CGA-15324 in the Rat: Project
No. Siss 2850. (Unpublished study received Feb 14, 1979, under 100-598; prepared
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00105243 Smith, J. (1978) A Revised Gas Chromatographic Method for Assaying Residues of
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00105244 Smith, J.; Kahrs, R; Ross, J. (1978) Gas Chromatographic Method for Assaying
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1978 under 100-599; sub-mitted by Ciba-Geigy Corp, Greensboro, NC;
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00105255 Reyna, M.; Arceo, R; Fischer, C. (1975) Final Report to Ciba-Geigy Corporation:
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00106649 Ciba-Geigy Corp. (1976) Summary: [Curacron 4E Insecticide]. Summary of studies
228973-B through 228973-D. (Unpublished study received Jan 17, 1977 under
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00108016 Nelson, R. (1975) Final Report to ...: 90-day Subacute Oral Toxicity Study with CGA
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1982 under 100-598; prepared by Stillmeadow, Inc., submitted by Ciba-Geigy Corp.,
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00109431 Cannelongo, B.; Sabol, E.; Soliz, D.; et al. (1982) Guinea Pig Sensitization: [CGA
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F-00167. Unpublished study prepared by Ciba-Geigy Corp., Environmental Health
Center. 8 p.
43213308 Minor, J.; Richter, A. (1994) A Two-Generation Reproduction Study in Rats with
CGA-15324 Technical: Final Report: Lab Project Number: F-00102. Unpublished
study prepared by Ciba-Geigy Corp., Environmental Health Center. 822 p.
43213309 Gilles, P. (1994) A Two-Generation Reproduction Study in Rats with CGA-15324
Technical: Amendment 1 to Final Report: Lab Project Number: F-00102. Unpublished
study prepared by Ciba-Geigy Corp., Environmental Health Center. 9 p.
43301901 Ritter, J. (1994) Metabolism of (phenyl-(carbon 14)) CGA-15324 in Lactating Goats:
Lab Project Number: F/00161. Unpublished study prepared by Environmental Health
Center, Ciba-Geigy Corp. 196 p.
43301902 Ritter, J. (1994) Metabolism of (phenyl-(carbon 14)) CGA-15324 in Chickens: Lab
Project Number: F/00164. Unpublished study prepared by Environmental Health
Center, Ciba-Geigy Corp. 274 p.
43354801 Geluwe, K. (1994) Validation of Analytical Method AG-326A and AG-298 for the
Determination of Profenofos Residues as 4-Bromo-l-Chlorophenol in Animal Tissues
with Accountability Data: Lab Project Number: ABR/94032. Unpublished study
prepared by Ciba Crop Protection Biochemistry Dept. 121 p.
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BIBLIOGRAPHY
MRID
CITATION
43430101 Eudy, L. (1994) Stability of Profenofos Fortified into Meat, Milk, and Egg Substrates
under Freezer Storage Conditions: Amendment 1: Lab Project Number: ABR-93033:
RI-SS-007-92: 318925. Unpublished study prepared by Ciba-Geigy Corp. 52 p.
43665301 Lail, L. (1995) Supplement to Product Chemistry: Technical Profenofos: Lab Project
Number: Z:\CC-DOC\PRODCHEM\40445001.doc;lca 5/24/95. Unpublished study
prepared by Ciba Geigy Corp. 14 p.
43665302 Lail, L. (1995) Product Chemistry: Technical Profenofos: Supplement: Lab Project
Number: Z:\CC-DOC\PRODCHEM\40445002.doc;lca 5/23/95. Unpublished study
prepared by Ciba Geigy Corp. 56 p.
92148004 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085810. One
Generation Reproduction Study of Profenofos (CGA-15324) in Bobwhite Quail:
Report No. 108-173. Prepared by WILDLIFE INTERNATIONAL LTD. 24 p.
92148006 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00072150. One
Generation Reproduction Study of Profenofos CGA-15324) in Mallard Duck: Report
No. 108-153. Prepared by WILDLIFE INTERNATIONAL LTD., 21 p.
92148007 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00072151. Simulated
Field Study with Curacron 6E in Bobwhite Quail, Mallard Duck, and Rabbits: Study
No. 108-156. Prepared by WILDLIFE INTERNATIONAL LTD. 17 p.
92148008 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00083075. Acute
Toxicity of Profenofos (CGH 15324) Technical to Bluegill (Lepomis macrochirus):
Report No. BW-78-12-371. Prepared by EG &G Bionomics. 16 p.
92148009 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00072149. Acute
Toxicity of Profenofos (CGA-15324) Technical to Rainbow Trout (Salmo gairdneri):
Report No. BW-79-1-382. Prepared by EG &G Bionomics. 18 p.
92148010 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085960. Acute
Toxicity of Profenofos (CGA-15324) to Pinfish (Lagodon rhomboides): Report No.
BP-80-2-35. Prepared by EG & G Bionomics Marine Research Lab. 17 p.
79
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BIBLIOGRAPHY
MRID
CITATION
92148011 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085962. Acute
Toxicity of Profenofos to Eastern Oysters Crassostrea virginica): Report No.
BP-80-2-37. Prepared by EG & G Bionomics Marine Research Lab. 18 p.
92148012 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085961. Acute
Toxicity of Profenofos to Pink Shrimp (Penaeous duorarum): Report No. BP-80-2-36.
Prepared by EG & G Bionomics Marine Research Lab. 17 p.
92148013 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085964. Chronic
Toxicity of Profenofos Technical to Daphnia magna under Flow-through Conditions:
Report No. BW-80-2-611. Prepared by EG&G Bionomics. 20 p.
92148014 Plautz, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085958. Toxicity
of Profenofos (CGA-15324) Technical to Fathead Minnow (Pimephales promelas):
Report No. BW-79-6-490. Prepared by EG&G Bionomics. 17 p.
92148052 Senzel, A.; Ross, J. (1990) Ciba-Geigy Corp. Phase 3 Summary of
MRID 00105217 and Related MRTDs 00106649, 00046061, 00046063,
00046064, 00046056, 00046067. Poultry Meat and Eggs - Feeding: Profenofos
Residues: Project ABR-78025. Prepared by CIBA-GEIGY CORP. 21 p.
92148053 Tweedy, B.; Marco, G. (1990) Ciba-Geigy Corp. Phase 3 Reformat of MRID
00105217 and Related MRTDs 00106649, 00046061, 00046063, 00046064,
00048056, 00046067. Poultry Meat and Eggs - Feeding: Profenofos Residues:
Project ABR-78025. Prepared by CIBA-GEIGY CORP. 53 p.
9214805 5 Tweedy, R.; Marco, G. (1990) Ciba-Geigy Corp. Phase 3 Reformat of MRID
00105217 and Related MRTDs 00106649, 00046060, 00045035, 00045038.
Magnitude of the Residues of Profenofos in Cottonseed: ABR-78025. Prepared by
CIBA-GEIGY CORP. 433 p.
92148057 Tweedy, B.; Marco, G. (1990) Ciba-Geigy Corp. Phase 3 Reformat of MRID
00105217 and Related MRIDs 00106649, 00046060. Magnitude of the Residues of
Profenofos in Processed Food and Feed from Cottonseed: Project ABR-78025.
Prepared by CIBA-GEIGY CORP. 120 p.
80
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BIBLIOGRAPHY
MRID CITATION
92148059 Swidersky, P. (1990) Ciba-Geigy Corp. Phase 3 Summary of MRID 00085952. The
Metabolism of Theta-carbon 14-CGA-15324 in Bluegill Fish: Project MI2-130-4F;
Report No. ABR-77076. Prepared by CIBA-GEIGY CORP. 18 p.
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Appendix D. GENERIC DATA CALL-IN
See attached table for a list of generic data requirements. Note that a complete Data Call-in
(DCI) with all pertinent instructions is being sent to registrants under separate cover.
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Appendix E. PRODUCT SPECIFIC DATA CALL-IN
See attached table for a list of product-specific data requirements. Note that a complete Data
Call-in (DCI), with all pertinent instructions, is being sent to registrants under separate cover.
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Appendix F. LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN
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Appendix G. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled
out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing
Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at
(703) 308-5551 or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-5.pdf.
http://www.epa.gov/opprd001/forms/8570-17.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
http://www.epa.gov/opprd001/forms/8570-27.pdf.
http://www.epa.gov/opprd001/forms/8570-28.pdf.
http://www.epa.gov/opprd001/forms/8570-30.pdf.
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8570-32
8570-34
8570-35
8570-36
8570-37
Certification of Attempt to Enter into an Agreement with
other Registrants for Development of Data
Certification with Respect to Citations of Data (in PR
Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties (in PR Notice
98-1)
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98- 1 )
http://www.epa.aov/opprd001/forms/8570-32.pdf.
httD://www.eDa.aov/ODDDmsdl/PR Notices/Dr98-5
.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5
.pdf.
http://www.eDa.gov/ODDDmsdl/PR Notices/Dr98-l
.pdf.
httD://www.eDa.aov/ODDDmsdl/PR Notices/Dr98-l
.pdf.
Pesticide Registration Kit
Dear Registrant:
www.epa.gov/pesticides/registrationkit/.
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
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d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States," PB92-221811, available through the National Technical Information Service
(NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program
resulting from the passage of the FQPA and the reorganization of the Office of Pesticide
Programs. We anticipate that this publication will become available during the Fall of
1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge a
fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765)
494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on
active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN
by telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.
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The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment
of receipt to the specific application submitted. EPA will stamp the date of receipt and
provide the EPA identifying File Symbol or petition number for the new submission. The
identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number if one has been assigned.
Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document 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 respective Chemical
Status Sheet.
a. Health and Environmental Effects Science Chapters.
b. Detailed Label Usage Information System (LUIS) Report.
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