vvEPA
United States Prevention, Pesticides EPA 738-R-O2-OO4
Environmental Protection and Toxic Substances May 2OO2
Agency (75O8C)
nterim Reregistration
Eligibility Decision
(IRED)
Fenamiphos
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United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508C)
EPA 738-F-02-003
May 2002
Fenamiphos Facts
EPA has assessed the risks of fenamiphos and prepared an Interim Reregistration Eligibility
Decision (IRED) document for this organophosphate (OP) pesticide. The IRED identifies risk
mitigation measures needed to reduce risk, as well as data needed to better characterize risks. The
sole registrant, Bayer Corporation, has requested voluntary cancellation of all existing fenamiphos
registrations rather than committing to develop additional data.
Used on variety of vegetables and fruits,
fenamiphos residues in food do not pose risk
concerns. However, exposure to drinking water
sources from shallow water tables (less than 50 feet
deep) and extremely vulnerable soils do pose risk
concerns. Extremely vulnerable soils are defined
as, "hydrologic soil group A soils that are
excessively drained and predominantly sand or
loamy sand such as soils in the suborder
psamments." These classifications and soil
taxonomy refer to USDA definitions. Therefore,
all use of fenamiphos in areas with extremely
vulnerable soils and shallow water tables will be
phased out by May 31, 2005. Use on all other soils
will cease effective as of May 31, 2007.
Fenamiphos is not used in a residential
setting. There is, however, use on turf including
golf course turf, which could lead to golfer
exposure from residues on treated courses.
Nevertheless, the Agency believes that the
watering-in of fenamiphos adequately protects
golfers. Implementation of risk mitigation during
the phase out, negotiated between the registrant and
the Agency, is expected to decrease the risks
associated with fenamiphos.
EPA's next step under the Food Quality
Protection Act (FQPA) is to consider available
information on the cumulative risk of the OP
The OP Pilot Public Participation Process
The organophosphates (OPs) are a
group of related pesticides that affect the
functioning of the nervous system. They are
among EPA's highest priority for review in
implementing provisions of the Food Quality
Protection Act (FQPA) of 1996.
EPA encourages the public to
participate in the review of the OP pesticides.
Through a six-phased pilot public
participation process, the Agency has
released for review and comment its
preliminary and revised scientific risk
assessments for individual OPs. (Please
contact the OP Docket, telephone 703-305-
5805, or see EPA's web site,
www.epa.gov/pesticides/op.)
EPA is exchanging information with
stakeholders and the public about the OPs,
their uses, and risks through Technical
Briefings, stakeholder meetings, and other
fora. USDA is coordinating input from
growers and other OP pesticide users.
Based on current information from
interested stakeholders and the public, EPA
is making interim risk management decisions
for individual OP pesticides, and will make
final decisions through a cumulative OP
assessment. (Please see
www.epa.gov/pesticides/cumulative.htm.)
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pesticides, which share a common mechanism of toxicity. The tolerance reassessment decision for
fenamiphos cannot be considered final until the cumulative risks of the OPs are considered.
EPA is reviewing the OP pesticides to determine whether they meet current health and safety
standards. OPs require decisions about their eligibility for reregistration under FIFRA. OPs with
food, drinking water, residential, and any other non-occupational exposures must be reassessed to
make sure they meet the new FFDCA safety standard, brought about by the Food Quality Protection
Act(FQPA)ofl996.
The fenamiphos interim decision was made through the OP pilot public participation process,
which increases transparency and maximizes stakeholder involvement in EPA's development of risk
assessments and risk management decisions. EPA worked extensively with affected parties to reach
the decisions presented in the IRED document. The agreement on the voluntary cancellation, based
on the registrant's decision not to develop data that were an essential part of the risk mitigation
proposal, concludes the OP pilot process for fenamiphos.
Uses
A nematicide and an insecticide, fenamiphos is used primarily to control nematodes and
thrips on various agricultural crops (i.e., citrus, grapes, peanuts, pineapples, tobacco, etc.) and
non-agricultural (i.e., turf and ornamentals) sites. Additionally, all uses are soil incorporated,
except for the pineapple use. There are no residential uses for fenamiphos.
Annual domestic use is low— approximately 780,000 pounds of active ingredient per year.
Fenamiphos is a Restricted Use Pesticide (RUP) due to high acute toxicity and toxicity to
wildlife.
Health Effects
Risks
Fenamiphos can cause cholinesterase inhibition in humans; that is, it can overstimulate the
nervous system causing nausea, dizziness, confusion, and at very high exposures (e.g.,
accidents or major spills), respiratory paralysis and death.
Dietary (acute and chronic) exposures from eating commodities treated with fenamiphos are
below the Agency's level of concern for the entire U.S. population, including infants and
children.
Dietary (drinking water) exposures are generally not of concern for surface and ground water
sources in soils that are not extremely vulnerable. However, exposure to shallow ground
water sources of drinking water associated with soils that are extremely vulnerable exceed the
Agency's level of concern.
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• EPA has risk concerns for workers who mix, load, and/or apply fenamiphos to agricultural
sites and golf courses.
Acute and chronic risks exceed the Agency's level of concern for terrestrial, aquatic, and
endangered species.
Risk Mitigation
The registrant has requested voluntary cancellation of existing fenamiphos product
registrations.
The registrant has agreed to cancel use, and formulation for use, of all of its existing
fenamiphos registrations in areas with extremely vulnerable soils and shallow water tables
effective as of May 31, 2005. Cancellation for use on all other soils will be effective as of
May 31,2007.
• All sale, distribution and use of existing stocks shall be prohibited for manufacturing and end-
use products, effective as of May 31, 2007.
Sale and distribution of existing stocks by persons other than the registrant may continue until
May 31,2008.
• Revised labels for all fenamiphos products have been submitted to the Agency in accordance
with the registrant's request for an amendment of all of its existing registrations. Use of stocks
in the channels of trade may continue until depleted, except where prohibited by the revised
labels.
The registrant has also agreed to produce no more than 500,000 pounds of fenamiphos
manufacturing use products for use in the United States the first year of the phase out which
ends May 31, 2003. Each subsequent year of the 5 year phase out, production will be reduced
by 20% of the previous year's production.
Next Steps
Numerous opportunities for public comment were offered as this decision was being
developed. The fenamiphos IRED is being issued in final (see www.epa.gov/pesticides/op or
www.epa.gov/pesticides/reregistration/status.htm). without a formal public comment period.
However, the docket remains open, and any comments submitted in the future will be placed
in this public docket.
• A Notice of Availability for this interim RED for fenamiphos will be published in the Federal
Register. A copy of the interim RED and all supporting documents are available on the
Agency's website at http://www.epa.gov/pesticides/op/fenamiphos.htm.
• A 6(f) Notice for fenamiphos will be published in the Federal Register announcing receipt of
request from the registrant to voluntary cancel fenamiphos.
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\
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
o
T
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 and public comments received related
to the preliminary and revised risk assessments for the organophosphate pesticide (OP) fenamiphos.
The public comment period on the revised risk assessment phase of the reregistration process is
closed. Based on comments received during the public comment period and additional data received
from the registrant, the Agency revised the human health and environmental effects risk assessments
and made them available to the public on September 14, 1999. Additionally, the Agency held a
Technical Briefing on September 2, 1999, where the results of the revised human health and
environmental effects risk assessments were presented to the general public. This Technical Briefing
concluded Phase 4 of the OP Public Participation Pilot Process developed by the Tolerance
Reassessment Advisory Committee, and initiated Phase 5 of that process. During Phase 5, all
interested parties were invited to participate and provide comments and suggestions on ways the
Agency might mitigate the estimated risks presented in the revised risk assessments. This public
participation and comment period commenced on September 10, 1999 and closed on November 15,
1999.
Based on its review, EPA has identified risk mitigation measures that the Agency believes are
necessary to address the human health and environmental risks associated with the current use of
fenamiphos. The EPA is now publishing its interim decision on the reregistration eligibility of and
risk management decision for the current uses of fenamiphos and its associated human health and
environmental risks. The reregistration eligibility and tolerance reassessment decisions for
fenamiphos will be finalized once the cumulative risks for all of the organophosphate pesticides are
considered. The enclosed "Interim Reregistration Eligibility Decision for Fenamiphos," which was
approved on March 31, 2002, contains the Agency's decision on the individual chemical fenamiphos.
A Notice of Availability for this Interim Reregistration Eligibility Decision (interim RED) for
fenamiphos is being published in the Federal Register. To obtain a copy of the interim RED
document, please contact the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building,
1200 Pennsylvania Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic
copies of the interim RED and all supporting documents are available on the internet at
http://www.epa.gov/pesticides/op/fenamiphos.htm.
The interim RED is based on the updated technical information found in the fenamiphos
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
fenamiphos (revised as of September 2, 1999), and a document 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. For fenamiphos, a proposal was submitted by Bayer Corporation, the only registrant.
Comments on mitigation or mitigation suggestions were submitted by the registrant, academia,
various industry stakeholders and the public.
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 a large multi-stakeholder advisory body that advised the
Agency on implementing the new provisions of the FQPA. The reregistration and tolerance
reassessment reviews for the organophosphate pesticides are following this new process.
Please note that the fenamiphos risk assessment and the attached interim RED concern only
this particular organophosphate. This interim RED presents the Agency's conclusions on the dietary
risks posed by exposure to fenamiphos alone. The Agency has also concluded its assessment of the
ecological and worker risks associated with the use of fenamiphos. 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 considering the risks 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 associated with the current uses of fenamiphos. The Agency will issue the
final tolerance reassessment decision for fenamiphos and finalize decisions on reregistration
eligibility once the cumulative risks for all of the organophophates are considered.
For reference purposes, this document contains a description of further generic and/or
product-specific data requirements for fenamiphos. EPA will collect these data via a Data Call-In
(DCI), which is being sent to registrants under separate cover. Additionally, for product-specific
DCIs, the first set of required responses is due 90 days from the receipt of the DCI letter. The second
set of required responses is due eight months from the date of the DCI.
In this interim RED, the Agency has determined that fenamiphos will be eligible for
reregistration provided all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measures outlined in Section IV of the document. The Agency
believes that current uses of fenamiphos may pose unreasonable adverse effects to human health and
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the environment, and that such effects can be mitigated with the risk mitigation measures identified in
this interim RED. Accordingly, the Agency recommends that registrants implement these risk
mitigation measures immediately. Sections IV and V of this interim RED describe labeling
amendments for end-use products and data requirements necessary to implement these mitigation
measures. Instructions for registrants on submitting the revised labeling can be found in the set of
instructions for product-specific data that accompanies this interim RED.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by fenamiphos. Where
the Agency has identified any unreasonable adverse effect to human health and the environment, the
Agency may at any time initiate appropriate regulatory action to address this concern. At that time,
any affected person(s) may challenge the Agency's action.
The Agency understands that the technical registrant, Bayer Corporation, intends to request
voluntarily cancellation of all fenamiphos registrations consistent with a phase out schedule amenable
to the Agency. Once the request for voluntary cancellation is received by the Agency, the terms and
conditions of the cancellation will be established in a separate document. If Bayer Corporation does
not submit a request for voluntary cancellation, Bayer will need to satisfy the measures described in
this interim RED in order for fenamiphos to be eligible for reregistration.
If you have questions on this document or the label changes necessary for reregistration,
please contact the Chemical Review Manager, Tawanda M. Spears at (703) 308-8050. For questions
about product reregistration and/or the Product DCI that accompanies this document, please contact
Bonnie Adler at (703) 308-8523.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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Interim Reregistration Eligibility Decision
for
Fenamiphos
Case No. 0333
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TABLE OF CONTENTS
Executive Summary 1
I. Introduction 6
n. Chemical Overview 8
A. Regulatory History 8
B. Chemical Identification 8
C. Use Profile 9
D. Estimated Usage of Pesticide 11
HI. Summary of Fenamiphos Risk Assessment 12
A. Human Health Risk Assessment 12
1. Dietary Risk from Food 13
a. Toxicity 13
b. FQPA Safety Factor 13
c. Population Adjusted Dose (PAD) 14
d. Toxicological Endpoints 14
e. Exposure Assumptions 14
f. Food Risk Characterization 15
2. Dietary Risk from Drinking Water 15
a. Surface Water 16
1) Surface Water Modeling 17
2) Surface Water Monitoring 17
b. Ground Water 18
1) Ground Water Monitoring 18
3. Drinking Water Levels of Comparison (DWLOCs) 21
4. Residential/Recreational (Golfer) Risk 22
5. Aggregate Risks 23
6. Occupational Risk 23
a. Toxicity 24
b. Exposure 25
c. Occupational Handler Risk Summary 26
1) Agricultural Handler Risk 27
2) Hand-held Equipment Golf Course Assessment 29
3) Post-Application Worker Risk 29
7. Human Incident Reports 30
B. Environmental Risk Assessment 31
1. Environmental Fate and Transport 32
2. Risk to Birds and Mammals 32
a. Toxicity (Hazard) Assessment 32
b. Exposure and Risk 33
3. Risk to Aquatic Species 35
a. Toxicity (Hazard) Assessment 35
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b. Exposure and Risk 36
4. Risks to Plants and Insects 37
a. Toxicity and Exposure to Terrestrial Plants 37
b. Toxicity and Exposure to Beneficial Insects 37
5. Incident Reports 38
6. Endangered Species 38
IV. Interim Risk Management and Reregistration Decision 39
A. Determination of Interim Reregistration Eligibility 39
B. Summary of Phase 5 Comments and Responses 40
C. Regulatory Position 42
1. FQPA Assessment 42
a. "Risk Cup" Determination 42
b. Tolerance Summary 42
c. Codex Harmonization 46
d. Residue Analytical Methods 47
2. Endocrine Disrupter Effects 48
3. Benefits 48
4. Labels 50
D. Regulatory Rationale 51
1. Human Health Risk Mitigation 51
a. Dietary Mitigation 51
1) Acute Dietary (Food) 51
2) Chronic Dietary (Food) 51
3) Drinking Water 51
4) Residential/Recreational (Golfer) 54
5) Aggregate 54
b. Occupational Risk Mitigation 54
1) Agricultural Uses 54
2) Postapplication Risk Mitigation 56
2. Environmental Risk Mitigation 56
a. Avian and Mammalian Species Mitigation 56
b. Aquatic Species Mitigation 57
E. Other Labeling 57
1. Endangered Species Statement 57
2. Spray Drift Management 57
V. What Registrants Need to Do 59
A. Manufacturing Use Products 60
1. Additional Generic Data Requirements 60
2. Labeling for Manufacturing Use Products 61
B. End-Use Products 61
1. Additional Product-Specific Data Requirements 61
2. Labeling for End-Use Products 61
C. Existing Stocks 61
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D. Required Labeling Changes Summary Table 62
VL Related Documents and How to Access Them 71
\T1. Appendices 72
Appendix A. Table of Use Pattern Eligible for Reregistration 73
Appendix B. Table of Generic Data Requirements and Data Supporting Guideline
Requirements for the Reregistration Decision 82
Appendix C. List of Available Technical Support Documents 88
Appendix D. Bibliography 90
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FENAMIPHOS TEAM
Office of Pesticide Programs:
Health Effects Risk Assessment
Gary Bangs
Catherine Eiden
Steven Knizner
Environmental Fate Risk Assessment
Elizabeth Behl
Norman Birchfield
R. David Jones
Laurence Libelo
Gabe Patrick
Donna Randall
Endangered Species
Ronald Kendall
Ann Stavola
Use and Usage Analysis
Timothy Kiely
Richard Michell
Registration Support
Cynthia Giles-Parker
Maria Rodriguez
Legal Counsel
Amy Branning
Donald Sadowsky
Risk Management
Susan Jennings
Tawanda Spears
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GLOSSARY OF TERMS AND ABBREVIATIONS
AE Acid Equivalent
a.i. Active Ingredient
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
AR Anticipated Residue
ARC Anticipated Residue Contribution
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CFR Code of Federal Regulations
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DWEL Drinking Water Equivalent Level. 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.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
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
G Granular Formulation
GENEEC Tier I Surface Water Computer Model
GLC Gas Liquid Chromatography
GLN Guideline Number
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.
HAFT Highest Average Field Trial
HOT Highest Dose Tested
IR Index Reservoir
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LC
50
LD
50
LEL
LOG
LOD
LOAEL
MATC
MCLG
mg/kg/day
mg/L
MOE
MP
MPI
MRID
NA
N/A
NAWQA
NOEC
NOEL
NOAEL
NPDES
NR
OP
OPP
OPPTS(EPA)
Pa
PAD
PADI
PAG
PAM
PCA
PDF
PHED
Pffl
ppb
PPE
ppm
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.
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.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal. The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Not Applicable
Not Applicable
(USGS) National Water Quality Assessment
No Observed Effect Concentration
No Observed Effect Level
No Observed Adverse Effect Level
National Pollutant Discharge Elimination System
Not Required
Organophosphate
(EPA) Office of Pesticide Programs
Office of Prevention, Pesticides and Toxic Substances
Pascal, the pressure exerted by a force of one newton acting on an area of one square
meter.
Population Adjusted Dose
Provisional Acceptable Daily Intake
Pesticide Assessment Guideline
Pesticide Analytical Method
Percent Crop Area
(USDA) Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
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PRN Pesticide Registration Notice
PRZM7 Pesticide Root Zone Model and Exposure Analysis Modeling System, which is a Tier
EXAMS II Surface Water Computer Model
Q!* The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RAC Raw Agriculture Commodity
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
RS Registration Standard
RUP Restricted Use Pesticide
SAP Science Advisory Panel
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TC Toxic Concentration. 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.
TRR Total Radioactive Residue
UF Uncertainty Factor
Hg/g Micrograms Per Gram
Hg/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
UV Ultraviolet
WHO World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
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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 decision for fenamiphos. Although the Agency has not yet considered
cumulative risks for the organophosphates, the Agency has determined that fenamiphos is eligible for
reregistration provided: (i) the use of fenamiphos on extremely vulnerable soils is phased out by May
31, 2005 (continued use on such soils would result in acute and chronic dietary risks, due to drinking
water, which are inconsistent with the Food Quality Protection Act of 1996); (ii) current data gaps for
use on other soils are addressed; (iii) the risk mitigation measures outlined in this document are
adopted to reduce risk from other uses and label amendments are made to reflect these measures; and
(iv) cumulative risks considered for the organophosphates support a final reregistration eligibility
decision.
The decisions outlined in this document do not include the final tolerance reassessment
decision for fenamiphos, however, some tolerance actions will be undertaken prior to completion of
the final tolerance reassessment (see below). The final tolerance reassessment decision for this
chemical will be issued once the cumulative risks for all of the organophosphates are considered. The
Agency may need to pursue further risk management measures for fenamiphos once cumulative risks
are considered.
The revised human health and environmental risk assessments are based on review of the
database 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 its risk mitigation decision on fenamiphos. After considering the
revised risks, as well as mitigation proposed by Bayer Corporation, and comments and mitigation
suggestions from other interested parties (such as the State of Florida, the National Golf Course
Superintendents Association, several independent golf courses, and a number of grower groups), EPA
developed its risk management decision that is discussed fully in this document.
Fenamiphos is an organophosphate nematicide/insecticide used on a variety of nematodes,
thrips, aphids, beetles, root weevils, and root borers. It was first registered in 1972 for at-plant control
of nematodes in annual field and vegetable crops or in established perennial, deciduous and tropical
fruit crops. In 1994, the Agency provided preliminary risk assessments to the registrant and discussed
its concerns about numerous wildlife incident reports. After these discussions, the registrant
voluntarily implemented various risk mitigation measures, including use restrictions and rate
reductions, to reduce certain risks identified in the risk assessments.
The revised risk assessments discussed in this decision document are based on current product
labels, which reflect the various changes made to the labels from 1994 to 1996. Use data from 1990
to 1998 indicate an average domestic use of approximately 780,000 Ibs a.i. per year.
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Dietary Risk
The acute dietary (food) risk estimate is below the Agency's level of concern for the general
U.S. population and all population subgroups. Infants (younger than one year of age), the most
highly exposed subpopulation, are expected to be exposed to fenamiphos at a level less than or equal
to 1% of the aPAD. The chronic dietary risk estimate is also below the Agency's level of concern for
the general population and all population subgroups. The exposure is estimated to be equal to or less
than 1% of the cPAD for all population subgroups including infants and children (from 1 to 6 years of
age), the most highly exposed subpopulation.
In calculating risks to populations drinking ground water, the Agency's assessment found that
the expected concentrations of fenamiphos in drinking water will vary depending on the type of soil
and depth to ground water. When soils are extremely vulnerable and the groundwater is shallow,
fenamiphos is expected to rapidly leach into ground water. As the soils become less vulnerable, the
expected concentrations drop. For the purposes of this assessment the Agency has established two
distinct categories of soil types: extremely vulnerable and vulnerable. The vulnerable category is
expected to portray worst-case exposure for all soil types that are not extremely vulnerable. The
extremely vulnerable category contains those soils classified as hydrologic soil group A soils that are
excessively drained and predominately sand or loamy sand and where the ground water table is less
than 50 feet deep. The Central Ridge of Florida is an example of an area where the soil would be
classified extremely vulnerable.
Dietary risks from residues on food combined with residues in drinking water are a concern
for people who rely on ground water sources of drinking water in areas where fenamiphos is used on
extremely vulnerable soils. In these areas, for both acute and chronic risk, the expected
environmental concentrations (EECs) in drinking water are substantially higher than the drinking
water levels of concern. Using turf as an example, the Agency found that the acute EEC is 425 ppb
and the chronic EEC is 45 ppb, while the acute drinking water level of concern (DWLOC) is 12 ppb
and the chronic DWLOC is 1 ppb. The Agency believes that the potential risk to the public from the
use of fenamiphos on extremely vulnerable soils is unreasonable and inconsistent with the Food
Quality Protection Act (FQPA). Therefore, these uses will be phased out by May 31, 2005.
The Agency believes risks are not of concern for those drinking groundwater in areas with
soils that are not extremely vulnerable or those drinking from surface water sources. In these areas,
for both acute and chronic risk, the EECs in drinking water are lower than the DWLOCs. Because
there is some uncertainty in the database, the Agency will be issuing a DCI to require additional data
to confirm its exposure conclusions for vulnerable soils.
Residential (Golfer) Risk
Although fenamiphos is not used in a residential setting, golfers may be exposed to
fenamiphos while playing on courses that have been treated with fenamiphos. Because fenamiphos is
watered-in on golf courses, the Agency believes any residual pesticide does not pose an exposure or
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risk concern for golfers and that no additional mitigation is needed at this time. The Agency will be
issuing a DCI requiring additional data to confirm these conclusions.
Aggregate Risk
An aggregate risk assessment looks at combined exposure from dietary (food and drinking
water routes) and residential or non-occupational sources, when appropriate. For fenamiphos, an
aggregate assessment would include dietary and golfer exposure. As discussed in the Dietary Risk
section above, the risk estimates are below the Agency's level of concern for all populations exposed
to combined fenamiphos residues from food and drinking water, provided the population is not
drinking water obtained from ground water sources in areas with extremely vulnerable soils. The
risks to golfers cannot be quantitatively included in the aggregate risk assessment at this time as the
data are not sufficient or robust enough to allow this calculation. The Agency believes that this
exposure is not significant and that its inclusion in the aggregate risk assessment would not change
the conclusions of the aggregate risk assessment.
Occupational Risk
The Agency's occupational risk findings show that many fenamiphos uses do not pose risks
of concern (i.e., MOEs are greater than 100). Some uses, however, pose occupational risks exceeding
the Agency's level of concern for certain handlers and workers. The Agency has worked with the
registrant and user community to explore ways of reducing occupational risks in general and believes
many of the measures agreed to by the registrant will reduce the occupational risk to levels not of
concern. In some cases, however, the Agency's risk estimates show that certain handlers remain at
risk levels higher then the Agency's risk reduction objectives.
The Agency assessment shows that, after mitigation, the use of the granular product does not
pose a risk of concern to workers for any crop other than loading and applying by push spreader on
turf. For workers using a push spreaders, the MOE is 28. All granular MOEs were calculated
assuming that the worker was wearing an organic vapor-removing respirator. To mitigate risks to
these levels, the following measures are necessary: limiting the amount of active ingredient a single
worker can handle to 50 Ib ai/day for turf uses and prohibiting body-mounted or hand-held
application equipment.
For mixer/loaders and applicators using liquid fenamiphos, MOEs are of concern (less than
100) for several different crops. Of the MOEs of concern for agricultural products, all are above 50,
with the majority between 65 and 75. For turf, the MOEs are 37 for mixer/loaders and 53 for
applicators using groundboom equipment with closed systems and enclosed cabs. To mitigate risks
to workers using the liquid formulation, the following measures are necessary: closed mixing/loading
systems and application by enclosed cab, reduced application rates for various crops, and limit the
amount of active ingredient a single worker can handle to 200 Ibs ai/day for turf uses.
Although these measures lessen the exposure for workers using fenamiphos products, the
MOEs for some mixer/loader and applicators are still less than 100. Because there are significant
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benefits from the uses of fenamiphos on turf, as discussed below, the Agency has determined that
additional mitigation of occupational risk is not necessary at this time.
Environmental Risk
The fenamiphos ecological assessment indicates that virtually all uses at maximum
application rates result in risks that exceed both the high acute and chronic risk levels of concern for
terrestrial, aquatic, and endangered species. Fenamiphos is either soil incorporated or watered-in,
which may reduce potential exposures to wildlife; however, because of its high toxicity, small
amounts pose a high risk to sensitive species. Incident data support this conclusion, as fish and bird
kill incident reports indicate losses of wildlife directly attributable to fenamiphos. The
implementation of earlier mitigation measures, such as lowering application rates to minimize runoff
potential, may be helping to reduce these types of incidents.
Research shows that fenamiphos must be applied at application rates outlined in this interim
RED for the pesticide to be efficacious. Therefore, the Agency is unable to further reduce these rates
to be more protective of avian and mammalian species. In addition to rate reductions on other crops
proposed in this document, the Agency is also proposing additional label changes to reduce exposure,
including: cancellation of cotton use and granular use on pineapples; reducing maximum seasonal
application rates for several crops; requiring more rapid watering in when irrigation is used to
incorporate fenamiphos; and restrictions on time of day applied during thunderstorm season to limit
the potential for runoff. Some of these measures are already on existing labels, but they must be
expanded to additional uses (as specified below) in order for fenamiphos to be eligible for
reregistration.
Although these measures may somewhat reduce fenamiphos exposure to aquatic and
terrestrial species, they are not expected to reduce it to levels that are not of concern to the Agency.
However, because there are significant benefits from the use of fenamiphos (see below), the Agency
is not proposing additional action at this time.
Benefits
Fenamiphos is one of only a handful of effective nematicides left for use in agriculture. It
provides effective control of many important plant parasitic nematodes and several important insect
pests, which can cause severe crop damage and significant yield losses if left unchecked. Fenamiphos
is effective for use both pre-plant and post-plant. As a post-plant application, fenamiphos is often the
only effective nematicide available. The post-plant application is critical for perennial crops, such as
pineapple, kiwifruit, tree fruits, grapes and raspberries, which must rely solely on a post-plant control
of nematodes after the first growing season. For most of these crops fenamiphos is the only effective
post-plant control. Fenamiphos is also important for the control of nematodes in a number of annual
crops as well, particularly in California (the state with the highest agricultural usage), where effective
nematode controls include several soil fumigants and fenamiphos. California has imposed use
restrictions on the soil fumigants, which limit the availability of these nematicide alternatives (e.g.,
Telone, methyl bromide, metam-sodium).
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Fenamiphos is also critical for the control of nematodes in golf course turf. The types and
extent of damage varies with the nematode type(s) present, population levels, types of grass,
environmental stress levels (soil temperature, water availability, etc.) and other unknown soil factors.
Nematodes are root parasites which cause damage including stunted growth, foliage discoloration,
premature wilting and death of plants.
Increased fertilizer and water are often used to treat nematode infestations and fenamiphos is
used only when the problem cannot be controlled by these means. Additional application of water is
not always an option, due to limits on water usage in some areas and under certain conditions. There
are no registered fenamiphos alternatives known to be effective for use on turf, and if fenamiphos is
not available on turf, golf courses and turf farms could be adversely impacted.
Process and Timeframes
This interim RED document for fenamiphos is being announced in a Notice of Availability
published in the Federal Register. This interim RED document includes guidance and time frames
for any necessary label changes for products containing fenamiphos. Note that there is no comment
period for this document, and that the time frames for the label changes outlined in this document are
shorter than those given in some earlier reregistration eligibility decisions. As part of the public
participation process, the Agency's risk assessments for fenamiphos have already been subject to
numerous public comment periods, and a further comment period for fenamiphos was deemed
unnecessary. 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 the risk mitigation measures outlined 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
fenamiphos can be considered final until the cumulative risks for all organophosphate pesticides are
considered. The cumulative assessment may result in further risk mitigation measures for
fenamiphos.
The Agency understands that the technical registrant, Bayer Corporation, intends to request
voluntarily cancellation of all fenamiphos registrations consistent with a phase out schedule amenable
to the Agency. Once the request for voluntary cancellation is received by the Agency, the terms and
conditions of the cancellation will be established in a separate document. If Bayer Corporation does
not submit a request for voluntary cancellation, Bayer will need to satisfy the measures described in
this interim RED in order for fenamiphos to be eligible for reregistration.
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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. 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 reassessment of all existing tolerances. For those chemicals that
have tolerances and are undergoing reregistration, the tolerance reassessment will be initiated through
this reregistration process. FQPA also requires that by 2006, EPA must review all tolerances in effect
on the day before the date of the enactment of the FQPA, which was August 3, 1996. 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. Fenamiphos belongs to a group of pesticides called
organophosphates (OPs), which share a common mechanism of toxicity - they all affect the nervous
system by inhibiting cholinesterase. Although the FQPA significantly affects the Agency's
reregistration process, it does not amend any of the existing reregistration deadlines. Therefore, the
Agency is continuing its reregistration program while it resolves the remaining issues associated with
the implementation of the FQPA.
This document presents the Agency's revised human health and ecological risk assessments;
its progress toward tolerance reassessment; and the interim decision on the reregistration eligibility of
fenamiphos. It is intended to be only the first phase in the reregistration process for fenamiphos. The
Agency will eventually proceed with its assessment of the cumulative risk of the OP pesticides and
issue a final reregistration eligibility decision for fenamiphos.
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 created. These issues were refined and developed through collaboration
between the Agency and an advisory committee, which was composed of representatives from
industry, environmental groups, and other interested parties. The committee 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
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• • Refining Dietary (Drinking Water) Exposure Estimates
• • Assessing Residential Exposure
• • Aggregating Exposure from all Non-Occupational Sources
• • Conducting 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 advisory committee calls for EPA 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 advisory committee process, the Agency
issued, on Sept. 29, 2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA's approach
for managing risks from organophosphate pesticides to occupational users. The Worker PR Notice
describes the Agency's baseline approach to managing risks to handlers and workers who may be
exposed to organophosphate pesticides, and the Agency expects that other types of chemicals will be
handled similarly. Generally, basic protective measures such as closed mixing and loading systems,
enclosed cab equipment, or protective clothing, as well as increased reentry intervals will be
necessary for most uses where current risk assessments indicate a risk and such protective measures
are feasible. The 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 the Worker PR Notice.
This document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment and describes the process for working with the public on
science policy issues for the organophosphate pesticides and the worker risk management PR Notice.
Section II provides a profile of the use and usage of the chemical. Section HI gives an overview of
the revised human health and environmental risk assessments resulting from public comments and
other information. Section IV presents the Agency's interim decision on reregistration eligibility and
risk management decisions. Section V summarizes the label changes necessary to implement the risk
mitigation measures outlined in Section IV. Section VI provides information on how to access
related documents. Finally, the Appendices list Data Call-In (DCI) information (requirements that the
Agency intends to issue to the registrant). The revised risk assessments and related addenda are not
included in this document, but are available on the Agency's web page
http://www.epa.gov/oppsrrdl/op/fenamiphos.htm, and in the Public Docket.
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n. Chemical Overview
A. Regulatory History
Fenamiphos was first registered in the United States in 1972 by Chemagro Corporation, a
Division of Baychem Corporation. Throughout the years, the company changed names, Mobay
Chemical Corporation, then Miles, Inc. and, finally, Bayer Corporation. Currently, Bayer
Corporation is the only manufacturer of fenamiphos technical and four end-use products.
The chemical was formulated as Nemacur (EPA Reg No 3125-269), a manufacturing use
product to be further formulated into end-use products for at-plant control of nematodes in annual
field and vegetable crops or in established perennial deciduous and tropical fruit crops. In 1987, the
Agency issued a Registration Standard for fenamiphos. As part of the Registration Standard and in a
separate Data Call-In Notice in September 1999, the Agency called-in additional data to better
understand the risks associated with using fenamiphos.
After the Agency's 1994 draft preliminary human health and ecological risk assessments
were provided to the registrant for review, the registrant voluntarily put into place numerous risk
mitigation measures, addressing many of the Agency's concerns at that time. These measures
included use restrictions and rate reductions to address certain risks identified in the risk assessments.
This Interim Reregistration Eligibility Decision document is the Agency's first reevaluation
of fenamiphos since issuance of the Registration Standard in 1987. The revised risk assessments,
which are summarized in this document, are based on current product labels and reflect the various
changes made to the labels from 1994 to 1996.
B. Chemical Identification
Common Name:
Chemical Name:
Fenamiphos
Ethyl 3 -methyl-4-(methylthio)phenyl-( 1 -methyl-
ethyl)phosphoramidate
o
/P\H,
^o
CH
Chemical Family:
CAS Registry Number:
Organophosphate
22224-92-6
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OPP Chemical Code:
100601
Empirical Formula: C13H22NO3PS
Molecular Weight: 303 4
Trade and Other Names: Nemacur ®
Basic Manufacturer:
Bayer Corporation
Technical fenamiphos is an off-white to tan waxy solid with a melting point of 49°C and a
vapor pressure of 4.7 x 10"5 mmHg at 20°C. Fenamiphos is soluble in dichloromethane, 2-propanol
and toluene, only slightly soluble in n-hexane, and insoluble in water.
C. Use Profile
The following information is based on the currently registered uses of fenamiphos:
Type of Pesticide: Nematicide/Insecticide
Summary of Use Sites:
Food:
Residential:
Public Health:
Other Nonfood:
Target Pests:
Apple, asparagus, banana, beets (garden), bok choy, Brussels
sprouts, cabbage, cherries, citrus (except on kumquat, tangelo,
or citrus hybrids in California), eggplant, garlic, grapes,
kiwifruit, nectarine, okra, peaches, peanuts, peppers (non-
bell), pineapples, raisins, raspberries, strawberries
None
None
Commercial, industrial, and ornamental turf, sod farm, golf
course turf, ornamental and shade trees, tobacco, and the
following ornamental plants: herbaceous plants,
nonflowering plants, woody shrubs and vines, and other
nonbearing crops
The majority of labeled uses are for plant parasitic nematodes
and thrips. Additional pests include aphids, cutworms, citrus
root weevil, flea beetles, Fuller rose beetle, mole crickets,
phylloxera, and wireworms.
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Formulation Types Registered:
Technical:
Granular:
Emulsifiable
Concentrate:
Method and Rates of Application:
Nemacur Concentrate (74.6%)
Nemacur 10% G and 15% G (10%
and 15% a.i., respectively)
Nemacur 3 (35% a.i.)
Equipment:
Method and Rate:
Use Classification:
Drip irrigation, granule applicator, groundboom, low pressure
ground sprayer, low pressure irrigation, soil incorporation
equipment spreader, sprinkler.
Broadcast, chemigation, soil band treatment, soil broadcast
treatment, soil drench treatment, soil in-furrow treatment, soil
incorporated treatment, soil treatment, spray.
Following application, labels instruct that both the
emulsifiable concentrate and granular formulations are to be
watered-in or mechanically incorporated into soil.
Current application rates vary depending on the commodity or
site. Overall, maximum single application rates range from 1
to 10 Ibs a.i./acre, with maximum yearly rates ranging from 2
to 20 Ibs a.i./acre.
At planting, bloom through foliar, fall, foliar, post-final
harvest, post-harvest, post-plant, post-transplant, pre-bloom
through foliar, pre-emergence, pre-plant, pre-transplant,
ratoon, transplant, at seedling, pre-seedling.
Restricted Use Pesticide (RUP) due to high acute
toxicity and toxicity to wildlife.
10
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D. Estimated Usage of Pesticide
This section summarizes the best estimates available for many of the pesticide uses of
fenamiphos, based on available pesticide usage information for the past eight years. A full listing of
all uses of fenamiphos, with the corresponding use and usage data for each site, has been completed
and is in the "Quantitative Usage Assessment" document, which is available on the internet at
http://www.epa.gov/pesticides/op/fenamiphos.htm and in the public docket. The data, reported on an
aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as the variability in
using data from various information sources. On average, approximately 780,000 pounds of
fenamiphos active ingredient are used annually, according to Agency and registrant estimates. Table
1 provides estimates for usage of fenamiphos.
Table 1. Fenamiphos Estimated Usage for Representative Sites
Crop
Lbs. a.i. Applied (wghtd
Avg. in 000 pounds)1
Percent Crop Treated
(Weighted Avg.)
Percent Crop Treated
(Likely Max)
Food Commodities
Apple
Banana
Beets, garden
Bok Choy
Brussels Sprouts
Citrus - Grapefruit
Citrus - Lemons
Citrus - Oranges
Citrus - Other2
Cabbage
Cherries
Eggplant, Peppers
Grapes
Kiwifruit
Nectarines
Peaches
Peanuts
Pineapple
5
Not Available
2
1
1
15
25
45
5
4
4
1
130
1
2
10
74
14
<1
3
<1
5
13
1
7
2
2
9
1
1
5
9
3
1
2
24
1
3
2
11
29
3
13
4
6
11
2
2
10
17
6
3
4
68
11
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Crop
Raspberries
Strawberries
Vegetables
Lbs. a.i. Applied (wghtd
Avg. in 000 pounds)1
o
J
<1
6
Percent Crop Treated
(Weighted Avg.)
9
1
1
Percent Crop Treated
(Likely Max)
21
2
2
Non-Food Sites
Tobacco
Turf, golf courses and sod
230
67
11
Not Available
22
Not Available
Ornamentals
Nursery Stock
50
Not Available
Not Available
Data from 1990 -1998; when percent crop treated is < 1%, the Agency uses 1% for dietary analysis
Includes kumquats, limes, tangelos and tangerines
HI. Summary of Fenamiphos Risk Assessment
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organophosphate pesticide fenamiphos, as fully presented in the documents,
"Human Health Risk Assessment, Fenamiphos," dated September 2, 1999 (golfer assessment
amended dated July 27, 2001; turf handler amended February 21, 2001; and occupational amended
June 25, 2000) and "Fenamiphos Environmental Risk Assessment," dated
March 6, 2002. The purpose of this summary is to assist the reader by identifying the key features
and findings of these risk assessments, and to better understand the conclusions reached in the
assessments.
These revised risk assessments for fenamiphos were presented at a September 2, 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 fenamiphos only; the Agency must consider cumulative risks of all the
organophosphate pesticides before any tolerance reassessments can be finalized.
A.
Human Health Risk Assessment
EPA issued its preliminary risk assessments for fenamiphos on August 12, 1998 (Phase 3 of
the public participation process). In response to comments and studies submitted during Phase 3, the
risk assessments were updated and refined. These updates and refinements included some minor
changes to the dietary consumption estimates, but there were no major changes in the assessments.
12
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1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the toxicity
database is complete, and that it supports an interim reregistration eligibility determination for all
currently registered uses. Further details on the toxicity of fenamiphos can be found in the September
2, 1999 Human Health Risk Assessment. A brief overview of the studies used for the dietary risk
assessment is outlined in Table 2.
The toxicology profile of fenamiphos demonstrates that fenamiphos, like other
organophosphates, has anticholinesterase activity in all species tested including mice, rats, rabbits and
dogs. Technical fenamiphos has high acute oral toxicity (Toxicity Category I), with an LD50 of 2.7
mg/kg in male rats and 3.0 mg/kg in female rats (MRTD 00033831). Fenamiphos did not cause
organophosphate induced delayed neurotoxicity in hens. No treatment-related pathological lesions
were seen in the central or peripheral nervous system of rats following a single gavage dose or
repeated dietary administration. The principal toxicological effects in rats and dogs following
subchronic and chronic oral (dietary) exposure was inhibition of plasma, red blood cell and/or brain
cholinesterase activity. Repeated dermal applications to rabbits for 21-days resulted in inhibition of
plasma, erythrocyte and brain cholinesterase activity. There was no evidence of increased
susceptibility of rat or rabbit fetuses following in utero exposure in prenatal developmental toxicity
studies, no offspring toxicity was seen at the highest dose tested (HDT) 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.
Fenamiphos is classified as a Group E chemical based on no evidence of carcinogen!city in
two adequate studies in mice and rats. Mutagenicity studies show that fenamiphos is not mutagenic
either in vivo or in vitro. Metabolism studies in the rat indicated no major differences between oral
and intravenously administered fenamiphos. Fenamiphos is degraded and/or eliminated within 48
hours postdosing and does not accumulate in tissues. The major metabolites are sulfoxides and
sulfones.
b. FQPA Safety Factor
The FQPA safety factor was reduced to IX. In prenatal developmental toxicity studies
following in utero exposure in rats and rabbits, there was no evidence of developmental effects being
produced in fetuses at doses that did not also induce maternal toxicity, nor was there evidence of an
increase in severity of effects at or below maternally toxic doses. In the pre/post-natal two-generation
reproduction study in rats, there was no evidence of enhanced susceptibility in pups when compared
to adults (i.e., effects noted in offspring occurred at maternally toxic doses or higher). There was no
evidence of abnormalities in the development of the fetal nervous system in the pre/post natal studies.
The toxicology database is complete and there are no data gaps according to the Subdivision F
Guideline requirements. Adequate actual data, surrogate data, and/or modeling outputs are available
to satisfactorily assess dietary (food and water) exposure and to provide a screening level drinking
13
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water exposure assessment. The assumptions and models used in the assessments do not
underestimate the potential exposure or risk for infants and children. Therefore, the additional 10X
factor as required by FQPA was reduced to IX.
c.
Population Adjusted Dose (PAD)
The PAD is a term that characterizes the dietary risk of a chemical, and reflects the Reference
Dose (RfD), either acute or chronic, that has been adjusted to account for the FQPA safely factor (i.e.,
RfD/FQPA safely factor). In the case of fenamiphos, the FQPA safely factor is IX; therefore, both
the acute and chronic PADs are identical to the corresponding acute and chronic RfDs. The Agency
applied the conventional uncertainty factor of 100X to account for both interspecies extrapolation
(10X) and intraspecies variability (10X). These uncertainty factors were applied to the No Observed
Adverse Effect Level (NOAEL) selected for risk assessment. For the aPAD, an additional 3X
uncertainty factor was applied to the lowest observed adverse effect level (LOAEL) because a
NOAEL was not identified in the acute rat neurotoxicity study. The acute PAD (aPAD) is 0.0012
mg/kg/day and the chronic PAD (cPAD) is 0.0001 mg/kg/day. The bases for the aPAD and cPAD
are summarized in Table 2 below. A risk estimate that is less than 100% of the acute or chronic PAD
is below the Agency's level of concern.
d. Toxicological Endpoints
Table 2 outlines the toxicological endpoints that are used in the dietary risk assessments.
These endpoints were established after review of the entire toxicological database including toxicity
and reproductive studies for both chronic and acute exposures.
Table 2. Summary of Toxicological Endpoints for Dietary Risk Assessments
Assessment
Acute
Dietary
Chronic
Dietary
Dose
(mg/kg/day)
0.37 (LOAEL)
0.01 (NOAEL)
0.03 (LOAEL)
Endpoint
plasma (male &
female), red blood cell
(male) cholinesterase
inhibition
plasma cholinesterase
inhibition
Study
Acute Rat
Neurotox
Chronic tox
-dogs
Uncertainty
Factor
300, add'l 3X
for use of
LOAEL
100
FQPA
Safety
Factor
IX
IX
PAD
0.0012
mg/kg
0.0001
mg/kg/day
NOAEL = No Observed Adverse Effect Level
LOAEL = Lowest Observed Adverse Effect Level
e. Exposure Assumptions
The Agency's dietary risk assessment for fenamiphos uses the Dietary Exposure Evaluation
Model (DEEM™), which incorporates consumption data generated from the USDA's Continuing
Surveys of Food Intakes by Individuals (CSFn), 1989-1992. Percent of crop treated data were also
used in this analysis. Both acute and chronic anticipated residues were calculated using residue
14
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monitoring data from USDA's PDF and the FDA Surveillance Monitoring Program data. PDF data
were evaluated from 1994-1997, while FDA Monitoring data were evaluated from 1995-1997. The
monitoring data analyzed samples for fenamiphos and its regulable metabolites (fenamiphos
sulfoxide and fenamiphos sulfone).
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. The Agency uses the estimated
maximum percent crop treated for the acute risk and the average estimate percent crop treated for the
chronic risk.
f. Food Risk Characterization
Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD does not
exceed the Agency's level of concern. Both the acute and the chronic dietary risk from food are
below the Agency's level of concern; that is, less than 100% of the acute or chronic PAD is utilized.
All subgroups, even the most exposed (infants younger than one year), are estimated to consume
residues on food that comprise less than 1% of the aPAD at the 99.9th percentile of exposure.
Similarly, on a chronic basis the most exposed subgroup (children from one to six years of age) is
expected to consume residues on food that comprise less than 1% of the cPAD.
Refinements to the dietary analyses were made using zeros rather than one-half the limit of
detection (LOD,/2) in the probabilistic analysis. The Agency adopts this approach when a substantial
amount of monitoring data are available showing very few to no detectable residues. For fenamiphos,
all but three samples (two grape and one strawberry) of the 26,619 samples analyzed by PDF and
FDA (for the above noted time periods) detected no residues of either fenamiphos or its regulable
metabolites.
2. Dietary Risk from Drinking Water
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and
uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is
considered to be an unrefined assessment and provides a high-end estimate of potential exposure. In
the case of fenamiphos, monitoring data for ground and surface water were available; however, for
surface water these data were not sufficient to estimate expected concentrations in water. For ground
water, these data were of higher quality and were used in the risk assessment. Therefore, both
modeling and monitoring were used to estimate drinking water risks from these sources.
The GENEEC (Generic Estimated Environmental Concentration) model and PRZM-EXAMS
(Pesticide Root Zone Model and Exposure Analysis Modeling System) model using the Index
Reservoir scenario were used to estimate surface water concentrations. Both of these models are used
for screening, with the PRZM-EXAMS model being somewhat more refined than GENEEC.
15
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For ground water, the Agency reviewed monitoring data from a variety of sources including
registrant-conducted studies, USGS monitoring, and state monitoring information to estimate impacts
from fenamiphos use on ground water quality. These monitoring data were used to estimate ground
water concentrations.
For fenamiphos, the Agency uses the term total fenamiphos residues to indicate that parent
fenamiphos plus its two primary degradates (fenamiphos sulfoxide and fenamiphos sulfone) are all
considered toxic and thus are all considered in calculating risk from drinking water. Fenamiphos and
its degradates are mobile and persistent. Parent fenamiphos is relatively mobile, while laboratory
studies show the sulfoxide and sulfone degradates are more mobile than the parent. Parent
fenamiphos has the potential to be moderately persistent under certain conditions. Although the
aerobic soil metabolism half-life is short (15.7 days), the anaerobic soil metabolism half-life for the
parent is approximately 87.9 days (13 weeks) which indicates that fenamiphos will persist after
reaching ground water. In water, the hydrolysis half-life of the parent is greater than 234 days.
Persistence data are incomplete for the degradates, but in soil they appear to be at least as persistent as
the parent.
a. Surface Water
Fenamiphos has the potential to reach surface water via spray drift and runoff. The typical
incorporation of fenamiphos into the soil should limit the fraction available for runoff. However,
relatively high application rates coupled with only moderate susceptibility to biodegradation can
result in substantial quantities of fenamiphos remaining within approximately the top one centimeter
of the soil. The Agency expects these residues to be available for runoff for several weeks
post-application (aerobic soil metabolism half-life of 16 days for fenamiphos and 62 days for
fenamiphos sulfoxide). Although fenamiphos is susceptible to rapid photodegradation on soil,
approximately only the top one millimeter of soil is typically exposed to solar irradiation. The rest of
the chemical in the top centimeter and below will not be exposed, and is not expected to be degraded
by photolytic processes.
Because surface drinking water monitoring data are limited, estimated environmental
concentrations (EECs) in surface drinking water for fenamiphos were based on results of Tier n
drinking water modeling (PRZM-EXAMS) using the Index Reservoir scenario. Modeling results for
a drinking water reservoir downgradient of a watershed planted in grapes are 141 ppb for the peak
concentration, 13.7 ppb for the annual mean, and 7.4 ppb for the overall mean (i.e., 36-year average).
Concentrations of degradates were not modeled. However, the model also used conservative
assumptions to compensate for key data that are missing, including photodegradation in water and
metabolism studies. The conservative assumptions lead to an overestimation in the model results,
while lack of consideration of the degradates leads to an underestimation. Overall, the Agency
expects the model results to overestimate the expected concentration in surface drinking water
sources. Additional fenamiphos-specific data are expected to refine these results.
16
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1) Surface Water Modeling
On turf, fenamiphos concentrations were estimated using a Tier I screening model
(GENEEC). For major crops, Tier IIPRZM-EXAMS screening model using the Index Reservoir
(IR) scenario and a Percent Crop Area (PCA) adjustment were used to estimate upper-bound
concentrations in surface water used as a source of drinking water. This model, in general, is based
on more refined, less conservative assumptions than the Tier I GENEEC screening model. Refined
modeling with the Index Reservoir scenario and the PCA is intended for use as a screen. That is, the
estimate should be higher than most values that are seen in areas where a particular crop is grown.
The Index Reservoir represents a watershed that is more vulnerable than most used as
drinking water sources. It was developed from a real watershed in western Illinois. The Index
Reservoir is used as a standard watershed that is combined with local soils, weather, and cropping
practices to represent a vulnerable watershed for each crop that could support a drinking water
supply. If a community derives its drinking water from a large river, the estimated exposure would
likely be higher than the actual exposure. Conversely, a community that derives its drinking water
from smaller bodies of water with minimal outflow would likely get higher drinking water exposure
than estimated using the Index Reservoir. Areas with a more humid climate that use a similar
reservoir and cropping patterns would likely have higher pesticide residues in their drinking water
than predicted by the model. For fenamiphos, the modeling is expected to overestimate expected
concentrations in surface water.
In addition, maximum application rates were used in the model. Also, when soil
incorporation was allowed for a specific use, that agronomic practice was simulated in the modeling
using the minimum depth of incorporation. Based on fenamiphos use on grapes, peanuts, peaches,
and tobacco, the models provide very conservative, upper-bound concentrations for drinking water
reservoirs ranging from 19 ppb (peanuts) to!41 ppb (grapes).
2) Surface Water Monitoring
Surface water monitoring data are limited for fenamiphos, fenamiphos sulfoxide, and
fenamiphos sulfone, in part because they are not currently regulated under the Safe Drinking Water
Act. The Agency has analyzed monitoring data from three sources: a study in Florida, STORET
(EPA's STOrage and RETrieval system for water and biological monitoring data), and a pilot
reservoir study. In none of these studies was sampling conducted with adequate frequency to capture
peak concentrations, which is to be expected as it is virtually impossible to determine peak
concentrations from non-targeted monitoring studies.
Miles and Pfeuffer (1994) summarized the results of monitoring by 27 sites in the South
Florida Water Management District (SFWMD). A total of 28 sampling events were documented
over a 4.5-year period. Sampling was quarterly from June 1989 through October 1990, which
subsequently increased to six times per year through November 1993. The study only analyzed
samples for parent fenamiphos and no detections were reported. Since peak concentrations are
expected to be of short duration, it is highly unlikely, given the nature of these monitoring data, that a
17
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peak concentration of fenamiphos would have been detected even if the degradates had been included
as analytes. Therefore, these data do not provide much useful information about the impact of
fenamiphos use on surface-water quality.
STORET lists 37 samples analyzed for fenamiphos from more than 20 sites in three states.
Fenamiphos was not detected in any of the samples. No information is provided about whether
samples were taken from fenamiphos use areas. As such, it is not possible to draw reliable
conclusions about fenamiphos from this monitoring data set.
From 1999 through 2000, EPA and USGS jointly sponsored a program to monitor twelve
drinking water reservoirs across the United States. Samples were analyzed for a number of
pesticides, including fenamiphos and its sulfoxide and sulfone degradates. Degradates of fenamiphos
were detected in three out of the twelve reservoirs at concentrations ranging from 0.005 to 0.033 ppb.
Degradates were also detected in the finished water (i.e., water that has been processed for use as
drinking water) at all three reservoirs at concentrations ranging from 0.007 to 0.022 ppb. One
reservoir, where fenamiphos sulfone had been detected in finished water for two consecutive months
during the first year of sampling, was not sampled during the second year of the program. Because
the pilot study was not designed to directly correlate fenamiphos use areas and loading in a watershed
with concentrations in downgradient reservoirs, predictions about the magnitude of fenamiphos and
its degradates in drinking water for reservoirs across the nation can not be made. However, the
results support the conclusion that fenamiphos and/or its degradates can migrate to surface waters and
then to community water systems that are in close proximity to use areas.
b. Ground Water
Because of its chemical characteristics, fenamiphos and its major degradates have the
potential to leach to ground water in vulnerable areas. Persistence data are incomplete for the
degradates, but they appear to be at least as persistent in soil as the parent. Both fenamiphos
sulfoxide and sulfone have been detected in ground water in Florida and elsewhere, indicating that
they are sufficiently persistent to leach in some environments.
Although ground water monitoring data for fenamiphos are not extensive, they are sufficient
to estimate concentrations in drinking water derived from ground water. Because expected
fenamiphos concentrations in ground water vary significantly, the Agency has calculated EECs from
a variety of uses on both vulnerable and extremely vulnerable use areas. Extremely vulnerable areas
are hydrologic soil group (HSG) A soils that are excessively drained and predominately sand or
loamy sand, such as soils in the suborder psamments. EECs for both types of soils are presented in
Table 4, following the ground water monitoring discussion.
1) Ground Water Monitoring
The Agency reviewed monitoring data from a variety of sources including
registrant-conducted studies, USGS monitoring, and state monitoring information to estimate impacts
from fenamiphos use on ground water quality. Because a maximum contaminant level has not been
18
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established for fenamiphos and its degradates, no monitoring is being conducted under the Safe
Drinking Water Act. The two major fenamiphos use states, California and Florida, have monitored
for this pesticide, but fenamiphos is also used in 27 other states where no reliable monitoring has been
conducted. Table 3 outlines the results of several fenamiphos monitoring studies.
Table 3. Ground Water Monitoring Data for Fenamiphos and its Degradates
Study
California prospective study on
grapes (1997-2000)
Georgia prospective study on
tobacco (1996-1998)
Florida prospective (1995-1996) -
citrus use site (4. 1 Ibs a.i./A) on the
Central Ridge
USGS Florida golf course study
(1992-1994)
Florida retrospective (1989-1992)
California monitoring program
(1985-1994)
Mississippi monitoring program
(1989-1995)1
Oregon monitoring program (1986-
1995)1
Texas monitoring program (1987-
1988)1
Washington monitoring program
(1988-1995)1
Well Type
monitoring
monitoring
monitoring
monitoring/
irrigation
monitoring
drinking water
drinking water
drinking water
drinking water
drinking water
#of
Wells Sampled
16
16
16
41
12
803
348
1000 samples
188
248
# Wells w/
Detections
5
2
9
8
12
0
0
0
0
0
Concentration
Range (ppb)
0.05 (parent)
0.06-2.13(sulfoxide)
0.53 (sulfone)
0.0 (parent)
0.04-0.05 (sulfoxide)
0.0 (sulfone)
0.10-0.58 (parent)
0.13-83 (sulfoxide)
0.14-3.3 (sulfone)
0.03 - 0.71 (parent)
0.2 - 0.75 (sulfoxide)
0.1 (sulfone)
0.1-24 (parent)
0.2-218 (sulfoxide)
0.1-27 (sulfone)
not detected
not detected
not detected
not detected
not detected
Study only analyzed for parent fenamiphos
The prospective and retrospective studies conducted by the registrant, and other studies
conducted by the USGS, and the State of California are of high quality. The other monitoring studies
did not necessarily coincide with use areas, making it difficult to interpret and use study results.
The most extensive ground water monitoring studies for fenamiphos were conducted in
Florida by the registrant at the request of USEPA and the State of Florida. The data from the Georgia
prospective ground water study do not show a pattern of movement to ground water. The data in
19
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Georgia suggest fenamiphos and its degradates may not leach in some soils. However, until the
factors limiting the movement at this site are defined, it is not possible to extrapolate these results to
other specific soils and geographical areas.
While not all of the monitoring data were collected from drinking water wells, these studies
provide solid evidence that fenamiphos and its degradates leach to ground water. Moreover, available
ground water monitoring data are sufficient to show that significant ground water contamination may
occur in areas with sandy soils. Prospective and retrospective studies have found concentrations of
total fenamiphos residues (parent and its degradates) of up to several hundred ppb.
Because available data indicate fenamiphos leaches much more readily in extremely
vulnerable soils than in other soils, the Agency has developed two separate sets of EECs to more
accurately portray risk. Expected concentrations in extremely vulnerable ground water are based on a
prospective ground water study conducted in Florida. Although a prospective ground water study
from California was used to estimate concentrations in other vulnerable soils, there are weaknesses in
this study. Therefore, the Agency intends to issue a DCI to require additional data to confirm the
conclusions of this assessment.
The EECs in the Table 4 are expected to occur in ground water as a result of normal
agricultural and non-agricultural uses. In extremely vulnerable areas, such as the Central Ridge
region of Florida, acute ground water EECs range from 43 to 425 ppb and chronic EECs range from 4
to 45 ppb. In other vulnerable soils, acute EECs range from 1 to 7 ppb and chronic EECs range from
0.1 to 0.93 ppb. Since fenamiphos may be used on a particular crop on similar soils but in areas
where climatic conditions vary, these EECs may not be conservative. For example, the study on
grapes in Fresno County, California, was conducted under drier conditions than other grape growing
areas; therefore, greater leaching and higher fenamiphos concentrations would be expected in areas
with higher rainfall. The Agency believes the expected concentrations outlined in Table 4 represent
use sites in the two different soil types.
Table 4. Drinking Water EECs For Ground Water Resources
Crop
Citrus (FLPGW)
Grapes (CAPGW)
Citrus
Citrus (FL)
Grapes/Raspberry
Peanuts
Maximum Application
Allowed on Label
(Ibs a.i./A/year)
4.1
6
7.5
10
6
7.5
Extremely
Vulnerable Soils
Acute
(ppb)
87.2
NA
160
213
128
160
Chronic (ppb)
9.2
NA
17
22
13
17
Other Vulnerable Soils
Acute
(ppb)
NA
2.1
2.63
3.50
2.10
2.63
Chronic
(ppb)
NA
0.28
0.35
0.47
0.28
0.35
20
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Crop
Pineapple2
Protea/Anthurium/nurseiy stock3
Iris/Lily/Narcissus/leather leaf fern
Bananas and plantains
Beets
Eggplant/nonbell pepper/asparagus
Cabbage and Brussels sprouts
Strawberries
Garlic/okra
Tobacco
Apples/Cherries/Peaches
Turf/Golf courses
Maximum Application
Allowed on Label
(Ibs a.i./A/year)
24
20
10
6.7
3.1
2
4.5
7.5
4.5
7.5
7.5
20
Extremely
Vulnerable Soils
Acute
(ppb)
510
425
213
142
66
43
96
160
96
160
160
425
Chronic (ppb)
54
45
22
15
7
4
10
17
10
17
17
45
Other Vulnerable Soils
Acute
(ppb)
8.40
7.00
3.50
2.35
1.09
0.70
1.58
2.63
1.58
2.63
2.63
7.00
Chronic
(ppb)
1.12
0.93
0.47
0.31
0.14
0.09
0.21
0.35
0.21
0.35
0.35
0.93
NA = Not Applicable
2 Proposed application rate reduction is expected to reduce the EECs for pineapple by almost two-thirds
3 Proposed application rate reduction is expected to reduce the EECs for protea by approximately one-half
3. Drinking Water Levels of Comparison (DWLOCs)
To determine the maximum allowable contribution of water-containing pesticide residues
permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by food
(and, if appropriate, residential uses) then determines a "drinking water level of comparison"
(DWLOC). The Agency uses the DWLOC as a surrogate to capture risk associated with exposure
from pesticides in drinking water. The DWLOC is the maximum concentration in drinking water
which, when considered together with dietary exposure, does not exceed the Agency's level of
concern.
The results of the Agency's acute drinking water analysis, which used screening models and
actual monitoring data to develop expected concentrations in water, are summarized in Table 5. For
surface water, the modeled concentrations exceed the DWLOC by a relatively substantial margin.
The Agency believes that uncertainties in the assessment, as discussed earlier, cause the model to
overestimate the expected concentrations in surface water.
For groundwater, the potential exposure derived from drinking water is not greater than the
Agency's DWLOC, provided fenamiphos is not used in areas with extremely vulnerable soils, as
21
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described earlier in the ground water section. In areas with extremely vulnerable soils, the potential
drinking water exposure derived from ground water is greater than the DWLOC. Table 5 summarizes
the DWLOCs and EECs for acute exposure.
Table 5. Summary of DWLOC Calculations for Acute Risk
Population
Subgroup
Adult Females
Adult Males
Infants (younger
than 1 year)
Acute PAD
(mg/kg/day)
0.0012
Exposure (mg/kg/day)
Expected
Food
0
0
0
Allowable
Water
0.0012
0.0012
0.0012
EECs in Water (ppb)
Extremely
Vulner.
Ground
425
Vulner.
Ground
7
Surface
141
DWLOC
(ppb)
36
42
12
For chronic risk, the potential drinking water exposure derived from ground water does not
exceed the DWLOC for any population, provided fenamiphos is not used in areas with extremely
vulnerable soils. In areas with extremely vulnerable soils, the potential drinking water exposure
derived from ground water exceeds the DWLOC by a large margin.
The potential drinking water exposure derived from surface water exceeds the chronic
DWLOC for all populations. However, the Agency believes that uncertainties in the assessment as
discussed earlier cause the model to significantly overestimate the expected concentrations in surface
water. Table 6 summarizes the DWLOCs and EECs for chronic exposure.
Table 6. Summary of DWLOC Calculations for Chronic Risk
Population
Subgroup
U.S.
Population
Children
(aged 1-6)
Acute PAD
(mg/kg/day)
0.0001
Exposure
(mg/kg/day)
Food
0
0
Allowable
Water
0.0001
0.0001
EECs in Water
(ppb)
Extremely
Vulner.
Ground
22
Vulner.
Ground
0.47
Surface1
13.7
DWLOC
(ppb)
4
1
Estimate is believed to be conservative because key environmental fate data are not available.
4. Residential/Recreational (Golfer) Risk
Fenamiphos is not used in a residential setting. However, because fenamiphos is used on golf
course turf, golfers may be exposed to its residues when playing on a treated course. In evaluating the
risk to golfers, the assessment considered exposure to be short-term, and assumes that no protective
22
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clothing is used. To evaluate these risks, the Agency initially conducted a post-application
assessment that showed the MOE is not greater than 100 until 18 days after treatment. However, a
recently published study (R.H. Snyder, et al., 1999) indicates that watering-in, as required by
fenamiphos labels, reduces dislodgeable residues of a liquid formulation of fenamiphos to less than
1% less than 24 hours after application. Data for granular formulations are not available, however,
the Agency believes that residues will also be significantly reduced from watering-in of these
products. Provided fenamiphos is watered-in after applications, the Agency believes that golfers will
be adequately protected. Additional data are being called-in for the granular formulation to confirm
this conclusion.
5. Aggregate Risks
An aggregate risk assessment looks at the combined risk from dietary exposure (food and
drinking water routes) and residential or non-occupational risk, when appropriate. Generally,
combined risks from these exposures must have MOEs of 100 or greater to not to be of concern to the
Agency. Although fenamiphos is not used in a home residential setting, it is used on golf course turf.
Therefore, golfers may be exposed to fenamiphos while playing on courses after treatment. The risks
to golfers is not included in the Agency's quantitative assessment of the aggregate risks at this time as
the data are not sufficient or robust enough to allow its inclusion in this calculation. However, the
Agency has qualitatively evaluated such risk and believes that this exposure is not significant and that
its inclusion in the aggregate risk assessment will not change its conclusions.
The Agency believes that the results of the drinking water and food aggregate assessment
discussed above describes total aggregate risk from exposure to fenamiphos residues. As discussed in
the drinking water section above, the Agency is not concerned about the risk to any population
exposed to combined fenamiphos residues from food and drinking water, provided the population is
not drinking ground water in areas with extremely vulnerable soils. In areas with extremely
vulnerable soils, the potential drinking water exposure derived from ground water is of concern. For
surface water, the Agency expects that additional chemical-specific environmental fate data will show
that concentrations are not of concern.
6. Occupational Risk
Occupational workers can be exposed to fenamiphos through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational handlers of fenamiphos include:
individual farmers or growers who mix, load, and/or apply pesticides, professional or custom
agricultural applicators, and turf management professionals. Risk for all of these potentially exposed
populations is measured by a Margin of Exposure (MOE) which determines how close the exposure
comes to a No Observed Adverse Effect Level (NOAEL). Generally, MOEs greater than 100 do not
exceed the Agency's risk concern.
The Agency considered the tasks (e.g.., mixing/loading, applying), fenamiphos formulation
(e.g.., liquid, granular), application method (e.g.., groundboom, soil-band or broadcast or in-furrow
treatment, chemigation, soil injection), application rate and similar parameters in assessing worker
23
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exposure. The Agency considered both direct and indirect or secondary exposure and risks that may
result from the use of fenamiphos, such as handlers not directly involved in mixing/loading or
applying the chemical. The Agency also reviewed human incident data that may pertain to the
occupational assessment.
a. Toxicity
The toxicity of fenamiphos is integral to assessing the occupational risk. All risk calculations
are based on the most current toxicity information available for fenamiphos, including a 21-day
dermal toxicity study and a 21-day inhalation toxicity study. The toxicological endpoints, and other
factors used in the occupational and residential risk assessments for fenamiphos are listed in Table 7
below. As this table indicates, all of the endpoints are based on route specific studies. Therefore,
additional factors are not necessary. Because fenamiphos is used in limited amounts, even by custom
applicators, chronic exposure is not expected.
Table 7. Summary of Toxicological Endpoints Used to Assess Worker and Golfer Risk
Assessment
Short- and intermediate-
term dermal
Short- and intermediate-
term inhalation
Dose
(mg/kg/day)
NOAEL1 = 2.5
LOAEL = 10
NOAEL = 0.061
LOAEL = 0.85
Endpoint
Plasma, blood and brain cholinesterase
inhibition
Plasma cholinesterase inhibition
Study
21 -day dermal toxicity in
rabbits
21-day inhalation
toxicity in rats
Marginal effects seen at the NOAEL in only female rabbits in this study (plasma cholinesterase decreased 30% on
day 10; brain cholinesterase decreased 11% on day 15)
According to the results of available acute toxicity studies, fenamiphos is in Toxicity
Category I for oral and dermal toxicity and in Toxicity Category II for inhalation toxicity. Because
fenamiphos causes mild eye irritation, it is in Toxicity Category HI. Fenamiphos is not irritating to
the skin (Toxicity Category IV) and is not a dermal sensitizer. Table 8 provides toxicity categories
for each of the routes of exposure.
Table 8. Acute Toxicity Profile for Occupational Exposure for Fenamiphos
Route of Exposure
Oral
Dermal
Inhalation
Eye Irritation
Dermal Irritation
Results
LD50 = males: 2.7 mg/kg
LD50= females: 3 .0 mg/kg
LD50 = males: 225 mg/kg
LD50= females: 178.8 mg/kg
LC50 = X).lmg/L
mild
not irritating
Toxicity
Category
I
I
II
III
IV
MRID
00033831
00037962
00154492
00082111
00082111
24
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Route of Exposure
Dermal Sensitizer
Results
negative
Toxicity
Category
N/A
MRID
00148464
b. Exposure
Chemical-specific exposure data were not available for fenamiphos, so risks to pesticide
handlers were assessed using data from the Pesticide Handlers Exposure Database (PHED). PHED is
a comprehensive generic/surrogate exposure database containing a large number of measured values
of dermal and inhalation exposures for pesticide handlers (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 quality of the data and exposure factors represents the best
sources of data currently available to the Agency for completing these kinds of assessments; the
application rates are derived directly from fenamiphos labels. The exposure factors (e.g., body weight,
protection factors, etc.) are all standard values that have been used by the Agency over several years,
and the PHED unit exposure values are the best available estimates of exposure. Some PHED unit
exposure values are high quality while others represent low quality, but are the best available data.
The quality of the data for each scenario assessed is discussed in the Human Health Assessment
document for fenamiphos, which is available in the public docket and on the internet at
http://www.epa.gov/pesticides/op/fenamiphos.htm.
Anticipated use patterns, application methods, and range of application rates were derived
from current labeling. Application rates specified on fenamiphos labels range from 1 to 10 pounds of
active ingredient per acre in agricultural settings, and 10 pounds of active ingredient per acre on turf.
The Agency typically uses acres treated per day values that are thought to represent eight hours of
work. For fenamiphos, refined values were provided by the registrant indicating the number of acres
that are typically treated for each site.
The Agency performed its own analysis of the maximum number of acres that are generally
treated with fenamiphos on one day. Based on this analysis, the Agency agreed to use maximum
acres treated values in the occupational risk assessment. The Agency's analysis also revealed that, for
low acreages, a single handler may perform the mixer/loader and applicator tasks on the same day.
Because PHED is largely setup to measure mixer/loader exposure separately from applicator
exposure, most of the Agency's calculations to assess these combined exposures are not robust
enough for regulatory use. The Agency's assessment does, however, provide additional information
that can be used to qualitatively assess risks.
Occupational handler exposure assessments are conducted by the Agency using different
levels of personal protection. The Agency typically evaluates all exposures with minimal protection
and then adds additional protective measures using a tiered approach to obtain an appropriate MOE
(i.e., going from minimal to maximum levels of protection). The lowest suite of personal protective
equipment (PPE) is baseline. If required (i.e., MOEs are less than 100), increasing levels of risk
mitigation and PPE are added. If MOEs are still less than 100, engineering controls (EC) are applied.
25
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In some cases, EPA will conduct an assessment using PPE or ECs taken from a current label. The
levels of protection that formed the basis for calculations of exposure from fenamiphos activities
include:
Baseline: Long-sleeved shirt and long pants, shoes and socks.
Label: Chemical-resistant suit, gloves, and footwear; socks; protective
eyewear; chemical-resistant headgear for overhead exposures;
dust/mist filtering respirator (outdoors); respirator with either organic
vapor-removing cartridge with prefilter approved for pesticides, or
canister approved for pesticides (enclosed areas)
• Minimum PPE: Baseline plus chemical-resistant gloves.
• Maximum PPE: Coveralls over long-sleeved shirt and long pants, chemical-resistant
gloves, chemical-resistant footwear plus socks, and an organic vapor-
removing respirator
• Engineering controls: Closed mixing/loading system and thereafter an enclosed cab during
application.
Finally, post-application exposure to workers entering treated agricultural fields was also
considered. Because the majority of labeled uses require that the applications are soil incorporated
and/or watered-in via irrigation or natural rainfall, and the timing is at or near planting or during the
dormant stage for most of the pest targets, post-application exposure to workers is not expected for
most crops.
c. Occupational Handler Risk Summary
The Agency initially identified seven major handler exposure scenarios for users of
fenamiphos: 1) loading granular formulations; 2) mixing liquid formulations for groundboom
applications; 3) mixing the liquid formulation for chemigation; 4) groundboom application; 5) soil
injection; 6) tractor-drawn granular application; and 7) loading and applying by push spreader. At a
later date, the Agency performed an additional analysis that combines scenarios 1 and 6, 2 and 4, to
account for low acreage situations where the mixer, loader and applicator are the same person
(chemigation is already assumed to be performed by the same individual). The data were inadequate
for conducting an assessment on the soil injection use; though it is assumed exposure would be no
greater than for the groundboom use.
As mentioned earlier, the occupational assessment uses acreage-treated information provided
by the registrant. These numbers, which are lower than Agency default values, are intended to more
closely reflect current practice. The Agency has validated this information through contacts with
growers and State representatives.
26
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1) Agricultural Handler Risk
In an effort to characterize the risk to agricultural workers, the occupational assessment
addressed the risk to workers on each crop for which fenamiphos is registered. For each scenario, at
least one crop has MOEs that are below 100 and of concern. MOEs of concern range from 28 to 86,
as outlined in Table 9, when mixing/loading and applying are performed by different people.
As mentioned earlier, occupational risks for handlers that mix, load and/or apply fenamiphos
were estimated using refined acres treated assumptions rather than Agency defaults, the maximum
application rate, and other standard assumptions on a crop-by-crop, site-by-site basis. The MOE
ranges presented in the Table 9 show the lowest and highest MOEs for each specific activity (i.e.,
load granulars), application equipment used (i.e., tractor drawn spreader), and crop-specific
parameters applicable to that scenario. As such, numerical relationships do not follow the typical
linear progression and may not correspond exactly. However, these MOEs reflect the actual
estimates for the parameters that were assessed. See the Human Health risk assessment dated
September 1999 for a detailed discussion of the MOEs and their derivation.
27
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Table 9. Agricultural Uses: Risk Concerns (combined dermal & inhalation MOEs)
Scenario
Load
Granular? (I)
Mix Liquids
Ground-
boom (II)
Mix Liquids
Chem-
igation (El)
Apply
Ground-
boom
(IV)
Soillnj.(V)
Apply Gran
Tractor-
Drawn (VI)
Crops
Turf
Other (peanut/eggplant)3
Turf
Tobacco,
pome/stone/citrus/ grape
Other (peanut/eggplant)3
(Pome/stone/citrus/
grapes/kiwi)/ornam.
Fern/Banana
Turf
Tobacco/grapes
(incl. Pome/stone/citrus)
Other (peanut/eggplant)3
Cotton
Turf
Other (Peanut/eggplant)3
Max.
Acre
40
50/2
40
55/40
50/10
80/20
9/5
40
55/40
50/10
10
40
50/10
Max.
Rate
10
3/10
10
6/6
3/2
3/10
5/10
10
6/6
3/2
3
10
3/2
Short-term and Intermediate-Term MOE
Base-
line
4.6
14 - 136
0.2
0.2-0.3
0.5-3.0
0.3
1.3
10
13-19
21 - 309
no data
6.8
20 - 163
Max PPE1
Dermal
119
389-2,917
18
21-57
57 - 357
29-35
156
44
53-96
147 - 875
no data
93
307-2,303
Inhalation
50
150 - 1,526
90
100-310
310-2,034
150 - 180
760 - 870
150
100-310
610-6,100
no data
70
230 - 2,034
Combined
35
108 - 1,002
15
17-48
48 - 304
24-29
129 - 132
34
42-73
118-765
no data
40
131-1,080
Engineering Controls2
Dermal
NA
NA
49
60-81
156 - 972
80-96
432
64
81 - 109
211-1,306
no data
NA
NA
Inhalation
NA
NA
153
153 - 203
432 - 2,669
203 - 244
1186
305
301-414
804 - 4,965
no data
NA
NA
Combined
NA
NA
37
43-58
115-713
57-69
317
53
64-86
167 -1,034
no data
NA
NA
1 MOE for label rates are the same as in Max PPE column. Label requires chemical-resistant coveralls, which have same protection as canvas coveralls.
2 NA = Not Available
3 Two crops with the lowest and highest MOEs that are greater than 100 with mitigation. Crops not listed have MOEs between these two values.
28
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Typically, the Agency assumes that mixing/loading and applying are two separate tasks
performed by two separate individuals. Because the acreage-treated values used in the fenamiphos
assessment are less than the default values, the Agency believes that these activities may be
performed by a single person. Consequently, the risks to workers who mix/load/apply fenamiphos
would be higher than portrayed in Table 9. To help characterize these risks, the Agency performed a
separate risk analysis, which showed that the MOEs for all scenarios were less than 100 when all
tasks were conducted by a single worker. The MOEs ranged from 14 - 75, with the majority being
less than 40. Unlike the separate mixer/loader and applicator assessment, the acres treated and
application rates were reported as ranges in the combined assessment.
2) Hand-held Equipment Golf Course Assessment
In addition to the MOEs discussed above for turf, the Agency conducted an assessment for
the application of granular fenamiphos to golf courses via hand-held or operator equipment, such as a
drop spreader or belly grinder. While the extent of the use of this equipment is somewhat uncertain,
these methods were examined for their potential use on turf. The following estimates are for a single
individual loading and applying the granular formulation on a golf course.
The drop spreader assessment was conducted using a draft review of the Occupational and
Residential Exposure Task Force study (MRID 44972201). Table 10 provides MOEs for hand
application methods on turf.
Table 10. Occupational Exposure Scenarios for Hand Application Methods on Turf
Mixer/Loader/Applicator MOEs for Granular Application on Turf
Hand Application Method
Drop Spreader
Drop Spreader
Belly Grinder
Belly Grinder
Acres Treated
1
5
1
5
Max Rate
(Ibai/A)
10
10
10
10
MaxPPE
140
28
3
0.6
3) Post-Application Worker Risk
The post-application occupational risk assessment considered exposures to workers entering
treated agricultural sites, as well as exposures that can occur as a result of turf management activities.
Post-application exposure is primarily a concern for human activities which may involve contact with
the soil after treatment (e.g., transplanting strawberries) or contact with plants after a foliar treatment.
There are no chemical-specific exposure data for handling fenamiphos-treated soil; therefore,
the Agency will be issuing a DCI to require post-application exposure data and to clarify the use
patterns and worker activities or practices which may result in postapplication exposure. These uses
29
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are on strawberries, asparagus, ornamental nonflowering plants, ornamental herbaceous plants,
ornamental woody shrubs and vines, and all nursery stock.
Pineapple is the only crop that is treated with a foliar application of fenamiphos. For
pineapples, the Agency reviewed a study that used Nemacur 3 (EC) at a rate of 10 Ib ai/acre (MRID
41901701). Using this study, the short/intermediate term MOE does not reach 100 until day 17. The
pineapple growers are proposing to reduce the application rate from 10 Ib ai/acre to 2 Ib ai/A, which
the Agency expects would reduce the average dislodgeable foliar residue. While it is widely
recognized that foliar residues are not directly proportional to application rate, the Agency believes
this technique is adequate to estimate foliar residues from the application to pineapples. Based on the
label rate reduction to 2 Ib ai/acre, the Agency believes that the MOE for harvesting pineapples would
be greater than 100 in less than 48 hours. The current WPS REI for pineapples of 48 hours is based
on multiple factors, including acute toxicity, and should be continued for post-application reentry.
7. Human Incident Reports
In evaluating incidents to humans, the Agency reviewed reports from the Incident Data
System (IDS), Poison Control Centers (PCC), California Pesticide Illness Surveillance Program and
National Pesticide Telecommunications Network (NPTN). Overall, relatively few incidents of illness
are associated with fenamiphos. From cases in the Incident Data System (IS) and the California data,
it appears that equipment malfunction and failure to adhere to protective equipment requirements are
significant factors leading to poisoning. Poison Control Center data are relatively sparse but suggest
that fenamiphos poisonings are similar to other cholinesterase inhibitors in terms of severity of
symptoms and requirements for health care.
The IS contains over 17,000 pesticide-related reports of incidents involving adverse effects to
humans and approximately 9,000 reports involving domestic animals since 1992. From 1996 to
1999, fenamiphos was identified in only five human cases. Of these, one case may have been due to
coincidental exposure to poison oak and not fenamiphos. Of the remaining four cases, two resulted in
complications requiring hospitalization.
The PCC data contains reports of 16 occupational cases and 27 non-occupational cases of
fenamiphos exposure from 1985 through 1992. Twenty-one of these cases were reported from 1993
through 1996. Six of the 21 PCC cases may be associated with unrelated effects and the remaining
cases were associated with various effects including nausea, vomiting, and abdominal pain. Eleven of
the 21 exposures were considered occupational and four were reported to be due to environmental
exposures, suggesting exposure to residues (e.g., spray from a hose leak to bystander or exposure to
irrigation water). Two of the environmental cases exhibited minor effects and two exhibited
potentially toxic effects.
The California Pesticide Illness Surveillance Program reported 26 illnesses that are possibly,
probably, or definitely related to fenamiphos exposure or fenamiphos in combination with other
pesticides. Of the 26 cases, fenamiphos was determined to be the primary pesticide associated with
30
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10 cases. Five of the 10 cases involved pesticide handlers, including three applicators and two
mixer/loaders.
Fenamiphos was not reported to be involved in human incidents on the list of the top 200
chemicals for which National Pesticide Telecommunications Network (NPTN) received calls from
1984 to 1991.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For detailed
discussions of all aspects of the environmental risk assessment, see the Environmental Fate and
Effects Division chapter, dated March 6, 2002, available on the internet at
http://www.epa.gov/oppsrrdl/op/fenamiphos.htm and in the public docket.
Whether or not terrestrial and aquatic animals will be adversely affected is dependent on the
fate, distribution, and magnitude of fenamiphos in their habitat. Environmental factors can greatly
modify the fate and distribution of fenamiphos. Like other chemicals, fenamiphos can be
biotransformed by microbial communities or other environmental fate processes, which influences the
degree of exposure to ecological components.
Fenamiphos is generally applied in the spring as a single band or broadcast soil application
for most crop uses. Spring is also the season when plants and animals reappear and reproduce. Many
terrestrial species traverse home ranges from several acres to several square miles in size, increasing
the likelihood of exposure to pesticides during and after treatment. In addition, bird banding studies
reveal that many birds return to nest in exactly the same locations every year, increasing the
likelihood of recurrent exposure if fenamiphos is used on the same treatment areas in subsequent
years.
The Agency's assessment suggests that the use of fenamiphos can result in adverse acute and
chronic effects to terrestrial and aquatic organisms. The fenamiphos ecological risk assessment
integrates the results of the exposure and ecotoxicity data to evaluate the potential for adverse
ecological effects. The method divides exposure estimates by ecotoxicity data to derive risk quotients
(RQs) for acute and chronic effects. RQs are then compared to levels of concern (LOCs), which are
criteria used to indicate potential effects to nontarget organisms. The criteria indicate that a pesticide
used as directed has the potential to cause adverse effects on nontarget organisms. An acute RQ
equal to or greater than 0.5 and/or a chronic RQ equal to or greater than 1.0 results in some concern to
the Agency, while RQs as low as 0.05 may be of concern under special circumstances (e.g., for
endangered aquatic species).
Based on estimated environmental concentrations (EECs) from modeling and toxicity data for
aquatic organisms, the Agency's levels of concern are exceeded for acute and chronic effects to fish
and invertebrates. On avian and mammalian food items, risk estimates exceed levels of concern for
potential acute and chronic effects to both birds and mammals.
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1. Environmental Fate and Transport
The environmental fate database is sufficient to identify the risks associated with fenamiphos
use. However, EPA intends to issue a DCI to require additional data for the parent and two major
degradates (fenamiphos sulfoxide and sulfone) to address areas of concern and uncertainty. These
data are expected to confirm the conclusions of this risk assessment.
Fenamiphos and its degradates are mobile and have a high potential for leaching into ground
water and contaminating runoff into surface waters. Moreover, evidence from laboratory studies
indicate the sulfoxide and sulfone degradates are more mobile than the parent fenamiphos.
Fenamiphos is relatively resistant to hydrolysis in sterile buffered systems with calculated half-lives
of 245 days at pH 5.0, 301 days at pH 7.0, and 235 days at pH 9.0. (MRID 42149302)
Although an aqueous photolysis study was conducted, it does not conform to Agency
guidelines and is expected to overestimate photolysis rates. Therefore, the photodegradation study in
water was not suitable for use in this assessment. A new study is being required to refine the risk
assessment.
When exposed to natural light on the soil surface, fenamiphos readily photodegrades, with a
half-life of 3.23 hours. Fenamiphos dissipates in soil by microbial degradation to fenamiphos
sulfoxide and sulfone. Eventually, further degradation of parent fenamiphos occurs via aerobic and
anaerobic soil metabolism, with respective degradation half-lives of 15.7 and 87.9 days. The half-life
for the degradates were determined to be 62 days for fenamiphos sulfoxide and 29 days for
fenamiphos sulfone. An additional ancillary study demonstrated that the rate of fenamiphos
degradation increases with temperature from 16° to 28° C. Persistence data are incomplete for the
degradates, but they appear to be at least as persistent as the parent in soil. (MRIDs 40524601,
40608001, 42149303, 41064302, 40933701, 41286901 and 40524601)
2. Risk to Birds and Mammals
a. Toxicity (Hazard) Assessment
Fenamiphos is classified as very highly toxic to birds and mammals. Due to the potency of
fenamiphos and its degradates (fenamiphos sulfoxide and sulfone), exposure to extremely small
quantities can result in the impairment of reproductive capability or the death of wildlife. Terrestrial
wildlife can be exposed to fenamiphos applied to the ground by deliberate or incidental ingestion of
soil and/or granules while feeding or preening, ingestion of residues on soil invertebrates and plants,
dermal contact, and inhalation. The Agency's risk assessment considers exposure to fenamiphos
from the oral route only.
Although label directions require soil incorporation by mechanical methods or by irrigation to
move fenamiphos down into the soil profile, a portion of the applied fenamiphos will be available as
(1) granules at the soil surface or (2) in solution as moist fenamiphos-laden soil. In addition to
32
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adverse effects resulting from exposure to parent fenamiphos, terrestrial organisms may be exposed to
the major environmental degradates (fenamiphos sulfone and sulfoxide).
Acute toxicity data on the major degradates are limited, however, data for fenamiphos sulfone
show that it is very highly toxic to mammals (LD50 = 2.6 ppm). It is likely that fenamiphos sulfoxide
is equally as toxic as the parent. Additional data being required on the environmental degradates are
expected to confirm the conclusions of this risk assessment. Table 11 summarizes the data that
support the toxicity endpoints used in assessing the risks of terrestrial animals. (MRID 00040215)
Table 11. Acute Toxicity Endpoints for Birds and Mammals
Toxicity Study
Test Species
% a.i.
Endpoint
Toxicity
Category
MRID
Acute (Single dose by gavage)
Avian Oral
Mammalian
Oral
Bobwhite quail
Laboratory rat
90.0
99.7
LD50 = 1.6 mg/kg
LD50 = 2.38 mg/kg (female)
3.15 mg/kg (male)
Very highly toxic
Very highly toxic
00121289
06F1693
Subacute (Five days of treated feed)
Avian Dietary
Bobwhite quail
88.0
LC50 = 38 ppm
Very highly toxic
00025959
Chronic effects to birds and mammals measured by reproduction studies show reproductive
effects occur at low concentrations. A statistically significant decrease in normal hatchlings and
survivors was observed when Bobwhite quail mated pairs were fed diets containing 8 ppm or more of
fenamiphos. The lowest NO AEL of 2 ppm was selected for calculating avian chronic risks. Table 12
discusses the reproductive endpoints for terrestrial animals that were used in the risk assessment.
Table 12. Reproductive Toxicity Endpoints for Birds and Mammals
Test Species
Bobwhite quail
Laboratory rat
% a.i.
90.0
89.0
NOAEL
(ppm)
2.0
2.5
LOAEL
(ppm)
8.0
10.0
Effects at LOAEL
Reduced hatchling survival at 14 days
Reduced body weight, cholinesterase
depression in parents and offspring
MRID
Accession
00121291
42491701
b. Exposure and Risk
For avian and mammalian species, the acute and chronic levels of concern (LOCs) are
exceeded for all uses of fenamiphos based on current application rates and methods. Even when
fenamiphos is soil incorporated to reduce exposures, estimated acute and chronic RQs are
significantly higher than the LOCs for both mammalian and avian species. The results of the risk
assessment, incident reports and field tests support the conclusion that all current uses of fenamiphos
33
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are likely to cause mortality as well as sublethal effects to terrestrial wildlife. The risk quotients are
presented below in Table 13 for the avian risk due to fenamiphos residues on plants and insects or
on/in soil from the liquid formulation and from ingestion of granules applied to the ground. The table
does not list chronic RQs for the granular formulation because the granules will dissolve over time.
Watering-in, as required by fenamiphos labels, was not accounted for in the exposure models for
either liquid or granular applications. Watering-in would be expected to reduce calculated risks. For
exposure to granules the RQs are expected to be reduced by less than 10% when one-half inch of
irrigation water is applied.
Fenamiphos applied in irrigation water and uses with high application rates result in the
highest expected risks. Fligh risk is expected as a result of exposure from the chemigation use with
low-pressure irrigation equipment using the emulsifiable fenamiphos formulation (Nemacur 3) in
grape vineyards, citrus and kiwi groves and stone fruit orchards. Water used to apply fenamiphos can
attract terrestrial organisms increasing the potential for exposure.
Table 13. Avian Acute/Chronic RQs from Fenamiphos Application
Crop
Citrus (FL)
Citrus (nonFl)
Peanuts
Pineapple
Tobacco/Grape
Turf
Application
Rate
(Ibs a.L/A)
5
7.5
2.5
9.0
6.0
10
Acute RQs
Residues (liquid product)
Fruits, pods,
seeds, & large
insects1
2.0
3.0
1.0
3.6
2.4
3.9
Short
grass1
32
47
16
>57
38
63
Granules2
(granular
product)
NA
NA
7 to 373
9 to 439
NA
65 to 3254
Chronic RQs
Residues (liquid product)
Fruits, pods, seeds,
& large insects 1
38
56
20
68
45
74
Short
grass1
600
900
312
>1,080
720
1,188
NA = not applicable
1 Represents exposure pathway from ingestion of residues on given food items. Watering-in was not accounted for
in the exposure model, but would be expected to reduce these risks.
2 RQs were calculated for a range of body sizes from large (1000 grams) to small (20 grams). Watering-in was not
accounted for in the exposure model, however, RQs are expected to be reduced by less than 10% when one-half
inch of irrigation water is applied.
Mammalian acute and chronic LOCs are exceeded for all crop uses at current rates and
application methods. The mammalian risks are presented in Table 14 as calculated risk quotients
based on exposure to fenamiphos residues.
34
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Table 14. Mammalian Acute/Chronic RQs from Fenamiphos Application
Crop
Citrus (FL)
Citrus (nonFl)
Peanuts
Pineapple
Tobacco/Grape
Turf
Application
Rate
(Ibs a.i./A)
5
7.5
2.5
9.0
6.0
10
Acute RQs
Residues
(liquid product)
Fruits, pods,
seeds, large
insects1
0.9 to 30
1.4 to 45
0.5 to 16
1.7 to > 77
1.1 to 36
1.9 to 59
Short grass1
76 to 479
>113to>718
39 to 249
>136to>862
91 to 575
150 to 948
Granules2
(granular
product)
not applicable
not applicable
5 to 334
6 to 394
not applicable
44 to 29 17
Chronic RQs
Residues
(liquid product)
Fruits, pods,
seeds, large
insects1
30
45
16
54
36
59.4
Short
grass1
480
720
250
>864
576
950
Range of RQs for four categories of food items and three consumption rates (15,66, 95% of body weight).
Watering-in was not accounted for in the exposure model, but would be expected to reduce these risks.
2 RQs were calculated for a range of body sizes from large (1000 grams) to small (20 grams). Watering-in was not
accounted for in the exposure model, however, RQs are expected to be reduced by less than 10% when one-half
inch of irrigation water is applied.
The acute and chronic RQs are based solely on dietary exposure via contaminated food
sources and/or pesticide granules. Since, fenamiphos is highly to very highly toxic to terrestrial
vertebrates, low level exposures by dermal, inhalation or oral routes considered singly or in
combination, can result in significant impairment or death of exposed organisms. Furthermore,
organisms which survive acute exposure and predation may still experience reproductive
impairment.
3. Risk to Aquatic Species
a. Toxicity (Hazard) Assessment
The available acute toxicity data on technical fenamiphos, outlined in Table 15, indicate that
it is very highly toxic to aquatic species. Fenamiphos applied to the ground at use sites may reach
surface water bodies through runoff from the site, spray drift, and contaminated groundwater/surface
water interactions. The degradates, fenamiphos sulfoxide and sulfone, are equally toxic to aquatic
invertebrates but are expected to be slightly less toxic to fish than fenamiphos. Because of the high
toxicity of fenamiphos and its degradates, small quantities reaching surface water may kill aquatic
organisms.
35
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Table 15. Acute Toxicity Endpoints for Aquatic Species
Toxicity Study
Freshwater Fish
Freshwater Invertebrate
Estuarine/Marine
Test Species
Bluegill Sunfish
Daphnid
Mysid Shrimp
% a.i.
88.0
88.7
88.7
LC50
(ppb)
9.5
1.9
6.2
Toxicity
Category
Very highly toxic
Very highly toxic
Very highly toxic
MRID
00025962
40799706
40799708
Chronic data for freshwater organisms show that growth and development was the most
sensitive endpoint to fenamiphos. The no observed effect concentrations (NOECs) and the lowest
observed effect concentrations (LOECs) for freshwater fish and invertebrates are outlined in Table
16. EPA intends to issue a DCI to require estuarine and marine data for chronic effects from
fenamiphos and its degradates.
Table 16. Reproductive Toxicity Endpoints for Aquatic Species
Toxicity Study
Freshwater Invertebrate
Life-Cycle
Freshwater Fish Early
Life-Stage
Test
Species
Water flea
Rainbow
trout
%
a.i.
99.6
88.7
NOEC1
(ppb)
0.12
3.8
LOEC2
(ppb)
0.24
7.4
Endpoints
Reproduction (# of
neonates/reproductive day
and mean body lengths)
Larval length and weight
MRID
43121401
40922201
41064301
No observed effect concentration
Lowest observed effect concentration
b. Exposure and Risk
In all acute and nearly every chronic case examined, the risk to nontarget aquatic organisms
exceeds the LOG for all fenamiphos use sites. RQs for the aquatic risk in relation to fenamiphos
residues range from 0.8 to 464 for acute and from 1.2 to 6,375 for chronic risk.
Acute RQs for estuarine/marine invertebrates exposed to runoff from large acreage crops,
turf, high-end application rate ornamentals, and non-bell peppers are provided in Table 17. For non-
turf and non-ornamental uses, the acute RQs for estuarine/marine invertebrates range from 1.3 to 11.
Acute RQs for high-end ornamental applications is 132 and is 142 for turf use. RQs from all
evaluated uses and rates exceed all LOCs for estuarine/marine invertebrates. Although required,
chronic data have not been submitted and therefore chronic estuarine RQ values cannot be
determined at this time.
36
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Table 17. Acute/Chronic RQs for Aquatic Species from Fenamiphos A
Crop
Peaches
Peanuts
Tobacco
Grapes
Ornamentals2
Turf
Maximum
single
application
rate
(Ibs H.L/A)1
7.5
2.6
6.0
6.0
10
10
Freshwater
Acute RQ
Fish
3.1
0.8
1.7
7.1
86
93
Invert.
16
4.2
8.6
35
432
464
Chronic RQ
Fish
5.1
1.2
2.6
11
103
156
Invert.
212
55
116
482
5,183
6,375
pplication
Estuarine/Marine
Acute RQ
Invert.
4.8
1.3
2.6
11
132
142
Although application rates may be the same for some crops, typical field conditions may differ leading to
different estimated surface water concentrations.
2 For ornamentals and turf, the expected concentrations in water were estimated using GENEEC, a Tier I, screening
model, which is expected to overestimate risk.
The Agency has limited monitoring data on the concentrations of fenamiphos and its
degradates in surface water; therefore, no reliable conclusions can be made from empirical
monitoring data to characterize the fate of fenamiphos in surface water in use areas. Based on the
screening-level model results, fenamiphos use near surface water is expected to result in
concentrations well above the median lethal concentration (LC50) for the more sensitive freshwater
fish and invertebrates tested.
4.
Risks to Plants and Insects
a. Toxicity and Exposure to Terrestrial Plants
Available information suggest that fenamiphos is toxic to plants. RQs could not be
calculated because toxicity data for plants are not available. The potential for acute risks to non-
endangered, endangered or threatened terrestrial, semi-aquatic and aquatic plants exposed to
fenamiphos at use sites is unknown. EPA intends to issue a DCI to require plant data to assess the
risks to terrestrial, semi-aquatic and aquatic plants. Currently, the Agency does not perform chronic
risk assessments for terrestrial and semi-aquatic plants.
b. Toxicity and Exposure to Beneficial Insects
Parent fenamiphos is rated as highly toxic to honey bees (with an LD50 of 1.87 jig/bee).
Fenamiphos is a systemic nematicide; after application it is readily absorbed by plant roots and
translocated throughout the target plant. Honey bees and other beneficial insects may have a greater
potential for extended exposures via the nectar and pollen of blooming plants growing in and around
treated areas. (MRID 00036935)
37
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5. Incident Reports
Incident reports submitted to EPA involving fenamiphos have been tracked in the Incident
Data System (IDS), microfiched, and then entered into a second database, the Ecological Incident
Information System (EIIS). Incidents have to labeled use and misuse of both liquid and granular
formulations of fenamiphos have been reported.
Prior to 1994, the EPA received a report in February of 1990 from Martin County,
Florida, about American Robins (Turdus migratorius) and Cedar Waxwings (Bombycilla cedromm)
killed by a fenamiphos application to turf. Tissue sample analyses confirmed that their poisoning was
the result of the fenamiphos application.
From 1994 to 1996, EPA received several reports of incidents. In June of 1995, an accidental
poisoning of a Great Blue Heron (Ardea herodias) was associated with an application of fenamiphos
to a golf course. Then, in November of 1996, EPA again received a report from Bay County, Florida,
that 28 American Coot (Fulica americand) were killed by a fenamiphos application to a golf course.
In 1998, 28 birds and 1000 fish were killed as a result of wrongful use of fenamiphos on a
kiwifruit orchard in Fresno, California. Then, in November of 2000, the Agency received a report
from Sonoma County, California, on a bird kill (320 birds mainly robins and bluebirds) associated
with chemigation of a grape vineyard with fenamiphos. Fenamiphos was detected in the gullets and
on feathers and feet of dead birds. The investigation was instigated by neighbors to the vineyard
reporting birds dying on their lawns. After the findings in the November 2000 case, a similar grape
vineyard incident of 17 dead birds reported in Mendocino County was revisited where fenamiphos
had been analyzed for in the gullets but not found. An analysis of feet and feathers confirmed
exposure to fenamiphos.
As a result of 1994-1996 incidents, mitigation measures were implemented to reduce the risks
resulting from fenamiphos use. Labels were subsequently amended to incorporate new rate
reductions and restrictions for many uses including turf. While these measures have not totally
eliminated incidents, the Agency believes that they may have reduced the severity and frequency of
wildlife incidents.
6. Endangered Species
Based upon the environmental risk assessment, fenamiphos exceeds the endangered species
levels of concern for birds, mammals, fish, invertebrates, insects, reptiles, and amphibians at the
current label application rates and methods.
Fenamiphos was included in the formal Section 7 consultation with the US Fish and Wildlife
Service (USFWS) for the corn cluster review in 1984. The Biological Opinion stated that this use of
fenamiphos would jeopardize the continued existence of the Attwater's greater prairie chicken and
the Aleutian Canada goose.
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Fenamiphos was also included in the reinitiated Biological Opinion of 1989 from the
USFWS. In this opinion, the Service found jeopardy to one species of amphibians, 17 species of
freshwater fish, 22 species of mussels, two species of freshwater crustaceans and four bird species for
its uses on various crops. Reasonable and Prudent Alternatives were given for each jeopardized
species. Reasonable and Prudent Measures were also given for twelve non-jeopardized species to
minimize incidental take of these species. These consultations and the findings expressed in the
Opinions, however, are based on old labels and application methods, less refined risk assessment
procedures and an older approach to consultation which is currently being revised through
interagency collaboration.
When the regulatory changes recommended in this IRED are implemented and the additional
ecological effects and environmental fate data are submitted and accepted by the Agency, the
Reasonable and Prudent Alternatives and Reasonable and Prudent Measures in the Biological
Opinion(s) may need to be reassessed and modified based on the new information.
IV. Interim Risk Management and Reregistration Decision
A. Determination of Interim Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant
data concerning an active ingredient, whether products containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the generic (i.e.,
an active ingredient specific) data required to support reregistration of products containing
fenamiphos active ingredients.
The Agency has completed its assessment of the occupational and ecological risks associated
with the use of pesticides containing the active ingredient fenamiphos, as well as a fenamiphos-
specific dietary risk assessment that has not considered the cumulative effects of the
organophosphates as a class. Based on a review of these data and public comments on the Agency's
assessments for the active ingredient fenamiphos, EPA has sufficient information on the human
health and ecological effects of fenamiphos to make interim decisions as part of the tolerance
reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. The
Agency has determined that fenamiphos is eligible for reregistration provided that: (i) current data
gaps and additional data needs specified below are addressed and the resultant data do not
demonstrate unreasonable adverse effects on the environment; (ii) the risk mitigation measures
outlined in this document are adopted, and label amendments are made to reflect these measures; (iii)
cumulative risks considered for the organophosphates support a final reregistration eligibility
decision; and (iv) the use of fenamiphos on extremely vulnerable soils is phased out by May 31,
2005, (because its continued use on such soils would result in acute and chronic dietary risks, due to
drinking water, which are inconsistent with the Food Quality Protection Act of 1996). Label changes
are described in Section V. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its interim determination of reregistration eligibility of fenamiphos, and lists the
submitted studies that the Agency found acceptable.
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Although the Agency has not yet considered cumulative risks for the organophosphates, the
Agency is issuing this interim assessment now in order to identify risk reduction measures that are
necessary to support the continued use of fenamiphos. Based on its current evaluation of fenamiphos
alone, the Agency has determined that fenamiphos products, unless labeled and used as specified in
this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to
implement any of the risk mitigation measures identified in this document, the Agency may take
regulatory action to address the risk concerns from use of fenamiphos.
At the time that a cumulative assessment is conducted, the Agency will address any
outstanding risk concerns. For fenamiphos, if all changes outlined in this document are incorporated
into the labels and the use on extremely vulnerable soils is phased-out by May 31, 2005, then all
current dietary risks will be mitigated. But, because this is an interim RED, the Agency may take
further actions, if warranted, after considering 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.
Because the Agency has not yet considered cumulative risks for the organophosphates, this
reregistration eligibility decision does not fully satisfy the reassessment of the existing fenamiphos
food residue tolerances as called for by the FQPA. When the Agency has considered cumulative
risks, fenamiphos tolerances will be reassessed in that light. At that time, the Agency will reassess
fenamiphos along with the other organophosphate pesticides to complete the FQPA requirements and
make a final reregistration eligibility determination. By publishing this interim decision on
reregistration eligibility and requesting mitigation measures now for the individual chemical
fenamiphos, 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 the cumulative assessment required under the FQPA. This
interim decision does not preclude the Agency from making further FQPA determinations and
tolerance-related rulemakings that may be required on this pesticide or any other in the future.
If the Agency determines, before finalization of the RED, that any of the determinations
described in this interim RED are no longer appropriate, the Agency will pursue appropriate action,
including but not limited to, reconsideration of any portion of this interim RED.
B. Summary of Phase 5 Comments and Responses
When making its interim reregistration decision, the Agency took into account all comments
received during Phase 5 of the OP Pilot Process. Overall, most people who submitted comments
supported the continued use of fenamiphos on one or more use sites and, in some cases, provided
information that helped the Agency refine the risk assessment. The registrant's comments focused
mostly on specific studies and related issues that the registrant believed were important to improving
the risk assessment. Generally speaking, there was limited information provided that addressed risk
mitigation measures for reducing risk to humans or the environment. These comments in their
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entirety are available in the docket. A brief summary of the comments and the Agency response is
noted here.
Comment: A number of comments focused on the value offenamiphos and the need for continued
availability. Comments of this type were received from academic scholars (representing universities
in Louisiana, Georgia, and Florida), a state extension agent (from Georgia), nursery operators (in
Michigan and Texas), and representatives from the American Nursery and Landscape Association,
the Georgia Farm Bureau Federation, and the Georgia Agricultural Commodity Commission for
Tobacco.
EPA Response: These comments provided valuable information on the use offenamiphos,
and showed the pesticide's recognized and widespread role in nematode control for a number of
different commodities and use sites.
Comment: The International Banana Association submitted information on the use pattern
and pest control alternatives for banana production, including estimates for the percent of banana
crop treated byfenamiphos and other chemicals.
EPA Response: This comment provided useful commodity specific information. Because the
most recent dietary risk (food) assessment showed little risks of concern, the assessment has not been
updated with the new information. If, however, it becomes necessary to refine the dietary risk
assessment values in the future, the Agency will incorporate this new information at that time.
Comment: Information submitted by the Pineapple Growers of Hawaii indicated the current
application rates used in Hawaii are lower than the maximum application rate specified on the
Nemacur 3 label. The pineapple growers also submitted an extensive document in support of
continued use offenamiphos on pineapples.
EPA Response: This information informed the Agency's understanding of the current use
practice on pineapples, leading to revision of the occupational risk assessment for workers involved
with pineapple cultivation. After considering this information and consulting with the registrant, the
registrant has agreed to lower the maximum application rate to the level currently used and
recognized by the Pineapple Growers of Hawaii. The current human health risk assessment now
reflects a lower application rate for calculating post-application residues, which dramatically reduced
the restricted entry interval originally under consideration by the Agency.
Comment: The registrant, Bayer Corporation, submitted comments addressing primarily the
Agency's risk assessment findings and the methods employed by the Agency to reach those findings.
EPA Response: Although these written comments by the registrant did not include measures
to reduce the risk offenamiphos, they helped the Agency to better characterize the risk assessment
and to frame the mitigation measures which were needed.
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C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with
this organophosphate. The assessment is 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 fenamiphos is within its own "risk cup,"
provided that the risk mitigation measures identified in the IRED are implemented, including the
termination of all uses on extremely vulnerable soils. In other words, if fenamiphos did not share a
common mechanism of toxicity with other chemicals, EPA would be able to conclude today that the
tolerances for fenamiphos meet the FQPA safety standards, provided the mitigation measures
outlined in this document are adopted and the use on extremely vulnerable soils is discontinued. 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, golfing, and drinking water. 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 fenamiphos would fit within the
individual risk cup if proposed mitigation were adopted, including the phasing out of the use on
extremely vulnerable soils by May 31, 2005. Therefore, the fenamiphos tolerances remain in effect
and unchanged until a full reassessment of the cumulative risk from all organophosphates is
considered.
b. Tolerance Summary
In the individual assessment, tolerances for residues of fenamiphos in/on plant commodities
[40 CFR §180.349] are presently expressed in terms of the combined residues of fenamiphos and its
cholinesterase-inhibiting metabolites.
Tolerances Listed Under 40 CFR §180.349 (a)(l):
Sufficient data are available to ascertain the adequacy of the established tolerances listed in 40
CFR §180.349(a) for the following commodities: apples; bananas; Brussels sprouts; cabbage;
cherries; citrus, oil; citrus pulp, dried; cottonseed; eggplant; garlic; grapefruit; grapes; lemons; limes;
okra; oranges; peaches; peanuts; pineapples; pineapples, bran; raisins; raspberries; strawberries; and
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tangerines. Table 18 summarizes fenamiphos tolerances, provides modifications in commodity
definitions and summarizes the recommendations for harmonizing U.S. tolerances with Codex MRLs.
The Agency proposes revoking the tolerance for pineapple bran since it is no longer
considered to be a major animal feed item (see Residue Chemistry Guidelines 860, August 1996). In
addition, the Agency proposes that the established tolerance for cottonseed be revoked because this
use is being canceled. The revocation will allow sufficient time for legally treated commodities to
clear the channels of trade.
A crop group tolerance of 0.5 ppm will be proposed for the citrus fruits group concomitant
with the reassignment of the established tolerances for grapefruits, lemons, limes, oranges, and
tangerines of 0.6 ppm. EPA also intends to propose that the tolerance for peanuts will be increased to
1.0 ppm.
Tolerances Listed Under 40 CFR §180.349 (a)(2):
Tolerances for milk, eggs and the fat, meat, and meat byproducts of cattle, goats, hogs,
horses, and sheep are no longer required due to the elimination of several feed items from Table 1 in
Residue Chemistry Guidelines Series 860 dated August 1996. Section 180.349(a) (2) should be
deleted from the CFR. See section 180.6(a)(3) for additional explanation.
Tolerances Listed Under 40 CFR §180.349(b) - Reserved
This section should be deleted from the CFR.
Tolerances Listed Under 40 CFR §180.349(c):
Sufficient data are available to ascertain the adequacy of the established tolerances listed in 40
CFR §180.349(c) (i.e., tolerances with regional registrations, as defined in 180. l(n), for the combined
residues of fenamiphos and its cholinesterase-inhibiting metabolites fenamiphos sulfoxide and
fenamiphos sulfone) for the following commodities: asparagus; beets, garden, roots; beets, garden,
tops; cabbage, Chinese; kiwifruits; and peppers, non-bell.
Table 18. Tolerance Summary for Fenamiphos and its Metabolites.
Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment*
(ppm)
Comment
Tolerances Listed Under 40 CFR §349(a)(l)
Apples
Bananas
Brussels sprouts
Cabbage
0.25
0.10
0.10
0.10
0.25
0.10
0.05
0.10
[Apple]
[Banana]
Codex harmonization
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Commodity
Cherries
Citrus, oil
Citrus pulp, dried
Cottonseed
Eggplant
Garlic
Grapefruit
Grapes
Lemons
Limes
Okra
Oranges
Peaches
Peanuts
Pineapples
Pineapples, bran
Raisins
Raspberries
Strawberries
Tangerines
Current
Tolerance (ppm)
0.25
25.0
2.5
0.05
0.1
0.50
0.60
0.10
0.60
0.60
0.30
0.60
0.25
0.02
0.30
10.0
0.3
0.1
0.6
0.60
Tolerance
Reassessment*
(ppm)
0.25
25.00
2.50
Revoke
0.05
0.50
Reassign
0.10
Reassign
Reassign
0.30
Reassign
0.25
1.00
0.30
Revoke
0.30
0.10
0.60
Reassign
Comment
[Cherry, sweet and cherry, tart]
[Citrus, oil, refined]
[Citrus, dried pulp]
Use on cotton is no longer supported
Lower level sufficiently accounts for
residues from current use practices
Reassign, concomitant with establishing
group tolerance for [fruit, citrus, group] of
0.5 ppm to harmonize with Codex
[Grape]
Reassign, concomitant with establishing
group tolerance for [fruit, citrus, group] of
0.5 ppm to harmonize with Codex
Reassign, concomitant with establishing
group tolerance for [fruit, citrus, group] of
0.5 ppm to harmonize with Codex
Reassign, concomitant with establishing
group tolerance for [fruit, citrus, group] of
0.5 ppm to harmonize with Codex
[Peach]
[Peanut]
[Pineapple]
No longer considered a feed item
[Grape, raisin]
[Raspberry]
[Strawberry]
Reassign, concomitant with establishing
group tolerance for [fruit, citrus, group] of
0.5 ppm to harmonize with Codex
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Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment*
(ppm)
Comment
Tolerances Listed Under 40 CFR §349(a)(2)
Cattle, fat
Cattle, meat
Cattle (mbyp)
Goats, fat
Goats, meat
Goats (mbyp)
Hogs, fat
Hogs, meat
Hogs (mbyp)
Horses, fat
Horses, meat
Horses (mbyp)
Milk
Sheep, fat
Sheep, meat
Sheep (mbyp)
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.01
0.05
0.05
0.05
Revoke
Based on revisions of the Series 860
Residue Guidelines (August 1996) (Table
1) meat and milk tolerances are no longer
required due to elimination of several
animal feed items used to estimated
secondary residues in livestock
commodities there is no reasonable
expectation of finite residues in meat or
milk. See 40 CFR 180.6(a)(3).
Delete Section 40 CFR Section 180.349(b).
Tolerances Listed Under 40 CFR §349(c)
Asparagus
Beets, garden, roots
Beets, garden, tops
Bok choy
Kiwifruit
Peppers, non-bell
0.02
1.5
1.0
0.5
0.1
0.6
0.02
1.50
1.00
0.50
0.10
0.60
[Beet, garden, roots]
[Beet, garden, tops]
[Cabbage, Chinese, Bok choy]
[Kiwifruit]
[Pepper, nonbell]
The term "reassessed" 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.
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The Agency intends to commence proceedings to revoke, modify the existing tolerances, and
correct commodity definitions in accordance with the table above. The establishment of a new
tolerance or raising tolerances will be deferred, pending the outcome of the cumulative assessment. If
the registrant elects not to support its domestic fenamiphos registrations, then the Agency will work to
identify which tolerances are being requested to be kept as import tolerances, whether the above
levels are appropriate, and whether additional data are necessary.
c. Codex Harmonization
Several maximum residue limits (MRLs) for fenamiphos have been established in various
commodities by the Codex Alimentarius Commission. The fenamiphos residues regulated by Codex
and the U.S. are equivalent. The recommended changes to U.S. tolerances are based on a
reassessment of existing tolerances and may or may not be compatible with Codex.
The Agency has reached a number of conclusions on efforts to harmonize U.S. tolerances
with Codex MRLs. These conclusions are outlined in Table 19. No questions of compatibility exist
with respect to commodities where: (i) no Codex MRLs have been established but U.S. tolerances
exist; and (ii) Codex MRLs have been established but U.S. tolerances do not exist. Compatibility
between the U.S. tolerances and Codex MRLs exists for bananas, cottonseed, and grapes. The
recommended increase in the level of the U.S. tolerance for peanuts to 1.0 ppm will not be compatible
with the Codex MRL of 0.05 ppm, but is necessary to allow for potential residues from use practices
in the United States.
The level of the U.S. tolerances should be decreased to achieve compatibility with the Codex
MRLs for Brussels sprouts (from 0.10 to 0.05 ppm) and oranges (from 0.6 for oranges to 0.5 ppm for
citrus fruits group). The available residue data support these decreased tolerance levels.
The U.S. tolerances for the following commodities are based on registered use patterns in the
U.S. and cannot be lowered to achieve compatibility with the Codex MRLs: cabbage, kiwifruits, and
pineapples. If the registrant elects not to support its domestic fenamiphos registrations and these
tolerances are still needed for imported commodities, then the import-only tolerances will be
established at the Codex MRLs.
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Table 19. Codex MRLs with Applicable U.S. Tolerances
Commodity
Bananas
Broccoli
Brussels sprouts
Cabbages, head
Cauliflower
Coffee beans
Cotton seed
Grapes
Kiwifruit
Melons, except watermelon
Oranges, sweet, sour
Peanut
Pineapple
MRL (mg/kg)1
0.1
0.052
0.052
0.052
0.052
0.1
0.052
0.1
0.052
0.052
0.5
0.052
0.052
U.S. Tolerance
(ppm)
0.10
0.1
(proposed)
0.10
0.10
0.1
(proposed)
0.2
(proposed)
0.05
0.10
0.10
0.05
(proposed for
cantaloupes)
0.6
0.02
0.30
Recommendation
Deferred comparison
Decrease U.S. tolerance
Retain U.S. tolerance
Deferred comparison
Decrease U.S. tolerance proposal
U.S. tolerance to be revoked
Retain U.S. tolerance
Decrease U.S. tolerance for citrus
fruits group
Increase U.S. tolerance from 0.02 to
1.0 ppm
Retain U.S. tolerance
1 All fenamiphos MRLs are final (CXL).
2 At or about the limit of detection.
d. Residue Analytical Methods
Adequate enforcement methods are available for determining residues of fenamiphos and its
cholinesterase-inhibiting metabolites in/on plant and animal commodities. The Pesticide Analytical
Manual (PAM) Vol. II lists two GLC methods, each with thermionic detection (TD) and a limit of
detection of 0.01 ppm. Method I (Bayer, Inc. Method 25402) is available for the determination of the
combined residues of fenamiphos and its sulfoxide and sulfone metabolites, measured as sulfone,
in/on plant commodities and Method n is available for the determination of the combined residues of
fenamiphos, its sulfoxide and sulfone metabolites, des-isopropyl fenamiphos, des-isopropyl
fenamiphos sulfoxide, and des-isopropyl fenamiphos sulfone in animal tissues and milk.
Residue data submitted in response to the Guidance Document and in support of petitions for
the establishment of new tolerances were collected using modifications of the available PAM Vol. II
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methods. These modified methods, along with other methods listed in PAM Vol. II, are adequate for
fenamiphos data collection and tolerance enforcement.
2. 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 the recommendations of its
Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there were scientific bases 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 the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA
will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may
have an effect in humans, FFDCA authority to require the wildlife evaluations. 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
Agency's EDSP have been developed, fenamiphos may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
3. Benefits
Fenamiphos is one of only a handful of effective nematicides available for use in agriculture.
It provides effective control of many important plant parasitic nematodes and several important insect
pests, which can cause severe crop damage and significant yield losses if left unchecked. Fenamiphos
is effective for use both pre-plant and post-plant. As a post-plant application, fenamiphos is often the
only effective nematicide available. The post-plant application is critical for perennial crops, such as
pineapple, kiwifruit, tree fruits, grapes and raspberries, which must rely solely on a post-plant control
of nematodes after the first growing season. For most of these crops fenamiphos is the only effective
post-plant control. Fenamiphos is also important for the control of nematodes in a number of annual
crops as well, particularly in California (the state with the highest agricultural usage), where effective
nematode controls include several soil fumigants and fenamiphos. California has imposed use
restrictions on the soil fumigants, which limits the availability of these nematicide alternatives (e.g.,
telone, methyl bromide, metam-sodium).
Fenamiphos is also critical for the control of nematodes in golf course turf. The two
predominant target pests in the major usage states are sting and lance nematodes. Other damaging
but less frequently encountered pests are awl, cyst, ring, root-knot, sheath, and sheathoid nematodes.
The types and extent of damage varies with the nematode type(s) present, population levels, types of
grass, environmental stress levels (soil temperature, water availability, etc.) and other unknown soil
factors. Nematodes are root parasites and cause damage including stunted growth, foliage
discoloration, premature wilting of plants, and death of plants.
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There are more than 2 million acres of golf course turf in the U. S. Private golf courses
account for nearly 85% of the approximately 17,000 golf courses in the U.S. and municipal/county
golf courses account for the remaining 15% of courses. The Southern U.S. accounts for nearly 35%
of the total number of golf courses in the U.S., followed by the North Central (32%), Northeast
(17%), and the West (16%). The average size of a golf course in the U.S., though it varies widely, is
122 acres. Approximately 2% of this acreage is greens, another 2% tees, 23% fairways, 70% roughs,
and the remaining 3% is miscellaneous grounds. Information supplied by golf course superintendents
in Florida suggests that fenamiphos is used mainly on tees and greens (90% of the time), with the
remaining use as the spot treatment of fairways. It appears that there is very little complete golf
course application of fenamiphos.
Limited data suggests that 80,000 to 100,000 pounds of fenamiphos are applied to turf
annually, of which 95% is used on golf courses. Between 1996 and 1999, estimates show that
fenamiphos usage on turf increased more than 25%. Although data limit estimates by region, the
majority of the fenamiphos usage on turf appears to occur in the Southern U.S., with Florida
accounting for more than 75% of the usage on turf. California is the only state with significant turf
usage outside of the Southern U.S. Fenamiphos is relatively expensive to apply (costing as much as
$300 per acre) and, as a result, more than 75% of the use is on private golf courses.
Estimates of the number of courses in Florida using fenamiphos range from 50 to 90% in a
given year, and those not using fenamiphos probably do not have severe nematode problems. It is
also estimated that in Florida, on average, 33% of the golf courses use none or very little fenamiphos
per year, 33% apply fenamiphos once per year, and 33% apply fenamiphos twice per year.
Increased fertilizer and water are often used to treat nematode infestations and fenamiphos is
used only when the problem cannot be controlled by these means. Water is not always an option, due
to limits on water usage in some areas and under certain conditions. There are no registered
fenamiphos alternatives known to be effective for use on turf, and if fenamiphos is not available on
turf, golf courses and turf farms could be adversely impacted.
Without fenamiphos, golf courses would likely face significant cost increases associated with
the replacement of nematode damaged turf. Depending on the method chosen by a golf course to
repair damaged turf, costs would range from $4,000 per green for renovation to $25,000 per green for
reconstruction. Additional economic costs would likely occur due to the closing of the affected areas
of a course for significant periods of time, and a decline in their customer base as a result of
diminished playing conditions. The replacement of turf is a worst-case scenario, but is a likely result
from uncontrolled nematode infestations. Nematode damage is most severe on tees, greens and
fairways, which golfers expect to be in good playing condition. It is not clear how much more often
turf damage would result in diminished playing conditions or turf would need to be replaced on golf
courses, but given that as many as 90% of the Florida golf courses (there are more than 1,600 courses
and the majority of fenamiphos used on turf is in Florida) use fenamiphos in a given year, damage
could be severe and widespread if fenamiphos were not available.
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4. Labels
A number of label changes are necessary in order for fenamiphos products to be eligible for
reregistration. Provided the following risk mitigation measures are incorporated in their entirety into
labels for fenamiphos-containing products, the Agency finds that all currently registered uses of
fenamiphos, except for the use in areas with extremely vulnerable soils, are eligible for reregistration,
pending consideration of cumulative risks of the organophosphates. The use in areas with extremely
vulnerable soils is ineligible for reregistration and will be phased out no later than May 31, 2005.
The risks of concern warranting label changes include dietary (ground water and surface
water sources of drinking water); occupational (many handler types and certain post-application
workers); and ecological (non-target terrestrial and aquatic organisms).
Mitigation measures include:
- Phase-out the use of fenamiphos on extremely vulnerable soils by May 31, 2005
(soils that are hydrologic soil group A, excessively drained and predominately sand or
loamy sand, such as soils in the suborder psamments, and where ground water is less
than 50 feet deep)
Closed mixing/loading systems and application by enclosed cab for liquid products
- Organic vapor-removing respirators and double-layer clothing for mixers, loaders and
applicators of the granular formulation
- Cancellation of the use on cotton and the granular formulation on pineapples (already
in process)
Reduce the application rate on protea (evergreen shrubs) to 10 Ib ai/A, pineapples to 2
Ib ai/A, and grapes to 4.5 Ib ai/A
- Revise use directions for all agricultural crops to indicate minimum row spacing
(derived from proposed maximum Ibs per acre) in addition to application by row
length (per 1000' of row)
Establish or lower the maximum amount of fenamiphos that can be applied per
season on: pineapples (reduced to 9 Ib, ratoon crop; 12 Ib plant crop), Brussel
sprouts (4.5 Ib), eggplant (2 Ib), peanuts (2.55 Ib), peppers (non-bell) (2 Ib), Bok
Choy (4.5 Ib), tobacco (6 Ib), citrus (5 Ib in FL, 7.5 Ib elsewhere), strawberries (4.5
Ib), asparagus (2 Ib), garden beets (3 Ib), ornamentals (10 Ib), leatherleaf fern (9 Ib),
garlic (4.5 Ib)
Prohibit use of any body-mounted or hand-held application equipment
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- For turf, limit the amount of product handled to that needed to treat 5 acres/person/day
(maximum of 50 pounds active ingredient) for granular products and to 20
acres/person/day (200 pounds ai/day) for liquid products
Prohibit the use between noon and sunset during the heavy thunderstorm season (June
through September) for all applications that require overhead irrigation for
incorporation
- When overhead sprinkler irrigation is used to incorporate fenamiphos, irrigation must
occur within 6 hours of the application
D. Regulatory Rationale
The following is a summary of the rationale for managing risks associated with the current
use of fenamiphos. Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V of this document.
1. Human Health Risk Mitigation
a. Dietary Mitigation
1) Acute Dietary (Food)
Dietary risk from food alone does not pose an acute risk of concern. The acute dietary
estimate is below the Agency's level of concern for the general U.S. population and all population
subgroups. Nursing infants (younger than 1 year of age), the most highly exposed subpopulation, are
exposed to fenamiphos at a level of less than 1% of the aPAD. No mitigation measures for acute
dietary food risk are necessary at this time.
2) Chronic Dietary (Food)
The chronic dietary risk estimate is also below the Agency's level of concern for the general
population and all population subgroups. The risk is estimated to be less than 1% of the cPAD for all
population subgroups, including the most highly exposed subgroup of infants and children (from 1 to
6 years of age). No mitigation measures for chronic dietary food risks are necessary at this time.
3) Drinking Water
In calculating risks to populations drinking ground water, the Agency's assessment found that
the expected concentrations in drinking water varied significantly depending on the type of soil and
depth to ground water. When soils are extremely vulnerable and the groundwater is shallow,
fenamiphos is expected to rapidly leach into ground water. As the soils become less vulnerable, the
expected concentrations drop dramatically. For the purposes of this assessment the Agency
established two distinct categories of soil types: extremely vulnerable and vulnerable. The vulnerable
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category is expected to portray worst-case exposure for all soil types that are not extremely
vulnerable. The extremely vulnerable category contains those soils classified as hydrologic soil
group A soils that are excessively drained and predominately sand or loamy sand and where the
ground water table is less than 50 feet deep. The Central Ridge of Florida is an example of an area
where the soil would be classified extremely vulnerable.
Groundwater in areas with vulnerable soils
The Agency is not concerned about people drinking ground water when fenamiphos is used in
areas with soils that are not extremely vulnerable. In these areas, for both acute and chronic risk, the
expected environmental concentrations (EECs) in drinking water are lower than the drinking water
levels of concern (DWLOCs). For turf, the crop with the highest application rate, the Agency found
that the acute EEC is 7 and the chronic EEC is 0.93 ppb, while the acute DWLOC is 12 ppb and the
chronic DWLOC is 1 ppb.
Although the EECs from use in areas that do not have extremely vulnerable soil are below the
DWLOCs, these estimates are based on results from the prospective ground water study that was
conducted in California. The Agency has concerns that deficiencies in this study make it difficult to
unequivocally conclude that higher concentrations will not occur in vulnerable soils. Therefore, the
Agency will be issuing a DCI requiring additional monitoring in these soils to confirm that
concentrations in ground water in such soils are not of concern.
Groundwater in areas with extremely vulnerable soils
The Agency is concerned about people drinking ground water in areas where fenamiphos is
used on extremely vulnerable soils. In these areas, for both acute and chronic risk, the expected
environmental concentrations (EECs) in drinking water are substantially higher than the drinking
water levels of concern (DWLOCs). Using turf as an example, the Agency found that the acute EEC
is 425 and the chronic EEC is 45 ppb, while the acute DWLOC is 12 ppb and the chronic DWLOC is
Ippb.
Based on this analysis, the Agency believes that the potential risk to the public from the use of
fenamiphos on extremely vulnerable soils is of concern and inconsistent with the Food Quality
Protection Act (FQPA). Therefore, this use is ineligible for reregistration and will be phased out by
May 31,2005.
The Agency's concern for groundwater is based on monitoring data associated with
agricultural crops grown in extremely vulnerable soils and leaching studies conducted on turf. These
studies provide solid evidence that fenamiphos and its degradates can leach to ground water.
Although available ground water monitoring data are limited in some aspects, they are sufficient to
show that significant ground water contamination would be expected in areas with sandy soils.
During the public comment period and subsequent mitigation discussions, the technical
registrant for fenamiphos, Bayer Corporation, and the State of Florida expressed a concern that the
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Agency's conclusions are based on data from agricultural scenarios, which may not directly translate
to turf. They have requested the opportunity to develop additional monitoring data supporting the use
on golf courses in extremely vulnerable soils. If the registrant elects to develop monitoring data,
Florida has agreed to participate in the study design/development, conduct and oversight in
cooperation with the Agency. Several other states have also expressed a preliminary interest.
The importance of fenamiphos to the golf course industry, particularly in Florida, is well
understood by the Agency. Nevertheless, the Agency believes existing data demonstrate that the use
on extremely vulnerable soils will result in ground water contamination at levels that pose dietary risk
concerns, particularly given the magnitude of the detections above the acute and chronic DWLOCs
and Bayer Corporation's earlier voluntary cancellation of the use of fenamiphos on citrus on the
Central Ridge of Florida based on these same monitoring data. Therefore, the use on extremely
vulnerable soils are ineligible for reregistration and will be phased out by May 31, 2005. However,
because these data are not irrefutable, the Agency will consider any data that are submitted during the
three-year phase-out period and, if appropriate, reconsider its decision before the final date of
cancellation for this use.
Surface Water
Modeling results for a drinking water reservoir downgradient of a watershed planted in
grapes are 141 ppb for the peak concentration, 13.7 ppb for the annual mean, and 7.4 ppb for the
overall mean (i.e., 36-year average). Although these estimates are substantially higher than the
DWLOCs of 12 ppb for acute exposure and 1 ppb for chronic exposure, the Agency believes that
these values significantly overestimate risk to people who drink water from surface water sources.
In making this determination, the Agency considered the fact that PRZM-EXAMS is a Tier n
model, and is considered to be a screening-level assessment. Also, as discussed earlier, the model
used conservative assumptions because key data are missing but also did not consider the degradates.
Overall, the Agency expects the model results to be higher than those actually found in surface water
used as a drinking water source. EPA will issue a Data Call-In for environmental fate data for
fenamiphos and its degradates to refine the assessment. In addition, the Index Reservoir scenario is
undergoing revision of several assumptions that are expected to lower the predicted concentrations for
fenamiphos. The Agency believes that, were complete environmental fate data available and model
updates and refinements implemented, the results would show that surface water in areas where
fenamiphos is used would contain total fenamiphos residues at concentrations that are less than the
DWLOC.
For fenamiphos to be eligible for reregistration (except for the use on extremely vulnerable
soils), a prohibition on its use between noon and sunset during the heavy thunderstorm season (June
through September) is necessary for all applications that require overhead irrigation for incorporation.
In addition, in cases when overhead sprinkler irrigation is used to incorporate fenamiphos, irrigation
will need to occur within 6 hours of the application.
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4) Residential/Recreational (Golfer)
Fenamiphos is not used in a residential setting. However, because fenamiphos is used on golf
course turf, golfers may be exposed to its residues when playing on a treated course. As discussed in
Section III, the Agency believes that exposure to golfers is not of concern, provided fenamiphos is
watered in after application to golf course turf. Additional data are being called-in for the granular
formulation to confirm this conclusion
5) Aggregate
An aggregate risk assessment looks at combined exposure from dietary (food and drinking
water routes) and residential or non-occupational sources, when appropriate. For fenamiphos, an
aggregate assessment would include dietary and golfer exposure. The risks to golfers cannot be
included in the aggregate risk assessment at this time as the data are not sufficient or robust enough to
allow this calculation. However, the Agency believes golfer exposure is not significant and that its
inclusion in the aggregate risk assessment will not change the conclusions of the aggregate risk
assessment. To confirm this determination, the Agency is requiring additional data.
As discussed in the drinking water section above, the Agency is not concerned about the risk
to any population exposed to combined fenamiphos residues from food and drinking water, provided
the population is not drinking ground water in areas with extremely vulnerable soils. Therefore, the
Agency believes that the results of the drinking water and food aggregate assessment also describes
total aggregate risk from exposure to fenamiphos residues. Also, as mentioned earlier, in areas with
extremely vulnerable soils, the potential drinking water exposure derived from ground water is of
concern and these uses are not eligible for reregistration.
b. Occupational Risk Mitigation
1) Agricultural Uses
The Agency's occupational risk findings show that many fenamiphos uses do not pose risks
of concern. Some uses, however, pose occupational risks exceeding the Agency's level of concern
for certain handlers and workers. The Agency has worked with the registrant and user community to
explore ways of reducing occupational risks in general and believes many of the measures agreed to
by the registrant will reduce the occupational risk to levels not of concern. In some cases, however,
the Agency's risk estimates show that certain handlers remain at risk levels higher then the Agency's
risk reduction objectives. To limit exposure to fenamiphos, the PPE and engineering controls
outlined in Table 20 are necessary.
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Table 20. PPE Summary for all Agricultural Scenarios
Scenario
Loading Granulars (Scenario
I)
Mixing Liquids
Groundboom (Scenario II)
Mixing Liquids
Chemigation (Scenario III)
Groundboom Applications
(Scenario IV)
Soil Injection
(Scenario V)
Granular, Tractor-Drawn
Application (Scenario VI)
Loading/Applying Push
Spreader (Scenario VII)
PPE
(in addition to long-sleeved shirt, long pants, socks, shoes)
Coveralls, chemical-resistant gloves, chemical-resistant
footwear plus socks, chemical-resistant headgear for overhead
exposures, and an organic vapor-removing respirator
Chemical-resistant gloves and chemical-resistant apron
Chemical-resistant gloves and chemical-resistant apron
none
not applicable
Coveralls, chemical-resistant gloves, chemical-resistant
footwear plus socks, and an organic vapor-removing
respirator
Coveralls, chemical-resistant gloves, chemical-resistant
footwear plus socks, and an organic vapor-removing
respirator
Engineering
Controls
not available
closed system
closed system
enclosed cab
not applicable
none
not available
Granular Product
The Agency assessment shows that, after mitigation, the use of the granular product does not
pose a risk of concern to workers for any crop other than for workers using a push spreader. For
workers using a push spreader, the MOE is 28. Mitigation that is necessary to reduce the risk from
the granular product include:
- using an organic vapor-removing respirator and a double layer of clothing
- limiting the amount of active ingredient a single worker can handle to 50 Ib ai/day for
turf uses
prohibiting use of any body-mounted or hand-held application equipment
Liquid Products
For mixer/loaders and applicators using liquid fenamiphos, MOEs are of concern (less than
100) for several different crops. Of the MOEs of concern for agricultural products, all are above 50,
with the majority from 65 - 75. For turf, the MOEs are 37 for mixer/loaders and 53 for applicators
using groundboom equipment. To mitigate these risks, the following measures are necessary:
Closed mixing/loading systems and application by enclosed cab
Reduced application rates for various crops
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- Limit the amount of active ingredient a single worker can handle to 200 Ibs ai/day for
turf uses
In light of the significant benefits that are derived from the use of fenamiphos, the Agency
believes that the products are eligible for reregistration provided that these mitigation measures are
implemented.
2) Postapplication Risk Mitigation
The Agency requires data and/or further clarification of the use patterns involving workers
handling or working with or in fenamiphos-treated soil which may result in postapplication exposure.
These uses are on strawberries, asparagus, ornamental nonflowering plants, ornamental herbaceous
plants, sod farm turf, ornamental woody shrubs and vines, and all nursery stock. For these sites the
48-hour REI will be required, until receipt and evaluation of the additional data. The Agency also
requires confirmation that the golf course use does not result in postapplication exposure as a result of
handling treated grass clippings.
Pineapple is the only crop that is treated with a foliar application of fenamiphos. Based on
chemical-specific data and a proposed label rate reduction to 2 Ib ai/acre from 9 Ib ai/acre, the
Agency believes that the MOE for harvesting pineapples would be greater than 100 in less than 48
hours. The current WPS REI for pineapples of 48 hours is based on multiple factors, including acute
toxicity, and should be continued for post-application reentry.
2. Environmental Risk Mitigation
The environmental risk assessment suggests that exposure to fenamiphos could result in both
acute and chronic risks of concern for terrestrial and aquatic organisms.
The fenamiphos ecological assessment indicates that virtually all uses at all maximum labeled
rates result in risks that exceed both the high acute and chronic risk levels of concern for terrestrial,
aquatic, and endangered species. Even though fenamiphos is either soil incorporated or watered-in,
which may reduce potential exposures to wildlife, it is highly toxic causing small amounts to pose a
high risk to sensitive species. Incident data, as outlined in Section in(B)(5) support this conclusion,
as fish and bird kill incident reports indicate losses of wildlife directly attributable to fenamiphos.
The implementation of earlier mitigation measures, such as lowering application rates and minimizing
runoff potential, may help in reducing these types of incidents.
a. Avian and Mammalian Species Mitigation
The Agency's risk assessment for avian and mammalian species exceeds the level of concern
for both acute and chronic exposure.
Because research shows that fenamiphos must be applied at current application rates for the
pesticide to be efficacious, the Agency is unable to reduce these rates to be more protective of avian
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and mammalian species that may be exposed on an acute basis. The Agency is, however, proposing
additional label changes to reduce exposure, including: cancellation of cotton use and granular use on
pineapples; reducing maximum seasonal application rates for several crops; and requiring more rapid
watering in, when irrigation is used to incorporate fenamiphos.
Although these measures may somewhat reduce fenamiphos exposure to wildlife, they are not
expected to reduce it to levels that are not of concern to the Agency. However, because there are
significant benefits from these uses of fenamiphos, as outlined above, the Agency is not proposing
additional action at this time.
b. Aquatic Species Mitigation
In all acute and nearly all chronic cases examined, the risk to nontarget aquatic organisms
exceeds the LOG for all fenamiphos use sites. RQs for the aquatic risk in relation to fenamiphos
residues range from 1.6 to 464 for acute and from 1.2 to 6,375 for chronic risk. The higher RQ
values are based on a less refined, Tier I, model that is expected to overestimate actual risk. The
Agency is requiring additional acute and chronic data on the degradates and additional chronic data
on the parents to refine the risks. These data are expected to confirm the conclusions reached in this
assessment.
To mitigate these risks, the Agency is proposing the following measures: cancellation of
cotton use and granular use on pineapples; reduction of the maximum seasonal application rates for
several crops; requiring more rapid watering in, when irrigation is used to incorporate fenamiphos;
and restrictions on time of day applied during thunderstorm season to limit the potential for runoff.
Although these measures may somewhat reduce fenamiphos exposure to aquatic species, they
are not expected to reduce it to levels that are not of concern to the Agency. However, because there
are significant benefits from these uses of fenamiphos, as outlined above, the Agency is not proposing
additional action at this time.
E. Other Labeling
In order to remain eligible for reregistration, other use and safety information need to be
placed on the labeling of all end-use products containing fenamiphos. For the specific labeling
statements, refer to Section V of this document
1. Endangered Species Statement
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that address these impacts. The Endangered Species Act requires Federal
agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify
designated critical habitat. To analyze the potential of registered pesticide uses to affect any
particular species, EPA puts basic toxicity and exposure data developed for interim REDs into
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context for individual listed species and their locations by evaluating important ecological parameters,
pesticide use information, the geographic relationship between specific pesticides uses and species
locations, and biological requirements and behavioral aspects of the particular species. This analysis
will include consideration of the regulatory changes recommended in this interim RED. A
determination that there is a likelihood of potential impact to a listed species may result in limitations
on use of the pesticide, consultations with the Fish and Wildlife Service and/or the National Marine
Fisheries Service, or other measures to mitigate any potential impact, as necessary.
The Endangered Species Protection Program as described in a Federal Register notice (54 FR
27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of the
interim program, the Agency has developed County Specific Pamphlets that articulate many of the
specific measures outlined in the Biological Opinions issued to date. The Pamphlets are available for
voluntary use by pesticide applicators on EPA's website at www.epa.gov/espp. A final Endangered
Species Protection Program, which may be altered from the interim program, is scheduled to be
proposed for public comment in the Federal Register in 2002.
2. Spray Drift Management
The Agency is in the process of developing more appropriate label statements for spray and
dust drift control to ensure that public health, and the environment is protected from unreasonable
adverse effects. In August 2001, EPA published draft guidance for label statements in a pesticide
registration (PR) notice ("Draft PR Notice 2001-X" http://www.epa.gov/ PR_Notices/#2001). A
Federal Register notice was published on August 22, 2001 (http://www.epa.gov/fedrgstr)
announcing the availability of this draft guidance for a 90-day public comment period. After receipt,
and review of the comments, the Agency will publish final guidance in a PR notice for registrants to
use when labeling their products.
Until EPA decides upon, and publishes the final label guidance for spray and dust drift,
registrants (and applicants) may choose to use the statements proposed in the draft PR notice.
Registrants should refer to, and read the draft PR notice to obtain a full understanding of the proposed
guidance, its intended applicability, exemptions for certain products, and the Agency's willingness to
consider other versions of the statements.
For purposes of complying with the deadlines for label submission outlined in this document,
registrants (and applicants) may elect to adopt the appropriate sections of the proposed language in
Table 21, or a version that is equally protective, for their end-use product labeling. The Agency
recognizes that the proposed language does not address application types other than liquids.
Registrants may therefore wish to adapt some variation of the old, and proposed new language for
their particular products, depending on their application methods.
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V. What Registrants Need to Do
In order to be eligible for reregistration, registrants need to implement the risk mitigation
measures outlined in sections IV and V, which include, among other things, submission of the
following:
A. For fenamiphos technical grade active ingredient products,
Within 90 days from receipt of the generic data call-in (DCI):
completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
B. For products containing the active ingredient fenamiphos,
Within 90 days from the receipt of the product-specific data call-in (PDCI):
completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
two copies of the confidential statement of formula (EPA Form 8570-4);
a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration";
(1) five copies of the draft label incorporating all label amendments
outlined in Table 21 of this document;
(2) a completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);
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(3) if applicable, a completed form certifying compliance with cost share
offer requirements (EPA Form 8570-32); and
(1) the product-specific data responding to the PDCI.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of fenamiphos for the above eligible uses
has been reviewed and determined to be substantially complete. If the registrant elects to continue
supporting its domestic registrations for fenamiphos, then the following data will be required.
875.2100 Foliar dislodgeable residue dissipation study for granular formulation on golf course
turf
875.2200 Soil residue dissipation (to evaluate exposures to workers transplanting strawberries)
83 5.2240 Photodegradation in water (using parent fenamiphos and degradates)1
835.4100 Aerobic Soil Metabolism (parent and degradates)2
835.4200 Anaerobic Soil Metabolism2
835.4300 Aerobic Aquatic Metabolism (parent and degradates)2
850.2100 Acute avian oral with one species2
850.2200 Avian sub-acute dietary with bobwhite2
850.1010 Acute aquatic invertebrate, Daphnia2
850.1025 Acute estuarine-marine with oyster2
850.1035 Acute estuarine-marine with mysid shrimp2
850.1035 Acute estuarine-marine with sheepshead minnow2
850.1350 Fish ELS for estuarine-marine (parent fenamiphos and degradates)2
850.1400 Fish early life stage (ELS), freshwater2
850.1500 Invertebrates life cycle for estuarine-marine (parent fenamiphos and degradates)2
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; for fenamiphos, these data are due in 2003.
1 Conducted using fenamiphos sulfoxide and fenamiphos sulfone
2 A total of six studies, three (one each for parent, fenamiphos sulfoxide, fenamiphos sulfone) using
subsoil (i.e., deep horizon material) and aquifer solid material, rather than topsoil. Another three
(one each for parent, fenamiphos sulfoxide, fenamiphos sulfone) using topsoil. All six studies
should measure the pH and Eh of the soil.
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2. Labeling for Manufacturing Use Products
To remain in compliance with FIFRA, manufacturing use product labeling should be revised
to comply with all current EPA regulations, PR Notices and applicable policies. The labeling should
bear the labeling contained in Table 21 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product. A product-specific
data call-in, outlining specific data requirements, will be sent separately from this interim RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section IV
above. Specific language to incorporate these changes is specified in the Table 21 at the end of this
section.
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 registrant may distribute and sell fenamiphos products
bearing old labels/labeling upon approval of new labels. Persons other than the registrant may
distribute or sell such products for 24 months from the date of the issuance of this interim RED.
Registrants and persons other than the registrant remain obligated to meet pre-existing label
requirements and existing stocks requirements applicable to products they sell or distribute.
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D. Required Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk
mitigation measures outlined in Section IV. The Table 21 describes how language on the labels
should be amended. Label language in Table 21 enclosed in quotation marks represents exact
language that should appear on the label. Instructions that are not enclosed in quotation marks
represent actions that the registrant must take to amend their labels or product registrations in order
for the product to be eligible for reregistration.
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Table 21: Required Labeling Changes Summary Table
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
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
"Only for formulation into an nematicide/insecticide for the following use(s) [fill blank only with those uses
that are being supported by MP registrant] ."
"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)."
Directions for Use
Directions for Use
All End Use Products
Handler PPE guidance
(all formulations)
Note: Any conflicting PPE requirements on the current label must be removed. PPE that is established on
the basis of Acute Toxicity testing with the end-use products must be compared with the active ingredient
PPE specified below in this document. The more protective PPE must be placed in the product labeling.
For guidance on which PPE is considered more protective, see PR Notice 93-7.
Not on label
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Description
Amended Labeling Language
Placement on Label
PPE requirements
established by the IRED
for liquid products
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" [registrant insert correct chemical-resistant
material]. "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-resistance category selection chart."
Mixers, loaders, and applicators using engineering controls must wear:
long-sleeved shirt and long pants,
shoes plus socks.
In addition, mixers and loaders must wear:
chemical-resistant gloves,
chemical-resistant apron
Handlers performing tasks such as equipment or spill clean-up, for which engineering controls are not
feasible must wear:
coveralls over long-sleeved shirt and long pants,
chemical-resistant gloves,
chemical-resistant footwear plus socks,
chemical-resistant headgear if overhead exposure,
chemical-resistant apron
A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides
(MSHA/NIOSH approval number prefix TC-14G), or a NIOSH-approved respirator with an
organic vapor (OV) cartridge or canister with any N*, R or P or He prefilter."
Note: N type filter must be dropped from respirator statement if product contains or is used with oil."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
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Description
Amended Labeling Language
Placement on Label
Engineering Controls for
liquid products
"Engineering Controls
Mixers and loaders must use a closed loading system providing dermal and inhalation protection and all
loaders must use and maintain this system in a manner consistent with the Worker Protection Standard
(WPS) for Agricultural Pesticides [40 CFR 170.240(d)(4). 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 no more than 2 ml per disconnect. In addition,
mixers and loaders must:
wear the personal protective equipment required above for mixers/loaders;
wear protective eyewear if the system operates under pressure;
be provided and have immediately available for use in an emergency, such as a broken
package, spill, or equipment breakdown the PPE specified above for handlers performing tasks
for which engineering controls are not feasible."
"Applicators using motorized ground equipment must use an enclosed cab that meets the definition in the
Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In
addition, applicators must:
wear the personal protective equipment required in the PPE section of this labeling for
applicators using engineering controls;
either wear the type of respirator specified in the PPE section of this labeling or use an enclosed
cab that is declared in writing by the manufacturer or by a government agency to provide at least
as much respiratory protection as the type of respirator specified in the PPE section of this
labeling;
must be provided and have immediately available for emergency use if exiting the cab in the
treated area becomes necessary the PPE specified above for handlers performing tasks for
which engineering controls are not feasible;
before reentering the cab, the applicators must take off any PPE that was worn in the treated area
and store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent
contamination of the inside of the cab."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
after PPE and User
Safety Requirements.)
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Description
Amended Labeling Language
Placement on Label
PPE requirements
established by the IRED
for granular products
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" [registrant inserts correct chemical-resistant
material]. "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-resistance category selection chart."
Mixers, loaders, applicators and other handlers must wear:
coveralls over long-sleeved shirt and long pants,
chemical-resistant gloves,
chemical resistant footwear plus socks,
chemical-resistant headgear (if overhead exposure).
A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides
(MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides
(MSHA/NIOSH approval number prefix TC-14G), or a NIOSH-approved respirator with an
organic vapor (OV) cartridge or canister with any N2, R or P or He prefilter."
"In addition, mixers, loaders and cleaners of equipment must wear a chemical-resistant apron"
Note: N type filter must be dropped from respirator statement if product contains or is used with oil."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
Engineering Controls for
granular products
"When handlers use closed systems, enclosed cabs in a manner that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6), the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals (Immediately
after PPE and User
Safety Requirements.)
User Safety Requirements
"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."
Immediately following
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
66
-------
Description
Amended Labeling Language
Placement on Label
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."
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
applicator and handler
statements in PPE
section
(Must place in box.)
Restricted-Entry Interval
Liquid and Granular
Formulations
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 48
hours."
"Exception: if the product is soil-incorporated, the Worker Protection Standard, under certain
circumstances, allows workers to enter the treated areas without the 48-hour restriction if there will be no
contact with anything that has been treated."
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as plants, soil, or water, is:
coveralls worn over long-sleeve shirt and long pants,
chemical-resistant gloves made of any waterproof material,
chemical-resistant footwear plus socks, and
chemical-resistant headgear (if overhead exposure)"
"Notify workers of the application by warning them orally and by posting warning signs at entrances to
treated area."
Agricultural Use
Requirements Box for
agricultural crops
or
Directions for Use
directly above
Agricultural Use
Requirement Box for
other crops
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons, either directly or through
drift. Only protected handlers may be in the area during application. For any requirements specific to your
State or Tribe, consult the agency responsible for pesticide regulations."
Direction for Use
immediately after the
misuse statement
67
-------
Description
Amended Labeling Language
Placement on Label
Spray Drift Restrictions
for Liquid Products
"Do not allow spray to drift from the application site and contact people, structures people occupy at any
time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas,
woodlands, pastures, rangelands, or animals."
"For ground boom applications, apply with nozzle height no more than 4 feet above the ground or crop
canopy, and when wind speed is 10 mph or less at the application site as measured by an anemometer. Use
(registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to AS AE 572
definition for standard nozzles or VMD for spinning atomizer nozzles."
For overhead chemigation:
"Apply only when wind speed is 10 mph or less."
On all product labels:
"The applicator also must use all other measures necessary to control drift."
Directions for Use
Restricted Use
Classification Required for
all Products
"Restricted Use Pesticide
Due to high acute toxicity and toxicity to wildlife
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."
Top of the Label
68
-------
Description
Amended Labeling Language
Placement on Label
Application Rate
Restrictions
See Appendix A for a detailed listing of methods, and other restrictions.
The following reduced application rates are being proposed:
pineapple: 2 Ib ai/A
protea: 10 Ib ai/A
grapes: 4.5 Ib ai/A
The following maximum applications per season are being proposed:
asparagus:
Bok Choy:
Brussels sprouts:
citrus:
eggplant: 2
garden beets:
garlic:
leatherleaffern:
ornamentals:
peanuts:
peppers (non-bell):2
pineapples:
strawberries:
tobacco:
2 Ib ai/A/season
4.5 Ib ai/A/season
4.5 Ib ai/A/season
5 Ib ai/A/season in Florida
7.5 Ib ai/A/season elsewhere
Ib ai/A/season
3 Ib ai/A/season
4.5 Ib ai/A/season
9 Ib ai/A/season
10 Ib ai/A/season
2.55 Ib ai/A/season
Ib ai/A/season
9 Ib ai/A/season, ratoon crop
12 Ib ai/A/season, plant crop
4.5 Ib ai/A/season
6 Ib ai/A/season
Directions For Use
under General
Precautions and
Restrictions
Labels should be amended to specify minimum row spacing (which corresponds to maximum Ib per acre)
in addition to application by 1000' of row length.
"Do not apply to hydrologic soil group A soils that are excessively drained and predominately sand or
loamy sand such as soils in the suborder psamments. These classifications and soil taxonomy refer to
USDA definitions, rf you are unsure of the type of soil you are treating, please consult with you county's
extension agent or the product manufacturer."
69
-------
Description
Application Equipment
Restrictions (granular
products)
Application Timing
Restrictions
Amended Labeling Language
"Apply this product with a tractor-drawn or push spreader only."
For all applications that require overhead irrigation for incorporation:
"Do not apply between noon and sunset during the heavy thunderstorm season (June through September)."
For all applications that require sprinkler irrigation for incorporation:
"irrigation must occur with 6 hours of the application."
Placement on Label
Direction for Use under
General Precautions and
Restrictions
Direction for Use under
General Precautions and
Restrictions
70
-------
VL Related Documents and How to Access Them
This interim Reregistration Eligibility Document 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 2, 1999. 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.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or
viewed via the internet at http://www.epa.gov/pesticides/op/fenamiphos.htm.
71
-------
VII. APPENDICES
72
-------
APPENDIX A. Table of Use Patterns Eligible
for Reregistration
73
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Formulation
[EPA Reg. No.]
Max. Single
App. Rate
(Ibai/A)
Max.
Seasonal
App. Rate
(lb ai/A/yr)
Minimum
Retreatment
Interval
(days)
Pre-
harvest
Interval
(days)
Restrictions/Comments
Apple, Cherry, Nectarine, Peach
Band
Post-plant
Ground
Low-pressure Irrigation
Post-plant
Sprinkler
SEC
[3125-283]
SEC
[3125-283]
7.5
3
7.5
6
Not
Specified
30
Apples =
72
Cherry,
Nectarine,
Peach = 45
Apples =
72
Cherry,
Nectarine,
Peach = 45
Center the treated band on the tree row using a band width
of 50% of the row spacing and covering the feeder root
system of the plant. Mechanically soil incorporate
immediately.
Soil incorporate.
Asparagus (CT, DE, ME, MD, MA NH, NJ, NY, PA RI only)
Band
Nursery, Post-Harvest,
Plant Crown
Ground
3EC
[3125-283]
2
2
Not
Specified
270
Center the treated band on the tree row using a band width
of 50% of the row spacing. Soil incorporate.
Banana (Hawaii only)
Band
Post-plant
Ground
SEC
[3125-283]
5
10
90
15
Do not apply product with less than a 4-foot total band
width. Immediately incorporate the product into the soil
with mechanical equipment.
74
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Formulation
[EPA Reg. No.]
Max. Single
App. Rate
(Ibai/A)
Max.
Seasonal
App. Rate
(lb ai/A/yr)
Minimum
Retreatment
Interval
(days)
Pre-
harvest
Interval
(days)
Restrictions/Comments
Banana, Plantains (Puerto Rico only)
Low Pressure Irrigation
Post-plant
Drip Tape
SEC
[3125-283]
4.5
13.5
120
Not
Specified
Soil incorporate.
Boy Choy (California only)
Band
Pre- or at- planting
Ground
15G
[3125-236]
4.5
4.5
Not
Specified
Not
Specified
Direct seeded only. Mechanically incorporate
immediately after application and prior to planting.
Brussels Sprouts
Band
Pre-, at-, or post-plant
Post-transplant
Ground
15G
[3125-236]
4.5
4.5
Not
Specified
Not
Specified
Except brussels sprouts grown for seed. Soil incorporate.
Cabbage
Band
Pre-, at-, or post-plant,
Pre-emergence
Ground
15G
[3125-236]
4.5
4.5
Not
Specified
Not
Specified
Includes tight-heading varieties of cabbage direct seeded
and transplanted. Except cabbage grown for seeds. Soil
incorporate.
75
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Formulation
[EPA Reg. No.]
Max. Single
App. Rate
(Ibai/A)
Max.
Seasonal
App. Rate
(lb ai/A/yr)
Minimum
Retreatment
Interval
(days)
Pre-
harvest
Interval
(days)
Restrictions/Comments
Citrus (Except Florida)
Band
Post-plant
Ground
Low pressure irrigation
Post-plant
Sprinkler
SEC
[3125-283]
SEC
[3125-283]
7.5
3
7.5
6
Not
Specified
30
30
30
In California do not apply to Kumquat, Tangelo, or Citrus
Hybrids. Center the treated band on the tree row using a
band width of 50% of the row spacing and covering the
feeder root system of the plant. Mechanically soil
incorporate immediately.
Soil incorporate.
Citrus (Florida only)
Band
Post-plant
Ground
Low pressure irrigation
Post-plant
Ground
SEC
[3125-283]
3EC
[3125-283]
5
3
5
4.5
Not
Specified
30
30
30
Center the treated band on the tree row using a band width
of 50% of the row spacing and covering the feeder root
system of the plant. Mechanically soil incorporate
immediately. Do not apply within 300 feet of a drinking
well.
Soil incorporate.
76
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Formulation
[EPA Reg. No.]
Max. Single
App. Rate
(Ibai/A)
Max.
Seasonal
App. Rate
(lb ai/A/yr)
Minimum
Retreatment
Interval
(days)
Pre-
harvest
Interval
(days)
Restrictions/Comments
Eggplant
Band
At transplant
Ground
Band
At transplant
Ground
SEC
[3125-283]
15G
[3125-236]
2
2
2
2
Not
Specified
Not
Specified
Not
Specified
Not
Specified
Mechanically soil incorporate immediately.
Immediately incorporate the granules mechanically into
the soil.
Garlic
In furrow
At planting
Ground
15G
[3125-236]
4.5
4.5
Not
Specified
Not
Specified
40" beds with two rows per bed. Soil incorporate.
Grape
Band
Bearing
Ground
Low pressure irrigation
Bearing
Sprinkler
SEC
[3125-283]
SEC
[3125-283]
4.5
4.5
4.5
4.5
Not
Specified
30
2
2
Center the treated band on the vine row using a band width
of 50% of the row spacing. Mechanically soil incorporate
immediately.
Soil incorporate.
77
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Formulation
[EPA Reg. No.]
Max. Single
App. Rate
(Ibai/A)
Max.
Seasonal
App. Rate
(lb ai/A/yr)
Minimum
Retreatment
Interval
(days)
Pre-
harvest
Interval
(days)
Restrictions/Comments
Kiwi fruit (California only)
Low pressure irrigation
Foliar
Sprinkler
SEC
[3125-283]
3
6
30
31
Soil incorporate.
Non-Bell Peppers (California, Georgia, and Puerto Rico only)
Band
At plant
Ground
15G
[3125-236]
2
2
Not
Specified
Not
Specified
Mechanically incorporate the granules into the soil.
Okra (Except California)
Band
At planting
Ground
15G
[3125-236]
2.25
2.25
Not
Specified
Not
Specified
Mechanically incorporate the granules into the soil.
Ornamental Bulbs (Iris, Narcissus, Lily) Except California
In-furrow or Band
At- or Post- plant
Tractor-drawn or Push
Spreader
10G
[3125-237]
10
10
Not
Specified
Not
Specified
Irrigate immediately after treatment using a minimum of Vi
inch of water.
Ornamentals (Leatherleaf Fern)
Irrigation
Sprinkler
Ground
SECTurf
[3125-283]
9
9
Not
Specified
Not
Specified
Apply in fall or early spring. Irrigation must occur within
6 hours of the application. Do not treat crop grown in the
greenhouse.
78
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
In-farrow or Band
At- or Post- plant
Tractor-drawn or Push
Spreader
Formulation
[EPA Reg. No.]
10G
[3125-237]
Max. Single
App. Rate
(Ibai/A)
9
Max.
Seasonal
App. Rate
(lb ai/A/yr)
9
Minimum
Retreatment
Interval
(days)
Not
Specified
Pre-
harvest
Interval
(days)
Not
Specified
Restrictions/Comments
Irrigate immediately after treatment using a minimum of Vi
inch of water.
Ornamentals (Protest, Anthurium, Nursery Stock)
In-farrow or Band
At- or Post- plant
Ground
10G
[3125-237]
10
10
Not
Specified
Not
Specified
Use on Protea is limited to Hawaii only. Irrigate
immediately after treatment using a minimum of 1A inch of
water.
Peanuts
Band
At plant
Ground
Band
At plant
Ground
3EC
[3125-283]
15G
[3125-236]
2.55
2.55
2.55
2.55
Not
Specified
Not
Specified
Not
Specified
Not
Specified
Mechanically soil incorporate immediately.
Mechanically soil incorporate immediately.
Pineapple
Foliar Spray or Drip
Irrigation
Post-plant
Ground
SEC
[3125-283]
2
12
30
60
Applications may begin immediately after planting.
79
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Foliar Spray or Drip
Irrigation
Ratoon
Ground
Formulation
[EPA Reg. No.]
SEC
[3125-283]
Max. Single
App. Rate
(Ibai/A)
2
Max.
Seasonal
App. Rate
(lb ai/A/yr)
9
Minimum
Retreatment
Interval
(days)
30
Pre-
harvest
Interval
(days)
60
Restrictions/Comments
First application may be made immediately following crop
harvest.
Raspberry (Except California)
Band
Ground
3EC
[3125-283]
6
6
Not
Specified
180
Apply during the period of October 1 to December 31.
Center the treated band on the tree row using a band width
of 50% of the row spacing and covering the feeder root
system of the plant. Mechanically soil incorporate
immediately.
Strawberries
Band
Pre-transplant
Ground
Band
Pre-transplant
Ground
Strawberries (Non-Bearin
Band
Post-transplant
Cultivation
3EC
[3125-283]
15G
[3125-236]
4.5
4.5
4.5
4.5
Not
Specified
Not
Specified
110
110
Double-row beds spaced 48 inches apart. Soil incorporate
immediately by cultivation prior to transplanting.
Soil incorporate immediately by cultivation.
E)
15G
[3125-236]
3.47
6.93
56
600
Nursery stock only. Soil incorporate immediately by
cultivation following application.
80
-------
Appendix A: FENAMIPHOS (CASE 0333): USE PATTERNS ELIGIBLE FOR REREGISTRATION
Application Type
Timing
Equipment
Formulation
[EPA Reg. No.]
Max. Single
App. Rate
(Ibai/A)
Max.
Seasonal
App. Rate
(lb ai/A/yr)
Minimum
Retreatment
Interval
(days)
Pre-
harvest
Interval
(days)
Restrictions/Comments
Table Beets (Illinois, Indiana, Michigan, New York, Ohio, and Pennsylvania only)
Band
Pre- or at- seedling
Cultivation
SEC
[3125-283]
3
3
Not
Specified
90
Soil incorporate immediately by shallow cultivation.
Tobacco (Except Shade Type)
Broadcast
Ground
3EC
[3125-283]
6
6
Not
Specified
Not
Specified
Soil incorporate to a depth of 2 to 4 inches by disking or
tilling.
Transplant Cabbage (Florida only)
Drench
Post-transplant
3EC
[3125-283]
1.7
1.7
Not
Specified
Not
Specified
Application must be separate from hand transplanting. Soil
incorporate.
Turf (Golf courses and sod farms)
Broadcast
Spray
SECTurf
[3125-283]
10
20
3
Sod =30
Irrigate area immediately following application. Do not
treat more 10 acres of turf on any golf course in a single
24-hour period. Not recommended for use on tees and
greens.
Turf (Golf courses, cemeteries, sod farms and industrial grounds)
Broadcast
Irrigation
10G
[3125-237]
10
20
3
Sod = 30
(In CA use only on golf courses and sod farms.) Soil
incorporate. Do not treat more 10 A/ 24 hrs.
81
-------
APPENDIX B. Table of the Generic Data
Requirements and Data Supporting Guideline
Requirements for the Reregistration Decision
82
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fenamiphos
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the reregistration for active
ingredients within the chemical case covered by this interim RED. It contains generic data
requirements that apply 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 (Columns 1, 2 & 3). The data requirements are listed in the order of New
Guideline Number and appear in 40 CFR §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
22161-0002, (703) 487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
1. Terrestrial food
2. Terrestrial feed
3. Terrestrial nonfood
4. Aquatic food
5. Aquatic nonfood outdoor
6. Aquatic nonfood industrial
7. Aquatic nonfood residential
8. Greenhouse food
9. Greenhouse nonfood
10. Forestry
11. Residential
12. Indoor food
13. Indoor nonfood
14. Indoor medical
15. Indoor residential
3. Bibliographical Citation (Column 5). If the Agency has acceptable data in its files, this column
lists the identification number of each study. Normally, this is the Master Record
Identification (MRID) Number, but may be a "GS" number if no MRTD number has been
assigned. Refer to the Bibliography (Appendix D) for a complete citation of the study.
83
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fenamiphos
New
Guideline
Number
Old
Guideline
Number
Requirement
Use
Pattern
Citation(s)
PRODUCT USE CHEMISTRY
830.1600
830.1620
830.1670
830.1700
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
61-2A
61-2B
61-2B
62-1
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Starting Materials and Manufacturing
Process
Description of Production Process
Discussion of Formation of Impurities
Preliminary Analysis
Color
Physical State
Odor
Melting Point/Melting Range
Boiling Point/Boiling Range
Density, Relative Density, Bulk Density
Solubility
Vapor Pressure
Dissociation Constant in Water
Octanol/Water Partition Coefficient
pH of Water Solutions or Suspensions
Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
43037101
43037101
43037101
43682501
40499802
40499802
40499802
40499802
WAIVED
40499802
40499802
40499802
40499802
40499802
40499802
40499802
ECOLOGICAL EFFECTS
850.2100
850.2100
850.2200
850.2200
850.2300
850.2300
850.2500
850.1075
850.1075
71-1A
71-1B
71-2A
71-2B
71-4A
71-4B
71-5B
72-1 A
72-1B
Avian Acute Oral Toxicity, Bobwhite Quail
Avian Acute Oral Toxicity, Mallard Duck
Avian Subacute Dietary Toxicity, Bobwhite
Quail
Avian Subacute Dietary Toxicity, Mallard
Duck
Avian Reproduction, Bobwhite Quail
Avian Reproduction, Mallard Duck
Actual Field Study
Fish Acute Toxicity, Bluegill Sunfish
Fish Acute Toxicity, Bluegill Sunfish - TEP
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
00121289
DATA GAP
00025959, DATA GAP
00025958
00121291
00121290
43872101, 42029901, 42029902,
42029903, 42029904, 42029905
00025962,00114012
40799704
84
-------
New
Guideline
Number
850.1075
850.1075
850.1010
850.1010
None
850.1025
850.1035
850.1300
850.1350
850.1400
850.1500
850.1730
850.1950
850.3020
Old
Guideline
Number
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
72-3C
72-4A
72-4B
72-4C
72-5
72-6B
72-7A
141-1
Requirement
Fish Acute Toxicity , Rainbow Trout
Fish AcuteToxicity , Rainbow Trout - TEP
Invertebrate Acute Toxicity, Daphnia
Invertebrate Acute Toxicity, Daphnia - TEP
Estuarine/Marine Fish Acute Toxicity
Estuarine/Marine Mollusk Acute Toxicity
Estuarine/Marine Invertebrate Acute
Toxicity
Fish - Early Life Stage
Estuarine/Marine Invertebrate Life Cycle
Early Life Stage, Freshwater Fish
Life Cycle Fish
Fish BCF (Aquatic Organism Accumulation)
Simulated Field Testing for Aquatic
Organisms
Honey Bee Acute Contact Toxicity
Use
Pattern
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Citation(s)
00114012
40799701
40799706, DATA GAP
43183501, DATA GAP
40799710
40799709, DATA GAP
40799708, DATA GAP
43157701,41064301
43124101,40922201
DATA GAP
DATA GAP
40274201, 40274202, 40274203
42029906
00036935
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6100
870.6200
870.3100
870.3150
870.3200
870.3465
None
870.6200
870.4100
81-1
81-2
81-3
81-4
81-5
81-6
81-7
81-8
82-1 A
82-1B
82-2
82-4
82-5B
82-7
83-1A
Acute Oral Toxicity, Rat
Acute Dermal Toxicity, Rabbit/Rat
Acute Inhalation Toxicity, Rat
Primary Eye Irritation, Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Delayed Neurotoxicity, Hen
Acute Neurotoxicity Screening Battery
90-Day Subchronic Feeding, Rodent
90-Day Subchronic Feeding, Nonrodent
(Dog)
21 -Day Dermal, Rabbit/Rat
21 -Day Inhalation, Rat
90-Day Neurotoxicity, Mammal
Subchronic Neurotoxicity Study
Chronic Feeding Toxicity, Rodent
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
00033831
00037962
00154492
00111667,00082111
00111667,00082111
00148464
00057606
44041501, 44041502, 44051401
00117403,00133475
00119238, 00119957, 00154493
00154497
40774809
44041501,44051401
44041501, 44041502, 44051401
00161361,40329601
85
-------
New
Guideline
Number
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
870.6300
870.5140
870.5375
870.5500
870.7485
Old
Guideline
Number
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
83-5
83-6
84-2A
84-2B
84-4
85-1
Requirement
Chronic Feeding Toxicity, Nonrodent (Dog)
Chronic Carcinogenicity (Feeding), Rat
Chronic Carcinogenicity (Feeding), Mouse
Prenatal Developmental Toxicity, Rat
Prenatal Developmental Toxicity, Rabbit
2-Generation Reproduction and Fertility
Effects, Rat
Combined Chronic
Toxicity /Carcinogenicity Study, Rat
Developmental Neurotoxicity Study, Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism, Rat
Use
Pattern
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Citation(s)
42183601,42684801
00161361,40329601, 00038490
00098614
41225401
40347602
41908901,42491701
00161361,40329601
44041501, 44041502, 44051401
00159027,40319001
00086981
00161367,40649101
41194901,41194902
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100
875.2200
875.2400
875.2500
132-1 A
132-1B
133-3
133-4
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
A,B,C
A,B,C
A,B,C
A,B,C
41901701, DATA GAP
DATA GAP
WAIVED
WAIVED
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.2370
835.4100
835.4200
835.4300
835.1240
835.1410
835.6100
835.1850
161-1
161-2
161-3
161-4
162-1
162-2
162-4
163-1
163-2
164-1
165-1
Hydrolysis
Photodegradation, Water
Photodegradation, Soil
Photodegradation, Air
Aerobic Soil Metabolism Study
Anaerobic Soil Metabolism Study
Aerobic Aquatic Metabolism Study
Leaching/Adsorption/Desorption
Laboratory Volatilization from Soil
Terrestrial Field Dissipation Study
Confined Accumulation in Rotational Crops
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
42149302
40608001, DATA GAP
40608001
WAIVED
42149303, 41064302, 40933701,
40524601, DATA GAP
41286901, DATA GAP
DATA GAP
40547502, 40547501, 40774808,
40774807
40774810
42149301, 42216201, 42149303
41659301
86
-------
New
Guideline
Number
835.1900
None
835.1950
835.7100
None
Old
Guideline
Number
165-2
165-3
165-4
166-1
166-2
Requirement
Field Accumulation in Rotational Crops
Accumulation in Irrigated Crops Study
Bioaccumulation in Fish
Small Scale Prospective Ground Water
Small Scale Retrospective Ground Water
Use
Pattern
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
Citation(s)
42043601
WAIVED
40274201, 40274202, 40274203
45419701
44391301
RESIDUE CHEMISTRY
860.1100
860.1300
860.1340
860.1340
860.1380
860.1480
860.1500
860.1520
860.1520
171-2
171-4B
171-4C
171-4D
171-4E
171-4J
171-4K
lllAL
lllAL
Chemical Identity
Nature of the Residue, Livestock
Residue Analytical Method, Plants
Residue Analytical Method, Animals
Storage Stability
Magnitude of Residues in Meat, Milk,
Poultry and Eggs
Crop Field Trials (Tobacco)
Processed Food (Grapes)
Processed Food (Peanuts)
A,B,C
A,B,C
A,B,C
A,B,C
A,B
A,B
C
A,B
A,B
43037101
43055401, 42945701, 40997701
40876001
00105945,00052526
43762801,43559401
43055401
42674901,41258102
41194903
41255702
OTHER
840.1100
840.1200
201-1
202-1
Spray Droplet Size Spectrum
Spray Drift Field Deposition (Evaluation)
A,B,C
A,B,C
WAIVED
WAIVED
87
-------
APPENDIX C. List of Available Technical
Support Documents
-------
Appendix C. Technical Support Documents for Fenamiphos
Additional documentation in support of this RED is maintained in the OPP docket, 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 4:00 pm.
The docket initially contained preliminary risk assessments and related documents as of
August 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 www.epa.gov/pesticides/op. Documents that have recently been added
include:
HEP Documents:
1. Re-analysis of Fenamiphos: Occupational Risk Assessment with Combined
Mixer/Loader plus Applicator for Certain Use Sites, June 12, 2000
2. Fenamiphos: Update to Occupational Exposure and Risk Assessment for
Mixer/Loader/Applicator on Golf Course Turf, February 21, 2001
3. Fenamiphos: Update to Occupational Exposure and Risk Assessment for
Postapplication Exposures, March 29, 2001
4. Review of "Dislodgeable Residues of Fenamiphos Applied to Turfgrass and
Implications for Golfer Exposure," Synder R., et al. Published in Soil and
Crop Science Society of Florida Proceedings 58; 51-57 (1999); July 27, 2001
EFED Documents:
1. Fenamiphos Environmental Risk Assessment, October 2, 2001
2. Updated RED for Fenamiphos; Fenamiphos Environmental Risk Assessment,
March 6, 2002
89
-------
APPENDIX D. Bibliography
90
-------
Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE INTERIM REREGISTRATION DECISION
(BIBLIOGRAPHY)
GUIDE TO APPENDIX D
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.
91
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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.
92
-------
BIBLIOGRAPHY
MRID
CITATION
00025103 Wakefield, M.; Orme, J.P.R.; Mullin, L.W.; et al. (1973) Determination of Residues of
Nemacur and Its Metabolites in Bananas: Report No. 36283. Rev. (Unpublished study
received Dec 31, 1979 under HI 79/11; prepared by Huntingdon Research Centre,
submitted by state of Hawaii for Mobay Chemical Corp., Kansas City, Mo.;
CDL:241562-C)
00025112 Burrows, I.E.; Harwood, A.M.; Joyce, C.A. (1971) The Determination of Bay 68138
(Nemacur) and Its Metabolites in Bananas: Report No. 30164. (Unpublished study
received Dec 31, 1979 under HI 79/11; prepared by Huntingdon Research Centre,
submitted by Chemagro, Kansas City, MO, for the state of Hawaii; CDL: 241563-G)
00025114 Burrows, I.E.; Way, D. (1971) Determination of Bay 68138 (Nemacur) and Its
Metabolites in Bananas: Report No. 30317. (Unpublished study received Dec 31,
1979 under HI 79/11; prepared by Huntingdon Research Centre, submitted by
Chemagro, Kansas City, MO, for the state of Hawaii; CDL:241563-I)
00025115 Olson, T.J. (1971) An Interference Study for the Nemacur(R) Crop Residue Method
for Bananas: Report No. 31041. (Unpublished study received Dec 31, 1979 under HI
79/11; prepared by Baychem Corp., submitted by Chemagro, Kansas City, MO, for the
state of Hawaii; CDL:241563-J)
00025958 Beavers, J.B.; Fink, R.; Brown, R. (1977) Final Report: Eight-Day Dietary
LC50-Mallard Duck: Project No. 149-108. (Unpublished study including unofficial
analytical report, received Mar 28, 1979 under 3125-236; prepared by Wildlife
International, Ltd. in cooperation with Washington College, submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:237905-E)
00025959 Nelson, D.L.; Burke, M.A. (1977) Dietary Toxicity of (R)Nemacur Technical to
Bobwhite Quail: Report No. 54042. (Unpublished study received Mar 28, 1979 under
3125-236; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:237905-F)
00025962 Lamb, D.W.; Roney, DJ. (1977) Acute Toxicity of (R)Nemacur Technical, Nemacur
Sulfoxide and Nemacur Sulfone to Bluegill: Report No. 54150. (Unpublished study
received Mar 28, 1979 under 3125236; submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL: 237905-1)
00028849 Morris, R.A.; Olson, TJ. (1980) Synopsis of Nemacur Residue Chemistry on Grapes.
(Unpublished study received Mar 4, 1980 under 3125-EX-173; prepared in
93
-------
BIBLIOGRAPHY
MRID
CITATION
cooperation with Chemonics Industries and Morse Laboratories, Inc., submitted by
Mobay Chemical Corp., Kansas City, Mo.; CDL:099304-A)
00029106 Mobay Chemical Corporation (1978) Addition to Synopsis of Nemacur Residue
Chemistry on Applies, Cherries and Peaches. (Unpublished study received Feb 11,
1980 under 3125-236; CDL:099241-A)
00033831 Lamb, D.W.; Matzkanin, C.S. (1975) The Acute Oral Toxicity of Nemacur Technical,
Desisopropyl Nemacur Sulfoxide and Desethyl Nemacur: Report No. 44531.
(Unpublished study received Jul 8, 1980 under 3125-236; submitted by Mobay
Chemical Co., Kansas City, Mo.; CDL:099496-C)
00035114 Bell, R.L.; Jacobs, K.; Gronberg, RR (1975) (R)Nemacur Residues in Poultry and
Eggs: Report No. 41,726. (Unpublished study received Jul 8, 1980 under 3125-236;
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:099497-H)
00036826 Chemago Corporation (1973) Chemagro Division of Baychem Corporation Residue
Experiment: 661-3942-72H; Report No. 35889. (Unpublished study including report
nos. 35945, 35946, 35947..., received May 23, 1973 under 3F1399; prepared in
cooperation with Analytical BioChemistry Laboratories; CDL:093747-C)
00036827 Analytical BioChemistry Laboratories (1973) Chemagro Division of Baychem
Corporation Residue Experiment: 261-3960-72H; Report No. 35890. (Unpublished
study including report nos. 35891, 35892, 35893..., received May 23, 1973 under
3F1399; submitted by Chemagro Corp., Kansas City, Mo.; CDL:093747-D)
00036829 Chemagro Corporation (1973) Chemagro Division of Baychem Corporation Residue
Experiment: KC-3947-72H; Report No. 35909. (Unpublished study including report
nos. 35910, 35911, 35912..., received May 23, 1973 under 3F1399; prepared in
cooperation with Analytical BioChemistry Laboratories; CDL:093747-F)
00036830 Gronberg, R.R.; Simmons, C.E.; Shaw, H.R, II (1973) Residues of (R)Nemacur in
Poultry Eggs and Tissue: Report No. 35995. (Unpublished study received May 23,
1973 under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.;
CDL:093747-G)
94
-------
BIBLIOGRAPHY
MRID
CITATION
00036831 Khasawinah, A.M. (1973) Metabolism of (R)Nemacur in Carrots: Report No. 36005.
(Unpublished study received May 23, 1973 under 3F1399; submitted by Chemagro
Corp., Kansas City, Mo.; CDL: 093747-H)
00036837 Khasawinah, A.M. (1973) Metabolism of 14C-ring, 3H-Methylthio Nemacur in Snap
Beans Grown in Closed Glass Chambers: Report No. 36542. (Unpublished study
received May 23, 1973 under 3F1399; submitted by Chemagro Corp., Kansas City,
Mo.; CDL: 093747-N)
00036839 Chemagro Corporation (1970) The Effect of Frozen Storage at 0 to -10F on
(R)Nemacur Residues in Meat Tissues: Report No. 27083. (Unpublished study
received May 23, 1973 under 3F1399; CDL:093744-B)
00036841 Chemagro Corporation (1970) Recovery of Bay 68138 from Oranges: Report No.
27441. (Unpublished study received May 23, 1973 under 3F1399; CDL:093744-D)
00036843 Chemagro Corporation (1970) Chemagro Corporation Residue Experiment: [Nemacur
on Brussels Sprouts]: Report No. 27926. (Unpublished study received May 23, 1973
under 3F1399; CDL: 093744-F)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, RL. (1975) Toxicity of Pesticides and
Other Agricultural Chemicals to Honey Bees; Laboratory Studies. By University of
California, Dept. of Entomology, UC, Cooperative Extension. (Leaflet 2287;
published study).
00037962 Crawford, C.R.; Anderson, R.H. (1972) The Acute Dermal Toxicity of (R)Nemacur
Technical to Rabbits: Report No. 34216. (Unpublished study received May 23, 1973
under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.; CDL:093741-A)
00037979 Loser, E. (1972) Bay 68 138 Generation Studies on Rats: Report No. 3424; Report No.
34029. (Unpublished study received May 23, 1973 under 3F1399; prepared by
Farbenfabriken Bayer, AG, submitted by Chemagro Corp., Kansas City, Mo.;
CDL:093742-M)
00038504 Chemagro Corporation (1971) Chemagro, a Division of Baychem Corporation,
Residue Experiment: Report No. 31572. (Unpublished study received May 23, 1973
under 3F1399; CDL:093745-A)
95
-------
BIBLIOGRAPHY
MRID
CITATION
00038506
00038507
00038508
00038509
000385 10
0003851 1
00038522
00041025
00041027
Waggoner, T.B. (1972) Metabolism of Nemacur [Ethyl 4-(methylthio)» ^m~» tolyl
isopropylphosphoramidate] and identification of two metabolites in plants. Journal of
Agricultural and Food Chemistry 20(1): 157-160. (Submitter report no. 32181; also In
unpublished submission received May 23, 1973 under 3F1399; submitted by
Chemagro Corp, Kansas City, Mo.; CDL:093745-C)
Chemagro Corporation (1972) Recovery of (R)Nemacur from Soybeans: Report No.
32929. (Unpublished study received May 23, 1973 under 3F1399; CDL:093745-D)
Chemagro Corporation (1972) Chemagro, Division of Baychem Corporation, Residue
Experiment No. 509-3939-71H: Report No. 32930. (Unpublished study including
report nos. 32931, 32932, 32933.., received May 23, 1973 under 3F1399;
CDL:093745-E)
Chemagro Corporation (1972) Chemagro, Division of Baychem Corporation, Residue
Experiment No. 409-391 1-71H: Report No. 32936. (Unpublished study received May
23, 1973 under 3F1399; CDL: 093745-F)
Chemagro Corporation (1972) Recovery of (R)Nemacur from Citrus: Report No.
33067. (Unpublished study received May 23, 1973 under 3F1399; CDL:093745-G)
Chemagro Corporation (1972) Chemagro, Division of Baychem Corporation, Residue
Experiment No. 409-3901-71H: Report No. 33075. (Unpublished study including
report nos. 33076, 33077, 33078.., received May 23, 1973 under 3F1399;
CDL:093745-H)
Chemagro Corporation (1973) Chemagro Division of Baychem Corporation Residue
Experiment 661-395 1-72H: Report No. 35112. Rev. (Unpublished study received
May 23, 1973 under 3F1399; CDL: 093745-T)
Mobay Chemical Corporation (1975) Addition to Synopsis of Nemacur Residue
Chemistry on Various Crops. Summary of studies 096124-B through 096124-G.
Unpublished study received Oct 23, 1975 under 3125-236; CDL:096124-A)
Simmons, C.E.; Gronberg, R.R (1975) The Fate of Carbon- 14-Labeled (R)Nemacur
and Nemacur Sulfoxide in Potatoes Processed by Pan or French Frying: Report No.
43 128. (Unpublished study received Oct 23, 1975 under 3 125-236; submitted by
Mobay Chemical Corp, Kansas City, Mo.; CDL:096124-D)
96
-------
BIBLIOGRAPHY
MRID
CITATION
00041028 Puhl, R. J. (1975) The Effect of Processing on (R)Nemacur and Metabolite Residues in
Sugar Beets: Report No. 43891. (Unpublished study received Oct 23, 1975 under
3125-236; submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:096124-E)
00041030 Simmons, C.E.; Thornton, J.S. (1975) The Fate of Carbon-14-Labeled (R)Nemacur
Sulfoxide in Tomatoes Processed by Canning: Report No. 44619. (Unpublished study
received Oct 23, 1975 under 3125236; submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL: 096124-G)
00041206 Dow Chemical U.S.A. (1973) Seed and Pod Vegetables: Summary of Residues in
Soybeans, Field Beans, Green Beans, and Peas, and in Forages of These Crops.
(Unpublished study received Jan 17, 74 under 1F1075; CDL: 090832-B)
00045595 Khasawinah, A.M. (1972) Metabolism of (R)Nemacur in Snap Beans Grown in
Closed Glass Chambers: Report No. 34992. (Unpublished study received Aug 28,
1980 under 3125-236; submitted by Mobay Chemical Corp., Kansas City, Mo.;
CDL:243126-K)
00045605 Morse Laboratories, Incorporated (1978) The Effect of Frozen Storage at 0 to -10 F on
Residues of (R)Nemacur in Corn: Report No. 66221. (Unpublished study received
Aug 28, 1980 under 3125-236; submitted by Mobay Chemical Corp., Kansas City,
Mo.;CDL:243126-W)
00045612 Hanna, G.R.; Schermoly, MJ. (1980) Residues in Rotational Crops following a Target
Crop Treated with (R)Nemacur: Report No. 68575. (Unpublished study
received Aug 28, 1980 under 3125-236; submitted by Mobay Chemical Corp., Kansas
City, Mo.; CDL:243126-AD)
00045614 Hanna, G.R. (1980) The Metabolism of Nemacur in Sandy Loam Soil: Report No.
68598. (Unpublished study received Aug 28, 1980 under 3125-236; submitted by
Mobay Chemical Corp., Kansas City.; CDL 243126-AF)
00049668 Thornton, J.S. (1976) Effect of Processing on Residues of (R)Nemacur in Oranges:
Report No. 47003. (Unpublished study received Sep 10, 1976 under 3125-236;
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:095284-C)
97
-------
BIBLIOGRAPHY
MRID
CITATION
00052494 Chemagro Corporation (1973) Supplement to Synopsis of Analytical and Residue
Information on Nemacur (Bay 68138) in Bananas. Summary of study 093749-B.
(Unpublished study received May 23, 1973 under 3F1399; CDL:093749-A)
00052495 Wakefield, M.; Orme, J.P.R.; Mullin, L.W.; et al. (1973) Determination of Residues of
Nemacur and Its Metabolites in Bananas: FBA116/73220; Report No. 36283. Method
dated Mar 21, 1973. (Unpublished study received May 23, 1973 under 3F1399;
prepared by Huntingdon Research Centre, submitted by Chemagro Corp., Kansas City,
Mo.; CDL:093749-B)
00052501 Chemagro Corporation (1974) Chemagro Corporation Residue Experiment No.
SE-3908-68H: Report No. 27032. (Unpublished study received on unknown date
under 3F1399; CDL:093748-G)
00052504 Khasawinah, A.M. (1972) The Uptake and Metabolism of (R)Nemacur Soil Residues
by Soybean Plants: Report No. 35012. (Unpublished study received May 23, 1973
under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.; CDL:093748-J)
00052508 Analytical BioChemistry Laboratories, Incorporated (1974) Chemagro Division of
Baychem Corporation Residue Experiment: 161-394672H: Report No. 36063.
(Unpublished study received on unknown date under 3F1399; submitted by Chemagro
Corp., Kansas City, Mo.; CDL:093748-Q)
00052509 Khasawinah, A.M. (1973) Metabolism of (R)Nemacur in Tomatoes: Report No.
38501. (Unpublished study received on unknown date under 3F1399; submitted by
Chemagro Corp., Kansas City, Mo.; CDL:093748-R)
00052510 Khasawinah, A.M. (1973) The Metabolism of (R)Nemacur in Cabbage: Report No.
39120. (Unpublished study received on unknown date under 3F1399; submitted by
Chemagro Corp., Kansas City, Mo.; CDL:093748-S)
00052511 Olson, TJ. (1974) The Effect of Alkali Refining on (R)Nemacur Residues in
Cottonseed Oil: Report No. 40113. (Unpublished study received on unknown date
under 3F1399; submitted by Chemagro Corp., Kansas City, Mo.; CDL:093748-T)
00052518 Chemagro Corporation (19??) [Summary Tables 6,7 and 8—Nemacur Residues in
Cotton Plants]. (Unpublished study received May 23, 1973 under 3F1399;
CDL:093743-G)
98
-------
BIBLIOGRAPHY
MRID
CITATION
00052525 Thornton, J.S. (1970) A Gas Chromatographic Method for the Determination of Bay
68138 and Metabolite Residues in Crops: Report No. 25402. Includes method dated
Aug 7, 1969. (Unpublished study including report nos. 25542, 26638, 27016...,
received May 23, 1973 under 3F1399; submitted by Chemagro Corp., Kansas City,
Mo.; CDL:093743-Q)
00052526 Thornton, J.S. (1970) A Gas Chromatographic Method for the Determination of
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