Reregistration

Eligibility Decision for Aldicarb

Reregistration Eligibility Decision (RED) Document

for Aldicarb

List A

Case Number 0140

Approved by:							Date:

		Steven Bradbury, Ph.D.

			Director

			Special Review and Reregistration Division

Table of Contents

  TOC \f \h \z    HYPERLINK \l "_Toc178410752"  Aldicarb Reregistration
Eligibility Decision Team	  PAGEREF _Toc178410752 \h  5

  HYPERLINK \l "_Toc178410753"  Glossary of Terms and Abbreviations
PAGEREF _Toc178410753 \h  6

  HYPERLINK \l "_Toc178410754"  Abstract	  PAGEREF _Toc178410754 \h  8

  HYPERLINK \l "_Toc178410755"  I. Introduction	  PAGEREF _Toc178410755
\h  9

  HYPERLINK \l "_Toc178410756"  II. Chemical Overview	  PAGEREF
_Toc178410756 \h  11

  HYPERLINK \l "_Toc178410757"  A. Chemical Identity	  PAGEREF
_Toc178410757 \h  11

  HYPERLINK \l "_Toc178410758"  B. Regulatory History	  PAGEREF
_Toc178410758 \h  12

  HYPERLINK \l "_Toc178410759"  C. Use and Usage Profile	  PAGEREF
_Toc178410759 \h  12

  HYPERLINK \l "_Toc178410760"  D. Tolerances	  PAGEREF _Toc178410760 \h
 13

  HYPERLINK \l "_Toc178410761"  III. Aldicarb Human Health and
Environmental Fate and Effects Risk Assessments	  PAGEREF _Toc178410761
\h  14

  HYPERLINK \l "_Toc178410762"  A. Human Health	  PAGEREF _Toc178410762
\h  14

  HYPERLINK \l "_Toc178410763"  B. Environmental Fate and Effects
PAGEREF _Toc178410763 \h  14

  HYPERLINK \l "_Toc178410764"  IV. Risk Management, Reregistration
Decision, and Tolerance Reassessment Decisions	  PAGEREF _Toc178410764
\h  18

  HYPERLINK \l "_Toc178410765"  A. Determination of Reregistration
Eligibility	  PAGEREF _Toc178410765 \h  18

  HYPERLINK \l "_Toc178410766"  B. Public Comments and Responses
PAGEREF _Toc178410766 \h  18

  HYPERLINK \l "_Toc178410767"  C. Regulatory Position	  PAGEREF
_Toc178410767 \h  19

  HYPERLINK \l "_Toc178410768"  1. Food Quality Protection Act Findings
 PAGEREF _Toc178410768 \h  19

  HYPERLINK \l "_Toc178410769"  a. "Risk Cup" Determination	  PAGEREF
_Toc178410769 \h  19

  HYPERLINK \l "_Toc178410770"  b. Determination of Safety to U.S.
Population (Including Infants and Children)	  PAGEREF _Toc178410770 \h
19

  HYPERLINK \l "_Toc178410771"  c. Endocrine Disruptor Effects	  PAGEREF
_Toc178410771 \h  19

  HYPERLINK \l "_Toc178410772"  d. Cumulative Risks	  PAGEREF
_Toc178410772 \h  20

  HYPERLINK \l "_Toc178410773"  2. Tolerance Summary	  PAGEREF
_Toc178410773 \h  20

  HYPERLINK \l "_Toc178410774"  D. Regulatory Rationale	  PAGEREF
_Toc178410774 \h  22

  HYPERLINK \l "_Toc178410775"  1. Human Health Risk Management and
Mitigation	  PAGEREF _Toc178410775 \h  22

  HYPERLINK \l "_Toc178410776"  a. Dietary Risk Mitigation (Food and
Drinking Water)	  PAGEREF _Toc178410776 \h  22

  HYPERLINK \l "_Toc178410777"  b. Aggregate Risk Mitigation	  PAGEREF
_Toc178410777 \h  23

  HYPERLINK \l "_Toc178410778"  c. Occupational Risk Mitigation
PAGEREF _Toc178410778 \h  23

  HYPERLINK \l "_Toc178410779"  2. Ecological Risk Management and
Mitigation	  PAGEREF _Toc178410779 \h  23

  HYPERLINK \l "_Toc178410780"  a. Terrestrial and Aquatic Organisms
PAGEREF _Toc178410780 \h  23

  HYPERLINK \l "_Toc178410781"  3. Mitigation Summary and Crop-Specific
Analyses	  PAGEREF _Toc178410781 \h  24

  HYPERLINK \l "_Toc178410782"  Citrus	  PAGEREF _Toc178410782 \h  25

  HYPERLINK \l "_Toc178410783"  Cotton	  PAGEREF _Toc178410783 \h  27

  HYPERLINK \l "_Toc178410784"  Dry Bean	  PAGEREF _Toc178410784 \h  30

  HYPERLINK \l "_Toc178410785"  Peanut	  PAGEREF _Toc178410785 \h  31

  HYPERLINK \l "_Toc178410786"  Potato	  PAGEREF _Toc178410786 \h  34

  HYPERLINK \l "_Toc178410787"  Soybean	  PAGEREF _Toc178410787 \h  36

  HYPERLINK \l "_Toc178410788"  Sugar Beet	  PAGEREF _Toc178410788 \h
37

  HYPERLINK \l "_Toc178410789"  Sweet Potato	  PAGEREF _Toc178410789 \h
40

  HYPERLINK \l "_Toc178410790"  4. Other Labeling Requirements	  PAGEREF
_Toc178410790 \h  41

  HYPERLINK \l "_Toc178410791"  5. Threatened and Endangered Species
Considerations	  PAGEREF _Toc178410791 \h  41

  HYPERLINK \l "_Toc178410792"  V. What Registrants Need to Do	  PAGEREF
_Toc178410792 \h  43

  HYPERLINK \l "_Toc178410793"  A. Manufacturing-Use Products	  PAGEREF
_Toc178410793 \h  43

  HYPERLINK \l "_Toc178410794"  1. Additional Generic Data Requirements
 PAGEREF _Toc178410794 \h  43

  HYPERLINK \l "_Toc178410795"  2. Labeling for Manufacturing-Use
Products	  PAGEREF _Toc178410795 \h  43

  HYPERLINK \l "_Toc178410796"  B. End-Use Products	  PAGEREF
_Toc178410796 \h  44

  HYPERLINK \l "_Toc178410797"  1. Additional Product-Specific Data
Requirements	  PAGEREF _Toc178410797 \h  44

  HYPERLINK \l "_Toc178410798"  2. Labeling for End-Use Products
PAGEREF _Toc178410798 \h  44

  HYPERLINK \l "_Toc178410799"  Appendix A. Aldicarb Uses and
Use-Patterns Eligible for Reregistration	  PAGEREF _Toc178410799 \h  58

  HYPERLINK \l "_Toc178410800"  Appendix B. Table of Generic Data
Requirements and Studies Used to Make the Reregistration Decision
PAGEREF _Toc178410800 \h  68

  HYPERLINK \l "_Toc178410801"  Appendix C. Technical Support Documents
 PAGEREF _Toc178410801 \h  75

  HYPERLINK \l "_Toc178410802"  Appendix D. Citations Considered to be
Part of the Database Supporting the Reregistration Decision
(Bibliography)	  PAGEREF _Toc178410802 \h  77

  HYPERLINK \l "_Toc178410803"  Appendix E. Generic Data Call-In (GDCI)
 PAGEREF _Toc178410803 \h  183

  HYPERLINK \l "_Toc178410804"  Appendix F. Product-Specific Data
Call-In (PDCI)	  PAGEREF _Toc178410804 \h  184

  HYPERLINK \l "_Toc178410805"  Appendix G. EPA’s Batching of Aldicarb
Products for Meeting Data Requirements for Reregistration	  PAGEREF
_Toc178410805 \h  185

  HYPERLINK \l "_Toc178410806"  Appendix H. List of Available Related
Documents and Electronically Available Forms	  PAGEREF _Toc178410806 \h
187

 Aldicarb Reregistration Eligibility Decision Team  TC "Aldicarb
Reregistration Eligibility Decision Team" \f C \l "1"

EPA Office of Pesticide Programs

Special Review and Reregistration Division

Sherrie Kinard

Anne Overstreet

Robert McNally

Health Effects Division

Jeff Dawson

Felicia Fort

Michael Metzger

Linda Taylor

Environmental Fate and Effects Division

Jonathan Angier

Tom Bailey

Jeanette Martinez

Dana Spatz

Biological and Economic Analysis Division

Derek Berwald

Angel Chiri

Colwell Cook

Arnet Jones

Monisha Kaul

Timothy Kiely

Istanbul Yusuf

Nicole Zinn

Registration Division

Joanne Edwards

John Hebert

Glossary of Terms and Abbreviations  TC "Glossary of Terms and
Abbreviations" \f C \l "1"

AGDCI	Agricultural Data Call-In

ai	Active Ingredient

aPAD	Acute Population Adjusted Dose

BCF 	Bioconcentration Factor

CFR	Code of Federal Regulations

cPAD	Chronic Population Adjusted Dose

CSF	Confidential Statement of Formulation

CSFII	USDA Continuing Surveys for Food Intake by Individuals

DCI	Data Call-In

DEEM	Dietary Exposure Evaluation Model

DFR	Dislodgeable Foliar Residue

DNT	Developmental Neurotoxicity

EC	Emulsifiable Concentrate Formulation

EDWC	Estimated Drinking Water Concentration

EEC	Estimated Environmental Concentration

EPA	Environmental Protection Agency

EUP	End-Use Product

FDA	Food and Drug Administration

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA	Federal Food, Drug, and Cosmetic Act

FQPA	Food Quality Protection Act

GLN	Guideline Number

IR	Index Reservoir

LC50	Median Lethal Concentration.  A statistically derived concentration
of a substance that can be expected to cause death in 50% of test
animals.  It is usually expressed as the weight of a substance per
weight or volume of water, air, or feed, e.g., mg/l, mg/kg, or ppm.

LD50	Median Lethal Dose.  A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation).  It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOC	Level of Concern

LOAEL	Lowest Observed Adverse Effect Level

MATC	Maximum Acceptable Toxicant Concentration

µg/g	Micrograms Per Gram

µg/L	Micrograms Per Liter

mg/kg/day	Milligram Per Kilogram Per Day

mg/L	Milligram Per Liter

MOE	Margin of Exposure

MRID	Master Record Identification Number. EPA's system for recording and
tracking studies submitted.

MUP	Manufacturing-Use Product

NOAEL	No Observed Adverse Effect Level

OPP	EPA Office of Pesticide Programs

OPPTS	EPA Office of Prevention, Pesticides, and Toxic Substances

PAD	Population Adjusted Dose

PCA	Percent Crop Area

PDP	USDA Pesticide Data Program

PHED	Pesticide Handler's Exposure Data

PHI	Pre-harvest Interval

ppb	Parts Per Billion

PPE	Personal Protective Equipment

ppm	Parts Per Million

PRZM/EXAMS

	Pesticide Root Zone Mode/Exposure Analysis Modeling System, Tier II
Surface Water Computer Model

Q*	The Carcinogenic Potential of a Compound, Quantified by the EPA’s
Cancer Risk Model

RAC	Raw Agriculture Commodity

RED	Reregistration Eligibility Decision

REI	Restricted-Entry Interval

RfD	Reference Dose

RQ	Risk Quotient

SCI-GROW2	Tier I Ground Water Computer Model

SAP	Science Advisory Panel

SF	Safety Factor

SLC	Single Layer Clothing

TGAI	Technical Grade Active Ingredient

USDA	United States Department of Agriculture

USGS	United States Geological Survey

UF	Uncertainty Factor

UV	Ultraviolet

WPS	Worker Protection Standard

Abstract  TC "Abstract" \f C \l "1"

	This document presents the Environmental Protection Agency’s (EPA’s
or the Agency’s) decision regarding the reregistration eligibility of
the registered uses of the active ingredient aldicarb.  The Agency has
conducted human health and environmental fate and effects risk
assessments for aldicarb and has assessed whether the aldicarb
tolerances are safe from an individual-chemical standpoint (considering
all issues other than cumulative exposures to other n-methyl carbamate
pesticides).  The Agency has determined that, with label amendments and
changes as specified in this document, aldicarb can be used without
resulting in unreasonable adverse effects on the environment, and that
there is a reasonable certainty that no harm will result to the general
U.S. population, infants, children, or other major identifiable
population subgroups, from the use of aldicarb (considering all issues
other than cumulative exposures to other n-methyl carbamate pesticides).
 The Agency has therefore determined that products containing the active
ingredient aldicarb are eligible for reregistration provided that the
risk mitigation measures outlined in this document are adopted and label
amendments are made to reflect these measures.

EPA has identified potential human health risks of concern associated
with the current registered uses of aldicarb from drinking water
exposure, and potential environmental risks of concern to birds, mammals
and fish.  To reduce these potential exposures and to address current
risks of concern, the Agency, in agreement with the technical registrant
of aldicarb, will implement label restrictions (increase drinking water
well set-backs when certain criteria are triggered) for application to
peanuts in the southeastern coastal plains for ground water
contamination concerns.  Additionally, application rate reductions,
state limitations, application restrictions, label amendments, and
termination of certain uses will also be implemented to reduce
environmental concerns.  The Agency is also requiring appropriate data
to confirm the decisions presented in this Reregistration Eligibility
Decision.

I. Introduction  TC "I. Introduction" \f C \l "1"

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 data submitted to
the Environmental Protection Agency (hereafter referred to as EPA or the
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 a pesticide, to determine the need for
additional data on health and environmental effects, and to determine
whether or not the pesticide meets the “no unreasonable adverse
effects” standard of FIFRA.

On August 3, 1996, the Food Quality Protection Act (FQPA) was signed
into law.  This Act amended FIFRA and the Federal Food, Drug, and
Cosmetic Act (FFDCA) to require reassessment of all existing tolerances
for pesticides in food.  EPA decided that, for those chemicals that have
tolerances and are undergoing reregistration, tolerance reassessment
would be accomplished through the reregistration process.  Under FQPA,
in reassessing these tolerances, the Agency must consider, among other
things, aggregate risks from non-occupational sources of pesticide
exposure, whether there is increased susceptibility among infants and
children, and the cumulative effects of pesticides that have a common
mechanism of toxicity.  In determining whether aldicarb tolerances can
be reassessed as safe, the Agency has concluded that the risks from
aggregate exposure to aldicarb are acceptable, and that the tolerances
can be reassessed as safe if they are acceptable when viewed in light of
the cumulative assessment of n-methyl carbamate pesticides.

	The intentional dosing human toxicity study (the Inveresk study) used
in the human health risk assessment for aldicarb has been reviewed by
EPA’s Human Studies Review Board, as required by EPA’s Human
Subjects Protections rule.  The Agency presented the Inveresk study to
the HSRB at a meeting on April 2 – 4, 2006.  The HSRB discussed the
study extensively and concluded that the cholinesterase data from the
aldicarb human study were reliable for use in the aldicarb single
chemical, aggregate risk assessment from both a science and ethical
standpoint.  The final report of the HSRB is available at   HYPERLINK
"http://www.epa.gov/osa/hsrb/files/april2006mtgfinalreport62606.pdf"
http://www.epa.gov/osa/hsrb/files/april2006mtgfinalreport62606.pdf

Risks summarized in this document are for aldicarb only.  FQPA requires
EPA to consider available information concerning the cumulative effects
of a particular pesticide's residues and "other substances that have a
common mechanism of toxicity" when considering whether to establish,
modify, or revoke a tolerance.  Potential cumulative effects of
chemicals with a common mechanism of toxicity are considered because
low-level exposure to multiple chemicals causing a common toxic effect
by a common mechanism could lead to the same adverse health effect as
would a higher level of exposure to any one of these individual
chemicals.  Aldicarb is a member of the N-methyl carbamate class of
pesticides.  The Agency has classified the N-methyl carbamate pesticides
and their common degradates as having a common mechanism of toxicity.

A cumulative risk assessment, which evaluates exposures based on a
common mechanism of toxicity, was conducted to evaluate risk from food,
drinking water, residential use, and other non-occupational exposures
resulting from registered uses of N-methyl carbamate pesticides,
including aldicarb.  EPA has concluded that the cumulative risks
associated with the N-methyl carbamate pesticides are below the
Agency’s level of concern.  With this determination, the Agency has
concluded the  reassessment process for aldicarb tolerances mandated by
section 408(q) of the FFDCA. For additional information, refer to the
document, Revised N-methyl Carbamate Cumulative Risk Assessment, which
is available in the EPA docket EPA-HQ-OPP-2007-0935 and on the website,
 HYPERLINK "http://www.epa.gov/pesticides/cumulative/"
http://www.epa.gov/pesticides/cumulative/ .

This document presents EPA's revised human health and environmental fate
and effects risk assessments, its progress toward tolerance
reassessment, and the reregistration eligibility decision for aldicarb.
The document consists of six sections.  Section I contains the
regulatory framework for reregistration and tolerance reassessment.
Section II provides a description of the chemical and a profile of the
use and usage of the chemical.  Section III references the revised human
health and environmental fate and effects risk assessments attached as
Appendices to this document.  Section IV presents the Agency's risk
management, reregistration eligibility, and tolerance reassessment
decisions.  Section V summarizes the data requirements necessary to
confirm the reregistration eligibility decision as well as specific
label changes and language necessary to implement the risk mitigation
measures outlined in Section IV.  Section VI, the Appendices, provides
related information and supporting documents.  The preliminary and
revised risk assessments for aldicarb are available in the public docket
EPA-HQ-OPP-2005-0163 located on-line in the Federal Docket Management
System (FDMS) at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov .

II. Chemical Overview  TC "II. Chemical Overview" \f C \l "1"

	A. Chemical Identity  TC "A. Chemical Identity" \f C \l "2"

Chemical Structure:

Empirical Formula:	  SEQ CHAPTER \h \r 1 C7H14N2O2S

Common Name:

Aldicarb

CAS Name:

2-methyl-2-(methylthio)propionaldehyde O- (methylcarbamoyl)oxime

CAS Registry Number:

116-06-3

OPP Chemical Code:

098301

Case Number:

0140

Technical Registrant:

Bayer CropSciences

Degradates:

Aldicarb sulfoxide:  2-Methyl-2-(methylsulfinyl)propionaldehyde
O-(methyl carbamoyl) oxime, and Aldicarb sulfone:
2-Methyl-2-(methylsulfonyl)propionaldehyde O-(methyl carbamoyl) oxime

The regulated residues are the combined residues of aldicarb and its two
cholinesterase-inhibiting metabolites, aldicarb sulfoxide and aldicarb
sulfone.  Aldicarb sulfoxide is considered to have similar potency to
the parent in terms of toxicity, while aldicarb sulfone is less potent.
Aldicarb and the sulfoxide and sulfone metabolites are the residues of
concern in both the tolerance expression and the reregistration
decision.

	Aldicarb is registered for use as a systemic insecticide and nematicide
on agricultural crops.  Aldicarb is absorbed by the root system, and is
subsequently translocated throughout the plant.  Aldicarb is a
restricted use pesticide and there are no aldicarb products intended for
sale to homeowners or for use in residential settings.  Aldicarb is
currently sold in the United States by Bayer CropScience, the basic
producer, under the trade name of Temik®.

Regulatory History  TC "B. Regulatory History " \f C \l "2"

	Aldicarb was first registered in 1970.  Marketing of aldicarb was
stopped in Long Island in 1980 due to high levels of aldicarb degradates
found in ground water there.  In 1981, aldicarb was classified as a
restricted use pesticide and in 1984 was placed under Special Review.
Aldicarb is currently under Special Review because of concerns regarding
ground water contamination.  Position Documents (PD’s) 1 and 2/3 were
published on 7/11/84 (49 FR 28320) and 6/29/88 (53 FR 24630),
respectively.  A Special Review Data Call-In-Notice (DCI) was issued
6/3/89 requiring the registrant to submit additional ground water data.
In addition, because a National Food Survey identified discrepancies
between anticipated residues in foods and actual residues from food
survey samples, the Special Review required a variety of studies related
to use on potatoes and citrus crops.  In 1990, the sale of aldicarb on
potatoes was voluntarily suspended due to detection of
tolerance-exceeding aldicarb residues on individual potatoes.  The
registrant agreed to dietary risk reduction actions involving voluntary
cancellation of use on bananas and registration amendments for uses on
potatoes, sweet potatoes, oranges and grapefruit.  The registrant
subsequently submitted extensive field residue and commercial storage
and processing data showing that more controlled application techniques
would ensure residues below the established tolerance and would not pose
any increased dietary risk.  The use on potatoes was re-instated in the
states of FL, ID, WA and OR, after new application methods demonstrated
significantly lower residues in potatoes.  Although dietary risk
concerns relating to use on potatoes have been resolved, aldicarb
remains in EPA's Special Review process because of concerns about risks
of ground water contamination.  In 1998,  the Agency issued a proposal
as part of Special Review to manage risks due to ground water concerns
through national measures consisting of the prohibition of aldicarb use
within 300 feet of a drinking water well, and geographically specific
measures consisting of the requirement for State Management Plans.  The
Agency will begin the process to close out the Special Review of
aldicarb in the near future.

	C. Use and Usage Profile  TC "C. Use and Usage Profile " \f C \l "2"

The following is information on the currently registered uses of
aldicarb.  Sections IV and V include information on those currently
registered uses which are eligible for reregistration and Appendix A
provides a detailed table of those uses which are eligible for
reregistration.

 Type of Pesticide:	Aldicarb is a systemic insecticide, acaricide and
nematicide used to control the following pests:  a number of nematode
species (suppression); leaf phylloxera; bud moth;; aphids; mites; white
flies; thrips; fleahoppers, leafminers; leafhoppers; overwintering boll
weevil; lygus; cotton leaf perforator; seedcorn maggot; Mexican bean
beetle; flea beetles; Colorado potato beetle; greenbug; chinch bug;
three cornered alfalfa hopper (suppression); and sugar beet root maggot.

Formulations:	Aldicarb is formulated and marketed solely as a granular
pesticide under the trade name Temik®.  The granulars (5, 10 and 15%
a.i.) consist of aldicarb adhered to a corn cob grit or gypsum
substrate, which are formulated to produce less dust than typical clay
substrates used for granular pesticides.  The gypsum granular is
available in closed loading systems.

Methods of Application:	End-use products containing aldicarb are
restricted use and can only be applied by a certified applicator.
Typically, aldicarb is applied early in the growing season, either
pre-plant, at-planting, or early post-emergent, using ground application
equipment.  Positive displacement application equipment and immediate
soil incorporation are required.  Aldicarb is also applied as a
split-season use to peanuts.  It is applied as a broadcast (at-pegging)
to the canopy of the peanut plant for nematode control.

Use Sites:	No aldicarb products are intended for sale to homeowners or
for use by professional applicators in residential environments.
Aldicarb is currently registered for use on agricultural crops including
citrus, cotton, dry beans, peanuts, pecans, potatoes, sorghum, soybeans,
sugar beets, sugarcane, sweet potatoes, and seed alfalfa (CA).  In
addition, aldicarb may be applied to field grown ornamentals (CA),
tobacco, and on coffee grown in Puerto Rico.

Application Rates:	The maximum application rates range from 1.05 pounds
(lbs) active ingredient (ai) per acre (A) for sorghum to 10.05 lbs ai/A
for pecans.

Estimated Usage:	Approximately 4.5 million pounds of  aldicarb  are used
annually.  Aldicarb is used mostly on cotton (approximately 64% of total
aldicarb use).  Other high use crops include peanuts, potatoes, sugar
beets, and citrus.

	D. Tolerances  TC "D. Tolerances" \f C \l "2"

Tolerances for aldicarb are expressed in terms of the combined residues
of aldicarb and its cholinesterase-inhibiting metabolites aldicarb
sulfoxide and aldicarb sulfone in plant, livestock, and processed food
and feed commodities [40 CFR §180.269, §185.150 (a), and §186.150].
Section IV includes a summary of the tolerance reassessment decision for
aldicarb and lists those tolerances the Agency will propose to revoke,
decrease, increase, maintain, reassign, and establish.

III.  Aldicarb Human Health and Environmental Fate and Effects Risk
Assessments  TC "III. Aldicarb Human Health and Environmental Fate and
Effects Risk Assessments " \f C \l "1"

Human health effects and environmental fate and effects risk assessments
have been performed for aldicarb.  These assessments demonstrate
potential human health risks of concern for ground water contamination
in the southeastern coastal plains resulting from the use on peanuts,
and environmental risks of concern to both terrestrial and aquatic
organisms resulting from all uses of aldicarb.  A summary of potential
risk concerns are presented below.  For additional information and the
risk assessments in their entirety, please refer to the revised human
health and environmental fate and effects risk assessments for aldicarb,
dated February 26, 2007, and November 30, 2005, respectively.  These
documents are also available in the public docket EPA-HQ-OPP-2005-0163
located on-line at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov .

Human Health  TC "A. Human Health " \f C \l "2"

	As discussed in Section 5.2 of the human health risk assessment (found
at   HYPERLINK "http://www.regulations.gov./"
http://www.regulations.gov./ ), there are risk estimates that exceed
EPA’s level of concern from aggregate dietary exposure to residents
living in the U.S. southeastern coastal plain who consume water from
rural ground water wells.

	Four drinking water (from ground water sources) concentration scenarios
were modeled for aldicarb:  three ground water scenarios for use on
peanuts/cotton in Georgia with an assumption of a 300 ft., 500 ft., and
1000 ft. setback, as well as an additional scenario in Florida for
aldicarb use on citrus with a 1000 ft. setback.  The estimated risks at
the 99.9th percentile are below the Agency’s level of concern for all
four scenarios, and for all population subgroups except for infants
under the Georgia 300ft. scenario (139% - 147% of the acute population
adjusted dose (aPAD)).  For all other scenarios, risk are not of concern
to the Agency.

Environmental Fate and Effects  TC "B. Environmental Fate and Effects "
\f C \l "2"

There are multiple lines of evidence, including studies in the open
literature and registrant submitted data, clearly demonstrating that
aldicarb is very highly toxic to both aquatic and terrestrial non-target
organisms (e.g., a single granule of TEMIK® 15G can kill a small bird).
 However, the degree to which there is exposure to aldicarb or its
degradates in the terrestrial and aquatic environments is much more
uncertain.  This is due in part to the physical properties (e.g., color,
size, and solubility) of the aldicarb granule, the variety of
application techniques, amounts applied, number of applications,
application intervals, and timing of applications.  Typically, the
aldicarb granules are spread on the surface and incorporated into the
soil by “shanking in”, “working into the soil”, “covering with
soil”, and/or “wetting in”.  Applications directly “in-furrow”
are also performed for some crops (e.g., sweet potato), but may be
followed by later applications that are less effectively
soil-incorporated.  The ecological risk assessment was conducted
assuming that the aldicarb granules are incorporated into the soil with
efficiencies ranging from 85 to 99 percent, leaving just 1 to 15 percent
of the applied granules on the soil surface available to terrestrial
organisms or to runoff to surface water (resulting in exposure to
aquatic organisms).  Certain application techniques, specifically,
in-furrow applications and banded applications that utilize
state-of-the-art methods (such as positive displacement and immediate
soil incorporation), may theoretically result in incorporation
efficiencies of 99 percent.  Other types of applications may result in
incorporation efficiencies closer to 85 percent.  Because of this
uncertainty, both scenarios were addressed in the ecological risk
assessment.  In addition to this, risk quotients were calculated for
both maximum labeled rates and typical application rates, showing the
range of expected outcomes.

There are two aldicarb degradates of concern, aldicarb sulfoxide and
aldicarb sulfone, that are also considered in the assessment.  These
degradates appear to form primarily in the shallow subsurface (although
some may also form within plant tissue) and are potentially more mobile
and persistent than the parent.  As a conservative assumption, all three
forms (parent aldicarb, sulfoxide, and sulfone) are considered as a
single constituent for aquatic exposure estimates because of the longer
degradate half-lives.  Parent only is considered for terrestrial
exposure because of its higher toxicity to animals, the likelihood that
most exposure would be to whole granules, and because only small amounts
of the degradates, relative to the parent, are expected to be present
directly on the surface.

Given the methods of application of the aldicarb granule (i.e., ground
application and incorporation into the soil), its high water solubility,
low vapor pressure, and low bioaccumulation potential, terrestrial
exposure to aldicarb is primarily confined to the treated field.
Off-site terrestrial exposure to aldicarb would be limited to cases
where, 1) a granule is re-deposited to lower-lying areas affected by
aldicarb runoff from nearby fields, or 2) a granule in the gut or on a
prey item such as a small bird or mammal is consumed by a predator.  The
series of events that would need to transpire in order to result in
off-site exposure are considered unlikely.

Summarizing the risk to terrestrial organisms, the acute risk level of
concern for birds and mammals is exceeded for all target crops at both
maximum allowed label rates and typical use rates.  The levels of
concern are consistently exceeded by a factor of greater than 100X and
are frequently exceeded by more than 1000X.  These results consider both
85 and 99 percent incorporation efficiencies.  The granules left exposed
on the surface appear to be the main source of exposure, but other
sources such as residues taken up by plants and soil invertebrates
(e.g., earthworms) may also serve as a means of exposure.

The following tables (Table 1 and Table 2) provide risk quotients that
were calculated based on maximum labeled application rates and the
average or typical application rates taken from the Biological and
Economic Analysis Division’s Quantitative Usage Analysis dated August
9, 2004, as well as label-indicated band widths and row spacing.
Granule incorporation efficiency was set at 85 percent (Table 1) or 99
percent incorporation (Table 2).  Based on this information, it is
evident that risk levels of concern are exceeded even at rates that are
less than the application rates allowed by the product labels and at
granule incorporation efficiencies approaching 100 percent.

Table 1.  Ranges of acute risk quotients for small, medium, and large
birds and mammals exposed to maximum label rate and typical application
rates at 85% incorporation efficiency.  TC "Table 1.  Ranges of Acute
Avian and Mammalian Risk Quotients" \f E \l "1"

Crop

(max. rate/typical rate in lbs ai/acre)	Maximum Rate

Avian RQs	Typical Rate

Avian RQs	Maximum Rate

Mammalian RQs	Typical Rate

Mammalian RQs

Citrus (4.95/3.7)	9 - 771	6 - 577	11 – 261	8 - 195

Cotton (4.05/0.6)	71 - 6396	11 - 948	93 – 2161	14 - 320

Dry Beans (2.1/1.0)	29 – 2620	13 - 1248	38 – 885	18 - 422

Peanuts (3.0/0.9)	31 - 2807	9 - 842	41 - 948	12 - 285

Pecans (10.05/3.1)	17 – 1566	5 - 483	23 – 529	7 - 163

Potatoes (3.0/2.7)	33 – 2963	30 - 2667	43 – 1001	39 - 901

Soybeans (3.0/0.7)	26 – 2339	6 - 546	34 – 790	8 - 184

Sugar beets (4.95/1.8)	32 – 2831	11 - 972	41 – 956	14 - 328

Alfalfa (3.0/NA)	5 - 451	not available	7 - 158	not available

Coffee (4.4/NA)1	246 – 22,110	not available	332 - 7738	not available

Sugarcane (3.0/NA)	50 – 4512	not available	68 – 1579	not available

Tobacco (3.0/NA)	20 – 1805	not available	27 – 632	not available

Ornamental (5.0/NA)	0.6 - 52	not available	0.8 – 18	not available

1 No incorporation assumed based on product label directions.

Table 2.  Ranges of acute risk quotients for small, medium, and large
birds and mammals exposed to maximum label rate and typical application
rates at 99% incorporation efficiency.  TC "Table 2.  Ranges of Acute
Avian and Mammalian Risk Quotients" \f E \l "1"

Crop

(max. rate/typical rate in lbs ai/acre)	Maximum Rate

Avian RQs	Typical Rate

Avian RQs	Maximum Rate

Mammalian RQs	Typical Rate

Mammalian RQs

Citrus (4.95/3.7)	0.6 - 52	0.4 - 39	0.8 – 17	0.6 - 13

Cotton (4.05/0.6)	5 – 428	0.7 - 63	6 - 145	0.9 - 21

Dry Beans (2.1/1.0)	2 – 175	0.9 - 84	3 - 59	1 - 28

Sorghum (1.05/0.4)	2 - 193	0.8 - 73	3 - 65	1 - 25

Peanuts (3.0/0.9)	2 - 188	0.6 - 56	2.7 - 64	0.8 - 19

Pecans (10.05/3.1)	1 – 105	0.4 - 32	2 – 35	0.5 - 11

Potatoes (3.0/2.7)	2 – 198	2 - 179	3 – 67	3 - 60

Soybeans (3.0/0.7)	2 - 157	0.4 - 37	2 - 53	0.5 - 12

Sugar beets (4.95/1.8)	2 – 190	0.7 - 65	3 - 64	0.9 - 22

Sweet potatoes (3.0/1.4)	1 – 125	0.7 - 58	2 – 42	0.8 - 20

Ornamental (5.0/NA)	0.6 - 52	not available	0.8 – 18	not available

The potential for mortality to birds has been an area of initial focus,
given aldicarb’s mode of action and very high acute toxicity.  Chronic
risk to birds has not yet been quantitatively assessed.  However, based
on inference from mammalian data, which involved comparing magnitudes of
LD50s between the mallard duck (1.0 mg/kg-bw) and rat (0.9 mg/kg-bw) and
then using this information together with the chronic information
available for the laboratory rat (reproductive NOAEL = 0.7 – 0.9
mg/kg-bw), the Agency expects that birds (as well as mammals) that
survive acute exposure to aldicarb may suffer adverse reproductive
(chronic) effects.  The Agency is requesting additional data to confirm
this hypothesis.

While there are some exceedences of acute levels of concern for aquatic
species, risk from chronic exposure to aldicarb and its degradates
appears to be more significant.  The chronic level of concern is
exceeded for several uses at maximum application rates and 99 percent
incorporation efficiency for freshwater fish and invertebrates, as well
as for estuarine/marine fish and invertebrates.  However, under typical
application rates, these risks for the most part are mitigated.  In
addition to risk based on exposure estimates from aquatic exposure
modeling, there were also exceedences of the Agency levels of concern
based on EECs derived from monitoring data.

There have been 29 incidents related to aldicarb reported in the
Environmental Incident Information System database (reported to the
Agency from 1988 to 2005).  Of these 29 incidents, 16 were from misuse,
11 were of undetermined use, and 2 were registered agricultural uses.
Approximately 17 of the 29 incidents reported included bird kills.
Fourteen bird kill incidents were from intentional misuse, and 3 were of
undetermined use.  Eight of these incidents also resulted in mammal
kills (all misuse or undetermined use).

When evaluating incident data, it is important to note that currently,
no systematic or reliable mechanism exists for the accurate monitoring
and reporting of wildlife kill incidents to the Agency.  Moreover,
before a pesticide incident can be reported or investigated, the dead
animals must first be found.  In the absence of monitoring following
pesticide applications, kills are not likely to be noticed in
agro-environments which are generally away form human activity.  It is
likely that poisoned birds may fly from the use sites, succumbing
outside of the area or scavengers may remove carcasses before they can
be observed, significantly reducing the chance  of detection.

IV. Risk Management, Reregistration, and Tolerance Reassessment
Decisions  TC "IV. Risk Management, Reregistration Decision, and
Tolerance Reassessment Decisions" \f C \l "1"

	A. Determination of Reregistration Eligibility  TC "A. Determination of
Reregistration Eligibility" \f C \l "2"

	Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether or
not products containing the active ingredient are eligible for
reregistration.  The Agency has previously identified and required the
submission of the generic (technical grade) data required to support
reregistration of products containing aldicarb as an active ingredient.
The Agency has completed its review of these generic data, and has
determined that the data are sufficient to support reregistration of all
products containing aldicarb provided the registrations are amended in a
manner consistent with this document.

	The Agency has completed its review of submitted data and its
assessment of the dietary (both food and drinking water), occupational,
and ecological risks associated with the use of pesticide products
containing the active ingredient aldicarb.  Based on these data and
public comments received on the Agency's assessments for the active
ingredient aldicarb, the Agency has sufficient information on the human
health and ecological effects of aldicarb to make a decision as part of
the tolerance reassessment process under FFDCA and reregistration
process under FIFRA, as amended by FQPA.

	Based on its evaluation of aldicarb, the Agency has determined that
products containing the active ingredient aldicarb, unless labeled and
used as specified in this document, would present risks inconsistent
with FIFRA and FFDCA.  Accordingly, should a registrant fail to
implement any of the risk mitigation measures identified in this
document, the Agency may take appropriate regulatory action to address
the risk concerns from the use of aldicarb.  If all changes outlined in
this document are incorporated into the product labels, then all current
risks for aldicarb will be adequately addressed for the purposes of this
determination under FIFRA.  Once a comprehensive endangered species
assessment is completed, further changes to these registrations may be
necessary as explained in Section IV.D.4 of this document below.

	B. Public Comments and Responses  TC "B. Public Comments and Responses"
\f C \l "2"

	Through the Agency's public participation process, EPA worked with
stakeholders and the public to reach these regulatory decisions for
aldicarb.  The Phase 3 public comment period on the risk assessments,
opened on May 17, 2006, and the Phase 5 public comment period on the
risk assessments and solicitation for additional input to use/usage
opened on November 14, 2006.  The Agency received comments from several
stakeholders (including stakeholders from public interest groups), and
the technical registrant, Bayer CropScience.  A complete listing of
these comments can be found at   HYPERLINK
"http://www.regulations.gov./"  http://www.regulations.gov./

These comments were reviewed and taken into consideration in preparing
the revised risk assessments and their supporting documents, including
this aldicarb RED.  The comments are available in their entirety in the
public docket EPA-HQ-OPP-2005-0163 located on-line at   HYPERLINK
"http://www.regulations.gov./"  http://www.regulations.gov./ .  The
Agency's responses to substantive comments are available in memoranda in
the public docket and the revised assessments available in the public
docket reflect these responses.

	C. Regulatory Position  TC "C. Regulatory Position" \f C \l "2"

		1. Food Quality Protection Act Findings  TC "1. Food Quality
Protection Act Findings" \f C \l "3"

a. “Risk Cup” Determination  TC "a. \"Risk Cup\" Determination" \f C
\l "4"

	As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with aldicarb.  The Agency has concluded that, with the
risk mitigation measures outlined in this document, the aggregate risk
from food and drinking water exposures to aldicarb is within its own
“risk cup.”  The Agency has determined that the human health risks
from these combined exposures are within acceptable levels and that,
considering every issue other than the cumulative impacts of exposure to
other n-methyl carbamate pesticides,  the established tolerances for
aldicarb, with label amendments and changes as specified in this
document, meet the safety standards under the FQPA amendments to Section
408(b)(2)(C) and 408(b)(2)(D) of the FFDCA.  In reaching these
determinations, EPA has considered the available information on the
special sensitivity of infants and children.

b. Determination of Safety to U.S. Population (Including Infants and
Children)  TC "b. Determination of Safety to U.S. Population (Including
Infants and Children)" \f C \l "4"

	The Agency has determined that there is a reasonable certainty that no
harm will result to the general U.S. population, infants, children, or
other major identifiable subgroups of consumers, from the use of
aldicarb.  The safety determination considers factors such as the
toxicity, use practices and exposure scenarios, and environmental
behavior of aldicarb.  In determining whether or not infants and
children are particularly susceptible to toxic effects from exposure to
residues of aldicarb, the Agency considered the completeness of the
hazard database for developmental and reproductive effects, the nature
of the effects observed, and other information.

The Agency determined it was necessary to retain a 2X FQPA database
uncertainty factor for aldicarb residues in the dietary human health
risk assessment because magnitude of the brain cholinesterase inhibition
was approximately 2-fold greater in the young rat compared to the adult
rat at similar acute doses.  For specific information relating to the
Agency’s decision on the FQPA factor, refer to section 3.4 in the
February 26, 2007 Human Health Revised Risk Assessment found at
HYPERLINK "http://www.regulations.gov./"  http://www.regulations.gov./

			c. Endocrine Disruptor Effects  TC "c. Endocrine Disruptor Effects"
\f C \l "4"

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 Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there were
scientific bases for including, as part of the program, 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.  When the appropriate
screening and/or testing protocols being considered under the Agency’s
Endocrine Disrupter Screening Program (EDSP) have been developed and
vetted, aldicarb may be subjected to additional screening and/or testing
to better characterize possible effects related to endocrine disruption.

			d. Cumulative Risks  TC "d. Cumulative Risks" \f C \l "4"

	FFDCA Section 408(b)(2)(D)(v) requires that the Agency consider
“available information” concerning cumulative effects of a
particular pesticides residues and “other substances that have a
common mechanism of toxicity” when considering whether to establish,
modify, or revoke a tolerance for pesticide residues in food.  EPA
considers cumulative effects from pesticides and other substances
because low-level exposures to multiple chemical substances causing a
common effect by a common mechanism could lead to the same adverse
health effect as would a higher level of exposure to each individual
substance.

Aldicarb is a member of the N-methyl carbamate class of pesticides,
which share a common mechanism of toxicity by affecting the nervous
system via cholinesterase inhibition.  A cumulative risk assessment,
which evaluates exposures based on a common mechanism of toxicity, was
conducted to evaluate risk from food, drinking water, residential use,
and other non-occupational exposures resulting from registered uses of
N-methyl carbamate pesticides, including aldicarb.  EPA has concluded
that the cumulative risks associated with the N-methyl carbamate
pesticides are below the Agency’s level of concern.  For additional
information, refer to the document, Revised N-methyl Carbamate
Cumulative Risk Assessment, which is available in the EPA docket
EPA-HQ-OPP-2007-0935 and on the website,   HYPERLINK
"http://www.epa.gov/pesticides/cumulative/"
http://www.epa.gov/pesticides/cumulative/ .

		2. Tolerance Summary  TC "2. Tolerance Summary" \f C \l "3"

	The tolerance summary and tolerance reassessment decision is presented
for aldicarb in Table 3 below.  Currently there are forty tolerances
listed in 40 CFR §180.269,  40 CFR §185.150, and 40 CFR §186.150 for
residues of aldicarb on raw and agricultural commodities and livestock
commodities.

The available aldicarb residue chemistry data are considered adequate to
reassess most tolerances.  The Agency will propose establishing a citrus
fruit crop group tolerance of 0.3 ppm.

Some commodities with established tolerances must be revised to reflect
the correct commodity definition.  Additional data are needed to
determine appropriate tolerances for residues in/on cottonseed and
cotton gin by-products.

The established tolerance for residues in peanut hulls should be revoked
since this raw agricultural commodity is no longer considered to be
significant livestock feed items (OPPTS Series 860.1000, Table 1, 8/96).
 The Agency recommends classification of residues in livestock
commodities under 40 CFR §180.6(a)(3); therefore, tolerances for
residues in livestock commodities should be revoked.

Table 3. Tolerance Reassessment Summary for Aldicarb and Aldicarb
Sulfone and Aldicarb Sulfoxide.  TC "Table 3.  Tolerance Reassessment
Summary for Aldicarb and Aldicarb Sulfone and Aldicarb Sulfoxide " \f E
\l "1"

Commodity	Current Tolerance

(ppm)	Tolerance

Reassessment (ppm)	Comment/

[Correct Commodity Definition]

Tolerances Listed Under 40 CFR 180.269:

Barley, hay	-	3.0	Rotational crop tolerances recommended by HED.

Barley, grain	-	0.02

	Barley, straw	-	0.1

	Beans (dry)	0.1	0.1	[bean, dry, seed]

Beets, sugar	0.05	0.05	[beet, sugar, roots]

Beets, sugar, tops	1	1	[beet, sugar, tops]

Cattle, fat	0.01	Revoke	There is no reasonable expectation of finite
residues.

Cattle, mbyp	0.01

Cattle, meat	0.01

Coffee beans	0.1	0.1	[coffee, green bean, import tolerance only]

Cottonseed	0.1	0.1	[cotton, undelinted seed]

Goats, fat	0.01	Revoke	There is no reasonable expectation of finite
residues.

Goats, mbyp	0.01

Goats, meat	0.01

Grapefruits	0.3	0.3	The registrant has proposed a crop group tolerance
of 0.3 ppm for fruit, citrus, group.

Lemons	0.3	0.3

	Limes	0.3	0.3

	Oranges	0.3	0.3

	Hogs, fat	0.01	Revoke	There is no reasonable expectation of finite
residues.

Hogs, mbyp	0.01

Hogs, meat	0.01

Horses, fat	0.01

Horses, mbyp	0.01

Horses, meat	0.01

Milk	0.002

Peanut	0.05	0.05

	Peanut, hulls	0.5	Revoke	Peanut hulls are not considered to be a
significant livestock feed item.

Pecan	0.5	Revoke	Revoke

Potato	1	0.2	The available data reflecting the supported use pattern
indicate the established tolerance should be reduced.

Sheep, fat	0.01	Revoke	There is no reasonable expectation of finite
residues.

Sheep, mbyp	0.01

Sheep, meat	0.01

Sorghum, stover (fodder)	0.5	Revoke

	Sorghum, grain	0.2	Revoke

	Soybean	0.02	0.02	soybean, seed

Sugarcane	0.02	Revoke	[import tolerance only]

Sugarcane, fodder	0.1	Revoke	These commodities are not considered to be
significant livestock feed items.

Sugarcane, forage	0.1	Revoke

	Sweet potatoes	0.1	0.1	sweet potato, root

Wheat, forage	-	1.0	Rotational crop tolerances recommended by HED.

Wheat, grain	-	0.02

	Wheat, straw	-	0.1

	Wheat, hay	-	3.0

	Required Tolerances to be Listed Under 40 CFR §180.269

Cotton, gin byproducts	--	TBD a

	Tolerances Listed Under 40 CFR §186.150:

Citrus pulp, dried	0.6	Revoke	Commodity covered by the raw agricultural
commodity tolerance.

Cottonseed, hulls	0.3	Revoke	Commodity covered by the raw agricultural
commodity tolerance.

a Data depicting the magnitude of aldicarb residues of concern in cotton
gin byproducts are required in accordance with Table 1 of OPPTS Series
860 Residue Chemistry Test Guidelines, 8/96.

	D. Regulatory Rationale  TC "D. Regulatory Rationale" \f C \l "2"

	The Agency has determined that products containing the active
ingredient aldicarb are eligible for reregistration provided that the
risk mitigation measures outlined in this document are adopted and label
amendments are made to reflect these measures.  The following is a
summary of the risk mitigation measures and EPA’s rationale for the
decision for managing risks associated with the use of aldicarb.  Where
labeling revisions are warranted, label changes and language are
specified in Section V.

		1. Human Health Risk Management and Mitigation  TC "1. Human Health
Risk Management and Mitigation" \f C \l "3"

			a. Dietary Risk Mitigation (Drinking Water)  TC "a. Dietary Risk
Mitigation (Food and Drinking Water)" \f C \l "4"

As discussed in Section 5.2 of the human health risk assessment (found
at   HYPERLINK "http://www.regulations.gov./"
http://www.regulations.gov./ ), there are risk estimates that exceed
EPA’s level of concern from aggregate dietary exposure to residents
living in the U.S. southeastern coastal plain who consume water from
rural ground water wells in specific vulnerable areas.

Four ground water scenarios were modeled for aldicarb.  The estimated
risks at the 99.9th percentile are below the Agency’s level of concern
for all four scenarios, and for all population subgroups except for
infants under the Georgia 300 feet peanut scenario.  For all other
scenarios, risk are not of concern to the Agency.

Therefore, in order to mitigate potential drinking water concerns in the
peanut growing regions in the states of Georgia, Alabama, South
Carolina, and Florida, an increased well set-back from 300 to 500 feet
is required for wells not encased to a depth of 100 feet in vulnerable
soils, and a shallow depth to ground water (less than 25 feet).

	The determination for this buffer was based upon both monitoring data
and modeling.  The Agency utilized the Natural Resource Conservation
Service’s (NRCS) criteria for high leaching potential soils for
Florida and encourages the technical registrant, Bayer CropScience to
use the same criteria when determining vulnerable soils for other
states.  The Agency’s review of “A Retrospective Ground Water
Monitoring Study for Aldicarb and Its Metabolites in the Southeastern
United States; Mississippi Delta; Texas; California; and Pacific
Northwest”, dated July 24, 2007, and found at   HYPERLINK
"http://www.regulations.gov./"  http://www.regulations.gov./  contains
the reference to the NRCS criteria.

b. Aggregate Risk Mitigation

  TC “b. Aggregate Risk Mitigation” \f C \l “4”

As previously discussed, food and drinking water are below the
Agency’s level of concern with the mitigation for ground water in the
Southeastern states of Alabama, Georgia, South Carolina, and Florida.
There are no residential exposures, therefore, no additional mitigation
is needed to address aggregate risk.  Label changes and language
necessary for reregistration are specified in Table 5 in Section V.

 		c. Occupational Risk Mitigation  TC “c. Occupational Risk
Mitigation” \f C \l “4”

As discussed in Section 10 of the human health risk assessment there are
no risks of concern to workers performing tasks such as mixing, loading,
and applying, based on current labeling.  Moreover, since aldicarb is
applied to soil when little foliage is present, there are no re-entry
risks, given the current Restricted-Entry Intervals (REIs).  Therefore,
no additional mitigation is necessary.

2. Ecological Risk Management and Mitigation  TC “2. Ecological Risk
Management and Mitigation” \f C \l “3”

As discussed in the environmental fate and effects risk assessment,
ecological risks (direct adverse acute effects) to non-target aquatic
and terrestrial organisms are of concern from the use of aldicarb.
Additionally, there are chronic risks to aquatic invertebrates
(freshwater and estuarine/marine) and freshwater fish.  Aldicarb is also
a potential ground water, and possibly surface water, contaminant.  The
ecological risk assessments exhibit RQ values which exceed the various
target levels of concern.  Risks are much higher, as evidenced by higher
RQ values, for terrestrial organisms, especially to birds.  In addition
to the mitigation outlined below, the Agency intends to require
additional confirmatory data which are listed in Table 4 of Section V.

Terrestrial and Aquatic Organisms  TC “a. Terrestrial and Aquatic
Organisms ” \f C \l “4”

Terrestrial

The Agency’s assessment suggests the potential for acute effects to
terrestrial organisms for all application scenarios.  Aldicarb is highly
toxic to birds, mammals, honeybees, and earthworms; however, due to
aldicarb’s granular formulation and, in most cases, immediate
incorporation into the soil, risks from exposure (undissolved granules
left on the surface) to birds and mammals are lessened.  In summary, the
Agency is concerned with all use patterns for acute effects to birds and
mammals.  As appropriate under FIFRA, the Agency has weighed the
potential risk with the expected benefits of continued use.  These
conclusions are presented below.

Aquatic

The Agency’s assessment also suggests the potential for adverse
effects to aquatic invertebrates and fish.  Adverse effects include
reduced survival and reduced reproduction when exposed to aldicarb
and/or its metabolites (aldicarb sulfoxide, aldicarb sulfone) as a
result of labeled use.  Aquatic plants are also subject to adverse
effects (reduced survival) when exposed to aldicarb and/or its
metabolites (aldicarb sulfoxide, aldicarb sulfone) as a result of
labeled use.

For potential risk to aquatic species, the chronic level of concern is
exceeded for several uses at maximum application rates and 99 percent
incorporation efficiency for freshwater fish and invertebrates, as well
as for estuarine/marine fish and invertebrates.  However, under typical
application rates, these risks for the most part are mitigated.  Direct
application of aldicarb to streams, lakes, and ponds is forbidden by
product labels; however, following a rain event, aldicarb may reach
aquatic environments from areas of application in sheet and channel-flow
runoff, because aldicarb is moderately persistent in terrestrial
environments and soluble in water.  It is unlikely that aquatic
organisms will be directly exposed to granules, both because of the
highly soluble nature of the compound (whole granules will dissolve
rather than be transported intact) and because of the application
methods (directly onto field).  Aquatic organisms could also be exposed
to aldicarb residues and degradates from ground water that is
subsequently discharged into a surface water body.

	3.  Mitigation Summary and Crop-Specific Analyses  TC “3. Mitigation
Summary and Crop-Specific Analyses ” \f C \l “3”

The Agency has worked with the technical registrant, Bayer CropScience,
to reduce potential exposure of aldicarb to wildlife and aquatic life.
Subsequently, Bayer has agreed to voluntarily cancel all current
registrations on the following crops:

Coffee

Ornamentals

Pecans

Sugarcane

Sorghum

Tobacco

Alfalfa grown for seed

These proposals for cancellation will be announced in the Federal
Register (FR).  A subsequent FR Notice will finalize the cancellation
absent significant comment to change the Agency’s position.  As part
of the Agency’s mitigation plan, labels will be amended shortly to
remove these uses.

To further reduce ecological concerns, the Agency has determined that
the label changes (as specified in Table 5 in Section V), as agreed upon
by the technical registrant Bayer CropScience, and discussed with
stakeholders for specific scenarios and crops, are appropriate and
required for reregistration eligibility.  Listed below are the specific
crop use sites/patterns for aldicarb along with corresponding RQs of
concern for birds and mammals, stakeholder input on use,
alternatives/benefits, mitigation, and EPA’s decision regarding
reregistration eligibility.  As a general matter, the Agency has
determined that although there is potential for harm to wildlife because
of use of aldicarb, that harm will generally be limited in time and
space.  The Agency also determined that these risks are often outweighed
by the benefits expected from use of aldicarb instead of existing
alternatives.  The Agency was also mindful in this analysis that
aldicarb does not pose risks of concerns to pesticide applicators or to
farm workers generally.

Citrus  TC “Citrus ” \f C \l “4”

Current Use Pattern

	Aldicarb is used on citrus in Florida and Texas only.  Application
currently consists of a side-dress application and is usually applied
along the side of the tree row in furrow and immediately covered with
soil.  The maximum application rate for use on citrus is currently 4.95
lbs ai/A.  Due to the nature of how aldicarb is applied to citrus (2
inches in depth), the Agency has assumed that 85% of the aldicarb
applied is covered with soil, and that 15% may remain on the surface for
potential terrestrial organism exposure.

	Because of acute toxicity and ground water contamination concerns,
anyone who applies aldicarb in Florida is required to obtain a permit
from the Florida Department of Agriculture and Consumer Services for
each application to be made.  This permitting process involves the
collaborative efforts of the registrant, state officials and growers to
ensure that every application of aldicarb is permitted and recorded.
For additional information on the aldicarb permitting system in
Florida’s State Division of Agricultural Environmental Services,
please see   HYPERLINK "http://www.flaes.org/temik/"
http://www.flaes.org/temik/ .

Risks of Concern Assuming 85% Soil Incorporation

RQs modeled for birds using maximum rates range from 9 to 771.  RQs
modeled for birds calculated using typical rates range from 6 to 577.
RQs modeled for mammals using maximum rates range from 11 to 261.  RQs
modeled for mammals using typical rates range from 8 to 195.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

	Stakeholder Involvement/Input on Citrus

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments received from respondents as listed in section
IV. B. above, the Agency met with and received comments from Bayer
CropScience, the Florida Department of Agriculture and Consumer Services
(FDACS), Florida Fruit and Vegetable Association (FFVA), USDA, and many
other interested stakeholders with specific knowledge relating to
aldicarb use on citrus.  These stakeholders have provided additional
information regarding aldicarb usage (application methods and rates) and
the use of aldicarb in citrus production.  In particular, these
stakeholders noted that aldicarb appears to effect plant growth,
resulting in increased yields when used on citrus. Subsequent meetings,
site visits and teleconference calls with Bayer, FDACS, and FFVA have
led to the Agency’s understanding of the aldicarb permitting process
in Florida.

Alternatives and Benefits

	  Aldicarb is a recommended insecticide for mites, the Asian Citrus
Psyllid (AsCP), and nematode control.  Citrus greening is a severe
vascular disease transmitted by the Asian citrus psyllid.  The psyllid
is a relatively new pest that now ranges throughout all the citrus
producing areas in Florida and Texas.  Greening is a disease that slowly
weakens and kills all types of citrus trees, and causes fruit to become
lopsided and taste bitter.  No cure exists for a tree that contracts the
disease.  As of 2006, greening had been found in more than 440 different
locations in at least 11 Florida counties.  Although the AsCP has been
found in the Rio Grande Valley of Texas, citrus greening has not been
found there at this time.

	There are several alternatives to aldicarb for control of mites, but
there appears to be no feasible alternative to aldicarb for nematode
control.  Estimated yield losses in Florida without aldicarb are 5 to 10
percent, which corresponds to an annual loss of about $4.6 to $9.3
million for oranges and grapefruit combined.  There are no alternatives
for control of AsCP, the vector for citrus greening.

	For nematode control specifically, aldicarb is used to control the
citrus and burrowing nematodes although it does not effectively control
the burrowing nematode as aldicarb only remains in the shallow part of
the root zone.  Other nematodes with limited economic importance in
Florida are the sting nematode and lesion nematode.

	EPA’s analysis concludes that the absence of aldicarb for use on
citrus acreage for controlling both nematodes and other insects can
result in yield losses of 5 to 10 percent.  Therefore, the cost to
growers will be quite high.  A 5 to 10 percent yield loss to the
“average” grower in Florida corresponds to a $97 to $193 in lost
revenue per acre.  For the grapefruit grower, a 5 to 10 percent yield
loss corresponds to a loss in revenue of $109 to $218 per acre.  If the
loss to nematodes increased over time, as nematode populations increase,
these losses may get worse.  The 2000/2001 – 2004/2005 value of orange
production in Florida was about $1.1 billion and the value of grapefruit
production was approximately $209 million.  A 10 percent reduction on
the 7 percent of acreage treated with aldicarb would result in a loss of
approximately $3.9 to $7.8 million annually to Florida orange growers,
and $0.7 to $1.5 million to Florida grapefruit growers.

For additional information, refer to the Agency’s complete
alternative/quantitative impact memo for citrus and the BEAD response to
Phase 3 comments for citrus, cotton and pecans which are available in
the public docket EPA-HQ-OPP-2005-0163  and located on-line at
HYPERLINK "http://www.regulations.gov/"  http://www.regulations.gov/ .

	Mitigation

	To reduce potential ecological risks, the Agency, in agreement with the
technical registrant of aldicarb, has developed several mitigation
measures to help address the above mentioned concerns. They include:

Label clarifications to specify application of granules in 3 to 6
furrows beside individual trees, that are 2 inches deep and spaced on
approximately 12 inch centers, immediately covering with soil.

Label modifications to help reduce the amount of aldicarb left on the
surface of the soil making it less available for the wildlife
potentially at risk.  For specific label language, please refer to Table
5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

Additionally, the Agency also acknowledges that, although risks were
calculated assuming 85% soil incorporation, actual aldicarb granules
available on or just under the soil’s surface for potential
consumption by birds or mammals is unlikely, given the methods of
application including positive displacement (mechanized placement of
granules beneath the soil) and lock-and-load containers which minimize
potential spillage of product.

The Agency has determined that there are benefits of aldicarb use on
citrus and, as quantified above, losing its use would involve additional
costs to growers.  Aldicarb has advantages to citrus growers for which
EPA cannot estimate dollar values, such as simplicity of management,
confidence in the level of control in the face of unexpected
infestation, and cost effectiveness when considering the full range of
pests and duration of control.

	Aldicarb provides control against insects, including nematodes, in
portions of citrus production areas.  Because of its long residual
activity, in many cases growers can apply one treatment of aldicarb,
rather than multiple treatments of other chemicals for equivalent insect
control.  Also, potential worker risks from multiple foliar applications
of these alternative products are not insignificant.  Therefore, the use
on citrus is eligible for reregistration.

Cotton  TC “Cotton ” \f C \l “4”

	Current Use Pattern

Aldicarb is used on cotton primarily for control of thrips, although it
controls other insect pests.  In addition, there is also evidence of
aldicarb use to control nematodes on cotton.  Aldicarb is applied
at-plant or as a side-dress application.  The at planting application is
administered in the furrow with the cotton seed and immediately covered
with soil.  Greater than 97% of the use on cotton is this at-plant
application.  The side-dress application is usually administered after
the cotton has emerged from the soil and is applied along the side of
the plant row (8 inches from the plants, two or three inches deep) in
furrow and immediately covered with soil.  The maximum application rate
for use on cotton is currently 4.05 lbs ai/A.  Due to the nature of how
aldicarb is applied to cotton (at a depth greater than 2 inches), the
Agency has estimated that 99% of the aldicarb applied is covered with
soil, and that only 1% remains on the surface for potential terrestrial
organism exposure.

Risks of Concern Assuming 99% Soil Incorporation

RQs modeled for birds using maximum rates range from 5 to 428.  RQs
modeled for birds calculated using typical rates range from 0.7 to 63.
RQs modeled for mammals using maximum rates range from 6 to 145.  RQs
modeled for mammals using typical rates range from 0.9 to 21.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

Stakeholder Involvement /Input on Cotton

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments received from respondents as listed in section
IV. B. above, the Agency met with and received comments from Bayer, the
National Cotton Council of America, Cotton Growers Association, Georgia
Cotton Commission, USDA, as well as many other interested stakeholders
with specific knowledge relating to aldicarb use on cotton.  In
particular, these stakeholders noted that aldicarb appears to effect
plant growth, resulting in increased yields when used on cotton.

	Alternatives and Benefits

The Agency acknowledges that the use of aldicarb has benefits to cotton
growers. Although thrips and other insects are targeted, aldicarb is
applied to cotton in Texas and the Southeast to control nematodes as
well.  Based on EPA proprietary data, an annual average of about 1.4
million acre treatments (about 38% of total applications) of aldicarb
have targeted nematodes between 2002 and 2006. The state with the most
acre treatments against nematodes is Georgia, with an annual average of
about 360,000 acres, followed by Texas (about 270,000 acres annually)
and North Carolina (about 200,000 acres annually).

For thrip control, no one chemical could replace aldicarb, but a
combination of chemicals could be used effectively.  This combination
for insect control was more expensive than aldicarb: the Agency
estimates that chemical costs alone would be about $2 per acre higher in
Mississippi and $22 per acre higher in California.  These chemicals also
do not share the advantages of aldicarb which are a longer period of
effectiveness and control over multiple pests, including nematodes.  If
nematodes are considered a target pest, as they are in Texas and the
Southeast, growers have fewer alternatives to aldicarb.  The best
control for nematodes would be 1,3-dichloropropene (1,3-D).  The
additional cost for replacing aldicarb with 1,3-D, along with the
combination of chemicals to provide control of thrips is about $38 per
acre.  Of that figure, $36 per acre is based on the chemical cost of
1,3-D.  If it were assumed that these acres were treated with 1,3-D
instead, the additional costs are over $50 million annually.

For additional information, refer to the Agency’s complete
alternative/quantitative impact memo for cotton which is available in
the public docket EPA-HQ-OPP-2005-0163  and located on-line at
HYPERLINK "http://www.regulations.gov/_"  http://www.regulations.gov/ .

Mitigation

To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop several mitigation measures to help
address the above mentioned concerns. They include:

At-plant application rate will be reduced to a maximum of 1.5 lbs ai/A.
This equates to a 63% reduction in rate as compared to the current
label.

Side-dress application rate will be reduced to 2.1 lbs ai/A.  This
equates to a 30% reduction as compared to the current label.

Per-season application rate is limited to 3.6 lbs ai/A.  This equates to
a 63% reduction as compared to the current label.

Label specifications to clarify the depth at which aldicarb is applied.
Additionally, modifications in label language to help reduce the amount
of aldicarb left on the surface of the soil, making it less available
for wildlife potentially at risk.  For specific label language, please
refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

The Agency has determined that there are benefits of aldicarb use on
cotton and, as specified above, losing its use would involve additional
costs to growers, some of which can be quantified directly.  Aldicarb
has advantages to cotton growers for which EPA cannot estimate dollar
values, such as simplicity of management, confidence in the level of
control in the face of unexpected infestation, and cost effectiveness
when considering the full range of pests and duration of control.

Aldicarb provides control of insects, including nematodes, in portions
of cotton production areas.  Alternative pesticides, which can be used
to control insect pests (e.g., thrips), are not effective in controlling
multiple pests.  Aldicarb also provides protection for a longer period
of time than any of the alternatives.  As stated above, because of its
long residual activity, in many cases growers can apply one treatment of
aldicarb, rather than multiple treatments of other chemicals for
equivalent insect control.  Also, potential worker risks from multiple
foliar applications of these alternative products are not insignificant.
 Therefore, the use on cotton is eligible for reregistration.

Dry Bean  TC “Dry Bean ” \f C \l “4”

	Current Use Pattern

Aldicarb application to dry beans currently consist of an at-plant
application.  The at- planting application is administered in the furrow
with the dry bean seed and immediately covered with soil at a depth
greater than 2 inches.  The maximum application rate for use on dry bean
is currently 2.1 lbs ai/A.  Due to the nature of how aldicarb is applied
to dry bean, the Agency has estimated that 99% of the aldicarb applied
is covered with soil and that only 1% remains on the surface for
potential terrestrial organism exposure.

Risks of Concern Assuming 99% Soil Incorporation

RQs modeled for birds using maximum rates range from 2 to 175.  RQs
modeled for birds calculated using typical rates range from 0.9 to 84.
RQs modeled for mammals using maximum rates range from 3 to 59.  RQs
modeled for mammals using typical rates range from 1 to 28.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

Stakeholder Involvement/Input for Dry Bean

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments from respondents as listed in section IV. B.
above, the Agency has met with and received comments from Bayer
CropScience, USDA, as well as many other interested stakeholders with
specific knowledge relating to aldicarb use on dry bean.

	Alternatives and Benefits

The Agency understands that aldicarb use on dry bean is of benefit to
dry bean growers in the states of Idaho, Michigan, Oregon and
Washington.  Aldicarb use in dry bean production is a valuable tool for
controlling aphids, leafhoppers, the Mexican bean beetle, and several
species of nematodes.  There are both foliar and seed treatment
alternatives, such as thiamethoxam, but only aldicarb provides season
long control at planting, and growers do not have to spray multiple
times.  In Michigan, aldicarb is also used to control the root-lesion
nematode, which can cause 10% yield reduction and is present in 50% of
the dry bean acreage if left uncontrolled.  On the acreage with
nematodes that is not treated, growers expect lower yields.

As with other crops, the main value of aldicarb as an insecticide is
that a single at-plant treatment will protect the seedling and young
plant for several weeks from attack by nematodes and several insect
pests, some of which are vectors of plant viruses.  Although
alternatives (such as esfenvalerate, dimethoate, propargite, and others)
exist for use against all insect pests controlled by aldicarb, it would
likely take at least two applications of foliar insecticides to provide
the same level of protection afforded by an at-plant aldicarb treatment.
 Where nematodes are also a problem, it would also take a pre-plant
application with a soil fumigant, such as 1,3-D.  While aldicarb
alternatives exist, the Agency believes that the economic impact on dry
bean growers of shifting to such alternatives for nematode control are
likely to be cost prohibitive, in which case the likely result of loss
of aldicarb would be that growers would face a financial penalty from
reduced yield because of nematodes.

	Mitigation

To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop several mitigation measures to help
address the above mentioned concerns. They include:

Geographically restricting the use to Idaho, Michigan, Oregon, and
Washington.

Modifications in label language to help reduce the amount of aldicarb
left on the surface of the soil, thereby making it less available for
wildlife potentially at risk.  For the label language modifications,
please refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

The Agency has determined that there are benefits of aldicarb use on dry
bean and that losing its use would involve additional costs to growers.
Aldicarb has advantages to dry bean growers for which EPA cannot
estimate dollar values, such as simplicity of management, confidence in
the level of control in the face of unexpected infestation, and cost
effectiveness when considering the full range of pests and duration of
control.  Therefore, the use on dry bean is eligible for reregistration.

Peanut  TC “Peanut ” \f C \l “4”

	Current Use Pattern

	Aldicarb is applied when peanuts are planted, or can be used as a split
treatment, where aldicarb is applied at-plant and also applied later in
the season when the plants are forming pegs, which develop into peanuts.
 This application is referred to as “at-pegging”.  Aldicarb is
generally used to control nematodes and thrips on peanuts, primarily in
the southern States, as well for the suppression of leafhoppers and
spider mites.  To better understand the potential risk and resulting
mitigation, these two use patterns are discussed in more detail below.

At Planting

Aldicarb is applied to peanuts at planting for protection against thrips
and several species of nematodes (e.g. root-knot, lesion, stubby root,
sting).  For thrips control the granules are applied in the seed furrow
and then covered with soil.  The peanut seed is then planted into the
treated zone.  When used for nematode control, aldicarb granules are
applied in a 6 to 12 inch band over an open furrow and covered with soil
to a depth of 2 to 4 inches.  Due to the nature of how aldicarb is
applied to peanuts at planting (at a depth greater than 2 inches), the
Agency has estimated that 99% of the aldicarb applied is covered with
soil and that only 1% remains on the surface for potential terrestrial
organism exposure.

	Risks of Concern for the At-Plant Application Method Assuming 99% Soil
Incorporation

RQs modeled for birds using maximum rates range from 2 to 188.  RQs
modeled for birds calculated using typical rates range from 0.6 to 56.
RQs modeled for mammals using maximum rates range from 2.7 to 64.  RQs
modeled for mammals using typical rates range from 0.8 to 19.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

At Pegging

	Aldicarb can also be applied later in the season when the plants are
forming pegs (at-pegging), which develop into peanuts.  In this case,
aldicarb is typically applied at the initiation of pegging, in a 12 to
18 inch band over the peanut row.  Unlike other aldicarb application
practices, soil incorporation does not occur because the plant has
already formed pegs (which develop into peanuts) just under the surface
of the soil.  Attempts to incorporate the granules would damage the
roots of the plants and any pegs that have formed.  Due to the nature of
how aldicarb is applied to peanuts at pegging (without any mechanical
means of soil incorporation), the Agency has assumed that 100% of the
aldicarb applied remains on the surface for potential terrestrial
organism exposure.

	Risks of Concern for the At-Pegging Application Method

RQs modeled for birds using maximum rates range from 31 to 2,807.  RQs
modeled for birds calculated using typical rates range from 9 to 842.
RQs modeled for mammals using maximum rates range from 41 to 948.  RQs
modeled for mammals using typical rates range from 12 to 285.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

Stakeholder Involvement/Input for Peanuts

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments from respondents listed in section IV. B. above,
the Agency has met with and received comments from Bayer, the National
Peanut Board, Florida Fruit and Vegetable Association, Florida
Department of Agriculture and Consumer Services, USDA, and other
interested stakeholders with specific knowledge relating to aldicarb use
on peanuts.

Alternatives and Benefits

	For the at-plant use of aldicarb, early season control of nematodes may
be achieved with a pre-plant soil fumigation with 1,3-D; however, it
would require one or more other insecticides (primarily ethoprop) to
address other pests.  Therefore, for the at-plant use of aldicarb, there
are no chemical or non-chemical alternatives that can provide both
insect and nematode control on peanuts during the first month after
plant emergence.

	For the at-pegging use of aldicarb, multiple treatments of the
alternatives may be required, and none of those alternatives also
control nematodes.  Because of aldicarb’s ability to control both
nematodes and insect pests, alternatives to aldicarb will consist of at
least one insecticide application for thrips control and one nematicide
application in areas where both pests exist.

	Based upon data reviewed by the Agency, withholding the at-pegging
aldicarb treatment caused a yield decrease of 56%.  Applying this loss
to dollars per acre, it is estimated that without the aldicarb
at-pegging use, revenues would fall from $290 to $227 per acre.

	Another important factor considered by the Agency was that nematode
damage to peanut plants does not stop with yield damage, but also causes
damage to the peanuts that are harvested.  The Agency is aware that,
potentially, this damage could correspond to a discount of about 10
cents per pound.  Therefore, revenue loss from reduced quality could be
as high as losses from reduced yields.

	In conclusion, without aldicarb, costs to growers from the yield losses
due to nematode damage alone are estimated to exceed $15 million a year
in Georgia, and up to $22 million a year nationwide.  It is clear to the
Agency that without the use of aldicarb there would be substantial costs
to growers who are currently using aldicarb approximately 30-45 days
after plant (at-pegging); up to $300 per acre based upon data from field
trials performed in Georgia.

For additional information, refer to the Agency’s complete
alternative/quantitative impact memo for peanuts which is available in
the public docket EPA-HQ-OPP-2005-0163  and located on-line at
HYPERLINK "http://www.regulations.gov/"  http://www.regulations.gov/ .

Mitigation

	To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop several mitigation measures to help
address the above mentioned concerns. They include:

For the split-season, at-pegging use of aldicarb, application must be
made late in the afternoon or early evening and immediately followed by
irrigation, and completed within 24 hours which will help dissolve
granules thereby making them unavailable for wildlife.

Label clarifications for post-emergent use:  apply granules in a band 12
to 18 inches wide on the row and into the plant canopy.  Ensure that
plant foliage is dry prior to application.  Dislodge granules from
foliage by suitable means that will not damage the plant.

Label clarifications to ensure that at-planting applications are done
over an open furrow which is 4 to 6 inches in width, known as
“T-band” applications.

For the specific label language for the application modifications,
please refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

The Agency has determined that there are benefits of aldicarb use on
peanut (both the at-planting and at-pegging use) and that losing its use
would involve additional costs to growers, as quantified above.
Aldicarb also has advantages to peanut growers for which EPA cannot
estimate dollar values, such as simplicity of management, confidence in
the level of control in the face of unexpected infestation, and cost
effectiveness when considering the full range of pests and duration of
control.  Therefore, the use on peanut is eligible for reregistration.

Potato  TC “Potato ” \f C \l “4”

Current Use Pattern

Aldicarb is currently registered for use on potatoes only in Oregon,
Idaho, Washington, Montana, northern Florida, and parts of Utah and
Nevada.  Aldicarb is used primarily to control green peach aphid,
Colorado potato beetle, and also provides some protection against
several species of nematodes.  Other pests controlled include
leafhoppers and flea beetles.

Aldicarb application to potatoes typically consists of an at-plant or
pre-plant application using positive displacement equipment.  Aldicarb
granules are applied within the row furrow and buried along with the
seed potato at planting to a depth of four to eight inches.  The potato
plant absorbs aldicarb through its roots, and once in the plant, the
residual activity of aldicarb protects the treated plant against pest
nematodes and insects for six to eight weeks.  The maximum application
rate for use on potato is currently 3.0 lbs ai/A.   Due to the nature of
how aldicarb is applied to potatoes (at a depth of 4 to 8 inches), the
Agency has estimated that 99% of the aldicarb applied is covered with
soil, and that only 1% remains on the surface for potential terrestrial
organism exposure.

Risks of Concern Assuming 99% Soil Incorporation

RQs modeled for birds using maximum rates range from 2 to 198.  RQs
modeled for birds calculated using typical rates range from 2 to 179.
RQs modeled for mammals using maximum rates range from 3 to 67.  RQs
modeled for mammals using typical rates range from 3 to 60.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

Stakeholder Involvement and Input for Potatoes

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments received from respondents listed in section IV.
B. above, the Agency has met with and received comments from Bayer, the
National Potato Council, USDA and other interested stakeholders with
specific knowledge relating to aldicarb use on potatoes.  These
stakeholders have provided additional information regarding aldicarb
usage (application methods and rates) and the need for aldicarb use to
remain in potato production.  In particular, these stakeholders noted
that aldicarb appears to effect plant growth, resulting in increased
yields when used on potatoes.

	Alternatives and Benefits

The Agency has determined that the benefits to growers of aldicarb use
on potatoes are very high in certain states (Washington, Oregon, Idaho
and Florida) and that losing its use would involve substantial costs to
growers.  There are also concerns with the potential for resistance if
aldicarb were not available.  Several nematodes, including the root-knot
nematode, the root lesion nematode, and the stubby root nematode are
major pests of potatoes and have wide host ranges, making management
with crop rotation difficult and relatively ineffective, although they
can be controlled by fumigants.  Aldicarb may also be used to reduce
root-knot nematode populations that remain high after soil fumigation.

	There are several alternatives for the use of aldicarb on potatoes, but
none of these will be an adequate substitute.  Even if aldicarb is
applied specifically to target nematodes, it is inappropriate to ignore
the beneficial effect of controlling insect pests, as well.  For this
reason, an analysis of alternatives to aldicarb considered multiple
chemicals so that both nematodes and insects can be targeted.

	Because of aldicarb’s ability to control both nematodes and insect
pests, alternatives to aldicarb will consist of multiple chemicals used
to target multiple pests.  The estimates of additional costs for using
alternatives to aldicarb range from $77 – 257 per acre in the Pacific
Northwest, and $77 – 218 in Florida.  It is clear that alternatives
will involve significant costs to growers who are currently using
aldicarb.

	For nematode control, the Agency believes that the most likely
alternative to aldicarb is the use of a fumigant, such as 1,3-D,
although additional chemicals would be required to control insect pests.
 While synthetic insecticides remain the most effective means for its
control, resistance by the Colorado potato beetle to all classes of
insecticides has been documented in many U.S. potato-producing regions.
 Widespread and locally diverse esfenvalerate and phosmet resistance was
 detected in all counties in southern and eastern Idaho.

For additional information, refer to the Agency’s complete
alternative/quantitative impact memo for potatoes which is available in
the public docket EPA-HQ-OPP-2005-0163  and located on-line at
HYPERLINK "http://www.regulations.gov/"  http://www.regulations.gov/ .

	Mitigation

To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop the mitigation below to help address
the above mentioned concerns:

Modifications in label language to clarify the manner in which aldicarb
is applied to potatoes, and immediately covering with soil.  For the
label language modifications, please refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

As discussed above, the Agency has determined that there are benefits of
aldicarb use on potatoes and that losing its use would involve
substantial costs to growers.  Aldicarb also has advantages to potato
growers for which EPA cannot estimate dollar values, such as simplicity
of management, confidence in the level of control in the face of
unexpected infestation, and  cost effectiveness when considering the
full range of pests and duration of control.  Therefore, the Agency
finds the use on potatoes eligible for reregistration.

Soybean  TC “Soybean ” \f C \l “4”

	Current Use Pattern

Aldicarb is applied to soybean at planting.  Aldicarb granules are
applied within the row furrow and buried along with the soybean seed at
planting.  The maximum application rate for use on soybean is currently
3.0 lbs ai/A.  Due to the nature of how aldicarb is applied to soybean
(at a depth greater than 2 inches), the Agency has estimated that 99% of
the aldicarb applied is covered with soil, and that only 1% remains on
the surface for potential terrestrial organism exposure.

Risks of Concern Assuming 99% Soil Incorporation

RQs modeled for birds using maximum rates range from 2 to 157.  RQs
modeled for birds calculated using typical rates range from 0.4 to 37.
RQs modeled for mammals using maximum rates range from 2 to 53.  RQs
modeled for mammals using typical rates range from 0.5 to 12.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

Stakeholder Involvement/Input for Soybean

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments from respondents listed in section IV. B. above,
the Agency has met with and received comments from Bayer, USDA and
soybean growers in Georgia, Minnesota and South Carolina with specific
knowledge relating to aldicarb use on soybeans.

Alternatives and Benefits

Aldicarb is used as a nematicide in late maturity soybean varieties
grown in Georgia, North Carolina, and South Carolina.  Because there are
few late maturity soybean varieties that are resistant to nematodes
(root-knot, reniform, and Columbian lance), growers of such varieties
depend more on aldicarb than growers of early maturity soybean
varieties, for which nematode resistant varieties exist.  In South
Carolina, approximately 60% of the soybean acreage has nematode
problems.  The only available aldicarb alternative for nematode control,
1,3-D, is too expensive for soybean production.  Without aldicarb,
soybean growers in the affected states would stop growing soybeans or
shift to very long rotations with other crops.  Aldicarb, therefore, is
a critical tool for soybean growers.

Mitigation

To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop several mitigation measures to help
address the above mentioned concerns. They include:

Limiting the use to the following states:  Georgia, North Carolina, and
South Carolina.

Reducing the application rate from 3.0 lbs ai/A to 1.5 lbs ai/A.  This
equates to a 50% reduction when compared to the current label.

Modifications in label language to help reduce the amount of aldicarb in
use and left on the surface of the soil (i.e., clarifications in the use
of positive displacement technology), making it less available for the
wildlife potentially at risk.  For the label language modifications,
please refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

The Agency has determined that there are benefits of aldicarb use on
soybeans in Georgia, North Carolina and South Carolina, and that losing
its use would involve additional costs to growers.  Aldicarb also has
advantages to soybean growers for which EPA cannot estimate dollar
values, such as simplicity of management, confidence in the level of
control in the face of unexpected infestation, and  cost effectiveness
when considering the full range of pests and duration of control.
Therefore, the  Agency finds the use on soybeans eligible for
reregistration.

Sugar Beet  TC “Sugar Beet ” \f C \l “4”

	Current Use Pattern

Aldicarb application to sugar beets currently consists of an at-plant
and a side-dress application.  The at planting application is
administered with the sugar beet seed and immediately covered with soil.
 The side-dress application is usually administered after the sugar beet
has emerged from the soil and is applied along the side of the plant row
in furrow and immediately covered with soil.

Aldicarb is used to manage sugar beet root maggot, nematode,
particularly sugar beet cyst nematode, beet leafminer, beet leafhopper,
aphids, flea beetles, wireworms, and cutworms, primarily in Idaho.

The maximum application rate for use on sugar beet is currently 4.95 lbs
ai/A.  Due to the nature of how aldicarb is applied to sugar beet (at a
depth greater than 2 inches), the Agency has estimated that 99% of the
aldicarb applied is covered with soil, and that only 1% remains on the
surface for potential terrestrial organism exposure.

Risks of Concern Assuming 99% Soil Incorporation

RQs modeled for birds using maximum rates range from 2 to 190.  RQs
modeled for birds calculated using typical rates range from 0.7 to 65.
RQs modeled for mammals using maximum rates range from 3 to 64.  RQs
modeled for mammals using typical rates range from 0.9 to 22.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

Stakeholder Involvement and Input for Sugar Beet

During Phases 5 and 6 of the Public Participation Process, in addition
to the written comments from respondents listed in section IV. B. above,
 the Agency has met with and received comments from Bayer, American
Sugarbeet Growers Association, Western Sugar Cooperative, NYSSA-NAMPA
Beet Growers Association, USDA, and other interested stakeholders with
specific knowledge relating to sugar beet production.  These
stakeholders have provided additional information regarding aldicarb
usage (application techniques and application rates) and the need for
aldicarb use to remain in sugar beet production.  In particular, these
stakeholders also noted that aldicarb appears to effect plant growth,
resulting in increased yields when used on sugar beet.

	Alternatives and Benefits

The Agency understands that aldicarb use on sugar beet is of great
benefit to the sugar beet industry, particularly in Western states, and
that losing its use would involve substantial costs to growers in those
states.  The available usage data indicate 75 percent of the sugar beet
acreage in Idaho, Montana, Oregon and Washington was treated with
aldicarb in 2005.  Aldicarb is used primarily to manage sugar beet root
maggot and nematodes on sugar beets, which are major pests of sugar
beets.  If left uncontrolled, yield losses from sugar beet root maggot
can be as much as 80%.  Yield losses from nematodes can be equally as
devastating to a sugar beet crop.

For insect control, sugar beet root maggot is a major pest of sugar
beets and aldicarb effectively controls both adults and larvae.   If
aldicarb were not available for the control of sugar beet maggot,
growers would likely use terbufos which is not as effective on both the
adult fly and larvae.  Additionally, EPA has required, and the terbufos
registrant has agreed, to a phased approach that will ultimately reduce
sales of terbufos by 55% by 2008.  Other pesticides available and used
to a lesser extent than aldicarb and terbufos include phorate,
chlorpyrifos, and carbofuran.  Phorate controls larvae but is mostly
used in areas with low pest pressure.  Carbofuran was available in Idaho
and Oregon under 24c labels to control larvae but does not have a long
residual value.  Further, the Agency expects to initiate action in the
near future to cancel all uses of carbofuran.  Esfenavalerate and
zeta-cypermethrin control adult flies but another insecticide would need
to be used to control larvae.  For nematodes, only fumigants are
available for control besides aldicarb but are significantly more
expensive than aldicarb.

For nematode control specifically, only fumigants are available as
alternatives, such as 1,3-D.  A major disadvantage to using 1,3-D is the
chemical cost relative to aldicarb (see below).  Another disadvantage of
using 1,3-D is that growers must wait for the soil to warm before
fumigating, and then wait for the gas to dissipate before planting,
shortening the growing season.  Growers would also need to consider the
added costs due to different application equipment using 1,3-D.

The estimates of costs for using aldicarb alternatives are more than $20
per treatment per acre to control the sugar beet root maggot and
approximately $88 to control nematodes. For comparison, the cost of
aldicarb is about $40 per acre. This assumes that the alternatives are
equally efficacious.  Although the alternatives for control of the sugar
beet root maggot appear to be less expensive, other considerations may
preclude their use. If the alternatives are less effective than
aldicarb, yield or quality impacts could also occur. In addition, if
multiple pests targeted by aldicarb are present, multiple
chemicals/applications may be needed to achieve a similar level of
control.

	For additional information, refer to the Agency’s response to Phase 5
comments found EPA-HQ-OPP-2005-0163  and located on-line at   HYPERLINK
"http://www.regulations.gov/"  http://www.regulations.gov/ .

Mitigation

To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop several mitigation measures to help
address the above mentioned concerns. They include:

Limit use to the following states:  California, Colorado, Idaho,
Montana, Nebraska, Oregon, Washington and Wyoming.

Modifications in label language to help reduce the amount of aldicarb
left on the surface of the soil (i.e., clarifications in the use of
positive displacement technology) and making it less available for the
wildlife potentially at risk.  For the label language modifications,
please refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

As discussed above, the Agency has determined that there are benefits of
aldicarb use on sugar beets in certain states (California, Colorado,
Idaho, Montana, Nebraska, Oregon, Washington and Wyoming) and that
losing its use would involve substantial costs to growers.  Aldicarb
also has advantages to sugar beet growers for which EPA cannot estimate
dollar values, such as simplicity of management, confidence in the level
of control in the face of unexpected infestation, and  cost
effectiveness when considering the full range of pests and duration of
control.  Therefore, the Agency finds the use on sugar beet eligible for
reregistration.

Sweet Potato  TC “Sweet Potato” \f C \l “4”

	Current Use Pattern

Aldicarb application to sweet potato typically consists of an at-plant
application using positive displacement equipment.  Aldicarb granules
are applied within the row furrow and buried along with the seed piece
at planting to a depth of four to eight inches.  The sweet potato plant
absorbs aldicarb through its roots and once in the plant, the residual
activity of aldicarb protects the treated plant against pest nematodes
and insects for six to eight weeks.  The maximum application rate for
use on sweet potato is currently 3.0 lbs ai/A.   Due to the nature of
how aldicarb is applied to sweet potatoes (at a depth of 4 to 8 inches),
the Agency has estimated that 99% of the aldicarb applied is covered
with soil, and that only 1% remains on the surface for potential
terrestrial organism exposure.

	Risks of Concern Assuming 99% Soil Incorporation

RQs modeled for birds using maximum rates range from 1 to 125.  RQs
modeled for birds calculated using typical rates range from 0.7 to 58.
RQs modeled for mammals using maximum rates range from 2 to 42.  RQs
modeled for mammals using typical rates range from  0.8 to 20.
Additionally, although RQs are low, the Agency’s assessment also
suggests the potential for adverse effects to aquatic invertebrates and
fish.

	Stakeholder Involvement and Input for Sweet Potato

During Phases 5 and 6 of the Public Participation Process, in addition
to receiving written comments from respondents listed in section IV. B.
above, the Agency has met with and received comments from Bayer, USDA,
and other interested stakeholders relating to aldicarb use on sweet
potato.  These stakeholders have provided additional information
regarding aldicarb usage (application and application rates) and the
need for aldicarb use to remain in sweet potato production.

Alternatives and Benefits

	The Agency understands that aldicarb use on sweet potatoes is of
benefit in the states of Louisiana and Mississippi and that losing
aldicarb’s use would involve substantial cost to growers.  It is a
very important tool for sweet potato growers where nematode pressure is
present.  Alternatives include 1,3-D, oxamyl and ethoprop, but they do
not, however, control a particular pest, the reniform nematode, as well
as aldicarb.  This nematode causes smaller, misshapen sweet potatoes
that cannot be marketed and aldicarb is the only tool which completely
controls this pest species.  Not controlling nematodes may result in
100% yield loss, and partial control can yield poor quality sweet
potatoes, which if sold on the processing market, will only bring 10% of
the prices of marketable sweet potatoes.

Mitigation

To reduce potential ecological risks, the Agency has directed, and the
registrant has agreed, to develop several mitigation measures to help
address the above mentioned concerns. They include:

Limit application of aldicarb to:  Louisiana and Mississippi only.

Addition of label language specifying granules be applied in a 12-inch
band within an open furrow and covered immediately during bed forming by
mechanically hilling 8 to 10 inches.

Slight modifications in label language to help reduce the amount of
aldicarb left on the surface of the soil (i.e., clarifications in the
use of positive displacement technology) and making it less available
for the wildlife potentially at risk.  For the label language
modifications, please refer to Table 5 in Section V.

EPA Decision

Aldicarb has the potential to cause adverse effects to birds, mammals
and aquatic species. However, due to the physical properties of
aldicarb’s granules (e.g., color, size, and solubility) and how
aldicarb is soil incorporated, actual exposure of potentially affected
populations to aldicarb granules is uncertain and may be overestimated.
Potential risks to birds and mammals would be limited primarily to the
treated fields where wildlife, if present, could ingest granules that
are not incorporated in the soil and that have not yet dissolved.
Therefore, the extent of exposure, both spatially and temporally, is
expected to be limited.  The Agency recognizes, however, that actual
exposure of wildlife to aldicarb is uncertain.

As discussed above, the Agency has determined that there are benefits of
aldicarb use on sweet potatoes in certain states (Louisiana and
Mississippi) and that losing its use would involve substantial costs to
growers.  Aldicarb also has advantages to sweet potato growers for which
EPA cannot estimate dollar values, such as simplicity of management,
confidence in the level of control in the face of unexpected
infestation, and  cost effectiveness when considering the full range of
pests and duration of control.  Therefore, the Agency finds the use on
sweet potatoes eligible for reregistration.

	4. Other Labeling Requirements  TC “4. Other Labeling Requirements”
\f C \l “3”

	In order to be eligible for reregistration, additional aldicarb
information needs to be included in the labeling of all end-use products
containing aldicarb.  Uses and use patterns need to be clarified as
indicated in Table 5 below to reflect and better describe actual use
patterns for aldicarb.  For the specific label statements and a list of
additional data requirements necessary to confirm this decision, refer
to Section V of this IRED document.

		5. Threatened and Endangered Species Considerations

  TC “5. Threatened and Endangered Species Considerations” \f C \l
“3”

	The Agency’s screening level risk assessment for endangered and
threatened species concluded that use of aldicarb has direct adverse
effects on listed species in the following taxonomic groups: terrestrial
invertebrates, birds, terrestrial phase amphibians, reptiles, mammals,
freshwater fish, freshwater invertebrates, estuarine/marine
invertebrates, and estuarine/marine fish.  There is also the potential
for indirect adverse effects for listed species in multiple taxonomic
groups that are dependent upon species that do experience direct adverse
effects.  These findings are based solely on EPA’s screening level
assessment and do not constitute “may affect” findings under the
Endangered Species Act.

	The Agency has developed the Endangered Species Protection Program to
identify pesticides whose use may cause adverse impacts on threatened
and endangered 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 that may affect any particular species, EPA
uses basic toxicity and exposure data developed for REDs and considers
it in relation to individual species by evaluating important ecological
parameters, pesticide use information, the geographic relationship
between specific pesticide uses and species locations, and biological
requirements and behavioral aspects of the particular species.  When
conducted, this species-specific analysis will take into consideration
any risk mitigation measures that are being implemented at the time as a
result of this RED.

	Following this future species-specific analysis, a determination that
there is a likelihood of potential effects to a listed species or its
critical habitat may result in further limitations on use of aldicarb,
other measures to mitigate any potential effects, or consultations with
the Fish and Wildlife Service and/or the National Marine Fisheries as
appropriate.  If the Agency determines use of aldicarb “may affect”
listed species or their designated critical habitat, EPA will employ the
provisions in the Services regulations (50 CFR Part 402).  Until a
species-specific analysis is completed, the risk mitigation measures
being implemented through this RED (e.g., rate reductions and geographic
restrictions) will reduce the likelihood that endangered and threatened
species may be exposed to aldicarb at levels of concern.  EPA is not
requiring specific aldicarb label language at the present time relative
to threatened and endangered species.  If, in the future, specific
measures are necessary for the protection of listed species, the Agency
will implement them through the Endangered Species Protection Program.

	EPA is currently engaging in informal consultations with the Fish and
Wildlife Service and the National Marine Fisheries Service, which is a
part of the National Oceanic and Atmospheric Administration.  This means
that the Agencies are working together to conduct a full endangered
species assessment for aldicarb, which is separate from this RED.  The
likelihood of potential impacts to endangered species will need to be
assessed for all counties in which: 1) crops registered for aldicarb use
are grown; and 2) contain habitat for at least one listed species.

V. What Registrants Need to Do  TC “V. What Registrants Need to Do”
\f C \l “1”

	The Agency has determined that products containing the active
ingredient aldicarb are eligible for reregistration provided that the
risk mitigation measures outlined in this document are adopted and label
amendments are made to reflect these measures.  The Agency intends to
issue DCIs for generic (technical grade) data and product-specific data.
 Generally, registrants will have 90 days from receipt of a generic DCI
to complete and submit response forms or request time extension and/or
waiver requests with a full written justification.  The DCIs will
include specific requirements and instructions on how to respond.  Table
4 below presents the additional generic data the Agency intends to
require for aldicarb to confirm the decision that products containing
the active ingredient aldicarb are eligible for reregistration.  For
product-specific DCIs, registrants will have eight months from receipt
of the DCI to submit data and to submit amended labels.  In order for
products containing the active ingredient aldicarb to be eligible for
reregistration, all product labels must be amended to incorporate the
specific changes and language presented in Table 5 below.  Table 5 also
describes how the required language should be incorporated.

	A. Manufacturing-Use Products  TC “A. Manufacturing-Use Products”
\f C \l “2”

1. Additional Generic Data Requirements  TC “1. Additional Generic
Data Requirements” \f C \l “3”

The generic database supporting the reregistration of aldicarb has been
reviewed and determined to be substantially complete.  However, EPA is
requiring the following additional data to confirm the decisions
presented in this RED.  The Agency intends to issue a generic DCI for
this data.

Table 4. Data requirements for the reregistration of aldicarb.  TC
"Table 4. Data requirements for the reregistration of aldicarb " \f E \l
"1"

Data Requirement	New OPPTS Guideline Number (GLN)

Magnitude of the Residue in Plant Studies

Data depicting the magnitude of aldicarb residues of concern in cotton
gin byproducts are required in accordance with Table 1 of OPPTS Series
860 Residue Chemistry Test Guidelines, 8/96.

	860.1500

Terrestrial Plant Toxicity – Tier 1 (seedling emergence)	850.4100

Terrestrial Plant Toxicity – Tier 1 (vegetative Vigor)	850.4150

Aquatic Plant toxicity Test – using Lemna spp. – Tiers I and II
850.4400

Avian Reproduction Study in Quail

Avian Reproduction Study in Duck

	850.2300

UV/Visible Aborption	830.7050

Comparative Cholinesterase Assay	Special Study

		2. Labeling for Manufacturing-Use Products  TC "2. Labeling for
Manufacturing-Use Products" \f C \l "3"

	To ensure compliance with FIFRA, labeling for all manufacturing-use
products (MUPs) should be revised to comply with all current EPA
regulations, PR Notices, and applicable policies.  The MUP labeling
should bear the specific language presented in Table 5 below.

	B. End-Use Products  TC "B. End-Use Products" \f C \l "2"

		1. Additional Product-Specific Data Requirements  TC "1. Additional
Product-Specific Data Requirements" \f C \l "3"

	Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of
eligibility has been made.  The registrant must review previous data
submissions to ensure 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 can be cited according to the instructions in the
Requirement Status and Registrations Response Form provided for each
product.  The Agency intends to issue a separate product-specific DCI
outlining specific data requirements.

		2. Labeling for End-Use Products  TC "2. Labeling for End-Use
Products" \f C \l "3"

	To be eligible for reregistration, labeling changes are necessary to
implement measures outlined in Section IV above.  The specific changes
and language are presented in Table 5 below.  Generally, conditions for
the distribution and sale of products bearing old labels/labeling will
be established when the label changes are approved.  However, specific
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.

Table 5. Summary of Required Labeling Changes for Aldicarb Products.
TC "Table 5. Summary of Required Labeling Changes for Aldicarb Products
" \f E \l "1"

Description

Amended Labeling Language for Manufacturing Use Products

Placement on Label

For all Manufacturing Use Products

 “Only for formulation into an insecticide/nematicide for the
following uses:  citrus, cotton, dry bean, peanuts, potatoes, soybean,
sugar beets, sweet potatoes.”

“Only formulation into low dust granular products such as products
that use a vinyl binder coating to adhere the aldicarb to either a corn
cob grit or a gypsum substrate.  Binding aldicarb to clay substrate is
prohibited.”

Directions for Use

Note to Registrant

This product may not be used to formulate products for use on alfalfa
grown for seed, coffee, ornamentals, pecans, sorghum, sugarcane, and
tobacco.

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

 “This product may be used to formulate products for specific uses 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
uses.”

“This product may be used to formulate products for any additional
uses 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 uses.”

Directions for Use

Environmental Hazards Statements

 “This pesticide is extremely toxic to birds and mammals. This
pesticide is toxic to fish and aquatic invertebrates.  Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries,
oceans, or other waters unless in accordance with the requirements of a
National Pollution Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge.
Do not discharge effluent containing this product to sewer systems
without previously notifying the local sewage treatment plant authority.
 For guidance contact your State Water Board or Regional Office of the
EPA.”

Precautionary Statements

End Use Products Intended for Occupational Use

Restricted Use Pesticide

 “Restricted Use Pesticide”

“Due to acute oral toxicity and to ground water contamination.  For
retail sale to and use only by Certified Applicators or persons under
the direct supervision of a Certified Applicator, and only for those
uses covered by the Certified Applicator’s certification.”

This statement must appear at the very top of the label's front panel
[see 40 CFR 156.10(j)(2)(i) for more information].  No other wording or
symbols should appear above the RUP statement.

PPE Requirements Established by the RED1 for low- dust granular
formulations that are packaged in closed loading and application systems
(e.g., Lock ‘n Load, Smartbox)

 “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."

“All loaders, applicators, and other handlers must wear;

> long-sleeved shirts and long pants,

> shoes plus socks.

In addition, loaders and handlers cleaning equipment or spills must
wear:

> chemical-resistant gloves made of any waterproof material, and

> chemical-resistant apron.

See engineering controls section for additional requirements.”

Immediately following/below

Precautionary Statements:  Hazards to Humans and Domestic Animals.

PPE Requirements Established by the RED1 for granular low- dust
formulations that are not packaged in a closed loading and application
system.

 “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."

“All loaders, applications and other handlers must wear at a minimum:

> coveralls over long-sleeved shirts and long pants,

> chemical-resistant gloves made of any waterproof material,

> chemical-resistant footwear plus socks, and

> protective eyewear.

In addition, loaders and handlers cleaning equipment or spills must
wear:

> chemical-resistant apron, and

> a NIOSH-approved respirator with a dust/mist filter with MSHA/ NIOSH
approval number prefix TC-21C or any N, R, P, or HE filter.”

“See engineering controls for additional options.”

Immediately following/below

Precautionary Statements:  Hazards to Humans and Domestic Animals.

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.”

Precautionary Statements:  Hazards to Humans and Domestic Animals
immediately following the PPE requirements.

Engineering Controls

for granular low- dust formulations that are packaged in closed loading
and application systems (e.g., Lock ‘n Load, Smartbox)

“Engineering Controls”

“This product is formulated into a (registrant inserts the trade name
of the closed system in which the product is marketed, such as Lock ‘N
Load or SmartBox) system that meets the definition of a closed loading
and application system in the Worker Protection Standard for
Agricultural Pesticides [40 CFR 170.240(d)(4)]. Loaders and applicators
using the closed-system packaging must:

--  wear the personal protective equipment required in the PPE section
of this labeling for loaders during loading, and

--  wear the personal protective equipment required in the PPE section
of this labeling for applicators during applying, and

-- be provided, have immediately available, and use in an emergency,
such as a broken package, spill, or equipment breakdown:
chemical-resistant gloves, chemical-resistant apron, chemical-resistant
footwear, protective eyewear, and a NIOSH-approved respirator with a
dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or any N
R, P, or HE filter.”

Precautionary Statements:  Hazards to Humans and Domestic Animals
(Immediately following PPE and User Safety Requirements.)

Engineering Controls: Enclosed Cabs for Ground Applicators

 “Engineering Control Options for Enclosed Cabs:

Applicators using an enclosed cab that meets the definition in the
Worker Protection Standard for Agricultural Pesticides [40 CFR
170.240(d)(5)] may wear reduced personal protective equipment, provided
they:

 -- wear a long-sleeve shirt, long pants, shoes, and socks

-- are provided, have immediately available, and use in an emergency,
such as a broken package, spill, or equipment breakdown:
chemical-resistant gloves, chemical-resistant apron, chemical-resistant
footwear, protective eyewear, and a NIOSH-approved respirator with a
dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or any N
R, P, or HE filter.

-- take off any PPE that was worn in the treated area before reentering
the cab, 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 following PPE and User Safety Requirements.)

User Safety Recommendations

“User Safety Recommendations”

“Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.

Users should remove clothing/PPE immediately if pesticide gets inside.
Then wash thoroughly and put on clean clothing.

Users should remove PPE immediately after handling this product.  Wash
the outside of gloves before removing.  As soon as possible, wash
thoroughly and change into clean clothing.”

Precautionary Statements under:  Hazards to Humans and Domestic Animals
immediately following Engineering Controls

(Must be placed in a box.)

Environmental Hazards 	“This pesticide is extremely toxic to birds and
wildlife.  Birds feeding on exposed granules may be killed.  Cover or
immediately soil incorporate granules spilled during loading.”

“This pesticide is toxic to fish and aquatic invertebrates.  Run-off
from treated areas may be hazardous to fish in neighboring areas.  Do
not apply directly to water, to areas where surface water is present or
to inter-tidal areas below the mean high water mark.  Do not contaminate
water when disposing of equipment wash waters.”

“This product is toxic to bees exposed to direct treatment. Do not
apply this product while bees are actively visiting the treatment
area.”

“Aldicarb is known to leach through soil into ground water under
certain conditions as a result of labeled use.  Use of this chemical in
areas where soils are permeable, particularly where the water table is
shallow, may result in ground-water contamination.”

“See use directions for individual crops for additional ground water
restrictions.  See soil tables.”

Precautionary Statements immediately following the User Safety
Recommendations

Environmental Hazards Statements Required by the RED and Agency Label
Policies

“Under the Endangered Species Act, it is a Federal Offense to use any
pesticide in a manner that results in the death of a member of an
endangered species.

This Act protects Attwater's Greater Prairie Chicken in the Texas
counties of Aransas, Austin, Brazoria, Colorado, Galveston, Goliad,
Harris, Refugio, and Victoria.

Prior to making applications in these counties, the user must determine
that this species is not located in or immediately adjacent to the area
to be treated. If the user is in doubt whether or not the above named
endangered species may be affected, he should contact either the
regional U.S. Fish & Wildlife Service office (Endangered Species
Specialist) or personnel of the State Fish and Game office.”

Precautionary Statements

Restricted-Entry Interval for products with directions for use within
scope of the Worker Protection Standard for Agricultural Pesticides
(WPS)

 “Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 48 hours.”