Document ID: EPA-HQ-OPP-2005-0507-0031
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-11T04:00Z

SEQ CHAPTER \h \r 1 United States			Prevention, Pesticides		EPA
738-R-06-014

Environmental Protection		and Toxic Substances		July 2006

Agency				(7509P) 

Reregistration

Eligibility Decision   

(RED) for Inorganic 

Chlorates

                        

REREGISTRATION ELIGIBILITY

DECISION

for

Inorganic Chlorates

Case No. 4049

Approved by:

______________________

Debra Edwards, Ph.D.

Director, Special Review and 

Reregistration Division

________________________

Date

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc187489621"  Inorganic
Chlorates Reregistration Eligibility Decision Team	  PAGEREF
_Toc187489621 \h  v  

  HYPERLINK \l "_Toc187489622"  Glossary of Terms and Abbreviations	 
PAGEREF _Toc187489622 \h  vi  

  HYPERLINK \l "_Toc187489623"  Abstract	  PAGEREF _Toc187489623 \h 
viii  

  HYPERLINK \l "_Toc187489624"  I.	Introduction	  PAGEREF _Toc187489624
\h  1  

  HYPERLINK \l "_Toc187489625"  II.	Chemical Overview	  PAGEREF
_Toc187489625 \h  3  

  HYPERLINK \l "_Toc187489626"  A.	Regulatory History	  PAGEREF
_Toc187489626 \h  3  

  HYPERLINK \l "_Toc187489627"  B.	Chemical Identification – Sodium
Chlorate	  PAGEREF _Toc187489627 \h  3  

  HYPERLINK \l "_Toc187489628"  C.	Use Profile	  PAGEREF _Toc187489628
\h  3  

  HYPERLINK \l "_Toc187489629"  D.	Estimated Usage of Sodium Chlorate	 
PAGEREF _Toc187489629 \h  4  

  HYPERLINK \l "_Toc187489630"  III.	Summary of Inorganic Chlorates Risk
Assessments	  PAGEREF _Toc187489630 \h  6  

  HYPERLINK \l "_Toc187489631"  A.	Human Health Risk Assessment	 
PAGEREF _Toc187489631 \h  6  

  HYPERLINK \l "_Toc187489632"  1.	Toxicity of Sodium Chlorate	  PAGEREF
_Toc187489632 \h  6  

  HYPERLINK \l "_Toc187489633"  2.	Carcinogenicity of Sodium Chlorate	 
PAGEREF _Toc187489633 \h  9  

  HYPERLINK \l "_Toc187489634"  3.        Sodium Chlorate Endocrine
Effects	  PAGEREF _Toc187489634 \h  10  

  HYPERLINK \l "_Toc187489635"  4.	Metabolites and Degradates	  PAGEREF
_Toc187489635 \h  10  

  HYPERLINK \l "_Toc187489636"  5.	Dietary Exposure and Risk (Food)	 
PAGEREF _Toc187489636 \h  11  

  HYPERLINK \l "_Toc187489637"  6.	Dietary Exposure and Risks (Drinking
Water)	  PAGEREF _Toc187489637 \h  13  

  HYPERLINK \l "_Toc187489638"  7.	Residential Exposure and Risk	 
PAGEREF _Toc187489638 \h  17  

  HYPERLINK \l "_Toc187489639"  8.	Aggregate Risk	  PAGEREF
_Toc187489639 \h  20  

  HYPERLINK \l "_Toc187489640"  9.	 Occupational Exposure and Risk	 
PAGEREF _Toc187489640 \h  21  

  HYPERLINK \l "_Toc187489641"  B.	Environmental Fate and Effects Risk
Assessment	  PAGEREF _Toc187489641 \h  27  

  HYPERLINK \l "_Toc187489642"  1.	Environmental Fate and Transport	 
PAGEREF _Toc187489642 \h  27  

  HYPERLINK \l "_Toc187489643"  2.	Ecological Exposure and Risk	 
PAGEREF _Toc187489643 \h  28  

  HYPERLINK \l "_Toc187489644"  IV.	Risk Management, Reregistration, and
Tolerance Reassessment	  PAGEREF _Toc187489644 \h  40  

  HYPERLINK \l "_Toc187489645"  A.	Determination of Reregistration
Eligibility	  PAGEREF _Toc187489645 \h  40  

  HYPERLINK \l "_Toc187489646"  B.	Public Comments and Responses	 
PAGEREF _Toc187489646 \h  40  

  HYPERLINK \l "_Toc187489647"  C.	Regulatory Position	  PAGEREF
_Toc187489647 \h  41  

  HYPERLINK \l "_Toc187489648"  1.	Food Quality Protection Act Findings	
 PAGEREF _Toc187489648 \h  41  

  HYPERLINK \l "_Toc187489649"  2.	Endocrine Disruptor Effects	  PAGEREF
_Toc187489649 \h  42  

  HYPERLINK \l "_Toc187489650"  3.	Cumulative Risks	  PAGEREF
_Toc187489650 \h  42  

  HYPERLINK \l "_Toc187489651"  4.	Endangered Species	  PAGEREF
_Toc187489651 \h  43  

  HYPERLINK \l "_Toc187489652"  D.         Tolerance Reassessment
Summary	  PAGEREF _Toc187489652 \h  44  

  HYPERLINK \l "_Toc187489653"  E.	Regulatory Rationale	  PAGEREF
_Toc187489653 \h  46  

  HYPERLINK \l "_Toc187489654"  1.	Human Health Risk Management	 
PAGEREF _Toc187489654 \h  46  

  HYPERLINK \l "_Toc187489655"  2.	Non-Target Organism (Ecological) Risk
Management	  PAGEREF _Toc187489655 \h  52  

  HYPERLINK \l "_Toc187489656"  3.	 Summary of Mitigation Measures	 
PAGEREF _Toc187489656 \h  57  

  HYPERLINK \l "_Toc187489657"  F.	Other Labeling Requirements	  PAGEREF
_Toc187489657 \h  58  

  HYPERLINK \l "_Toc187489658"  1.	 Endangered Species Considerations	 
PAGEREF _Toc187489658 \h  58  

  HYPERLINK \l "_Toc187489659"  2.	Spray Drift Management	  PAGEREF
_Toc187489659 \h  59  

  HYPERLINK \l "_Toc187489660"  V.	What Registrants Need to Do	  PAGEREF
_Toc187489660 \h  60  

  HYPERLINK \l "_Toc187489661"  A.	Manufacturing-Use Products	  PAGEREF
_Toc187489661 \h  60  

  HYPERLINK \l "_Toc187489662"  1.	Generic Data Requirements	  PAGEREF
_Toc187489662 \h  60  

  HYPERLINK \l "_Toc187489663"  2.	Labeling for Manufacturing-Use
Products	  PAGEREF _Toc187489663 \h  61  

  HYPERLINK \l "_Toc187489664"  B.	End-Use Products	  PAGEREF
_Toc187489664 \h  61  

  HYPERLINK \l "_Toc187489665"  1.	Additional Product-Specific Data
Requirements	  PAGEREF _Toc187489665 \h  61  

  HYPERLINK \l "_Toc187489666"  2.	Labeling for End-Use Products	 
PAGEREF _Toc187489666 \h  61  

  HYPERLINK \l "_Toc187489667"  C.	Labeling Changes Summary Table	 
PAGEREF _Toc187489667 \h  61  

  HYPERLINK \l "_Toc187489668"  D.	Existing Stocks	  PAGEREF
_Toc187489668 \h  61  

  HYPERLINK \l "_Toc187489669"  Summary of Labeling Changes for Sodium
Chlorate	  PAGEREF _Toc187489669 \h  63  

  HYPERLINK \l "_Toc187489670"  Appendix A.  Use Patterns Eligible for
Reregistration for Sodium Chlorate	  PAGEREF _Toc187489670 \h  71  

  HYPERLINK \l "_Toc187489671"  Appendix B.  Generic Data Requirements
and Studies Used in Reregistration	  PAGEREF _Toc187489671 \h  81  

Appendix C.  Bibliography  HYPERLINK \l "_Toc187489672"  	  PAGEREF
_Toc187489672 \h  85  

  HYPERLINK \l "_Toc187489673"  Appendix D:  Technical Support Documents
94 

  HYPERLINK \l "_Toc187489674"  Appendix E:  List of Available Related
Documents and Electronically Available Forms	95 

 Inorganic Chlorates Reregistration Eligibility Decision Team

Biological and Economic Analysis Assessment

Rafael Prieto

Alan Halvorson 

Nicole Zinn

Andrew Lee

Environmental Fate and Effects Risk Assessment

Brian Anderson 

Silvia Termes

Jim Goodyear

Stephanie Syslo

	

Health Effects Risk Assessment

Susan Hummel

Bonnie Cropp-Kohlligian

Abdullah Khasawinah

Matthew Crowley

Thurston Morton

Gary Otakie

Registration Support

	Juanita Gilchrist

	Jim Tompkins

	

Risk Management

Molly Clayton

Kimberly Nesci

Office of General Counsel

	Erin Koch

Glossary of Terms and Abbreviations

a.i.		Active Ingredient

aPAD		Acute Population Adjusted Dose

APHIS		Animal and Plant Health Inspection Service

ARTF		Agricultural Re-entry Task Force

BCF		Bioconcentration Factor

CDC		Centers for Disease Control

CDPR		California Department of Pesticide Regulation 

CFR		Code of Federal Regulations

ChEI		Cholinesterase Inhibition

CMBS		Carbamate Market Basket Survey

cPAD		Chronic Population Adjusted Dose

CSFII		USDA Continuing Surveys for Food Intake by Individuals

CWS		Community Water System

DCI		Data Call-In

DEEM		Dietary Exposure Evaluation Model

DL		Double layer clothing {i.e., coveralls over SL}

DWLOC	Drinking Water Level of Comparison

EC		Emulsifiable Concentrate Formulation

EDSP		Endocrine Disruptor Screening Program

EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee

EEC		Estimated Environmental Concentration.  The estimated pesticide
concentration in an environment, such as a terrestrial ecosystem.

EP		End-Use Product

EPA		U.S. Environmental Protection Agency

EXAMS		Tier II Surface Water Computer Model  		

FDA		Food and Drug Administration

FFDCA		Federal Food, Drug, and Cosmetic Act

FIFRA		Federal Insecticide, Fungicide, and Rodenticide Act

FOB		Functional Observation Battery	

FQPA		Food Quality Protection Act

FR		Federal Register						

GL		With gloves

GPS		Global Positioning System

HIARC		Hazard Identification Assessment Review Committee

IDFS		Incident Data System

IGR		Insect Growth Regulator

IPM		Integrated Pest Management

RED		Reregistration Eligibility Decision

LADD		Lifetime Average Daily Dose

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

LCO		Lawn Care Operator

LD50		Median Lethal Dose.  Statistically derived single dose causing
death in 50% of the test animals when administered by the route
indicated (oral, dermal, inhalation), expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.

LOAEC		Lowest Observed Adverse Effect Concentration

LOAEL		Lowest Observed Adverse Effect Level

LOC		Level of Concern

LOEC		Lowest Observed Effect Concentration

mg/kg/day	Milligram Per Kilogram Per Day

MOE		Margin of Exposure 

MP		Manufacturing-Use Product

MRID		Master Record Identification (number).  EPA's system of recording
and tracking studies submitted.

MRL		Maximum Residue Level

N/A		Not Applicable

NASS		National Agricultural Statistical Service

NAWQA	USGS National Water Quality Assessment

NG 		No Gloves

NMFS		National Marine Fisheries Service

NOAEC		No Observed Adverse Effect Concentration

NOAEL		No Observed Adverse Effect Level

NPIC		National Pesticide Information Center

NTP		National Toxicology Program 

NR		No respirator

OP		Organophosphorus

OPP		EPA Office of Pesticide Programs

ORETF		Outdoor Residential Exposure Task Force

PAD		Population Adjusted Dose

PCA		Percent Crop Area

PDCI		Product Specific Data Call-In

PDP		USDA Pesticide Data Program

PF10		Protections factor 10 respirator

PF5		Protection factor 5 respirator

PHED		Pesticide Handler's Exposure Data 

PHI		Preharvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

PRZM		Pesticide Root Zone Model

RBC		Red Blood Cell

RAC		Raw Agricultural Commodity

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RPA		Reasonable and Prudent Alternatives

RPM		Reasonable and Prudent Measures

RQ		Risk Quotient

RTU		(Ready-to-use)

RUP		Restricted Use Pesticide

SCI-GROW	Tier I Ground Water Computer Model

SF		Safety Factor

SL		Single layer clothing

SLN		Special Local Need (Registrations Under Section 24(c) of FIFRA)

STORET	Storage and Retrieval

TEP		Typical End-Use Product

TSH		Thyroid Stimulating Hormone

TGAI		Technical Grade Active Ingredient

TRAC 		Tolerance Reassessment Advisory Committee

TTRS		Transferable Turf Residues

UF		Uncertainty Factor

USDA		United States Department of Agriculture

USFWS		United States Fish and Wildlife Service

USGS		United States Geological Survey 

WPS		Worker Protection Standard

Abstract tc "EXECUTIVE SUMMARY" 

	The Environmental Protection Agency (EPA or the Agency) has completed
the human health and environmental risk assessments for the Inorganic
Chlorates and is issuing its risk management decision and tolerance
reassessment.  The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use
patterns of currently registered products and additional information
received through the public docket.  After considering the risks
identified in the revised risk assessments, comments received, and
mitigation suggestions from interested parties, the Agency developed its
risk management decision for uses of inorganic chlorates that pose risks
of concern.  As a result of this review, EPA has determined that
inorganic chlorate-containing products are eligible for reregistration,
provided that risk mitigation measures are adopted and labels are
amended accordingly.  That decision is discussed fully in this document.
 

Sodium chlorate is an inorganic salt herbicide that was first registered
in 1966.  It is a defoliant and a desiccant that is primarily used on
cotton, but it also has other agricultural and non-agricultural uses. 
As a non-selective herbicide it is used to kill grasses and weeds in
industrial and non-agricultural sites such as driveways, tennis courts,
and recreational areas.  The initial risk assessment indicated some
ecological and occupational risks of concern.  Risk assessments were
revised based on refinements to the assessments as well as mitigation
measures.  Occupational and ecological risks resulting from
non-agricultural uses have been mitigated by reducing application rates,
as well as limiting applications of sodium chlorate to spot treatments
only.  Use on rights-of-way and ditch banks will be cancelled.  The
Agency may require changes to the language of the sodium chlorate label
in the future if deemed necessary under the Endangered Species
Protection Program.

I.	Introduction	

	The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended in 1988 to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984.  The amended Act calls
for the development and submission of data to support the reregistration
of an active ingredient, as well as a review of all submitted data by
the U.S. Environmental Protection Agency (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 the 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” criteria of FIFRA. 

	On August 3, 1996, the Food Quality Protection Act (FQPA) was signed
into law.  This Act amends FIFRA and the Federal Food, Drug, and
Cosmetic Act (FFDCA) to require reassessment of all existing tolerances
for pesticides in food.  FQPA also requires EPA to review all tolerances
in effect on August 2, 1996, by August 3, 2006.  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 of infants and children, and the cumulative
effects of pesticides with a common mechanism of toxicity.  When a
safety finding has been made that aggregate risks are not of concern and
the Agency concludes that there is a reasonable certainty of no harm
from aggregate exposure, the tolerances are considered reassessed.  EPA
decided that, for those chemicals that have tolerances and are
undergoing reregistration, tolerance reassessment will be accomplished
through the reregistration process. 

Of the inorganic chlorates listed as active ingredients (i.e., sodium
chlorate (073301), calcium chlorate (073302), potassium chlorate
(073303), and magnesium chlorate (530200)), only sodium chlorate is
present as an active ingredient in currently registered products.  As
such, sodium chlorate is the primary focus of the reregistration
eligibility decision.  Sodium chlorate is a strong oxidizer and may be
reduced to a variety of chemical species depending on the environmental
conditions.  As a consequence of its reaction as an oxidant, sodium
chlorate generates reduced chloro species (i.e., chlorine in lower
oxidation states than chlorate), such as chlorite and hypochlorite. 
Since chlorite is also an active ingredient and is being considered in
the chlorite/chlorine dioxide reregistration eligibility decision (case
number 4043).  The Agency will not consider the tolerances for chlorate
reassessed until the assessment of chlorite is complete.  As mentioned
above, 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.” 
Potential cumulative effects of chemicals with a common mechanism of
toxicity are considered because low-level exposures 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.  

EPA has not made a common mechanism of toxicity finding as to parent
sodium chlorate and any other substances, and sodium chlorate does not
appear to produce a toxic metabolite that is in common with those
produced by other substances.  For the purposes of this reregistration
eligibility decision (RED), therefore, EPA has not assumed that the
inorganic chlorates have a common mechanism of toxicity with other
substances.  For information regarding EPA’s efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released
by EPA’s Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA’s website at
http://www.epa.gov/pesticides/cumulative/.

	This document presents EPA’s revised human health and ecological risk
assessments, its progress toward tolerance reassessment, and the
reregistration eligibility decision for inorganic chlorates.  The
document consists of six sections.  Section I contains the regulatory
framework for reregistration/tolerance reassessment; Section II provides
a profile of the use and usage of the chemical; Section III gives an
overview of the human health and environmental effects risk assessments;
Section IV presents the Agency's decision on reregistration eligibility
and risk management; and Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section
IV.  Finally, the Appendices list related information, supporting
documents, and studies evaluated for the reregistration decision.  The
revised risk assessments for inorganic chlorates are available in the
Office of Pesticide Programs (OPP) public docket under docket number
OPP-2005-0507 available on the Agency’s web page at
http://www.epa.gov/oppsrrd1/reregistration/inorganicchlorates/.

II.	Chemical Overview

Of the inorganic chlorates listed as active ingredients (i.e., sodium
chlorate (073301), calcium chlorate (073302), potassium chlorate
(073303), and magnesium chlorate (530200)), only sodium chlorate is
present as an active ingredient in currently registered products. 
Sodium chlorate, calcium chlorate, and potassium chlorate are present as
inert ingredients in currently registered products and exposures as a
result of those uses are addressed herein. Sodium chlorate is a
defoliant/desiccant, and is used as an herbicide.   

	A.	Regulatory History

Sodium chlorate was first registered in February 23, 1966 by Value
Gardens Supply, LLC, for use on both annual and perennial grasses and
weeds for the following non-agricultural use sites: garage areas, tennis
courts, curbs, driveways, walks, and patios.  On October 30, 1968,
Helena Chemical Company registered it for use as a desiccant on
agricultural sites (sorghum and cotton).  Currently, there are 56 active
product registrations containing sodium chlorate as an active
ingredient, including 11 technical (manufacturing use) registrations,
and 45 end-use products ranging from 2.3% to 99.7% active ingredient. 
Sodium chlorate is currently manufactured by seven companies.  The
compound may be used in combination with other herbicides, such as
atrazine, 2,4-D, bromacil, diuron, and sodium metaborate.

	

	B.	Chemical Identification – Sodium Chlorate

Chemical Structure:

 

Common Names:		Sodium chlorate, soda chlorate, chloric acid, sodium salt

Chemical Name:		Sodium chlorate

Trade Names:			  SEQ CHAPTER \h \r 1 Ferti-Lome, Barespot, Tri-Kil,
Bareground, Prometon, Pramitol, 

Killsall, TriChlor

Chemical Family:		Inorganic salt

Case Number:			4049

CAS Number:			  SEQ CHAPTER \h \r 1 7775-09-9

PC Code:			073301

Molecular Weight:		106.5

Empirical Formula:		  SEQ CHAPTER \h \r 1 NaClO3

Technical Registrants:		EKA Chemicals, ERCO Chemicals, Kerr-McGee
Chemical, 

Nexen Chemical USA, Moore Agricultural Products Company, Inc. 

	C.	Use Profile

	The following is information on the currently registered uses of sodium
chlorate, including an overview of use sites and application methods.  A
detailed table of the uses of sodium chlorate eligible for
reregistration is available in Appendix A.

Type of Pesticide:		Herbicide (desiccant/defoliant)

Target Pest:			Broadleaf weeds

Mode of Action:	Non-selective, contact herbicide that penetrates the
cuticle causing cell death by altering the metabolic processes.	

Use Sites

Agricultural uses:	Agriculturally, it is primarily used on cotton;
however, it is also applied to a wide variety of other crops including,
but not limited to, rice, corn, soybeans, dry beans, potatoes,
sunflowers, flax, safflower, chili peppers (for processing only), grain
sorghum, and wheat.  

Non-agricultural Uses:	Sodium chlorate is used on nonagricultural
(residential and industrial) areas such as rights-of-ways, building
perimeters, ditch banks, bleachers, airport runways, vacant lots, fire
hydrants, or as a pre-paving treatment.  It is also used by a small
percentage of water treatment facilities for the generation of chlorine
dioxide.

Use Classification:	General Use	

Formulation Types:	Agricultural products are all formulated as soluble
concentrates/liquids; non-crop products are formulated as soluble
concentrates/liquids and granules or pellets/tablets.

Application Methods:	Sodium chlorate as a defoliant/desiccant in
agricultural settings is applied using aerial and groundboom equipment. 
As an herbicide in nonagricultural settings, it is applied using
handheld equipment such as a low-pressure handwands or sprinkling cans;
it is also applied via groundboom or handgun sprayer application methods
for larger commercial scenarios.  Granular formulations can be applied
using belly grinders, push-type spreaders, tractor-drawn spreaders, or
by hand.

Application Rates: 	In agriculture, rates range from 6 pounds active
ingredient per acre (6 lb/Ai/A) to 12.5 lbs ai/A.  Industrial and other
noncrop site rates range from 132 to 1032 lbs ai/A, based on current
labels.  Sodium chlorate can be applied multiple times per year. 

Application Timing:	Sodium chlorate is applied post-emergence.  

	D.	Estimated Usage of Sodium Chlorate

	The primary non-pesticidal use for sodium chlorate is as a precursor in
chlorine dioxide generation through a closed system to bleach wood
pulp/paper.  The pesticidal uses of sodium chlorate, including the
agricultural uses as a defoliant/desiccant, are a small percentage
(approximately 2%) of the total sodium chlorate used in the United
States.  According to Agency data, approximately 2.8 million pounds of
sodium chlorate are applied annually to agricultural, residential, and
commercial use sites.  A screening-level usage analysis (SLUA) of sodium
chlorate from 1998 to 2005 indicates that approximately 2.1 million
pounds of sodium chlorate are used annually on agricultural use sites in
the United States.  In terms of pounds applied, the greatest use is on
cotton (1.9 million lbs ai per year); annually this represents
approximately 5 percent of cotton acreage treated.

	Exposure to the chlorate may also occur as a result of the drinking
water disinfection process.  This use and resulting exposure are
explained in detail in this document.  

III.	Summary of Inorganic Chlorates Risk Assessments

The following is a summary of EPA’s revised human health and
ecological risk assessments for inorganic chlorates, as presented fully
in the documents, revised Inorganic Chlorates. HED Chapter of the
Reregistration Eligibility Decision Document (RED), dated January 26,
2006, and the revised Sodium Chlorate Ecological Risk Assessment, dated
June 1, 2006.  The purpose of this summary is to assist the reader by
identifying the key features and findings of these risk assessments, and
to help the reader better understand the conclusions reached in the
assessments.  

	The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to reach the
safety finding and regulatory decision for sodium chlorate.  While the
risk assessments and related addenda are not included in this document,
they are available from the OPP Public Docket, located at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov , under docket
number EPA-HQ-OPP-2005-0507.  

	EPA's use of human studies in the sodium chlorate risk assessment is in
accordance with the Agency's Final Rule promulgated on January 26, 2006,
related to Protections for Subjects in Human Research, which is codified
in 40 CFR Part 26.  

A.	Human Health Risk Assessment

	The human health risk assessment incorporates potential exposure,
hazard, and risks from all sources, which include food, drinking water,
residential (if applicable), and occupational scenarios.  Aggregate
assessments combine food, drinking water, and any residential or other
non-occupational (if applicable) exposures to determine potential
exposures to the U.S. population.  The Agency’s human health
assessment considers all U.S. populations, including infants and young
children.  For more information on the inorganic chlorates human health
risk assessment, see Revised Inorganic Chlorates.  HED Chapter of the
Reregistration Eligibility Decision Document (RED) dated June 26, 2006.

		1.	Toxicity of Sodium Chlorate

	Toxicity assessments are designed to predict whether a pesticide could
cause adverse health effects in humans (including short-term or acute
effects such as skin or eye damage, and lifetime or chronic effects such
as cancer, developmental effects, or reproductive effects), and the
level or dose at which such effects might occur.  The Agency has
reviewed all toxicity studies submitted for sodium chlorate and has
determined that the toxicological database is complete, reliable, and
sufficient for reregistration.  For more details on the toxicity and
carcinogenicity of the inorganic chlorates, see Revised Inorganic
Chlorates.  HED Chapter of the Reregistration Eligibility Decision
Document (RED) dated January 26, 2006, which is available under docket
number EPA-HQ-OPP-2005-0507.

			a.	Acute Toxicity Profile 

In acute toxicity tests, sodium chlorate is slightly toxic by the oral
(Toxicity Category IV), dermal (Toxicity Category III), and inhalation
routes (Toxicity Category IV).  Sodium chlorate crystals were mildly
irritating to the rabbit eye (Toxicity Category III), and were a minimal
to mild dermal irritant (Toxicity Category III).  Incident reports show
that ingestion of toxic doses of sodium chlorate by humans produces
gastritis, hemolysis, methemoglobinemia, hemoglobinurea, late toxic
nephritis, and acute renal failure.  Doses in excess of 100 mg/kg are
generally fatal to humans.  The acute toxicity profile for sodium
chlorate is summarized in Table 1 below.

Table 1.  Acute Toxicity Profile - Sodium Chlorate

Guideline Number	Study Type	MRID No.	Results	Toxicity Categorya

870.1100	Acute oral -Rats	41819901	LD50 (5000 mg/kg (rat)	IV

870.1200	Acute dermal - Rabbits	42497601	LD50 = > 2000 mg/kg	III

870.1300	Acute inhalation - Rats	41819903	LC50 = 5.59 mg/L	IV

870.2400	Acute eye irritation - Rabbit	00085090  00102998

41819904	mildly irritating	III

870.2500	Acute dermal irritation - Rabbit	42497602	minimally irritating
III

870.2600	Skin sensitization - guinea pigs	41819906	not a dermal
sensitizer	NA

a.  The technical acute toxicity values included in this document are
for informational purposes only.  The data supporting these values may
or may not meet the current acceptance criteria.

b.	FQPA Safety Factor Considerations 

The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act (FQPA), directs the Agency to use an additional
ten fold (10x) safety factor (SF) to account for potential pre- and
postnatal toxicity and completeness of the data with respect to exposure
and toxicity to infants and children.  FQPA authorizes the Agency to
modify the 10x FQPA SF only if reliable data demonstrate that the
resulting level of exposure would be safe for infants and children.  

For sodium chlorate, based on the hazard data and the exposure data, t 
SEQ CHAPTER \h \r 1 he FQPA SF was reduced to 1x.  There was no pre- or
postnatal sensitivity or susceptibility observed in the submitted
developmental studies in rats and rabbits or the 2-generation
reproduction study in rats.  However, there is a concern for developing
offspring because of the effects of inorganic chlorate on thyroid
function in rats.  The thyroid hormone system plays a critical role in
development, and it is therefore important to understand whether the
thyroid hormone system in the developing young differs in response to
thyroid toxicants compared to adults.  There exists, therefore, an
uncertainty regarding information on comparative thyroid response in
young versus (vs.) adult rats; however, a SF reflecting the uncertainty
in comparative response is not necessary and the 10x FQPA SF can be
removed (reduced to 1x).

The rationale for removal of the FQPA SF lies in the comparative thyroid
physiology of rats vs. humans.  As a consequence of these dynamic
differences, rats are much more sensitive to thyroid toxicants, such as
chlorate, than humans and non-human primates.  As discussed in the
section below, the chronic reference dose (RfD) for inorganic chlorates
is 0.03 mg/kg/day based on thyroid hypertrophy in adult rats.  There is
a study of the effects of chlorate on adult monkeys, in which the no
observed adverse effects level (NOAEL) for effects on blood thyroxine
levels was 58 mg/kg/day.  If the NOAEL from the monkey study were used
to derive a chronic RfD with uncertainty factors of 10x for interspecies
extrapolation and 10X for intraspecies variability, and an FQPA SF of
10x reflecting uncertainties in effects to the young, the chronic RfD
would be 0.06 mg/kg/day.  The chronic RfD selected by the risk
assessment team of 0.03 mg/kg/day derived from a chronic rat study,
conducted by the National Toxicology Program (NTP),  is therefore
protective of thyroid effects in primates (including a 10X factor for
uncertainty with respect to developing young) without the necessity of
an additional uncertainty factor applied to the rat data.

In addition, the moderately refined dietary food assessment uses field
trial data and percent crop treated estimates for all commodities, and
the residential exposure assessment is based on reliable data; as such,
exposure will not be underestimated.  The dietary drinking water
assessment uses residues in finished drinking water collected from water
treatment facilities, which use chlorine dioxide or hypochlorite to
treat drinking water.  See Revised Inorganic Chlorates.  HED Chapter of
the Reregistration Eligibility Decision Document (RED) dated January 26,
2006, for additional details. 

Toxicological Endpoints 

The toxicological endpoints used in the human health risk assessment for
sodium chlorate are listed in Table 2 below.  Although several studies
were considered, an acute reference dose (aRfD) was not identified. 
None of the available studies provided an endpoint of toxicity
attributable to a single exposure.  

Sodium chlorate is unlikely to be absorbed by the skin based on its high
water solubility and ionic nature; therefore, a risk assessment for
dermal exposure is not needed and a dermal endpoint was not selected. 
For inhalation absorption, a default factor of 100% was used since, per
Agency policy, the inhalation dose was derived from an oral endpoint.  

The usual interspecies uncertainty factor is 10x, but there are several
important quantitative dynamic differences between rats and humans with
respect to thyroid function that permit an interspecies factor of less
than 10x for a thyroid toxicant like sodium chlorate.  The half-life of
thyroid hormone T4 in rats is approximately 12 hours, whereas in humans,
the half-life is 5-9 days.  The shorter half-life in rats is likely
related to a high-affinity binding globulin for thyroxin that is present
in humans, but absent in rodents.  In the absence of a functional
thyroid gland, a rat requires approximately 10-times more T4 than an
adult human for full reconstitution.  Constitutive thyroid stimulating
hormone (TSH) levels are nearly 25-times higher in rats than in humans,
reflecting the increased activity of the thyroid-pituitary axis in rats.
 Therefore, the 10x interspecies factor can be reduced to 3x based on
dynamic considerations.  The uncertainty factors (UF) and safety factors
used to account for interspecies extrapolation, intraspecies
variability, and susceptibility of infants and children (FQPA SF) are
also described in Table 2. 

 

Table 2.  Summary of Toxicological Doses and Endpoints for Chlorate per
se for Use in Human Risk Assessments for Inorganic Chlorates

Exposure Scenario	Dose, Uncertainty Factors	FQPA Safety Factor and Level
of Concern	Study and Endpoint for Risk Assessment

Acute Dietary

	Acute RfD= not applicable	Although several studies were considered, an
acute reference dose (aRfD) was not identified.  None of the available
studies provided an endpoint of toxicity attributable to a single
exposure.

Chronic Dietary

(all populations)	

BMDL1 = 0.9 mg/kg/day

UF = 30 (3x interspecies and 10x intraspecies)

Chronic RfD = 0.03 mg/kg/day	FQPA SF = 1X

cPAD = Chronic RfD

                FQPA SF

cPAD= 0.03 mg/kg/day	

Chronic Study in rats (NTP, 2004).

The LOAEL= 5 mg/kg/day based on increased thyroid gland follicular cell
hypertrophy and follicular cell mineralization. 

Short- and Intermediate-Term Incidental Oral

	

Oral NOAEL =30 mg/kg/day

UF = 100	FQPA SF = 1X

Residential LOC for MOE =100	

Subchronic study in rats McCauley et al, 1995.  Pituitary effects
(vacuolization) and thyroid gland effects (colloid depletion), body
weight decrease and organ weight changes and reduction in erythrocyte
counts and hemoglobin content at the LOAEL of 100 and 150 mg/kg/day in
males and females, respectively

Short-, Intermediate-, and Long-Term Dermal

	

Not applicable	Dermal absorption is unlikely due to the ionic nature and
water solubility of sodium chlorate

Short-, Intermediate-, and Long-Term Inhalation

	

NOAEL =30 mg/kg/day2

UF = 100	FQPA SF = 1X

Residential LOC for MOE =100

Occupational LOC for MOE =100	

McCauley et al, 1995

Cancer (Oral, dermal, inhalation)	

Classification:  Not likely to be carcinogenic to humans at doses that
do not alter thyroid hormone homeostasis. 

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no
observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose (a = acute, c = chronic), RfD =
reference dose, MOE = margin of exposure, LOC = level of concern, NA =
Not Applicable

1.  A NOAEL was not identified in this study.  Therefore a bench mark
dose (BMD) analysis was performed and a BMDL of 28 mg sodium chlorate/L
(22 mg chlorate/L) was calculated.  This corresponds to 0.9 mg
chlorate/kg/day oral dose.  

2.  A 100% inhalation absorption factor is used for extrapolating from
an oral endpoint of toxicity.

2.	Carcinogenicity of Sodium Chlorate

	Sodium chlorate is a thyroid toxicant producing thyroid gland
follicular cell hypertrophy in rats and mice following chronic
exposures.  The Agency classified sodium chlorate as not likely to be
carcinogenic to humans at doses that do not alter thyroid hormone
homeostasis in accordance with the EPA policy, Assessment of Thyroid
Follicular Cell Tumors, dated March 1998.  This policy states that
nonmutagenic pesticides that induce elevated levels of TSH and thyroid
follicular cell tumors in the rat are classified as not likely to be
carcinogenic to humans at doses that do not alter thyroid hormone
homeostasis.  

The preliminary results of a draft 2-year National Toxicology Program
(NTP) bioassay study on sodium chlorate to determine the potential of
this chemical to induce tumors in laboratory animals (rats and mice)
(NTP, 2004) showed evidence of thyroid gland follicular cell hyperplasia
and follicular cell tumors in male rats.  The effects may be attributed
to changes in levels of thyroid hormones seen after administration of
high doses of sodium chlorate.  A final study report is expected later
this year.  In female mice there was equivocal and marginal evidence of
increased pancreatic islet carcinoma.  Sodium chlorate was negative in
most bacterial gene mutation assays and in several cytogenetics tests,
including a hypoxanthine-guanine phosphoribosyl-transferase (HGPRT)
assay in Chinese hamster ovaries and a micronucleus assay.  

The Agency selected a  SEQ CHAPTER \h \r 1  chronic endpoint based on
the thyroid effects from the NTP bioassay study using a benchmark dose
analysis approximation of the NOAEL.  This endpoint is protective for
all populations, including children because children are not expected to
be more susceptible to chlorate-induced thyroid effects than adults. 
Therefore, the current chronic risk assessments presented in this
document are protective of any cancer-related effects for all
populations.  For more information, see the document Revised Inorganic
Chlorates.  HED Chapter of the Reregistration Eligibility Decision
Document (RED) dated January 26, 2006.

	3.        Sodium Chlorate Endocrine Effects

The EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
pesticides active and other ingredients) “may have an effect in humans
similar to an effect produced by a naturally occurring estrogen, or
other such endocrine effects as the Administrator may designate.” 
Following recommendations of its Endocrine Disruptor and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific
basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system.  

	The available toxicity studies on sodium chlorate demonstrate the
thyroid gland to be its target of toxicity.  The endpoints selected to
assess chronic dietary risk and short- and intermediate-term oral and
inhalation risks in this document are protective of the observed thyroid
effects seen in the available toxicity studies.  When additional
appropriate screening and/or testing protocols being considered under
the Agency’s Endocrine Screening Disruption Program have been
developed, sodium chlorate may be subject to further screening and/or
testing to better characterize effects related to endocrine disruption. 

 

		4.	Metabolites and Degradates

The Agency reviewed the metabolism of the inorganic chlorates, and
concluded that there are several residues of concern in food.  In
plants, the terminal residues of sodium chlorate in/on plants are likely
chlorate (ClO3-), chlorite (ClO2-), and chloride (Cl-).  Based on
published rat metabolism data, terminal residues of sodium chlorate in
animal tissues are also expected to be chlorate (ClO3-), chlorite
(ClO2-), and chloride (Cl-).

  In the environment, because chlorate is a strong oxidizing agent
(oxidation state V), it gets reduced to chlorine species in lower
oxidation states, such as the oxyanions chlorite (ClO2-, oxidation state
III) and hypochlorite (ClO-, oxidation state I), chlorine dioxide
(oxidation state IV), and chloride (oxidation state -I).  Thus, at least
some, and possibly a substantial, reduction of the chlorate resulting
from the application of sodium chlorate is likely to occur in the field
prior to any runoff to surface water.  Under environmental (terrestrial
field) redox conditions, and based on chemical equilibria alone, the
thermodynamically favored, end reduction product of chlorate in soil and
in water is the chloride anion.  Any intermediate chlorine dioxide that
may form under environmental conditions will undergo photochemical
reactions when exposed to sunlight.  The chlorine oxyanions, chlorite
and hypochlorite (other possible more reduced intermediates in the
ultimate reduction of chlorate to chloride), are strong oxidizers in
themselves; thus, they are also reduced and/or undergo
disproportionation reactions.  Although reduction reactions of chlorate,
chlorite, and hypochlorite are said to occur very fast, how fast they
occur is not known (i.e., the actual rate constants in the environment
are not known).  Therefore, at any given time the distribution of
reduced species (type and concentration) cannot be estimated.  However,
it is unlikely that a single reduced species would be present.  Chlorite
is being considered in the chlorite/chlorine dioxide reregistration
eligibility decision (case number 4043).  (See Revised Inorganic
Chlorates.  HED Chapter of the Reregistration Eligibility Decision
Document (RED) dated January 26, 2006, for additional details.) 

5.	Dietary Exposure and Risk (Food)

  SEQ CHAPTER \h \r 1 	  SEQ CHAPTER \h \r 1 Dietary exposure (food
only) to inorganic chlorates as the chlorate ion (ClO3-) may be expected
from the following dietary exposure routes: 1) from sodium chlorate as
an active ingredient in conventional (agricultural) pesticides used on
food crops; 2) from sodium chlorate and potassium chlorate as inert
ingredients in conventional pesticides used on food crops or in poultry
premises; 3) from secondary residues in meat/milk/poultry/eggs due to
residues in animal feedstuffs; 4) from sodium chlorate and calcium
chlorate as inert ingredients in antimicrobial agents used as fruit,
vegetable, and egg sanitizing washes, as treatments to mushrooms to
control bacterial blotch, as treatments to seed used for sprouting, for
conditioning live oysters, in poultry drinking water, in fish filleting,
and in pecan cracking/dyeing; and 5) as a potential redox of chlorine
dioxide and sodium chlorite in conventional and antimicrobial
pesticides; (6) from degradation of hypochlorites in antimicrobial
agents used as fruit and vegetable washes; and, (7) from translocation
of very small amounts of chlorate ion (ClO3-) by plants (translocation
of significant amounts would be phytotoxic to plants) from the
environment which may be present as a result of inorganic chlorate
pesticide uses.

No acute dietary endpoint was selected because effects attributable to a
single dose were not seen in the available data.  Chronic and cancer
dietary analyses were conducted for the general U.S. population and
various population subgroups.    SEQ CHAPTER \h \r 1 

a.	Exposure Assumptions

osure Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID™, Version 2.03), which uses food consumption data from the
USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998.    SEQ CHAPTER \h \r 1 No food monitoring data are
available for this risk assessment; therefore, exposure estimates in
food were based on field trial data or, in the case of
fruit/vegetable/other washes, were derived from a film thickness model. 
No chemical-specific livestock metabolism or feeding data are available;
exposure estimates in meat, milk, poultry, and eggs were derived from
rat metabolism data, field trial data, and livestock reference
information concerning feed consumption, tissue weights, and milk
production.  Default concentration factors (no chemical-specific
processing data are available) and the effects of washing after foliar
treatments were also incorporated into the risk assessment.  Percent
crop treated data were used in this analysis.  Exposures were single
point estimates; no residue decline was utilized.

b.	Population Adjusted Dose

	A population adjusted dose, or PAD, is the reference dose (RfD)
adjusted for the FQPA SF.  A risk estimate that is less than 100% of the
acute PAD (aPAD), the dose at which an individual could be exposed over
the course of a single day and no adverse health effects would be
expected, does not exceed EPA’s level of concern.  Likewise, a risk
estimate that is less than 100% of the chronic PAD (cPAD), the dose at
which an individual could be exposed over the course of a lifetime and
no adverse health effects would be expected, does not exceed EPA’s
level of concern.  

			c.	Acute Dietary Risk (Food)

No acute dietary endpoint was selected because effects attributable to a
single dose were not seen in the available data; therefore, an acute
dietary risk assessment was not conducted.  

d.	  SEQ CHAPTER \h \r 1 Chronic Dietary Risk (Food)

A chronic (non-cancer) dietary risk assessment was conducted for all
potential chlorate dietary exposure routes using food consumption data
from 1994-1996 and 1998.  The chronic dietary exposure and risk
estimates resulting from food intake were determined for the general
U.S. population and various population subgroups.

The chronic (non-cancer) dietary (food only) risk is below the
Agency’s level of concern for the general US population and all
population subgroups.  The most likely highest exposed population
subgroup, children 1-2 years of age, was at 28% of the cPAD.  See Table
3 below for details.

	

Table 3.  Results of Chronic Dietary (Food only) Exposure Analysis 

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	% cPAD

All populations	0.03	0.002730	9

All infants (< 1 year old)

0.004511	15

Children 1-2 years old

0.008376	28

Children 3-5 years old

0.006906	23

A cancer dietary risk assessment was conducted for all potential
chlorate dietary exposure routes, using the same dietary (food only)
exposure estimates used in the chronic (non-cancer) dietary risk
assessment for the US population.  As discussed above, sodium chlorate
is a thyroid toxicant producing thyroid gland follicular cell
hypertrophy in rats and mice following chronic exposures, and may be
producing follicular cell tumors in rats.  The lack of mutagenicity
indicates that the thyroid tumors are induced by a non-mutagenic
mechanism.  Children are not expected to be more susceptible to
chlorate-induced thyroid effects than adults, and the endpoint selected
for the thyroid effects is protective for all populations, including
children.  Therefore, as shown in Table 3 above, the chronic (food only)
dietary risk assessment is protective for cancer for the general US
population, since the estimated risk does not exceed 100% of the cPAD.

6.	Dietary Exposure and Risks (Drinking Water)

Drinking water exposure to pesticides can occur through surface and
groundwater contamination.    SEQ CHAPTER \h \r 1 Chronic dietary (water
only) risk assessments were conducted using DEEM-FCID™ Version 2.03
and drinking water consumption data from the USDA’s CSFII from
1994-1996 and 1998.  Exposures were single point estimates; no residue
decline was utilized.

	Drinking water exposure can result from several different uses for
sodium chlorate.  Agriculturally, sodium chlorate is used as a defoliant
and dessicant, primarily on cotton; however, it is also applied to a
wide variety of other crops including, but not limited to, rice, corn,
soybeans, dry beans, potatoes, sunflowers, flax, safflower, chili
peppers (for processing only), grain sorghum, and wheat.  As a
non-selective herbicide, it is applied to industrial/non-crop areas such
as rights-of-ways, building perimeters, ditch banks, bleachers, airport
runways, vacant lots, fire hydrants, or as a pre-paving treatment. 
Sodium chlorate is also used to generate chlorine dioxide, which is then
used to bleach wood pulp/paper and, in some cases, treat drinking water.
 All of these uses could result in chlorate reaching water systems. 
However, the majority of chlorate in drinking water is a result of
drinking water disinfection treatment practices. 

	In the US, there are two primary methods of drinking water treatment. 
The first method is the generation of chlorine dioxide.  In the second
method, either gaseous chlorine or hypochlorite is used to produce free
chlorine.  Each of these methods, except the use of gaseous chlorine,
produce chlorate as a disinfection byproduct (DBP).  The American Water
Works Association (AWWA) Disinfection Systems Committee tracks
disinfection practices in US community water systems.  AWWA’s most
recent comprehensive survey (completed in 1998) estimated that, of all
community water systems (CWS), approximately 20% of CWSs serving
populations greater than 10,000 use sodium hypochlorite (2% generated it
on-site), 8% use chlorine dioxide, and <1% use calcium hypochlorite. 
For CWSs using groundwater and serving populations less than 10,000, the
survey estimated that approximately 34% use sodium hypochlorite, none
use chlorine dioxide, and at least 4.5% use calcium hypochlorite.  For
CWSs using surface water and serving less than 10,000, the survey
estimated that 17% use sodium hypochlorite, 6% use chlorine dioxide, and
9% use calcium hypochlorite.

	For chlorine dioxide generation, both sodium chlorate and sodium
chlorite are used as precursor materials, and both typically result in
chlorate byproduct in finished drinking water.  Sodium chlorite is more
commonly used than sodium chlorate.  The free chlorine disinfection
process involves the use of either gaseous chlorine, or sodium or
calcium hypochlorite, as precursor materials.  Historically, gaseous
chlorine has far more widely been used than hypochlorite to produce free
chlorine.  In recent years, primarily as a result of various homeland
security measures, many drinking water systems are switching from
gaseous chlorine to hypochlorite.  While the use of gaseous chlorine
does not result in chlorate byproduct in finished drinking water, the
use of either sodium or calcium hypochlorite can produce chlorate
byproduct, and this will be discussed in greater detail later in this
section.

Chlorine Dioxide 

The use of chlorine dioxide can introduce chlorate  into the finished
water by several routes.  Drinking water plants generally use sodium
chlorite as a starting material (i.e., feedstock) in the production of
chlorine dioxide.  Chlorate ion may be present as a contaminant in the
sodium chlorite feedstock (usually less than four percent of the active
chlorite is chlorate).  A typical range of chlorate carryover to the
finished water from chlorite feedstock contamination is about 50 µg/L
for a 1 mg/L dose of chlorine dioxide.  Technology to generate chlorine
dioxide using sodium chlorate is now available to the drinking water
industry, which introduces the possibility of chlorate carryover to the
finished water from the chlorate feedstock.  However, since this method
is more technically complicated than the method used with sodium
chlorite, sodium chlorite is far more commonly used in the generation of
chlorine dioxide than sodium chlorate.

	

Chlorate ion (ClO3-) may also be produced due to inefficient generation
of chlorine dioxide.  Excess chlorine will favor the production of
chlorate over chlorine dioxide, as will keeping the generator mixtures
at highly alkaline (pH > 11) or acidic (pH < 3) conditions.  If the
concentrations of feedstock reactants are too low, or too much dilution
water is added during the reaction, chlorate formation is also favored.

Chlorite ion (ClO2-) is a major degradation product resulting from the
reaction of chlorine dioxide with inorganic and organic constituents in
the water.  When free chlorine is used after the application of chlorine
dioxide in the treatment process, chlorite is oxidized to chlorate. 
This conversion will continue over time as the water travels through the
distribution system.  Chlorate ion is also formed by photodecomposition
of chlorine dioxide when treated water is exposed to bright sunlight in
open basins.  

There are ways that water systems can control the levels of chlorate in
drinking water, and these will be discussed in Section 4 of this
document. 

Hypochlorite

Chlorine-based disinfectants, such as free chlorine, are also used by
drinking water treatment systems to treat drinking water.  Some of these
water systems use sodium hypochlorite or calcium hypochlorite as their
source of free chlorine.  Chlorate ion can be formed in these products
during the manufacturing process, but the decomposition of hypochlorite
solutions during storage is the more significant source of chlorate ion
in systems using hypochlorite.  

Chlorate ion concentrations increase between the time of manufacture and
delivery to the water plant.  The rate at which hypochlorite ion
disproportionates to chlorate is influenced by concentration of
hypochlorite, pH, and temperature.  As with the chlorine dioxide
methods, there are several ways that water systems using hypochlorite
can control the levels of chlorate; these will be discussed in Section 4
of this document. 

Drinking Water Exposure

Data on the occurrence of chlorate ion in drinking water were available
from two primary sources:  1) the Information Collection Rule (ICR)
Auxiliary 1 Database, Version 5.0, and 2) the American Water Works
Association Research Foundation (AwwaRF) study on the control of
chlorate ion in hypochlorite solutions.  The ICR data is the more
extensive data set, and the water systems represented in the ICR
database serve 60% of the total US population.  The EPA Office of Water
(OW) issued the ICR in order to collect data to support future
regulation of microbial contaminants, disinfectants, and disinfection
byproducts.  Monitoring for chlorate was included in the ICR, since
chlorate is a disinfection byproduct.  Source water and drinking water
were monitored for chlorate ion between July 1997 and December 1998. 
Water systems serving a population of at least 100,000 were required to
monitor for chlorate ion at treatment plants using chlorine dioxide or
hypochlorite solutions in the treatment process.  Plants using chlorine
dioxide collected monthly samples of the source water entering the
plant, the finished water leaving the plant, and at three sample points
in the distribution system (near the first customer, an average
residence time, and a maximum residence time).  Plants using
hypochlorite solutions were  required to collect quarterly samples of
the water entering and leaving the plant.  If chlorine dioxide or
hypochlorite solutions were used intermittently at a plant, chlorate ion
samples were only required in sample periods in which they were in use. 

The ICR Database was considered the more appropriate data source for
estimating average chlorate concentrations in drinking water from
individual water treatment plants.  The AwwaRF study is a less robust
data set, consisting of only one sample per utility, whereas the ICR
database included multiple samples over an 18 month period.  Both the
AwwaRF study and the ICR data reveal high concentrations of chlorate ion
to be a local problem affecting a relatively small number of systems.  

Based on the ICR monitoring data, the Agency was able to assess exposure
to chlorate in drinking water.  The ICR data confirm the presence of
chlorate in untreated source water which may be the result of
agricultural and other uses of sodium chlorate.  However, the chlorate
concentrations in ambient water are generally very low and are minor
compared to those observed in drinking water treated with chlorine
dioxide or hypochlorite.  Table 4 below summarizes the annual chlorate
concentrations calculated for each plant.  The data listed for
hypochlorite plants is the average chlorate concentrations, taken from
samples collected at the entry point to a distribution system.  The
figures for chlorine dioxide in the next two columns (chlorine dioxide
plans and combined hypochlorite and chlorine dioxide plants) represent
the distribution system average chlorate concentrations.  As previously
explained, for chlorine dioxide plants, samples were collected from
three points in the distribution systems; the data from these three
collection points were used to calculate a distribution system average. 
Monitoring in the distribution system was required by the ICR, since
chlorate concentrations are expected to change as the water travels
through the distribution system.  The concentration changes, because
many of the chlorine dioxide systems use chlorine to maintain a
disinfectant residual in the distribution system, and chlorine reacts
with the chlorite ion to form chlorate ion.

  Table 4.  Distribution of Average Annual   SEQ CHAPTER \h \r 1
Chlorate Concentrations - ICR Data

	Hypochlorite

Plantsa	Chlorine Dioxide

Plants b	Combined Hypochlorite and Chlorine Dioxide Plants

Number of Public Water Systems	44	22	66

Number of Water Treatment Plants 	61	29	90

Chlorate Concentration ((g/L) 

10th Percentile	23	  52 	24

20th Percentile	37	79	53

50th Percentile (Median)	99	129	108

80th Percentile	155	217	179

90th Percentile	239	264	242

Maximum	502	691	691

a.  Concentrations for hypochlorite plants are an average of samples
collected from distribution system entry points. 

b.   For chlorine dioxide pants, the distribution system average
concentration was calculated for each WTP using the three distribution
system sample points.  

		b.	Acute Dietary Risk (Drinking Water)

No acute dietary endpoint was selected because effects attributable to a
single dose were not seen in the available data; therefore, an acute
dietary (drinking water only) risk assessment was not conducted.  

			c.	  SEQ CHAPTER \h \r 1 Chronic Dietary Risk (Drinking Water)

	The chronic dietary (water only) risk assessment for chlorate in
drinking water, using the highest annual average concentration estimated
at 0.69 mg/L, is below 100% of the cPAD, and therefore, is below the
Agency’s level of concern for the general US population and all
population subgroups except infants (<1 year of age).  The highest
exposed subgroup, infants, was 159% of the cPAD, based on the highest
annual average concentration of chlorate in Table 4 (0.69 mg/L).  Using
the 90th percentile annual average concentration estimated at 0.24 mg/L,
the chronic (non-cancer) dietary (water only) risk for infants was 55%
of the cPAD.  Also for infants, using the median annual average
concentration estimated at 0.11mg/L, the risk was 25% of the cPAD.  See
Table 5 below for details.

T      Table 5.  Sum  Table 5.  Summary of Estimated Chronic Dietary
(water only) Exposure and Risk for

Sodium Chlorate by Average Annual Concentration in Large Drinking Water
Systems

Population Subgroup	

cPAD

mg/kg/day	

% cPAD

Water Estimated at the

Highest Annual Average

(0.69 mg/L)	

Water Estimated at the

90th Percentile Annual Average

(0.24 mg/L)	

Water

Estimated at the Median Annual Average

(0.11 mg/L)

General U.S. Population	

0.03	

49	

17	

8

All Infants (< 1 yr)

159	

55	

25

Children 1-2 yrs

72	

25	

12

Children 3-5 yrs

67	

23	

11

Children 6-12 yrs

47	

16	

7

Youth 13-19 yrs

35	

12	

6

Adults 20-49 yrs

45	

16	

7

Adults 50+ yrs

48	

17	

8

Females 13-49 yrs

45	

16	

7

                        7.	Residential Exposure and Risk

		  SEQ CHAPTER \h \r 1 Residential exposure assessments consider all
potential non-occupational pesticide exposure, other than exposure due
to residues in foods or in drinking water.  For sodium chlorate, the
Agency has evaluated potential exposure and risk to sodium chlorate for
homeowners who handle (mix, load, and apply) products containing sodium
chlorate.  The Agency also evaluated potential post-application exposure
and risk to adults and children entering sodium chlorate-treated areas,
such as lawns, or patio areas.  Since the episodic nature of residential
exposure for sodium chlorate is inconsistent with the mechanism of
chlorate carcinogenicity, a residential cancer risk assessment was not
conducted.

To estimate residential non-cancer (dermal and inhalation) risks, the
Agency calculates a margin of exposure (MOE), which is the ratio of the
NOAEL selected for risk assessment to the exposure.  This MOE is
compared to a level of concern which is the same value as the
uncertainty factor (UF) applied to a particular toxicity study.  The
standard UF is 100x (10x to account for interspecies extrapolation and
10x for intraspecies variation), plus any additional FQPA SF retained
due to concerns unique to the protection of infants and children.  The
FQPA SF for sodium chlorate is reduced to1x for reasons explained above;
thus, the Agency’s LOC is 100. 

	a.        Residential Handler Risks

		The Agency determined that there is the potential for residential
handlers to be exposed to sodium chlorate in outdoor residential
settings during the application of conventional pesticide products
containing sodium chlorate as the active ingredient.  Sodium chlorate
can be used as a non-selective herbicide in outdoor residential
environments as a spot treatment or edging treatment around patios,
along fence lines, lawn edges, around foundations, underneath or around
wood decks, and in cracks and crevices of driveways.  Although there is
the potential for dermal exposure by residential handlers, sodium
chlorate is an inorganic salt; therefore, significant absorption of
sodium chlorate through intact skin is not expected.  Hence, only a
short-term risk assessment for residential handlers exposed to sodium
chlorate via the inhalation exposure route was conducted.

The risk assessment considered seven residential exposure scenarios
based on the types of equipment and techniques that can potentially be
used to make sodium chlorate applications, such as handheld equipment
(hand wand sprayers) and ready-to-use (RTU) methods (sprinkler cans). 
The use patterns assessed are representative of the range of sodium
chlorate residential uses.  

The Agency considered residential handler exposure scenarios to be
short-term (1-30 days) only due to infrequency of use associated with
homeowner products.  The residential risk assessment is also based on
estimates of what and how much homeowners would typically treat, such as
the size of the lawn or garden, based on the Agency’s standard
operating procedures for residential exposures.  For more information on
the daily volume handled and the area treated used in each residential
handler scenarios, refer to Inorganic Chlorates: Residential and
Occupational Exposure Assessment for the Reregistration Eligibility
Decision Document, dated January 26, 2006.

Risk to homeowners handling sodium chlorate products are below the
Agency’s LOC.  The inhalation MOEs for all scenarios assessed are
greater than 100 (ranging from 370 to 710,000).  See Table 6 for further
detail.

Table 6.  Sodium Chlorate Residential Risk Estimates1

Exposure Scenario (Scenario #)	

Daily Area Treated	

Crop/Target	

Application Rate	

Inhalation MOE2

Mixing/loading/applying liquids with a low pressure hand wand sprayer 	

1000  ft2/day	

Spot/edging treatment	

23.7 

 lb/Ai/1000 ft2	

3000

Loading/applying RTU liquid with a trigger pump sprayer 	

1  gallon/day	

Spot/edging treatment	

0.196

lb/Ai/gallon	

87000

Mixing/loading/applying liquids with a sprinkler can 	

1000 ft2/day	

Spot/edging treatment	

23.7

lb/Ai/1000 ft2	

5200

Applying liquid with a RTU sprinkler can 	

1 gallon /day	

Spot/edging treatment	

0.27

lb/Ai/gallon	

710000

Applying granules by hand 	

1000 ft2/day	

Spot/edging treatment	

12

lb/Ai/1000 ft2	

370

Loading and applying granules with a belly grinder 	

1000 ft2/day	

Spot/edging treatment	

12

lb/Ai/1000 ft2	

2800

Loading and applying granules with a push-type spreader 	

1000 ft2/day	

Spot/edging treatment	

12

lb/Ai/1000 ft2	

200000

   1.  Residential exposures assessments do not include personal
protective equipment (PPE).

   2.  Inhalation MOE = Oral NOAEL (30 mg/kg/day) / Daily Inhalation
Dose.  The LOC for MOE is 100.

		b.  	 Residential Post-Application Risks

The Agency uses the term “post-application” to describe exposures to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide.  Unlike residential handler
exposure, where the EPA assumed only adults will be handling and
applying sodium chlorate products, individuals of varying ages can
potentially be exposed when reentering or performing activities in areas
that have been previously treated.  For products containing sodium
chlorate as the active ingredient, a post-application exposure
assessment was not conducted for the following reasons:

Although potential for post-application dermal exposure in residential
and occupational settings exists, sodium chlorate is an inorganic salt;
therefore, significant absorption of sodium chlorate through the skin is
not expected.

Post-application inhalation exposure is not expected due to a negligible
vapor pressure.

Post-application exposure assessments for residential settings (dermal
and incidental oral) are not typically performed for spot
treatments/edging treatments.

		However, for products containing sodium chlorate as an inert
ingredient, there is the potential for post-application exposure in
outdoor residential settings from entering areas previously treated. 
Therefore, a residential post-application risk assessment was conducted
based on this use.  As an inert ingredient in herbicide formulations
professionally broadcast on residential sites, there is potential for
children to have incidental oral exposures (i.e., hand-to-mouth,
object-to-mouth, and soil ingestion).  As stated above, residential
post-application exposures via dermal and inhalation routes are not of
concern.  Although there is the potential for post-application dermal
exposure in residential settings, sodium chlorate is an inorganic salt;
therefore, significant dermal absorption of sodium chlorate through
intact skin is not expected.  Post-application inhalation exposure for
sodium chlorate is not expected due to negligible vapor pressure.

A series of conservative assumptions and exposure factors served as the
basis for completing the residential post-application risk assessment,
and those assumptions and factors are listed in detail in the previously
referenced Inorganic Chlorates: Residential and Occupational Exposure
Assessment for the Reregistration Eligibility Decision Document, dated
January 26, 2006.  The risk estimates for incidental oral exposures to
sodium chlorate as an inert ingredient in other pesticide formulations
and the highest exposed population subgroup are shown in Table 7.  The
combined oral MOE of 23,000 is greater than 100; therefore, the risk is
below the Agency’s level of concern.

		

Table 7.  Residential Post-application Risk Estimates for Sodium
Chlorate as an Inert Ingredient in Herbicide Products Applied
Professionally to Residential Sites

Population Subgroup	

Scenario	

Route	

MOE	

Combined MOE

            

               Child	

Hand-to-Mouth	

Oral	

29000	

23000

	

Object-to-Mouth	

Oral	

110000

Soil Ingestion	

Oral	

8600000

	

8.	  SEQ CHAPTER \h \r 1 Aggregate Risk

	The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA,
Section 408(b)(2)(A)(ii)) require “that there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and other exposures for which there is reliable information.” 
Aggregate exposure will typically include exposures from food, drinking
water, residential uses of a pesticide, and other non-occupational
sources of exposure.  

	In accordance with FQPA, the Agency must consider and aggregate
pesticide exposures and risks from three major sources: food, drinking
water, and if applicable, residential or other non-occupational
exposures.  In an aggregate assessment, exposures from relevant sources
are added together and compared to quantitative estimates of hazard
(e.g., a NOAEL), or the risks themselves can be aggregated.  When
aggregating exposures and risks from various sources, the Agency
considers both the route and duration of exposure.  Aggregate exposure
and risk assessments for sodium chlorate include the following
scenarios: short-term (food + water + residential handler) and chronic
dietary (food + drinking water).  Results of the aggregate risk
assessment are summarized here, and are discussed more extensively in
the document: Revised Inorganic Chlorates.  HED Chapter of the
Reregistration Eligibility Decision Document (RED) dated January 26,
2006, which is available in the public docket and on the internet.

			a.	Short-Term Aggregate Risk (food + drinking water)

Short-term aggregate risk was assessed for adults only, using the
highest exposure scenario (inhalation exposure while applying granules
by hand).  Short-term aggregate risk for children would be less than the
short-term aggregate risk for adults (MOE of 324), because the
short-term MOE for residential risk to children from the use of sodium
chlorate as an inert is significantly greater (i.e., lower risk) than
the residential handler short-term MOE for adults.  Thus, all short-term
aggregate risks are below the Agency’s level of concern (i.e., MOEs
are greater than 100), as presented in Table 8.

	

Table 8.  Short-Term Aggregate Risk Calculations

Population	

Target Aggregate MOE	

MOE

Food + water  	

MOE inhalation 	

Aggregate MOE

(food + water + residential) 

    Adult	

100	

1715	

400	

324

	

   			b.	Chronic Aggregate Risk (food + drinking water)

	Since no chronic residential (non-dietary) exposure scenarios have been
identified, the chronic aggregate risk assessment considers exposure
only through food and drinking water.  To assess aggregate risks from
chronic food and drinking water exposure, the Agency used conservative
Tier 1 chronic food estimates and incorporated drinking water monitoring
data collected under the Information Collection Rule (ICR).  For chronic
aggregate dietary risks, using the estimated highest annual average of
drinking water concentrations, food and drinking water chronic exposure
estimates were above the Agency’s level of concern for all infants (<1
year old), the most highly exposed population, at 174% cPAD.  Chronic
aggregate dietary risks were at the Agency’s level of concern (100 %
cPAD) for children 1-2 years of age.  All other population subgroups
were <100 % cPAD, and therefore, below the Agency’s level of concern. 
At the 90th percentile and median annual average water concentration,
all population subgroups are below the Agency’s LOC.  The results of
this assessment for sodium chlorate are presented below in Table 9.  

Table 9.  Summary of Chronic Dietary Aggregate (food + drinking water)
Risk for Sodium Chlorate

Population Subgroupa	cPAD

(mg/kg/day)	% cPAD (food + drinking water)

Highest Annual Average

(0.69 mg/L)	90th Percentile Annual Average

(0.24 mg/L)	Median Annual Average

(0.11 mg/L)

General US Population	0.03	58	26	17

All Infants (< 1 yr)

174	70	40

Children 1-2 yrs

100	53	39

Children 3-5 yrs

90	47	34

				  tc "7.3	Cancer Dietary Risk - Food + Water  " \l 2 9.	
Occupational Exposure and Risk 

The occupational risk assessment addresses risks to workers who may be
exposed to sodium chlorate when mixing, loading, or applying a pesticide
(i.e., handlers), and when entering treated sites for routine tasks
(post-application).  Please see Table 2 for the toxicological endpoints
used in the sodium chlorate occupational assessment.  Based on the
registered use patterns of sodium-chlorate, short-term (1-30 days) and
intermediate-term (1-6 months) occupational exposures were assessed;
long-term (> 6 months) exposure is not expected.  

Exposure for workers generally occurs via the dermal or inhalation
route; however, since sodium chlorate is an inorganic salt, and
significant absorption of sodium chlorate through the skin is not
expected, a dermal toxicological endpoint was not selected.  As such, a
risk assessment for dermal exposure was not performed.  Similarly,
post-application exposure was not assessed due to the physical and
chemical characteristics of sodium chlorate as an inorganic salt; no
significant amount of sodium chlorate is expected to be absorbed through
the skin, and the vapor pressure is negligible.  Further, for the
antimicrobial use of sodium chlorate in chlorine dioxide generation for
drinking water treatment, exposure to chlorate is expected to be
negligible because of its conversion to chlorine dioxide inside the
closed generators.  Post-application exposure to chlorine dioxide will
be addressed in the chlorine dioxide risk assessment and RED.

The occupational assessment estimates non-cancer risks using the MOE
approach.  MOEs greater than 100 are below the Agency’s level of
concern for short- and intermediate-term occupational exposure. 

Occupational exposure to sodium chlorate was assessed using data from
the Pesticide Handler Exposure Database (PHED) and Outdoor Residential
Exposure Task Force (ORETF).  In addition, standard default assumptions
pertaining to average body weight, work day, and area treated daily were
used to calculate risk estimates.  Application rates used in this
assessment are derived directly from current sodium chlorate labels. 
Worker exposure and risk estimates are based on the best data currently
available to the Agency.  

	The occupational risk assessment is summarized here.  For further
detail, see the following documents: (1) Revised Inorganic Chlorates. 
HED Chapter of the Reregistration Eligibility Decision Document (RED)
dated January 26, 2006; (2) Inorganic Chlorates: Occupational and
Residential Exposure Assessment for the Reregistration Eligibility
Decision (RED) Document (Case 4049), dated June 13, 2005; and (3) Sodium
Chlorate:  Occupational and Residential Exposure Assessment of
Antimicrobial Uses for the Reregistration Eligibility Decision Document
dated January 24, 2005. tc "a.	Toxicity " \l 4 

	

a.	Handler Risks

	Occupational handler exposure assessments are conducted by the Agency
using different levels of protection.  The Agency typically evaluates
all exposures with minimal protection and then adds protective measures
in a tiered approach to determine the level of protection necessary to
obtain appropriate MOEs.  The lowest level (baseline) includes long
sleeve shirts, long pants, shoes, and socks.  A single layer of PPE
includes the addition of chemical-resistant gloves to the baseline
attire of long sleeves, long pants, shoes, and socks.  A respirator may
also be added if there is a concern for inhalation exposure.  If MOEs at
that level of PPE are less than 100, increasing levels of PPE are
applied (i.e., coveralls are added to provide a double layer of
protective clothing or respirators).  If MOEs are still less than 100
with maximum PPE, then engineering controls are applied (i.e., enclosed
cabs or cockpits and closed mixing/loading systems).  Note that the
lower levels of PPE protect against dermal exposure, and dermal exposure
is not anticipated for sodium chlorate.  The types of protection,
including PPE and engineering controls, which were used to calculate
inhalation occupational exposure from sodium chlorate are as follows:

	•	Baseline:	            	No respirator

	•	PPE:			   Dust/mist respirator with an 80% reduction factor

	•	Engineering Controls:	   Enclosed cockpits or enclosed cabs 

	Anticipated use patterns and current labeling for sodium chlorate
indicate several major occupational exposure scenarios that can result
in handlers receiving inhalation exposures to sodium chlorate, including
the antimicrobial use of sodium chlorate to generate chlorine dioxide
for drinking water treatment.  These exposure scenarios are based on the
chemical formulations, equipment, and techniques that handlers can use
to make sodium chlorate applications.  Exposures are also considered
based on their duration.  The Agency assessed short- (1 to 30 days) and
intermediate-term (30 days to several months) exposures to sodium
chlorate, though the results were essentially the same because the
toxicological endpoints for short- and intermediate-term exposures are
the same in the case of sodium chlorate.  For short and
intermediate-term exposures, MOEs greater than 100 are not of concern to
the Agency.

	Risks to handlers treating water systems are below the Agency’s level
of concern, with inhalation MOEs of 800 to 95,000 depending on the size
of the generator.  All sodium chlorate applications to chlorine dioxide
generators occur in closed delivery systems.  In addition, risk for most
occupational handler scenarios do not exceed the Agency’s level of
concern of 100 (i.e, most scenarios had MOEs > 100) at the baseline
level of protection.  However, risks for the following occupational
scenarios did exceed the Agency’s level of concern at baseline level
of protection:

Mixing/Loading liquids for groundboom application to industrial/non-crop
sites at 1032 lb/Ai per acre (MOE = 42) and 523 lb/Ai per acre (MOE =
84);

Loading granules for tractor-drawn spreader applications to
industrial/non-crop sites at 523 lb/Ai per acre (MOE = 59); 

Applying sprays to industrial/non-crop sites using groundboom equipment
(open cab) at 1032 lb/Ai per acre (MOE = 69); at 523 lb/Ai per acre (MOE
= 140); 

Mixing/Loading/Applying liquids for low pressure handwand applications
to industrial/non-crop sites at 1032 lb/Ai per acre (MOE = 34) and 523
lb/Ai per acre (MOE = 67); and

Loading/Applying granules to industrial/non-crop sites using a belly
grinder at 523 lb/Ai per acre (MOE = 65);

	Inhalation handler risk for these scenarios did not exceed the
Agency’s level of concern with the addition of a dust/mist respirator
(with an 80% reduction factor).  Additionally, risks for certain
scenarios were below the Agency’s level of concern, without the
application of PPE or engineering controls, once lower application rates
were used.  All risks of concern were at the high end of application
rates (>523 lb/Ai per acre), whereas at lower rates the risks were not
of concern.  Table 10 summarizes the risk results for short-term and
intermediate-term occupational handlers.  

Table 10.  Sodium Chlorate: Short- and Intermediate-Term Occupational
Inhalation Exposure

Exposure Scenario 	Daily Area Treated1	Crop/Target	Application Rate

(lb/Ai/A)	Baseline

Inhalation MOE2	PPE3	Engineering Controls

Mixer/Loaders

Mixing/Loading liquids for aerial application 	1200	Cotton, Corn, Rice,
Dry Beans, Grain Sorghum, Flax, Safflower, Sunflower, Soybeans	7.5	190
-------	--------

Fallow Land, Wheat	6	240	-------	--------

	350	Chili Peppers (for processing only), Potatoes	12.5	400	-------
--------

Ornamental Gourds, Cucurbits (grown for seed)	6	830	-------	--------

Guar Beans, Southern Peas	7.5	670	-------	--------

Mixing/Loading liquids for groundboom application 	200	Cotton, Corn,
Rice, Dry Beans, Grain Sorghum, Flax, Safflower, Sunflower, Soybeans	7.5
1200	-------	--------

Fallow Land, Wheat	6	1500	-------	--------

	80	Chili Peppers (for processing only), Potatoes	12.5	1800	-------
--------

Ornamental Gourds, Cucurbits (grown for seed)	6	3600	-------	--------

Guar Beans, Southern Peas 	7.5	2900	-------	--------

	40	Industrial/Non-Crop Sites	1032	42	210	--------

	523	84	420	--------

	132	330	-------	--------

Mixing/Loading liquids for rights-of-way sprayer application 	5
Rights-of-Way & Industrial/Non-Crop Sites	1032	340	-------	--------

	523	670	-------	--------

	132	2700	-------	--------

Loading granules for tractor-drawn spreader application 	40
Industrial/Non-Crop Sites	523	59	300	--------

	240	130	-------	--------

	161	190	-------	--------

Applicators

Aerial spray applications 

(enclosed cockpit)	1200	Cotton, Corn, Rice, Dry Beans, Grain Sorghum,
Flax, Safflower, Sunflower, Soybeans	7.50	--------	-------	3400

Fallow Land, Wheat	6	--------	-------	4300

	350	Guar Beans, Southern Peas	7.5	--------	-------	12000

Chili Peppers (for processing only), Potatoes	12.5	--------	-------	7100

Ornamental Gourds, Cucurbits (grown for seed)	6	--------	-------	15000

Groundboom spray applications 	1200	Cotton, Corn, Rice, Dry Beans, Grain
Sorghum, Flax, Safflower, Sunflower, Soybeans	7.5	1900	-------	--------

Fallow Land, Wheat	6	2400	-------	--------

	350	Guar Beans, Southern Peas	7.5	4700	-------	--------

Chili Peppers (for processing only), Potatoes	12.5	2800	-------	--------

Ornamental Gourds, Cucurbits (grown for seed)	6	5900	-------	--------

	40	Industrial/Non-Crop Sites	1032	69	340	1200 (closed cab)

	523	140	-------	2300 (closed cab)

	

132	540	-------	9200 (closed cab)

Rights-of-way sprayer applications 	5	Rights-of-Way &
Industrial/Non-Crop Sites	1032	110	-------	--------

	523	210	-------	--------

	132	820	-------	--------

Tractor-drawn spreader applications	40	Industrial/Non-Crop Sites	523	84
420	460 (closed cab)

	240	180	-------	990 (closed cab)

	161	270	-------	1500 (closed cab)

Flaggers

Flagging for aerial spray applications	350	Various Agricultural Crops
12.5	1400	-------	--------

Mixer/Loader/Applicators & Loader/Applicators

M/L/A liquids with a low pressure handwand sprayer 	2
Industrial/Non-Crop Sites	1032	34	170	--------

	523	67	330	--------

	132	270	-------	--------

M/L/A liquids with a handgun sprayer 	5	Industrial/Non-Crop Sites	1032
230	-------	--------

	523	450	-------	--------

	132	1800	-------	--------

L/A granules with a belly grinder 	1	Industrial/Non-Crop Sites	523	65
320	--------

	240	140	-------	--------

	161	210	-------	--------

L/A granules with a push-type spreader	5	Industrial/Non-Crop Sites	523
110	-------	--------

	240	240	-------	--------

	161	360	-------	--------

1.   Amount treated is presented in acres/day. 

2.   Inhalation MOE = Oral NOAEL (30 mg/kg/day) / Daily Inhalation Dose.
 LOC for MOE is 100.

3.   PPE dust/mist respirator with an 80% reduction factor.

	

      Incident  tc "Incident " \l 2  Reports

	  SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 Available sources of
incident data in humans were reviewed for the active ingredients sodium
chlorate and calcium chlorate (not currently registered).  No data were
found in any of the available databases on calcium chlorate, so this
review exclusively addresses sodium chlorate.  Data were available from
the following sources: OPP Incident Data System (IDS) consisting of
reports submitted to EPA by registrants, other federal and state health
and environmental agencies, and the public, since 1992; Poison Control
Centers (1993-2001); California Department of Pesticide Regulation for
pesticide poisoning since 1982; National Pesticide Telecommunications
Network (NPTN) for ranking of the top 200 active ingredients for which
phone calls were received during calendar years 1984-1991; and National
Institute of Occupational Safety and Health’s Sentinel Event
Notification System for Occupational Risks (NIOSH SENSOR) from
1998-2002.

A total of 21 cases were recorded by the Poison Control Center from 1993
through 2001.  Seven reported minor symptoms, and two reported moderate
medical outcomes, primarily due to dermal effects such as swelling and
rash.  It is difficult to draw any conclusions from these reports
because of the small number of cases.

	Detailed descriptions of 36 cases submitted to the California Pesticide
Illness Surveillance Program (1982-2002) were reviewed.  However, sodium
chlorate was determined to be the primary cause of illness in just four
of these cases, and all four occurred in an agricultural setting (three
in cotton fields and one unknown).  Two of these cases were classified
as systemic and one each involved skin or eye effects.  The two systemic
cases involved applicators; one with nausea and the other with nausea,
headache, and itching skin after spraying for one week.  Both of these
cases were classified as “possibly” due to sodium chlorate.  The
skin case involved a worker exposed to drift from an adjacent field and
the eye case occurred when a worker bumped into a spray nozzle while
getting off the tractor and was splashed in the face.  The skin case was
classified as “probably,” and the eye case as “definitely,” due
to sodium chlorate.

	A number of suicidal ingestions of sodium chlorate have been reported
in the literature, and many of these have led to death.  The chance of
ingesting a fatal dose accidentally is small unless the compound is
mistaken for a drug and taken purposely.  However, a near-fatal
poisoning occurred when a 13-year-old boy “tasted” crystals of this
weed killer which he found in his father’s shed.  In spite of
intensive treatment, recovery did not begin until about the 15th day and
required a little over 40 days. 

Dermal absorption associated with agricultural use of sodium chlorate is
not sufficient to cause systemic poisoning.  Even by mouth, a large dose
is required to produce illness.  A 6.35% solution of potassium chlorate
was long used as a gargle, or a 300-mg tablet was allowed to dissolve
slowly in the mouth to treat pharyngitis before modern antibiotics
became available.  The toxicities of the sodium and potassium salts are
similar.  It was considered that a dose of 10,000 mg was fatal.  The
smallest recorded fatal dose was 7500 mg.  However, vigorous treatment
saved one person who had ingested about 40,000 mg.

	B.	Environmental Fate and Effects Risk Assessment

	A summary of the Agency’s environmental fate and effects risk
assessment is presented below.  For detailed discussion of all aspects
of the environmental risk assessment, please see the Revised
Environmental Fate and Ecological Risk Assessment of Sodium Chlorate,
dated June 1, 2006; it is available on the internet and in the public
docket.  This risk assessment was refined and updated to incorporate
public comments and data received during the phase 3 public comment
period.

 

		1.	Environmental Fate and Transport  tc "		1.	Environmental Fate and
Transport " \l 3 

	Sodium chlorate, an inorganic salt, is not a naturally occurring
chemical.  It is made by electrolysis of brine under controlled
temperature and pH conditions to optimize the efficiency of the process
and yield.  Since targeted, guideline studies designed to understand the
environmental fate of chlorate are not available, open, peer-reviewed
chemical literature and descriptive chemistry of the chlorine system
were used as the basis for understanding the redox behavior of chlorate
(at least on a qualitative basis) and for generating a screening-level
environmental fate assessment.  

	Physical and chemical properties of a chemical can be used to identify
potential routes of exposure.  For example, the vapor pressure and
Henry’s Law Constant provide an indication of the potential to
volatilize from soil and water (partitioning into air), and the
n-octanol/water partition coefficient provides an indication of the
potential to bioaccumulate in fish or other aquatic organisms.  Based on
the very low vapor pressure and very high solubility of sodium chlorate
in water, sodium chlorate is not expected to volatilize from soil or
water.  In addition, the low log n-octanol/water partition coefficient
indicates that sodium chlorate has low potential to bioaccumulate.  

	As stated above, sodium chlorate is highly soluble.  In addition,
sodium chlorate is completely ionized in water, thus producing sodium
(Na+) and the chlorate (ClO 3-) anion.  Anions do not bind readily to
soil or sediment particulates and, therefore, are expected to be very
mobile.  Assuming that chlorate does not undergo any redox reactions, it
is expected to be very mobile and to partition predominantly into the
water.  However, extensive redox reactions are expected to occur in the
environment that will reduce the concentration of chlorate in the water
column.  

	The redox chemistry of chlorate affects its behavior in soils and
natural water.  Therefore, identification of the conditions under which
chlorate and other oxyanions of chlorine may predominate is an important
consideration in the environmental fate and risk assessment of chlorate.
 The oxidation-reduction reactions of chlorate with organic matter and
other inorganic chemical species are very complex and depend on the
redox conditions of the media, nature and concentration of reductants,
chlorate concentration, temperature, pH, and degree of moisture (soils).
 For example, chlorate is generally more stable under alkaline than
acidic conditions; however, when a chemical element (chlorine) can exist
in two or more oxidation states (i.e., chlorite and chlorate), the redox
potential of the media also effects the predominance of the reduction
products.  Nitrate concentrations in soil and water (as well as other
physical and chemical properties of soil and water) play an important
role in the redox chemistry of chlorate in the environment.

		2.	Ecological Exposure and Risk

	  SEQ CHAPTER \h \r 1 To estimate potential ecological risk, EPA
integrates the results of exposure and ecotoxicity studies using the
risk quotient method.  Risk quotients (RQs) are calculated by dividing
acute and chronic estimated environmental concentrations (EECs) by
ecotoxicity values for various wildlife and plant species.  RQs are then
compared to levels of concern (LOCs), and when the RQ exceeds the level
of concern for a particular category, the Agency presumes a risk of
concern to that category.  See Table 11 below for the Agency’s
ecological LOCs.  Risk characterization provides further information on
potential adverse effects and the possible impact of those effects by
considering the fate of the chemical and its degradates in the
environment, organisms potentially at risk, and the nature of the
effects observed.  

Table 11.  EPA’s  Ecological Levels of Concern (LOCs) and Risk
Presumptions

If a calculated RQ is greater than the LOC presented, then the Agency
presumes that…	LOC

terrestrial animals	LOC

aquatic animals	LOC

plants

Acute Risk …there is potential for acute risk; regulatory action may
be warranted in addition to restricted use classification	0.5	0.5	1.0

Acute Endangered Species …endangered species may be adversely affected
0.1	0.05	1.0

Chronic Risk …there is potential for chronic risk	1	1	NA

		

a.	Terrestrial Organisms

Birds and Mammals

Exposure 

	Sodium chlorate may be applied as a spray (agricultural and
nonagricultural uses) or as granules (nonagricultural uses only).  The
Agency’s methods for assessing exposure to terrestrial organisms are
different for each of these application methods and are discussed below.

	For spray applications, the Agency’s terrestrial exposure model
(ELL-FATE) was used to estimate exposures and risks to avian and
mammalian species.  Input values on avian and mammalian toxicity, as
well as chemical application and foliar dissipation half-life data, are
required to run the model.  The model provides estimates of both
exposure concentrations and RQs.  Specifically, the model provides
estimates of concentrations (maximum and average) of chemical residues
on the surface of different types of foliage that may be sources of
exposure to avian, mammalian, reptilian, or terrestrial phase amphibian
receptors.  The surface residue concentration (ppm) is estimated by
multiplying the application rate (pounds active ingredient per acre) by
a value specific to each food item.  In all screening-level assessments,
the organisms are assumed to consume 100% of their diet as one food
type.  These exposure estimates are only applicable to the applied
pesticide, sodium chlorate.  It is uncertain to what extent exposure to
reduced species of chlorate, such as chlorite, may occur.

		ELL-FATE was run for sodium chlorate for use on agricultural crops
using the inputs provided in Table 12 below.  In the absence of foliar
dissipation half-life data for sodium chlorate, the Agency’s default
half-life value of 35 days was used for all scenarios.  

Table 12.  Input Parameters for Sodium Chlorate Used in ELL-FATE

Crop	Maximum labeled application rate	No. of applications	Application
interval

Chili peppers; white/Irish potatoes	12.5 lbs ai/A	1	N/A

Cotton	7.5 lbs ai/A	2	30 days

Corn; flax, guar; southern peas; rice; safflower; sorghum; soybeans;
sunflower	7.5 lbs ai/A	1	N/A

Agricultural fallow land; dried beans; corn; cucurbits, flax, gourds;
guar; southern peas; white/Irish potatoes; rice; safflower; sorghum;
soybeans; sunflower	6 lbs ai/A	1	N/A

    

	The predicted upper 90th percentile and mean chlorate EECs
(agricultural and non-agricultural uses) on various wild animal food
items are presented in Table 13 below.  

Table 13.  EECs (mg ai/kg-food item) for Terrestrial Animal Risk
Assessment for Sodium Chlorate

Crops	Predicted 90th Percentile Residue Levels	Predicted Mean Residue
Levels

	short grass	tall grass	broadleaf forage, small insects	fruit, pods,
seeds, small insects	short grass	tall grass	broadleaf forage, small
insects	fruit, pods, seeds, small insects

Agricultural Uses (Spray Applications)

Chili peppers; white/Irish potatoes	3000	1400	1700	190	1100	450	560	88

Cotton	2800	1300	1600	170	990	420	520	81

Corn; flax, guar; southern peas; rice; safflower; sorghum; soybeans;
sunflower	1800	830	1000	110	640	270	340	53

Agricultural fallow land; dried beans; corn; cucurbits, flax, gourds;
guar; southern peas; white/Irish potatoes; rice; safflower; sorghum;
soybeans; sunflower	1400	660	810	90	510	220	270	42

Non-Agricultural Uses (Spray Applications)

Industrial sites such as driveways, paths, brick walks, cobble gutters,
tennis courts	12500	5700	7000	780	4400	1900	2300	360

Parking lots, fence lines, building perimeters, ditch banks, picnic
areas, vacant lots, wood decks, bleachers, cemeteries, fuel tanks,
runways, helo pads, etc.	125,000	57,000	70,000	7800	44,000	19,000	23,000
3600

		For granular applications, estimation of chlorate loading per unit
area (mg/ft2) is calculated.  This approach, which is intended to
represent exposure via multiple routes (e.g., incidental ingestion of
contaminated soil, dermal contact with treated seed surfaces and soil
during activities in the treated areas, preening activities, and
ingestion of drinking water contaminated with pesticide) and not just
direct ingestion, considers observed effects in toxicity studies and
relates them to the amount of pesticide applied to surface area. The
maximum labeled application rate for the active ingredient is the basis
for the exposure estimate.  The terrestrial EECs for sodium chlorate’s
non-agricultural use granular applications are presented in Table 14
below.  

Table 14.  Range of Terrestrial EECs (Granular Applications) for Sodium
Chlorate 

 Non-Agricultural Uses

Use	Application Rate

(lbs ai/A)	EEC (mg/ft2)a

Parking lots, under asphalt paving, fence lines, building perimeters,
ditch banks, picnic areas, vacant lots, wood decks, bleachers,
cemeteries, fuel tanks, runways, helo pads, etc.	520	5400

Around buildings, storage areas, fences, pumps, machinery, fuel tanks,
recreational areas, roadways, guard rails, airports, rights of ways.	160
1700

   a.   EEC = Application rate (lbs/Acre) x 453,000 mg/lb ÷ 43,600 sq
ft/Acre

						b.	Toxicity 

	 Effects characterization describes the potential effects a pesticide
can produce in a terrestrial organism, and is based on
registrant-submitted studies that describe acute and chronic toxicity
effects for various terrestrial animals.  Table 15 summarizes the
toxicity effects and reference values used to assess risks for sodium
chlorate to mammals and birds.

Table 15.  Toxicity Reference Values for Mammals and Birds for Sodium
Chlorate.  tc "Table 37.  Toxicity reference values for mammals and
birds for permethrin. " \f D  

Exposure Scenario	Species	Toxicity Value Used in Risk Assessment	Effect

Mammals

Acute	Rat	LD50 = > 5000 mg/kg-bw	At 5000 mg/kg-bw, 1/10 animals died.

Chronic	Rat	NOAEC = 500 mg/kg-bw, highest dose tested (approx. 10,000
ppm)	No reproductive effects

Birds

Acute	Mallard duck	LD50 > 2510 mg/kg-bw	No mortality and no clinical
signs of toxicity were observed.

Chronic	Bobwhite quail	NOAEC = 271 ppm	The LOAEC was 964 ppm based on
effects on egg production and thickness, embryonic survival, and
hatchling body weight.

		           			c.	Avian Risk Estimates 

		Acute RQs for birds were not calculated, because no mortality or signs
of toxicity were observed in the submitted subacute or acute toxicity
studies at concentrations that are above the limit for these types of
studies.  

	Avian chronic RQs for agricultural crops, at the estimated upper 90th
percentile residue levels, are presented in Table 16 below.  RQ values
for all crops and all avian food items assessed, except the fruits,
pods, seeds, and small insects category, marginally exceeded the
Agency’s chronic LOC of 1.0.  The highest chronic avian RQ was 11
(chili pepper/potato and short grass scenario).  Chronic RQs based on
mean EECs, although not presented here, would be approximately three
times lower for most food items than those based on the 90th percentile
residue levels shown below.

  Table 16.   Avian Chronic Risk Quotients for Sodium Chlorate
Agricultural Uses

Crops	Short grass	Tall grass	Broadleaf forage, small insects	Fruit,
pods, seeds, small insects

Chili peppers; white/Irish potatoes	11.0	5.2	6.3	0.7

Cotton	10.0	4.8	5.9	0.63

Corn; flax, guar; southern peas; rice; safflower; sorghum; soybeans;
sunflower	6.6	3.1	3.7	0.41

Agricultural fallow land; dried beans; corn; cucurbits, flax, gourds;
guar; southern peas; white/Irish potatoes; rice; safflower; sorghum;
soybeans; sunflower	5.2	2.4	3.0	0.33

		Chronic RQs for birds are not presented for chlorate’s
non-agricultural uses (granular or spray).  However, RQs would be
considerably higher for birds foraging where chlorate is applied at the
rates assessed for the non-agricultural uses.  EECs ranged from 12,500
to 125,000 (short grass food item), which would result in chronic avian
RQs of 46 to 460.  The size of the treated areas for these uses is
uncertain, and this will be discussed further in Section IV of this
document; therefore, the likelihood that a bird would consume 100% of
its diet from a non-agricultural area treated with sodium chlorate is
uncertain.

					d.	Mammalian Risk Estimates	

Acute  tc "

Acute  " \l 4 RQs were not calculated for mammals.  The LD50 from a core
acute oral toxicity study in rats was >5000 mg/kg-bw.  In this study,
10% (1/10) of the rats administered 5000 mg/kg died.  Mortality was not
observed at any other dose.  Therefore, the data were not sufficient to
allow for characterization of the dose-response relationship and the
proximity of the LD50 to 5000 mg/kg-bw is uncertain.  For this reason,
acute RQs were not calculated.  However, Tables 17 and 18 below present
a comparison of the body weight adjusted LD50s to the agricultural and
non-agricultural EECs, respectively, based on current use rates and the
spray application method.  These ratios can be used to estimate high-end
acute risk to exposed mammals.  Actual RQs would be lower than the
values in Tables 17 and 18.  

Table 17.  Proximity of the lowest observed acute toxic dose in mammals
to the upper 90th percentile EEC (mg/kg-bw) for the range of maximum
application rates for all agricultural uses

Food item	Size of mammal

(grams)	Adjusted lowest observed toxic dose (mg/kg-bw)	Range of EECs

(mg/kg-bw)a	Ratio of lowest observed toxic dose to the upper 90th
percentile EEC (unitless)

Short grass	15	10,989	1400 - 2900	0.13 - 0.26

	35	8891	950 - 2000	0.11 - 0.22

	1000	3846	200 - 450	0.052 - 0.12

Tall grass	15	10,989	630 - 1300	0.057 - 0.12

	35	8891	440 - 910	0.049 - 0.10

	1000	3846	99 - 210	0.026 - 0.055

Broadleaf plants/small insects	15	10,989	770 - 1600	0.070 - 0.15

	35	8891	540 - 1100	0.061 - 0.12

	1000	3846	120 - 250	0.031 - 0.065

Fruits, pods, large insects	15	10989	86 - 180	<0.01 - 0.016

	35	8891	59 - 120	<0.01 - 0.013

	1000	3846	14 - 28	<0.01 - <0.01

a.  EECs were calculated by assuming that small, medium, and large
mammals consume 95%, 66%, and 15% of their body weight daily.  Only the
highest and lowest EECs from chlorate’s agricultural uses are used in
this assessment.

For sodium chlorate’s agricultural uses, all of the acute ratios are
below the Agency’s acute and endangered species LOC of 1.0 and 0.1,
respectively, with the exception of small mammals eating short grass. 
The highest exceedence is for 15 gram mammals eating short grass (ratio
= 0.26).  

	Based on current non-agricultural use application rates, the only group
that does not exceed the Agency’s acute mammalian LOC of 1.0 is
animals eating fruits, pods, or large insects (ratios range from 0.3 to
0.7).  The Agency’s acute mammalian endangered species LOC of 0.1 is
potentially exceeded for all size animals and food items.  While the
ratios presented in Table 18 suggest that there could be risk to mammals
of all sizes that forage in the area where chlorate is used for the
non-agricultural spray applications, the risk was likely over-estimated,
since an LD50 has not been established.  The highest dose tested in the
available toxicity studies (5000 mg/kg-bw) induced 10% mortality.  The
proximity of the LD50 to 5000 mg/kg-bw is uncertain.  Furthermore, many
of the non-agricultural uses will likely result in small contiguously
treated areas; therefore, the likelihood that an animal will consume
100% of its diet from the areas treated with sodium chlorate is low for
some of these uses.  Nonetheless, the EECs were predicted to be up to 11
times higher than 5000 mg/kg-bw for the non-agricultural uses. 
Therefore, there may be some acute risk to mammals at levels of concern
to the Agency for non-agricultural uses.  

Table 18.  Proximity of the lowest observed acute toxic dose in mammals
to the predicted EEC (mg/kg-bw) for the range of maximum application
rates for all non-agricultural uses (spray applications)

Food item	Size of mammal

(grams)	Adjusted lowest observed toxic dose

(mg/kg-bw)	Range of EECs

(mg/kg-bw)a	Ratio of lowest observed toxic dose to the upper 90th
percentile EEC (unitless)

Short grass	15	10989	11,900 - 119,000	1.1 - 11

	35	8891	8200 - 82,000	0.93 - 9.3

	1000	3846	1900 - 19,000	0.49 - 4.9

Tall grass	15	10989	5400 - 54,000	0.49 - 4.9

	35	8891	3800 - 38,000	0.43 - 4.3

	1000	3846	860 - 8600	0.22 - 2.2

Broadleaf plants/small insects	15	10989	6700 - 67,000	0.61 - 6.1

	35	8891	4600 - 46,000	0.52 - 5.2

	1000	3846	1100 - 11,000	0.27 - 2.7

Fruits, pods, large insects	15	10989	740 - 7400	0.07 - 0.7

	35	8891	520 - 5200	0.06 - 0.6

	1000	3846	120 - 1200	0.03 - 0.3

a.  EECs were calculated by assuming that small, medium, and large
mammals consume 95%, 66%, and 15%, respectively, of their body weight
daily, and were calculated using the lowest and highest labeled
application rates (52 lbs ai/A and 520 lbs ai/A) that are most likely to
result in exposure

RQs were not calculated for acute risk for non-agricultural granular
applications for reasons previously discussed.  However, Table 19 below
presents a comparison of the body weight adjusted lowest observed toxic
dose in rats (5000 mg/kg-day) to the granular application EECs (mg/ft2).
 These ratios indicate a potential acute risk to mammals of all size
classes, as the lowest ratio (0.43 for large mammals and the building
and storage area perimeter scenario) exceeds the acute endangered
species LOC of 0.1.

Table 19.  Range of ratios of chlorate’s body weight adjusted LD50 to
granular EECs (mg/ft2) for sodium chlorate’s non-agricultural uses
(granular formulations)

Use	Body Weight (g)	Rat LD50

mg/kg-bw	EEC (mg/ft2)a	Ratio of LD50  to EEC

Parking lots, under asphalt paving, fence lines, building perimeters,
ditch banks, picnic areas, vacant lots, wood decks, bleachers,
cemeteries, fuel tanks, runways, helo pads, etc.

	15	10,989	5400	33

	35	8891	5400	17

	1000	3846	5400	1.4

Around buildings, storage areas, fences, pumps, machinery, fuel tanks,
recreational areas, roadways, guard rails, airports, rights of ways.

	15	10,989	1700	10

	35	8891	1700	5.4

	1000	3846	1700	0.43

a.  EEC = Application rate (lbs/Acre) x 453,000 mg/lb ÷ 43,600 sq
ft/Acre

For mammals, the Agency typically evaluates the mammalian reproductive
effects for exposures greater than 30 days.  Interpretation of the RQs
resulting from the NOAEL of 500 mg/kg-day observed in a 2-generation rat
study is difficult in this respect.  Although the study did indicate
some chronic effects, reproduction effects were not observed at any dose
level tested.  Because 500 mg/kg was the highest dose tested, it is
uncertain whether there is a NOAEL for reproductive effects.  In
addition, if there is an actual NOAEL for reproductive effects, it could
be much greater than 500 mg/kg.  

However, the Agency calculated RQs based on the 500 mg/kg-day NOAEL as a
conservative estimate of risk, as presented in Table 20.  Based on this
conservative estimate, chronic mammalian LOC of 1.0 was only slightly
exceeded for the smallest weight classes of mammals for most food items
and the largest weight class of mammals feeding on short grass.  Based
on the lack of observed reproductive effects in the chronic study and
the slight RQs exceedances for agricultural uses, the Agency does not
anticipate a chronic risk of concern to mammals from agricultural uses
of sodium chlorate.  

Table 20.  Mammalian Chronic Risk Quotients for Sodium Chlorate’s
Agricultural Uses (Spay Application)

Use	Food Item	15-gram mammal	35-gram mammal	1000-gram mammal

Single application of 12.5 lbs ai/A

Chili peppers; white/Irish potatoes

Chili peppers; white/Irish potatoes	Short Grass	2.6	2.2	1.2

	Tall Grass	1.2	1.0	0.55

	Broadleaf plants/small insects	1.5	1.3	0.67

	Fruits/pods/large insects	0.16	0.14	0.07

Multiple applications (7.5 lbs ai/A, 2 applications, 30-day interval)

Cotton	Short Grass	2.4	2.1	1.1

	Tall Grass	1.1	0.95	0.51

	Broadleaf plants/small insects	1.4	1.2	0.62

	Fruits/pods/large insects	0.15	0.13	 0.07

Single application (7.5 lbs ai/A)a

Corn; flax, guar; southern peas; rice; safflower; sorghum; soybeans;
sunflower

Agricultural fallow land; dried beans; corn; cucurbitsa, flax, gourds;
guar; southern peas; white/Irish potatoes; rice; safflower; sorghum;
soybeans; sunflower 	Short Grass	1.6	1.3	0.72

	Tall Grass	0.72	0.61	0.33

	Broadleaf plants/small insects	0.88	0.75	0.40

	Fruits/pods/large insects	0.10	0.08	0.04

a.  EECs and RQs are similar for the 7.5lbs a.i/A  (corn, et al.) and 
6.0 lbs a.i./A (agricultural fallow land, et al.) and single
applications, and LOC exceedances are equivalent; therefore, only
results from the single application of 7.5 lbs ai/A are presented.

Reproduction RQs were not calculated for chlorate’s non-agricultural
uses (spray or granular applications).  However, based on the high
application rates and resulting high potential EECs, risks from
chlorate’s non-agricultural uses could be considerably higher than
risks presented for agricultural uses.  

				2.	Non-Target Insects

	EPA currently does not estimate RQs for terrestrial non-target insects.
 Furthermore, the Agency has no insect toxicity data for sodium
chlorate.

				3.	Non-Target Terrestrial Plants

	Based on chlorate’s non-selective mode of action and lack of adequate
toxicity data, the Agency presumes risk to non-target terrestrial plants
at levels above the Agency’s level of concern for all uses.  The risks
to plants cannot be quantified at this time due to lack of data;
however, the Agency will require data to address this uncertainty.

b.          Aquatic Organisms

At the present time, there is no methodology to estimate exposure
concentrations in water for non-metal inorganic chemical species that
can be found in different oxidation states (e.g., for inorganic chemical
species that can exhibit extensive pH-pE dependent redox chemistry, such
as the chlorine system).  As an approximation on the impact of chlorate
on surface water quality, the Tier I GENEEC-2 simulation model was used
to estimate exposure concentrations in aquatic systems.  Extreme
assumptions in the environmental persistence of chlorate were made that
resulted in high-end exposure concentrations in the standard ecological
pond scenario.  The predicted chlorate concentrations are believed to be
high because the chemical speciation of chlorate was not considered in
the assessment.  As previously discussed, under thermodynamic
equilibrium conditions, chloride is likely the predominant species in
natural environments.  This analysis, however, indicates that chlorate
can be reduced to chloride, but not how fast the reduction will occur. 
Since there are no input parameters for the model that take into account
the redox behavior of chlorate, it was assumed that unchanged chlorate
runs off into surface water, where it remains as chlorate.

	Unlike the drinking water assessment described in the human health risk
assessment section of this document, the exposure values used in the
ecological risk assessment do not include the Index Reservoir (IR) and
Percent Cropped Area (PCA) factor refinements.  These factors represent
a drinking water reservoir, not the variety of aquatic habitats relevant
to a risk assessment for aquatic animals, such as ponds adjacent to
treated fields.  Therefore, the EEC values used to assess exposure and
risk to aquatic animals are not the same as those used to assess
exposure and risk to humans from pesticides in drinking water.  

				1.	Fish	

	

	Acute toxicity studies for both freshwater and marine/estuarine fish
were consistent with a “practically non-toxic” designation for fish.
 No effects were observed in sheepshead minnows (estuarine/marine) or
bluegill (freshwater) fish at up to 1000 mg/L.  For inorganic chlorates,
RQs were not calculated for freshwater or estuarine/marine fish, since
the proximity of the LC50 to the highest concentration tested (1000
mg/L) could not be estimated.  Although 1000 mg/L is not an LC50, which
is the toxicity value usually used to derive RQs, this value was used
only to estimate high-end risk to exposed fish.  EECs for both
agricultural and nonagricultural uses of sodium chlorate were more than
20-fold lower than the toxic concentration observed in fish of 1000 mg/L
(all RQs would be less than 0.05, and below the Agency’s acute LOC of
0.5 and the acute endangered species LOC of 0.05).  Therefore, acute
risk to freshwater and estuarine/marine fish is not of concern to the
Agency.

	No chronic toxicity studies in fish have been submitted to the Agency,
nor were any identified in the ECOTOX database.  However, the Agency
will require data to address this area of uncertainty.

 

2.  	Aquatic Invertebrates 

For freshwater invertebrates, acute RQs are based on the EC50 of 920
mg/L (daphnids) and EECs calculated by GENEEC-2; these are presented in
Table 21 below.  All RQs are below the acute LOC of 0.5 and the
endangered species acute LOC of 0.05; therefore, acute risk to
freshwater invertebrates is not of concern to the Agency.

Table 21.  Acute Freshwater Aquatic Invertebrate Risk Quotients 

Use	Application Rate Range	Maximum EEC	EC50	RQ

Agricultural uses	4.5–7.5 lb/Ai/A	0.91 mg/L	920 mg/L	<0.01

Non-agricultural uses	132–520 lb/Ai/A	39 mg/L	920 mg/L	<0.042

For saltwater invertebrates, acute RQs were not calculated, because the
proximity of the LC50 from a supplemental 96-hr study (mysid shrimp) to
the highest concentration tested (1000 mg/L), could not be estimated. 
However, the ratios of chlorate’s EECs (agricultural and
nonagricultural uses) to the concentration of 1000 mg/L were calculated,
and the highest resulting value was 0.04.  As this is well below the
acute LOC of 0.5, in addition to the endangered species acute LOC of
0.05, acute risk to saltwater invertebrates is not of concern to the
Agency.  

	Chronic risk to invertebrates was not assessed, since treatment-related
effects were not observed at any concentration in available studies.  

				3.	Aquatic Plants

Toxicity (EC50) and exposure (EEC) values, as well as RQs, for
non-endangered aquatic plants are shown in Tables 22.  For
non-endangered aquatic plants, the Agency calculates RQs by dividing
EECs by EC50 values..  For sodium chlorate, the LOC (1.0) was not
exceeded for either the agricultural or nonagricultural uses of
chlorate; therefore, risk to non-endangered aquatic plants is not of
concern to the Agency.     

 to0.9 mg/L	133 mg/L	43 mg/L	<0.01	0.02

Non-agricultural	Up to 39 mg/L	133 mg/L	43 mg/L	Up to 0.29	0.91

The RQs for endangered aquatic plants are presented in Table 23.  The
Agency calculates RQs for endangered aquatic plants by dividing EECs by
NOAECs.   For endangered aquatic plants, the Agency’s LOC (1.0) was
exceeded for sodium chlorate’s non-agricultural uses (RQ = 12.6). 
However, the EECs for the non-agricultural use sites are likely
conservative; therefore, additional information on use patterns would
allow for characterization of potential risks to aquatic plants.  Also,
testing on three additional required plant species is required for
herbicides.  Overall, additional data are needed to allow for a full
characterization of potential risk to aquatic plants. 

 Table 23.  Endangered Species Algal Risk Quotients Agricultural and
Non-Agricultural Uses

Use	Maximum Peak EEC	Algal EC50	Duckweed EC50	Algal RQ	Duckweed RQ

Agricultural	Up to 0.9 mg/L	62.5 mg/L	3.1 mg/L	Up to 0.014	Up to 0.29

Non-Agricultural	Up to 39 mg/L	62.5 mg/L	3.1 mg/L	Up to 0.62	Up to 12.6

			c.	Endangered Species

 

	The Agency’s screening level assessment results in the determination
that sodium chlorate will have no acute risks to birds, no acute risks
to fish (freshwater and estuarine/marine), and no acute or chronic risks
to aquatic invertebrates (freshwater and estuarine/marine).  

	However, the preliminary risk assessment for endangered species
indicates that RQs exceed endangered species LOCs for chronic risks to
birds (RQs up to 11 for agricultural uses and greater for
non-agricultural uses); acute risks to mammals (RQs up to 33); chronic
risks to mammals (RQs up to 1.2 for agricultural uses and greater for
non-agricultural uses); and risks to aquatic plants (RQs up to 13).  
Risks could not be calculated for terrestrial plants and for chronic
risks to fish; however, the Agency will be requiring data.  

	Further, potential indirect effects to any species dependent upon a
species that experiences effects from use of sodium chlorate can not be
precluded based on the screening level ecological risk assessment. 
These findings are based solely on EPA’s screening level assessment
and do not constitute “may affect” findings under the Endangered
Species Act.

			d.	Ecological Incidents

	A review of the Ecological Incident Information System (EIIS) database
for ecological incidents involving chlorate was completed on October 25,
2004.  There were no chlorate incidents in the database 

IV.	Risk Management, Reregistration, and Tolerance Reassessment

	A.	Determination of Reregistration Eligibility

  SEQ CHAPTER \h \r 1 	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 (i.e., active
ingredient-specific) data required to support reregistration of products
containing sodium chlorate 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
sodium chlorate.  

	The Agency has completed its assessment of the dietary, occupational,
residential, and ecological risk associated with the use of pesticide
products containing the active ingredient sodium chlorate.  Based on a
review of these data and on public comments on the Agency’s
assessments for the active ingredient sodium chlorate, the Agency has
sufficient information on the human health and ecological effects to
make decisions as part of the tolerance reassessment process under FFDCA
and reregistration process under FIFRA, as amended by FQPA.  The Agency
has determined that sodium chlorate-containing products are eligible for
reregistration provided that: (i) the risk mitigation measures outlined
in this document are adopted, (ii) label amendments are made to reflect
these measures, and (iii) a safety finding can be made for sodium
chlorite.  Label changes are described in Section V.  Appendix A
summarizes the uses of sodium chlorate that are eligible for
reregistration.  Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration
eligibility of sodium chlorate, and lists the submitted studies that the
Agency found acceptable.  Data gaps are identified as generic data
requirements that have not been satisfied with acceptable data.

	Based on its evaluation of sodium chlorate, the Agency has determined
that sodium chlorate products, unless labeled and used as specified in
this document, would present risks inconsistent with FIFRA. 
Accordingly, should a registrant fail to implement any of the risk
mitigation measures identified in this document, the Agency may take
regulatory action to address the risk concerns from the use of sodium
chlorate.  If all changes outlined in this document are incorporated
into the product labels, then all current risks for sodium chlorate will
be adequately mitigated for the purposes of this determination under
FIFRA.  Once an Endangered Species assessment is completed, further
changes to these registrations may be necessary as explained in Section
III.B.2.c. of this document.

	

	B.	Public Comments and Responses  tc "	B.	Public Comments and Responses
" \l 2 

	Through the Agency’s public participation process, EPA worked with
stakeholders and the public to reach the regulatory decisions for sodium
chlorate.  EPA released its sodium chlorate preliminary risk assessments
for public comment on February 1, 2006, for a 60-day public comment
period (Phase 3 of the public participation process).  During the public
comment period on the risk assessments, which closed on April 3, 2006,
the Agency received comments from the sodium chlorate task force,
technical registrants, and private citizens.  These comments in their
entirety, responses to the comments, as well as the preliminary and
revised risk assessments, are available in the public docket
(OPP-2005-0507) at http:www.regulations.gov.  

	C.	Regulatory Position

1.	Food Quality Protection Act Findings

			a.	“Risk Cup” Determination

	As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with this pesticide.  The Agency has determined that,
if the mitigation described in this document is adopted and labels are
amended, and a safety finding can be made for sodium chlorite, human
health risks as a result of exposures to sodium chlorate are within
acceptable levels.  In other words, EPA has concluded that the
exemptions from tolerances for sodium chlorate meet FQPA safety
standards.  In reaching this determination, EPA has considered the
available information on the special sensitivity of infants and
children, as well as exposures to sodium chlorate from all possible
sources.  

			b.	Determination of Safety to U.S. Population

  SEQ CHAPTER \h \r 1 	The Agency has determined that provided a safety
finding can be made for sodium chlorite, the Agency has determined that
the established tolerance exemptions for sodium chlorate, with
amendments and changes as specified in this document, meet the safety
standards under the FQPA amendments to section 408(b)(2)(D) of the
FFDCA, and that there is a reasonable certainty no harm will result to
the general population or any subgroup from the use of sodium chlorate. 
In reaching this conclusion, the Agency has considered all available
information on the toxicity, use practices and exposure scenarios, and
the environmental behavior of sodium chlorate.  As discussed in Section
III, the acute, chronic, and cancer dietary (food and drinking water)
risks from sodium chlorate are below the Agency’s acute and chronic
LOC, provided that mitigation measures outlined in this document are
adopted and labels are amended.  

			c.	Determination of Safety to Infants and Children

  SEQ CHAPTER \h \r 1 

	EPA has determined that the established tolerance exemptions for sodium
chlorate, with amendments and changes as specified in this document, and
provided that a safety finding can be made for sodium chlorite, meet the
safety standards under the FQPA amendments to section 408(b)(2)(C) of
the FFDCA, that there is a reasonable certainty of no harm for infants
and children.  The safety determination for infants and children
considers factors on the toxicity, use practices and environmental
behavior noted above for the general population, but also takes into
account the possibility of increased dietary exposure due to the
specific consumption patterns of infants and children, as well as the
possibility of increased susceptibility to the toxic effects of sodium
chlorate residues in this population subgroup.  

In determining whether or not infants and children are particularly
susceptible to toxic effects from exposure to residues of sodium
chlorate, the Agency considered the completeness of the hazard database
for developmental and reproductive effects, the nature of the effects
observed, and other information.  On the basis of this information, the
FQPA SF has been reduced to 1X for sodium chlorate.  The rationale for
the decisions on the FQPA SF can be found in Section III and the
following document: HED Chapter of the Reregistration Eligibility
Decision Document (RED), dated January 26, 2006.  

		2.	Endocrine Disruptor Effects

  SEQ CHAPTER \h \r 1 

	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 endocrine effects as the Administrator may designate.” 
Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system. 
EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife.  For pesticides, EPA will use FIFRA and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations.  As the science develops and resources allow,
screening for additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).

	The available toxicity studies on sodium chlorate demonstrate the
thyroid gland to be its target of toxicity.  The endpoints selected to
assess chronic dietary risk and short- and intermediate-term oral and
inhalation risks in this document are protective of the observed thyroid
effects seen in the available toxicity studies.  When additional
appropriate screening and/or testing protocols being considered under
the Agency’s EDSP have been developed, sodium chlorate may be
subjected to further screening and/or testing to better characterize
effects related to endocrine disruption.

		3.	Cumulative Risks

The FFDCA, as amended by the FQPA, requires that the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  The reason for consideration of other
substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a
common toxic mechanism could lead to the same adverse health effect as
would a higher level of exposure to any of the substances individually. 
The EPA has not made a common mechanism of toxicity finding as to sodium
chlorate and any other substances.  For the purposes of this
reregistration eligibility decision (RED), therefore, EPA has not
assumed that the inorganic chlorates have a common mechanism of toxicity
with other substances.  For information regarding EPA’s efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA’s Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA’s website at
http://www.epa.gov/pesticides/cumulative/.

		4.	Endangered Species 

	The Agency’s screening-level assessment results in the determination
that sodium chlorate will have no acute risks to birds, no acute risks
to fish (freshwater and estuarine/marine), and no acute or chronic risks
to aquatic invertebrates (freshwater and estuarine/marine).  

	However, the preliminary risk assessment for endangered species
indicates that RQs exceed endangered species LOCs for chronic risks to
birds (RQs up to 11 for agricultural uses and greater for
non-agricultural uses); acute risks to mammals (RQs up to 33); chronic
risks to mammals (RQs up to 1.2 for agricultural uses and greater for
non-agricultural uses); and risks to aquatic plants (RQs up to 13).  
Risks could not be calculated for terrestrial plants and for chronic
risks to fish; however, the Agency will be requiring data.  

	Further, potential indirect effects to any species dependent upon a
species that experiences effects from use of sodium chlorate cannot be
precluded based on the screening-level ecological risk assessment. 
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 endangered
and threatened species, and to implement mitigation measures that
address these impacts.  The Endangered Species Act (ESA) 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 the REDs and considers it in relation to individual
species and their locations by evaluating important ecological
parameters, pesticide use information, geographic relationship between
specific pesticide uses and species locations, and biological
requirements and behavioral aspects of the particular species, as part
of a refined species-specific analysis.  When conducted, this
species-specific analysis will take into consideration any regulatory
changes in this RED that are being implemented at that time. 

	Following this future species-specific analysis, a determination that
there is a likelihood of potential impact to a listed species or its
critical habitat may result in:  limitations on the use of sodium
chlorate, other measures to mitigate any potential impact; or
consultations with the Fish and Wildlife Service or the National Marine
Fisheries Service as necessary.  If the Agency determines use of sodium
chlorate “may affect” listed species or their designated critical
habitat, EPA will employ the provisions in the Services regulations (50
CFR Part 402).  Until that species-specific analysis is completed, the
risk mitigation measures being implemented through this RED will reduce
the likelihood that endangered and threatened species may be exposed to
sodium chlorate at levels of concern.  EPA is not requiring specific
sodium chlorate 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.

           D.         Tolerance Reassessment Summary

Table 24 summarizes the reassessment of the sodium chlorate tolerance
exemptions pending a safety finding can be made for sodium chlorite.  40
CFR must be updated to reflect the tolerance exemptions in the table
below.  The tolerance exemptions listed in 40 CFR must be reorganized in
order to: (i) incorporate the recommendations made by the Agency
concerning the sodium chlorate residues of concern that need to be
regulated for plant and animal commodities; (ii) include tolerance
exemptions that are needed to cover sodium chlorate residues of concern
in/on the raw agricultural commodities and processed commodities of
rotational crops; and (iii) conform with the requirements of FQPA. 

	

Table 24.  Tolerance Reassessment Summary for Sodium Chlorate 

Listed under 40 CFR 180.1020(a)

Commodity	

Current Tolerance (ppm)	

Tolerance Reassessment (ppm)	

[Correct Definition]

Comments

Beans, dry, edible	

Exempt	

Exempt	

[Bean, dry, seed] 

Corn, fodder	

Exempt	

Exempt	

[Corn, field, stover; Corn, field, forage; Corn, field, grain; Corn,
sweet, stover; Corn, pop, stover; Corn, pop, grain; Corn, sweet, forage]
 

Corn, forage	

Exempt

Corn, grain	

Exempt

Cottonseed	

Exempt	

Exempt	

[Cotton, undelinted seed] 

Flaxseed	

Exempt	

Exempt	

[Flax, seed] 

Flax, straw	

Exempt	

Revoke	

Flax straw is not listed in Table 1 of OPPTS 860.1000

Guar beans	

Exempt	

Exempt	

[Guar, seed] 

Peas, southern	

Exempt	

Exempt	

[Pea, southern, seed] 

Potatoes	

Exempt	

Exempt	

[Potato]

Peppers, chili	

Exempt	

Exempt	

[Pepper, nonbell]

Rice	

Exempt	

Exempt	

[Rice, grain; Rice, straw] 

Rice, straw	

Exempt

Safflower, grain	

Exempt	

Exempt	

[Safflower, seed] 

Sorghum, grain	

Exempt	

Exempt

	

[Sorghum grain, grain; Sorghum, grain, stover; Sorghum, grain, forage] 

Sorghum, fodder	

Exempt

Sorghum, forage	

Exempt

Soybeans	

Exempt	

Exempt	

[Soybean, seed] 

Sunflower seed	Exempt	Exempt	[Sunflower, seed]

Wheat	None	Exempt	[Wheat, grain] 

Listed under 40 CFR 180.1020(b)

Wheat	

Exempt	Revoke	

[Wheat, grain] Time-limited exemption currently expires on 12/31//2006

Existing Exemptions

	Sodium chlorate is currently registered for preharvest and foliar
applications as a defoliant or desiccant to the following food/feed
crops:  beans, corn, cotton, flax, guar, chili peppers, potatoes, rice,
safflower, sorghum (grain), southern peas (i.e., cowpeas), soybeans, and
sunflowers.

	Sodium chlorate exemptions under 40 CFR 180.1020(a) from the
requirement of a tolerance should be amended as follows to: (1) specify
defoliant and desiccant use only, (2) specify use on crops rather than
raw agricultural commodities, and (3) include an exemption for wheat
(grain).

40 CFR 180.1020(a) Sodium chlorate is exempt from the requirement of a
tolerance for residues when used as a defoliant or desiccant in
accordance with good agricultural practice on the following crops:  Bean
(dry, seed), Corn (field, stover), Corn (field, forage), Corn (field,
grain), Corn (sweet, stover), Corn (pop, stover), Corn (pop, grain);
Corn (sweet, forage), Cotton (undilented seed), Flax (seed), Guar
(seed), Peas (southern, seed), Peppers (nonbell), Potatoes, Rice
(grain), Rice (straw), Safflower (seed), Sorghum (grain, grain), Sorghum
(grain, stover), Sorghum (grain, forage), Soybean (seed), and Sunflower
(seed).  

	Under 40 CFR 180.1020(b), a time-limited exemption from the requirement
of a tolerance is established for residues of the defoliant/desiccant in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA.  This exemption was granted for wheat and
expires 12/31/06.  The use of sodium chlorate on wheat is also addressed
herein with the intention to convert the time-limited exemption status
to a permanent exemption from the requirement of a tolerance under 40
CFR.1020 (a).  The proposed use rate is for a single application of
sodium chlorate to wheat at 6 lbs ai/A with a 3-day PHI.

Needed Exemptions

	Sodium chlorate (873301) as an inert ingredient in herbicide
formulation products can be applied professionally to agricultural
(corn, guava, macadamia nuts, sorghum grain, sugarcane, wheat),
commercial (non-agricultural), and residential sites.  These
conventional pesticide products contain < 1 % sodium chlorate and can be
applied at rates no greater than 0.07 lb (as sodium chlorate) per acre.

	Potassium chlorate (900583) as an inert ingredient in fungicide
products can be applied in poultry premises.  These conventional
pesticide products contain < 20% potassium chlorate and can be applied
at rates not greater than 0.01 lb (as potassium chlorate) per 500 ft3. 
See Table 25 below for the tolerance exemptions needed for sodium
chlorate.

 ADVANCE \d6 Table 25.  Tolerance Exemptions Needed for sodium chlorate

 ADVANCE \d6 Tolerance Exemption Expression	PC Code	 ADVANCE \d6 CAS Reg
No.	 ADVANCE \d6 40 CFR §	 ADVANCE \d6 Use

(Pesticidal)	 ADVANCE \d6 List Classification

Sodium chlorate	873301	7775-09-9	180.920 1	Stabilizer	3

Potassium chlorate	900583	3811-04-9	180.930 2	Oxidizer	3

1.  Residues listed in 40 CFR §180.920 [formerly 40 CFR§ 180.100(d)]
are exempted from the requirement of a  

tolerance when used in accordance with good agricultural practice as
inert (or occasionally active) ingredients in 

 pesticide formulations applied to growing crops only. 

2.  Residues listed in 40 CFR §180.930 [formerly 40 CFR§ 180.100(e)]
are exempted from the requirement of a 

tolerance when used in accordance with good agricultural practice as
inert (or occasionally active) ingredients in  

pesticide formulations applied to animals. 

Codex/International Harmonization

	There are no Codex maximum residue limits (MRLs) for sodium chlorate.

E.	Regulatory Rationale

	The following is a summary of the rationale for managing risks
associated with the use of sodium chlorate for sodium chlorate products
to be eligible for reregistration.  Where labelling revisions are
warranted, specific language is set forth in Table 28 of Section V.  

		1.	Human Health Risk Management

			a.	Dietary (Food) Risk Mitigation

Acute Dietary (Food) Risk

	No acute dietary endpoint was selected for sodium chlorate, because
effects attributable to a single dose were not seen in the available
data.  Therefore, dietary acute risk is not of concern to the Agency,
and no mitigation measures are required to address acute risk.

Chronic Dietary (Food) Risk

The chronic dietary risk assessment for food only is below the
Agency’s level of concern (LOC) for the general US population and all
population subgroups.  The most highly exposed population subgroup,
children 1-2 years of age, was at 28% of the chronic Population Adjusted
Dose (cPAD).  Since this is less than 100% of the cPAD, no mitigation is
needed.

b. 	Residential Risk Mitigation

				

All residential (non-occupational) handler and post-application risk
estimates for inorganic chlorates, as active or inert ingredients in
conventional pesticide products used in residential environments, are
below the Agency’s LOC (i.e., MOEs are greater than the LOC of 100). 
The handler inhalation MOEs ranged from 370 to 710,000.  The
post-application combined MOE (for inert ingredients) was 23,000 for all
potential routes of exposure to children; therefore, no residential
mitigation is necessary.  

			c.	Aggregate Risk Mitigation

As discussed in Section III of this RED, aggregate risk refers to the
combined risk from food, drinking water, and residential exposures. 
Aggregate risk can result from one-time (acute), short-term and/or
chronic exposures. 

Acute Aggregate Risk 

For sodium chlorate, acute aggregate risk was not assessed, because
effects attributable to a single dose were not seen in the available
data.  Therefore, acute aggregate risk is not of concern to the Agency.

Short-Term Aggregate Risk 

Short-term aggregate risk was quantitatively assessed for adults only,
using the highest exposure scenario (inhalation exposure while applying
granules by hand) resulting in an MOE of 324.  Short-term aggregate risk
for children was qualitatively assessed and not of concern to the Agency
because the short-term residential risk to children from the use of
sodium chlorate as an inert is minimal (MOE of 23,000).  All short-term
aggregate risks are below the Agency’s LOC (i.e., MOEs are greater
than 100); therefore, no mitigation is necessary.

Chronic Aggregate Risk 

Since no chronic residential (non-dietary) exposure scenarios have been
identified for sodium chlorate, the chronic aggregate risk assessment
considers exposure only through food and drinking water.  The Agency
believes there is no chronic risk of concern, for the US general
population or any subpopulation group, for the reasons described below.

The chronic dietary (water only) risk assessment for chlorate in
drinking water, using the highest annual average concentration from ICR
data of 0.69 mg/L, is below the Agency’s level of concern for the
general US population and all subgroups except all infants <1 year of
age.  The highest exposed population subgroup, all infants <1 year of
age, was 159% of the cPAD.  Using the 90th percentile annual average
concentration of 0.24 mg/L, the chronic dietary (water only) risk for
all infants <1 year of age was <55% of the cPAD; using the median annual
average concentration estimated at 0.11 mg/L, estimated chronic risk
from drinking water was 25% of the cPAD.  The contribution of exposure
from food sources increases total dietary risk (food + drinking water)
to 174% of the cPAD for infants <1 year of age at the highest annual
average, but remains below EPA’s level of concern at the 90th
percentile (70% of the cPAD). 

		Data on the occurrence of chlorate ion in drinking water were
available from two primary sources:  the Information Collection Rule
(ICR) Auxiliary 1 Database, Version 5.0, and the AwwaRF research study
on the control of chlorate ion in hypochlorite solutions.  The most
extensive data are from the ICR where source water and drinking water
were monitored for chlorate ion between July 1997 and December 1998. 
Water systems serving a population of at least 100,000 were required to
monitor for chlorate ion at treatment plants using chlorine dioxide or
hypochlorite solutions in the treatment process.  Although the ICR water
systems represent roughly one percent of the total number of drinking
water systems in the United States, these systems serve almost 60% of
the population.  Under the ICR, plants using chlorine dioxide collected
monthly samples of the source water entering the plant, the finished
water leaving the plant, and at three sample points in the distribution
system (near the first customer, an average residence time, and a
maximum residence time).  Samples were taken throughout the distribution
systems for plants using chlorine dioxide, since the concentration of
chlorate is expected to change within the system due to the conversion
of chlorine dioxide to chlorate that occurs in the presence of chlorine.
 Plants using hypochlorite solutions were required to collect quarterly
samples of the water entering and leaving the plant.  

		The AwwaRF data consists of samples collected in 1993 by 111 water
treatment plants using hypochlorite.  The majority of the systems in the
AwwaRF project serve populations less than 100,000, and a large subset
of those serve populations less than 10,000.  Samples of source water,
hypochlorite solution, and finished drinking water from 111 of water
systems were analyzed for chlorate.  Only one set of samples was
collected for each system, and samples were not collected at plants
using chlorine dioxide.  Furthermore, the background information on the
111 water systems that participated in the project was not linked to the
samples they provided; therefore, the chlorate concentrations can not be
directly related to the size of the water system or type of hypochlorite
solution in use. 

		The AwwaRF samples were typically found to have higher concentrations
of chlorate than the samples collected from the larger ICR systems.  The
difference in chlorate concentrations could be the result of a number of
factors, such as: 1) The AwwaRF data represents a single point in time,
while the ICR data reflects an average over 18 months; 2) most of the
AwwaRF samples were collected from utilities that served populations of
less that 100,000, while all of the ICR samples were from utilities
serving at least 100,000; and 3) hypochlorite treatment plant practices
may have changed between when the AwwaRF samples were collected (1993)
and the ICR samples were collected (1997-1998).  When the AwwaRF study
was conducted, utilities were just becoming aware of the formation of
chlorate ion in hypochlorite solutions.  The AwwaRF project was funded
in order to provide water treatment facilities with information on how
to minimize the formation of chlorate byproduct; it is possible that
facilities consequently revised their treatment practices.

		The ICR Database was considered the more appropriate source for
estimating exposure averages from individual water treatment plants,
primarily because the AwwaRF study is a less robust data set consisting
of only one sample per utility, whereas the ICR database collected
multiple samples over an 18 month period, from plants using both
hypochlorite and chlorine dioxide.  Both the AwwaRF study and the ICR
data reveal high concentrations of chlorate ion to be a local situation
affecting a relatively small number of systems.  Of the ICR data set,
only four water treatment plants had average chlorate ion concentrations
that exceeded the Agency’s level of concern (i.e., 370 ppb or 0.37
mg/L, for the infant subpopulation) including one treatment plant
serving 218,000 people that had the highest annual average (0.69 mg/L). 
Of the four plants that exceeded, two treatment plants used chlorine
dioxide, and two used hypochlorite.  The total number of people served
by the four water treatment plants exceeding 0.37 mg/L represents 0.5%
of the ICR population, or 621,000 people.  All three exposure ranges
(highest average, 90th percentile, and median) are presented in Section
III.  Only the “highest average” exposures resulted in potential
chronic risk estimates that were above the Agency’s LOC, and only for
infants.  Over 99% of the ICR population receives finished water below
the Agency’s LOC of 0.37 mg/L.

 

The chlorate ion (ClO 3-) is a disinfection byproduct (DBP) of water
treatment which can be formed during the on-site generation of chlorine
dioxide (ClO 2-), the decomposition of chlorine dioxide in the water
treatment system, the decomposition of hypochlorite (OCl-) during
storage, and the interaction of chlorite ion and free chlorine. 
Treatment of public water supplies is necessary to kill pathogens that
may exist in the drinking water, such as cholera, typhoid, and
dysentery.  Outbreaks of these diseases decreased significantly when
disinfection of the water systems was introduced in the early 1900s. 
While there are many important public functions of water treatment, the
Agency is taking steps to limit the exposure of chlorate ion as a DBP to
the public. 

In order to help reduce potential exposure to chlorate, the Agency’s
Office of Pesticide Programs (OPP), in conjunction with the Office of
Water (OW), is working with the American Water Works Association (AWWA),
the Chlorine Institute, and individual water communities to provide
community water systems with information on Best Management Practices
(BMPs) for use in drinking water treatment.  BMPs may include measures
such as production modifications, operational changes, materials
substitution, materials and water conservation, and other such measures.
 For example, water systems that use hypochlorite solutions can minimize
the levels of chlorate ion by purchasing high quality hypochlorite
solutions and through careful storage during use.  While decomposition
of hypochlorite solutions cannot be avoided, the rate of decomposition
can be managed.  Among the major factors affecting stability are the
following:  concentration of the hypochlorite solution, temperature of
the solution, pH of the solution, and exposure to light sources.  The pH
of the solution should be in the 12 to 13 range to minimize
decomposition.  Hypochlorite solutions should be protected from high
temperatures and sunlight, and storage time should be minimized, both
from the time of manufacture to delivery, and from the time of delivery
to use.  The solutions can also be diluted to control decomposition as
long as the proper pH is maintained and high quality dilution water is
used.  The primary ways in which water systems using chlorine dioxide
can control the levels of chlorate in the finished water is through high
efficiency operation of their chlorine dioxide generators and by
reducing chlorite ion concentrations prior to the addition of free
chlorine.  The BMPs could also include additional training of the water
systems employees on the proper handling of these chemicals. 

The Agency believes that sodium chlorate does not constitute a risk of
concern to the general population or any population subgroups, since the
LOC exceedances are associated with a small number of water treatment
facilities and inappropriate treatment practices.  Furthermore, the
Agency anticipates that the community water system outreach strategy
previously discussed will greatly reduce potential drinking water
byproduct exposure.

			d.	Occupational Risk Mitigation

With the consideration of mitigation measures proposed by registrants
and the use of engineering controls (enclosed cockpits or cabs), all
occupational handler risks for the use of inorganic chlorates as an
active or inert ingredient in conventional pesticides are below the
Agency’s LOC (i.e., MOEs are greater than the LOC of 100).  For sodium
chlorate, occupational exposure durations are short- (1-30 days) and
intermediate term (1-6 months) only.  Long-term (> 6 months) exposure is
not expected based on the use pattern for sodium chlorate. 
Post-application dermal and inhalation exposures are negligible due to
the chemical’s physical and chemical characteristics as an inorganic
salt.  No significant amount of sodium chlorate is expected to be
absorbed through the skin and the vapor pressure is negligible;
therefore, a post-application exposure assessment was not conducted.

Antimicrobial Uses of Sodium Chlorate

	Risks to handlers treating water systems are below the Agency’s LOC;
therefore, no mitigation measures are necessary.

Agricultural Uses of Sodium Chlorate

 With the exception of aerial applications, for which enclosed cockpits
are required, the handler and flagger MOEs for sodium chlorate’s
agricultural uses are below the Agency LOC at baseline level of
protection (long sleeve shirt, long pants, shoes, and socks).  MOEs
range from 190 (mixing/loading liquids for aerial application on cotton,
corn, et al.) to 3600 (mixing/loading liquids for groundboom application
on ornamental gourds and cucurbits).  Further, the maximum application
rate for use on cotton will be reduced from 7.5 lbs ai/A to 6 lbs ai/A,
with a limitation of one application (except for California, where two
applications will be allowed).  No additional mitigation is required for
occupational risk resulting from the agricultural uses of sodium
chlorate.

Non-agricultural Uses of Sodium Chlorate

 The Agency’s review of sodium chlorate labels, in addition to
discussions with registrants, indicates that the current
non-agricultural use labels are not reflective of actual use practices. 
The non-agricultural use labels currently allow for larger application
rates than are necessary for efficacy, as well as allow for unlimited
treatment areas, although sodium chlorate’s non-agricultural
formulations are typically used as spot treatments.  

Mitigation measures for sodium chlorate’s non-agricultural uses to be
included on product labels will reduce risk from the occupational and
ecological exposures to sodium chlorate.  The registrants have agreed to
the following non-agricultural use mitigation measures for sodium
chlorate:

All non-agricultural uses will be limited to spot treatments only (with
the exception of the granular formulation for use under asphalt,
although this use will be limited to an 8000 ft2 treatment area).  The
uses limited to spot treatments include, but are not limited to:
building perimeters (including farm buildings), driveways, parking lots,
fence rows, military installations, pipelines, railroads, lumberyards,
industrial sites (transformers, generators, utility poles, etc.), tennis
court perimeters, picnic areas, bleachers, cemeteries, fuel tanks,
airport runways, helo pads, wood decks, guard rails, highway medians,
sidewalks/walkways, vacant lots, fire hydrants, recreational areas, and
other similar areas.

Use on rights-of-way and ditch banks will be cancelled.

The label will specify a maximum application rate of 0.9 lb/Ai/100 ft2 

The Agency generally converts application rates to a per acre basis for
assessment purposes; therefore, the rate of 0.9 lb/Ai/100 ft2 is
referred to as 392 lb/Ai/A in this document.  However, because all
non-agricultural uses will be limited to spot treatment applications
only, all 392 pounds of a.i. will not be applied on any one given acre. 
Assuming only one acre is considered for treatment, sodium chlorate can
only be applied to up to 8000 ft2, which equates to up to approximately
78 lbs ai being applied to any given acre.  It is assumed that more than
one acre will be treated.  

Risk calculations have been developed to better represent the current,
actual use pattern for sodium chlorate, and occupational risk was
reassessed based on the revised use pattern discussed above (i.e.,
application rates, target sites, and amount treated).  Following is a
summary of the Inorganic Chlorates: Addendum to the Occupational and
Residential Exposure Assessment for the Reregistration Eligibility
Decision (RED) Document, dated May 18, 2006.

	

All data, factors, and assumptions used in the addendum are the same as
those used in the previous occupational risk assessment.  These include,
but are not limited to:

body weight (70 kg representing adult handlers);

toxicological endpoints (short-/intermediate-term oral NOAEL of 30
mg/kg/day) and uncertainty factors (Level of Concern (LOC) for the MOE
is 100);

application rates (in lb/Ai/A – presented as a range to encompass the
various registered products); and,

unit exposures (from PHED and/or ORETF database, both of which have
undergone appropriate review by the Human Studies Review Board).  

However, factors regarding application equipment used and daily area
treated were revised based on updated use pattern information and
proposed product label revisions.  The previous assessment, summarized
in Section III, was based on applications with larger, industrial
equipment such as tractor spreaders or groundboom sprayers.  As a result
of mitigation measures agreed to by the technical registrants, sodium
chlorate applications to non-agricultural areas (i.e., building
perimeters, ditch banks, bleachers, airport runways, vacant lots, fire
hydrants, or as a pre-paving treatment) will be limited to
“handheld” equipment such as rotary spreaders and pump or power
sprayers.  In addition, the standard Agency assumptions for the amount
applied per work day is based on the application equipment used to
determine exposure and risk.  Since submitted information indicates that
no more than 8,000 ft2 of an acre (approximately 20%) will be treated
with sodium chlorate, the Agency has adjusted the standard assumptions
for acres treated per day to reflect this spot treatment-type scenario. 

Based on the revised assumptions for the daily area treated and on
application methods suitable for spot treatments (low-pressure handwand
sprayers, belly grinders, push-type spreaders), the risks for all
non-agricultural uses, even at the currently labeled application rate
(523 lbs ai/A instead of 392 lb/Ai/A), are below the Agency LOC.  The
higher application rate of 523 lb/Ai/A was used, because at the time the
Inorganic Chlorates: Addendum to the Occupational and Residential
Exposure Assessment for the Reregistration Eligibility Decision (RED)
Document, dated May 18, 2006, was prepared, the 392 lb/Ai/A maximum
application rate mitigation measure was not yet finalized.  The
mitigation measures outlined above reduce the occupational risk from all
of sodium chlorate’s non-agricultural uses to below the Agency’s
level of concern at baseline level of protection (long sleeve shirt,
long pants, shoes, and socks).  The risks based on the revised
non-agricultural use patterns for sodium chlorate are summarized in
Table 26 below.

 

Table 26:  Sodium Chlorate:  Short- and Intermediate-Term Occupational
Inhalation Exposure

Exposure Scenario	Daily Area Treated (Acres/day)	Crop/Target	Application
Rate 

(lbs ai/Acre)a	Inhalation MOE 

(at baseline)

Mixer/Loader/Applicators & Loader/Applicators

Mixing/Loading/Applying liquids with a low- pressure handwand sprayer
0.4	Industrial/Non-Crop Sites	523	330

	132	1300

M/L/A liquids with a handgun sprayer	1	Industrial/Non-Crop Sites	523
2200

	132	8800

L/A granules with a belly grinder	0.2	Industrial/Non-Crop Sites	523	320

	240	710

	161	1100

L/A granules with a push-type spreader	1	Industrial/Non-Crop Sites	523
550

	240	1200

	161	1800

 a.  Application rate will be reduced to 0.9 lb/Ai/100 ft2 (392
lb/Ai/A).

 		2.	Non-Target Organism (Ecological) Risk Management

	Chlorate is a strong oxidizer and may be reduced to other chemically
related species under some environmental conditions.  The extent and
rate to which this occurs will depend on the redox chemical species
(including organic matter) in the water or soil.  Extensive spatial and
temporal variability is expected for the reactions of chlorate in the
environment.  However, the currently available simulation models do not
allow for a quantitative evaluation of the potential exposure levels of
each the reduced products of chlorate (i.e., speciation and
predominance) and how fast these chemical species may form.  Therefore,
there is a high degree of uncertainty in the ecological exposure and
risk assessment.  This is important because a reduction product of
chlorate (chlorite) is expected to be more toxic to most aquatic and
terrestrial species, particularly aquatic invertebrates.

			a.	Terrestrial Organisms 

					1.	Birds and Mammals

	EPA’s screening-level risk assessment, based on currently labelled
maximum application rates, for both agricultural and non-agricultural
uses for sodium chlorate, suggests potential acute and chronic risk for
birds 

					

Avian Acute Risk

	Avian acute risk was not calculated, since no mortality or signs of
toxicity were observed in the submitted subacute or acute toxicity
studies at concentrations that are above the limit for these types of
studies; therefore, acute risk to birds is not expected.  However, the
Agency cannot preclude acute or subacute risk from the non-agricultural
uses.  Some labels have maximum application rates up to 1032 lbs ai/A,
and the ecological assessment for risk from non-agricultural uses was
based on rates ranging from 52 to 523 lbs ai/A, with corresponding EECs
from 12,500 and 125,000 ppm, respectively.  These EECs are approximately
2.5 to 25-fold higher than the highest concentration tested in the
subacute bird toxicity studies.  The non-agricultural use mitigation
outlined above, including the reduction of the maximum application rate
to 392 lbs ai/A, and a limitation to spot treatments only (except for
use under asphalt, although this use is limited to no more than an 8000
ft2 area).  Reducing the maximum application rate from 520 lbs ai/A to
392 lbs ai/A will reduce the estimated environmental concentrations of
chlorate by approximately 25%.  Further, to the extent that there is any
potential acute risk to birds from the non-agricultural uses, the fact
that these uses will result in small contiguously treated areas could
limit avian exposure.

Avian Chronic Risk

	 Maximum chronic RQs, based on EECs derived with 90th percentile
residue estimates from the Kenaga nomogram, exceed the Agency’s avian
LOC of 1.0 for all agricultural uses assessed for birds eating short
grass, tall grass, broadleaf forage, and small insects.  Chronic RQs
based on EECs derived with mean residue estimates from the Kenaga
nomogram, although not presented in Section III, would be approximately
three times lower for any single application of sodium chlorate.  The
highest agricultural use chronic RQ was 11 (chili peppers/white, Irish
potatoes and the short grass food category).  The second highest RQs
were for cotton (ranging from 10.0 for the short grass food category, to
0.63 for fruits, pods, seeds, and small insects).  Cotton is also by far
the most common agricultural use of sodium chlorate, with approximately
1,900,000 lbs ai applied annually.  

	To address the chronic risk to birds from use on cotton, the maximum
application rate will be reduced from 7.5 lbs ai/A to 6 lbs ai/A, and
applications will be limited to a single applications in all states
except California, where a second application will be allowed.  This
mitigation measure will reduce chronic risk to birds from use on cotton
by approximately one- half, with RQs ranging from 5.31 (on the short
grass food category), to 0.33 (on fruits, pods, seeds, and small
insects) for all states except California.  In California, the chronic
avian RQs based on the reduced maximum application rate of 6 lbs ai/A,
and two applications, will be reduced to a range of 8.25 (on the short
grass food category) to 0.52 (on fruits, pods, seeds, and small
insects). 

	Chronic avian RQs for sodium chlorate were based on a NOAEC of 271 ppm
from the bobwhite quail chronic reproductive toxicity test.  However,
maximum EECs for a majority of the uses and classes of food items were
also higher than the LOAEC in bobwhite quail of 964 ppm.  At the LOAEC,
reproductive effects occurred, including a 67% reduction in eggs laid
and 64% reduction in number of hatchlings per egg laid.  Therefore, if
actual exposure is equivalent to the maximum values calculated with the
T-REX model, there is a greater certainty that frank reproductive
effects in birds might occur.

	However, the duration of exposure needed to produce reproductive
effects in birds is an uncertainty.  This uncertainty is significant in
the case of sodium chlorate, because as a broad-spectrum herbicide, its
toxic effects on plants are visible within several days.  Since the
vegetation in the treated area will die, it is uncertain whether or not
this vegetation will be attractive to birds as a feed item long enough
for the chronic effects to occur.  

Chronic RQs were not calculated for sodium chlorate’s non-agricultural
uses.  However, based on the high application rates and resulting high
potential EECs, risks from sodium chlorate’s non-agricultural uses
could be considerably higher than those described in Section III for the
agricultural uses.  The non-agricultural use mitigation outlined above,
including a reduction in the maximum labeled application rate to 0.9 lbs
ai/100 ft2 (392 lbs ai/A), would reduce the EECs of chlorate by
approximately 25% in the areas treated.  Furthermore, the limitation of
most non-agricultural uses to spot treatments only is expected to reduce
the likelihood that a terrestrial organism will come into contact and
consume all of its diet from a treated area.  However, RQs still exceed
the chronic LOC for birds (1.0).  See the Analysis of proposed changes
to sodium chlorate’s application rates and maximum treated area on
potential ecological risks presented in EFED’s reregistration
eligibility decision (RED) document, dated June 13, 2006 for further
detail.  

Mammalian Acute Risk 

Acute  tc "

Acute  " \l 4 RQs were not calculated for mammals.  The LD50 from a core
acute oral toxicity study in rats was >5000 mg/kg-bw.  In this study,
10% (1/10) of the rats administered 5000 mg/kg died.  Mortality was not
observed at any other dose.  Therefore, the data were not sufficient to
allow for characterization of the dose-response relationship and the
proximity of the LD50 to 5000 mg/kg-bw is uncertain.  Although RQs were
not calculated for mammals, Tables 17, 18 and 19 in Section III present
a comparison of the body weight adjusted LD50s to EECs for agricultural
spray, and the non-agricultural spray and granular, formulations,
respectively.  These ratios can be used to estimate high-end risk to
exposed mammals.  Risk quotients would be lower than the values in
Section III.  

For sodium chlorate’s agricultural uses, all of the mammalian acute
risk estimates are below the Agency’s acute and endangered species LOC
of 1.0 and 0.1, respectively, with the exception of small mammals eating
short grass.  The highest exceedence is for 15 gram mammals eating short
grass (risk ratio = 0.26); therefore, no mitigation is necessary.

For sodium chlorate’s non-agricultural uses, the ratios indicate a
potential acute concern to mammals for both spray and granular
formulations, with the highest ratios calculated for small mammals
(ratios =11 and 33 for spray and granular formulations, respectively). 
While the ratios presented in Section III suggest that there could be
acute risk to mammals of all sizes that forage in the area where sodium
chlorate is applied to non-agricultural use sites, the risk was likely
over-estimated, since an LD50 has not been established.  Furthermore, as
previously explained, a reduction in the maximum application rate for
the non-agricultural uses to 392 lbs ai/A would reduce the EEC’s of
chlorate in treated areas by approximately 25%.  Limitation of the
treatments to spot treatments only would be expected to further reduce
the likelihood that a terrestrial organism will come into contact and
consume all of its diet from that area.  

Mammalian Chronic Risk

 

For mammals, the Agency typically evaluates the mammalian reproductive
effects for exposures greater than 30 days.  The interpretation of the
effects seen in the 2-generation rat reproduction toxicity study, used
to derive the mammalian reproduction toxicity endpoint for sodium
chlorate, is difficult in this respect.  While effects were observed at
70 mg/kg-bw and above, the effects are not clearly associated with
reduced reproductive success or survival.  The mammalian reproductive
NOAEC is based on the highest dose tested in this study (500 mg/kg-bw),
although no toxic or reproductive effects were observed at this level. 
Therefore, the NOAEC could be higher than 500 mg/kg-bw, which would
result in lower mammalian reproduction risk estimates.  However, the
Agency calculated risk ratios based on the 500 mg/kg-day NOAEL as a
conservative estimate of risk, as presented in Section III.  For the
agricultural uses of sodium chlorate, the chronic mammalian LOC of 1.0
was only slightly exceeded for the smallest weight classes of mammals
for most food items and the largest weight class of mammals feeding on
short grass (RQs range from 2.6 to 0.07).  The mitigation measures
previously outlined for sodium chlorate use on cotton (maximum
application rate reduced from 7.5 lbs ai/A to 6 lbs ai/A, with the
limitation of a single application, except in California, where a second
application will be allowed), will further reduced chronic mammalian
risk.  Furthermore, based on the lack of observed reproductive effects
in the chronic study and the slight LOC exceedances for agricultural
uses, the Agency does not anticipate a chronic risk of concern to
mammals from these uses.  

As with the agricultural uses, mammalian reproduction RQs were not
calculated for sodium chlorate’s non-agricultural uses.  However, the
higher application rates for the non-agricultural uses, and the
resulting higher EECs, suggest that the risk for these uses would be
higher than the risk estimates presented for the agricultural uses. 
Note that the mammalian reproduction RQs for the agricultural uses of
sodium chlorate, presented in Section III, are a conservative estimate
of risk.  Furthermore, as previously explained, to reduce risk from
sodium chlorate’s non-agricultural uses, the maximum application rate
will be reduced to 0.9 lb/Ai/100 ft2.  This mitigation measure will
reduce the EECs by approximately 25%.  In addition, the limitation to
spot treatments will reduce the likelihood that mammals will come into
contact and consume all of its diet from a treated area.  See the
Analysis of proposed changes to sodium chlorate’s application rates
and maximum treated area on potential ecological risks presented in
EFED’s reregistration eligibility decision (RED) document, dated June
13, 2006, for further detail.  

Non-Target Insects

	EPA currently does not estimate RQs for terrestrial non-target insects.
 In addition, the Agency has no toxicity data for sodium chlorate. 
Therefore, EPA will require data to address this uncertainty.

				3.	Non-Target Terrestrial Plants

	Based on chlorate’s non-selective mode of action and lack of adequate
toxicity data, the Agency presumes risk to non-target terrestrial plants
at levels above the Agency’s level of concern for all uses.  The risks
to plants cannot be quantified at this time due to lack of data;
however, the Agency will require data to address this uncertainty.

b.	Aquatic Organisms

	1. 	Fish

	

	There is no acute risk of concern, from either the agricultural or
non-agricultural uses of sodium chlorate, to freshwater or
estuarine/marine fish.  All risk ratios are less than 0.05, which is
below the Agency’s acute LOC of 0.5 and below the acute endangered
species LOC of 0.05.  However, some data suggest that brown trout
(freshwater fish) could be substantially more sensitive than other fish
species tested to chlorate’s toxicity.  It is uncertain if these data
are reliable; therefore, the Agency will require additional testing in
brown trout to address this area of uncertainty.  

No chronic fish toxicity studies are available to allow for chronic risk
to fish to be quantified.  Therefore, the Agency will require data to
address this uncertainty.

2. 	Aquatic Invertebrates

For freshwater invertebrates, acute RQs are below the acute LOC of 0.5
and the endangered species acute LOC of 0.05, for both agricultural and
non-agricultural uses of sodium chlorate.  Therefore, acute risk to
freshwater invertebrates is not of concern to the Agency, and no
mitigation is required.

For saltwater invertebrates, the acute risk ratios for sodium
chlorate’s agricultural and nonagricultural uses were below the
Agency’s acute LOC of 0.5, in addition to the endangered species acute
LOC of 0.05 (highest ratio = 0.04 for non-agricultural uses). 
Therefore, acute risk to saltwater invertebrates is not of concern to
the Agency.  

	Chronic risk to invertebrates (freshwater and saltwater) was not
assessed, since treatment-related effects were not observed at any
concentration in available studies.  

				3.	Aquatic Plants

For non-endangered aquatic plants, the Agency’s LOC of 1.0 was not
exceeded for either the agricultural or nonagricultural uses of sodium
chlorate (highest RQ = 0.91 for non-agricultural uses).  Therefore, risk
to non-endangered aquatic plants is not of concern to the Agency.     

For endangered aquatic plants, the Agency’s LOC of 1.0 was not
exceeded for sodium chlorate’s agricultural uses (highest RQ = 0.29),
but the LOC was exceeded for sodium chlorate’s non-agricultural uses
(highest RQ = 12.6).  However, the mitigation measures listed above for
the non-agricultural uses of sodium chlorate, including a reduction in
the application rate and treated area, result in a reduction of the
endangered vascular plant RQ from 12.6 to 1.5.  While this is a
significant improvement, it is still above the Agency’s endangered
plant LOC of 1.0.   Furthermore, because of a lack of submitted data,
there is uncertainty remaining on sodium chlorate’s toxicity to
aquatic plants.  The Agency will require data to address this area of
uncertainty.   

		3.	 Summary of Mitigation Measures

	The following mitigation measures are necessary for sodium chlorate to
be eligible for reregistration.   These include use restrictions,
voluntary cancellations and/or use deletions, and personal protective
equipment.     

Agricultural use mitigation:

Engineering controls (enclosed cockpits) for aerial applications on
agricultural crops.

For cotton, the maximum application rate will be reduced from 7.5 lbs
ai/A to 6 lbs ai/A, and applications will be limited to a single
applications in all states except California, where a second application
will be allowed.  

Non-agricultural use mitigation:

All non-agricultural uses will be limited to spot treatments only (with
the exception of the granular formulation for use under asphalt,
although this use will be limited to an 8000 ft2 treatment area).  The
uses limited to spot treatments include, but are not limited to:
building perimeters (including farm buildings), driveways, parking lots,
fence rows, military installations, pipelines, railroads, lumberyards,
industrial sites (transformers, generators, utility poles, etc.), tennis
court perimeters, picnic areas, bleachers, cemeteries, fuel tanks,
airport runways, helo pads, wood decks, guard rails, highway medians,
sidewalks/walkways, vacant lots, fire hydrants, recreational areas, and
other similar areas.

Use on rights-of-way and ditch banks will be cancelled.

The label will specify a maximum application rate of 0.9 lb/Ai/100 ft2.

F.	Other Labeling Requirements  tc "	F.	Other Labeling Requirements " \l
2 

	To be eligible for reregistration, various use and safety information
will be included in the labeling of all end-use products containing
sodium chlorate.  For the specific labeling statements and a list of
outstanding data, refer to Section V of this RED document.

  SEQ CHAPTER \h \r 1 		1.	 Endangered Species Considerations

	The Agency’s screening level assessment results in the determination
that sodium chlorate will have no acute risks to birds, no acute risks
to fish (freshwater and estuarine/marine), and no acute or chronic risks
to aquatic invertebrates (freshwater and estuarine/marine).  

	However, the preliminary risk assessment for endangered species
indicates that RQs exceed endangered species LOCs for chronic risks to
birds (RQs up to 11 for agricultural uses and greater for
non-agricultural uses); acute risks to mammals (RQs up to 33); chronic
risks to mammals (RQs up to 1.2 for agricultural uses and greater for
non-agricultural uses); and risks to aquatic plants (RQs up to 13). 
Risks could not be calculated for terrestrial plants and for chronic
risks to fish; however, the Agency will be requiring data.  

	Further, potential indirect effects to any species dependent upon a
species that experiences effects from use of sodium chlorate can not be
precluded based on the screening level ecological risk assessment. 
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 endangered
and threatened species, and to implement mitigation measures that
address these impacts.  The Endangered Species Act (ESA) 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 the REDs and considers it in relation to individual
species and their locations by evaluating important ecological
parameters, pesticide use information, geographic relationship between
specific pesticide uses and species locations, and biological
requirements and behavioral aspects of the particular species, as part
of a refined species-specific analysis.  When conducted, this
species-specific analysis will take into consideration any regulatory
changes recommended in this RED that are being implemented at that time.

	Following this future species-specific analysis, a determination that
there is a likelihood of potential impact to a listed species or its
critical habitat may result in: limitations on the use of sodium
chlorate, other measures to mitigate any potential impact, or
consultations with the Fish and Wildlife Service or the National Marine
Fisheries Service as necessary.  If the Agency determines use of sodium
chlorate “may affect” listed species or their designated critical
habitat, EPA will employ the provisions in the Services regulations (50
CFR Part 402).  Until that species-specific analysis is completed, the
risk mitigation measures being implemented through this RED will reduce
the likelihood that endangered and threatened species may be exposed to
sodium chlorate at levels of concern.  EPA is not requiring specific
sodium chlorate 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.

           

		2.	Spray Drift Management  tc "			2.	Spray Drift Management " \l 4 

	The Agency has been working closely with stakeholders to develop
improved approaches for mitigating risks to human health and the
environment from pesticide spray and dust drift.  As part of the
reregistration process, EPA will continue to work with all interested
parties on this important issue.

	From its assessment of sodium chlorate, as summarized in this document,
the Agency concludes that certain drift mitigation measures are needed
to address the risks from off-target drift for sodium chlorate,
including a requirement for medium to coarse droplet size.  Label
statements implementing these measures are listed in the "spray drift
management" section of the label table (Table 28 in Section V of this
RED document.  In the future, sodium chlorate product labels may need to
be revised to include additional or different drift label statements.

  SEQ CHAPTER \h \r 1 V.	What Registrants Need to Do

	A.	Manufacturing-Use Products  tc "	A.	Manufacturing Use Products " \l
2 

		1.	Generic Data Requirements  tc "			1.	Outstanding Data Requirements
" \l 2 

	The generic data base supporting the reregistration of sodium chlorate
has been reviewed and determined to be substantially complete.  However,
there are a few data gaps remaining, and these data, presented in Table
27, must be submitted or the Agency may take regulatory action on
registrations of pesticide products containing sodium chlorate.    

Table 27. Guideline Requirements for Sodium Chlorate

Data Requirement	Old Guideline Number	New OPPTS Guideline No.

Magnitude of the Residue-  Meat/Milk/Poultry/Eggs	171-4j	860.1480

Submittal of Analytical Reference Standards	171-13	860.1650

28-Day Inhalation Toxicity	82-4	870.3465

Terrestrial Field Dissipation or Retrospective Monitoring Study	164-1
835.6100

Freshwater Fish Early Life Stage	72-4 (a)	850.1400

Avian Reproduction (1-Generation, Duck)	71-4b	850.2300

Seedling Emergence (Tier II only) 	123-1 (a)	850.4225

Vegetative Vigor  (Tier II only)	123-1 (b)	850.4250

Aquatic Plant Toxicity, using Lemna spp. (Tier II)	123-2	850.4400

Honey Bee Acute Contact Toxicity	141-1	850.3020

While the terrestrial field dissipation (835.6100) guideline study may
not be appropriate for sodium chlorate, the Agency is still concerned
about the prolonged use of sodium chlorate on cotton (about 50 years). 
Terrestrial field dissipation data are not available for sodium
chlorate, and the guideline requirement for this study was never waived.
 There are some reports that sodium chlorate can be persistent in the
field (ranging from 6 months to 5 years, depending on application rate,
soil type, fertility, organic matter, moisture, and weather conditions).
 Also, several labels report that sodium chlorate is effective for the
control of weeds for up to a year, which indicates that chlorate may
persist for up to a year.  Therefore, the range of persistence of sodium
chlorate in the field remains a major uncertainty in the environmental
fate behavior of this chemical.  Use of sodium chlorate in the field
requires that it be applied in conjunction with a fire retardant to
minimize fire incidents. It is unclear how the fire retardant could
influence the persistence in the field.  Even though the persistence of
chlorate in the field is uncertain, a terrestrial field dissipation data
from a study conducted as per guideline 835.6100 may not provide
adequate data because of the complexity of the chlorine oxyanion system
and analytical chemistry methodology.  Given that chloride is the end
chemical species of chlorate, it poses the question of increased
chloride from year-after-year usage (i.e., salinization), and leaching
of chloride to ground water, particularly in areas where chloride is not
a significant, natural component in soil and/or ground water. 
Therefore, the Agency recommends a retrospective monitoring study (soil;
ground water) aimed to address the effect of prolong use of sodium
chlorate on cotton.  The study must be conducted upon agreement of a
protocol, but monitoring sites in coastal areas should not be included. 

		2.	Labeling for Manufacturing-Use Products  tc "			3.	Labeling for
Manufacturing-Use Products " \l 3 

	To ensure compliance with FIFRA, manufacturing-use product (MUP)
labeling should be revised to comply with all current EPA regulations,
PR Notices, and applicable policies.  The MUP labeling should bear the
labeling contained in Table 28.

B.	End-Use Products  tc "	B. 	End-Use Products " \l 2 

		1.	Additional Product-Specific Data Requirements  tc "			1.	Additional
Product-Specific Data Requirements " \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 that they meet current EPA acceptance criteria and
if not, commit to conduct new studies.  If a registrant believes that
previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each
product.  The Agency intends to issue a separate product-specific data
call-in (PDCI) outlining specific data requirements.

2.	Labeling for End-Use Products  tc "			2.	Labeling for End-Use
Products " \l 3 

	To be eligible for reregistration, labeling changes are necessary to
implement measures outlined in Section IV above.  Specific language to
incorporate these changes is provided in Table 28.  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.

C.	Labeling Changes Summary Table

For sodium chlorate to be eligible for reregistration, all sodium
chlorate labels must be amended to incorporate the risk mitigation
measures outlined in Section IV.  Table 28 describes how language on the
labels should be amended.

Existing Stocks 

Registrants may generally distribute and sell products bearing old
labels/labeling for 18 months after the date of approval of revised
labels implementing the changes described in this RED.  Registrants and
all other persons remain obligated to meet pre-existing label
requirements and existing stocks requirements applicable to stocks they
sell or distribute.      



Table 28.  Summary of Labeling Changes for Sodium Chlorate

Description	Amended Labeling Language	Placement on Label

Manufacturing Use Products

For all Manufacturing Use Products	“Only for formulation as a
defoliant/dessicant applied to agricultural crops [Registrant insert
crops supported], as an herbicide applied in nonagricultural settings
(residential, commercial, and industrial) or as an antimicrobial for the
following uses: - [Registrant, please insert].”	Directions for use

Environmental Hazards Statements 	“ENVIRONMENTAL HAZARDS”

“Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National Pollutant Discharge Eliminations
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 Environmental Protection Agency.” 
Precautionary Statements:  Environmental Hazards

End-Use Products Intended for Occupational Use (WPS and Non-WPS)

PPE Requirements for All Formulations

	“Personal Protective Equipment (PPE)”

“Some materials that are chemical-resistant to this product are
[registrant inserts correct material(s)].”  For more options, follow
the instructions for category [insert A, B, C, D, E, F, G or H] on the
chemical-resistance category selection chart.

“All mixers, loaders, applicators, and other handlers must wear:

long-sleeved shirt and long pants, and

shoes and socks” 

“See engineering controls for additional requirements.”  Note:  this
statement should be placed on labels containing agricultural crop
scenarios.  It should not be placed on labels where the sole uses are in
nonagricultural settings, including commercial, industrial, or
residential.	Immediately following/below Precautionary Statements: 
Hazards to Humans and Domestic Animals

Engineering Controls for products within the scope of the Worker
Protection Standard (WPS)

	Enclosed Cockpits/Cabs

“Applicators must use an enclosed cockpit or enclosed cab that meets
the requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides [40 CFR 170.240(d)(6)]. 

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

User Safety Requirements

	 “Follow manufacturer’s instructions for cleaning/maintaining PPE. 
If no such instructions for washables exist, use detergent and hot
water.  Keep and wash PPE separately from other laundry.”

 “Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product’s concentrate.  Do
not reuse them.”	Precautionary Statements:  Hazards to Humans and
Domestic Animals immediately following the PPE 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

(Must be placed in a box.)

Environmental Hazards Statements 	“ENVIRONMENTAL HAZARDS”

“Do not apply directly to water, or to areas where surface water is
present, or to inter-tidal areas below the mean high water mark.  Do not
contaminate water when cleaning equipment or disposing of equipment
washwater or rinsate.”	Precautionary Statements: Hazards to Humans and
Domestic Animals

Restricted-Entry Interval

For products within the scope of the Worker Protection Standard (WPS)
“Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 12 hours.”

	Directions for Use, in Agricultural Use Requirements box

Early Reentry Personal Protective Equipment 

For Products Subject to WPS as required by Supplement 3 of PR Notice
93-7	“PPE required for early entry to treated areas that is permitted
under the Worker Protection Standard and that involves contact with
anything that has been treated, such as soil or water, is 

coveralls,

shoes and socks, and 

chemical-resistant gloves made of any waterproof material.”

	Directions for Use, in Agricultural Use Requirements Box

Entry Restrictions for Non WPS Uses	Product applied as a spray:

“Do not enter of allow others to enter until treated areas have
dried”

Products applied dry:

“Do not enter or allow other to enter until dusts have settled.”	If
no WPS uses on the product label, place the appropriate statement in the
Directions for Use Under General Precautions and Restrictions.  If the
product also contains WPS uses, then create a Non-Agricultural Use
Requirements box as directed in PR Notice 93-7 and place the appropriate
statement inside that box.

General Application Restrictions 	“Do not apply this product in a way
that will contact workers or other persons, either directly or through
drift.  Only protected handlers may be in the area during
application.”

	Place in the Directions for Use directly above the Agricultural Use Box

Application Restrictions- Agricultural Uses	For cotton, the maximum
application rate is 6 lbs ai/A per application.  A maximum of one
application per year is permitted, except in California, where a maximum
of two applications per year is permitted.  	Place in the Directions for
Use for applications to cotton.

Application Restrictions- Non-agricultural Uses	Application rates for
products labeled for non-agricultural use must be amended to reflect the
maximum application rate: 0.9 lb/Ai/100 ft2.

Liquid formulations:

“Non-agricultural uses are limited to spot treatments only. Broadcast
applications are prohibited.”  Use on rights-of-way and ditch banks is
prohibited.

Granular formulations:

“Non-agricultural uses are limited to spot treatments with the
exception of applications under asphalt.  Applications under asphalt may
only be applied with handheld equipment such as a rotery spreader and
are limited to 8,000 square feet per site”.  Use on rights-of-way and
ditch banks is prohibited.

	Place in the Directions Under Application Resrictions.

Spray Drift Label Language for Products Applied as a Spray to
Agricultural Sites

	"Spray Drift Management”

“A variety of factors including weather conditions (e.g., wind
direction, wind speed, temperature, relative humidity) and method of
application can influence pesticide drift.  The applicator must evaluate
all factors and make appropriate adjustments when applying this
product.” 

Wind Speed

“Do not apply at wind speeds greater than 15 mph.”

Droplet Size

“Apply as a medium or coarser spray (ASAE Standard 572)”

Temperature Inversions

“If applying at wind speeds less than 3 mph, the applicator must
determine if a) conditions of temperature inversion exist, or b) stable
atmospheric conditions exist at or below nozzle height.  Do not make
applications into areas of temperature inversions or stable atmospheric
conditions.”

Other State and Local Requirements

“Applicators must follow all state and local pesticide drift
requirements regarding application of sodium chlorate.  Where states
have more stringent regulations, they must be observed.”

Equipment

“All application equipment must be properly maintained and calibrated
using appropriate carriers or surrogates.”

Additional requirements for aerial applications:

1.  “The boom length must not exceed 75% of the wingspan or 90% of the
rotor blade diameter.”

2.  “Release spray at the lowest height consistent with efficacy and
flight safety.  Do not release spray at a height greater than 10 feet
above the crop canopy unless a greater height is required for aircraft
safety.”

3.  “When applications are made with a crosswind, the swath must be
displaced downwind.  The applicator must compensate for this
displacement at the up and downwind edge of the application area by
adjusting the path of the aircraft upwind.”

Additional requirement for groundboom application:

“Do not apply with a nozzle height greater than 4 feet above the crop
canopy.”	Directions for Use under General Precautions or Restrictions
and/or Application Instructions

End Use Products Primarily Used by Consumers/Homeowners

Environmental 

Hazards Statement 	“ENVIRONMENTAL HAZARDS”

“This product is toxic to fish and shrimp.  Do not apply directly to
water.  Do not contaminate water when cleaning equipment or disposing of
equipment washwaters or rinsate.”  “Drift and runoff may be
hazardous to aquatic organisms in water adjacent to treated areas.”

 	Precautionary Statements under Environmental Hazards 

Entry Restrictions 

	Products applied as a spray:

“Do  SEQ CHAPTER \h \r 1  not allow adults, children, or pets to enter
the treated area until sprays have dried.”

Products applied dry:

“Do not allow adults, children, or pets to enter the treated area
until dusts have settled.”

	  SEQ CHAPTER \h \r 1 Directions for use under General Precautions and
Restrictions

General Application Restrictions 	“Do not apply this product in a way
that will contact adults, children, or pets, either directly or through
drift.” 	Place in the Direction for Use 

Application Restrictions 	Liquid Formulations

“Use is limited to spot treatments only.  Broadcast applications are
prohibited  Use on ditch banks is prohibited.”

Granular Formulations

“Use is limited to spot treatments only, with the exception of
applications under asphalt.  Applications under asphalt are limited to
8,000 square feet per site. Use on ditch banks is prohibited. “

Application rates for products labeled for non-agricultural use must be
amended to reflect the maximum application rate:  0.9 lb/Ai/100 ft2.

	Place in the Directions under Application Restrictions

Appendix A.  Use Patterns Eligible for Reregistration for Sodium
Chlorate

Use Site	Formulation Type	Maximum Application Rate/App.1	Unit	Reentry
Interval (Hours)	Pregrazing/

Preharvest/

Preslaughter Interval (Days)	Limitations

Agricultural Drainage Systems	Soluble Concentrate/ Liquid	0.8	W2	N/A	N/A

	Agricultural Fallow/Idleland	Soluble Concentrate/ Liquid	6	lb/A	12 h
N/A	Do not apply through any type of irrigation system.

Beans- Dried Type	Soluble Concentrate/ Liquid	6	lb/A	12 	Preharvest (7)
Do not apply through any type of irrigation system.

Corn (Unspecified)	Soluble Concentrate/ Liquid	6	lb/A	12 	Pregrazing
(14) Preharvest (14)	Do not apply through any type of irrigation system.

Cotton (Unspecified)	Soluble Concentrate/ Liquid	6	lb/A	12 	Preharvest
(7)	Do not apply through any type of irrigation system.

One application per season in all states except CA, where two
applications are permitted.

Cotton (Unspecified)	Soluble Concentrate/ Liquid	5.28	lb/20 gal	12 
Preharvest (7)	Do not apply through any type of irrigation system.

One application per season in all states except CA, where two
applications are permitted.

Cotton (Unspecified)	Soluble Concentrate/ Liquid	5.28	lb/4 gal	12 
Preharvest (7)	Do not apply through any type of irrigation system.

One application per season in all states except CA, where two
applications are permitted.

Cotton (Unspecified)	Soluble Concentrate/ Liquid + Liquid Ready to Use
4.706	lb/A	4 	Preharvest (7)	Do not apply through any type of irrigation
system.

One application per season in all states except CA, where two
applications are permitted.

Cucurbit Vegetables	Soluble Concentrate/ Liquid	6.1875	lb/A	12
Pregrazing (14)	Do not apply through any type of irrigation system.

Grown for seed only.

Flax	Soluble Concentrate/ Liquid	7.5	lb/A	12 	Pregrazing (14) Preharvest
(7)	Do not apply through any type of irrigation system.

Gourds	Soluble Concentrate/ Liquid	6	lb/A	N/A	N/A	Do not apply through
any type of irrigation system.

Guar	Soluble Concentrate/ Liquid	7.5	lb/A	12 	Preharvest (7)	Do not
apply through any type of irrigation system.

Human Drinking Water Systems	Soluble Concentrate/ Liquid	2	W	N/A	N/A

	Lakes/Ponds/Reservoirs (with Human or Wildlife Use)	Soluble
Concentrate/ Liquid	10	W	N/A	N/A

	Peas- Southern	Soluble Concentrate/ Liquid	7.5	lb/A	12 	Preharvest (7)
Do not apply through any type of irrigation system.

Pepper (Chili Type)	Soluble Concentrate/ Liquid	12.5	lb/A	12 	Preharvest
(10)	Do not apply through any type of irrigation system.

Potato – White/Irish	Soluble Concentrate/ Liquid	12.5	lb/A	12 
Preharvest (7)	Do not apply through any type of irrigation system.

Rice	Soluble Concentrate/ Liquid	7.5	lb/A	12 	Pregrazing (14) Preharvest
(7)	Do not apply through any type of irrigation system.

Safflower (Unspecified)	Soluble Concentrate/ Liquid	7.5	lb/A	12 
Preharvest (7)	Do not apply through any type of irrigation system.

Sorghum	Soluble Concentrate/ Liquid	7.5	lb/A	12 	Pregrazing (14)
Preharvest (7)	Do not apply through any type of irrigation system.

Soybeans (Unspecified)	Soluble Concentrate/ Liquid	7.5	lb/A	12 
Preharvest (7)	Do not apply through any type of irrigation system.

Sunflower	Soluble Concentrate/ Liquid	7.5	lb/A	12	Pregrazing (14)
Preharvest (7)	Do not apply through any type of irrigation system.

Airports/Landing Fields	Granular	12	lb/1K sq. ft	12 	N/A	Do not apply to
sandy soils.

Applications limited to spot treatments only.

Airports/Landing Fields	Pelleted/ Tableted	1.393	lb/1K sq. ft	N/A	N/A	Do
not apply to sandy soils.

Applications limited to spot treatments only.

Cables/Cable Coverings	Granular	5.4	lb/1K sq. ft	N/A	N/A	Do not apply to
sandy soils.

Applications limited to spot treatments only.

Commercial Storages/Warehouse Premises	Pelleted/ Tableted	1.393	lb/1K
sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Commercial/Industrial Water Cooling Systems	Liquid Ready to Use	250,000
W	N/A	N/A

	Commercial/Industrial Water Cooling Systems	Soluble Concentrate/ Liquid
224	W	N/A	N/A

	Drainage Systems	Granular	12	lb/1K sq. ft	12 	N/A

	Drainage Systems	Soluble Concentrate/ Liquid	10	W	N/A	N/A

	Fencerows/Hedgerows	Granular	12	lb/1K sq. ft	12 	N/A	Do not apply to
sandy soils.

Applications limited to spot treatments only.

Fencerows/Hedgerows	Pelleted/ Tableted	1.393	lb/1K sq. ft	N/A	N/A	Do not
apply to sandy soils.

Applications limited to spot treatments only.

Household/Domestic Dwellings Outdoor Premises	Liquid Ready to Use	3.267
lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Household/Domestic Dwellings Outdoor Premises	Soluble Concentrate/
Liquid	0.5588	lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Industrial Areas (Outdoor)	Granular	12	lb/1K sq. ft	12 	N/A	Do not apply
to sandy soils.

Applications limited to spot treatments only.

Industrial Areas (Outdoor)	Pelleted/ Tableted	1.393	lb/1K sq. ft	N/A	N/A
Do not apply to sandy soils.

Applications limited to spot treatments only.

Industrial Processing Water	Liquid Ready to Use	250000	W	N/A	N/A

	Industrial Processing Water	Soluble Concentrate/ Liquid	10	W	N/A	N/A

	Industrial Processing Water	Soluble Concentrate/ Liquid	8000	gal/A	N/A
N/A

	Industrial Waste  Disposal Systems	Soluble Concentrate/ Liquid	224	W
N/A	N/A

	Lakes/Ponds/Reservoirs (Without Human or Wildlife Use)	Soluble
Concentrate/ Liquid	10	W	N/A	N/A

	Machinery (Non-food)	Pelleted/ Tableted	1.393	lb/1K sq. ft	N/A	N/A	Do
not apply to sandy soils.

Applications limited to spot treatments only.

Nonagricultural Outdoor Buildings/Structures	Granular	12	lb/1K sq. ft	12
	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Nonagricultural Outdoor Buildings/Structures	Pelleted/ Tableted	1.393
lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Nonagricultural Outdoor Buildings/Structures	Liquid Ready to Use	3.267
lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Nonagricultural Outdoor Buildings/Structures	Soluble Concentrate/ Liquid
7.267	lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Fencerows/Hedgerows	Granular	12	lb/1K sq. ft	N/A	N/A	Do not apply to
sandy soils.

Applications limited to spot treatments only.

Fencerows/Hedgerows	Pelleted/ Tableted	1.393	lb/1K sq. ft	N/A	N/A	Do not
apply to sandy soils.

Applications limited to spot treatments only.

Fencerows/Hedgerows	Liquid Ready to Use	3.267	lb/1K sq. ft	N/A	N/A	Do
not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Fencerows/Hedgerows	Soluble Concentrate/ Liquid	7.267	lb/1K sq. ft	N/A
N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Nonagricultural Uncultivated Areas/Soils	Granular	240	lb/A	N/A	N/A	Do
not apply to sandy soils.

Applications limited to spot treatments only.

Nonagricultural Uncultivated Areas/Soils	Granular	9	lb/1K sq. ft	N/A	N/A
Do not apply to sandy soils.

Applications limited to spot treatments only.

Applications limited to spot treatments only.

Nonagricultural Uncultivated Areas/Soils	Pelleted/ Tableted	5.48	lb/1K
sq. ft	N/A	N/A	Do not apply to sandy soils. 

Applications limited to spot treatments only.

Do not enter treated areas without protective clothing until dust has
settled.

Nonagricultural Uncultivated Areas/Soils	Liquid Ready to Use	3.267	lb/1K
sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Nonagricultural Uncultivated Areas/Soils	Soluble Concentrate/ Liquid
23.7	lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Ornamental Lawns and Turf	Granular	12	lb/1K sq. ft	N/A	N/A	Do not apply
to sandy soils.

Applications limited to spot treatments only.

Pasteurizer/Warmer/Cannery/Cooling Water Systems	Soluble Concentrate/
Liquid	0.16	W	N/A	N/A

	Paths/Patios	Granular	12	lb/1K sq. ft	12 	N/A	Applications limited to
spot treatments only.

Paths/Patios	Liquid Ready to Use	3.267	lb/1K sq. ft	N/A	N/A	Applications
limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Paths/Patios	Soluble Concentrate/ Liquid	7.267	lb/1K sq. ft	N/A	N/A
Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Paved Areas (Private Roads/ Sidewalks)	Granular	12	lb/1K sq. ft	12 	N/A
Applications limited to spot treatments only.

Paved Areas (Private Roads/Sidewalks)	Liquid Ready to Use	3.267	lb/1K
sq. ft	N/A	N/A	Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Paved Areas (Private Roads/Sidewalks)	Soluble Concentrate/ Liquid	14.81
lb/1K sq. ft	N/A	N/A	Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Pulp/Paper Mill Water Systems	Liquid Ready to Use	3980	W	N/A	N/A

	Pulp/Paper Mill Water Systems	Soluble Concentrate/ Liquid	1600	W	N/A
N/A

	Recreational Areas	Granular	12	lb/1K sq. ft	12 	N/A	Do not apply to
sandy soils.

Applications limited to spot treatments only.

Recreational Areas	Pelleted/ Tableted	1.393	lb/1K sq. ft	N/A	N/A	Do not
apply to sandy soils.

Applications limited to spot treatments only.

Recreational Areas	Soluble Concentrate/ Liquid	14.607	lb/1K sq. ft	N/A
N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Do not allow children or pets on treated areas until surfaces are dry.

Secondary Oil Recovery Injection Water	Soluble Concentrate/ Liquid	1200
W	N/A	N/A

	Sewage Systems 	Granular	12	lb/1K sq. ft	12 	N/A

	Sewage Systems	Liquid Ready to Use	250000	W	N/A	N/A

	Sewage Systems	Soluble Concentrate/ Liquid	2	W	N/A	N/A

	Urban Areas 	Granular	12	lb 1K sq. ft	12 	N/A	Do not apply to sandy
soils.

Applications limited to spot treatments only.

Wood Protection Treatment To Buildings/Products Outdoor	Granular	12
lb/1K sq. ft	N/A	N/A	Do not apply to sandy soils.

Applications limited to spot treatments only.

Sodium chlorate does not have a maximum number of application per year
(or crop cycle) restriction for any use site except cotton.

W = Parts per million calculated by weight.

Appendix B.  Table of Generic Data Requirements and Studies Used to
Make the Reregistration Decision for Sodium Chlorate

GUIDE TO APPENDIX B

	Appendix B contains a listing of data requirements which support the
reregistration for active ingredients within the case Sodium Chlorate
covered by this RED.  In contains generic data requirements that apply
nitrapyrin in all products, including data requirements for which a
“typical formulation” is the test substance.

The data table is organized in the following formats:

Data requirement (Column 1).  The data requirements are listed in the
order in which they appear in 40 CFR 158.  The reference numbers
accompanying each test refer to the test protocols set in the Pesticide
Assessment Guidance, which is available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161.  (703)
487-4650.

Use Pattern (Column 2).  This column indicates the use patterns for
which the data requirements apply.  The following letter designations
are used for the given use patterns.

Terrestrial food

Terrestrial feed

Terrestrial non-food

Aquatic food

Aquatic non-food outdoor

Aquatic non-food industrial

Aquatic non-food residential

Greenhouse food

Greenhouse non-food

Forestry

Residential

Indoor food

Indoor non-food

Indoor medical

Indoor residential

3.  Bibliographic Citation (Column 3).  If the Agency has acceptable
data in its files, this column lists the identifying number of each
study.  This normally is the Master Record Identification (MRID) number,
but may be a “GS” number is no MRID number has been assigned.  Refer
to the Bibliography appendix for a complete citation of the study.

Appendix B.  Data Supporting Guideline Requirements for the
Reregistration of Sodium Chlorate

New Guideline Number	Old Guideline Number	Description	Use Patterns
Citations

PRODUCT CHEMISTRY

830.1550	61-1	Product Identity and Composition	All	PDCI Requirement

830.1600	61-2A	Description of materials used to produce the product	All
PDCI Requirement

830.1620	61-2B	Description of production process	Al	PDCI Requirement

830.1670	61-2B	Formation of Impurities	All	PDCI Requirement

830.1700	62-1	Preliminary Analysis	All	PDCI Requirement

830.1750	62-0	Certification of Limits	All	PDCI Requirement

830.1800	62-3	Analytical Method	All	PDCI Requirement

830.6302	63-2	Color	All	PDCI Requirement

830.6303	63-3	Physical State	All	PDCI Requirement

830.6304	63-4	Odor	All	PDCI Requirement

830.6313	63-13	Stability to normal and elevated temperatures, metals,
and metal ions	All	PDCI Requirement

830.7000	63-12	pH	All	PDCI Requirement

830.7050	None	UV/Visible Absorption	All	Data Gap

830.7200	63-5	Melting Point	All	PDCI Requirement

830.7220	63-6	Boiling Point	All	PDCI Requirement

830.7300	63-7	Density	All	PDCI Requirement

830.7370	63-10	Dissociation Constants in Water	All	PDCI Requirement

830.7550	63-11	Partition coefficient, shake flask method	All	PDCI
Requirement

830.7840	63-8	Solubility	All	PDCI Requirement

830.7950	63-9	Vapor Pressure	All	PDCI Requirement

ENVIRONMENTAL TOXICITY

850.2100	71-1A	Avian Acute Oral Toxicity – Quail	All	42149401

850.2100	71-1A	Avian Acute Oral Toxicity – Duck	All	42149401

850.2200	71-2A	Avian Dietary Toxicity – Quail	All	254177, 41819907,
41819908

850.2200	71-2B	Avian Dietary Toxicity – Duck	All	41819907, 41819908

850.2300	71-4A	Avian Reproduction – Quail	All	46729701 Data Gap

850.2300	71-4B	Avian Reproduction – Duck	All	46729701 Data Gap

850.1075	72-1A	Fish Toxicity Bluegill	All	41887202, 41887203, 94068006

850.1075	72-1C	Freshwater Fish Toxicity Rainbow Trout	All	41887203,
94068007 

850.1010	72-2A	Freshwater Invertebrate Toxicity	All	41887204, 43874801,
46524001, 94068009

850.1075	72-3A	Estuarine/Marine Toxicity – Fish	All	41887207

850.1025	72-3B	Estuarine/Marine Toxicity – Mollusk	All	41887205,
41887206

850.1035	72-3C	Estuarine/Marine Toxicity – Shrimp	All	41887206

850.1300	72-4	Freshwater Invertebrate Toxicity – Chronic	All	46731301

850.1400	72-4	Freshwater Fish Early-Life Stage	All	Data Gap

850.3020	141-1	Honey Bee Acute Contact	All	Data Gap

850.4100	122-1A	Seed Germ./Seedling Emerg. Tier I	All	46300802

850.4150	122-1B	Vegetative Vigor, Tier 1	All	46300801

850.4200	122-1C	Seed Germination/root Elongation 	All	419485-01

850.4250	123-1B	Vegatative Vigor, Tier 2	All	Data Gap

850.5400	122-2	Aquatic Plant Growth	All	41887201, 46687601 Data Gap

850.4400	123-2	Aquatic Plant Growth, Tier II	All	418887201, Data Gap

TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity - Rat	All	41819901

870.1200	81-2	Acute Dermal Toxicity – Rabbit/Rat	All	41819902,
42497601

870.1300	81-3	Acute Inhalation Toxicity – Rat	All	41819903

870.2400	81-4	Primary Eye Irritation  - Rabbit	All	00085090, 00102998,
41819904

870.2500	81-5	Primary Skin Irritation	All	41819905, 42497602

870.2600	81-6	Dermal Sensitization	All	41819906

870.3100	82-1A	Subchronic Oral Toxicity: 90-Day Study Rodent	All
40444801, 40460402

870.3150	82-1B	Subchronic Oral Toxicity: 90-Day Study Non-rodent	All
40460402

870.3465

90-Day Inhalation Toxicity	All	Data Gap

870.3700	83-3A	Developmental Toxicity – Rat	All	40460401

870.3800	83-4	2-Generation Reproduction – Rat	All	46524001

870.5100	84-2	Bacterial Reverse Gene Mutation	All	41256201

870.5300	84-2	Cytogenetics	All	41256202

870.5395	84-2	Mammalian Erythrocyte Test	All	41256203

870.5500	84-2	Bacterial DNA Damage/Repair	All	41256204

870.5550	84-2	Unscheduled DNA Synthesis in Mammalian Cells in Culture
All	41256205

ENVIRONMENTAL FATE

835.6100

Terrestrial Field Dissipation	All	Data Gap

RESIDUE CHEMISTRY

860.1300	171-4A	Nature of Residue – Plants	A,B   SEQ CHAPTER \h \r 1 
00062497, 00066805

860.1340	171-4C	Residue Analytical Method – Plants	A,B  SEQ CHAPTER \h
\r 1 
00049610,0006802,00066804,00066808,00066809,00066810,00123747,00124680,0
0135224

860.1480	171-4J	Magnitude of Residue in Meat, Milk, Poultry and Eggs 

Ruminant and Poultry Feed	A,B  SEQ CHAPTER \h \r 1 	Data Gap

860.1500	171-4K	Crop Field Trials   SEQ CHAPTER \h \r 1 

Flaxseed and Flax (straw)	A,B	00136326

Guar Beans	A,B	00136388

Peas (southern)	A,B	00128727

Peppers (chili)	A,B	00116554

Potatoes	A,B	42464201,42930601

Rice and Rice Straw	A,B	00159210

Sorghum (grain, fodder,forage)	A,B	00123727

Soybeans	A,B	00128727

Sunflower Seed	A,B	00135224

Wheat	A,B	00136326

860.1650	171-13	Submittal of analytical reference standards	A,B	Data Gap

  SEQ CHAPTER \h \r 1 GUIDE TO APPENDIX C

1.	CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of
all studies considered relevant by EPA in arriving at the positions and
conclusions stated elsewhere in the Reregistration Eligibility Document.
 Primary sources for studies in this bibliography have been the body of
data submitted to EPA and its predecessor agencies in support of past
regulatory decisions.  Selections from other sources including the
published literature, in those instances where they have been
considered, are included.

2.	UNITS OF ENTRY.  The unit of entry in this bibliography is called a
"study".  In the case of published materials, this corresponds closely
to an article.  In the case of unpublished materials submitted to the
Agency, the Agency has sought to identify documents at a level parallel
to the published article from within the typically larger volumes in
which they were submitted.  The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional
bibliographic citation.  The Agency has also attempted to unite basic
documents and commentaries upon them, treating them as a single study.

3.	IDENTIFICATION OF ENTRIES.  The entries in this bibliography are
sorted numerically by Master Record Identifier, or "MRID number".  This
number is unique to the citation, and should be used whenever a specific
reference is required.  It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies
(see paragraph 4(d)(4) below for further explanation).  In a few cases,
entries added to the bibliography late in the review may be preceded by
a nine character temporary identifier.  These entries are listed after
all MRID entries.  This temporary identifying number is also to be used
whenever specific reference is needed.

4.	FORM OF ENTRY.  In addition to the Master Record Identifier (MRID),
each entry consists of a citation containing standard elements followed,
in the case of material submitted to EPA, by a description of the
earliest known submission.  Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded
to provide for certain special needs.

a	Author.  Whenever the author could confidently be identified, the
Agency has chosen to show a personal author.  When no individual was
identified, the Agency has shown an identifiable laboratory or testing
facility as the author.  When no author or laboratory could be
identified, the Agency has shown the first submitter as the author.

b.	Document date.  The date of the study is taken directly from the
document.  When the date is followed by a question mark, the
bibliographer has deduced the date from the evidence contained in the
document.  When the date appears as (19??), the Agency was unable to
determine or estimate the date of the document.

c.	Title.  In some cases, it has been necessary for the Agency
bibliographers to create or enhance a document title.  Any such
editorial insertions are contained between square brackets.

d.	Trailing parentheses.  For studies submitted to the Agency in the
past, the trailing parentheses include (in addition to any
self-explanatory text) the following elements describing the earliest
known submission:

(1)	Submission date.  The date of the earliest known submission appears
immediately following the word "received."

(2)	Administrative number.  The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.

(3)	Submitter.  The third element is the submitter.  When authorship is
defaulted to the submitter, this element is omitted.

(4)	Volume Identification (Accession Numbers).  The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears.  The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library."  This accession number is in turn followed by an
alphabetic suffix which shows the relative position of the study within
the volume.

Ecological Effects Bibliography

41819907	Long, R.; Beavers, J.; Smith, G. (1991) Sodium Chlorate: A
Dietary LC50 Study with the Northern Bobwhite: Lab Project Number:
311-101. Unpublished study prepared by Wildlife International Ltd. 19 p.

41819908	Long, R.; Beavers, J.; Smith, G. (1991) Sodium Chlorate: A
Dietary LC50 Study with the Mallard: Lab Project Number: 311-102. Un-
published study prepared by Wildlife International Ltd. 19 p. 

41887201	Ward, T.; Boeri, R. (1991) Static Acute Toxicity of Sodium
Chlorate to the Freshwater Alga, Selenastrum capricornutum: Lab Project
Number: 90161-AW. Unpublished study prepared by Resource Analysts, Inc.
23 p. 

41887202	Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of
Sodium Chlorate to the Bluegill Sunfish, Lepomis macrochirus: Lab Proj-
ect Number: 90142-AW. Unpublished study prepared by Resource Analysts,
Inc. 23 p. 

41887203	Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of
Sodium Chlorate to the Rainbow Trout, Oncorhynchus mykiss: Lab Project
Number: 90143-AW. Unpublished study prepared by Resource Analysts, Inc.
23 p. 

41887204	Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of
Sodium Chlorate to the Daphnid, Daphnia magna: Lab Project Number:
90144-AW. Unpublished study prepared by Resource Analysts, Inc. 23 p. 

41887206	Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of
Sodium Chlorate to the Mysid, Mysidopsis bahia: Lab Project Number:
90117-DE. Unpublished study prepared by Resource Analysts, Inc. 23 p. 

41887207	Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of
Sodium Chlorate to the Sheepshead Minnow, Cyprinodon variegatus: Lab
Project Number: 90115-DE. Unpublished study prepared by Resource
Analysts, Inc. 23 p. 

42149401	Fink, R. (1990) Acute Oral LD50-Mallard Duck: [Sodium
Chlorate]: Final Report: Project Nos. 176-101; WI-704. Unpublished study
prepared by Wildlife International. 18 p. 

43874801	Owusu-Yaw, J. (1995) Acute Toxicity of Sodium Chlorate to the
Water Flea, Daphnia magna, Under Static Test Conditions: Amended Final
Report: Lab Project Number: 3195436-0100-3100. Unpublished study
prepared by Environmental Science & Engineering, Inc. 227 p. 

46524001	Gaoua, W. (2004) Two-Generation Study (Reproduction and
Fertility Effects) by Oral Route (Gavage) in Rats: Sodium Chlorate.
Project Number: 22824/RSR, 

M/CHLORATE/CEFIC/BIT. Unpublished study prepared by Centre International
de Toxicologie. 2362 p. Relates to L0000973.

46687601	Scheerbaum, D. (2003) Sodium Chlorate Aquatic Plant Toxicity
Test, Lemna minor, Static, 7 d. Project Number: 030724AT, TLA93762,
LA9376. Unpublished study prepared by Dr. U. Noack-Laboratorien. 42 p.

46729701	Arch, A. (2004) Sodium Chlorate: Assessment to Determine the
Effects on Reproduction in the Bobwhite Quail (Colinus virginianus):
Final Report. Project Number: K3AK1008. Unpublished study prepared by
Central Science Laboratory. 171 p.

46731301	Thomas, P. (2004) Chronic Toxicity of Sodium Chlorate to
Daphnia magna Under Semi-Static Conditions in a 21 Day Reproduction
Test. Project Number: ER/F03043/T02006/ODC. Unpublished study prepared
by AKZO Nobel Functional Chemicals BV. 30 p.

Toxicology Bibliography

85090	Hansen, K.L.; Thompson, D.C.; Beck, L.S. (1981) Primary Eye Irri-
tation Study: Sodium Chlorate: Project No. 1739-B. (Unpublished study
received Oct 7, 1981 under 10659-46; prepared by Elars Bioresearch
Laboratories, Inc., submitted by Occidental Chemical Co., Houston, Tex.;
CDL:246040-A) 

102998	Hansen, K.; Thompson, D.; Beck, C.; et al. (1981) Primary Eye
Irri- tation Study: Sodium Chlorate: Project No. 1739-B. (Unpublished
study received May 21, 1982 under 7001-343; prepared by Elars
Bioresearch Laboratories, Inc., submitted by Occidental Chemical Co.,
Lathrop, CA; CDL:247564-G) 

41819901	Shapiro, R. (1991) EPA Acute Oral Toxicity Limit Test: Sodium
Chlorate Crystal, Batch No. DL-1: Lab Project Number: T-488. Unpublished
study prepared by Product Safety Labs. 19 p. 

41819902	Shapiro, R. (1991) EPA Dermal Toxicity Limit Test: Sodium
Chlorate Crystal, Batch No. DL-1: Lab Project Number: T-91. Unpublished
study prepared by Product Safety Labs. 14 p. 

41819903	Shapiro, R. (1991) EPA Acute Inhalation Limit Test: Sodium
Chlorate Crystal, Batch No. DL-1: Lab Project Number: T-493. Unpublished
study prepared by Product Safety Labs. 33 p. 

41819904	Shapiro, R. (1991) EPA Primary Eye Irritation Test: Sodium
Chlorate Crystal, Batch No. DL-1: Lab Project Number: T-489. Unpublished
study prepared by Product Safety Labs. 18 p. 

41819905	Shapiro, R. (1991) EPA Dermal Irritation Test: Sodium Chlorate
Crystal, Batch No. DL-1: Lab Project Number: T-490. Unpublished study
prepared by Product Safety Labs. 16 p. 

41819906	Shapiro, R. (1991) EPA Guinea Pig Sensitization Test (Buehler):
Sodium Chlorate Crystal, Batch No. DL-1: Lab Project Number: T-492.
Unpublished study prepared by Product Safety Labs. 27 p. 

42497601	Shapiro, R. (1991) EPA Acute Dermal Toxicity Limit Test: Sodium
Chlorate Crystal: Lab Project Number: T-911. Unpublished study prepared
by Product Safety Labs. 15 p. 

42497602	Shapiro, R. (1991) EPA Acute Dermal Irritation Test: Sodium
Chlorate Crystal: Lab Project Number: T-912. Unpublished study prepared
by Product Safety Labs. 15 p. 

46524001	Gaoua, W. (2004) Two-Generation Study (Reproduction and
Fertility Effects) by Oral Route (Gavage) in Rats: Sodium Chlorate.
Project Number: 22824/RSR, M/CHLORATE/CEFIC/BIT. Unpublished study
prepared by Centre International de Toxicologie. 2362 p. Relates to
L0000973.

Residue Chemistry Bibliography

5620  	United States Borax & Chemical Corporation (1967) Residue Data.
(Unpublished study received Apr 1, 1969 under 9F0783; CDL: 091347-A)

49610	Rhone-Poulenc Chemical Company (1959) Method of Analysis for
Chlorates.  (Unpublished study received Jan 4, 1962 under 359-400;
CDL:119511-B) 

48007  	Abernathy, J.; Miller, C.S.; Richard, J. (1975) Sodium chlorate
on Sunflowers. Prepared in cooperation with Texas A & M Univ.,
Agricultural Experiment Station and Iowa State Univ., Ames Laboratory. 
Unpublished study; 17 p. 

48009  	Smith, D.T.; Eastin, E.F.; Wiese, A.F.; et al. (1976) Summary of
Experimental Conditions and Data from Texas and Oklahoma in 1975. 
(Unpublished study received Aug 12, 1980 under 2342-964; prepared in
cooperation with Texas A & M Univ., Agricultural Experiment Station and
others, submitted by Kerr-McGee Chemical Corp., Oklahoma City, Okla.;
CDL:243078-I) 

48064  	Abernathy, J.; Scrib, J.; Miller, C.S.; et al. (1975) Sodium
chlorate on Sunflowers: Summary of Experimental Conditions and Data from
Texas in 1975; prepared in cooperation with Texas A & M Univ.
Agricultural Experiment Station and Iowa State Univ., Ames Laboratory
E.R.D.A. Unpublished study; 17 p. 

48065  	Smith, D.T.; Eastin, E.F.; Wiese, A.F.; et al. (1975) Summary of
Experimental Conditions and Data from Texas and Oklahoma in 1975. 
(Unpublished study received Aug 12, 1980 under 2342-964; prepared in
cooperation with Texas A & M Univ., Agricultural Ex- periment Station
and others, submitted by Kerr-McGee Chemical Corp., Oklahoma City,
Okla.; CDL:243079-E)

49609  	Chipman Chemical Company, Incorporated (1962) Progress Report:
Residue Data following the Field Use of Shed-a-Leaf on Tomatoes as a
Defoliant/Desiccant in California and New York State from Applications
Made Fall of 1961.  (Unpublished study received Jan 4, 1962 under
359-400; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:119511-A)

53626  	Chipman Chemical Company, Incorporated (1961) Residue Data
Sheet. (Unpublished study received Jan 4, 1962 under 359-400; submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL: 119510-A)

58490  	Pennwalt Corporation (1975) Efficacy of Sodium chlorate--Rice.
(Reports by various sources; unpublished study, including published
data, received Oct 14, 1976 under 4581-328; CDL:232133-T) 

62497	 Pernert, J.C. (1960) On the Possibility of Toxic Residues
following Cotton Defoliation by Chlorate.  (Unpublished study received
Dec 18, 1969 under 0F0926; prepared by Hooker Chemical Corp., submitted
by Fenrich-Vincent Associates, Manhasset, N.Y.; CDL: 093232-G) 

66802	Fenrich-Vincent Associates (1969) Analytical Methods and Results
of Tests on the Amount of Residue Remaining in or on Raw Cottonseed When
an (Inert Ingredient) has Been Used on the Cotton Plant.  Unpublished
study; 14 p. 

66803  	Walaski, L.J. (1960) Residue Analysis and Reports.  (Unpublished
study received May 30, 1970 under 0F0926; prepared by Chipman Chemical
Co., Inc., submitted by Fenrich-Vincent Associates, Manhasset, N.Y.;
CDL:091580-N) 

66804	 Gauditz, I. (1959) The Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Methods Used:
(Penco De-fol-ate).  (Unpublished study received May 30, 1970 under
0F0926; submitted by Fenrich-Vincent Associates, Manhasset, N.Y.;
CDL:091580-O) 

66805	 Banderis, A. (1965) Colorimetric Determination of chlorate in
soil and plant extracts.  Journal of the Science of Food and Agriculture
16(Sep):558-564.  (Also In unpublished submission received May 30, 1970
under 0F0926; submitted by Fenrich-Vincent Associates, Manhasset, N.Y.;
CDL:091580-P)

66808	Peniston, Q.P. (1968) Letter sent to E.H. Karr dated Jan 3, 1968:
Determination of sodium chlorate residues on cottonseed: Report # 3. 
(Unpublished study received May 30, 1970 under 0F0926; prepared by Food,
Chemical & Research Laboratories, Inc., submitted by Fenrich-Vincent
Associates, Manhasset, N.Y.; CDL:091580-T) 

66809	  Peniston, Q.P. (1968) Letter sent to E.H. Karr dated Jul 30,
1968: Determination of sodium chlorate residues in ground
cottonseed--report # 4: Lab. No. 5639.  (Unpublished study received May
30, 1970 under 0F0926; prepared by Food, Chemical & Re- search
Laboratories, Inc., submitted by Fenrich-Vincent Associates, Manhasset,
N.Y.; CDL:091580-U) 

66810	Peniston, Q.P. (1969) Letter sent to E.H. Karr dated Feb 18, 1969:
Further studies on determination of sodium chlorate residues in ground
cottonseed--report #5: Lab. No. 5879; prepared by Food, Chemical &
Research Laboratories, Inc.  Unpublished study; 2 p

74958  	Rhone-Poulenc Chemical Company (1964) Tests with Shed-a-leaf L.
(Compilation; unpublished study received Apr 16, 1964 under 359- 399;
CDL:023331-A)

74967	Walaski, L.J. (1962) Analyses of Dry Edible Beans, Stalks, and
Pods for Possible Residues of Borate and Chlorate: BB/9/62. 
(Unpublished study received Dec 3, 1962 under 359-399; prepared by
Chipman Chemical Co., Inc., submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:101365-B) 

75021  	Chipman Chemical Company, Incorporated (1960) Results of
Analyses for Chlorate and Borate Residues on Cottonseed from 1959 & 1960
California Cotton Samples.  (Unpublished study received Jan 19, 1961
under 359-399; submitted by Rhone-Poulenc Chemical Co., Monmouth
Junction, N.J.; CDL:119545-A) 

75023  	Rhone-Poulenc Chemical Company (1963) Residues in Sorghum and
Rice.  (Compilation; unpublished study, including letter dated Jul 1,
1963 from L.R. Reed to Commissioner of Food & Drugs, Food & Drug
Administration, Department of Health, Education, & Wel- fare, received
Jul 2, 1963 under unknown admin. no.; CDL: 119636-A) 

75025  	Walaski, L.J. (1963) Analysis of Potatoes for Possible Residues
of Borate following Applications of Chlorate/Sodium Metaborate
Combinations for Vinekilling: BB/1/63.  (Unpublished study received May
21, 1963 under 359-399; prepared by Chipman Chemical Co., Inc.,
submitted by Chipman Chemical Co., Bound Brook, NJ; CDL: 119640-A)  

116554	California, Dept. of Agriculture (1971) Application of
Shed-A-Leaf on Chili Peppers: Results.  (Compilation; unpublished study
received Oct 13, 1972 under 2E1286; CDL:091822-A) 

123745	Interregional Research Project No. 4 (1973) The Results of Tests
on the Amount of Sodium Chlorate Residue Remaining on or in Grain
Sorghum, Including a Description of the Analytical Method Used. 
(Compilation; unpublished study received Apr 13, 1973 under 3E1386;
CDL:093698-C) 

123747	Banderis, A. (1965) Colorimetric determination of chlorate in
soil and plant extracts.  J. Sci. Ef. Agric. 16(Sep):558.  (Also In
unpublished submission received 1965 under 3E1386; submitted by
Interregional Research Project No. 4, New Brunswick, NJ; CDL: 093699-B) 

124680	Roth, F. (1967) A test for chlorate residues.  Bulletin of
Environmental Contamination & Toxicology 2(4):251-254.  (Also In
unpublished submission received Jun 23, 1972 under 2E1286; submitted by
California, Dept. of Agriculture, Sacramento, CA; CDL:094665-A)

128727	Interregional Research Project No. 4 (1983) The Results of Tests
on the Amount of Residues Remaining in or on Southern Peas, Including a
Description of the Analytical Method Used.  (Compilation; unpublished
study received Jun 10, 1983 under 3E2910; CDL:071699-A) 

135224	Interregional Research Project No. 4 (1975) The Results of Tests
on the Amount of Sodium Chlorate Residue Remaining in or on Sunflower
Seeds, Including a Description of the Analytical Method Used. 
(Compilation; unpublished study received Jul 1, 1976 under 6E1825;
CDL:097356-A) 

136326	Interregional Research Project No. 4 (1978) The Results of Tests
on the Amount of Sodium Chlorate Residue Remaining in or on Flax, Oats,
and Wheat Including a Description of the Analytical Method Used. 
(Compilation; unpublished study received Oct 20, 1978 under 9E2142;
CDL:097460-A) 

136388	Interregional Research Project No. 4 (1979) Results of Tests
Concerning the Amount of Sodium Chlorate Residue Remaining in or on Guar
Including a Description of the Analytical Method Used. (Compilation;
unpublished study received Jun 15, 1979 under 9E2220; CDL:098331-A) 

140109	Interregional Research Project No. 4 (1975) The Results of Tests
on the Amount of Sodium Chlorate Residue Remaining in or on Sunflower
Seeds, Including a Description of the Analytical Method Used. 
(Compilation; unpublished study received Jul 1, 1976 under 6E1825;
CDL:095932-A) 

140483	Interregional Research Project No. 4 (1977) The Results of Tests
on the Amount of Sodium Chlorate Residue Remaining in or on Corn
Including a Description of the Analytical Method Used.  (Compilation;
unpublished study received Jun 24, 1977 under 7E1972; CDL:097261-A) 

140486  	Interregional Research Project No. 4 (1976) The Results of
Tests on the Amount of Sodium Chlorate Residue Remaining on or in Rice
and Rice Straw Including a Description of the Analytical Method Used. 
(Compilation; unpublished study received Apr 6, 1976 under 6E1996;
CDL:097358-A) 

159210	Kerr-McGee Chemical Corp. (1975) Sodium Chlorate on Rice: Summary
of Experimental Conditions and Data from Texas and Louisiana in 1975. 
Unpublished study.  12 p.

159211  	Ladd, R. (1976) Meat and Milk Residue Study with Antor
Herbicide in a Dairy Cow [Dosing Information Only]: Project No. 76-12:
IBT No. 8580-09096.  Unpublished study prepared by Industrial Bio- Test
Laboratories, Inc.  21 p. 

42464201  	McGaughey, R. (1992) Determination of the Magnitude of
Residues of Sodium Chlorate in Potatoes Treated with DEFOL6: Final
Report: Lab Project Number: DREX-9002: 9006-010X: 04-9012.  Unpublished
study prepared by Compliance Services Intl.  112 p. 

42930601  	McGaughey, R. (1993) Determination of the Magnitude of
Residues of Sodium Chlorate in Potatoes Treated with DEFOL 6: Lab
Project Number: DREX-9002.  Unpublished study prepared by Minnesota
Valley Testing Labs.  22 p.

APPENDIX D:  Technical Support Documents

  TC "Appendix C. Technical Support Documents" \f C \l "2"  

Additional documentation in support of this RED is maintained in the OPP
docket EPA-HQ-OPP-2005-0507.  This docket may be accessed in the OPP
docket room located at Room S-4900, One Potomac Yard, 2777 S. Crystal
Drive, Arlington, VA.  It is open Monday through Friday, excluding
Federal holidays, from 8:30 a.m. to 4:00 p.m.  All documents may be
viewed in the OPP docket room or downloaded or viewed via the Internet
at the following site:     HYPERLINK "http://www.epa.gov/REDs/" 
http://www.regulations.gov .

.

The Agency documents in the docket include:

1.  	Reader’s Guide to the Inorganic Chlorates FDMS-Docket #
OPP-2005-0507.

2.  	Sodium Chlorate Review of Selected Risk Assessment Issues for
Sodium Chlorate. Phase 3 Comments to the Sodium Chlorate RED.

3.  	Inorganic Chlorates: Addendum to the Occupational and Residential
Exposure Assessment for the Reregistration Eligibility Decision (RED)
Document (Case 4049)

4.  	Sodium Chlorate (CAS Reg. No. 7775-09-9) Reregistration
(Terrestrial Food/Feed and Non-food/Non-feed Uses) Reregistration Case
4049 Ecological Risk Assessment

5.  	Analysis of proposed changes to sodium chlorate’s application
rates and maximum treated area on potential ecological risks presented
in EFED’s reregistration eligibility decision (RED) document.

6.  	Reregistration Eligibility Decision (RED) for Inorganic Chlorates

Appendix E:  List of Available Related Documents and Electronically
Available Forms  

Pesticide Registration Forms are available at the following EPA internet
site:  http://www.epa.gov/opprd001/forms/.	

Pesticide Registration Forms (These forms are in PDF format and require
the Acrobat reader) 

Instructions:

Print out and complete the forms. (Note: Form numbers that are bolded
can be filled out on your computer then printed.)

The completed form(s) should be submitted in hardcopy in accord with the
existing policy.

Mail the forms, along with any additional documents necessary to comply
with EPA regulations covering your request, to the following address for
the Document Processing Desk.:

			Document Processing Desk (distribution code)*

			Office of Pesticide Programs (7504P)

			Environmental Protection Agency		

		1200 Pennsylvania Ave, NW

		Washington, DC 20460-0001

* Distribution Codes are as follows:

(APPL) Application for product registration

(AMEND) Amendment to existing registration

(CAN) Voluntary Cancellation

(EUP) Experimental Use Permit

(DIST) Supplemental Distributor Registration

(SLN) Special Local Need

(NEWCO) Request for new company number

(NOTIF) Notification

(PETN) Petition for Tolerance

(XFER) Product Transfer

DO NOT  fax or e-mail any form containing “Confidential Business
Information” or “Sensitive Information.”

If you have any problems accessing these forms, please contact Nicole
Williams at (703) 308-5551 or by e-mail at
williams.nicole@epamail.epa.gov.  If you want these forms mailed or
faxed to you, please contact Lois White, white.lois@epa.gov or Floyd
Gayles, gayles.floyd@epa.gov.

If you have any questions concerning how to complete these forms, please
contact OPP’s ombudsperson for conventional pesticide products: Linda
Arrington, (703) 305-5446

The following Agency Pesticide Registration Forms are currently
available via the Internet at the following locations:

8570-1	Application for Pesticide Registration/Amendment
http://www.epa.gov/opprd001/forms/8570-1.pdf

8570-4	Confidential Statement of Formula
http://www.epa.gov/opprd001/forms/8570-4.pdf

8570-5	Notice of Supplemental Registration of Distribution of a
Registered Pesticide Product 
http://www.epa.gov/opprd001/forms/8570-5.pdf

8570-17	Application for an Experimental Use Permit
http://www.epa.gov/opprd001/forms/8570-17.pdf

8570-25	Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need 
http://www.epa.gov/opprd001/forms/8570-25.pdf

8570-27	Formulator's Exemption Statement
http://www.epa.gov/opprd001/forms/8570-27.pdf

8570-28	Certification of Compliance with Data Gap Procedures 
http://www.epa.gov/opprd001/forms/8570-28.pdf

8570-30	Pesticide Registration Maintenance Fee Filing 
http://www.epa.gov/opprd001/forms/8570-30.pdf

8570-32	Certification of Attempt to Enter into an Agreement with other
Registrants for Development of Data 
http://www.epa.gov/opprd001/forms/8570-32.pdf

8570-34	Certification with Respect to Citations of Data  (in PR Notice
98-5)	http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf

8570-35	Data Matrix  (in PR Notice 98-5)
http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf

8570-36	Summary of the Physical/Chemical Properties  (in PR Notice 98-1)
http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf

8570-37	Self-Certification Statement for the Physical/Chemical
Properties  (in PR Notice 98-1)
http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf

Pesticide Registration Kit 
http://www.epa.gov/pesticides/registrationkit/

Dear Registrant:

	For your convenience, we have assembled an online registration kit
which contains the following pertinent forms and information needed to
register a pesticide product with the U.S. Environmental Protection
Agency's Office of Pesticide Programs (OPP):

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food
Quality Protection Act (FQPA) of 1996.

Pesticide Registration (PR) Notices

a.	83-3 Label Improvement Program-Storage and Disposal Statements

b.	84-1 Clarification of Label Improvement Program 

c.	86-5 Standard Format for Data Submitted under FIFRA 

d.	87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)

e.	87-6 Inert Ingredients in Pesticide Products Policy Statement

f.	90-1 Inert Ingredients in Pesticide Products; Revised Policy
Statement 

g.	95-2 Notifications, Non-notifications, and Minor Formulation
Amendments 

h.	98-1 Self Certification of Product Chemistry Data with Attachments 
(This document is in PDF format and requires the Acrobat reader.) 

Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices.

Pesticide Product Registration Application Forms (These forms are in PDF
format and will require the Acrobat reader.)

a.	EPA Form No. 8570-1, Application for Pesticide Registration/Amendment

b.	EPA Form No. 8570-4, Confidential Statement of Formula 

c.	EPA Form No. 8570-27, Formulator's Exemption Statement 

d.	EPA Form No. 8570-34, Certification with Respect to Citations of Data

e.	EPA Form No. 8570-35, Data Matrix

General Pesticide Information (Some of these forms are in PDF format and
will require the Acrobat reader.)

Registration Division Personnel Contact List

Biopesticides and Pollution Prevention Division (BPPD) Contacts

Antimicrobials Division Organizational Structure/Contact List

53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)

40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)

40 CFR Part 158, Data Requirements for Registration (PDF format)

50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985) 

	Before submitting your application for registration, you may wish to
consult some additional sources of information.  These include: 

The Office of Pesticide Programs' Web Site

The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address: 

			National Technical Information Service (NTIS)

		5285 Port Royal Road

		Springfield, VA 22161 

The telephone number for NTIS is (703) 605-6000. 

The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information
Systems. This service does charge a fee for subscriptions and custom
searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their website.

The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of
pesticides. You can contact NPTN by telephone at (800) 858-7378 or
through their website:  http://npic.orst.edu

	

The Agency will return a notice of receipt of an application for
registration or amended registration, experimental use permit, or
amendment to a petition if the applicant or petitioner encloses with his
 submission a stamped, self-addressed postcard. The postcard must
contain the following entries to be completed by OPP: 

Date of receipt 

EPA identifying number 

Product Manager assignment 

Other identifying information may be included by the applicant to link
the acknowledgment of receipt to the specific application submitted. EPA
will stamp the date of receipt and provide the EPA identifying File
Symbol or petition number for the new submission. The identifying number
should be used whenever you contact the Agency concerning an application
for registration, experimental use permit, or tolerance petition.

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To assist us in ensuring that all data you have submitted for the
chemical are properly coded and assigned to your company, please include
a list of all synonyms, common and trade names, company experimental
codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or
academic facilities).  Please provide a CAS number if one has been
assigned.

 Unless they chemisorb to soil or sediment particulates.  Chemisorption
of chlorate is unlikely.

The term “redox chemistry” is used as an overall term for oxidation
and reduction reactions.  Other terms that are frequently used for
oxidizers are “oxidants,” “oxidizing agents.”  Reductants are
frequently referred to as “reducing agents.”  All redox reactions
require an oxidant and a reductant.  Reductants are electron donors,
while oxidants are electron acceptors.

	

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 PAGE   97