Kaolin 

(PC Code: 100104) 

Preliminary Work Plan and Summary Document 

Registration Review: Initial Docket 

March 2014 

Case 6039 

Approved by: 

~~·f)1 Biopesticides and 

Pollution Prevention Division 

Date: 
Kaolin 

TABLE OF CONTENTS 

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I. PRELIMINARY WORK PLAN ...................................................................................................... 4 

A. Overview ................................................................................................................................................................. 4 

B. Statutory and Regulatory Authority ..................................................................................................................... 4 

C. Background and Regulatory Information ............................................................................................................ S 

D. Anticipated Data Needs and Risk Assessments .................................................................................................... 7 

E. Risk to Threatened and Endangered Species ..................................................................................................... 11 

F. Endocrine Effects ................................................................................................................................................. 12 

G. lncidents ................................................................................................................................................................ 13 

H. Timeline ................................................................................................................................................................. 13 

l. Guidance for Commenters ................................................................................................................................... 13 

J. Next Steps .............................................................................................................................................................. 1S 

II. BIBLIOGRAPHY ........................................................................................................................... 15 

A. Studies Supporting Registration Review of Kaolin ........................................................................................... 16 

B. U.S. Environmental Protection Agency Risk Assessment Memoranda ........................................................... I8 

2 
Kaolin 

BPPD 

CFR 

DCI 

EDSP 

EPA 

FFDCA 

FIFRA 

FQPA 

FR 

FWP 

IDS 

MRIDNo. 

MRL 

OPP 

PC Code 

PWP 

TGAI 

TMDL 

us 

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ACRONYMS AND ABBREVIATIONS 

The EPA's Biopesticides and Pollution Prevention Division 

Code ofFederal Regulations 

Data Call-In 

Endocrine Disruptor Screening Program 

U.S. Environmental Protection Agency 

Federal Food, Drug, and Cosmetic Act 

Federal Insecticide, Fungicide, and Rodenticide Act 

Food Quality Protection Act 

Federal Register 

Final Work Plan 

Incident Data System 

Master Record Identification Number: The EPA's system of recording and tracking studies submitted to the 

Office of Pesticide Programs. 

Maximum Residue Limit 

The EPA's Office of Pesticide Programs 

Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals. 

Preliminary Work Plan 

Technical grade of the active ingredient 

Total Maximum Daily Load 

United States 

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I. PRELIMINARY WORK PLAN 

A. Overview 

The docket for kaolin (Case 6039) is now open, initiating the first public comment period for this 

Registration Review case (docket number EPA-HQ-OPP-2014-0107). Six products containing kaolin are 

currently registered for outdoor, commercial and residential use food use to control insects and powdery 

mildew, and as a plant growth regulator. This Preliminary Work Plan (PWP) explains what the U.S. 

Environmental Protection Agency's (EPA) Office of Pesticide Programs knows about kaolin, highlights 

its anticipated data and assessment needs, identifies types of information that would be especially useful 

in conducting the review, and provides an anticipated timeline for completing the Registration Review 

process for kaolin. 

The Registration Review process was designed to include a public participation component and by 

sharing this information in the docket, EPA intends to inform the public of what it knows about kaolin 

and what types of new data or other information would be helpful to receive as it moves toward a 

decision on kaolin. The EPA encourages all interested stakeholders to review the PWP and to provide 

comments and additional information that will help the EPA's decision-making process for this 

biochemical pesticide. Interested stakeholders could include the following: environmental nonprofit or 

interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, 

institutional, residential, and other users of pesticides; or the public at large. In addition to general areas 

on which persons may wish to comment, there are some areas identified in the PWP about which the 

EPA specifically seeks comments and information. 

The PWP begins by describing the statutory and regulatory authorities for Registration Review. Next, it 

provides background on kaolin, which includes a description of its mode of action, the currently 

registered pesticide product, application rates and methods, use sites, and tolerance exemption 

information. Then, it lists the anticipated data needs, risk assessments, and a projected Registration 

Review timeline for this case. Finally, the PWP provides guidance for commenters, explains the next 

steps EPA will be taking, summarizes background information, and lists supporting studies, risk 

assessments, and other documents available for the Registration Review of kaolin. 

Further information about this case, including background and supporting documents, is available at 

http://www.regulations.gov (under "SEARCH for: Rules, Comments, Adjudications or Supporting 

Documents," enter the docket identification number, which is indicated above). 

B. Statutory and Regulatory Authority 

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review program. All 

pesticides distributed or sold in the United States (US) must generally be registered by the EPA, based 

on scientific data showing that they will not cause unreasonable risks to human health or the 

environment when used as directed on the product labeling. The Registration Review program is 

intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all 

registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will occur over 

time. Through the Registration Review program, the EPA periodically reevaluates pesticides to make 

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sure that, as change occurs, products in the marketplace can continue to be used safely. Information on 

this program is provided on the EPA's website. 1 

The EPA is implementing the Registration Review program pursuant to Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) section 3(g) and will review each registered pesticide every 15 years to 

determine whether it continues to meet the FIFRA standard for registration. The regulations governing 

Registration Review begin at 40 C.F.R. § 155.40. The EPA will consider benefits information and data as 

required by FIFRA. The public phase of Registration Review begins when the initial docket is opened 

for each case. The docket is the EPA's opportunity to state what it knows about the pesticide and what 

additional risk analyses and data or information it believes are needed to make a Registration Review 

decision. After reviewing and responding to comments and data received in the docket during this initial 

comment period, the EPA will develop a Final Work Plan (FWP) and the anticipated schedule for the 

Registration Review of kaolin. 

C. Background and Regulatory Information 

i. Summary of the Active Ingredient, Usage and Associated Pesticide Products 

Kaolin, a soft, white clay, is extensively used in ceramics manufacturing and as an indirect food additive 

(i.e. food contact paper and cellophane) in cosmetics and healthcare products, including toothpaste and 

antiperspirants, and can be used directly in food as an anti-caking agent up to 2.5% (62 FR 19685, Apr. 

23, 1997). Kaolin has GRAS (Generally Recognized as Safe) status under 21 CFR §186.1256, and is 

registered as a biochemical pesticide for use to control insects and powdery mildew, and for use as a 

plant growth regulator to protect against heat stress and sun damage. Information submitted to the 

Agency regarding kaolin supports its lack of toxicity, including a long history of kaolin use by humans 

without an indication of deleterious effects (U.S. EPA, 2000). 

Table 1. provides a summary of the chemical facts for kaolin. 

Table 1. Chemical Facts for Kaolin 

PC code 100104 

Case Number 6039 

CAS Number 1332-58-7 

Year ftrst registered 1998 

Pesticide Type Insecticide, fungicide, plant growth regulator 

Chemical class Biochemical 

Reregistration Eligibility Not applicable. Because it was registered after November 1984, kaolin was not 

Decision (RED) subject to reregistration. 

Tolerance Reassessment Not applicable. Kaolin is exempt from the requirement for a tolerance. See 40 

Eligibility Decision (TRED) CFR § 180. 1180. 

Cumulative group Not applicable. Kaolin has not been identified as a member of a cumulative 

group that shares a common mechanism of toxicity. 

40 CFR Citation 40 CFR § 180.1180 (Exemption from the requirement for a tolerance.) 

Non-pesticidal uses Ingredient in the manufacture of china, porcelain, paper, rubber, paint and 

contained in cosmetics and food packaging materials. Approved as a direct food 

additive up to 2.5%. 

1 See htm:llwww.epa.gov/oppsrrd //registration review/. 

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Table 2. summarizes the use and usage information for kaolin. Please see Usage Report in Support of a 

Registration Review for Kaolin ( 100104) in the registration review docket for more details. 

Table 2. Kaolin Use and Usage Information 

Summary of Use Biochemical pesticide registered for use as an insecticide (broad spectrum), 

fungicide (against powdery mildew) and plant growth regulator (for protection 

from heat stress and sun damage). 

Use Sites Commercial and residential agricultural use as a foliar spray. 

Summary of Usage Screening level estimates of agricultural use of kaolin from 2004-2012 indicate 

an average total of 2,683,000 pounds of active ingredient was used each year. 

This usage estimate includes use on 25 different. crops. 

Formulation Type(s) Wettable powder and liquid concentrate. 

Application Method(s) Products can be applied by handheld or mechanical sprayers. 

Technical Registrant(s) Tessenderlo Kerley, Inc. 

No. of Registrations 6 Section 3 productsl 

Restricted Usc No 

Table 3. Information About the Currently Registered Kaolin Pesticide Products 

EPA Product Name 

Registration (% Active Date Application Rates Application 

Number Ingredient; Registered Methods 

Fonnulation Type) 

Foliar spray via 

handheld and 

6.25 - 100 lbs per acre

1

; backpack 

2935-534 Snow Plus (95.2%; July 28, 2005 coat all portions of plant sprayers and 

wettable powder) slow moving that are to be protected (less than 3 

mph) ground 

boom 

Foliar spray via 

handheld and 

M-97-009 Crop 6.25 - 100 lbs per acre'; backpack 

6 1842-15 Protectant (I 00.0%; March 17, coat all portions of plant sprayers and 

wettable powder) 1998 that are to be protected slow moving 

(less than 3 

mph) ground 

boom 

Foliar spray via 

handheld and 

Surround® CF Crop 6.25 - I 00 lbs per acre'; backpack 

61842- 16 Protectant (95%; May 13, 1999 coat all portions of plant sprayers and 

wettable powder) that are to be protected slow moving 

(less than 3 

mph) ground 

boom 

2 Section 3 product labels can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gol'lpestlabllppls.home). 

6 

Use Sites 

Commercial outdoor 

food use and non-food 

use and commercial 

greenhouse use; 

outdoor residential 

food use 

AgricuJtural outdoor 

food use 

Agricultural outdoor 

food use 
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Table 3. Information About the Currently Re2istered Kaolin Pesticide Products 

EPA Product Name 

Registration (%Active Date Application Rates Application Use Sites Number Ingredient; Registered Met bods 

Formulation Type) 

Foliar spray via 

handheld and 

M-98-A 10 Crop 6.25- 100 lbs per acre1

; backpack 

61842-17 Protectant (90.0%; May 13, 1999 coat all portions of plant sprayers and Agricultural outdoor 

wettable powder) that are to be protected slow moving food use 

(less than 3 

mph) ground 

boom 

Foliar spray via 

handheld and 

Surround® WP Crop 6.25 - 100 lbs per acre 1

; backpack Commercial outdoor 

61842-18 Protectant (95%; October 7, coat all portions of the sprayers and food use and non-food 

liquid concentrate) 1999 plant to be protected slow moving use and commercial 

(less than 3 greenhouse use 

mph) ground 

boom 

For formulation into 

commercial or 

Manufacturing Use September 12, residential use 

6 1842-19 Product (95.0%; 2003 N/A N/A products for food or 

powder) non-food use, outdoor 

or greenhouse, or use 

on animals 

Pome frutts and stone frutt (except pear) and troptcal crops apply 25-50 lbs/acre, pear apply up to 1 00 lbs/acre; CitruS frutts 

and tree nuts apply 25-75 lbs/acre; berries, grapes, fruiting vegetables and bulb vegetables apply 12.5-50 lbs/acre; legumes, 

root/tuber vegetables, cucurbits, brassica and leafy vegetables and cotton apply 12.5-25 lbs/acre; cereal grains and nongrass 

animal feeds apply 12.5-37.5 lbs/acre; nursery and ornamental plants apply 6.25-37.5 lbs/acre 

ii. Tolerance Actions 

Kaolin is exempt from the requirement of a tolerance as follows: 

40 C.F.R. § 180.1180 Kaolin; exemption from the requirement of tolerance: (b) Kaolin is exempted 

from the requirement of a tolerance for residues wheri used on or in food commodities to aid in the 

control of insects, fungi, and bacteria (food/feed use). 

Federal Register Citation - Final Rule 62 FR 19685, Apr. 23, 1997, as amended at 63 FR 9430, Feb. 25, 

1998. 

D. Anticipated Data Needs and Risk Assessments 

Provided below are tables of the current data requirements for biochemical pesticides as set forth in 40 

CFR § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health 

assessment, and nontarget organisms and environmental fate) and descriptions are included regarding 

how the data requirements have been fulfilled or where data have been waived. At this time, no data 

gaps (anticipated data needs) for kaolin have been identified. The most recent comprehensive risk 

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assessment for kaolin was completed October 31, 1997, in support of the first biochemical registration 

of kaolin, which occurred on March 17, 1998 (U.S. EPA, 1997). Because there are no data gaps for 

kaolin and no additional information has been received on this biochemical since it was first registered, 

the Agency does not anticipate the need to conduct a new risk assessment during registration review. 

i. Product Analysis ( 40 C.F.R. § 158.2030) 

Table 4. Summary of Product Analysis Data for Kaolin 

Harmonized Has Data Requirement MRID No. or Other Guideline Data Requirement 

Number Been Addressed? How? Source 

44143801 

44658701 

44659201 

880.1100 Product Identity and Composition Yes- Study 44839201 

46040201 

46488801 

49083101 

44143801 

44658701 

Description of Staring Materials, Production, 44659201 

880.1200 Yes - Study 44839201 and Formulation Process 46040201 

46488801 

49083101 

44143801 

44658701 

44659201 

880.1400 Discussion ofF ormation of Impurities Yes - Study 44839201 

46040201 

46488801 

49083101 

44143801 

44658701 

44659201 

830.1700 Preliminary Analysis Yes- Study 44839201 

46040201 

46488801 

49083101 

44143801 

44658701 

44659201 

830.1750 Certified Limits Yes- Study 44839201 

46040201 

46488801 

49083101 

44143801 

44658701 

44659201 

830.1800 Enforcement Analytical Method Yes - Study 44839201 

46040201 

46488801 

49083101 

8 
Kaolin 

Harmonized 

Guideline 

Number 

830.6302 

830.6303 

830.6304 

830.6313 

830.6315 

830.6317 

830.6319 

830.6320 

830.7000 

830.7050 

830.7100 

830.7200 

830.7220 

830.7300 

830.7520 

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Table 5. Summary of Physical and Chemical Characteristics for Kaolin 

Has Data Requirement MRID No. or Other Data Requirement Been Addressed? How? Source 

44143802 

44658702 

Color Yes - Study 44659202 

44839202 

46040202 

44143802 

44658702 

Physical State Yes - Study 44659202 

44839202 

46040202 

44143802 

44658702 

Odor Yes - Study 44659202 

44839202 

46040202 

44143802 

Stability to Nonnal and Elevated Yes - Study 44658702 

Temperatures, Metals and Metal Ions 44659202 

44839202 

Flammability Not applicable; data are not required for technical 

grade active ingredients. 

Storage Stability Not applicable; data are not required for technical 

grade active ingredients. 

Miscibility Not applicable; data are not required for technical 

grade active ingredients. 

Corrosion Characteristics Not applicable; data are not required for technical 

grade active in ~edients. 

44143802 

44658702 

pH Yes - Study 44659202 

44839202 

46040202 

UV /Visible Light Absorption Not applicable to the TGA1 test substance.' 

Viscosity Not applicable; data are not required for technical 

grade active in ~edients . 

44143802 

Melting Point/Melting Range Yes- Study 44658702 

44659202 

44839202 

Boiling Point/Boiling Range Not applicable to the TGA1 test substance.2 

44143802 

Density/Relative Density/Bulk Density 44658702 

Yes - Study 44659202 (Specific Gravity) 44839202 

46040202 

Particle Size, Fiber Length, and Diameter Not applicable to the TGAI test substance.3 

Distribution 

9 
Kaolin 

Harmonized 

Guideline 

Number 

830.7550 

830.7560 

830.7570 

830.7840 

830.7950 

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Table 5. Summary of Physical and Chemical Characteristics for Kaolin 

Has Data Requirement MRID No. or Other Data Requirement Been Addressed? How? Source 

Partition Coefficient (n-Octanol Water) Not applicable to the TGAI test substance.

2 

44143802 

Water Solubility Yes- Study 44658702 

44659202 

44839202 

Vapor Pressure Not applicable to the TGAI test substance.2 

. . UVNisible L1ght AbsorptiOn data are not applicable because kaolm IS a white msoluble sohd . 2 Not applicable since kaolin is a solid at room temperature. 

3 Particle size, fiber length, and diameter distribution data is not applicable because kaolin is not fibrous (with diameter 2:0.1 J.tm). 

ii. Human Health Assessment (40 C.F.R. § 158.2050) 

Acute human health toxicity studies indicate very low mammalian toxicity (Toxicity Category IV for 

acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, and primary dermal irritation; 

Toxicity Category III for primary eye irritation). Subchronic human health toxicity studies have been 

waived based upon the long history of safe use of kaolin (U.S. EPA, 2000). 

Table 6. Summary of Human Health Assessment Data for Kaolin 

Harmonized Has Data Requirement MRID No. or Other Guideline Data Requirement 

Number Been Addressed? How? Source 

44356701 

870.1 100 Acute Oral Toxicity - Rat Yes - Study 44356705 

46040203 

870.1200 Acute Dermal Toxicity Yes - Study 44356702 

46040204 

44400701 

870.1300 Acute Inhalation Toxicity - Rat Yes- Study 44400702 

46040205 

44356704 

870.2400 Primary Eye Irritation Yes- Study 45460401 

46040206 

870.2500 Primary Dermal Irritation Yes - Study 44356703 

46040207 

870.2600 Dermal Sensitization Yes- Data Waiver U.S. EPA, 2000 

None Hypersensitivity Incidents Yes- Study 44143803 

870.3100 90-Day Oral (one species) Yes- Data Waiver U.S. EPA, 2000 

870.3250 90-Day Dermal - Rat Yes - Data Waiver U.S. EPA, 2000 

870.3465 90-Day Inhalation - Rat Yes - Data Waiver U.S. EPA, 2000 

870.3700 Prenatal Developmental - Rat Preferably Yes - Data Waiver U.S. EPA, 2000 

870.5100 Bacterial Reverse Mutation Assay Yes- Data Waiver U.S. EPA, 2000 

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'fable 6. Summary of Human Health Assessment Data for Kaolin 

Harmonized Has Data Requirement MRID No. or Other Guidelille Data Requirement 

Number Been Addressed? How? Source 

870.5300 In vitro Mammalian Cell Assay Yes- Data Waiver U.S. EPA, 2000 870.5375 

iii. Nontarget Organisms and Environmental Fate (40 C.F.R. § 158.2060) 

Table 7. Summary of Nontarget Organism Data for 

Harmonized Has Data Requirement Been MRID No. or Other GuideliDe Data Requirement 

Number Addressed? How? Source 

850.2100 Avian Acute Oral Toxicity Yes - Study 46040210 

850.2200 Avian Diet.ary Toxicity Yes - Dat.a Waiver U.S. EPA, 2000 

850.1075 Fish Acute Toxicity, Freshwater Yes- Study 46040212 

850.1010 Aquatic Invertebrate Acute Toxicity, Yes- Study 46040213 Freshwater 

850.4100 Terrestrial Plant Toxicity, Seedling Yes- Study 44143804 Emergence 

850.4150 Terrestrial Plant Toxicity, Vegetative Yes- Study 44143804 Vigor 

44356706 

880.4350 Nontarget Insect Testing Yes- Study 44356707 

44356708 

46040215 

E. Risk to Threatened and Endangered Species 

Kaolin clay is an abundant natural mineral found in most rock weathering zones and soil profiles. It 

results from the weathering of other minerals in soils) and does not break down into any other 

substances; it remains as clay (USGS) 2009). When used as directed in the currently registered pesticide 

products) kaolin washes off of treated trees and plants with the first rainfall event and is incorporated 

into the soil. 

The avian acute oral toxicity study for kaolin on file with the Agency determined a No Observed Effect 

Level (NOEL) 2: 2) OOOrng/kg, LDso 2: 2, OOOmg/kg and Lowest Lethal Dose (LDD) 2: 2,000mg/kg. 

Avian dietary toxicity data requirements for kaolin have been waived based upon the long, widespread 

use of kaolin as an agricultural ingredient and the lack of reported avian toxicity incidents associated 

with this use. The freshwater fish acute toxicity study on file determined an LC5o value> 100 mg/L (the 

highest concentration tested) and a No Observed Effect Concentration = 100 mg/L. The freshwater 

aquatic invertebrate study on file determined 24- and 48-hour ECso values to be> 100 mg/L (the highest 

concentration tested) and a 48-hour No Observed Environmental Concentration = 100 mg/L. 

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In nontarget insect testing, the 48-hour acute contact LD50 value for honey bees exposed to kaolin was 

> 1 OOf.!g a.i.lbee, the highest dose tested. The 48-hour no observed effect dose was = 1 OOf.!g a.i.lbee. The 

48-hour acute dietary LCso value for honey bees was determined to be > 1000 ppm a.i., the highest 

concentration tested. The 48-hour no observed effect concentration was = 1 000 ppm a.i. A literature 

review submitted to support the terrestrial plant (seedling emergence and vegetative vigor) data 

requirements summarized five studies of kaolin use on terrestrial plants at rates comparable to those on 

the registered pesticide product labels. No deleterious effects of the use of kaolin were seen in any of 

these studies (MRID 44143804). Results from Tier 1 toxicity studies did not trigger the need for 

' environmental fate and groundwater data to be generated for kaolin. Acute human health toxicity studies 

submitted in support of the registration of kaolin indicate very low mammalian toxicity (Toxicity 

Category IV for acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, and primary dermal 

irritation; Toxicity Category III for primary eye irritation). 

Consequently, adverse effects to terrestrial and aquatic organisms from the use of kaolin pesticide 

products are expected to be negligible; therefore, the effects determination for endangered/threatened 

species and designated critical habitat is a "No Effect." EPA anticipates conducting no further analysis of 

potential risks to endangered or threatened species, unless data or information are obtained during the 

Registration Review process that would indicate such an assessment would be needed to inform the 

Agency's decision. 

F. Endocrine Effects 

As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 

408(p ), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to 

implement the screening program that is to be used to test all pesticides in order to determine whether 

certain substances (including pesticide active and other ingredients) may have an effect in humans or 

wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects 

as the Administrator may designate." 

FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of 

the Estrogenic Substances Screening Program a biologic substance or other substance if a determination 

is made that the substance is not anticipated to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. 

Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 

67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening was published on June 14, 2013,

3 and includes some pesticides 

scheduled for registration review and chemicals found in water. Kaolin is not among the group of 

pesticide active ingredients on the lists to be screened under the EDSP. 

The EPA, as part of this Preliminary Work Plan, believes that kaolin is a substance that would not likely 

produce any effect in humans similar to an effect produced by a naturally occurring estrogenic 

substance. As such, pursuant to Section 408(p )( 4), the EPA will determine in the future whether it can 

exempt kaolin from the requirements of the Section 408(p) EDSP. In the event the EPA does determine 

to exempt this substance from the EDSP, an order will be issued. 

3 See http://www.regulations.gov/#!documentDetail:D=EPA-HO-OPPT-2009-0477-0074 for the second list of chemicals. 

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For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, 

future lists, the test guidelines and the Tier 1 screening battery, please visit our website at 

http://www. epa.govlendo/. 

G. Incidents 

From March 17, 1998 (the frrst date ofkaolin pesticide registration) through January 29,2014, the 

Office of Pesticide Programs' (OPP's) Incident Data System (IDS) indicates two minor human incidents 

from the use of pesticide products containing kaolin as their active ingredient. There were no reported 

incidents to domestic animals, drinking water, surface water, groundwater, plants, wildlife or other nontargets. A search of OPP's Environmental Incident Information System (EllS) revealed no incidents 

associated with kaolin. The database contains information dating back to the 1970s. The EPA will 

consider any incident data or comments submitted in response to this Preliminary Work Plan. 

H. Timeline 

B e 1 OW IS e proJec e 1me me or eg1strat10n . th · tdf r t1 R · R . ev1ew case 6039 K aom. r 

Activities Estimated Month/Year 

Opening the Docket 

Open Docket and 60-Day Public Comment Period for March 2014 

Close Public Comment Period May 2014 

Case Development 

Issue Final Work Plan September 2014 

Issue Data Call-in NIA 

Data Submission N/A 

Open 30-Day Public Comment Period for Draft Risk Assessments NIA 

Close Public Comment Period NIA 

Registration Review Decision 

Open 60-Day Public Comment Period for Proposed Registration Review June 2015 

Decision 

Close Public Comment Period August 2015 

Final Decision December 2015 

*Estimated Total (years) 1 year and 2 months .. * This schedule 1s subject to revision should unforeseen Issues anse durmg the registration rev1ew process. In the event an 

issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time. 

That Final Work Plan will identify any newly anticipated data needs and set forth a new timeline. 

I. Guidance for Commenters 

The public is invited to comment on the EPA's Preliminary Work Plan and rationale. The areas below 

highlight topics of special interest to the EPA where comments, information and data, or reference to 

sources of additional information could be of particular use. The EPA will consider all comments, as 

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well as any additional information or data provided in a timely manner, prior to issuing a Final Work 

Plan for this case. 

i. Environmental Justice 

The EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, and 

enforcement of environmental laws, regulations, and policies. To help address potential environmental 

justice issues, the EPA seeks information on any groups or segments of the population who, as a result of 

their location, cultural practices, or other factors, may have unusually high exposure to the pesticidal use 

of kaolin, compared to the general population. Please comment if you are aware of any 

subpopulations that may have atypical, unusually high exposure compared to the general 

population. 

ii. Water Quality 

Kaolin is not identified as a cause of impairment for any water bodies listed as impaired under section 

303(d) of the Clean Water Act.4 In addition, no Total Maximum Daily Loads (TMDLs) have been 

developed for kaolin.5 More information on impaired water bodies and TMDLs can be found on EPA's 

website.6 The EPA invites submission of water quality data for this pesticide. To the extent possible, 

data should conform to the quality standards in Appendix A of the Office of Pesticide Programs (OP P) 

Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in 

OPPs Registration Review Risk Assessment and Management Proces/ to ensure they can be used 

quantitatively or qualitatively in pesticide risk assessments. 

iii. Trade Irritants 

Through the Registration Review process, the EPA intends to solicit information on trade irritants and, to 

the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize 

tolerance and international Maximum Residue Limits (MRLs), and, if necessary, may modify tolerance 

levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues 

resulting from lack ofMRLs or disparities between U.S. tolerances and MRLs in key export markets, 

providing as much specificity as possible regarding the nature of the concern. 

Pesticidal food-use of kaolin is covered under an existing exemption from the requirement of a 

tolerance. Moreover, there are no known MRLs for kaolin. Therefore, the EPA does not anticipate that 

current uses of kaolin will pose concerns as trade irritants. 

iv. Additional Information 

Stakeholders are also specifically asked to provide information and data that will assist the EPA in 

refining the risk assessments. The EPA is interested in obtaining the following information regarding 

kaolin: 

4 Based on information provided at http:/ \l'ww.epa.gov/owowltmd/1. 5 Based on information provided at hllp:lliaspub.epa.govltmdl waters I 0 'text search.tmdl search form. 6 See hllp:. www.epa.gov owow tmd/1. 7 This document can be found at hllp:l/www.epa.govloeesrrdllregistralion review/water quality sop.htm. 

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Kaolin EPA-HQ-OPP-20 14-0107 

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..,. Any data, information, and/or scientific rationale that could be used to fill data gaps 

..,. Confirmation on the following label information: 

- Sites of application 

- Formulations 

-Application methods and equipment 

- Maximum application rates 

- Frequency of application, application intervals, and maximum number of applications 

- Geographic limitations on use 

..,. Use or potential use distribution (e.g., acreage and geographical distribution of relevant use 

sites) 

..,. Median and 90th percentile reported use rates (lbs active ingredient/1,000 square feet) from 

usage data - national, state, and county 

..,. Application timing (date of first application and application intervals) -national, state, and 

county 

..,. Usage/use information for nonagricultural uses 

..,. Typical application interval (days) 

..,. State or local use restrictions 

..,. Monitoring data 

..,. Foreign technical registrants not listed above who supply technical kaolin to the US market 

J. Next Steps 

After the 60-day comment period closes, the EPA will review and respond to any comments received in 

a timely manner, then issue a Final Work Plan for case 6039: Kaolin. 

15 
Kaolin EPA-HQ-OPP-2014-0107 

www. regulations.gov 

II. BIBLIOGRAPHY 

A. Studies Supporting Registration Review of Kaolin 

MRID Citation Receipt 

Date 

Sekutowski, D. (1996) Kaolin--Product Indentity (sic) and Disclosure oflngredients, 

44143801 Manufacturing Process, Discussion on the Formation of Unintentional Ingredients, Stability 21 -0ct-1996 Information and Storage Conditions: Lab Project Number: IR-4 PR NO. 83B: 83B: 9005-02-MT. 

I Unpublished study prepared by Engelhard Corp. 79 p. 

Mosko, J. (1996) Kaolin--Analysis of Samples, Certification oflngredient Limits, Analytical 

44I43802 Methods for Certified Limits, (and) Physical and Chemical Properties: Lab Project Number: IR-4 21 -0ct-1996 

PR NO. 83B: 838. Unpublished study prepared by Engelhard Corp. 36 p. 

1 Mosko, J. (1996) Kaolin--Hypersensitivity Incidents: Lab Project Number: IR-4 PR NO. 83B: 144143803 21-0ct-19961 83B. Unpublished study prepared by Engelhard Corp. 4 p. I 

44143804 Glenn, D. (1996) Kaolin Plant Studies: Lab Project Number: IR-4 PROJECT NO. 83B: 83B. 2 I -Oct-1996 Unpublished study prepared by USDA-ARS Appalachian Fruit Research Station. 39 p. 

1

44356701 Wnorowski, G. (I997) Acute Oral Toxicity Limit Test (in Rats): Satintone 5HB: Lab Project 20-Aug- I 997 Number: 4903: P320. Unpublished study prepared by Product Safety Labs. 15 p. 

I 

Wnorowski, G. (1997) Acute Dermal Toxicity Limit Test (in Rats): Satintone 5HB: Lab Project 144356702 Number: 4904: P322. Unpublished study prepared by Product Safety Labs. 15 p. 20-Aug-1997 

144356703 Wnorowski, G. (I 997) Primary Skin Irritation (in Rabbits): M-96-0 18: Lab Project Number: 4906: 20-Aug-1997 P326. Unpublished study prepared by Product Safety Labs. 16 p. 

\ Wnorowski, G. (I 997) Primary Eye Irritation (in Rabbits): M-96-018: Lab Project Number: 4905: 144356704 20-Aug-1997 

I P324. Unpublished study prepared by Product Safety Labs. 25 p. 

1

44356705 Wnorowski, G. (1997) Acute Oral Toxicity Limit Test (in Rats): M-96-018: Lab Project Number: 20-Aug- 1997 

! 5003: P320. Unpublished study prepared by Product Safety Labs. 15 p. 

I Palmer, S.; Krueger, H. (1997) M-96-0 18 Kaolin: An Acute Contact Toxicity Study with the 

144356706 Honey Bee: (Final Report): Lab Project Number: 469-101. Unpublished study prepared by 20-Aug- 1997 

Wildlife International Ltd. 21 p. 

Hoxter, K.; Palmer, S.; Krueger, H. ( 1997) M-96-0 18 Kaolin: An Acute Dietary Toxicity Study 

44356707 with the Honey Bee: (Final Report): Lab Project Number: 469-102. Unpublished study prepared 20-Aug-1997 

by Wildlife International Ltd. 20 p. 

! Puterka, G. (1997) Report on the Effect of M-96-018 Kaolin on Insect Predators: Lab Project 

144356708 Number: 83B. Unpublished study prepared by USDA-ARS Appalachian Fruit Research Station. 20-Aug-1997 

10 p. 

44400701 Wnorowski, G. (1997) Acute Inhalation Toxicity Limit Test (in Rats): M-96-018: Lab Project 14-0ct -1997 Number: 5424: P330. Unpublished study prepared by Product Safety Labs. 24 p. 

44400702 Wnorowski, G. (1997) Acute Inhalation Toxicity Limit Test (in Rats): M-97-009: Lab Project 14-0ct-1997 Number: 5405: P330. Unpublished study prepared by Product Safety Labs. 25 p. 

Sekutowski, D. (1998) M-98-AOS Kaolin--Product Identity and Disclosure oflngredients, 

44658701 Manufacturing Process, Discussion on the Formation of Unintentional Ingredients--Amendment 21-Sep-1998 

No. I to MRID No. 44143801: Lab Project Number: 83B. Unpublished study prepared by 

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Kaolin EPA-HQ-OPP-20 14-0 I 07 

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I J Engelhard Corporation. 45 p. I 

I Sekutowski, D. ( 1998) M-98-A05 Kaolin--Analysis of Samples, Certification of Ingredient Limits, 

144658702 Analytical Methods for Certified Methods, Physical and Chemical Properties--Amendment No. I 2I-Sep-I998 to MRlD No. 44143802: Lab Project Number: 83B. Unpublished study prepared by Engelhard 

I Corporation. 27 p. 

Sekutowski, D. ( 1998) M-98-A I 0 Kaolin--Product Identity and Disclosure of Ingredients, 

44659201 Manufacturing Process, Discussion on the Formation of Unintentional Ingredients--Amendment 2I-Sep-I998 No.I to MRID 4414380 I: Lab Project Number: 83B. Unpublished study prepared by Engelhard 

Corporation. 45 p. 

Sekutowski, D. (I998) M-98-AIO Kaolin--Analysis of Samples, Certification oflngredient Limits, 

44659202 Analytical Methods for Certified Limits, Physical and Chemical Properties--Amendment No.I to 2I-Sep-I998 MRID 44143802: Lab Project Number: 83B. Unpublished study prepared by Engelhard 

Corporation. 17 p. 

Sekutowski, D. ( 1999) Surround WP Kaolin--Product Identity and Disclosure oflngredients, 

44839201 Manufacturing Process, Discussion on the Formation of Unintentional Ingredients--Amendment 26-MayNo.2 to MRID No. 44143801: Lab Project Number: 83B. Unpublished study prepared by 1999 

Engelhard Corp. 79 p. 

Sekutowski, D. ( 1999) Surround WP Kaolin--Analysis of Samples, Certification of Ingredient 

44839202 Limits, Analytical Methods for Certified Limits, Physical and Chemical Properties--Amendment 26-MayNo. 2 to MRID No. 44I43802: Lab Project Number: 83B. Unpublished study prepared by 1999 

Engelhard Corp. 20 p. 

Merkel, D. (2000) Primary Eye Irritation for Surround WP Crop Protectant: Rabbits: Lab Project 

45460401 Number: 9914: P324: E011IO-ID. Unpublished study prepared by Engelhard Corporation. 16 p. 20-Jul-200 I 

I {OPPTS 870.2400} 

Schulteis, D. (2003) Snow Plus: Manufacturing Process, Product Identity and Composition, 

46040201 Discussion of the Formation of Unintentional Ingredients, Preliminary Analysis, Certified Limits 18-Jul-2003 and Enforcement Analytical Methods. Project Number: WBPUOO 13/1. Unpublished study 

prepared by Wilbur-Ellis Company. 20 p. 

Wo, C. (2003) Weco WBPI OOI3 Snow-Plus: Physical and Chemical Characteristics: Color, 

46040202 Physical State, Odor, pH and Density. Project Number: I3280. Unpublished study prepared by I8-Jul-2003 

Product Safety Labs. 12 p. 

146040203 Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Acute Oral Toxicity Up and Down Procedure in I8-Jul-2003 Rats. Project Number: 13I63. Unpublished study prepared by Product Safety Labs. I5 p. 

146040204 Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Acute Dermal Toxicity Study in Rats- Limit 18-Jul-2003 Test. Project Number: 13164. Unpublished study prepared by Product Safety Labs. 15 p. 

1

46040205 1 Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Acute Inhalation Toxicity Study in Rats- Limit 

Test. Project Number: 13264. Unpublished study prepared by Product Safety Labs. 22 p. 

18-Jul-2003 

46040206 1 Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Primary Eye Irritation Study in Rabbits. Project 18-Jul-2003 Number: 13165. Unpublished study prepared by Product Safety Labs. 17 p. I 

146040207 Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Primary Skin Irritation Study in Rabbits. Project 18-Jul-2003 Number: 13166. Unpublished study prepared by Product Safety Labs. 16 p. 

I 

460402IO Mach, J. (2003) Oral Toxicity of Weco WBPI 0013 on Northern Bobwhite, Colinus virginianus. I8-Jul-2003 l Project Number: 03005, 48047. Unpublished study prepared by Genesis Laboratories, Inc. 40 p. 

1460402I2j Madsen, T. (2003) Acute Toxicity of Weco WBPI 0013 to the Rainbow Trout, Oncorhynchus 18-Jul-2003 I 

17 
I 

Kaolin 

46040213 

46040215 

46488801 

49083101 

49083102 

B. 

EPA-HQ-OPP-2014-0107 

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mykiss, Determined under Static Conditions. Project Number: 48045. Unpublished study prepared 

by Analytical Bio-Chemistry Labs., Inc. 33 p. 

Madsen, T. (2003) Acute Toxicity of Weco WBPI 0013 to the Water Flea, Daphnia magna, 

Determined Under Static Conditions. Project Number: 48046. Unpublished study prepared by 18-Jul-2003 

Analytical Bio-Chemistry Labs., Inc. 32 p. 

Aufderheide, J. (2003) Acute Toxicity of Weco WBPI 0013 tot he Honeybee, Apis mellifera. 

Project Number: 48048. Unpublished study prepared by Analytical Bio-Chemistry Labs., Inc. 31 18-Jul-2003 

p. 

Schulteis, D. (2005) Snow Plus: Biochemical Pesticides Data Requirements, Manufacturing 

Process, Product Identity and Composition, Discussion of Formation of Unintentional Ingredients, 09-Mar-2005 Preliminary Analysis, Certified Limits, and Enforcement Analytical Methods. Project Number: 

WBPl/0013/ 1. Unpublished study prepared by Wilbur Ellis Co. 16 p. 

Tillman, A. (20 12) Product Identity and Composition, Description of the Materials Used, 

Description of the Production Process, Discussion of the Formation of Impurities, Certified 18-Mar-20 13 Limits, and Enforcement Analytical Method for M-97-009 Kaolin. Project Number: TK/201208. 

Unpublished study prepared by Tessenderlo Kerley, Inc. 44p. 

Tillman, A. (2012) Characterization ofM-97-009 Kaolin. Project Number: TKl/201209. 18-Mar-2013 Unpublished study prepared by RJ Lee Group and Micro Macro International. 128p. 

U.S. Environmental Protection Agency Risk Assessment Memoranda 

U.S. EPA. 1997. Registration ofthree end-use products M-96-018 Kaolin (EPA Symbol No. 070060-G), 

M-97-002 Kaolin (EPA Symbol No. 070060-E) and M-97-009 Kaolin (EPA Symbol No. 070060-

R), containing 98.8%, 99.4%, and 100% anhydrous kaolin, respectively, as the active ingredient; 

and a Tolerance Exemption Petition (PP# 7E04908) for anhydrous kaolin (Chemical No. 

100404), a New Active Ingredient in or on All Food Commodities to Control Insects, Fungus, 

and Bacterial Damage to Plant Crops (Food/Feed Use). Memorandum from R. Jones to D. 

Benmhend. U.S. Environmental Protection Agency (U.S. EPA). October 31, 1997. 

U.S. EPA. 2000. Kaolin (100104) Registration Eligibility Document. U.S. Environmental Protection 

Agency (U.S. EPA). Issued April, 2000. Available at: 

http://www.epa.gov/oppOOOOl/chem search/reg actions/reregistration/red PC-100104 1-AprOO.pdf 

U.S.G.S., 2009. Environmental Characteristics of Clays and Clay Mineral Deposits. U.S. Geological 

Survey. Updated April1, 2009. Available at: http://pubs.usgs.gov/info/clays/ 

18