# 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 CONTE N TS EPA- HQ-OPP-2014-0 107 www. regulations.gov



### I. PRELIMINARY WORK PLAN .... ... .... .... . . . ...... . .... ........... . ...... . ...................................................... 4 A. Overview ... . ... . .. . ... .... ... ..... .. . ...... . ............... .. ..... .. .. ............... .. ...... ................ . ...... . ... . .............. .... . ................. ..... ... .. . . 4 B . Statutory a nd Regulatory Authority .. . ...... . ... . ... . .. . ... . ...... . ... . ...... . ... . ... . .. . ... . ... . .. . ... . .. .. .. .. .. .. .. . ....... . .. .. ....... . ............. 4 C . Background a nd Regulatory Information . . .. . ... . .. .. .. . .. .. .. . ... . .. .. .......... . .......... . .................. ....... . .................... .. .. .. .. . S D. Anticipated Data Needs and Risk Assessments........ ............................................................. . ... ... . ........... .. .. . ... .. . . 7 E. Risk to Threatened a nd Endangered Species ... . ................................................................. .. . ......... . ... . ... . ... .. ...... 11 F. E ndocrine Effects ...... . .. . ... . ...... . .. .. .. . .. .. .. . ... . ...... . .. .. .................... .... ...................... .. .. .. ...... . .. .. .. .. .. . ................. .. ... . .. 12 G. l ncidents ................ . .. . . ... .. .. . .. .. . ... . ............... . .......................... . ...... ..... ... . ...... . ... . ................................... . ....... ...... .... 13 H . Timeline .. .. ...... . ..... ...................................... .................... . .. .. .. . ... . .. .. .. . ...... .. ...... .. .. . ... . ......... .. ................ .. ... .. . .. .. .. .. .. 13 l. G uidance for Commenters....... .... .. ............................. .. .. . ........................... . .. ........... . .............. . .. . ... . .. .. .. .. .. .. .. .. .... 13 J . Next Steps ... .. ... . . ...................................... .. ................. . . .. . ....... . .. . ... . ...... . ... . .. .. ... . .. . ... ......... .. ...... .. .. . ... ..... .. .. .. .. .. .. .. .. 1S 

### II. BIBLIOGRAPHY ............ . .. .. .. . . . .............................................................................................. .. ..... 15 A. Studies S upporting Registration Review of Kaolin ........................................................................................... 16 B. U. S. Environmental Protection Agency Risk Assess ment Memoranda .. .. ..... . ... .. . . . ... . ... . .. . .. . ...... ...... . .............. I8

2Kaolin

BPPD CFR DCI EDSP EPA FFDCA FIFRA FQPA FR FWP IDS MRIDNo. MRL OPP PC Code PWP TGAI TMDL 

# us EPA-HQ
- OPP
-2014
- 0 107 www. 

### regulations.gov 

## 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 Federa l Food, Drug, and Cosmetic Act Federa l Insecticide , Fungicide, and Rodenticide Act Food Quality Protect ion 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 Pestic ide chem ical code: a six
-digit number ass igned by OPP to ident ify pest icide chemicals. Preliminary Work Plan Technical grade of the active ingredient Total Maximum Daily Load United States

3Kaolin EPA-HQ-OPP-20 14
-0 107 www.regulations.gov 

### I. 

### PRELIMINARY WORK PLAN 

### A. Overview The docket for kao lin (Case 6039) is now open, initiating the first public comment period for this Registration Review case (docket number EPA-HQ-OPP-2014-0107). S ix products containing kaolin are currently reg i stered for outdoor, commerc ial and residential use food use to contro l insects and powdery mildew, and as a p lant growth regulator. This Preliminary Work P lan (PWP) explain s what the U.S. Envi ronmental Protection Agency ' s (EPA) Office of Pesticide Programs knows about kaolin, highlights its anticipated data and assessment needs, identifies types of information th a t would be especially useful in conducting the review, and provides an anticipated time line for compl eting the Registration Review proce ss for kaolin. The Regi stration Revi ew process was designed to include a public pa rticipatio n component and b y sharing this information in the docket , EPA inte nds to inform t he public of what it knows about kaolin and what types of new data or other informa tion would be he lpful to receive as it moves toward a decision on kaolin. The EPA encourages all interes ted stakeho lders to review the PWP and to provide comments and additio nal information that will help the EPA's deci s ion-making process for this bi ochemical pest ic ide . Interested stakeholders could include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor o r commodity g roups; commercial, institutional , residential, and ot her users ofpesticides; or the public at large . 

### In addition to general areas on which person s may wish to comment , there are some areas identified in the PWP about which the EPA specifica ll y seeks comments and inf ormat ion. 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 regi stered p esticide product, application rates and methods, use s ites, and to lerance exemption info rmation. Then , it lists the anticipa ted data need s, risk assessments, and a projected Registration Review time li ne for thi s case. Finally, the PWP provi de s guidance for commen ter s, explains the next steps EPA will be taking , summarizes background information , and lis ts supporting studies, risk assessments, and other documents available for the Re gistration Review of kaolin. Further inf ormation about this case, including background and suppor ting documents, is available at http :// www.regulations.gov 

### (under "S EARCH for: Rul es, Comment s, Ad judica tions or Supporting Do cuments," enter the docket identification numb er, which i s indicated above). 

### B. S tatutory and Regulatory Authority The Food Quality Protection Act (FQP A) of 1996 mandated a Registration Review program. A ll pe sticide s di stributed or sold in the United States (US) must genera lly be registered b y the EPA , based on scientific data sho wing that they will not cause unreasonable risks to human h ealth or the environment when used as directed on the product labeling. The Registration Review program is intended to make s ure that, as the ability to assess ri s k 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 enviro nm ent. Changes in science, public policy, and pe sticide use practices will occur over time. Thro ugh the Registration Review program, the EPA periodically reevalu ates pesticides to make
4Kaolin EPA-HQ-OPP-2014-0107 www.regulation s.gov 

### 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 Regi s tration Review program pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will review each reg istered pes ticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing Reg istration 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 cas e . 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 kao lin . 

### 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 cell ophane) 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 2 1 CFR §186. 1 256 , 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. T able 1. Chemical Facts for Kaolin PC code 100104 Case Number 6039 CAS Number 1332-58-7 Year ftrst registered 1998 Pesticide Type Insecticide, fungicid e, plant growth reg ulator Chemical class Biochemical Reregistration Eligibility Not applicable. Because it was regi s t e red after November 1984, kaolin was not Decision (RED) subject to r eregist rati on. Tolerance Reassessment No t applicable. Kaolin is exempt from the requirement for a tolerance. See 40 Eligibility Decision (TRED) CFR § 180. 1 180 . Cumulative group Not appl icab le. Kaolin has not been identified as a member of a cumulative group that shares a common mechani s m of toxicity. 40 CFR Citation 40 CFR § 1 80.1180 (Exemption from the requirement for a to lerance.) Non
-pesticidal uses Ingred ient 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/. 5Kaolin EPA-HQ-OPP-2014-0107 www. regulations . gov 

### Table 2. s ummari zes the u se and usage information for kaolin. Please see Usage Report in Support of a 

## Registration Review for Kaolin (100104) in the regi stration review docket for more detail s.
Tab le 2. Kaolin Use and Usage Information Summa r y of Use Biochemical pesticide registered for use as an in sec ti c ide (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 p o und s of active ingredient was used each year. This usage estimate includes use o n 25 different. crop s. Formulation Type(s) Wettable powder and liquid concentrate. Application Method(s) Produc ts can be applied by handheld or me chani cal sprayers. Technical Registrant(s) Tessender lo Kerley , Inc. No. o f Registrations 6 Section 3 products l Restricted U sc No

Table 3. Information About the C urrently Reg istered 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 Plu s (95.2%; July 28 , 2005 coat all portions of plant sprayers and wettab le powder) slow mo vi ng that are t o be protec ted (less than 3 mph) ground boom Fo li ar spray via

handheld and M
- 97
- 009 Crop 6.25
- 100 lbs per acre' ; backpack 6 1 842-15 Pro tectant (I 00 .0 %; March 17 , coat all portions of plant sprayers and wettable powder) 1998 that are to be pro tec ted s low moving (less than 3 mph) groun d boom Foliar spray via

hand he ld and Surro und ® CF Crop 6. 25
- I 00 lbs per acre'; backpac k 61842- 16 Pro te c tant (95 %; May 13 , 1999 coat all po rti o ns of plant sprayers and wettable powder) that are t o be pr o tec ted s l ow mov in g (less than 3 mph) ground boom
2 Sec tion 3 pr o du c t labels can be obtained from the Pe sticide Product Label Sy ste m (PPLS ) web s ite ( 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 o utd oor food use

Agricultural outdoor food useKaolin EPA-HQ-OPP-2014-0 107 www. 

### regulations.gov Table 3. I n formation About the Currently Re2istered Kaolin Pesticide Products EPA Product N a me 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 acre 1 ; backpack 61842-17 Protectant (90.0%; May 13, 1999 coat all portions of plant sprayers and Agricultural outdoor wettab le powder) that are to be protected slow moving food use (less than 3 mph) ground boom Folia r spray via handheld and Surround® WP Crop 6.25
- 100 lbs per acre 1; backpack Commerci al outdoor 61842-18 Protectant (95%; October 7, coat all portions of the sprayers and food use and non-food liquid concentra te) 1999 plant to be protected s l ow movi ng use and commercial (less than 3 greenhouse use mph) ground boom For formulation into commercial or Manufacturing Use September 12 , residentia l use 6 1 842-19 Produc t (95.0%; 2003 N / A N/A products for food or powder) non-food use, outdoor or greenhouse , or use on animals Pome frutt s 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 app ly 12.5-50 lbs/ acre; legumes , root/tuber vegetables, cucurbits, brassica and leafy vegetables and cotton app ly 12.5-25 lbs / acre; cereal grains and nongras s 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 to lerance as follows: 40 C.F.R. § 

### 1 80.1180 Kaolin; exemption from the requirement oftolerance: (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 Cita ti on - F inal 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 environ mental 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 (anticip ated data needs) for kao lin have been identified. The most recent comprehensive risk 7Kaolin EPA-HQ-OPP-2014-0107 www.regulations.gov 

### assessment for kao l in was completed October 3 1 , 1997, in 

### support ofthe first biochemical registration of kao lin, which occurred on March 17, 1998 (U.S. EPA, 1997). Because there are no data gaps for kao lin 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 ofFormation of Impurit ies Yes
- Study 44839201 46040201 46488801 49083101 44143801 44658701 4465920 1 830.1700 Preliminary Analysis Yes- Study 4483920 1 4604020 1 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 

### 8Kaolin

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 EPA-HQ-OPP-20 14-0 I 07 www.regulations.gov
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 Tempera ture s, 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 appl icable; data are not required for technical grade active in**~edients.** 44143802 44658702 pH Yes
- Study 44659202 44839202 46040202 UV /V isible Light Absorption Not app lica ble to the TGA1 test substance.' Viscosity Not app licable; 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/ Relativ e 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 9Kaolin


### Harmonized

Guideline Number 830.7550 830.7560 830.7570 830.7840 830.7950 EPA-HQ-OPP-20 14-0107 www.regulations.gov 

### Table 5. Summar y of Phys ical 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 applicab le to the TGAI test substance. 2



### . . UVNisible L1ght Absorpt iOn 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 le ngth , 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 I V for acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, and primary dermal irritation; Toxicity Category III for primary eye irritation). Subchronic human health toxici ty studies have been waived based upon the long history of safe use ofkaolin (U.S. EPA, 2000). Table 6. Summar y 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 Tox icity
- 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 Irritat ion Yes
- Study 45460401 46040206 870.2500 Primary Dermal I rritation Yes
- Study 44356703 46040207 870.2600 Dermal S e nsitization Yes- Data Waiver U.S. EPA, 2000

None Hype rsensitivity 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 Waiv er 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 10Kaolin EPA-HQ-OPP-20 14-0 I07 www.regulations.gov '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 Ye s- Data Waiver 

### U . S. EPA, 2000 870.5375 

### iii
. 

### Nontarget Organisms and Environmental Fate (40 C.F.R. § 

### 158.2060) T able 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 Freshwa ter 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 Kao lin 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 oftreated 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 toxic ity incidents associated with this use. The freshwater fish acute toxicity study on file determined an LC 5

### o 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. 11Kaolin EPA-HQ-OPP-2014-0 107 www.regulations. gov 

### In nontarget insect testing , the 48-hour acute contact LD 5 0 

### 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 = 

### 1OOf.!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 = 

### 1000 ppm a.i. A literature review submitted to support the terrestrial plant (seedling emergence and vegetative vigor) data requirements summarized five studies ofkaolin use on terrestrial plants at rates comparable to those on the registered pesticide product label s. No deleterious effects of the use of kaolin were seen in any of these studies (MRID 44143804). Re sults 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 ofthe registration ofkaolin 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 ofkaolin 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 conduct i ng 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 pes ticide 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 . 12Kaolin 

### EPA-HQ-OPP-20 14-0107 www.regulations.gov 

### 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.gov l endo /. 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 ofpesticide 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 cons ider any incident data or comments submitted in response to this Preliminary Work Plan . 

### H. Timeline e OW IS 

### e proJec e 1me me or eg1strat10n B 1 . th · tdf 

# r t1 R · 

### R . ev1ew case 6039 K 

# r aom. 

### Activities Estimated Month/Year Opening the Docket Open Docket and 60
- Day Public Comment Period for March 20 14 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 a ll comments, as 13Kaolin EPA-HQ-OPP-20 14-0 I07 

### www.regulations.gov 

### 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 addre ss potential environmental justice issues, the EPA seeks information on any groups or segments ofthe population who, as a result of their location , cultural practices, or other factors, may have unusually high exposure to the pesticidal use ofkaolin, compared to the general population. Please comment ifyou 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 ofwater 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 (OPP) Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPPs Registration Review RiskAssessment 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 facilita ting irritant resolution. The EPA will work to harmonize tolerance and international Maximum Residue Limits (MRLs), and, if necessary, may modify tolerance level s to do so. Growers and other stakeholders are asked to comment on any trade irritant issues res ulting from lack ofMRLs or disparities between U.S. to lerances 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 /owow l tmd/ 1. 5 Based on information provided at hllp: ll ias

pub. e pa .gov l t

mdl wa ters I0 ' text search.tmdl search fo rm . 6 See hllp:. www. epa . gov owow tmd/ 1 . 7 This document can be found at hllp: l /www.epa.gov l oeesrrdll registralion review / water quality sop.htm . 14

### Kaolin EPA-HQ-OPP-20 14-0107 www.regulations.gov



### ..,. 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 informa tion for nonagricultural uses

..,. Typical application interval (days)

..,. Sta te or lo cal 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.

15Kaolin 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 oflngredi ents, 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 Engelha rd Corp. 36 p. 1 Mosko, J. (1996) Kaolin
-- Hypersensitivi ty Incidents : Lab Project Number: IR-4 PR NO. 83B: 21-0ct-19961 144143803 83B . Unpublished study prepared by Engelhard Corp. 4 p. I 44143804 Glenn, D. (1996) Kaolin Plant Studies: Lab Project Numb er: 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 Toxic ity L imit Test (in Rats): Satintone 5HB: Lab Project 144356702 Number: 4904: P322. Unpublished study prepared by Product Safety Labs. 15 p . 20-Aug-1997 1 44356703 Wnorowski, G. (I 997) Primary Skin Irritation (in Rabbits): M-96
- 0 18: Lab Proj ect 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 w ith the 1 44356706 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 Eff ect of M-96-018 Kaolin on Insect Predators: Lab Proj ect 1 44356708 Number: 83B. Unpub lished 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 Saf ety 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. Unpub lished study prepared by 16Kaolin EPA-HQ-OPP-20 14-0 I 07 www.regulations.gov 

# I J Engelhard Corporation. 45 p. 

# I I Sekutowski, D. ( 1998) M-98-A05 Kaolin--Analysis of Samples, Certification of Ingredient Limits, 1 44658702 Analytical Methods for Certified Method s, Physical and Chemical Properties--Amendment No. I 2I-Sep-I998 to MRlD No. 44143802: Lab Pro ject 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. Unp ubl ished 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: Phys ical and Chemical Characteristics: Co lor, 46040202 Physical State, Odor, pH and Density. Project Number: I3280. Unpublished study prepared by I8-Jul-2003 Product Safety Labs. 12 p. 1 46040203 Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Acute Oral Toxicity Up and Down Procedur e in I8-Jul-2003 Rats. Project Number : 13I63. Unpublished study prepared by Product Safety Labs . I5 p. 1 46040204 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 1Moore, G. (2003) Weco WBPI 0013 Snow-Plus: Acute Inhalation Toxicity Study in Rats- Limit Test. Project Number: 13264. Unpublished study prepared by Produ ct 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 1 46040207 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 . 1 460402I2j Madsen, T. (2003) Acute Toxicity of Weco WBPI 0013 to the Rainbow Trout, Oncorhynchus 18-Ju l -2003 

# I 17I Kaolin

4 6040213
4 6040215

46488801

49083101
49083102 

## B. EPA- HQ-OPP-2014-0107 www. regulations. gov mykiss, Determined under S tatic Conditions . Project Number: 48045. Unpublished s tudy prepared by Analytical B io-Chem istry Labs . , Inc . 33 p . Madsen, T. (2003) A cute To xicity of Weco WBPI 0013 to the Water Flea, Daphnia magna , Determined Under Static Conditions . Pro ject Number: 48046. Unpubli shed study prepared by 18-Jul-2003 Analytical Bio-Chemi stry Labs., Inc. 32 p . Aufderheide, J. (2003) Acute Tox ic ity 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 D ata Requ irements , Manufacturing Process , Product Identity and Composition , Discussion of Formation o f Uni ntent ional Ingred ients, 09-Mar-2005 Prelimi nary An alysis, Certified Limi ts, and Enforcement Analytical Methods. Project Number: WBPl/ 0013 / 1. Unp ub lished study prepared by Wilbur E lli s Co. 16 p . Tillman , A. (20 12) Product Identi ty and Composition, D escription of the Materials Used, Descr iption o f the Production Process , Dis cussion of the Formation of Impurities, Certified 1 8-Mar-20 13 Limi ts, and Enfo rcement Analytical Method for M
- 97-009 Kaolin. Proj ect Number : TK/201208. Unpublished study prepared by Tessenderlo Kerley, Inc. 44p. T illman , A. (2012) Cha racterization ofM-97
- 009 Kaol in . Proj ect Number : TKl/20 1209. 18-Mar-2013 Unpublished stu dy 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 Sym bol No. 070060-E) and M-97-009 Kao lin (EPA Symbol N o. 070060- R) , containing 98.8%, 99.4% , and 100% anhy drous kaolin, respectively, as the active ingredient; and a Tolerance Exempti on Petition (PP# 7E04908) for anhydrous kaolin (Chemical No . 100404), a New Active Ingredient in or on All Foo d Commodities to Contro l Insects, Fungus, and B acterial Damage to Plant Crop s (Food/Feed Use). Memorandum from R. Jones to D. 

### Benmhend . U. S. Environmental Protection Agency (U.S . EPA) . October 3 1 , 1997. U.S . EPA. 2000 . Kaolin (100104) Registration Eligibility Document. U .S . Environmental Protection Agenc y (U.S. EP A). Issue d 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 C haracteristics of Clays and Clay Mineral Deposits. U.S . Geological Survey. Updated April1, 2009. Available at: http: // pubs.usgs.gov/info/clays/

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