I ,3 -Di chl oropr opene Barcode 0410115

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### MEMORANDUM

Date : Se pt ember 5, 20 13 OFFICE OF CHEMICAL SAFETY AND POLLUTION PRE V ENTION



### SUBJECT: 1,3-Dicbloropropene. H uman Hea lth Assessment Sco p i n g Document in 

### Support of Re gistration Review.

PC Code: 02 900 1 DP Barcode: 0410115
Decision No.: 476422 Registration No.: NA
Petition Nos.: NA Regulatory Action: Registration Review
Risk Assess Typ e: Scoping D oc ument C aseNo.: NA
TXRNo.: NA CAS No.: 4643-05-4 a nd 4643-06-5
MRIDNo.: NA 40 CFR § 180.636



### FROM: Ideliz Negron

- Encarnac i on, Ph.D.

,

# C~e**~,f.** Li nd a Tay lor

, Ph.D.,**To xic** **ologi ~~0**  

### . - Matthew Llo yd, MPH, ORE Assessor

### -~ Risk Assessment Bran ch V N il



### THRU: Health Eff ects Div ision (75 09P) Office of Pesticide Pro grams

Michael Metzger, Branch Chief Risk Assessment Branch V Nil 

### Jeffrey Dawson

, Senior Scie n tist
I mm edia t e Offi ce Hea lth Effec t s Division (7509P) Office of Pesticide Programs

TO: Margaret Hathaway, Risk Manager Re viewer Pest i cide Re-evaluation D i vision (7508P) Office of Pesticide Programs

Pa ge 1 of30l ,3-Dichloropropene Barcode 0410115

EXECUTIVE SUMMARY

EPA's Health Effects Division (HED) has evaluated the available data and the most recent human health r i sk assessments for the fumigant 1 ,3-dichloropropene (1 ,3 -D) to determine the

scope of work necessary to support the registration review process. HED has considered the

current use patterns (OPPIN Database and current label s) as well as the available toxicity and

exposure information for 1 ,3 -D. 1 ,3 -D is a broad spectrum fumigant registered for pre-plant control of nematodes and other soil pests and for post-plant drip irrigation in vineyards to control
nematodes and 

### Phylloxera.



### Toxicity /Hazard

The toxicology database for 1 ,3-dichloropropene is complete. No additional toxicology or hazard data are required to support registration review. Acute and subchronic neurotoxicity studies in
rats, which are required 

### in accordance with new data requirements for conventional pesticide registration (40 CFR Part 158), have not been submitted for 1

, 3-D. However, based on a weightof-evidence (WOE) approach considering all the available hazard and exposure information for
1 ,3 -D

, the Hazard and Science Pol ic y Council (HASPOC; TXR # 0056626) concluded that the

acute and subchronic neurotoxicity studies are not required for 1,3-D at this time. An immunotoxicity st udy was submitted as part of the new EPA guideline requirements and is under

re view.

There is no evidence that 1

, 3-dichloropropene is a developmental, reproductive, or neurotoxic
chemical. The r e is evidence of mutagenicity 

### in the data ba se, and 1 ,3 -D has been classified as "likely to be carcinogenic to humans " 

### via both the oral and inhalation routes of exposure. There
i s no concern for increased quantitati ve or qualitative susceptibi li ty of the young following in



### utero and pre-and pos t -nata l exposure to 1,3-D 

### via inhalation in developmental toxicity st udies in

rats and rabbits or in the reproduction study in rats. Therefore, the risk assessment team concluded that the lOX FQPA Safety Factor can be reduced to 1X. 1,3-D has low acute t oxicity (lethality) by t he inhalation route of exposure <1\ld moderate acute toxicity by t he oral and dermal

routes of exposure. It is moderately irritating to

. the eye and skin and is a dermal sensitizer. The major target organs following**repeate~** inhalatiqn and oral exposures to 1,3-D are t he stomach/forestomach, nasal cavity; and lung in rats and mice.



### Residue Chemistry

Tolerances are established in the 40 CFR §180.636 for residues of 1,3-D inion grapes. S tudi es

were submitted by the registrant to cover several deficiencies noted in the residue chemistry chapter in support for the use in vineyards. The se studies will be considered by the HED

. In addition, th e tol erance expression needs to be modified according to the new Interim Guidance

on Tolerance Expressions.



### Dietary Exposure

Chronic and cancer dietary assessments were conducted for the combined exposure from food
and drinking water (surface wate r modeling data and ground water monitoring data). Chronic

Page 2 of301,3

- Dichloropropene Barcode D410115



### Page 3 of 30 dietary risk estimates were below HED’s level of concern for the general population and for all population subgroups. Cancer risks were not of concern for residues in/on food or ground water but were of concern for residues in/on food and surface water. Updated dietary exposure assessments for 1,3

- D will be n ecessary ( see Section 4.0 )

.
Aggregate Risk Assessment

To date, exposures from the oral (dietary) and inhalation (residential bystander) routes of exposure have not been aggregated, as there is not a common toxic effect by these two routes of

exposure

. Similarly, no aggregate cancer assessment was completed because the types of tumors observed in the inhalation and oral carcinogenicity studies a re different. Based on this

, the aggregate assessment is based on food and drinking water dietary exposure onl y , which was addressed in the dietary assessment. Any change in endpoint selection for 1,3

- D that impacts the toxicity determination of the dietary or inhalation routes of exposure may require a revised aggregate risk assessment.

Occupational & Residential Exposure

1,3

- D is registered for use as a (1) pre

- plant agricultural soil fumigant; (2) post

- plant drip irrigation fumigation; and (3) golf course turf fumigant

. 1,3

- D is a Restricted Use Pesticide and the primary risk concerns are for inhala tion exposure for workers involved in soil fumigations and for residential bystanders around treated areas. The occupational and residential exposure database for 1,3

- D is adequate for Registration Review , with the exception of ambient air studies for rep resentative airsheds

, which the Agency will require and incorporate during Registration Review

. Additional details on the specific airshed monitoring data are available in Section 14.0.

The following data deficiency was identified for 1,3

- D (see Appendix D ) :

Occupational/Residential Exposure:

o Ambient Airshed monitoring data

The following regulatory recommendation was identified for 1,3

- D:

Modification of the tolerance expression in the 40 CFR § 180. 636 according to the new HED guidance , see section 3.0

.

1.0 1,3

- D ICHLOROPROPENE 

### F ORMULATIONS AND 

### U SE 

### P ATTERNS



### HED used the Biological and Economics Analysis Division (BEAD) Label Data System to identify all agricultural and non

- agricultural uses of 1,3

- dichloropropene

. See 1,3

- D the HED Master Label Report ( 02 / 28 / 2013 ) for a complete list. In addition, the BEAD Chemical Profile for Registration Review was used to characterize the use pattern of 1,3

- D ( In Progress ; C. Chen et al.).1,3

- Dichloropropene Barcode D410115



### Page 4 of 30 1,3

- Dichloropropene is a soil fumigant containing approximately equal proportions of the cis and

trans isomers formulated as a pressurized gas, liquid ready to use, emulsifiable concentrate, or a flowable concentrate

. The liquid concentrates are intended for direct metering into drip irrigation systems , and other formulatio ns are used in more conventional soil fumigation applications (i.e., shank/chisel/plowsole pre

- plant soil treatments)

. The concentr ations of the active ingredients in the end

- use products range from 37.1 to 97.5%

. 1,3

- Dichloropropene is registered for pre

- plant and for post

- plant applications to control nematodes and/or garden symphylans

. Registered products for pre

- plant applications may be applied by drip irrigation, soil injection and row and broadcast applications

. The only post

- plant use registe red is for drip irrigation to established vineyards. Several 1,3

- D products also contain the fumigant chloropicrin to enhance plant pathogen and weed control. The human health risk assessment of chloropicrin is addressed separately.

Agricultural Uses

1 ,3

- D is registered for pre

- plant use on soils being prepared for the production of a variety of agricultural crops including vegetables, fruits, nuts, forage crops, tobacco, fiber crops

, golf course turf and nursery crops. O nly the post

- plant use in vineyards is considered a food

- use , since the potential for residues in foods results from that use

. End

- use products containing t his active ingredient are listed in the 1,3

- D HED Master Label Report (02/28/2013 )

.

Non

- Agricultural and Residential Uses

1 ,3

- D has no residential uses but is registered for non

- agricultural uses on golf course turf where there is potential for non

- occ upational exposure. Other non

- agricultural uses include ornamental and/or shade trees, ornamental herbaceous and non

- flowering plants, and ornamental woody shrubs and vines.

2.0 H AZARD 

### I DENTIFICATION 

### /T OXICOLOGY



### The toxicology database for 1,3

- dichloropropene is adequate for the purpose of human health risk assessment . No additional data are required. The major target organs following repeated oral and inhalation exposures to 1,3

- D are the stomach/forestomach, nasal cavity, and lung in rats and mice. Consistent with the irritant properties of 1,3

- D , there was evidence of degenerative changes in the nasa l olfactory epithelium and histopathological changes of the respiratory epithelium in rats and mice after subchronic inhalation exposure. Following chronic inhalation exposure, the olfactory region of the nasal cavity appeared to be the target organ in ra ts while lung adenomas were induced in mice. Similarly, following oral exposure, 1,3

- D induced histopathological lesions in rats and/or mice, including forestomach squamous cell papillomas and carcinomas, liver masses/neoplastic nodules, urinary bladder c arcinomas, and alveolar/brochiolar adenomas. Increases in hematopoietic activity and decreased body weights were seen in dogs. 1,3

- D showed moderate acute (lethality) toxicity by the oral and dermal routes of exposure, low acute (lethality) toxicity by t he inhalation route of exposure, was moderately irritating to the eye and skin, and was a dermal sensitizer in guinea pigs.1,3

- Dichloropropene Barcode D410115



### Page 5 of 30 For endpoint selection, since a n appropriate toxicity endpoint was not identified in the database to quantitate risk from a singl e oral exposure to 1, 3

- D, there is no acute reference dose (aRfD). The chronic reference dose (cRfD) is based on decreased body weight gain and an increased incidence of basal cell hyperplasia of the nonglandular stomach mucosa in the rat chronic toxicity /carcinogenicity oral study. The acute inhalation point of departure (POD) in based on clinical signs and decreased body weight in the 4

- hour acute inhalation study. Dermal endpoints were not selected since dermal exposure is not expected given the high va por pressure of 1,3

- D and the application methods used. The point of departure (POD) for short

- term inhalation exposure risk assessment is based on decreased maternal body weight gains in an inhalation developmental toxicity study in rabbits. The POD for intermediate

- term inhalation exposure risk assessment is based on histopathological lesions in the olfactory region of the nasal cavity in a 13

- week inhalation toxicity study in rats. The POD for long

- term inhalation exposure risk assessment is based on na sal histopathology in the chronic toxicity/carcinogenicity inhalation study in mice

.

1,3

- D is rapidly absorbed into the bloodstream

, extensively metabolized, and rapidly eliminated

, mainly in the urine and to a lesser extent as CO 2 

### in expired air and in the feces. The primary urinary excretion product is the mercapturic acid conjugate of 1,3

- dichloropropene and its corresponding sulfoxide.

There was no evidence of reproductive effects in a 2

- generation reproduction study in rats via the inhalation route. In the developmental toxicity study in rats via inhalation, decreased ossification of the vertebral centra was observed at the highest dose tested while decreased maternal body weight gain and food consumption were observed at all dos e levels. No developmental effects were observed in the rabbit developmental toxicity study via inhalation exposure, while maternal toxicity was manifested as decreased body weight gains. There is no concern for increased quantitative or qualitative suscep tibility of the young following in utero (rats and rabbits) and

pre

- and post

- natal exposure (rats) to 1, 3

- dichloropropene via inhalation in developmental toxicity studies in rats and rabbits or in a reproduction study in rats. Additionally, there is no

ev idence of neurotoxicity. Therefore, t he risk assessment team concluded that the 10X FQPA Safety Factor can be reduced to 1X. 1,3

- D has been classified as “likely to be carcinogenic to humans” via both the oral and inhalation routes of exposure. Forestomach , liver, mammary, thyroid, adrenal, urinary, and lung tumors were observed in the 2

- year rat oral carcinogenicity study and bronchioloalveolar adenomas were observed in the 2

- year mouse inhalation study. There is evidence of mutagenicity (gene mutations in bacteria and cultured mammalian cells in conjunction with clastogenic activity and sister chromatid exchanges in several mammalian cell lines and induction of DNA strand breaks both in vitro and in vivo ) in the 1,3

- D data base. As a result, cancer potency factors (Q 1 

### *) have been calculated for oral and inhalation routes of

exposure.

Attachment A provides a summary of the relevant toxicological endpoints used in the 2008 human health risk assessment. In a screening literature search , a National Toxicology Program ( NTP ) report of po tential effects of 1,3

- D on the immune system was identified, and this study along with the recently submitted immunotoxicity study will be evaluated during registration review. During Registration Review, the Agency will reevalua te the 1,3

- D endpoints, points of1,3

- Dichloropropene Barcode D410115



### Page 6 of 30 departure (PODs), and uncertainty factors for the various assessments based on current HED policy, recently submitted study (immunotoxicity/published data), and any other data.

3.0 R ESIDUE 

### C HEMISTRY



### 1,3

- Dichloropropene is a soil fumigant registered for pre

- plant use on soils to be planted to all crops and for post

- plant use in established vineyards using drip irrigation systems only

. Commercial 1,3

- D is a mixture of approximately equal proportions of the cis and trans isomer s. The nomenclature, registration numbers, PC Code and chemical structure of 1,3

- D are listed in Appendix B

.

The uses of 1,3

- D have been classified as food and non

- food based on residue chemistry considerations. Plant metabolism studies have been conducted with tomatoes, sugar beets, and soybeans (C. Olinger , D318734, 5/24/ 20 07 ). These studies were conducted at greatly exaggerated rates considering the proposed use, and prior to planting. Residues of the parent were metabolized in the plant to acetic acid and malonic acid and generally incorporated into natural plant constituents. Based on this finding, the us e of 1,3

- D as pre

- plant soil fumigant is considered a non

- food use and tolerance s are not needed. P ost

- plant use in vineyards is considered a food use and the residues of concern for tolerance enforcement and risk assessment are the cis and trans isomers of the parent, 3

- chloroallyl alcohol (CAAL)

, and 3

- chloroacrylic

a cid (CAAC).

A confined rotational crop study conducted with wheat, let tuce, carrots and radishes show ed extensive incorporation of radiolabeled residues into natural plant biochemical cons tituents. No tolerances or plant

- back restriction s are required. Livestock metabolism studies are not required for 1,3

- D due to the absence of residues of concern for pre

- plant uses and absence of feed items associated with grape vineyards

.

A tolerance for residues of 1,3

- D in/on grapes is established in the 40 CFR 180.636. An adequate enforcement method was submitted for th e determination of parent

. An independent laboratory validation (ILV) was requested for t he method for the determinati on of CAAL and CAAC . The ILV has been submitted to the agency . Multi

- residue method data and storage stability data in grapes was also required for the parent and it’s CAAL and CAAC metabolites and already submitted by the registrant as well

.

HED establ ished interim guidance on writing tolerance expressions for enforcement purposes (S. Knizner, 27/May/2009). In order to add clarity to the language used to establish the coverage of the tolerance expression and measurement of the level of the residue in t he Raw Agricultural Commodity ( RAC ) the text in the 40 CFR § 180. 636 should read: “(a) General. (1) Tolerances are established for residues of 1,3

- dichloropropene , including its metabolites and degradates, in or on the commodities in the table below. Com pliance with the tolerance levels specified below is to be determin ed by measuring cis

- and trans

- 1,3

- dichloropropene and its metabolites cis

- and trans

- 3

- chloroacrylic acid, and cis

- and trans

- 3

- chloroallyl alcohol , in or on the commodity

. ”1,3

- Dichloropropene Barcode D410115



### Page 7 of 30 Conclus ions : The submitted residue chemistry studies will be reviewed by HED. In addition, the tolerance expression in 40 CFR § 180. 636 needs to be modified according to the new HED guidance.

4.0 D IETARY 

### E XPOSURE



### The last dietary assessment for 1,3

- D was performed to support the Section 3 requests for use on vineyards ( C. Olinger , D 217283

, 06 / 1 0/200 7 ). A dietary risk analysis was conducted for the combined residues of the parent and metabolites assuming all grapes are treated . The analysis ( food only ) showed that all populat ions are exposed to less than 1% of the population adjusted dose (PAD) for chronic risk. This is below the Agency’s level of concern (i.e., when dietary exposure exceeds 100% of the PAD ) . The estimate d cancer risk ( 3x10 - 7



### , food only) is also below the A gency ’s level of concern.

Residues of concern in drinking water are the cis and trans isomers of the parent, the 3

- chloroacrylic acid (CAAC) and 3

- chloroallyl alcohol (CAAL) degradates. The E nvironmental Fate and Effects Divisio n (EFED) p rovided the drinking water assessment using simulation models to estimate the potential concentration of 1,3

- D and the degradates in surface water while tap water monitoring data were used to estimate concentration s in ground water.

A dietary ex posure analysis was conducted for the combined exposure from food and water. The chronic assessment for 1,3

- D and the degradates CAAC and CAAC showed that all populations are exposed to less than 1% of the population adjusted dose for food plus water from ground water sources and less than 5% of the population adjusted dose for food plus water from surface water sources. The cancer risk analysis for the combined residues of parent and CAAC and CAAL degradates in food and water from ground water sources di d not exceed the level of concern. However, the cancer risk analysis for the combined residues of parent and CAAC and CAAL degradates in food and water from surface water sources based on modeling data exceeded the level of concern

. HED considered th ose estimates to be highly conservative, and actual exposures to be likely much lower for a number of reasons such as: volatilization, one of the main dissipation routes of 1,3

- D, was not accounted for adequately in PRZM

- EXAMS; the lack of aerobic aquatic and soil metabolism studies; and lack of indirect photolysis studies (C. Olinger

, D 347789

, 01/24/2008 ). Moreover, limited surface water monitoring data (123 samples) in areas of high used showed that 1,3

- D and its degradates were not detected

. In addition, it was suggested that additional environmental fate data may be helpful to refine the drinking water

assessment.

Conclusions : D ietary exposure assessments for 1,3

- D may be necessary to consider the most recent food consumption data from the 2003

- 2008 U

. S. Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat in America, and to include newly estimated drinking water concentrations based on refined drinking water assessments and/or from updated drinking water monitoring data. It is noted that new drinking water models may be used during regist ration review which may lead to new EDWCs. In addition, if new points of departure are selected a revised dietary assessment may be needed

.1,3

- Dichloropropene Barcode D410115



### Page 8 of 30 5.0 T OLERANCE 

### A SSESSMENT AND 

### I NTERNATIO NAL 

### H ARMONIZATION



### Where possible, EPA encourages the harmonization of the US Tolerances and Maximum Residue Limits (MRLs) in key export markets. A table with the US tolerances, the Canada MRLs, Mexico MRLs and Codex MRLs for 1,3

- dichloropropene in registered RACs is provided in Appendix C

- International Residue Limits

. There are currently no established Codex, Canadian and /or Mexican MRLs for 1,3

- dichloropropene in/on grapes ; therefore, harmonization is not germane to this actio n

.

6.0 R ESIDENTIAL 

### E XPOSURE



### The residential exposure databases for 1,3

- D are adequate for Registration Review, with the exception of ambient monitoring exposure data for representative usage areas in the U.S

. Additional details on these data are available in Section 14.0.

There are currently no registered 1,3

- D products intended for residential use. However, there are registered commercial use patterns where there is potential for residential bystander inh alation exposure. Specifically, the Agency assesses non

- occupational (bystander) inhalation exposure from residential proximity to treated farm fields (i.e., near field sources) and from regional ambient air concentrations from many applications within a r egion (i.e., ambient sources). Field volatility studies indicate that peak emissions for 1,3

- D from treated field occur up to 72 hours after application. Therefore, the Agency assesses acute exposures for near field sources. There is also potential for inh alation exposure to 1,3

- D via ambient air as a result of regional 1,3

- D applications. These exposures can be acute as well as longer

- term in nature.

There are two recent documents that analyzed acute residential bystander inhalation exposure to 1,3

- D based on numerous flux studies and PERFUM ( P robabilistic E xposure and R isk model for Fum igants) air modeling for a variety of 1,3

- D scenarios ( Olinger ; D3 47789 ; 01 / 24 /200 8 and Olinger ; D3 37328 ; 04 / 12 /20 07 )

. Data from available field volatility studies ha ve been included where possible, for the registered use on established grape vines 1 

### , bedded row crops, and others

. For registration review and as per other fumigants, these exposures will need to be further characterized as appropriate which may includ e f urther computer modeling analyses with
PERFUM , or other applicable modeling system, as needed

.

The se risk assessments ( Olinger ; D3 47789 ; 01 / 24 /200 8 and Olinger ; D337328 ; 04 / 12 /20 07 ) also addressed ambient air inhalation exposure to 1,3

- D based on California ambient air monitoring studies

. Data in these assessments include targeted monitoring by the California Air Resources Board (CARB) (high agricultural use areas in

- season) and the Toxic Air Contaminant (TAC) program (background levels in urban en vironments). The assessments included non

- cancer and cancer risk estimation. The results of these assessments show no non

- cancer risk estimates of concern for ambient air inhalation exposures to 1,3

- D for any of the exposure durations assessed. Cancer ris k estimates using monitoring data in urban environments were generally

. Below 1x 10 -

1 MRID 452961011,3

- Dichloropropene Barcode D410115



### Page 9 of 30 6 

### and the assumptions in the near field source and ambient source assessments provide a conservative assessment of risk.

The cancer risk estimates using monitoring data from high agricultural use areas in

- season generally ranged from ranged from 2 x 10 - 6 

### to 9 x 10 - 8



### . The cancer assessment is expected to represent high

- end exposure and risk since it is not likely that a byst ander will be exposed to a high

- use air concentration over a lifetime

. B uffer distances for 1,3

- dichloropropene were established based on the concerns over longer

- term exposure (i.e., cancer assessment).

California Department of Pesticide Regulation (DP R) manages a township cap permitting program designed to assist growers in their transition away from methyl bromide as a soil fumigant while also protecting public health by minimizing long

- term problematic exposure to 1,3

- D in ambient air. The use of 1, 3

- D has been capped at 90,250 pounds/per year/per township under a program of restrictions developed after the pesticide was reintroduced to the California market in 1995. The Agency is monitoring California’s Toxic Air Contaminant Identification Program t o reevaluate ambient 1,3

- D exposures.

Conclusions: As per prior fumigant risk assessments, bystander risk to 1,3

- D from soil fumigations may need to be evaluated and updated during registration review should additional information about soil emission s become available , the label prescribed use conditions change

, and /or the relevant durations of the applica ble HECs change . Additional or updated PERFUM modeling and ambient air analyses may also be required if the points of departure (PODs) or uncertainty factors (UFs) for the residential exposure assessment change. Additionally, HED plans to reevaluate bystander cancer risk estimates based on requir ed ambient air monitoring data.

During Registration Review, HED also plans to update the fumigant factors document (Dawson, Smith, and Shelat ; D 385314 ; 1 / 11 /20 11) which affects all of the soil fumigants, including 1,3

- D. The fumigant factors document lays out recommendations for good agricultural practices as they are associated with buffer reduction credits, and builds on previous analyses of factors impacting fumigant emissions from soil fumigant applications.

7.0 A GGREGATE 

### E XPOSURE AND 

### R ISK 

### A SSESSMENT



### For the acute, short

- , intermediate

- , and long

- term assessments the toxicity endpoints selected for inhalatio n and dietary exposures are not expected to be aggregated as there is not a common toxicity observed. 1,3

- D has been classified as likely to be carcinogenic to humans via the oral and inhalation routes. However, the types of tumors observed in the inhala tion and oral studies were different , see section 2.0

. T herefore, oral and inhalation cancer risks will not be aggregated.

For the acute dietary exposure scenario , the aggregate exposure and risk estimates for 1,3

- D include only food and drinking water, and risk estimates are currently below HED’s level of

concern.

Conclusions: Dietary exposure estimates for 1,3

- D and its metabolites may be revised during registration review. Any change in endpoint selection for 1,3

- D that impacts the toxicity1,3

- Dichloropropene Barcode D410115



### Page 1 0 of 30 determin ation of the dietary or inhalation routes of exposure may require a revised aggregate risk

assessment.

8.0 O CCUPATIONAL 

### E XPOSURE



### The HED occupational exposure database s for 1,3

- D are ade quate for Registration Review. There are several main categories of re gistered occupational uses of 1,3

- D, including the following : (1) use as a pre

- plant agricultural soil fumigant; (2) use as a post

- plant drip irrigation fumigation; and (3) golf course turf fumigations.

Occupational Handlers

There is potential for occupational handler inhalation exposure to 1,3

- D based on the registered use pattern. D ermal exposure is not expected given the high vapor pressure of 1,3

- D and based on the application methods used . Therefore, HED has not estimated occupational risk est imates associated with dermal exposures. Because 1,3

- D formulations are Restricted Use Pesticides, it may only be applied under the direct supervision of a trained, certified applicator. There are two recent documents that analyzed occupational handler i nhalation exposure to 1,3

- D (Olinger; D347789; 01/24/2008 and Olinger; D337328; 04/12 / 2007).

HED assessed inhalation exposure for representative occupational uses of 1,3

- D for the acute, short

- and intermediate

- term exposure durations, as well as a cancer exposure assessment. That said, the majority of worker exposure will be for the acute and short

- term exposure durations given the 1,3

- D use pattern . Chemical

- specific worker exposure data are available, and were used to the extent possible to address occu pational handler exposure . The available data used in the occupational handler assessments , along with the corresponding activities considered in the research, to date include:

MRID 42946201 and 42845602: drum and bulk loaders and applicators, irrigatio n maintenance worker, rock removers, bed shapers;
MRID 43880401: mini

- bulk loaders and applicators;
MRID 45120702 / 45400202: pre

- bed row applications (Yetter rig), shovel men, operators, drivers.

The occupational risk assessment did identify risk estimate s of concern without respirator protection, but the 1,3

- D labels include OV respirators (i.e. PF10 respiratory protection) during the loading and application of 1,3

- D. Assuming use of appropriate respiratory protection, the occupational risk estimates do n ot exceed HED’s level of concern (i.e., MOEs > 30) for all non

cancer assessments. Cancer risk estimates for the occupational use of 1,3

- D are refined in that they rely on both available chemical

- specific air monitoring and chemical

- specific lifetime use i nformation provided by BEAD. Cancer risk estimates based on the 2007/2008 risk assessments are in 10 - 5 

### to 10 - 6 

### range, taking into account personal protective equipment and engineering controls for handling and application of 1,3

- D.1,3

- Dichloropropene Barcode D410115



### Page 11 of 30 Occupational Post Appli cation

HED also performed occupational bystander assessments based on available field volatility data for 1,3

- D scenarios involving pre

- and post

- plant drip irrigation, and row applications.

As part of the 1998 RED, the Agency placed various restrictions on reentry of workers into fumigated fields (i.e., 5 day restricted entry interval (REI)). Additionally, the organic vapor ( OV ) respirator requirement on 1, 3

- D labels apply to all occupational workers before and during a 5 day REI . With these risk mitigations in place, risks to reentry workers did not exceed the HED’s level of concern for either non

- cancer risk estimates. Buffer distances for 1,3

- D were established based on longer

- term exposure (i.e., cancer risk estimates)

.

Conclusions: The occupational exposure database is adequate to support the Registration Review process for the HED uses of 1,3

- D

. Additional or updated PERFUM modeling and ambient air analyses may be required during Registration Review if the points of departure (PODs) or uncertainty factors (UFs) for the occupational bystander exposure assessment change. Additionally, cancer risk estimation may be revisited based on HED evaluating the chronic/carcinogencity study, wo rker risk estimate policy revisions, and updated chemical

specific lifetime use information.

9.0 P UBLIC 

### H EALTH AND 

### P ESTICIDE 

### E PIDEMIOLOGY 

### D ATA

Adapted from: E. Evans and S. Recore, D 411762, 05 / 15 /201 3



### OPP’s Incident Data System ( IDS ) includes reports of alleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, an d individual consumers. IDS records incidents resulting in higher severity outcomes in more detail, in a module called the Main IDS module. Main IDS incidents involving only one pesticide are considered to provide more certain information about the poten tial effects of exposure from the pesticide. The less severe human incidents (minor, unknown, or no effects outcomes) are reported by registrants as counts called aggregate summaries and are recorded in a separate module called Aggregate IDS.

For the M ain IDS, from January 1, 200 8 to February 19, 2013, there were 5 incidents reported for single chemical only in the database. One incident, an allergic reaction that was classified as major severity because it involved a severe allergic reaction, was dete rmined to be a reaction to a prescription and not the pesticide. T his incident does not appear to be related to the implicated product. Three of the other incidents were classified as moderate severity and one was classified as minor severity. In A ggreg ate IDS , from January 1, 200 8 to February 19, 2013, there were 20 reported incident s involving telone

. These incidents were classified as minor severity.

The SENSOR

- Pesticides database covers 11 states from 1998

- 2009, although reporting varies from state to state. A query of SENSOR

- Pesticides 1998

- 2009 finds a total of 18 cases, stemming from ten events, involving Telone. Of these 18 cases, 15 were low in severity, one1,3

- Dichloropropene Barcode D410115



### Page 12 of 30 was moderate in severity a nd two were high in severity. The high severity cases occurred in Washington in 2008 (railroad switchman transporting the product) and North Carolina in 2008 (worker unclogging disconnected lines) and involved telon e products co

- formulated with chloropicrin. Six cases were reported following one drift/volatilization event that occurred in Florida in 2006 in which a pesticide application made to a golf course drifted onto a residential area. All 6 cases were low in severity.

C onclusion s : Based on the low frequency and severity of incident cases reported for Telone in both IDS and SENSOR

- Pesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency will contin ue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

10.0 E NVIRONMENTAL 

### J USTICE



### Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations," ( http: //www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf

. As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well

- established procedures. In line with OPP policy, HED estimates risks to population sub groups from pesticide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled b y the USDA under the Continuing Survey of Food Intake by Individuals (CSFII) and are used in pesticide risk assessments for all registered food uses of a pesticide. These data are analyzed and categorized by subgroups based on age, season of the year, eth nic group, and region of the country. Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant. Whenever appropriate, non

- dietary exposures base d on home use of pesticide products and associated risks for adult applicators and for toddlers, youths, and adults entering or playing on treated areas post

- application are evaluated. Further considerations are currently in development as OPP has committ ed resources and expertise to the development of specialized software and models that consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary patterns among specific subgroups.

11.0 C UMULATIVE 

### R ISK 

### A SSESSMENT



### Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as

to 1,3

- D and any other substances and 1,3

- D does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 1,3

- D has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals ha ve a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by1,3

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### Page 13 of 30 EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from subst ances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/

.

12.0 E NDOCRINE 

### D ISRUPTOR 

### S CREENING 

### P ROGRAM



### As required by FIFRA and FFDCA, EPA reviews numerous stud ies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and se x ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for 1,3

- D

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 1,3

- D are subject to the endocrine screening part of the Endocrine Di sruptor Screening Program (EDSP).

EPA has developed the EDSP 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 estro gen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship be tween the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pes ticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013 2 

### and includes some pesticides scheduled for Registration Review and chemicals found in water

. For further informatio n on the status of the EDSP, the policies and procedures, the list s of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 3

2 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemicals.

3 http://www.epa.gov/endo/1,3

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### Page 14 of 30 In the interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of 1,3

- D . Before completing this Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination.

13.0 H UMAN 

### S TUDIES



### The chemical specific studies used to develop the previous occupational handler assessment have not been reviewed for compliance with required ethical standards for conducting human studies. Prior to final decisions under Registration Review for 1,3

- D th e Agency will ensure that the studies are subjected to the appropriate review

.
The study MRIDs are as follows: An Evaluation of 1,3

- Dichloropropene Worker Exposures Associated With TELONE “Soil Fumigant Loading Application and Re

- entry Final Report

o MRIDs: 42946201 /42845602 An Evaluation of Worker Exposure to Airborne Concentrations of 1,3

- dichloropropene during loading and application of TELONE Soil Fumigants Packaged in Traveler Cylinders

o MRIDs: 43880401 Water and Air Concentrations of 1,3

- Dichloropropene Following a Golf Course Turf Application in the Southeast United States

o MRIDs: 45120702/45400202

14.0 D ATA 

### R EQUIREMENTS



### This data is required in order to complete the 1,3

- D registration review risk assessment.

Occupational/Residential Exposure:

o Airshed monitoring data 4 

### for:

 Southeast climate zone (e.g., Florida, Georgia, or Virginia)

 Mid

- Atlantic to Upper mid

- west climate zone (e.g. Michigan, Wisconsin)

 Pacific North

- West climate zone (e.g. ,Idaho, Washington)

 The Southwest climate zone (e.g. California, Arizona)

Additional information about the required ambient monitoring data can be found in HED’s 2008 memo “ Health Effects Division Recommendations for Fumigant Data to Refine Exposure Assessments” 

### (D353724). This “special study” data requirement is nec essary because the available ambient data used in the assessment is dated and did not take place in high use areas. Additional justification for the study requirement is identified in Appendix D.

4 “Special Study” data requirement. See Appendix D for more information1,3

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### Page 15 of 30 15.0 R EFERENCES



### EPA 2002

. 2002 Edition of the Drinking Water Standards and Health Advisories. EPA 822/R/02/038. Washington, DC: Office of Water, EPA.

Van Alstine, J., (April 23, 2013), TXR #0056626, 1,3

- D ichloropropene ( 1,3

- D ): Summary of Hazard and Science Policy Council (HASPOC ) Meetings of March 28, 2013: Recommendations on the Requirement of the Neurotoxicity Battery (Acute and Subchronic Neurotoxicity Studies).

J. Dawson and C. Smith, 07/01/2008, D353724, Health Effects Division Recommendations for Fumigant Data to Refine Exposure Assessments

.

1,3

- D RED Document ; December, 1998.

1,3

- Dichloropropene: HED Human Health Risk Assessment For Phase 5; DP Barcode: D337328, PC Code: 029001 ; April 12, 2007.

1,3

- Dichloropropene: Proposed New Use for Drip Irrigation in Vineyards: HED Human Health Risk Assessment; DP Barcode: D340059, PC Code: 029001 ; June 6, 2007.

Review of Special Local Need Registration 24(c) for Telone II (EPA Reg. 62719

- 32) to Control Potato Cyst Nematodes (PCN) in Soils Involved with the USDA/ISDA PCN Eradication Program

- SLN: ID

- 070015 (PC Code 029001, DP Barcode 345158) ; November 16, 2007.

1,3

- Dichloropropene: Follow

- up on Proposed New Use for Drip Irrigation in Vineyards: Drinking Water and Residential Assessments; DP Barcode: D346778, PC Code: 029001 ; December 14, 2007.

1,3

- Dichloropropene: Proposed New Use for Drip Irrigation in Vineyards: Revised HED Human Health Risk Assessment; DP Barcode: D347789, PC Code: 029001 ; January 24, 2008

Health Effects Division Recommendations for Fumigant Dat a to Refine Exposure Assessments. D353724 ; July 1, 2008.

1,3

- Dichloropropene , PC Code 029001, DP Barcode 369764 ; Responses To Technical Issues Associated With Telone Use In Florida On Golf Courses and Labeling Issues In California ; October 27, 2009.1,3

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### Page 16 of 30 Ap pendix A: Toxicology Profile and Executive Summaries

A.1 Toxicology Data Requirements The requirements (40 CFR 158.340) for food uses for 1,3

- D ichloropropene are in Table 1. Use of the new guideline numbers does not imply that the new (1998) guideline protocols were used.

Study Technical

Required Satisfied

870.1100 Acute Oral Toxicity

................................ ....................... 870.1200 Acute Dermal Toxicity

................................ .................. 870.1300 Acute Inhalation Toxicity

................................ .............. 870.2400 Primary Eye Irritation

................................ .................... 870.2500 Primary Dermal Irritation

................................ .............. 870.2600 Dermal Sensitization

................................ ...................... yes yes yes yes yes yes yes

yes yes yes yes yes
870.3100 Oral Subchronic (rodent)

................................ ............... 870.3150 Oral Subchronic (nonrodent)

................................ ......... 870.3200 21

- Day Dermal

................................ .............................. 870.3250 90

- Day Dermal

................................ .............................. 870.3465 90

- Day Inhalation

................................ .......................... yes yes yes CR

yes yes

yes

no A

- yes
870.3700a Developmental Toxicity (rodent)

................................ ... 870.3700b Developmental Toxicity (nonrodent)

............................. 870.3800 Reproduction

................................ ................................ . yes yes yes yes

yes

yes
870.4100a Chronic Toxicity (rodent)

................................ .............. 870.4100b Chronic Toxicity (nonrodent)

................................ ........ 870.4200a Oncogenicity (rat)

................................ .......................... 870.4200b Oncogenicity (mouse)

................................ .................... yes yes yes yes yes

yes

yes

yes 870.5100 Mutagenicity

— Gene Mutation

- bacterial

..................... 870.5300 Mutagenicity

— Gene Mutation

- mammalian

................ 870.5xxx Mutagenicity

— Structural Chromosomal Aberrations

... yes yes yes yes

yes

yes
870.6100a Acute Delayed Neurotoxicity (hen)

............................... 870.6100b 90

- Day Neurotoxicity (hen)

................................ ........... 870.6200a Acute Neurotoxicity Screening Battery (rat)

................. 870.6200b 90

- Day Neurotoxicity Screening Battery (rat)

............... 870.6300 Develop. Neurotoxicity

................................ ................. no

no

yes yes CR no

no
waived* waived*

- 870.7485 General Metabolism

................................ ...................... 870.7600 Dermal Penetration

................................ ........................ 870.7800 Immunotoxicity

................................ ............................. yes CR

yes yes

-
yes *HASPOC TXR#0056626; A highly volatile chemical; very low dermal exposure anticipated relative to inhalation; realistic quantification of dermal risk is not possible (study not required). CR = Conditionally Required.1,3

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### Page 17 of 30 A.2. A cute Toxicology Acute Profile of 1,3

- Dichloropropene

Guideline No. Study Type MRIDs # Results Toxicity Category

870.1100 Acute Oral (rat) 40220901 LD 50 = 224 mg/kg II

870.1200 Acute Dermal (rabbit) 40220902 LD 50 = 333 mg/kg II

870.1300 Acute Inhalation (rat) 40220903 LC 50 = 3.88 mg/L IV

870.2400 Primary Eye Irritation (rabbit) 40220904 Severe irritant II

870.2500 Primary Skin Irritation (rabbit) 40220905 Slight irritant III

870.2600 Dermal Sensitization ( guinea pig) 40220906 Sensitizer

--


### Toxicity Profile

Guideline No./ Study Type MRID No./ Classification /Doses Results

Subchronic Toxicity Studies

870.3100 90

- Day oral toxicity rodents [Fischer 344 rats] 42954802 (1993) Acceptable/guideline 0, 5, 15, 50 or 100 mg/kg/day in diet NOAEL = 5 mg/kg/day LOAEL = 15 mg/kg/day based on hyperkeratosis and/ or basal cell hyperplasia in the non

- glandular portion of the stomach (both sexes)

870.3100 90

- Day oral toxicity rodents [B6C3F1 mice] 42954801 (1993) Acceptable/guideline 0,15, 50, 100 or 175 mg/kg/day in diet NOAEL = 15 mg/kg/day LOAEL = 50 mg/kg/day based on decreased body weights and body weight gain (both sexes)

870.3100 90

- Day oral toxicity nonrodent See 870.4100b, below

870.3465 30

- Day inhalation toxicity rodent [Fischer 344 rats] 00039685 (1978) Acceptable/guideline 0, 3, 10 or 30 ppm (0, 0.0136, 0.045 or 0.136 mg/L) 6 hours/day, 5 days/week NOAEL = 30 ppm (0.136 mg/L), highest dose tested LOAEL = >30 ppm

870.3465 30

- Day inhalation toxicity rodent [CD

- 1 mice] 00039685 (1978) Acceptable/guideline 0, 3, 10 or 30 ppm (0, 0.0136, 0.045 or 0.136 NOAEL = 30 ppm (0.045 mg/L), highest dose tested LOAEL = >30 ppm (0.136 mg/L)1,3

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### Page 18 of 30 Guideline No./ Study Type MRID No./ Classification /Doses Results

mg/L) 6 hours/day, 5 days/week

870.3465 90

- Day inhalation toxicity rodent [Fischer 344 rats] 00146461 (1984) Acceptable/guideline 0, 10, 30, 90 or 150 ppm (0, 0.045, 0.136, 0.408,or 0.680 mg/L) 6 hours/day, 5 days/week NOAEL = 10 ppm (0.045 mg/L) LOAEL = 30 ppm (0.136 mg/L) based on histop athological lesions in the nasal turbinates

870.3465 30

- Day inhalation toxicity rodent [B6C3F1 mice] 00146461 (1984) Acceptable/guideline 0, 10, 30, 90 or 150 ppm (0, 0.045, 0.136, 0.408,or 0.680 mg/L) 6 hours/day, 5 days/week NOAEL = 10 ppm (0.045 mg/L) LOAEL = 30 ppm (0.136 mg/L) based on histopathological lesions in the nasal turbinates

Developmental and Reproductive Toxicity Studies

870.3700a Prenatal developmental in rodents [Fischer 344 rats] 00144715, 00152848 (1983) Acceptable/guideline 0, 20, 60 or 120 ppm (0, 0.091, 0.272 or 0.545 mg/L) by inhalation 6 hours/day during gestation days 6 through 15 Maternal NOAEL = <20 ppm (0.091 mg/L) LOAEL = 20 ppm (0.091 mg/L) based on decreased body weight gain and food consumption Developmental NO AEL <120 ppm (0545 mg/L), highest concentration tested LOAEL =120 ppm (0545 mg/L) based on increased delay in ossification of the vertebral centra

870.3700b Prenatal developmental in nonrodents [New Zealand White Rabbit] 00144715, 00152848 (1983) Acceptable/guideline 0, 20, 60 or 120 ppm (0, 0.091, 0.272 or 0.545 mg/L) by inhalation 6 hours/day during gestation days 6 through 18 Maternal NOAEL = 20 ppm (0.091 mg/L) LOAEL = 60 ppm (0.272 mg/L) based on decreased body weight gain Developmental NOA EL 120 ppm (0545 mg/L), highest concentration tested LOAEL >120 ppm (0545 mg/L)

870.3800 Reproduction and fertility effects [Fischer 344 rats] 40312401, 40835301(1987) Acceptable/guideline 0, 10, 30 or 90 ppm (0, 0.045, 0.136, or 0.408 mg/L) by inhalation 6 hours/day, 5 days/week (premating) 6 hours/day, 7 days/week (F 0 breeding at weeks 11

- 13, during gestation and lactation; F 1a and F 1b , dams from gestation day 20 until postpartum day 5; F 1 ♂♀ parents after weaning and continued for 12 weeks, 5 days/week Parental/Systemic NOAEL = 30 ppm (0.136 mg/L) LOAEL = 90 ppm (0.408 mg/L) based on decreased body weight gain, microscopic non

- glandular stomach lesions and hyperplasia of the nasal r espiratory epithelium with focal degeneration of the olfactory tissue

Reproductive NOAEL = 90 ppm (0.408 mg/L), highest concentration tested LOAEL >90 ppm (0.408 mg/L)

Offspring NOAEL = 90 ppm (0.408 mg/L), highest concentration tested LOAEL >90 ppm

Chronic Toxicity Studies1,3

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### Page 19 of 30 Guideline No./ Study Type MRID No./ Classification /Doses Results

870.4100b Chronic toxicity nonrodent [Beagle dog] 42441001 (1992) Acceptable/guideline 0, 0.5, 2.5 or 15 mg/kg/day microcapsules by dietary admix NOAEL = 2.5 mg/kg/day LOAEL = 15 mg/kg/day based on decreased body weight gain, microcytic anemia, an increase in hematopoietic activity in both sexes and possible increased liver weights in males

870.4300 Combined Chronic Oral Toxicity/Carcino

genicity for 2 year rat stud y [Fischer 344 rats] 43763501 (1995) Acceptable/guideline 0, 2.5, 12.5 or 25 mg/kg/day microcapsules by dietary admix Chronic Toxicity NOAEL = 2.5 mg/kg/day LOAEL = 12.5 mg/kg/day based on decreased body weight gain and an increase in the incidence of basal cell hyperplasia of the

non

- glandular mucosa of the stomach Carcinogenicity: Increased incidence of rats with primary hepatocellular adenomas: 0, 2.5, 12.5 and 25 mg/kg/day = ♂ 2/50, 1/50, 6/50 and 9/50; ♀ 0/50, 0/50, 0/50 and 4/50

870.4300 Combin ed Chronic Toxicity/Carcinogenici ty (104 week) [Fischer 344 rats] 00146469 (1985) NTP study Acceptable/guideline 0, 25 or 50 mg/kg/day by oral gavage 3 times/week for 104 weeks Chronic Toxicity NOAEL = not established LOAEL = 25 mg/kg/day based on increased tumor incidence Carcinogenicity: Increased incidence of squamous cell papillomas of the forestomach: 0, 25 and 50 mg/kg/day = ♂ 1/52, 1/52 and 9/52; ♀ 0/52, 2/52, 3/52. Squamous cell carcinomas: ♂ 0/52, 0/52 and 4/52. Neoplastic nodules of the liver: ♂ 1/52, 6/52 and 7/52: ♀ 6/52, 6/52, 10/52.
NTP concluded that there was “clear evidence of carcinogenicity” in males and “some evidence” of carcinogenicity in females

870.4300 Combined Chronic Toxicity/Carcino

g enicity (104 week)[B6C3F1 mice] 43757901 (1995) Acceptable/guideline 0, 2.5, 25 or 50 mg/kg/day microcapsules by dietary admix Chronic toxicity NOAEL = 2.5 mg/kg/day LOAEL = 25 mg/kg/day based on lower body weights and decreased body weight gain (both sexes)

Carcinogenicity: No evidence of carcinogenicity but study not adequate for assessment due to several deficiencies in conduct.

870.4300 Combined Chronic Toxicity /Carcino

genicity (104 week)[B6C3F1 mice] 00146469 (1985) NTP study Acceptable/guideline 0, 25 or 50 mg/kg/day by oral gavage 3 times/week for 104 weeks Chronic Toxicity NOAEL = not established LOAEL = 25 mg/kg/day based on increased mortality in males Carcinogenicity: Increased incidence of squamous cell papillomas of the forestomach: 0, 25 and 50 mg/kg/day = ♀ 0/50, 1/50, 2/50. Squamous cell carcinomas of thee forestomach: ♀ 0/50, 0/50, 2/50 . Transitional cell carcinomas of the urinary bladder: ♀ 0/50, 8/50, 21/50. Alveolar/bronchiolar adenomas: ♀ 0/50, 3/50, 8/50. In ♂, study was inadequate for carcinogenicity.
NTP concluded that there was “clear evidence of carcinogenicity” in females

870. 4300 Combined Chronic Toxicity/Carcino

genicity (2 years) [Fischer 344 rats] 40312201 (1987) Acceptable/guideline 0, 5, 20 or 60 ppm (0, 0.023, 0.091 or 0.272 mg/L) by inhalation 6 hours/day, 5 days /week for 509 days Chronic Toxicity NOAEL = 20 ppm (0.091 mg/L) LOAEL = 60 ppm (0.272 mg/L) based on histopathological changes in nasal tissue (males and females) and a suggestion of decreased body weight gain (first year of the study only)

There was no evidence of carcinogenicity

870.4300 Combined Ch ronic 40312301 (1987) Acceptable/guideline Chronic Toxicity NOAEL = 5 ppm (0.023 mg/L) LOAEL = 20 ppm (0.091 mg/L) based urinary bladder1,3

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### Page 20 of 30 Guideline No./ Study Type MRID No./ Classification /Doses Results

Toxicity/Carcino

genicity (2 years) [B6C3F1 mice] 0, 5, 20 or 60 ppm (0, 0.023, 0.091 or 0.272 mg/L) by inhalation 6 hours/day, 5 days /week for 510 days hyperplasia, and hypertrophy/hyperplasia of the nasal respiratory mucosa

Carcinogenicity: Increased incidence of bronchioloalveolar adenomas: 0, 5, 20 or 60 ppm = ♂ 9/50, 6/50, 13/50 or 22/50. Although th e lung tumors were benign, tumor induction was concentration dependent, the tumor incidence was dose dependent, the tumor incidence was outside of the historical controls, and the tumor type was seen in the mouse oral bioassay.

Genotoxicity Studies

Gene Mutation 870.5300
In vitro mammalian cell in culture gene mutation assay Chinese hamster ovary (CHO) cells 47020332 ( Acceptable/guideline 50

- 250 μM

- S9 50

- 200 μM +S9 Negative up to cytotoxicity (≥200 μM

- S9) or the highest dose tested +S9

Gene Mutation 870.5300 Drosophila melanogaster sex

linked recessive lethal mutations 00146469 (1985) Acceptable/guideline 0, 5750 ppm/feeding Positive: Induction of sex

- linked recessive lethal mutations but negative for the induction of reciprocal translocations at 5 750 ppm National Toxicology Program (NTP); Valencia et al.

, Environ Mutagenesis 7:325

- 348.

Gene Mutation 870.5300 Host Mediated assay 00039688 (1978) Acceptable/guideline 0, 30, 60 mg/kg (oral gavage administration at 1, 2 & 3 hrs) Negative up to the highest dose tested

Cytogenetics 870.5375
In vitro mammalian cytogenetics assay CHO cells NTP (1989) Acceptable/Guideline 4.91

- 49.1 μg/mL

- S9 (Trial 1) 50

- 100 μg/mL

- S9 (Trial 2) 10

- 50 μg/mL +S9 (Trial 1 only) Negative up to concentrations causing 50% reduction in cell confluency (≥50 μg/mL ± S9)NTP: Loveday et al. , Environ Mutagenesis 13:6

– 94.

Cytogenetics 870.5395
In vivo mouse micronucleus assay 259101 (1985) Acceptable/guideline 0, 38, 115, 380 mg/kg Negative up to a lethal dose (380 mg/kg)

Cytogenetics 870.5450 Dominant Lethal Mutation in Sprague Dawley Rats 44302801 (1997) Acceptable/guideline 0

- 150 ppm, 7 da/wk, 10 wks (whole body inhation) Negative up to the LOAEL of 150 ppm, based on adverse effects on body weight.

Other Effects 870.5500 00039688 (1978) Acceptable/guideline Positive: Preferential inhibition of the DNA repair deficient strain at 1250 μg/well1,3

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### Page 21 of 30 Guideline No./ Study Type MRID No./ Classification /Doses Results

Bacterial DNA repair Bacillus subtilis H15 & M45 50

- 1,250 μg/well

Other Effects 870.5550 Unscheduled DNA Synthesis Primary rat hepatocytes 00146467(1985) Acceptable/guideline

3x10 - 3 to 1x 10 - 6 

### M Negative up to a cytotoxic level (3 x 10 - 4 M)

Other Effects 870.5900
In vitro sister chromatid exchange(SCE) CHO cells NTP (1989) Acceptable/Guideline 0.995

- 29.900 μg/mL

- S9 (Trial 1) 30

- 50 μg/mL

- S9 (Trial 2) 2.990

- 29.900 μg/mL +S9 (Trial 1 only) Positive: Significant and concentration

- related ↑in SCE induction at 30

- 50 μg/mL

- S9 & 10

- 30 μg/mL +S9. These levels were not cytotoxic.

METABOLITES OF 1,3

- DICHLOROPROPENE

Gene Mutation 870.5100
In vitro bacterial reverse gene mutation

assay Salmonella typhimurium TA98, TA100, TA1535, TA1537 Escherichia coli WP2 (uvrA) 44940327 (1999) 3

- Chloroacrylic acid Acceptable/guideline 500

- 5000 μg/plate ±S9 Negative in independently performed preincubation assays up to the limit concentration

Gene Mutation 870.5100
In vitro bacterial reverse gene mutation

assay Salmonella typhimurium TA98, TA100, TA1535, TA1537 Escherichia coli WP2 (uvrA) 44940326 (1999) 3

- Chloroallyl alcohol Acceptable/guideline 33.3

- 5000 μg/plate ±S9 Negative in independently performed preincubation assays up to the limit concentration

Gene Mutation 870.5300
In vitro mammalian cell in culture gene mutation assay mouse lymphoma L5178Y 44940311 (1999) 3

- Chloroallyl alcohol Acceptable/guideline Trial 1:12.5

- 925 μg/mL

- S9; 1.5

- 100 μg/mL +S9 Trial 2:12.5

- 500 μg/mL

- S9; 3

- 100 μg/mL +S9 Positive: Dose

- related and reproducible ↑ MF at 400 and 500 μg/mL

- S9 & 75 and 100 μg/mL +S9: no difference in the induction of small or large mutant colonies

Cytogenetics 870.5395
In vivo mouse (CD

- 1) micronucleus assay 44940312 (1999) 3

- Chloroacrylic acid Acceptable/guideline 62.5

- 250 mg/kg (♂)
62.5

- 200 mg/kg (♀) Negative up to overtly toxic (death and/or decreased activity) highest doses1,3

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### Page 22 of 30 Guideline No./ Study Type MRID No./ Classification /Doses Results

Immunotoxicity 870.7800 (sheep red blood cell assay) 49074801 (2010) 28

- day dietary male F344/DuCrl Rats Under review

MECHANISM STUDIES

Gene Mutation
In vitro bacterial reverse gene mutation

assay Salmonella typhimurium TA100 plus mouse lung homogenate 44460501 (1998) Unacceptable /non

guideline 100

- 450 μg/plate

- metabolic activation; 150

- 1000 μg/plate + untreated mouse lung homogenate

- glutathione (GSH)or 75

- 1000 μg/plate +GSH; 75

- 1000 μg/plate ± GSH + mouse lung S9 (pretreated with 63 ppm 1,3

- D, 5da/wk, 2.5 wks) Negative at any concentration ± GSH and ± untreated or 1,3

- D lung S9 but under conditions that would not favor a mutagenic

response

- S9 (no epoxidized soybean stabilizer, purification through silicic column and storage at 5 C under N 2 ) or +S9 because of low level microsomal/oxidative proteins in the lung preparation

Gene Mutation
In vivo with transgenic Big Blue B6C3F1 mice gene mutation assay target gene (lacI

) 44470501 (1998) Unacceptable /non

guideline 0, 10, 60, 150 ppm (via whole body inhalation) 6 hrs/da, 5 da/wk, 2 wks Negative in lung and liver tissue but test system uncertaintie s weaken the understanding of the negative response.

Other Mutagenic Effects
In vitro DNA binding

assays 44446301 (1997) Unacceptable /non

guideline 11 mM reacted w calf thymus DNA ± S9 (Aroclor 1254

- induced rat liver) ± GSH Inconclusive

- S9; negative +S9 ± GSH but uncertainties regarding use of optimum conditions

Mechanism of Tumorigenicity ♂B6C3F1 mice & ♂
Fischer 344 rats 44446302 (1997) Unacceptable /non

- guideline 0, 5,12.5, 25, 100 mg/kg (oral gavage

- rats) 3, 12 26 days 0, 10, 30, 60, 150 ppm (whole body inhalation

mice) 6 hrs/da, 5 da/wk, 2 wks RATS:. No mortality or clinical signs S ↓GSH at 25 & 100 mg/kg (adaptive process) but liver tumors were seen in the 2

- yr bioassay at 12.5 mg/kg. No conclusion possible for ap optosis or cell proliferation because of variability in data. No conclusion possible for DNA adduct formation because of variability in data & small sample size.

MICE: No mortality or clinical signs. Data show conjugation of 1,3

- D w GSH in lung tissue , no clear effect on cell proliferation or apoptosis in bronchiole epithelium or bladder transitional cells or DNA adduct formation in lungs but extreme variability and small sample size compromised the findings.

Concerns regarding whether a biological effective dose was achieved.

GSH Activity in Several Mammalian Cell Lines: ♂B6C3F1 44460503 (1998) Unacceptable /non

- guideline GSH measurements in cell No conclusions relative to the correlation between physiological levels of GSH and mitigatio n of mutagenicity1,3

- Dichloropropene Barcode D410115



### Page 23 of 30 Guideline No./ Study Type MRID No./ Classification /Doses Results

mice & ♂ Fischer 344 rats primary rat hepatocytes, CHO cells, Chinese hamster lung cells, Salmonella typhimurium lines reacted with various substrates: 13 C

- 1,3

- D; 4

- chloro

- 1,3

- dinitrobenzene;

para

- nitro

phenylethylbromide; trans

4

- phenyl

- 3

- buten

- 2

- one Low level GSH activity with S. typhimuruim but conflicting results with various mammalian cell lines ( i.e. , high & low level GSH activity with cell lines producing negative mutagenicity data and high GSH activity with 2 cell lines that were positive in standard mutagenicity assays)

Bioavailabity of Microencapsulated Telone II in Female
Rats 44460502 Unacceptable /non

- guideline Phase I: 25 mg/kg 13 C

- 1,3D coadministered w 25 mg/kg microencap

- sulated 1,3

- D sampled at 1,3,5,10,15, 20, 30, 40,50,or 60 min. Phase II: 25 or 50 mg/kg

13 C

- 1,3D + microencap

sulated 1,3

- D; 25 or 50 mg/kg 13 C

- 1,3D + 7.5 or 15 mg/kg microencap

- sulated 1,3

- D No conclusions because of unclear study design, technical deficiencies and biased treatment of the data.

Initiation

- Promotion: Mechanism of Mouse Lung Tumors ♂A/J mice 45897502B&D Unacceptable /non

- guideline 16 mg/kg vinyl carbamate(VC) (initiator) ± 0, 60 ppm 1,3

- D (whole body inhalation 6 hrs/da, 5 da/wk, 25 wks) Lung adenomas in 1,3

- D alone 26% vs 10% in air control suggest initiating event. Lack of ↑total tumors for VC

- treated alone vs. VC + 1.3

- D does not support a promoter role for 1,3

- D

Initiation

- Promotion: Mechanism of Rat Liver Tumors ♂
Fischer 344 rats 45897502 (1998) C&D Unacceptable /non

- guideline 100 mg/kg diethylnitrosamine (DEN, initiator) + 0, 25 mg/kg/da 1,3

- D; 80 mg/kg phenobarbital (PB, promoter); or 5

- 10 mg/kg 2

- acetylaminofluorene (2

- AAF, complete carcinogen) Data do not support a promotional role for 1,3

- D.1,3

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### Page 24 of 30 Summary of Toxicological Doses and Endpoints for 1,3

- D ichloropropene for Use in Human Risk Assessments

Table x.x. Summary of Toxicological Dose and Endpoints for Use in 1,3

- Dichloropropene Dietary Risk Assessments

Exposure/ Scenario Point of Departure Uncertainty/ FQPA Safety
Factors Level of Concern

for Risk Assessment RfD, PAD Study and Toxicological Effects

1,3

- D Combined with Degradates: 3

- Chloroallyl Alcohol and 3

- Chloroacrylic Acid
Acute Dietary Exposure (any Subpopulation) No endpoint attributable to a single exposure was identified.

Chronic Dietary Exposure NOAEL = 2.5

mg/kg/day UF A = 10x

UF H =10x FQPA SF= 1x Chronic PAD =

0.025 mg/kg/day 2

- year combined chronic toxicity/

carcinogenicity study (rat) LOAEL = 12.5 mg/kg/day Decreased body weight gain, increased incidence of basal cell hyperplasia of nonglandular stomach mucosa

Cancer (oral) Classified as “likely to be carcinogenic in humans. Q 1 * = 1.22 x 10 - 1 (mg/kg/day) - 1 2

- Year Combined Chronic/Carcinogenicity study

- Rats Combined forestomach, liver, mammary thyroid, adrenal, urinary, lung tumors, multistage model, 3/4 scaling factor. UF = uncertainty factor. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. RfD = reference dose. PAD = Population Adjusted Dose; UF A = extrapolation from animal to human (interspecies). UF H = potential variation in se nsitivity among members of the human population (intraspecies). NA = Not Applicable

Table 3.3. Summary of Toxicological Dose and Endpoints for Use in 1,3

- Dichloropropene Human Health Inhalation Risk Assessment (Non

- Occupational)

Exposure Scenario Point of Departure Uncertainty/ FQPA Safety Factors HED HECs Study and Toxicological Effects

Acute Inhalation NOAEL = 454 ppm 75.67 ppm
UF H = 10X
UF A = 3X FQPA = 1X acute (4

- hour) inhalation studies (rat)

LOAEL = 583 ppm, based on clinical signs (tremors, convulsions, salivation, lacrimation, diarrhea, lethargy) and decreased body weight (mortality observed at > 647 ppm)

Short

- Term Inhalation (1 to 30 days) NOAEL = 20 ppm

(maternal) 5.0 ppm
UF H = 10
UF A = 3 FQPA = 1X developmental inhalation toxicity study (rabbit )

LOAEL = 30 ppm, based on maternal decreased body weight gains

Intermediate

- term Inhalation (1

- 6 months) NOAEL = 10 ppm 0.205 ppm
UF H = 10X
UF A = 3X FQPA = 1X 13

- week inhalation study (rat)

LOAEL = 30 ppm, based on nasal histopathology

Long

- Term Inhalation (>6 months) NOAEL = 5 ppm 0.182 ppm UF H = 10X
UF A = 3X FQPA = 1X Chronic toxicity/carcinogenicity study (mouse)

LOAEL = 20 ppm, based on nasal histopathology

Cancer (inhalation) Classification: Likely to be carcinogenic to humans Q 1 * = 4 x 10 - 6 (μg/m 3 ) - 1 2

- year inhalation bioassay

– mouse bronchioloalveolar adenomas UF = uncertainty factor; H EC = Human Equivalent Concentration; HED = Human Equivalent Dose; NOAEL = no observed1,3

- Dichloropropene Barcode D410115



### Page 25 of 30 Table 3.3. Summary of Toxicological Dose and Endpoints for Use in 1,3

- Dichloropropene Human Health Inhalation Risk Assessment (Non

- Occupational)

Exposure Scenario Point of Departure Uncertainty/ FQPA Safety Factors HED HECs Study and Toxicological Effects

adverse effect level; LOAEL = lowest observed adverse effect level; UF A = extrapolation from animal to human (interspecies).
UF H = potential variation in sensitivity among members of the human population (intraspecies). NA = Not Applicable

Table 3.4. Summary of Toxicological Dose and Endpoints for Use in 1,3

- Dichloropropene Human Health Inhalation Risk Assessment (Occupational) Exposure Scenario Point of Departure Uncertainty Factors HED HECs Study and Toxicological Effects

Acute NOAEL = 454 ppm 227.0 ppm UF = 30 acute inhalation studies

– rat

LOAEL = 583 ppm, based on clinical signs (tremors, convulsions, salivation, lacrimation, diarrhea, lethargy), decreased body weight (mortality observed at > 647 ppm)

Short

- Term Inhalation (1 to 30 days) NOAEL = 20 ppm (maternal) 15.0 ppm UF = 30 developmental inhalation toxicity study

-

rabbit LOAEL = 30 ppm, based on maternal decreased body weight gains

Intermediate

- Term Inhalation (1 to 6 months) NOAEL = 10 ppm 0.86 ppm UF = 30 13

- week inhalation toxicity

- rat

LOAEL = 30 ppm, based on histopathological lesions in olfactory region of nasal cavity

Long

- Term Inhalation (>6 months) NOAEL = 5 ppm 0.77 ppm UF = 30 Chronic toxicity/carcinogenicity study

-

mice LOAEL = 20 ppm, based on nasal histopathology UF = uncertainty factor; HEC = Human Equivalent Concentration; HED = Human Equivalent Dose; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; NA = Not Applicable,1,3

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### Page 26 of 30 Appendix B: Chemistry

1.0 PHYSICAL/CHEMICAL PROPERTIES CHARACTERIZATION

1.1 Identification of Active Ingredient

Table 2. 1. Test Compound Nomenclature
Compound Structure

Common name cis

- 1,3

- Dichloropropene trans

- 1,3

- Dichloropropene Company experimental name 1,3

- D

IUPAC name (EZ)

- 1,3

- Dichloropropene

CAS name 1,3

- Dichloro

- 1

- propene CAS registry number 542

- 75

- 6

End

- use product (EP) CordonTM, TeloneTM
Compound Structure

Common name cis

- CAAL trans

- CAAL

IUPAC name (EZ)

- 3

- chloroprop

- 2

- en

- 1

- ol CAS registry number 4643

- 05

- 4 4643

- 06

- 5
Compound Structure

Common name cis

- CAAC trans

- CAAC

IUPAC name (EZ)

- 3

- chloroacrylic acid

CAS name 1609

- 93

- 4 2345

- 61

- 1



### 1.2 Physical and Chemical Properties

Table 2. 2. Physicochemical Properties of the Technical Grade Test Compound 1,3

- Dichloropropene.

Parameter Value Reference
Molecular Weight 110.97 g/mol

Boiling point 104 C for cis isomer ; 112.6 C for trans isomer 1,3

- Dichloropropene Reregistration Eligibility Decision Document

(12/1998)

pH The molecule does not contain ionizable groups. It is not an acid or

base.
Density 1.209 g/mL at 25 C 1,3

- Dichloropropene Reregistration Eligibility Decision Document

(12/1 998) Water solubility 2,180 mg/L for cis isomer ; 2,320 mg/L for trans isomer1,3

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### Page 27 of 30 Cis and trans 1,3

- d ichloropropene (MW = 110.97 g/mol) are liquid s with boiling point of 104
and 112.6 C , respectively

. These ha ve high water solubility ( 2 g/ L ) and high vapor pressure ( 34.3 mm Hg for cis isomer and 23.0 mmHg for trans isomer at 2 5 C)

.

Solvent solubility Not available

Vapor pressure 34.3 mm Hg for cis isomer at 25 C; 23.0 mm Hg for trans isomer at 25 C 1,3

- Dichloropropene Reregistration Eligibility Decision Document

(12/1998)
Dissociation constant, pK
a The molecule does not dissociate.

Octanol/water partition coefficient, Log(K OW ) 1,3

- dichloropropene 2.04 trans isomer 2.22 @ 25 o C cis isomer 1.82 @ 20 o C The Pesticide Manual, 11th Ed., 1997.

UV/visible absorption spectrum Not available1,3

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### Page 28 of 30 Appendix C: International Residue Limits



### 1,3

- Dichloropropene (PC Code 029001 )

Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 1 Codex
40 CFR 180. 636 : Tolerances are established for the combined residues of the fungicide cis

- and trans

- 1,3

- dichloropropene and its metabolites cis

- and trans

- 3

- chloroacrylic acid, and cis

- and trans

- 3

- chloroallyl alcohol None None

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg)
US Canada Mexico 1 Codex Grapes 0.018

Completed: M. Negussie; 04/23/2013

1 Mexico adopts US tolerances and/or Codex MRLs for its export purposes

.1,3

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### Page 29 of 30 Appendix D : Data Requirements

Guideline Number: Special Study Study Title: Ambient Air Monitoring Rationale for Requiring the Data The Agency evaluated risks from single sources using monitoring data and modeling techniques that relied on data which represent currently required agricultural practices as well as innovations designed to further reduce emissions . Risks from exposures to ambient 1,3

- D, however, were estimated from monitoring data collected solely in California to represent conditions at a regional and state

- wide level. The California monitoring data are dated (i.e., did not capture emissions tha t result from currently mandated good agricultural practices). The California Air Resources Board (CARB) generated most of the data considered in the Agency's risk assessment for 1,3

- D’s registered uses. Fumigants like 1,3

- D are also widely used in other states such as Florida.

The Agen cy’s risk assessment for 1,3

- D i dentified the uncertainties associated with relying on the CARB data and concluded that it was difficult to determine how the use of the data would either over

- or under

predict actual expos ures for those living in high use areas under currently mandated agricultural practices . The following describes the major factors that lead to this uncertainty:

o The CARB monitoring data was based on cultural practices used in the 2000 to 2001 period whic h does not reflect today’s required practices.

o The CARB monitoring data does not reflect usage in high use regions other than California

, such as
Florida.

o The CARB monitoring data w ere intended to be used to evaluate sub

- chronic/seasonal exposures and

not for evaluating chronic exposure.

The Agency intends to call

- in ambient 1,3

- D studies for representative highest use areas of the US 5

. Representative areas include: Southeast (e.g. Florida/Georgia/Virginia)
Mid

- Atlantic to Upper Mid

- west (e.g., Michigan/Wisconsin) Pacific Northwest (e.g., Idaho/Washington) Southwest (e.g. California/Arizona) The goal is to determine whether exposures in high use areas from ambient levels of 1,3

- D are of concern given the current use patterns and good agricultural practices required on the 2010 amended labels. Criteria that must be considered in selecting the sites include: Areas of highest 1,3

- D use Duration of the season of use for a candidate study area Geographically unique features that could effect ambient concentration levels (e.g. valleys, flat terrain) Weather considerations which may adversely impact ambient exposures Proximity of use to populations Proximity of use to sensitive sites (e.g. schools) Proximity of use to minority populations to address en vironmental justice concerns Logistical access The sampling design must focus on community level exposures in a longitudinal fashion. Monitoring samples should be collected at least twice per week during the use season and once per week during the

5 See HED’s memo, “ Recommendations for Fumigant Data to Refine Exposure Assessments” D353724 for additional information. Specific airsheds to be determined based on consultation with the Agency. At least two airsheds shall be monitored in appropriate use se asons over the course of a 2 year interval. All sites will be defined based on criteria similar to CARB (High areas of use in high seasons of use).1,3

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### Page 30 of 30 non

- us e season for a period of two consecutive years.

Practical Utility of the Data

How will the data be used? The ambient concentrations from high use areas will be used to confirm that exposure to ambient 1,3

- D is below the Agency's level of concern in light of the changes in use patterns required by the 2010 amended labels.

How could the data impact the Agency’s future decision

- making? If the data indicates that risks from ambient exposu re to 1,3

- D are a risk of concern, t he Agency will consider re quiring additional risk mitigation measures (e.g., recapture systems, lowering application
rates, establishing use caps in high use areas, and other emission reduction controls). If data indicates that risks are not a concern, no changes to risk mitigati on measures currently required by EPA would be needed.