UNITE D STATES ENV IRO NMENTAL PROTECTIO N AGENCY

WASHINGTON

, D.C. 20460

MEMORANDUM

D A TE: Sep t ember 1 5

, 2015 OFFICE OF

CHEM I C AL SAFETY AND
POLLUTION PREV ENT IO N

SU BJ ECT: Foramsulfuron: Dr aft H uman Health Risk Assessment in Support of Registration Review.

P C Co d e: 122020
Decision No.: 500058
Petition No.: NA
Risk Assessment T y pe: S in g l e C hemic a l Aggregate
TXRNo.: NA
MRIDNo .: NA DP Barcode: 0425 7 0 2

Re g istr a tion No.: NA
Re g ul atory Action: Regi s tration Review
Case No .: N I A
CAS No.: 173159-57-4
40 CFR: 180.1219

FROM: Karlyn Middleton

, M.S.

, Risk Assessor/Tox i cologist

Za id a Figueroa

, DrPH

, Indu stria l**Hygienist ~**  Michael A. Doherty, Ph.D.

, Chemis t**.** 'A 1 ./
Ri sk Assessment B ranch II**--'~ ~**  H ealth Effect s D iv i sion (7509 P )

THROUGH: Christina Swartz

, Br a nch

## Chief**~~** Ri sk Assess ment Branch II

H ea lth Effec t s Division (7509P)

TO: Jo se Gayoso

, Chemical Re view Manager

Kevin Coste llo

, Branch C hi ef

Risk Management and Impl e mentation B ra nch 

### II (RMIB 11 )

Pe s ticide Re- Eva luation Division (7508P)As part o f r eg istration review, HED has

examined the toxicological and exposure databases for assessing human health risks

associated with foramsulfuron

. Sig n ifican t c h anges r e l a ti ve to t h e la st ri sk assessme nt ( D 32420 l

, K. Bailey

, 2006) include:

I ) The immunotoxicity

, neurotoxicity

, and inhalation toxicit y study requirements

have been waived. 2) HED notes that in accorda n ce w i t h the c rit e ria described in PR Notice 95

- 3,
foramsulfuron may be eligible for reduction of the RE I to 4 hours. The registered

labels for foramsu l furon currently specify a re stricte d e ntry interval (RE I ) of 12
hours.

Pagel of 13Page 2 of 13 Table of Contents

1.0 Executive Summary

................................ ................................ ................................ .. 3
2.0 HED Recommendations

................................ ................................ ............................ 3
3.0 Introduction

................................ ................................ ................................ ............... 4
3.1 Chemica l Identity and Physical/Chemical Characteristics

................................ . 4
3.2 Pesticide Use Pattern and Anticipated Exposure Pathways

................................ 5
3.3 Consideration of Environmental Justice

................................ ............................. 5
4.0 Hazard Identification/Toxicology

................................ ................................ ............. 6 4.1 Summary of Toxicological Effects/Endpoint Selection

................................ ..... 6
4.2 Endocrine Disruptor Screening Program

................................ ............................ 7
5.0 Dietary Exposure

................................ ................................ ................................ ...... 8
6.0 Residential (Non

- Occupational) Exposure/Risk Characterization

........................... 8
6.1 Spray Drift

................................ ................................ ................................ ........... 8
7.0 Aggregate Exposure/Risk Characterization

................................ .............................. 9
8.0 Cumulative Exposure/Risk Characterization

................................ ............................ 9
9.0 Occupational Exposure/ Risk Characterization

................................ ........................ 9
10.0 Public Health and Pesticide Epidemiology Data

................................ ...................... 9
11.0 Literature Refere nces

................................ ................................ .............................. 10
12.0 References

................................ ................................ ................................ ............... 11 Appendix A. Toxicology Data Requirements and Toxicology Profile

.............................. 11 Appendix B. Registered Foramsulfuron Products and Use Patterns

................................ 12 Appendix C. Restricted Entry Interval (REI)

................................ ................................ ... 13Page 3 of 13 1.0 Executive Summary

Foramsulfuron (2

- [[[[(4,6

- dimethoxy

- 2

- pyrimidinyl)amino]carbony]amino]sulfonyl]

- 4

- (formylamino)

- N,N

- dimethylbenzamide) is a sulfonylurea herbicide used as a post

emergent foliar spray. Its mode of action is through inhibition of branched

- chain amin o acid synthesis. Foramsulfuron is registered for post

- emergence use on field corn, sweet corn, popcorn, and also for use on golf course turf, sports fields, commercial lawns, cemeteries, parks, campsites, recreational areas, home lawns, roadsides, school grounds,
and sod farms to contr ol season al grasses and broadleaf weeds

.

A human health scoping document was conducted for foramsulfuron in 2012 ( D 402334

, D

. McNeilly ); the immunotoxicity study was identified as a data gap

. However, the immunotoxicity study requirement has since been waived for the entire class of sulfonylurea chemicals (TXR#0056723). Additionally, HED’s Hazard and Science Policy Council (HASPOC) has waived the inhalation toxicity and neurotoxicity (acute and subchronic) study requirement s for foramsulfuron (TXR# 005 6408 )

. The toxicology
database for foramsulfuron is considered complete and adequate for risk assessment. The
last human health risk assessment was completed in 2006 ( D324201 , K. Bailey) . Since then, no new toxicity , exposure , or residue chemistry data have been received.

Currently, foramsulfuron has an exemption from the requirement of a tolerance (40 CFR § 180.1219). The Health Effects Division (HED) previously determined that the toxicological profile of foramsulfuron support ed a tolerance exemption for food uses because no adverse effects were observed in the submitted toxicological studies regardless of the route of exposure

. The HED Registration Review Team for
foramsulfuron continues to support the tolerance exemption for t his herbicide

. In addition, no quantitative dietary, occupational, residential

, or aggregate exposure assessments are needed for HED to conclude that there are no human health risk concerns
associated with dietary and non

- dietary exposure to foramsulfuron

. The registered labels for foramsulfuron specify a restricted entry interval (REI) of 12 hours based on the acute toxicity of the technical material. However, REIs may be further reduced if certain criteria are met in accordance with the Pesticide Regist ration (PR) Notice 95

- 3 [Reduction of WPS Interim REIs for Certain Low Risk Pesticides] 1 . Foramsulfuron is
consistent with the criteria outlined in PRN 95

- 3 that allow for a 4

- hour REI (see appendix C) . Therefore, HED would recommend for reduction of the REI for
foramsulfuron.

2.0 HED Recommendations

There are no recommendations. However, HED notes that in accordance with the criteria
described in PR Notice 95

- 3, foramsulfuron may be eligible for reduction of the REI to 4
hours

. The registered labels for foramsulfuron currently specify a restricted entry interval (REI) of 12 hours

.

1 Available: http://www.epa.gov/PR_Notices/pr95

- 3.htmlPage 4 of 13 3.0 Introduction

Foramsulfuron is a sulfonylurea herbicide used as a post

- emergent foliar spray. The structure and physical/chemical properties are found in the table in section 3.1.

3.1 Chemical Identity and Physical/Chemical Characteristics

Table 3.1.1

. Foramsulfuron Nomenclature. Compound

Common name Foramsulfuron

IUPAC name 1

- (4,6

- dimethoxypyrimidin

- 2

- yl)

- 3

- [2

- (dimethylcarbamoyl)

- 5

- formamidophenylsulfonyl]urea

CAS name 2

- [[[[(4,6

- dimethoxy

- 2

- pyrimidinyl)amino]carbonyl]amino]sulfonyl]

- 4

- (formylamino)

- N,N

- dimethylbenzamide

CAS # 173159

- 57

- 4

End

- use product/EP 35% a.i. WDG

Table 3.1.2. Physicochemical Properties of Technical

- Grade Foramsulfuron

. Parameter Value Reference Molecular weight (g/mole) 452.5 From molecular
formula Melting point/range (°C) 202 EPA Fact Sheet pH 4.5 (1% dilution in distilled water) EPA Fact Sheet

Density (g/cm 3 ) 1.44 g/cm 3 at 20°C EPA Fact Sheet Water solubility ( g/L at 20 °C) 3.29 g/L EPA Fact Sheet Solvent solubility (g/L at 20 °C) 1.9 g/L (Acetone) 0.36 (Ethyl Acetate) 0.01 (Heptane) 1.66 (Methanol) Pesticide Properties Database, University of Hertfordshire, UK

Vapor pressure at 20 °C (Pa) 4.2x10

- 11 EPA Fact Sheet Dissociation constant (pK
a ) Octanol/water partition coefficient Log(K OW ) 4.01 EPA Fact SheetPage 5 of 13 3.2 Pesticide Use Pattern and Anticipated Exposure Pathways

Foramsulfuron is registered for post

- emergence use on field corn, sweet corn, popcorn, and also for use on golf course turf, sports fields, commercial lawns, cemeteries, parks, campsites, recreational areas, home lawns, roadsides, school grounds, and sod f arms to control season al grasses and broadleaf weeds. The registered product formulations include three water dispersible granules (WDG) and a suspension concentrate (SC). The percentage of active ingredient ranges from 19.8 to 35.0% in WDG formulations. The SC formulation contains 0.19 lbs ai/gal ( Appendix C ). Foramsulfuron is labeled for ground

, aerial

, and handheld applications ; it is not labeled for application via chemigation
systems.

Bas ed on the use patterns (i.e., 2 applications per season), the duration of exposure for occupational workers from the registered uses is expected to be short

- term (1 to 30 days)
and intermediate

- term (1 to 6 months) in duration. Short

- term exposures are expected
f rom the products registe red in residential settings

. Long

- term exposure is not anticipated

.

The Personal Protective Equipment (PPE) statement on the registered labels require
workers to wear a long

- sleeved shirt, long pants, shoes with socks, and gloves . The restricted entry interval (REI) on all the registered labels is 12 hours

.

Exposure Pathways

Individuals may be exposed to foramsulfuron via their diet (food and drinking water). In addition, dermal and inhalation exposures are possible for both residential and occupati onal handlers. Post

- application exposure is possible for those who re

- enter treated areas, including incidental oral (hand

- to

- mouth) and dermal post

- application exposures for children playing on treated turf and workers entering treated fields

. Moreover, there is the potential for indirect exposure to foramsulfuron related to spray drift. However, there are no risk concerns associated with these exposures, based on the lack of adverse effects in the toxicity database.

3.3 Consideration of Environmental Justice

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 Populatio ns and Low

Income Populations," ( http://epa.gov/compliance/ej/resources/policy/exec_order_12898.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 subgroups 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. Extensiv e data on food consumption patterns are compiled by the U.S. Department of Agriculture (USDA) under the NationalPage 6 of 13 Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003

- 2008) and are used in pesticide risk assessments for all

r egistered food uses of a pesticide. These data are analyzed and categorized by subgroups based on age and ethnic group. 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 based on home use of pestic ide 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 committed resources and expert ise 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.

4.0 Hazard Identification/Toxicology

The toxicology database for foramsulfuron is complete. The immunotoxicity study requirement (TXR#0056723) , as well as the inhalation toxicity and neurotoxicity (acute and subchronic) study requirements for foramsulfuron (TXR#0056408) have been waived by HED’s HASPOC . Since the l ast risk assessment and scoping document were done , no new toxicity data have been received.

4.1 Summary of Toxicological Effects /Endpoint Selection

No treatment

- related effects were seen in subchronic or chronic oral, or dermal toxicity
studies with foramsulfuron. No treatment

- related effects were seen in rat or rabbit developmental toxicity studies or a rat reproduction study. All toxicity studies were conducted with doses up to the limit dose (1000 mg/kg/day) , with the exception of th e developmental rabbit study ( high dose = 500 mg/kg/day ) . T here was no evidence of carcinogenicity in cancer studies with rats or mice and there is no concern for mutagenicity. In rats, foramsulfuron is primarily excreted in feces as parent compound
with in three days of oral dosing.

Acute lethality studies conducted with foramsulfuron indicate that it has low acute toxicity via the oral, dermal, and inhalation routes of exposure ( Toxicity Categories III or IV)

. It is mildly irritating to the eyes ( Toxicity Category IV) and not a dermal irritant or
sensitizer.

D ue to the absence of toxicity in the toxicology studies, endpoints and p oints of d eparture (POD s ) were not selected for assessing risks ( dietary, incidental oral, dermal, and
inhalation )

.Page 7 of 13 4.2 Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies 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, orga n weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex 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 foramsulfuron, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. Howeve r, as required by FFDCA section 408(p ),
foramsulfuron is subject to the endocrine screening part of the Endocrine Disruptor 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 estrogen, 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 est rogen, 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 whic h, 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 between 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 pesticide active ingredients and 9 in ert ingredients. A
second list of che micals identified for EDSP screening was published on June 14, 2013 2 and includes some pesticides s che duled for Registration Review and che micals found in

water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the list s of
che micals, 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/Page 8 of 13 5.0 Dietary Exposure

The toxicological profile of foramsulfuron supports a tolerance exemption, since no adverse effects were observed in the submitted toxicological studies at any dose regardless of the route of exposure

. A tolerance exemption was previously establ ished under 40 CFR §180.1219 for use on field corn, popcorn, and sweet corn

. Based on the very low toxicity of foramsulfuron described above, HED con tinues to conclude that quantitative dietary exposure assessments are not needed, and that there is a reas onable certainty that no harm will result to the general population, to infants and children or any other population subgroup from dietary (food and water) exposure.

6.0 Residential (Non

- Occupational) Exposure/Risk Characterization

Foramsulfuron is regis tered for controlling broadleaf weeds in lawns and other turf areas in residential settings

. Even though both registered residential products are intended for professional and commercial applicators, they are not labeled as restricted

- use products,
and ho meowners may purchase and use these products on residential lawns, resulting in the potential for residential handler exposure

. However, a quantitative handler exposure

assessment is not necessary due to the absence of endpoints and PODs for residential dermal and inhalation routes of exposure

.

Post

- application exposures are also expected for adults and children following use of
foramsulfuron on residential sites

. These exposures include dermal exposures for adults and children, and incidental oral ( i .e., hand

- to

- mouth, objects

- to

- mouth, and soil ingestion) exposure for children

. In conjunction with the 2007 Part 158 Data Requirements, HED typically requires submission of a turf transferable residue (TTR) study to determine exposure and risk associated with children playing on treated turf

. However, HED has reasonable certainty that no harm will result from this exposure since there is no toxicity associated with the dermal or oral routes of exposure to
foramsulfuron . As a result, HED has concluded th at a TTR study is not needed.

There are no residential handler and/or post

- application risks of concern associated with residential uses of foramsulfuron, based on the absence of endpoints and doses for residential dermal and inhalation routes of exposure.

6.1 Spray Drift

Spray drift is a potential source of exposure to those nearby pesticide applications. This is particularly the case with aerial application, but , to a lesser extent, spray drift can also be a potential source of exposure from the ground application methods employed for foramsulfuron. However, f or the reasons discussed under Residential Exposure/Risk
Characterization (section 6.0) , there are no ri sks of concern associated with potential spray drift exposure to foramsulfuron.Page 9 of 13 7.0 Aggregate Exposure/Risk Characterization

Aggregate risk is determined from the combined exposure from dietary and residential sources and relevant endpoints for risk assessment

. In the case of foramsulfuron, aggregate exposure is not of concern based on the lack of toxicity for any exposure route
or duration at levels relevant to assessing human health risks

.

8.0 Cumulative Exposure/Risk Characterization

In 2015, E PA’s Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis [http://www.epa.gov/oppfead1/cb/csb_page/updates/2015/framework

- for

- screening

analysis.html]. This document pro vides guidance on how to screen groups of pesticides for cumulative evaluation using a two

- step approach beginning with the evaluation of available toxicological information and if necessary, followed by a risk

- based screening approach. This framework sup plements the existing guidance documents for establishing common mechanism groups (CMGs) 4 and conducting cumulative risk assessments (CRA) 5

. The Agency has utilized this framework to evaluate the SUs of which orthosulfamuron is a member (J. D’Agostino; D42 8798; 9/9/15). Although the SUs share some chemical and toxicological characteristics, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further mechanistic data are required and no further cumulative evaluation is necessary.

9.0 Occupational Exposure / Risk Characterization

Use of foramsulfuron for weed control in agricultural, residential, commercial/industrial, and public areas will result in occupational handler and post

- application exposures

. However, t here are no occupational handler or post

- application risks of concern associated with agricultural and non

- agricultural uses of foramsulfuron based on the lack of toxicity for any exposure route or duration at levels relevant to assessing human health
risks

. Due to the low toxicity of foramsulfuron, the label specified PPE (i.e., long

sleeved shirt, long pants, shoes with socks, and gloves ) is expected to provide adequate protection for handlers

. Post

- application exposures also are not of concern; workers may

re

- enter treated areas after the labeled Restricted Entry Interval (REI) of 12 hours based on the acute toxicity of foramsulfuron

.

10 .0 Public Health and Pesticide Epidemiology Data

For this evaluation, the OPP Incident Da ta System (IDS) was utilized to retrieve pesticide incident data ( D403611 0 ). The purpose of the database search is to identify potential

4 Guidance For Identifying Pesticide Chemicals and Other Substances that have a Common Mechanism of Toxicity (USEPA, 1999)

5 Guidanc e on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity (USEPA, 2002)Page 10 of 13 patterns in the frequency and severity of the health effects attributed to foramsulfuron

exposure. IDS records inciden ts resulting in higher severity outcomes in more detail, in a module called the Main IDS module. This system stores incident data for death, major and moderate incidents, and it includes more details about the location, date and nature of
the incident. M ain IDS incidents involving only one pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide. The less severe human incidents (minor, unknown, or no effects outcomes) are reported by registra nts as counts called aggregate summaries and are recorded in a separate module called Aggregate IDS.

In Aggregate IDS (minor, unknown, or no effects outcomes) , from January 1, 2007 to June 13, 2012, there were 3 reported incidents involving foramsulfuron

.

For the Main IDS, from January 1, 2007 to June 13, 2012, there were 2 incidents reported
for the single chemical only in the database and 1 additional incident reported involving
more than one chemical. These incidents were classified as moderate severity. Overall, there are few incidents involving foramsulfuron reported to IDS.

The AHS is a high quality

, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS inclu des private
and commercial pesticide applicators and their spouses . If there are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase of the p rocess and, if appropriate, fully reviewed in the risk assessment phase of the process

. The AHS includes information on use of 50 different pesticide active ingredients commonly used in agriculture. Foramsulfuron is not included in the AHS, and therefore this study does not provide information for this document.

Based on the low frequency and severity of the incident cases reported for foramsulfuron, there does not appear to be a concern at this time that would warrant further investigation.

11

. 0 Litera ture References

A literature search was performed for foramsulfuron

. The search did not reveal information that would impact the current risk assessment

.Page 11 of 13 12. 0 References

Author Barcode Date Title K. Rury TXR#0056723 6/06/2013 Sulfonylureas: Summary of Hazard and Science Policy Council (HASPOC) Meeting on July 18, 2013: Recommendations on Data Requirement for Immunotoxicity Studies for Sulfonylurea Pesticides D. McNeilly D 402334 11/08/2012 Foramsulfuron: Human Health Assessment Scoping

Document in Support of Registration Review

S. Recore D403611 7/19/2012 Foramsulfuron : Review of Human Incidents K. Rury TXR#0056408 6/08/2012 Foramsulfuron: Summary of Hazard and Science Policy Council (HASPOC) Meeting on July 19th, 2012: Recommendations on data requirements for immunotoxicity, acute and subchronic neurotoxicity,
and subchronic inhalation studies K. Bailey D390069 12/20/2006 Human Health Risk Assessment for the Proposed uses in/on Sweet
Corn and Popcorn.

Appendix A. Toxicology Data Requirements and Toxicology Profile

A.1

. Toxicology Requirements

The toxicology requirements (40 CFR 158.340) for foramsulfuron are presented below.

Test 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 21/28

- Day Dermal

................................ ........................ 870.3465 21/28

- Day Inhalation

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

no yes
yes
yes

no *

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)

................................ .................. 870.4300 Chronic/Oncogenicity

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

870.5100 Mutagenicity

— Gene Mutation

- bacterial

.................... 870.5375 Mutagenicity

— Structural Chromosomal Aberrations

.. 870.5395 Mutagenicity

— Other Genotoxic Effects

...................... yes
yes
yes yes
yes
yesPage 12 of 13 Test Technical

Required Satisfied

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

no ---

--- Not required * Not required *

---
870.7485 General Metabolism

................................ ..................... 870.7800 Immunotoxicity yes
yes yes Not required *

* The Hazard and Science Policy Council (HASPOC) determined that these studies are not required.

A.2. Toxicity Profiles

Toxicity profiles are not presented since no treatment related effects were seen in any of the available toxicity studies up to the limit dose tested. Also, the available mutagenicity studies were all negative.

Appendix B

. Registered Foramsulfuron Products and Use Patterns

Table B.1 . Use Patterns of End

- use Product Formulations of Foramsulfuron.

EPA Reg. No. & (Formulation types) % AI Use sites Application method/Comments

264

- 685 (WDG) 35.0 Field, sweet and pop corn Air and ground broadcast spray, 2 applications per year. A RTI was not specified. Maximum application rate is
0.038 lbs ai/A.

264

- 688 99.1 Field, sweet and pop corn, golf course turf, sports fields, commercial lawns, cemeteries, parks, campsites, recreation areas, home lawns, roadsides, school grounds, and sod farms. NA [Technical Active Ingredient]

432

- 1266 (SC) 2.34 (0.19 lbs

ai/gal) Commercial and residential turf Ground broadcast and spot treatments; 2 applications at 14

- 21 day interval. Maximum single application rate is 0.052
lbs ai/A.

432

- 1519 (WDG) 19.8 Commercial and residential turf Ground broadcast and spot treatments; 2 applications per year at 14

- 21 day interval. No interval specified for the spot treatment

use. 432

- 1533 (WDG) 24 Many non

- crop sites... Ground broa dcast and spot treatments; Abbreviations used: AI = active ingredient, NA = not applicable, RTI = re

- treatment interval: SC=soluble concentrate, WDG = water dispersible granule or dry flowable (DF).Page 13 of 13 Appendix C. Restricted Entry Interval (REI)

Based on the acute toxicity categories and post

- application assessment for foramsulfuron the Worker Protection Standard (WPS) Interim Restr icted Entry Interval (REI) for
foramsulfuron is 12

- hours. REIs may be further reduced if certain criteria are met in accordance with the Pesticide Registration (PR) Notice 95

- 3 [Reduction of WPS Interim REIs for Certain Low Risk Pesticides] 6 . In PR Notic e 95

- 3, there are a set of criteria listed for the active ingredient that must be met for chemicals to be eligible for a reduced
REI. These criteria include:

1. The active ingredient is in Toxicity category III or IV based upon data for acute
dermal toxicit y, acute inhalation toxicity, primary skin irritation, and primary eye irritation. Acute oral toxicity data were used if no acute dermal data were available. If EPA lacked data on primary skin irritation, acute inhalation, or primary eye irritation of the active ingredient, the Agency reviewed data on that
end

- point for similar active ingredients (analogs), and excluded such active ingredients from consideration for the reduced REI, if the analog is in Toxicity Category I or II for that endpoint.
2. The active ingredient is not a dermal sensitizer (or in the case of biochemical and microbial active ingredients, no known reports of hypersensitivity exist).
3. The active ingredient is not a cholinesterase inhibitor (NMethyl carbamate and Organophosphate) as these ch emicals are known to cause large numbers of pesticide poisonings and have the potential for serious neurological effects.
4. No known reproductive, developmental, carcinogenic, or neurotoxic effects have been associated with the active ingredient. If active i ngredients did not have data available for these chronic health effects, EPA considered data on appropriate chemical and biological analogs. Active ingredients that have been classified as carcinogenic in Category B (probable human carcinogen) or Category C with a potency factor, Q* (possible human carcinogen, for which quantification of potential risk is considered appropriate), or are scheduled for the Health Effects Division's Cancer Peer Review process, were omitted from consideration.
5. EPA does not poss ess incident information (illness or injury reports) that are ``definitely'' or ``probably'' related to post

- application exposures to the active ingredient.

Upon review of the criteria for the active ingredient only , it appears that foramsulfuron is
consistent with the criteria in PRN 95

- 3 that allow for a 4

- hour REI. Note: The PR Notice also includes similar criteria for the end

- use product. These criteria have not been evaluated by HED. Based solely on the activ e ingredient criteria, HED would
recommend for reduction of the REI for foramsulfuron.

6 Available: http://www.epa.gov/PR_Notices/pr95

- 3.html