### Clopyralid Registration Review Human Health Scoping Document D416096

Page 2 of 32 Executive Summary

The Health Effects Division (HED) Clopyralid Registration Review Team has evaluated the status of the human health risk assessment for clopyralid to determine the scope of work necessary to supp ort Registration Review

. This scoping exercise is based primarily on the most recent ly complete d human health risk assessment (Dotson et al

. 6 June 2012, D391397) to support uses on apples, teff, Brassica leafy greens, and rapeseed

.

Based on the current ly registered uses, exposures to clopyralid can be expected to occur via the dietary (food and drinking water), occupational (handler and post

- application), and residential (handler and post

- application) exposure pathways through oral, dermal, and /o r inhalation routes of exposure.

Clopyralid is a n herbicide belonging to both the picolinic acid and pyridine chemical group s

. It is used to control broadleaf weeds

. It is structurally similar to plant auxins and acts as an “auxin imitator,” disrupting plant growth by binding to auxin receptors

. Clopyralid is registered for use on a variety of food / feed crops and on turf in the U.S. for the postemergen ce control of broadleaf weed s , particularly thistles and clover. The mammalian mode of action is unkno wn.
The toxicology database for clopyralid is considered complete and no additional studies are required

. Endpoints have been selected for assessing chronic dietary exposure, inhalation exposure, and incidental oral exposure

. An endpoint for assessing a single oral exposure was not identified and an acute reference dose ( RfD ) was not selected

. The available toxicology studies did not indicate the potential for neurotoxicity, immunotoxicity, or reproductive toxicity, and there is no evidence of increased qualitative or quantitative susceptibility of fetuses or offspring in developmental and reproduction studies

. Additionally, the e xposure estimates were based on conservative assumptions

. Therefore, HED reduced the required 10x Food Quality Protection Ac t (FQPA) Safety Factor to 1x

. C lopyralid is c lassified as “not likely to be carcinogenic to humans.” During registration review, no major changes are expected for the toxicology database, endpoint and dose selection or uncertainty factors.

T he residue chemistry database is complete ; t he metabolism of clopyralid in crops and livestock is adequately understood and the tolerances are supported by adequate data

. A dequate enforcement method s are available for crop and livestock commodities

. The tol erance expression [40 CFR 180.431] is in accord with current policy , containing coverage and compliance statements, and does not need to be revised during registration review . U.S. tolerances are generally harmonized with Canadian MRLs, with the exception of livestock commodities and a few crops

. Harmonization may be possible during registration review

. There

are no new residue chemistry data needed to support dietary exposure assessment for clopyralid. HED expects to co mplete a new dietary exposure ass essment during registration review in order to address new EDWCs

. The residential exposure database is complete ; registered residential uses have been assessed in accordance with the updated (2012) Residential SOPs, and there were no risks of concern. A dditional work to assess residential exposure and risk is not expected under registration review

.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 3 of 32 Provided there are no changes to the residue estimates for drinking water, a n updated aggregate risk assessment is not likely to be required to support reg istration review

. The occupational exposure database is complete

. Additional work to assess occupational exposure and risk is not expected under registration review

. Product labels which contain the monoethanolamine salt of clopyralid acid specify a r estricted

entry interval (REI) of 12 hours. However, the acid form of clopyralid is classified as Toxicity Category I for eye irritation. Therefore, all products containing the acid form of clopyralid should, according to the Worker Protection Standard g uidelines, have an REI of 48 hours. HED recommends that PRD ensure that the appropriate REI is provided on product labels.

Introduction

HED has evaluated the most recent complete human health risk assessment for clopyralid conducted in 2012 , as well as older evaluations

, to determine any outstanding data requirements or additional data required to complete registration review for this herbicide

. HED has also

c o nsidered updates to its toxicity, exposure and usage databases, and the latest Agency science policy and risk assessment methodologies.

Clopyralid is a pyridinoxy acid herbicide registered for use on a variety of field, fruit, and vegetable crops in agricultural settings

. For non

- crop uses, clopyralid is registered for application to pastures and rangeland, rights

- of

- way, forestry sites, tree plantations, ornamental grasses in landscapes and nurseries, and nonresidential turf grass (including golf courses and recreational areas)

. Clopyralid is not registered for use on residential turf/lawns

. Re gistered formulations containing clopyralid as an active ingredient include liquids, granules, and water

dispersible granules

. In those formulations, clopyralid may be in the form of organic (e.g., monoethanolamine, triethanolamine) or inorganic (e.g., potassium) salts.

Information on the chemical identi t y of clopyralid is included in Attachment 1

.

Hazard Identification/ Toxicology

The toxicology database for clopyralid is considered complete

. Available studies include a 21

- day dermal toxicity study in the rabbit and the following oral studies: a subchronic toxicity in the mouse, chronic toxicity in the dog, chronic toxicity/carcinogenicity in the rat, carcinogenicity in the mouse, prenatal toxicity in the rat and rabbi t, reproductive toxicity in the rat, metabolism in the rat, and immunotoxicity in the rat

. In addition, there is a complete battery of genotoxicity studies

. Subchronic studies for rats and dogs are not available; however, requirements for these studies w ere satisfied by the chronic toxicity studies

. Acute and subchronic neurotoxicity studies in the rat are not available ; h owever, HED’s Hazard and Science Policy Council (HASPOC) concluded that these studies are not required based on the lack of evidence o f neurotoxicity in the available studies conducted with clopyralid as well as with other structurally related compounds (TXR#0056270)

. In addition, based on similar weight of evidence considerations, a developmental neurotoxicity study is not required for clopyralid. HASPOC also determined that

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 4 of 32 a 28

- day inhalation toxicity study in the rat (§870.3465) is not required

. Although there are data to indicate potential irritation portal of entry effects fo r the respiratory tract ( based on gastric lesions in some oral studies and severe primary eye irritation), the current MOEs are high

, and

are more than 100

- fold higher than the level of concern for all residential scenarios and all but one occupational exp osure scenario

. Additionally, clopyralid has low volatility, low acute inhalation toxicity, and the points of departure selected from oral studies are sufficiently conservative to allow for uncertainties associated with route

- to

- route extrapolation for in halation risk assessment

. Toxicity was observed in the rat and dog following chronic exposure, but consistent target organs were not identified

. In a one

- year dog study, reductions in red blood cell parameters, increased liver weight (males), and vacuola ted adrenal cortical cells (females) were reported

. Skin lesions and clinical chemistry changes (decreased serum glucose, protein, albumin) were observed at the highest dose

. In the rat, epithelial hyperplasia and thickening of the limiting ridge of the stomach were observed at the LOAEL, and decreased body weight was observed at the highest dose

. Only decreased body weight/weight gain and food efficiency in males were observed in the mouse carcinogenicity study at doses exceeding the limit dose

. Subchr onic data were available only for the mouse, where decreased body weight was observed in a 90

- day oral study in males and females at dietary levels exceeding the limit dose (1000 mg/kg/day)

. No systemic toxicity was observed in rabbits following dermal ex posure up to the limit dose for 21 days

. A rat immunotoxicity study showed no treatment

- related effects on the immune system, and immunotoxicity was also not observed in other studies

. There was no indication of increased qualitative or quantitative pr e

- and/or postnatal susceptibility

. No developmental toxicity was observed in the rat at doses that caused maternal mortality and decreased maternal body weight gain

. Decreased fetal body weight and hydrocephalus were observed in the rabbit but only at a dose that caused significant maternal toxicity including mortality, clinical signs of toxicity, decreased body weight gain, and gastric mucosal lesions

. Reproductive toxicity was not observed in the rat, but mean pup weights (Day 28) were reduced, and re lative liver weights were increased at doses that caused parental toxicity (decreased body weight/weight gain and food consumption; gastric lesions).

There were no direct clinical or histopathological indications of neurotoxicity in the available studies at doses up to or exceeding the limit dose

. Hydrocephalus was observed in the young in the rabbit developmental study in the presence of significant maternal toxicity, including a high rate of mortality

. However, no indications of neurotoxicity were obse rved in maternal animals at the same dose, in other species, or in studies on other structurally related chemicals

. Therefore,
acute , subchronic , and developmental neurotoxicity studies in the rat are not required based on lack of evidence of neurotoxicity for clopyralid and related chemicals

. Clopyralid is classified as “not likely to be carcinogenic to humans.” No evidence of carcinogenicity was observed in ra t and mouse 2

- year bioassays at doses exceeding the limit dose

. No positive findings for mutagenicity or clastogenicity were observed in a battery of mutagenicity studies

. An acceptable metabolism stud y in rats indicated c lopyralid was essentially comple tely absorbed at both low and high doses , with no significant differences in metaboli sm between males and females

, or between dose groups

. Excretion was primarily via

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 5 of 32 the urine , an d no r adioactivity was retained in tissues

. There was no evidence of metab olism; only parent compound was identified in the urine and feces.

The acute toxicity of clopyralid is low (Toxicity Category III or IV) via oral, inhalation and dermal exposure, and it is not a dermal irritant or sensitizer

. However, in its acid form,

c lopyralid is a severe eye irritant (Category I).

Based on the existing use patterns and the submitted toxicology studies, HED selected endpoints for assessment of human health risk for chronic dietary exposure, residential incidental oral exposure, and oc cupational and residential inhalation exposure

. For acute dietary exposure, an endpoint resulting from a single exposure was not identified

. As a result, an aRfD was not determined

. The finding of hydrocephalus in the young in the rabbit developmental study was not considered to be an appropriate endpoint because it was observed only at the highest dose tested in the presence of severe maternal toxicity, including a high rate of mortality

. For chronic dietary exposure, the NOAEL of 15 mg/kg/day from th e rat chronic toxicity/carcinogenicity study was selected, based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes at the LOAEL of 150 mg/kg/day

. For short

- term incidental oral exposure as well as short

- term inhalation exposure , the maternal toxicity NOAEL of 75 mg/kg/day from the rat developmental toxicity study was selected based on mortality, decreased maternal body weight gain, and decreased food consumption at the LOAEL of 250 mg/kg/day

.

For interm ediate

- term inhalation exposure, the NOAEL of 15 mg/kg/day from the rat dietary chronic toxicity/carcinogenicity study was selected based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes at the LOAEL of 150 mg/kg/day

. Although it is of chronic duration, it was selected to be protective of gastric irritation that might result from oral exposure of intermediate duration , and is considered to be a conservative endpoint for this exposure scenario.

Quantific ation of dermal risk is not required due to lack of dermal or systemic toxicity following repeated dermal applications at the Limit Dose (1000 mg/kg/day) in a 21

- day dermal toxicity study and there are no developmental or reproductive concerns.

Conclusion s for Hazard Identification/Toxicology

The toxicology database for clopyralid is c omplete and there are no additional studies required

. In the absence of additional data, HED does not anticipate revising the regulatory endpoints, points of departure (PoDs) and uncertainty factors/safety factors (UF/SFs) during registration review

. Residue Chemistry and Dietary Exposure

The residue chemistry database for clopyralid is complete and adequate to support dietary exposure and risk assessment based on exposure through food and drinking water.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 6 of 32 The nature of the residue in plants and livestock is adequately understood

. P arent compound is the only major residue in plants; i n livestock, the major residues are the parent clopyralid and its glycine conjugat e (3,6

- DCPA

- glycine)

. The residue definition for enforcement for plants and liv e stock is clopyralid. For risk assessment, the residue definitions are clopyralid in plants and combined residues of clopyralid and 3,6

- DCPA

- glycine (expressed as clopyralid) in livestock.

Adequate analytical method s for enforcing tolerance s in plant and livestock matrices are available

. The FDA multiresidue methods are not likely to recover clopyralid ; however, it does appear to be adequately recovered by the “QuEChERS” multiresidue method (http://www.quechers.com).

Field trial data generated using acceptable data collection methods and supported by adequate storage stability data are available for all registered crops

. Adequate processing studies are available

. Adequa te livestock feeding studies have been submitted for clopyralid

. Tolerances in crops and livestock range from 0.05 to 500 ppm and are based on quantifiable residues.

A drinking water assessment ( D391398, W

. Shaughnessy, 19 December 2011 ) was conducted by the Environmental Fate and Effects Division (EFED) for clopyralid

. EFED has determined that the most recent drinking water assessment does not reflect the highest use rate for clopyralid; therefore, new EDWCs will be provided during registration review

. The most recent dietary risk estimates for clopyralid are below HED’s level of concern (D399390, D

. Dotson, 6 June 2012)

. There is no acute dietary endpoint for clopyralid; therefore, acute dietary risk is not a concern for this chemical

. A chronic diet ary (food + drinking water) exposure and risk assessment was conducted for clopyralid using the Dietary Exposure Evaluation Model DEEM

- FCIDTM, Version 2.03 which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994

- 1996 and 1998

. The assessment is highly conservative because it is based on tolerance

- level residues and the assumption of 100% crop treated for all included commodities

. DEEM Version 7.81 default processing factors were used for all processed commodities for which they were available

. Clopyralid is c lassified as “ n ot likely to be carcinogenic to humans

. ” As a result, cancer risk is not an issue for this chemical

. The most recent dietary risk estimates for c lopyralid were below HED’s level of concern for all population subgroups (maximum risk estimate was 25% cPAD for children 1

- 2 years old). As noted above, EFED will be providing HED with new EDWCs for clopyralid; therefore, HED will conduct a new dietary a ssessment during registration review

. Conclusions for Residue Chemistry/Dietary Exposure and Risk

The residue chemistry database is complete and adequate for the purpose of tolerance

- setting and dietary risk assessment

. HED expects to conduct a new diet ary risk assessment with up

- to

- date EDWCs during registration review; additional work related to residue chemistry is not expected.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 7 of 32 Residential Exposure and Risk

Handler Exposure C lopyralid and its associated salts are registered for use on non

- residential turf, golf courses, athletic and recreational fields, ornamentals grasses, and landscapes

. Since clopyralid is not a restricted

- use pesticide, HED conducted a residential handler exposure assessment to be protective of potential homeowner exposure and for the purpose of conducting an aggregate risk
assessment

. The primary source of information used to evaluate residential handler exposure was the most recent clopyralid residential exposure assessment (D391748, S

. Oonnithan, 30 April 2012 )

. This review assessed residential handler short

- term inhalation exposure resulting from use of hand

held equipment (i.e., hose

- end, back

- pack, manually pressurized handwand sprayers and push

type spreader) for both liquid and granular formulations using the 2012 Residential Standard Operating Procedures (SOPs)

. Residential handler MOEs ranged from 340,000 to 24,000,000 and are not of concern.

It should be noted that the product (Reg

. No

. 62719

- 263) assessed for the granular formulation mentioned abov e was cancelled on September 12, 2012

. HED performed a preliminary screen of several other granular lawn products containing clopyralid to determine whether there were additional products that could result in higher risks of concern

. These granular produ cts (Conditional Reg

. Nos

. 228

- 343, 961

- 390, and 961

- 39) all have lower application rates than the assessed product

. Therefore risk estimates for those products would be less than the risks presented in the 2012 assessment

.

Post

- application Exposure A post

- application incidental oral exposure assessment for children playing on treated lawns was conducted for both liquid and granular formulations

. Quantitative dermal and inhalation post

application exposure and risk assessments were not conducted in th e previous assessment due to the lack of hazard via the dermal and inhalation routes

. Post

- application MOEs ranged from 10,000 to 4,600,000 and are not of concern.

In accordance with the updated Part 158 data requirements (2007), a turf transferrable res idue (TTR) study is required for all residential or occupational turf uses (e.g., sod farms, golf courses, parks, and recreational areas). However, a TTR study is not required for clopyralid at this time because post

- application incidental oral exposure c alculated previously resulted in MOEs at least 10 times higher than the level of concern (e.g., an MOE> 1,000 if the LOC = 100); therefore, using the default residue transfer values should provide an adequate margin of safety for any potentially higher res idues seen in a chemical

- specific TTR study.

Spray Drift and Vol atilization Residential exposures resulting from off

- site transport (e.g., spray drift or volatilization) might occur as a result of applications of clopyralid

. The Agency is in the process of evaluating these types of exposures and might, as appropriate, develop policies and procedures to identify the need for and, subsequently, the way to incorporate these post

- application exposures into the

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 8 of 32 Agency’s risk assessments

. The need for spray dr ift and volatilization risk assessment for clopyralid will be examined during registration review.

Conclusions for Residential Exposure and Risk

All residential risk estimates are in accord with current policies and practices for residential
assessment

. The risk estimates are below HED’s level of concern and no additional residential exposure and risk assessments are anticipated during registration review.

Aggregate Risk Assessment

The most recently completed aggregate risk assessment was conducted i n connection with requested new uses on apples, teff, Brassica leafy greens, and rapeseed

. Aggregate risk estimates, which included exposure from food, drinking water, and recreational turf grass sources, were below HED’s level of concern for all groups a nd exposure durations

. HED will be conducting a new dietary assessment during registration review to address updated EDWCs for clopyralid. Depending on the results of that assessment relative to current dietary exposure estimates, HED may need to conduct an updated aggregate risk assessment to support registration review.

Occupational E xpos ur e
Occupational and commercial handler assessments are based only on inhalation exposures

, because clopyralid does not cause systemic toxicity via the dermal route

. The primary source of information used to evaluate occupational handler and post

- application exposure was the most recent clopyralid occupational exposure assessment (D391748, S

. Oonnithan, 30 April 2012)

. Occupational Handler Exposure The registrant has not submitted chemical

- specific exposure data to estimate handler exposures

. In the absence of chemical

- specific data, i t is HED policy to use the best available data to assess handler exposure s

. Sources of such generic (surrogate) handler data incl ude the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1) and the Agricultural Handler Exposure Task Force (AHETF) database, or other registrant

- submitted occupational exposure studies

. Some of these data are proprietary (e.g., AHETF data) and s ubject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA )

. The standard values recommended for use in predicting handler exposure that are used in this assessment, known as “unit exposures

, ” are outlined i n the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 1



### . ” That table , along with additional information on the HED policy addressing the use of surrogate data, including descriptions of the various sources, can be found at the Agency website 2



### . End use products containing clopyralid and its associated salts are formulated as liquids, granules, and water dispersible granules (WDG)

. They may be applied as a broadcast foliar or soil directed spray by ground, aerial, hand held equipmen t, granular spreader and/or tree

1 Available: http://www.epa.gov/opp00001/science/handler

- exposure

- table.pdf
2 Available: http://www.epa.gov/pestici des/science/handler

- exposure

- data.html

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 9 of 32 injection

. The 2012 occupational exposure review assessed occupational and commercial handler short

- and intermediate

- term inhalation exposure resulting from the use of one product formulated as an emulsifiable concentrate (EC) applied by ground and hand

- held equipment only

. These scenarios incorporate revised unit

- exposure values and body weights, and resulted in risk estimates which were not of concern at baseline level of personal protective equipment (PPE) consisting of long

- sleeved shirt, long pants, socks and shoes

. However, the EC formulation is not repr esentative of the worst

- case scenario for exposure

. Therefore, HED performed a preliminary screen of several WDG products (Reg

. Nos

. 62719

- 315 and 352

- 593) containing clopyralid and its associated salts with the same application rate as the EC formulation product assessed in 2012, using the most current unit exposure and body weight estimates

. Although the WDG inhalation post

- application exposure risk estim ates resulted in
more exposure than those calculated for the EC formulation, all risk estimates were significantly greater than the level of concern (LOC = MOE > 100) and did not result in risks of concern

. No additional occupational uses need to be re

- ev aluated during registration review

. Product labels which contain the monoethanolamine salt of clopyralid acid specify a restricted

entry interval (REI) of 12 hours. However, the acid form of clopyralid is classified as Toxicity Category I for eye irrit ation. Therefore, all products containing the acid form of clopyralid should, according to the Worker Protection Standard guidelines, have an REI of 48 hours.

Occupational Post

- application Exposure A quantitative dermal post

- application exposure assessme nt was not completed for the agricultural and non

- agricultural uses of clopyralid due to the lack of dermal toxicity

.

Chemical

- specific dislodgeable foliar residue (DFR) and turf transferable residue (TTR) data have not been submitted

. These data are n ot needed for clopyralid due to the lack of an endpoint for dermal risk assessment

. During registration review, HED will consider the impact of new policies and procedures, such as addressing volatilization exposure, as well as the potential for
exposure from spray drift

. However, no risk issues are expected and no additional data are needed at this time.

A quantitative post

- application inhalation exposure as sessment was not performed for clopyralid b ased on the Agency's current practices

. However, ther e are potential sources of inhalation exposure to workers performing post

- application activities in previously treated fields

. These potential sources include volatilization of pesticides and re

- suspension of dusts and/or particulates that contain pesticides

. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on M arch 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html )

. The Agency is in the process of evaluating the SAP report as well as available post

- application inhalation exposure data generated by the Agricultural Reentry Task Force and m ay, as appropriate, develop policies and procedures, to identify the need for and, subsequently, the way to incorporate occupational post

- application inhalation exposure into the Agency's risk
assessments

. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post

- application inhalation exposure assessment for clopyralid.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 10 of 32 The technical clopyralid acid is classified as Toxicity Category I for severe eye irritation

. In

a ccordance with the Worker P rotection Standard (WPS) guidelines, the label for a product that contains an active ingredient which is classified as T oxicity C ategory I must include appropriate PPE (in this case, protective eyewear) and specify an REI of not less than 48 hours

. Some e nd

use products containing clopyralid specify an REI of 12 hours

. Discrepancies between PPE and REI to avoid potential eye injury to all post

- application workers will need to be resolved during registration review

. Conclusions for Occupational Exposure a nd Risk

No chemical

- specific data, such as dislodgeable foliar residue (DFR) and turf transferable residue (TTR) data

, are required to support registration review for clopyralid due to the lack of an endpoint for dermal risk assessment

. During registration review, HED will consider the impact of new policies and procedures, such as addressing volatilization exposure, as well as the potential for exposure from spray drift

. However, no risk issues are expected and no additional data are needed at this time

. Public Health and Pesticide Epidemiology Data

The Agency has reviewed the available incident data for clopyralid (D 416106

, E. Evans and S

. Recore, 20 November 2013 ) and concludes that based on the low frequency and generally low severity of incident cases reported for clopyralid , there does not appear to be a concern at this time that would warrant further investigation

. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysi s will be included in the risk
assessment.

Tolerance Assessment and International Harmonization

Tolerances for clopyralid are established under 40 CFR §180. 431 for residues of the herbicide from applications in the acid form or from application of its salts

. The tolerance listing is in accordance with current language and specifies that for plant and livestock commodities, compliance with the tolerance levels shall be determined by measuring only clopyralid.

There are no Codex Maximum Residue Limits (MRLs) established for residues of clopyralid at this time

. Canadian MRLs exist for many commodities with U.S. tolerances, and the residue definitions are the same for the U.S. and Canada

. For commodities with listings in each country, U.S. tolerances ar e generally harmonized with Canadian MRLs for plant commodities ; however, U.S. tolerances and Canadian MRLs for livestock commodities are not harmonized

. For plant commodities, the following limits are not harmonized: blueberry, strawberry, and processed commodities of barley, oat, and wheat

. During registration review, HED will examine the basis for the U.S. tolerances and, to the extent possible, harmonize with Canadian MRLs for plant and livestock commodities

. The International Residue Limit Status Sh eet is attached to this document as Attachment 4

. There are no pending requests for the establishment of new tolerance s for clopyralid.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 11 of 32 Environmental Justice

Potential areas of environmental justice concerns , to the extent possible, were considered in the 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/nepa/tools/guidance/Volume1/2

- 6

- EO_12898envjustice.pdf )

. The Office of Pesticide Programs (OPP) typically considers the highest potential exposures from the legal use of a pesticide when conducting human health ri sk assessments, including, but not limited to, people who obtain drinking water from sources near agricultural areas, the variability of diets within the U.S., and people who may be exposed when harvesting crops

. Should these highest
exposures indicate po tential risks of concern, OPP further refines the risk assessments to ensure that the risk estimates are based on the best available information.

Cumulative

EPA has not , at this time, made a determination as to whether clopyralid shares a common mechanism of toxicity with any other substances

.

Human Studies

Past clopyralid risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation e xposure

. These data, which include studies from the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1); the Outdoor Residential Exposure Task Force (ORETF) database; the Agricultural Re

- entry Task Force (ARTF) database; and other registrant

- submi tted exposure monitoring studies, are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements

. For certain studies that review may have included review by the Human Studies Review Bo ard

. Descriptions of data sources as well as guidance on their use can be found at http://www.epa.gov/pesticides/science/handler

- exposure

data.html and http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.html.

Data Requirements

None

References

Table 1 : HED Memoranda Relevant to Registration Review Author Barcode/ TXR # Date Title

Dotson, D., Hansen, L., Oonnithan, S D391397, D401055 6 June 2012 Clopyralid

. Human Health Risk Assessment for New Uses on Apples, Teff, Brassica Leafy Greens, and Rapeseed

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 12 of 32 Table 1 : HED Memoranda Relevant to Registration Review Author Barcode/ TXR # Date Title

Rury, K. TXR#0056270 29 March 2012 Clopyralid: Summary of Hazard and Science Policy Council (HASPOC) Meeting of March 29, 2012: Recommendation on the need for 28

- day inhalation and acute/subchronic neurotoxicity studies in the rat and for a tu rf transferable residue study Shaughnessy, W. D 391398 19 December 2011 Tier I Drinking Water Assessment for Proposed New Use of Clopyralid on Apple, Leafy Brassica Greens Subgroup 5B, and Rapeseed Subgroup 20A, E xcept Camelina (Gold of Pleasure) Dotson, D. D399390 6 June 2012 Clopyralid Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Apples, Teff, the Leafy Brassica Greens Subgroup (5

- B), and the Rapeseed Subgroup (20

- A) Oonnithan, S. D391748 30 April 2012 Clopyralid: Occupational Exposure Assessment for a New Use on Apples; Expansion of Crop Group 5B; and Revised Residential Exposure Assessment for use on Turf Evans, E. and Recore, S. D416106 20 November 2014 Clopyralid : Tier I Review of Human Incidents

Attachment s

Attachment 1

. Chemical Identity Attachment 2

. Toxicity Profile Tables Attachment 3

. Endpoint Tables Attachment 4

. International Residue Limits Table Attachment 5

. Summary of End

- Use Products Containing Clopyralid

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 13 of 32 Attachment 1. Clopyralid Chemical Identity

Table A.1.1. Clopyralid Nomenclature Compound

Common N ame Clopyralid Acid Company E xperimental N ame Dowco 290

IUPAC N ame 3,6

- dichloropyridine

- 2

- carboxylic acid
CAS N ame 3,6

- dichloro

- 2

- pyridinecarboxylic acid
CAS R egistry N umber 1702

- 17

- 6 (acid)

Table A.1.2. Physicochemical Properties of the Technical Grade Clopyralid
Parameter Value References 

### Physical State Solid A world Compendium, The Pesticide Manual, 14 th 

### Edition

. C.D

. S Tomlin (Editor)

, 2006. Color Colorless Melting P oint/ R ange 151

- 152°C Dissociation Constant ( pKa ) 2 Density at 20°C 1.57 g/cm 3 

### Vapor P ressure at 25°C 1.0 x 10 - 5 

### mm Hg ( 1.33 mPa )
Water S olubility at 20°C 7.85 g/L
Solvent solubility (g/L) at 20°C Acetone : 250 Ethyl acetate : 102 Xylene : 4.6 Hexane : 6.0 Octanol/water partition coefficient, Log (K OW 

### ) - 1.81 (pH 5)

- 2.63 (pH 7)

- 2.55 (pH 9)

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 14 of 32 Attachment 2

. Toxicity Profile Tables

Table A.2.1

. Acute Toxicity Profile for Clopyralid Guideline Number Study Type Classification MRID Number Results Toxicity Category 870.1100 Acute

- oral

- rat 41641301 LD 50 (M/F) > 5,000 mg/kg IV 870.1200 Acute

- dermal

- rat 41641302 LD 50 (M/F) > 5000 mg/kg IV 870.1300 Acute

- inhalation

- rat 41848301 LC 50 (M/F) > 1 mg/L III 870.2400 Acute

- eye irritation

- rabbit 41641304 Severe irritation at 7 days (corrosive) I 870.2500 Acute

- dermal irritation

- rabbit 41641305 Not an irritant IV 870.2600 Skin sensitization

- guinea pig 41641306 Not a sensitizer

-

Table A.2.2 Subchronic, Chronic and Other Toxicity Profile for Clopyralid Guideline No

. Study Type MRID No

. (year)/ Classification /Doses Results

870.3100 90

- Day oral toxicity (rat) An acceptable study is not available

. Requirement satisfied by combined chronic oral toxicity/carcinogenicity study in the rat (870.4300). 870.3100 90

- Day oral toxicity (mouse) 00127276 (2003) Acceptable/guideline 0, 200, 750, 2000 or 5000 mg/kg/day NOAEL = 2000 mg/kg/day LOAEL = 5000 mg/kg/day based on decreased body weight gain.

870.3150 90

- Day oral toxicity (dog) An acceptable study is not available

. Requirement satisfied by chronic oral study in the dog (870.4100). 870.3200 21

- Day dermal toxicity (rabbit) 41790701 (1990) Acceptable/guideline 0, 100, 500 or 1000 mg/kg/day Systemic NOAEL = 1000 mg/kg/day (limit dose) Systemic LOAEL = not established (>1000 mg/kg/day). Local dermal NOAEL < 100 mg/kg/day (LDT) Local dermal LOAEL = 100 mg/kg/day, based on epithelial hyperplasia at application site 870.3250 90

- Day dermal toxicity Study not required

.

870.3465 28

- Day inhalation toxicity (rat) Study not required.

870.3700a Prenatal developmental in (rat) 00127279 (1981) Acceptable/guideline 0, 15, 75 or 250 mg/kg/day Maternal NOAEL = 75 mg/kg/day LOAEL = 250 mg/kg/day based on mortality, decreased body weight gains and reduced food consumption. Developmental NOAEL = 250 mg/kg/day (HDT) LOAEL = not established (>250 mg/kg/day). 870.3700b Prenatal developmental in (rabbit) 41649801,

- 02 (1990) Acceptable/guideline 0, 50, 110 or 250 mg/kg/day by gavage Materna l NOAEL = 110 mg/kg/day LOAEL = 250 mg/kg/day based on mortality, decreased body weight gains, reduced food consumption and lesions in the gastric mucosa. Developmenta l NOAEL = 110 mg/kg/day LOAEL = 250 mg/kg/day based on decreased fetal body weight and hydrocephalus.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 15 of 32 Table A.2.2 Subchronic, Chronic and Other Toxicity Profile for Clopyralid Guideline No

. Study Type MRID No

. (year)/ Classification /Doses Results

870.3800 Reproduction and fertility effects (rat) 00138155 (1983) Acceptable/guideline 0, 150, 500 or 1500 mg/kg/day in diet Parental NOAEL = 500 mg/kg/day (M/F) LOAEL = 1500 mg/kg/day(M/F), based on decreased body weights and body weight gain in F 0 and F 1 males; body weights in F 1 and F 2 females

Reproductive NOAEL ≥1500 mg/kg/day LOAEL = n ot attained based on lack of effects on reproductive parameters (>1500 mg/kg/day)

Offspring NOAEL = 500 mg/kg/day (M/F) LOAEL = 1500 mg/kg/day (M/F), based on decreased Day 28 body weights in F 1 male pups and increased relative liver weights of F 1a male and female pups and F 1b male pups. 870.4100a Chronic toxicity (rat) Requirement satisfied by 870.4300.

870.4100b Chronic toxicity (dog) 00158256 (1984) Acceptable/guideline 0, 100, 320 or 1000 mg/kg/day by capsule NOAEL = 100 mg/kg/day LOAEL = 320 mg/kg/day based on decreases in RBC parameters, increased liver weight (males) and vacuolated adrenal cortical cells (females)

. Clinical chemistry changes (decreased serum albumin, globulin, and protein) and skin lesions were observed at high dose. 870.4200a Carcinogenicity (rat) Requirement satisfied by 870.4300.

870.4200b 24

- month Carcinogenicity (mouse) 00162393, 00162434 (1984) Acceptable/guideline 0, 100, 500 or 2000 mg/kg/day in the diet (24 months) NOAEL = 500 mg/kg/day LOAEL = 150 mg/kg/day based on decreased body weight/weight gain and reduced food efficiency.

N o evidence of carcinogenicity 870.4300 Chronic toxicity/carcinoge nicity (rat) 00162393, 00162434 (1986) Acceptable/guideline 0, 15, 150 or 1500 mg/kg/day in the diet (104 weeks) NOAEL = 15 mg/kg/day LOAEL = 150 mg/kg/day based on gastric lesions (epithelial hyperplasia and thickening of the limiting ridge)

. At 1500 mg/kg/day, decreased body weight gains and food consumption were also observed.

no evidence of carcinogenicity Gene Mutation 870.5100 Study not submitted

. Not required due to lack of tumorigenicity in rat and mouse bioassays and negative findings in all other genotoxicity assays, including host

- mediated assays in Salmonella and Saccharomyces.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 16 of 32 Table A.2.2 Subchronic, Chronic and Other Toxicity Profile for Clopyralid Guideline No

. Study Type MRID No

. (year)/ Classification /Doses Results

Gene Mutation 870.5300 In Vitro and In Vivo Host Mediated Assay ( Salmonella strains TA 1530, G

- 46 and Saccharomyces strain D

- 3) (1973) In vivo assays were conducted using mice 00057086 (1973) Acceptable/guideline In vitro testing: without S9 activation at 5% w/v sol ution In vivo testing: 0, 4, 40 or 400 mg/kg by gavage to 10 mice Negative

– no evidence of induced mutant colonies over background levels in Salmonella or Saccharomyces strains tested in either the in vitro or the in vivo assays.

Cytogenetics 870

. 5385 In Vivo Micronucleus assay, Rat 00073638 (1973) Acceptable/guideline 0, 4, 40 or 400 mg/kg for one day or for 5 days to male rats; sacrifice at 6, 24 or 48 hrs postdosing for all groups. Negative

– no evidence of an increase in the formation of chromosomal aberrations in bone marrow at any dose tested

.

Other Effects 870.5450 Dominant Lethal Assay in Rats 00059053, 00099100 (1973)

Acceptable/guideline

4, 40 or 400 mg/kg/day for 5 days to male rats prior to mating Negative

– no evidence of treatment

- related resorptions.

Other Effects 870.5550 Unscheduled DNA Synthesis, Rat Hepatocytes 00156387 (1985), 41790702 (1990) Acceptable/guideline 5x10 - 5 , 1.56x10 - 4 , 5x10 - 4

, 1.56x10 - 3 , 5x10 - 3

, 1.56x10 - 2 , 5x10 - 2 M, incubated for 18

- 20 hrs Negative

– no evidence of increased unscheduled DNA synthesis in the initial or supplementary assays testing up to insoluble/toxic concentrations.

870.6200a Acute neurotoxicity screening battery (rat) Study not required.

870.6200b Subchronic neurotoxicity screening battery (rat) Study not required.

870.6300 Developmental neurotoxicity Study not required.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 17 of 32 Table A.2.2 Subchronic, Chronic and Other Toxicity Profile for Clopyralid Guideline No

. Study Type MRID No

. (year)/ Classification /Doses Results

870.7485 Metabolism and pharmacokinetics (rat) 41790703 (1991) Acceptable/guideline 5.0 and 50 mg/kg, single oral dose; 5.0 mg/kg, single IV dose and 5.0 mg/kg/day, repeated daily dose for 14 days Clopyralid was rapidly and completely absorbed and eliminated with 95 to 115% of the administered dose recovered by 72 hr, most within 6

- 12 hrs postdosing

. Almost all radioactivity was eliminated via the urine ir respective of dose or route of administration (91 to 113% of AD), with <4% excreted in the feces

. Tissue retention was negligible (<0.01% AD)

. There was essentially no metabolism of clopyralid: only parent compound was identified

. No significant gender , dose or exposure route differences were identified. 870.7600 Dermal penetration Study not available.

870.7800 Immunotoxicity (rat) 48300001 (2011) Acceptable/guideline 0, 158, 530, or 1062 mg/kg/day Systemic NOAEL = 1062 mg/kg/day (limit dose) Systemic LOAEL = not established (>1062 mg/kg/day) Immunotoxicity NOAEL = 1062 mg/kg/day Immunotoxicity LOAEL = not established (>1062 mg/kg/day)

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 18 of 32 Attachment 3

. Summary of Toxicological Dose and Endpoints for Clopyralid

Table A.3 .1

. Toxicological Doses and Endpoints for Clopyralid for Use in Dietary and Residential Human Health Risk Assessments. Exposure/ Scenario Point of Departure Uncertainty/FQ PA Safety

Factors Level of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary (All populations including infants and children) An appropriate endpoint for a single exposure was not identified.

Chronic Dietary ( All populations including infants and children) NOAEL= 15 mg/kg/day UF A = 10X UF H = 10X SF FQPA =1 cRfD=0.15 mg/kg/day

cPAD=0.15 mg/kg/day 2

- Year Combined Chronic Toxicity /Carcinogenicity (oral)

– rat LOAEL = 150 mg/kg/day, based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes. Incidental Oral, Short

term (1

- 30 days) NOAEL= 75 mg/kg/day UF A = 10X UF H = 10X SF FQPA =1 Residential LOC for MOE= 100 Developmental Toxicity (oral)

– rat Maternal LOAEL = 250 mg/kg/day, based on decreased body weight gain and food consumption during GD 6

- 9. Dermal, Short

- term (1

- 30 days) No systemic toxicity was observed up to the limit dose (1000 mg/kg/day) in a rabbit 21

- day dermal toxicity study and there are no developmental or reproductive concerns. Inhalation, Short

- term (1

- 30 days) Oral study NOAEL = 75 mg/kg/day (inhalation toxicity assumed to be equivalent to toxicity via the oral route) UF A = 10X UF H = 10X SF FQPA =1 Residential LOC for MOE = 100 Developmental Toxicity (oral)

– rat Maternal LOAEL = 250 mg/kg/day, based on decreased body weight gain and food consumption during GD 6

- 9.

Inhalation Intermediate

term (1

- 6 months) Oral study NOAEL= 15 mg/kg/day (inhalation toxicity assumed to be equivalent to toxicity via the oral route) UF A = 10X UF H = 10X SF FQPA =1 Residential LOC for MOE= 100 2

- Year Combined Chronic Toxicity /Carcinogenicity (oral)

– rat LOAEL 150 mg/kg/day, based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes.

Cancer (all routes) “Not likely to be carcinogenic to humans.” Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures

. NOAEL = no observed ad verse effect level

. LOAEL = lowest observed adverse effect level

. UF = uncertainty factor

. UF A = extrapolation from animal to human (interspecies)

. UF H = potential variation in sensitivity among members of the human population (intraspecies)

. SF FQPA = FQPA Safety Factor

. PAD = population adjusted dose (a = acute, c = chronic)

. RfD = reference dose

. MOE = margin of exposure

. LOC = level of concern

.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 19 of 32 Table A.3 .2

. Summary of Toxicological Doses and Endpoints for Clopyralid for Use in Occupational Human Health Risk Assessments. Exposure/ Scenario Point of Departure Uncertainty Factors Level of Concern for Risk Assessment Study and Toxicological Effects

Dermal, Short

- and Intermediate

- term (1

- 30 days and 1

- 6 months, respectively) No systemic toxicity was observed up to the limit dose (1000 mg/kg/day) in a 21

- day dermal toxicity study and there are no developmental or reproductive concerns.

Inhalation, Short

- term (1

- 30 days) NOAEL = 75 mg/kg/day (inhalation toxicity assumed to be equivalent to toxicity via the oral route) UF A = 10X UF H = 10X Occupational LOC for MOE = 100 Developmental Toxicity (oral)

– rat

Maternal LOAEL = 250 mg/kg/day, based on decreased body weight gain and food consumption during GD 6

- 9.

Inhalation, Intermediate

term (1

- 6 months) NOAEL = 15 mg/kg/day (inhalation toxicity assumed to be equivalent to toxicity via the oral route) UF A = 10X UF H = 10X Occupational LOC for MOE = 100 2

- Year Combined Chronic Toxicity /Carcinogenicity (oral)

– rat

LOAEL = 150 mg/kg/day, based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes.

Cancer (all routes) “Not likely to be carcinogenic to humans.” Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures

. NOAEL = no observed adverse effect level

. LOAEL = lowest observed adverse effect level

. UF = u ncertainty factor

. UF A = extrapolation from animal to human (interspecies)

. UF H = potential variation in sensitivity among members of the human population (intraspecies)

. MOE = margin of exposure

. LOC = level of concern

. N/A = not applicable

.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 20 of 32 Attachment 4

. Clopyralid International Residue Limits Table
Clopyralid (117401/117403; 10/29/2013)
Table A.4.1. Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex 40 CFR 180.431

(a) General

. Tolerances are established for residues of the herbicide clopyralid, including its metabolites and degradates, in or on the commodities in the table below from its application in the acid form or in the form of its salts

. Compliance with the tolerance levels specified below is to be determined by measuring only clopyralid, (3,6

- dichloro

- 2

- pyridinecarboxylic acid) 3,6

- dichloro

- 2

- pyridinecarboxylic acid None None

Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 2 Codex Apple 0.05 Asparagus 1.0 Barley, bran 12 Barley, grain 3.0 3 7 barley milling fractions, excluding flour Barley, hay 9.0 Barley, pearled barley 12 Barley, straw 9.0 Beet, garden, tops 3.0 3 Beet, garden, roots 4.0 4 Beet, sugar, molasses 10 10 Beet, sugar, roots 2.0 2 Beet, sugar, tops 3.0 Brassica, head and stem, subgroup 5A 2.0 2 broccoli, brussels sprouts, cabbage, cauliflower, Chinese broccoli, Chinese mustard cabbages, kohlrabi, napa Chinese cabbages Brassica, leafy greens, subgroup 5B 5.0 5 mustard greens Bushberry subgroup 13

- 07B 0.50 0.1 blueberries Canola, meal 6.0 Canola, seed 3.0 3 rapeseeds (canola) Cattle, fat 1.0 0.05 Cattle, liver 3.0 0.05 meat byproducts of cattle Cattle, meat 1.0 0.05 Cattle, meat byproducts, except liver 36.0 0.36 kidney of cattle Corn, field, forage 3.0 Corn, field, grain 1.0 1 Corn, field, milled byproducts 1.5 Corn, field, stover 10.0 Corn, pop, grain 1.0 1 Corn, pop, stover 10.0 Corn, sweet, forage 7.0

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 21 of 32 Table A.4.1. Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex Corn, sweet, kernel plus cob with husks removed 1.0 1

Corn, sweet, stover 10.0 Cranberry 4.0 4 Egg 0.1 0.05 Flax, meal 6.0 Fruit, stone, group 12 0.5 0.5 American plums, Apricots, beach plums, black cherries, Canada plums, capulins, cherry plums, chicksaw plums, chokecherries, damson plums, fresh prune plums, Japanese apricots, Japanese plums, klamath plums, nanking cherries, nectarines, peaches, plumcots, plums, sloes,

sw eet cherries, tart cherries Goat, fat 1.0 0.05 Goat, liver 3.0 0.05 meat byproducts of goats Goat, meat 1.0 0.05 Goat, meat byproducts, except liver 36.0 0.36 kidney of goats Grass, forage 500.0 Grass, hay 500.0 Hog, fat 0.2 0.05 Hog, meat 0.2 0.05 Hog, meat byproducts 0.2 0.05 Hop, dried cones 5.0 5 Horse, fat 1.0 0.05 Horse, liver 3.0 0.05 meat byproducts of horses Horse, meat 1.0 0.05 Horse, meat byproducts, except liver 36.0 0.36 kidney of horses Milk 0.2 0.01 Oat, forage 9.0 Oat, grain 3.0 3 7 oat milling fractions, excluding flour Oat, groats/rolled oats 12 Oat, straw 9.0 Peppermint, tops 3.0 3 Plum, prune, dried 1.5 1.5 dried prune plums Poultry, fat 0.2 0.05 Poultry, meat 0.2 0.05 Poultry, meat byproducts 0.2 0.2 kidney of poultry Rapeseed, forage 3.0 Rapeseed, meal 6.0 Rapeseed, subgroup 20A, except gold of pleasure 3.0 3 flaxseeds, mustard seeds (oil seed type) Sheep, fat 1.0 0.05 Sheep, liver 3.0 0.05 meat byproducts of sheep Sheep, meat 1.0 0.05 Sheep, meat byproducts, except liver 36.0 0.36 kidney of sheep Spearmint, tops 3.0 3

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 22 of 32 Table A.4.1. Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 Codex Spinach 5.0 5 Strawberry 4.0 1 Swiss chard 3.0 Teff, forage 9.0 Teff, grain 3.0 Teff, hay 9.0 Teff, straw 9.0 Turnip, greens 4.0 4 turnip tops Turnip, roots 1.0 1 Wheat, bran 12 Wheat, forage 9.0 Wheat, germ 12 Wheat, grain 3.0 3 7 wheat milling fractions, excluding flour Wheat, middling 12 Wheat, shorts 12 Wheat, straw 9.0 Completed by: M

. Negussie; 10/31/13

1 Mexico adopts U.S. tolerances and/or Codex MRLs for its export purposes.

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 23 of 32 Attachment 5

– Summary of End

- Use Products Containing Clopyralid

Summary Report for 117401

- Monoethanolamine

Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

228

- 332 MILLENNIUM ULTRA 2 Conditionally Registered (01

- Apr

- 1998) N 228 NUFARM AMERICAS, INC. 2.54 Clopyralid, monoethanolamine salt

228

- 333 RIVERDALE MCDA L.A.C

. SELECTIVE HERBICIDE Conditionally Registered (25

- Feb

- 1998) N 228 NUFARM AMERICAS, INC. 2.58 Clopyralid, monoethanolamine salt

228

- 344 RIVERDALE MILLENNIUM ULTRA GRANULAR WEED KILLER Conditionally Registered (09

- Jun

- 2004) N 228 NUFARM AMERICAS, INC. 0 .187 Clopyralid, monoethanolamine salt

228

- 372 ECLIPSE SELECTIVE HERBICIDE Conditionally Registered (28

- Feb

- 2000) N 228 NUFARM AMERICAS, INC. 2.53 Clopyralid, monoethanolamine salt

228

- 491 CLEAN SLATE Conditionally Registered (08

- Aug

- 2006) N 228 NUFARM AMERICAS, INC. 40.9 Clopyralid, monoethanolamine salt

228

- 564 BRAZEN HERBICIDE Registered (08

- Apr

- 2008) N 228 NUFARM AMERICAS, INC. 12.1 Clopyralid, monoethanolamine salt

34704

- 885 CLOPYRALID Conditionally Registered (24

- Aug

- 2005) N 34704 LOVELAND PRODUCTS, INC. 40.9 Clopyralid, monoethanolamine salt

34704

- 895 COLT Conditionally Registered (03

- Nov

- 2005) N 34704 LOVELAND PRODUCTS, INC. 11.3 Clopyralid, monoethanolamine salt

42750

- 89 CLOPYRALID MEA AG Conditionally Registered (01

- Jun

- 2005) N 42750 ALBAUGH INC 40.9 Clopyralid, monoethanolamine salt

42750

- 92 CLOPYRALID MEA+2,4

- D Conditionally Registered (01

- Jun

- 2005) N 42750 ALBAUGH INC 5.1 Clopyralid, monoethanolamine salt

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 24 of 32 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

42750

- 94 CLOPYRALID MEA IVM Conditionally Registered (15

- Jun

- 2005) N 42750 ALBAUGH INC 40.9 Clopyralid, monoethanolamine salt

42750

- 95 CLOPYRALID MEA T&O Conditionally Registered (15

- Jun

- 2005) N 42750 ALBAUGH INC 40.9 Clopyralid, monoethanolamine salt

42750

- 201 FLUROXYPYR + CLOPYRALID Conditionally Registered (23

- Sep

- 2009) N 42750 ALBAUGH INC 11.3 Clopyralid, monoethanolamine salt

53883

- 254 CLOPYRALID 3 LB Registered (03

- Feb

- 2009) N 53883 CONTROL SOLUTIONS, INC. 40.9 Clopyralid, monoethanolamine salt

62719

- 48 CURTAIL Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 5.1 Clopyralid, monoethanolamine salt

62719

- 73 STINGER Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

62719

- 83 RECLAIM Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

62719

- 84 LONTREL 35A HERBICIDAL CONCENTRATE Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 46.1 Clopyralid, monoethanolamine salt

62719

- 259 TRANSLINE Conditionally Registered (30

- Mar

- 1994) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

62719

- 512 WIDEMATCH HERBICIDE Conditionally Reregistered (30

- Apr

- 2004) N 62719 DOW AGROSCIENCES LLC 11.3 Clopyralid, monoethanolamine salt

62719

- 635 GF

- 2506 Registered (28

- Jul

2011) N 62719 DOW AGROSCIENCES LLC 12 Clopyralid, monoethanolamine salt

62719

- 645 GF

- 2791 Registered (15

- Feb

- 2012) N 62719 DOW AGROSCIENCES 30.82 Clopyralid, monoethanolamine salt

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 25 of 32 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

LLC

70506

- 94 AGVALUE CLOPYRALID AG HERBICIDE Conditionally Registered (06

- May

- 2003) N 70506 UNITED PHOSPHORUS, INC 40.9 Clopyralid, monoethanolamine salt

71368

- 66 GARRISON HERBICIDE Conditionally Registered (11

- Aug

- 2006) N 71368 NUFARM, INC. 40.9 Clopyralid, monoethanolamine salt

71368

- 86 TRUSLATE SELECTIVE HERBICIDE Conditionally Registered (19

- Dec

- 2008) N 71368 NUFARM, INC. 11.3 Clopyralid, monoethanolamine salt

81927

- 14 ALLIGARE CLOPYRALID 3 Conditionally Registered (25

- May

- 2007) N 81927 ALLIGARE, LLC 40.9 Clopyralid, monoethanolamine salt

81927

- 28 ALLIGARE CODY HERBICIDE Registered (24

- Jun

- 2008) N 81927 ALLIGARE, LLC 5.1 Clopyralid, monoethanolamine salt

81927

- 28 ALLIGARE CODY HERBICIDE Registered (24

- Jun

- 2008) N 81927 ALLIGARE, LLC 39 2,4

- D, triisopropanolamine salt

CA990010 TRANSLINE Registered (07

- Oct

- 1999) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

CA990027 STINGER Registered (20

- Feb

- 2000) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

GA110003 STINGER Registered (26

- May

- 2011) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

ID040011 STINGER Registered (15

- Oct

- 2004) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

MI100004 STINGER Registered (27

- Oct

- 2010) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

MI110001 STINGER Registered (24

- May

- 2011) N 62719 DOW AGROSCIENCES 40.9 Clopyralid, monoethanolamine salt

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 26 of 32 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

LLC

NY040004 STINGER Reregistered (05

- Aug

- 2004) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

OR030009 STINGER Registered (29

- Jul

2003) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

OR090018 STINGER Registered (10

- Mar

- 2011) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

OR100011 STINGER Registered (27

- Oct

- 2010) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

OR120010 STINGER Registered (06

- Sep

- 2012) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

OR970024 STINGER Registered (12

- Jan

- 1998) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

WA030006 STINGER Registered (30

- Jan

- 2009) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

WA100005 STINGER Registered (25

- Oct

- 2011) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

WA970033 STINGER Registered (26

- Oct

- 1997) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

WI080002 STINGER Registered (18

- Jun

- 2008) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

WI100003 STINGER Registered (03

- Sep

- 2010) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 27 of 32 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

WI130008 STINGER Registered (03

- Jul

2013) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid, monoethanolamine salt

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 28 of 32 Summary Report for 117403

- Clopyralid

Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

228

- 323 RIVERDALE TRUPOWER SELECTIVE HERBICIDE Conditionally Registered (26

- Nov

- 1997) N 228 NUFARM AMERICAS, INC. 5.18 Clopyralid

228

- 343 MILLENNIUM ULTRA WEED AND FEED Conditionally Registered (03

- Oct

- 1998) N 228 NUFARM AMERICAS, INC. 0 .071 Clopyralid

228

- 371 RIVERDALE MTCA PREMIUM SELECTIVE HERBICIDE Conditionally Registered (01

- Feb

- 2000) N 228 NUFARM AMERICAS, INC. 1.3 Clopyralid

228

- 568 BRAZEN SF HERBICIDE Registered (08

- Apr

- 2008) N 228 NUFARM AMERICAS, INC. 12.1 Clopyralid

352

- 593 ACCENT GOLD HERBICIDE Conditionally Registered (19

- Nov

- 1997) N 352 E

. I

. DU PONT DE NEMOURS AND COMPANY (S300/419) 51.7 Clopyralid

352

- 612 DUPONT ACCENT GOLD WDG HERBICIDE Conditionally Registered (08

- Aug

- 2001) N 352 E

. I

. DU PONT DE NEMOURS AND COMPANY (S300/419) 51.4 Clopyralid

1381

- 246 WELD HERBICIDE Registered (18

- Mar

- 2011) N 1381 WINFIELD SOLUTIONS, LLC 5.6 Clopyralid

5905

- 590 HM

- 1144 HERBICIDE Registered (21

- Feb

- 2013) N 5905 HELENA CHEMICAL CO 6 Clopyralid

34704

- 1017 HAT TRICK THREE WAY HERBICIDE Conditionally Registered (16

- Apr

- 2009) N 34704 LOVELAND PRODUCTS, INC. 6 Clopyralid

34704

- 1019 COLT CF HERBICIDE Conditionally Registered (13

- Aug

- 2009) N 34704 LOVELAND PRODUCTS, INC. 8.6 Clopyralid

35935

- 57 CLOPYRALID TECHNICAL HERBICIDE Conditionally Registered (24

- Mar

- 2009) N 35935 NUFARM LIMITED 97 Clopyralid

35935

- 84 MILLENNIUM ULTRA Registered (27

- N 35935 NUFARM LIMITED 5.58 Clopyralid

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 29 of 32 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

MC Jun

- 2011)

42750

- 86 CLOPYRALID TECHNICAL Conditionally Registered (17

- May

- 2005) N 42750 ALBAUGH INC 98 Clopyralid

42750

- 91 CLOPYRALID ACID + MCPA ESTER Conditionally Registered (01

- Jun

- 2005) N 42750 ALBAUGH INC 5 Clopyralid

42750

- 184 CLOPYRALID TECHNICAL HERBICIDE Conditionally Registered (19

- May

- 2008) N 42750 ALBAUGH INC 97 Clopyralid

58501

- 1 CONFRONT WEED STICK Canceled (29

- Jul

2002) N 58501 TERAGRO INC. 0 .57 Clopyralid

62719

- 80 LONTREL T TECHNICAL Conditionally Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 95 Clopyralid

62719

- 81 LONTREL F TECHNICAL Conditionally Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 80.8 Clopyralid

62719

- 86 CURTAIL M Conditionally Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 5 Clopyralid

62719

- 217 XRM

- 5202 Conditionally Registered (12

- Dec

- 1996) N 62719 DOW AGROSCIENCES LLC 1.3 Clopyralid

62719

- 232 CONFRONT* F Conditionally Registered (16

- Apr

- 1992) N 62719 DOW AGROSCIENCES LLC 12.1 Clopyralid

62719

- 253 HORNET Conditionally Registered (25

- May

- 1994) N 62719 DOW AGROSCIENCES LLC 62.5 Clopyralid

62719

- 262 TURF FERTILIZER CONTAINS CONFRONT Conditionally Reregistered (18

- Sep

- 2000) N 62719 DOW AGROSCIENCES LLC 0 .18 Clopyralid

62719

- 278 NAF

- 280 Conditionally N 62719 DOW 56.3 Clopyralid

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 30 of 3 2 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

Registered (26

- Mar

- 1996) AGROSCIENCES LLC

62719

- 279 NAF

- 281 Conditionally Registered (26

- Mar

- 1996) N 62719 DOW AGROSCIENCES LLC 56.3 Clopyralid

62719

- 300 HORNET MUP Conditionally Registered (11

- Feb

- 1998) N 62719 DOW AGROSCIENCES LLC 62.5 Clopyralid

62719

- 305 LONTREL TURF AND ORNAMENTAL Conditionally Registered (14

- Oct

- 1998) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid

62719

- 337 REDEEM R & P Conditionally Registered (16

- Mar

- 2000) N 62719 DOW AGROSCIENCES LLC 12.1 Clopyralid

62719

- 570 SURESTART HERBICIDE Registered (01

- Mar

- 2007) N 62719 DOW AGROSCIENCES LLC 4.27 Clopyralid

70506

- 93 AGVALUE CLOPYRALID TECHNICAL Conditionally Registered (01

- May

- 2003) N 70506 UNITED PHOSPHORUS, INC 96 Clopyralid

71368

- 88 TRUSLATE PRO HERBICIDE Conditionally Registered (01

- Apr

- 2009) N 71368 NUFARM, INC. 5.6 Clopyralid

75147

- L CLOPYR

- M Under Review (03

- Sep

- 2002) N 75147 AGVALUE

CLOPYR, LLC 5 Clopyralid

89167

- GU AX ACETOCHLOR + 2 HERBICIDE Under Review (26

- Aug

- 2013) N 89167 AXION AG PRODUCTS, LLC 4.27 Clopyralid

ID130010 COLT CF HERBICIDE Registered (12

- Aug

- 2013) N 34704 LOVELAND PRODUCTS, INC. 8.6 Clopyralid

WI030003 STINGER Registered (29

- Apr

- 2003) N 62719 DOW AGROSCIENCES LLC 40.9 Clopyralid

62719

- EUP

- 26 Issued (19

- May

1994) N 62719 DOW AGROSCIENCES 23.1 Clopyralid

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 31 of 32 Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

LLC

62719

- EUP

- 27 Issued (02

- Jun

1994) N 62719 DOW AGROSCIENCES LLC 25 Clopyralid

### Clopyralid Registration Review Human Health Scoping Document D416096

Page 32 of 32 Summary Report for 117404

– Triethanolamine Salt

Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

961

- 390 LEBANON LAWN FERTILIZER CONTAINS CONFRONT AND TEAM Conditionally Registered (12

- Jan

- 2001) N 961 LEBANON SEABOARD CORPORATION 0 .18 Clopyralid, triethanolamine

961

- 391 LEBANON TURF FERTILIZER WITH CONFRONT AND TEAM Conditionally Registered (12

- Jan

- 2001) N 961 LEBANON SEABOARD CORPORATION 0 .18 Clopyralid, triethanolamine

42750

- 125 TRICLOPYR TEA + CLOPYRALID TEA R&P Registered (06

- Apr

- 2006) N 42750 ALBAUGH INC 12.1 Clopyralid, triethanolamine

62719

- 92 CONFRONT Conditionally Registered (04

- Dec

- 1989) N 62719 DOW AGROSCIENCES LLC 12.1 Clopyralid, triethanolamine

66222

- 222 QUALI

- PRO 2

- D HERBICIDE Registered (22

- Nov

- 2010) N 66222 MAKHTESHIM AGAN OF NORTH AMERICA, INC. 12.1 Clopyralid, triethanolamine

81927

- 30 ALLIGARE PRESCOTT HERBICIDE Registered (29

- Apr

- 2008) N 81927 ALLIGARE, LLC 12.1 Clopyralid, triethanolamine



### Summary Report for 117423

– Potassium Salt

Registration # Name Status Restricted Use Product Company # Company Name Percent Active Ingredient Active Ingredient

62719

- 315 HORNET WDG Conditionally Registered (27

- Jul

1999) N 62719 DOW AGROSCIENCES LLC 60 Clopyralid potassium