2 S ummary
The U.S. Environmental Protection Agency (EPA or the Agency) is proposing to grant an unconditional registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the new uses of the herbicide dicamba on genetically

- modified
dicamba

- tolerant cotton and genetically

- m odified dicamba

- tolerant soybean. The proposed new uses will be added to the currently registered herbicide product M1691 (EPA Registration
Number 524

- 582), containing 58.1% of the active ingredient dicamba, diglycolamine salt (DGA) for pre

- and post

- emerg ence (in

- crop) applications to dicamba

- tolerant cotton and soybean.

The U.S. Department of Agriculture (USDA) granted deregulation status for dicamba

- tolerant cotton and soybean on January 15, 2015 under the Plant Protection Act.

I. Chemical Information

Chemical Name: Dicamba (benzoic acid, 3,6

- dichloro

- 2

- methoxy

- , aka 3,6

- dichloro

- o

- anisic acid)

EPA PC Code: 128931

Chemical Abstract Service (CAS) Number: 104040

- 79

- 1

Mode of Action: Dicamba is in the Benzoic Acid family that is used post

- emergence for selective control of broadleaf weeds. Like the phenoxy herbicides, dicamba mimics auxins, a type of plant hormone and causes abnormal cell growth by affecting cell division.

Registran t: Monsanto Company

Proposed Product: M1691 Herbicide

Background

On April 28, 2010 and July 30, 2012, respectively, EPA received applications from the Monsanto Company (Monsanto) to register new uses of dicamba, as the DGA salt, on genetically

- modified di camba

- tolerant soybean and cotton.

Dicamba is an active ingredient that is used through acid formulations and a variety of salt formulations, and is registered for a variety of food and feed uses. The proposed new uses on cotton and soybeans would expand the current timing of dicamba applications to dicamba

tolerant soybeans and cotton. Dicamba is currently registered for use on preplant and pre

- harvest soybeans and on preplant and postharvest cotton. The proposed use would add post

- emergence (over

- the

- to p) applications to dicamba

- tolerant cotton and soybean crops.

Dicamba is a member of the Benzoic acid family of herbicides (Herbicide Resistance Action Committee (HRAC) Group 4). Dicamba works by increasing plant growth rate. Once sufficient
concentratio n is reached, the plant outgrows its own nutrient supplies and ultimately dies.

This proposal discusses several Agency considerations of the proposed use for dicamba on
dicamba

- tolerant soybeans and cotton, including discussions of human health and envi ronmental risks associated with the proposed uses. Due to the multiple forms of dicamba, EPA considered all relevant data associated with the active ingredient when assessing its risks. For example, the3 assessment for human health considered data associ ated with the BAPMA salt of dicamba, even though this registration action is being proposed for a formulation containing only the DGA salt
of dicamba. This is because the data on the BAPMA salt was relevant to the analysis and resulted
in the most conserva tive risk estimation to be used in each exposure scenario to be protectiv e of all exposures of dicamba. On the other hand, assessments focus on effects of the DGA salt when product specific considerations are discussed. For example, to determine appropriate spray drift buffers, the Agency examined drift potential using studies conducted on the DGA salt
formulation.

Proposed New Uses

Cotton

On currently registered dicamba products for use on conventional cotton, pre

- emergence treatment can be mad e at 8 fluid ounces (0.25 lb a.e. dicamba) per acre per season. The maximum single/annual application rate proposed for use on dicamba

- tolerant cotton for all preplant, at

- planting, and pre

- emergence applications is 32 fluid ounces (1.0 lb a.e. dicamba) pe r
acre per season.
For the proposed new use, for post

- emergence (in

- crop) application of dicamba for use on
dicamba

- tolerant cotton, the maximum single in

- crop application rate is 16 fluid ounces (0.5 lb a.e. dicamba) per acre. This rate is also the minimu m single application in order to reduce the selection for resistant weeds. The maximum annual application rate for post

- emergence in
dicamba

- tolerant cotton is 64 fluid ounces (2.0 lb a.e. dicamba) per acre.

If a preplant application of 32 fluid ounces (1 .0 lb a.e. dicamba) per acre is made, then the combined total post

- emergence (in

- crop) annual applications must not exceed 32 fluid ounces (1.0 lb a.e. dicamba) per acre for dicamba

- tolerant cotton

. The combined total per year for all applications must not exceed 64 fluid ounces (2.0 lb a.e. dicamba) per acre. The minimum retreatment interval is 7 days; the pre

- harvest retreatment interval for cottonseed including the livestock feeding of cotton gin b y

- products is 7 days.

Soybeans

On currently registered dicamba products, the maximum single and maximum annual application
rate allowed to both conventional and dicamba

- tolerant soybeans for all preplant, at

- planting, and

pre

- emergence applications is 32 f luid ounces (1.0 lb a.e. dicamba) per acre per season.

For the proposed new use for post

- emergence (in

- crop) application of this product to dicamba

tolerant soybeans, the maximum single in

- crop application rate is 16 fluid ounces (0.5 lb a.e. dicamba) per acre. This rate is also the minimum single application in order to reduce the selection for resistant weeds. The maximum annual application rate for post

- emergence in soybeans is 32 fluid ounces (1.0 lb a.e. dicamba) per acre.

The combined total per year for all applications must not exceed 64 fluid ounces (2.0 lb a.e dicamba) per acre. The minimum retreatment interval is 7 days; the pre

- harvest interval, including feeding of soybean hay is 14 days (R1 Growth stage).4 Evaluation

In evaluating a pesticide registration application, the EPA assesses a wide variety of information on the pesticide’s toxicity ( i.e., effects on humans and other non

- target organisms), exposure ( i.e., where and how the pesticide is used), and environmental fate ( i.e., how the chemical will move in the environment) to determine the likelihood of adverse effects ( i.e., risk) to human health and the environment resulting from the proposed uses. Risk assessments are developed to evaluate the environmental fate of the compound as well as how it might affect a wide range of

non

- target organisms including humans, terrestrial and aquatic wildlife and plants. On the basis of these assessments, EPA evaluates and approves language for each pesticide label to ensure the directions for use and safety measures are appropriate to mitigate any potential risk. The pesticide’s label hel ps to communicate essential limitations and mitigations that are necessary for public safely. Once the risks are assessed and mitigation measures have been incorporated, EPA balances any remaining potential risks against the benefits of the use of the prod uct. EPA will grant an application if it determines that the benefits of the use of the product outweigh its risks.

II. Human Health Risk

A summary of the human health risk assessment, Dicamba and Dicamba BAPMA Salt: Human

Health Risk Assessment for Prop osed Section 3 New Uses on Dicamba

- tolerant Cotton and Soybean , is provided below.

As stated earlier in this document, the data associated with the BAPMA salt were considered to be the most appropriate form to use for assessing the potential for risks to human health. In the human health risk assessment for dicamba, risks were assessed in a manner that assures human health protectio n to all forms of the chemical. This is a complex analysis because (1) the re are a variety of different forms of dicamba in r egistered or proposed to be registered products that
must be considered ( e.g., dicamba acid, dicamba BAPMA salt, other dicamba salts such as DGA), (2) the data showing greater toxicity for a major metabolite in foods (DCSA) relative to the parent compound, and (3) the different types of toxicity and potency seen with different routes of exposure (specifically, portal of entry effects observed in inhalation toxicity studies for
BAPMA vs. other forms of dicamba )

. When determining the safety of a pesticide, EPA evaluates the available toxicity data and considers its validity, completeness, and reliability, as well as the relationship of the results of the studies to human risk. EPA also considers available information concerning the variability of
the sensiti vities of major identifiable sub

- groups of consumers, including infants and children. Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern (LOC) to use in evaluating the risk posed by h uman exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicologic al study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe expo sure level

- generally referred to as a population

- adjusted dose (PAD) or a reference dose (RfD)

- and a safe margin of exposure (MOE). For non

- threshold risks (e.g., cancer), the Agency assumes that any amount of5 exposure wil l lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime (dicamba has been determined to be “not likely” to be carcinogenic and therefore a non

- threshold approach does not apply in this case )

. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process,

see http://www.epa.gov/pesticides/factshe ets/riskassess.htm

.

The following risk assessment endpoints were selected for dicamba to be protective to all forms
of the chemical.

• For the acute dietary assessment, the most sensitive, single

- day toxic effect seen across
the entire dicamba database was chosen for quantifying risks, i.e., maternal neurotoxic effects seen in a developmental toxicity study in which animals w ere dosed with the
BAPMA salt. Although dietary exposure could occur from agricultural use of other salts of dicamba resulting in lower risk estimates, the assessment quantified risks assuming

everyone exposed to dicamba would be exposed to the more toxic BAPMA salt to assure protection from all forms of the chemical.

• For the chronic dietary assessment, the endpoint was selected from a re production study in which animals were dosed with the DCSA metabolite (a plant metabolite), a compound much more chronically toxic than any of the parent dicamba acid or salts pesticides. Although chronic dietary exposure could occur from exposure to vari ous salts of dicamba rather than just this metabolite, risks were estimated assuming all residues in foods were the more toxic metabolite, thus assuring protection from all forms of the chemical.

• For the inhalation exposure assessment, risks were quantifie d separately for the BAPMA
salt vs. other forms of dicamba since the BAPMA salt is (1) only used in agricultural settings and residential inhalation exposures would therefore not be expected, and (2) more toxic than other forms of dicamba with regard to po rtal of entry inhalation toxicity.

• Finally, we assessed the toxicity specific to the counter

- ion of the BAPMA salt, i.e.,
BAPMA itself. The potential for increased risk resulting from this chemical was assessed
and determined to be low relative to the to xicity from the parent compounds and DCSA; therefore, protecting for exposures to the parent compounds and DCSA will also protect for exposures to BAPMA itself.

A. Summary of Toxicological Effects

The toxicology database for dicamba is complete and sufficient for assessing the toxicity and characterizing the hazard of dicamba. Toxicology studies for dicamba acid, its salts [isopropylamine (IPA), diglycolamine (DGA), and N, N

- Bis

- (3

- aminopropyl) methylamine (BAPMA)], and the plant me tabolites [DCSA (3, 6

- dichlorosalicylic acid) and DCGA (3, 6

- dichlorogentisic acid] were all considered for risk assessment of dicamba. In scenarios where

co

- exposure to the various forms could occur, the most protective point of departure (POD) was
utili zed.

Dicamba acid has been classified as having a low acute toxicity via oral, dermal and inhalation routes (Acute Toxicity Categories III or IV). It is both an eye and dermal irritant (Toxicity Category II), b ut it is not a skin sensitizer.6 Dicamba is classified as “not likely to be carcinogenic to humans” based upon the lack of evidence of carcinogenicity in mice and rats in the acid form when tested at adequate dose levels. The Agency determined, based on a reviews of epidemiological data ( see Elizabeth Evans and Shanna Recore, Dicamba: Tier I (Scoping) Review of Human Incidents and Epidemiology

, 11/10/15), that the existing data did not support a conclusion that links human cancer to dicamba

exposure.

B. Toxicological Endpoints and Doses Used in the Human Health Risk Assessment

Once a pesticide’s toxicological profile is determined, EPA identifies toxicological Points of Departure (POD) and Levels of Concern (LOC) to use in evaluating the risk posed by human exposure to the pesticide. For ha zards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological
stud y to determine the dose at which no adverse effects are observed (the No Observed Adverse Effect Level (NOAEL)) and the lowest dose at which adverse effects of concern are identified (the Lowest Observed Adverse Effect Level (LOAEL)). Uncertainty factors ( UF)/safety factors (SF) are used in conjunction with the POD to calculate a safe exposure level

– generally referred to as a Population

- adjusted Dose (PAD) or a Reference Dose (RfD)

– and a safe Margin of Exposure (MOE). For non

- threshold risks, EPA assum es that any amount of exposure will lead to some degree of risk. Thus, EPA estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime.

1. Acute Dietary

The acute dietary endpoint was selected from the dicamba BAPMA salt rat developmental toxicity study, which represents the most sensitive endpoint in the dicamba toxicology database resulting from a single

- dose dietary exposure. The NOAEL is 29 mg/kg/day, and the LOAEL is 86 mg/kg/day based on ataxia, un steady gait, and convulsions in female rats. This NOAEL POD is protective of acute effects of dicamba via the oral route of exposure to the general population, including infants and children. A separate acute dietary endpoint for reproductive females ages
13

- 49 is not required since no acute developmental toxicity effects were observed in the dicamba database. An uncertainly factor of 100X was applied with 10X for interspecies extrapolation from animal to human, and 10X for intraspecies variation in sensiti vity amongst the human population. As discussed in Section C below, the Food Quality and Protection Act (FQPA) safety factor was reduced to 1X, resulting in an aRfD/aPAD of 0.29 mg/kg/day.

2. Chronic Dietary

The chronic dietary endpoint was selected from the DCSA plant metabolite reproduction toxicity study, which represents the most sensitive endpoint in the toxicology database resulting from repeated

- dose dietary exposure. The NOAEL is 4 mg/kg/day, and the LOAEL is 37 mg/kg/day based on decreased pup we ights. The NOAEL POD is protective of chronic effects of dicamba via the oral route of exposure to the general population, including infants and children. A 100X UF was applied (10X interspecies and 10X intraspecies), and the FQPA SF was reduced to 1X

resu lting in a cRfD/cPAD of 0.04 mg/kg/day.7 3. Incidental Oral (Short

- and Intermediate

- Term)

The incidental oral endpoint was selected from the dicamba acid rat multi

- generation reproductive toxicity study, which represents the most appropriate endpoint in the toxicology database for assessing short

- (1 to 30 days) and intermediate

- term (1 to 6 months) incidental oral (hand

- to

- mouth) exposure. The NOAEL is 136 mg/kg/day, with a LOAEL of 450 mg/kg/day based on impaired pup growth. A 100X UF was applied (10X i nterspecies and 10X intraspecies), and the FQPA SF was reduced to 1X resulting in a level of concern of 100.

4. Inhalation (All Durations)

For dicamba acid and the DGA salt inhalation risk assessment for short and intermediate term durations, the POD was based on the route

- specific dicamba acid inhalation toxicity study in Wistar rats with a LOAEL of 0.050 mg/L based on local effects of hyperplasia in the lungs and lymph nodes (NOAEL = 0.005 mg/L, non

- systemic, pulmonary regional deposited dose ratio (RDD R) = 0.590).

The standard interspecies extrapolation UF can be reduced from 10X to 3X for dicamba acid due to the calculation of human equivalent concentrations (HECs) accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. Therefor e, the LOC for dicamba acid inhalation exposures is for MOEs less than 30 (3X for interspecies extrapolation, 10X for intraspecies variation, and 1X for FQPA SF when applicable). The inhalation HEC/HED results are listed in Appendix A.5.

5. Dermal (All Durations)

No dermal endpoint was selected since no adverse effects were observed in the subchronic dermal studies for dicamba acid, IPA salt, and DGA salt up to the limit dose.

6. Cancer

Dicamba is classified as “Not Likely to be Carcinogenic to Human s.” This decision was based on the lack of findings in the cancer studies in rats and mice, which were tested at adequate dose levels to assess the carcinogenicity of dicamba. Mutagenicity studies generally did not demonstrate evidence of mutagenic potenti al for dicamba and the concern for genotoxicity in the
acid form is low. Epidemiology studies were also examined and no links were found t o dicamba exposure and cancer. Additionally, the DCSA metabolite also had a lack of findings in a chronic/carcinogenicity study in rats.

C. FQPA Safety Factor

EPA has determined that the 10X FQPA Safety Factor for protection of infants and children, mentioned above, can be reduced to 1X for the acute and chronic dietary risk assessment for the following reasons and discussed in more detail below: (1) The toxicity database for dicamba is complete with respect to the required 870 guideline studies. (2) For dicamba, there is no8 evidence of increased susceptibility following in utero exposures to rats and ra bbits and following pre and/or post

- natal exposure to rats in a two

- generation reproduction study. For the dicamba acid and BAPMA salt, no developmental toxicity was seen at the highest doses tested in the prenatal developmental studies with rats. (3) Con sistent neurotoxic signs (e.g., ataxia, decreased motor activity, impaired righting reflex and gait) were observed in multiple
studies in rats and rabbits.

After considering the available toxicity data, EPA determined that there is no need for a developme ntal neurotoxicity study or additional UFs to account for neurotoxicity due to the following: (1) although clinical signs of neurotoxicity were seen in pregnant animals, no evidence of developmental anomalies of the fetal nervous system were observed in th e prenatal developmental toxicity studies, in either rats or rabbits, at maternally toxic doses up to 300 or 400 mg/kg/day, respectively; (2) there was no evidence of behavioral or neurological effects on the offspring in the two

- generation reproduction st udy in rats; (3) the ventricular dilation of the brain in the combined chronic toxicity and carcinogenicity study in rats was only observed in females at the high dose after two years of exposure at doses of 127 mg/kg/day. The significance
of this observat ion is questionable, since no similar histopathological findings were seen in two
sub

- chronic neurotoxicity studies at the limit dose or other chronic studies.

There are no residual uncertainties identified in the exposure databases. The acute dietary foo d exposure assessment was performed using tolerance level residues and 100% crop treated assumptions. The chronic dietary food exposure assessment used average residues for crops, tolerances levels for livestock commodities, and percent crop treated assum ptions for several registered uses. Conservative ground and surface water estimates calculated using the latest models were used. Similarly, conservative residential Standard Operating Procedure (SOPs) were used to assess post

- application exposure of child ren as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by dicamba.

1 . Complete ness of the Toxicology Database

The toxicity database for dicamba is adequate to characterize the potential for prenatal or postnatal risk to infants and children. Acceptable rat and rabbit developmental toxicity studies,
two rat 2

- generation reproduction studies, and acute/subchronic neurotoxicity studies in rats are

a vailable.

2. Evidence of Neurotoxicity

There is evidence of neurotoxicity resulting from exposure to dicamba throughout the toxicology database (i.e., impaired gait, impaired righting reflex, ataxia, decreased motor activity, rigidity upon handling, etc ). These signs of neurotoxicity were observed in multiple studies in rats and rabbits. However, after considering the available toxicity data, the Agency determined that a developmental neurotoxicity study (DNT) is not required f or the following reasons: ( 1) although clinical signs of neurotoxicity were seen in pregnant animals, no evidence of developmental anomalies of the fetal nervous system were observed in the prenatal developmental toxicity studies, in either rats or rabbits, at maternally toxic doses up to 300 or 400 mg/kg/day, respectively; (2) there was no evidence of behavioral or neurological effects on the offspring in9 the two

- generation reproduction study in rats; (3) the ventricular dilation of the brain in the combined chronic toxicity and car cinogenicity study in rats was only observed in females at the high dose after two years of exposure at doses of 127 mg/kg/day . The significance of this observation is questionable, since no similar histopathological finding was seen in two sub

chronic ne urotoxicity study at the limit dose or other chronic studies.

3. Evidence of Sensitivity/Susceptibility in the Developing or Young Animal

There is no evidence of susceptibility to the young following in utero exposure to dicamba acid,
dicamba BAPMA or DC SA. Quantitative offspring susceptibility was observed in the 2

- generation reproduction study for the DCSA metabolite based on decreased pup weights, which occurred at a dose at which no parental effects were observed. However, the degree of concern
for th e susceptibility is low, because there is a well

- established NOAEL for offspring toxicity in that study and DCSA has rapid clearance. Additionally, the current points of departure are health protective and therefore address the concern for offspring toxici ty observed in the reproduction
studies.

4. Residual Uncertainty in the Exposure Database

The residential exposure assessment assumes maximum label use rate as well as other conservative assumptions. The acute dietary exposure assessment is based on an e xaggerated exposure scenario which assumes that all commodities being consumed retain tolerance level residues, and the chronic dietary exposure assessment assumes field trial residues in which the crops were treated using the use patterns likely to lead t o maximum residues. Additionally, the drinking water estimates utilized conservative models. Therefore, the Agency does not believe that exposure to dicamba will be underestimated.

D. Cumulative effects

EPA has not made a common mechanism of toxicity findin g for dicamba and any other substance, and dicamba does not appear to produce a toxic metabolite produced by other substances. For the purposes of this Proposed Registration Decision, therefore, EPA has assumed
that dicamba does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pes ticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on
EPA’s website at https://www.epa.gov/pesticide

- science

- and

- assessing

- pesticide

risks/cumulative

- assessment

- risk

- pesticides

.

E. Dietary (Food + Drinking Water) Risk

Dicamba is a selective systemic herbicide used to control a variety of broadleaf weeds and registered for a variety of food/feed uses. Permanent tolerances for dicamba are established under 40 CFR § 180.227 for a wide variety of crops and livestock commodi ties.10 Acute and chronic aggregate dietary food and drinking water exposure and risk assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM

- FCID) Version 3.16. This software uses 2003

- 2 008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).

1. Acute Dietary Risk

For acute exposure assessments, individual one

- day food consumpti on data are used on an
individual

- by

- individual basis. The reported consumption amounts of each food item are multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user basis (i.e., only those who reported eating
relevant commodities /food forms) and a per

- capita basis (i.e., those who reported eating the relevant commodities as well as those who did not). In accordance with EPA policy, per capita exposure and risk are reported for analyses.

Risks are considered to be of no concern when they are less than 100% of the aPAD or cPAD, a value determined by dividing the point of departure for the most sensitive and pertinent toxicological effect for each exposure scenario by required uncertainty fa ctors. The acute analysis was an unrefined determination which used tolerance level residues and assumed 100 percent crop treated (%CT) for all existing and proposed uses. The dietary exposure analyses that were performed result in acute dietary risk estim ates that are below the Agency’s LOC for both food and water. For the U.S. population the exposure was 0.042760 mg/kg/day, which utilized 15% of the acute population adjusted dose (aPAD) at the 95th percentile. The highest exposure
and risk estimates were for all infants (<1 year old). At the 95th percentile, the exposure for all infants (<1 year old) was 0.089 mg/kg/day, which utilized 31% of the aPAD.

2. Chronic Dietary Risk

For chronic dietary exposure assessment, an estimate of the residue level in ea ch food or food

form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food /food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD. This procedur e is performed for each population subgroup.

The chronic analysis was a partially refined determination which used average residues based on field trial studies for crops, tolerance levels for livestock commodities, and relevant % crop treated (CT) data f or several existing uses. The chronic risk estimates for dicamba are below the Agency’s LOC for the general U.S. population and all population subgroups. The highest exposure and risk estimates were for the population subgroup of children ages 1

- 2 with a r isk estimate for dicamba for food and water of 42% of the cPAD.11 F. Residential (Non

- Occupational) Exposure/Risk Characterization

There are no residential uses being proposed for dicamba with this current registration; however, there are existing reside ntial uses of dicamba that have been reassessed in this document to reflect updates to HED’s 2012 Residential SOPs along with policy changes for body weight assumptions. The revision of residential exposures will impact the human health aggregat e risk

asse ssment for dicamba. Registered uses of dicamba include solid and liquid products in concentrates or ready

- to

- use sprays for use as spot and broadcast treatments on turf.

1. Residential Handler Exposure

Based on the currently registered uses, residential handlers may receive exposure to dicamba when mixing, loading and applying the pesticide to lawns and turf. Since there was no dermal hazard identified for dicamba, only inhalation risk estimates were qua ntitatively assessed. The inhalation risk estimates were based on the following application scenarios:

• Mix/Load/Apply Liquid with Hand

- held Equipment

• Apply Ready

- To

- Use Sprays with Hand

- held Equipment

• Load/Apply Granules with Hand

- held Equipment

The MOEs for the exposure scenarios assessed range from 190 to 220,000. Since there is potential risk concern only when inhalation MOEs are less than a LOC of 30, residential handler exposures are not a concern.

2. Post

- application Exposure

There is the potential for post

- application exposure for individuals exposed as a result of being in an environment that has been pr eviously treated with dicamba. Since no dermal hazard was identified for dicamba, the quantitative exposure/risk assessment for residenti al post

- application exposures is based on the following scenarios:

• Children (1 to < 2 years old) incidental oral exposure to treated turf.

• Children (1 to < 2 years old) episodic granular ingestion exposure.

The assessment of post

- application exposure to l iquid formulations is protective of exposure to solid formulations, except for the episodic granular ingestion scenario which was quantitatively assessed. The life stages selected for assessment are health protective for the exposures and risk
estimates fo r any other potentially exposed life stages.

The post

- application assessment for turf includes only the incidental oral routes of exposure. The series of assumptions and exposure factors that served as the basis for completing the residential post

- applica tion risk assessment are detailed in the 2012 Residential SOPs (https://www.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/standard

- operating

procedures

- residential

- pesticide). In addition, chemical

- specific residue data were used in the

assessmen t. The residential post

- application risk estimates are not of concern for dicamba since all MOEs are greater than the LOC of 100 (the lowest MOE = 6600 for use of liquids on lawns).12 3. Residential Bystander Post

- application inhalation exposure

The potential exposure to bystanders from vapor phase dicamba residues emitted from treated fields has been evaluated for the proposed uses of dicamba on dicamba

- tolerant corn and soybean. Bystander exposure to dicamba emitted from treated fields depends o n two main factors: 1) the rate at which these chemicals volatilize from a treated field (described as the off

gassing, emission or flux), and 2) how those vapors are dispersed in the air over and around the treated field. Volatilization can occur during t he application process or thereafter. It can result from aerosols evaporating during application, while deposited sprays are still drying (possibly
via co

- distillation), or after as dried deposited residues volatilize.

Volatilization modeling for a single day was completed using the Probabilistic Exposure and Risk model for Fumigants (PERFUM). There are a variety of factors that potentially affect the emission rates of dicamba and subsequent offsite transport including: field condition (bare soil, growing or mature crop canopy), field parameters (soil type, moisture, etc.), formulation type, meteorological conditions, and application scenario (rate, method).

A chemical

- specific flux study was used to estimate a flux rate of 0.0004 ug/m 2 /s for dicamba.
Th is flux rate, along with an assumption of a single 40 acre field, and using Bradenton, FL meteorological data from Bradenton, FL were used with PERFUM to estimate risk.

The field volatility study suggests that volatilization of dicamba from treated crops d oes occur, which could result in bystander exposure. Results of PERFUM modeling, however, indicate that airborne concentrations are negligible, and even at the edge of the treated fields risk estimates are
not of concern.

4. Spray Drift

Spray drift is alw ays a potential source of exposure to residents nearby to spraying operations.
Off

- target movement of pesticides can occur via many types of pathways and it is governed by a variety of factors. Sprays that are released and do not deposit in the application area end up off

target and can lead to exposures to those it may directly contact. They can also deposit on surfaces where contact with residues can eventually lead to indirect exposures ( e.g. , children playing on lawns where residues have deposited next to treated fields). The potential risk estimates from these residues are calculated using drift modeling coupled with methods employed for residential risk assessments for turf products.

The approach to be used for quantitatively incorporating spray drift into risk assessment s is based on a premise of compliant applications which, by definition, should not result in direct exposures to individuals because of existing label language and other regulatory requirements intended to prevent them. Direct exposure s would include inhalation of the spray plume or being sprayed directly. Rather, the exposures addressed here occur indirectly through contact with impacted areas, such as residential lawns, when compliant applications are conducted. Given this premise, ex posures for children (1 to 2 years old) and adults who have contact with turf where residues are assumed to have deposited via spray drift thus resulting in an indirect exposure are the focus of this analysis, analogous to how exposures to turf products ar e considered in risk

assessment.13 Several dicamba products have existing labels for use on turf, thus it was considered whether the risk assessment for that use would be considered protective of any type of exposure that would be associated with spray drift . Because the registered residential uses on turf result in exposure greater than potential exposure from spray drift, no new residential assessment needs to be completed. If the maximum application rate on crops adjusted by the amount of drift expected is less than or equal to existing turf application rates, the existing turf assessment is considered protective of spray drift exposure. The proposed maximum single application rate of dicamba is
1 lb ae/A

. The highest degree of spray drift noted for any app lication method immediately adjacent to a treated field (Tier 1 output from the aerial application using fine to medium spray quality) results in a deposition fraction of 0.26 of the application rate. For the purposes of the proposed uses on dicamba, this is considered a screening level assumption since the proposed
use is for groundboom applications only. A quantitative spray drift assessment for dicamba is not required because the maximum application rate to a crop/target site multiplied by the adjustment factor for drift of 0.26 is less than the maximum direct spray residential turf application rate 1 lb ae/A for any dicamba products. The turf post

- application MOEs have been previously assessed, are based on the revised SOPs for Residential Exposure Asses sment, and were not found to be of concern, as noted above.

5. Aggregate Risk Assessment

In accordance with the FFDCA, HED must consider and aggregate (add) pesticide exposures and risks from three major sources: food, drinking water, and residential expo sures. In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative estimates of hazard, or the risks themselves can be aggregated. When aggregating exposures and risks from various sources, HED considers both the route and duration of exposure. Since residential exposure is expected, aggregate exposure consists of exposure from residential, food and drinking water sources.

Acute and chronic aggregate risks include only dietary exposure from food and drinking w ater sources. Since there are residential uses, short

- term aggregate risks were assessed which include contributions from food, drinking water, and residential exposure. Intermediate

- term aggregate risks were not considered as residential exposure is not e xpected to occur for more than 30 days. Cancer aggregate risk was not quantified since dicamba is not a carcinogen. A common toxicological endpoint of concern was not identified for short

- , intermediate

- and long

- term durations via the oral, dermal, and in halation routes. Therefore, the aggregate exposure risk assessment should include exposure across the oral routes only, as appropriate for the populations of concern (i.e., food and water for adults; and food, water and incidental oral for children).

a. Acute Aggregate Risk

The acute aggregate risk assessment includes only food and water exposure; therefore, the acute dietary (food and drinking water) assessment represents acute aggregate risk. The acute dietary exposure assessment was conducted using tol erance

- level residues, DEEM default processing factors and 100% crop

- treated information for all registered and proposed use sites. Drinking water values were incorporated directly into the assessment.14 The most highly exposed population subgroup is all infants (<1 year old; 31% of the aPAD). The acute dietary exposure estimates are not of concern for the general U.S. population or any population subgroup

.

b. Short

- term aggregate risk

The short

- term aggr egate risk assessment includes food, water and residential exposure. The resulting short

- term aggregate risks are not of concern for children (MOEs > LOC 100). For adults, since there was no dermal hazard identified in the route

- specific dermal studies and the inhalation effects were not systemic, the chronic dietary assessment is protective for short term aggregate risks.

6. Long

- term aggregate risk

The chronic (long

- term) aggregate risk assessment includes only food and water exposure. The chronic dietary analysis was a partially refined determination which used average residues based on field trial studies for crops, tolerance levels for livestock commodities, and relevant % crop treated (CT) data for several existing uses. The chronic risk estimates for dicamba are below the Agency’s LOC for the general U.S. population and all population subgroups. The highest exposure and risk estimates were for the population subgroup of children ages 1

- 2 with a risk estimate for dicamba for food and water of 42% of th e cPAD.

7. Occupational Risk Assessment

a. Short

- and Intermediate

- term handler Risk

EPA uses the term occupational handler to describe people who mix, load and/or apply pesticides professionally (e.g., farmers, profes sional pesticide applicators). Based on the anticipated use patterns and current labeling, types of equipment and techniques that can potentially be used (e.g., mixing/loading liquids for ground boom application, and applying sprays by ground boom equipment), occupational handler exposu re is expected from the new

uses.

The occupational handler risk estimates are not of concern (i.e., MOEs > LOC of 30) for all of the scenarios for the use of dicamba on genetically

- modified cotton and soybean. At baseline personal protective equipment ( PPE) (i.e., no respirator), the occupational handler inhalation MOEs are 380 for mixer/loaders and 250 for applicators using ground boom equipment.

b. Short and Intermediate term Post

- application Risk

EPA uses the term post

- application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as reentry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, inc luding activities related to crop production, such as scouting for pests or harvesting. Post

- application exposure levels vary over time and depend on such things as the type of activity, the nature of the crop or target that was treated, the type of pestic ide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post

- application exposure.15 i. Dermal Post

- application Risk

There is no pote ntial hazard via the dermal route for dicamba; therefore, a quantitative occupational post

- application dermal risk assessment was not completed.

ii. Inhalation post application Risk

There are multiple potential sources of post

- application inhalation exposure to individuals performing post

- application activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advic e 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 March 2, 2010 ( http://www.regulations.gov/#! documentDe tail;D=EPA

- HQ

- OPP

- 2009

- 0687

- 0037

. The Agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (https://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2014

- 0219

- 00 02). During Registration Review, the Agency will utilize this analysis to determine if additional data (i.e., flux studies, route

- specific inhalation toxicological studies) or further analysis is required for the active ingredient dicamba, generically.

In addition, the Agency is continuing to evaluate the available post

- application inhalation exposure data generated by the Agricultural Reentry Task Force. Given these two efforts, the Agency will continue to identify the need for and, subsequently, the way to incorporate occupational post

- application inhalation exposure into the Agency's risk assessments.

III. Environmental Risk

A summary of the environmental fate and ecological effects, and potential environmental risks
from the use of dicamba on dicamba

- tolerant soybean and cotton is provided below. More detailed discussions can be found in the Agency documents titled, Ecological Risk Assessment for Dicamba and its Degradate, 3,6

- dichlorosalicylic acid (DCSA), for the Proposed New Use
on Dicamba

- T olerant Soybean (MON87708) and Ecological Risk Assessment for Dicamba DGA Salt and its Degradate, 3,6

- dichlorosalicylic acid (DCSA), for the Proposed Post

- Emergence New Use on Dicamba

- Tolerant Cotton (MON 87701), and its addendums entitled, Addendum to
the Environmental Fate and Ecological Risk Assessment for the Section 3 New Use of on
Dicamba

- Tolerant Soybean and Dicamba DGA; Second Addendum to the Environmental Fate and Ecological Risk Assessment for Dicamba DGA salt and its Degradate, 3,6

- dichlorosalic ylic acid (DCSA) for the Section 3 New Use on Dicamba

- Tolerant Soybean . These documents are in
the docket. A fuller description of how these potential risks are assessed can be found

at: https://www.epa.gov/pesticide

- science

- and

- assessing

- pesticide

- risks/ecological

- risk

assessment

- pesticides

- technical

.

A. Environmental Fate

1. Degradation

Dicamba is generally stable to abiotic processes, and is more persistent under anaerobic conditions. It is stable to abiotic hydrolysis at all pH levels and photodegrades slowly in water16 and soil. Under anaerobic soil conditions, the dicamba parent molec ule has a half

- life of 141 days. It is not persistent under aerobic conditions; aerobic soil metabolism is the main degradative process for dicamba, with a half

- life of 6 days. Dicamba was found in two acceptable field dissipation studies in soil segments deeper than 10 cm with half

- lives ranging from 4.4 to 19.8 days. In aquatic systems, dicamba degrades more rapidly when sediment is present and has an aerobic soil metabolism half

- life in sediment

- water system of ~24 days.

The major degradate of dicamba i s 3,6

- dichlorosalicylic acid (DCSA). It is persistent when formed under anaerobic conditions, comprising more than 60% of the applied dose after 365 days of anaerobic incubation in sediment

- pond water system. DCSA is not persistent when
formed under aerobi c conditions and degrades roughly at the same rate as the parent dicamba
with a half

- life of 8.2 days. Like the parent molecule, DCSA is mobile and was also found in the two acceptable field studies in soil segments deeper than 10 cm. If it were to reach a naerobic groundwater, it would likely persist ; however, EPA does not expect DCSA to reach groundwater at levels that would be of concern. DCSA is formed in aerobic soil under laboratory conditions at the maximum of 17.4 % of the applied parent dose. Other minor dicamba degradates of concern
are DCGA and 5

- OH

- dicamba, and both are less toxic than the parent molecule and DCSA. The formation of DCGA in the laboratory studies did not exceed 3.64%, and the formation of 5

- OH dicamba did not exceed 1.9 % in soil

- w ater system during anaerobic aquatic degradation of dicamba under laboratory conditions. DCSA was also a major metabolite in plant metabolism and magnitude of residue studies for dicamba

- tolerant soybean and cotton, comprising approximately 80% and 20%, re spectively, of dicamba

- related residues in plant tissues for these

crops.

2. Mobility

Dicamba is very soluble and mobile. It may reach surface water via field/site runoff, spray drift during application, and by v apor drift from volatilization. It is not exp ected to bioaccumulate in aquatic organisms as it is an anion at environmental pHs. Since dicamba is not persistent under aerobic conditions, very little dicamba is expected to reach groundwater. The major degradage of dicamba, DCSA, is persistent under an aerobic conditions; however EPA does not expect DCSA to reach groundwater at le vels that would be of concern. The major route of exposure to non

target organisms is likely spray drift and runoff. Also, multiple literature studies show that there is a high vapor drift from soybean fields resulting in non

- target plant injury. The assessments related to these routes of exposure are described in the sections below.

3. Runoff

The Agency has considered the potential effects due to runoff, and has developed proposed mitig ation to limit off

- site runoff. A component of the model used to assess terrestrial risk assumes that the mass of pesticide running off the treated field is directly related to the pesti cide’s solubility in water. In the case of dicamba DGA salt, the dissociated salt yield s highly soluble dicamba acid. The model assumes that the high solubility of the acid results in a runoff mass of 5 percent of the field

- applied mass, which is consider ed to be a highly conservative estimate because the model does not account for loss of chemical from degradation, partitioning, or the temporal aspects of runoff (e.g., a rain event following application that exceeds soil’s field capacity).17 4. Spray Drift

The Agency considers spray drift exposure to be the principal risk issue associated with the proposed label use of dicamba DGA salt, owing to a variety of lines of evidence, including past experience with other dicamba formulations. In addition, visual ob servations of off

- field plant damage have been reported following dicamba applications, likely the result of subsequent spray
drift and/or volatilization of dicamba residues.

The Agency used a weight of evidence approach incorporating spray drift modeling, a spray drift droplet deposition study, and raw data from field trials to determine an appropriate in

- field buffer to avoid dicamba exposure to non

- target organ isms (e.g., endangered plants). EPA has also determined that the label must specify that nozzle s must be used that produce extra

- course and
ultra

- course droplet spectra for application to reduce the potential for spray drift. Based on the weight of evidence approach, EPA determined that labels must include language to maintain an
in

- field buffer (t o the edge of the field in all directions) of 100 feet when applying at the 0.5 lb a.e./A application rate and 220 feet when applying at the 1.0 lb a.e./A application rate in order to restrict the movement of residues to the field. Using these buffers, exp ected residues at the field's edge from spray drift would be below apical endpoints for the most sensitive tested species ( i.e. NOAEC for soybean plant height)

.

5. Volatilization

After reviewing submitted data relating to the volatility of dicamba , the Agency had concerns regarding the volatility of dicamba, and possible post

- application, vapor

- phase off

- site transport
that might damage non

- target plants. Monsanto responded to these concerns with a submission that acknowledged the long

- recognized v olatility of dicamba acid and described measurements
of the volatilization in the different formulations.

Though the Agency found the information helpful, the submission did not include enough detail to verify the measurements in the studies. Therefore, in order to be protective of potential effects

to non

- target plants from volatilization, labels must include language to maintain an in

- field buffer (to the edge of the field in all directions) of 100 feet when applying at the 0.5 lb a.e./A application rate and 220 feet when applying at the 1.0 lb a.e./A application rate. Although the Agency is not requiring additional data to be submitted at this time, if EPA receives volatility data under varied conditions of temperature and relative humidity, as these fact ors play a strong role in volatility under field conditions, it may reconsider whether this mitigation requirement is

necessary.

EPA is aware that for use of dicamba in Arkansas, the Arkansas Plant Board has an in

- field buffer that is greater than what is being proposed by EPA (400 feet as opposed to 110 to 220 feet). EPA has reviewed the information associated with the larger buffer in Arkansas to asses s why these differences exist. EPA’s buffer is determined by evaluation of plant toxicity data required under FIFRA and conducted under GLP conditions where apical endpoints, plant height, and yield, are used as measures of plant growth and reproduction. Once the no observed adverse effect concentration (NOAEC) was determined for the most sensitive endpoint ( i.e., plant height) for the most sensitive plant species tested ( i.e., soybeans), EPA uses field studies and modeling to determine the distance from site of application to where the NOEC is not expected to be exceeded. It is further noted that the labels for the proposed uses will specify a spray nozzle and pressure combination that is expected to reduce drift of the herbicide, which are18 drift reduction measures not on the previously registered dicamba formulations and could also influence the size of a pr otective buffer. In telephone conversations between EPA and the Arkansas Plant Board, it was reported that Arkansas’ buffer distance of 400 feet was not computed as a result of submitted data, but as a precautionary measure that was based on
information and observations from extension specialists from Arkansas and neighboring states, discussions with Monsanto, and historical information involving qualitative visual observations of damage in the field with products not containing the specific nozzle and pr essure requirements contained on the proposed label

. The Arkansas Plant Board felt that a 400 foot buffer should exceed what would be necessary to protect neighboring crop fields that are directly adjacent to
fiel ds receiving dicamba treatment. The Arkansa s Plant Board also reports that their buffer requirement may be revisited and/or removed after a period of initial use (if registered) once
additional observations are made.

B. Ecological Risk

Ecological risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. The process of integrating the results of exposure with the ecotoxicity data is c alled the risk quotient method. For this method, risk quotients (RQs) are calculated b y dividing exposure estimates by ecotoxicity values, both acute and chronic (RQ = Exposure / Toxicity). RQs are then compared to EPA’s levels of concern (LOCs). The LOCs are criteria used by the Agency to indicate potential risk to non

- target organisms. T he criteria indicate whether a pesticide, when used as directed, has the potential to
cause adverse effects to non

- target organisms.

For terrestrial animals, the Agency’s acute risk LOCs are set at 0.5 for non

- listed species and 0.1 for listed species. Fo r aquatic animals, acute risk LOCs are also set at 0.5 for non

- listed species
but for listed species, they are set at 0.05. The chronic risk LOC is set at 1.0 for both te rrestrial and aquatic animals. For plants, acute risk LOCs are set at 1 for both non

- l isted and listed species. The potential difference in sensitivity for listed plant species compared to non

- listed plant species is addressed through the use of different toxicity endpoints in the RQ equation [the concentration causing effects to 25% of the test population (EC25) for non

- listed plants vs the NOEC or concentration causing effects t o 5% of the test population (EC05) for listed species]. Chronic risk is not assessed for plants.

Dicamba is currently registered for use on several food and non

- fo od use sites, including cotton and soybean. The proposed uses on dicamba

- tolerant soybeans and cotton would expand the timing of applications from pre

- emergence and pre

- harvest only for soybeans and pre

- emergence and post

- harvest only for cotton to allowin g post

- emerge nce over

- the

- top applications. The maximum yearly application rates would remain 2.0 lb a.e./acre for both cotton and soybeans. However, as detailed in section I of this document, the applicator could now split the 2.0 lb a.e./acre between pr e

- emergence and post

- emergence applications.

EPA has a specific process based on sound science that it follows when assessing risks to listed species for pesticides like dicamba that will be used on seeds that have been genetically modified
to be tolerant to the pesticide. The Agency begins with a screening level assessment that includes a basic ecological risk assessment based on its 2004 Overview of the Ecological Risk Assessment Process document. [USEPA, 2004, available at http://www.epa.gov/oppfead1/end anger/litstatus/riskasses.htm ]. That assessment uses broad19 default assumptions to establish estimated environmental concentrations of particular pesticides. If the screening level assessment results in a determination that no levels of concern are
exceeded , EPA concludes its analysis. On the other hand, where the screening level assessment does not rule out potential effects (exceedances of the level of concern) based on the broad default assumptions, EPA then uses increasingly specific methods and exposure models to refine
its estimated environmental concentrations.

The results of the screening level risk assessments indicate that the RQs do not exceed the Agency’s LOC for terrestrial invertebrates (including pollinators), freshwater fish, aquatic

- phase

am phibians, estuarine/marine fish, freshwater invertebrates, or estuarine/marine invertebrates for either acute or chronic exposures. Acute RQs for aquatic plants and mammals, and chronic RQs for birds, reptiles, and terrestrial

- phase amphibians also do not exceed the Agency’s LOC. The screening level assessment uses broad default assumptions to establish estimated environmental concentrations of particular pesticides. It does not make effects determinations related to any particular listed species. Instead, species

- specific assessments are conducted for effects determinations. A more detailed description can be found in Section IV below.

For both cotton and soybeans, based on the proposed maximum application rates, the screening level analysis indicates that risks for acute exposure to listed and non

- listed birds, and listed and

non

- listed terrestrial dicot plant species, result in RQs that exceed the Agency’s LOCs. For soybeans, there is also a potential for direct adverse effects to birds and mammals from ch ronic exposure to the dicamba degradate DCSA. Though the rates are similar to those in currently registered dicamba pesticide products, there is potential for ecological concerns related to a potential increase in acres treated with dicamba products, resul ting in additional acres with
residues of DCSA in dicamba

- tolerant soybeans. Before considering mitigation measures, EPA also found a potential for increased susceptibility of direct adverse effects to late season plants from spray drift.

While concern lev els are exceeded in the screening level assessment, further refinement, as discussed below, suggest that risks are lower.

1. Risk to Birds

For birds, the screening level assessment indicated that the RQs exceeded the Agency’s LOCs on an acute basis for both soybean and cotton. More specifically, the screening level assessment
found that the acute LOCs are exceeded for listed and non

- listed b irds, with a maximum acute
dose

- based RQ of 2.21 for small birds consuming short grass. Chronic LOCs were also exceeded for birds feeding on DCSA residues in dicamba

- tolerant soybeans, with a maximum chronic dietary RQ of 1.7 for small birds consuming soyb ean forage/hay.

The Agency’s screening level assessment employed residue estimates based on reasonable upper bound modeling assumptions for dicamba DGA residues on food items consumed by birds. These residue estimates have been developed for a variety of wildlife food items, and are based on measured residues from a large number of fi eld trials on many pesticides. The Agency’s assessment also used the maximum labeled rate of the pesticide and the empirical maximum
measured concentrations for DCSA residues in dicamba

- tolerant soybeans and cotton plan ts to determine the RQ values. To represent a maximum, or “worst

- case” estimate of risk, these high

end exposure estimates for a variety of food items were compared, across a variety of body weights and sizes, t o the most sensitive oral dose toxicity endpoint in order to generate RQs.20 Some of these RQs exceeded the LOC. While the LOCs were exceeded, further consideration of all lines of evidence shows that risks under more realistic use scenarios are expected to be lower. For example, high

- end dicamba residues compared to endpoints from toxicity studies using chemicals incorporated in the animal’s diet do not trigger concerns, suggesting that dicamba consumed in the diet may possibly be less available than assum e d using dose

- based

exposures. Further, more frequently expected residues levels, such as mean or median estimates of exposure, would be lower by a factor of two or more, suggesting that residues are often not likely to trigger concerns for many food items. In addition, estimates of exposure in screening level assessments are the maximum levels expected, and represent residues at the actual point of

ap plication, right on the field. The exposure analysis in this screening level risk assessment
indicates that the transport of dicamba off

- field by spray drift decreases with distance, suggesting that exposures to dicamba, and therefore associated risks, can be substantially lower for organisms with territories established at distance from the field. With this la st line of evidence in mind, the draft pesticide label requires an in

- field 110 to 220

- foot buffer to further reduce off

- site exposure for birds (buffer is discussed in more detail in the “Risk to Plants” section, below). Exposures to DCSA residues are on ly expected for birds feeding on dicamba

- tolerant plants on the field, and are not expected off the field, regardless of spray drift of parent dicamba residues.

2. Risk to Mammals

For parent dicamba, none of the RQs for mammals exceed any of the Agency’s LO Cs. Acute RQs range from <0.01 to 0.04 and chroni c RQs range from 0.01 to 0.84. However, the screening level assessment using the maximum exposure values from empirical datasets for DCSA residues
in dicamba

- tolerant soybean resulted in exceedances of the chronic LOC for all size classes of mammals consuming soybean forage and hay, or consuming insects that had consumed soybe an tissues with DCSA residues. These RQs range from 1.1 to 3.3. A screening level assessment using the maximum exposure values from e mpirical data for DCSA residues in dicamba

- tolerant cotton did not result in exceedances of the chronic LOC for any mammal (chronic RQs ranged from <0.01 to 0.34).

The Agency’s screening level assessment employed residue estimates based on reasonable upper bound modeling assumptions for dicamba residues, the maximum labeled rate of the pesticide, and the empirical maximum measured concentrations for DCSA residues in dicamba

- tolerant soybeans and cotton plan ts to determine the RQ values. EPA further consider ed more realistic residue estimates and other lines of evidence, such as food preferences and foraging ranges relative to distance from the site of application. This analysis showed reduced concerns for adverse effects because larger mammals have more vari ed diets and larger home ranges where feeding is more likely to occur well away from treatment areas.

Consideration of these lines of evidence also produces reduced risk estimates for small herbivorous mammals, due to reduced exposure, but does not reduc e risk estimates for these organisms to the point that c oncern levels are not exceeded. As in the case for birds, the draft pesticide label requires an on

- field 110 to 220

- foot buffer in all directions to further reduce off

site exposure for mammals (buffer is discussed in more detail in the “Risk to Plants” section, below). Exposures to DCSA residues are only expected for mammals feeding on dicamba

tolerant plants on the field, and are not expected off the field, regardless of spray drift of parent
dicamba residues.21 3. Risk to Plants

For aquatic plants, the only RQ that would exceed an Agency LOC of 1.0 is for any listed non

vascular aquatic plants for the par ent dicamba, with an RQ of 8.5. However, ther e are currently
no listed non

- vascular aquatic plants.

Dicamba exposure to terrestrial and semi

- aquatic plants was estimated through modeling for plants residing near a use area that may be exposed via runoff and/or spray drift. Only a single application a t the maximum rate for a particular use and compound

- specific solubility information is considered, because it is assumed that for plants, toxic effects are likely to manifest shortly after the initial exposure, and that subsequent exposures do n ot contrib ute to the

response. Hence, estimates are based on application rate, the solubility factor, and default assumptions of drift.

For a single application of dicamba at the maximum label rate for the proposed uses, the RQs exceeded the LOC (1.0) for terrestria l dicots due to spray drift, and for dicots in semi

- aquatic

areas due to runoff and spray drift. The RQs for dicots in semi

- aquatic areas were 4.15 for non

listed species and 7.58 for listed species. The RQs for spray drift were 19.49 for non

- listed speci es of dicots and 38.3 1 for listed species of dicots. The RQs for dicots in dry areas were 0.49
for non

- listed species and 0.89 for listed species which are both less than the LOC for plants of
1.0.

Although the RQ analysis indicated there may be risks to plants from runoff and spray drift, studies conducted on the dicamba DGA formulation demonstrates that labeling restrictions will help to reduce spray drift off field. The registrant submitted additional studies for a refined spray drift analysis using the specific Tee Jet® TT11004 nozzles and the formulation in its application for registration. The analysis indicates that the dicamba product applied through the specific Tee Jet® TT11004 nozzle is protective of plants from exposures of the M1691 herbicide w hen an adequate buffer is incorporated between the application equipment and the edges of the treated
field

. Additionally, to further mitigate against potential risks to plants from spray drift, the product labeling requires the use of 110

- 220 foot (depending on application rate) buffer between the last treated row and the closest edge of the field to be treated (in all directions). The Agency considered exposure to spray drift to be the principal risk issue associated with the proposed labeled use for all taxa. EPA considered a variety of lines of evidence, including past experience
with other dicamba formulation s and associated spray drift incident reporting.

4. Synergism

EPA is aware that a common agricultural practice involves tank mixing of pesticides, resulting in
the co

- occurrence of chemical stressors to non

- target plants including endangered species. This

p henomenon has been described in academic research as well as patent application filings where the combined mixture is sometimes claimed to have enhanced activity or synergistic effects. In EPA’s risk assessments, the Agency uses GLP guideline studies to d etermine potential toxicity to plants, involving apical endpoints such as bi omass and reproductive health. EPA believes this approach is ver y reliable for these purposes. However, at this time, the topic of synergy and multiple stressors is an uncertainty in assessing risk to non

- target plants including endangered22 species. Therefore, EPA is proposing a tank mix prohibition on the M1691 label to address this uncertainty.

IV. Endangered Species for Dicamba Diglycolamine Salt (DGA)

Below is a summary of the endangered species assessments for dicamba (DGA). More detailed discussions can be found in the EPA documents titled, Addendum to Dicamba Diglycolamine Salt (DGA) Section 3 Risk Assessment: Refined Endangered Species Assessment fo r Proposed
New Uses on Herbicide

- Tolerant Soybean and Cotton in 16 states (Arkansas, Illinois, Iowa, Indiana, Kansas, Louisiana, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Dakota, Tennessee, and Wisconsin); Addendum to Dicamba Diglycolamine (DGA) Salt Section 3 Risk Assessment: Endangered Species Effects Determinations for Dicamba
DGA on Herbicide

- Tolerant Cotton and Soybean in 7 U.S. States: AL, GA, KY, MI, NC, SC, and TX; and Addendum to Dicamba Diglycolamine (DGA) Salt Section 3 Risk Assessment: Endangered Species Effects Determinations for Dicamba DGA on Herbicide

- Tolerant Cotton and Soy in 11 U.S. States: AZ, CO, DE, FL, MD, NM, NJ, NY, PA, VA and WV. These documents are in the docket for this proposed decision.

In the screening level risk assessment performed for the new application timing of dicamba (DGA) on genetically modified cotton and soybean to be tolerant to dicamba, EPA determined that direct concerns were unlikely ( i.e . levels of concern were not exceed ed) for mammals (acute) and (chronic

- for cotton use only), birds, reptiles, and terrestrial

- phase amphibians (chronic from parent dicamba or DCSA degradate from use on cotton), terrestrial insects, freshwater fish, aquatic

- phase amphibians (acute and chro nic), estuarine/marine fish (acute and chronic), freshwater invertebrates (acute and chronic), estuarine/marine invertebrates (acute and chronic), and aquatic plants (vascular and non

- vascular). However, potential indirect effect risk
concerns were identif ied for any species that have dependencies (e.g., food, shelter, and habitat) on mammals, birds, reptiles, terrestrial

- phase amphibians, or terrestrial plants that are directly
affected.

EPA has a specific process based on sound science that it follows wh en assessing risks to listed species for pesticides like dicamba that will be used on seeds that have been genetically modified to be tolerant to the pesticide. The Agency begins with a screening level assessment that includes a basic ecological risk asse ssment consistent with its 2004 Overview of the Ecological Risk Assessment Process document. [USEPA, 2004, available at https://www.epa.go v/endangered

species/ecological

- risk

- assessment

- process

- under

- endangered

- species

- act ]. That assessment uses broad default assumptions to establish estimated environmental concentrations of particular pesticides. If the screening level assessment results in a determination that no levels of concern are exceeded EPA concludes its analysis. On the other hand, where the screening level assessment does not rule out potential effects (exceedances of the level of concern) based on the broad default assumptions, EP A then uses increasingly specific methods and exposure models to refine its estimated environmental exposures. At each step, EPA compares the more refined exposures to the toxicity of the pesticide active ingredient to determine whether the pesticide excee ds levels of concern established for listed aquatic and terrestrial species. EPA determines that there is “no effect” on listed species if, at any step in the screening level assessment, no levels of concern are exceeded. If, after performing all of the s teps in the screening level assessment, a pesticide still23 exceeds the Agency’s levels of concern for listed species, EPA then conducts a species

- specific refined assessment to make effects determinations for individual listed species. The refined

assessmen t, unlike the screening level assessment, takes account of species’ habitats and behaviors to determine whether any listed species may be affected by use of the pesticide.

The screening level ecological risk assessment generates a series of taxonomic (e. g., mammals, birds, fish, etc.) risk quotients (RQs) that are the ratio of estimated exposures to acute and chronic effects endpoints. These RQs are then compared to EPA established levels of concern (LOCs) to determine if risks to any t axonomic group are of concern. The LOCs address risks for
both acute and chronic effects. Acute effects LOCs range from 0.05 for aquatic animals that are Federally

- listed threatened or endangered species (listed species) to 0.5 for aquatic non

- listed animal species and 0.1 t o 0.5 for terrestrial animals for listed and non

- listed species. The LOC
for chronic effects for all animal taxa (listed and non

- listed) is 1. Plant risks are handled in a similar manner, but with different toxicity thresholds (NOAEC/EC 05 and EC 25, respectively) used in RQ calculation for listed and non

- listed species and an LOC of 1 used to interpret the RQ. As described above, if the screening level assessment shows that an RQ exceeds either the acute or chronic LOC, a concern for direct toxic effe cts is identified for that particular taxon and a species

- specific assessment is necessary to make an effects determination. On the other hand, if RQs fall below the LOC, a no effect determination is identified for the corresponding taxon.

This registrat ion for dicamba is being proposed for registration for use in the states of Alabama, Arkansas, Arizona, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Ne w Mexico, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin. Additional states may be added to the labeling once an assessment of listed species is completed for any
such state.

Based on EPA’s LOCATES v.2.4.0 database and information from the U.S. Fish and Wildlife Service (USFWS), EPA identified the listed species that are inside the “action area” (area of concern where use of pesticide may result in exposure to endangered species) associated with the new cotton and soybean uses within a total of 30 states.

The following criteria were used to assess listed species in the action area:

• For listed individuals inside the action area but n ot part of an affected taxa nor relying on the affected taxa for services involving food, shelter, biological mediated resources necessary for survival and reproduction, use of a pesticide would be determined to have
“no effect.”

• For listed individuals outside the action area, use of a pesticide would be determined to
have “no effect.”

• Listed individuals inside the action area may either fall into the “no effect” or “may effect” categories depending upon their specific biological needs and circumstances of

exposure.24 • Those that fall under the “may effect” category are found to be either “likely” or “not likely to be adversely affected.” This determination is made in consultation with the
Services

• A “likely” or “not likely to adve rsely affect” determination is made using criteria that categorizes the effect as insignificant, highly uncertain, or wholly beneficial.

Spray drift mitigation language including a 360 degree infield buffer (to varying length, depending on application r ate) on the label is intended to limit off site transport of dicamba DGA through spray drift, as well as volatilization

. Therefore, EPA expects that exposure will remain confined to the dicamba (DGA) treated field. Consequently, EPA concluded a no effect determination for all but 24 species originally identified as potentially at

- risk (in the screening level assessment) because they are not expected to occur on cotton and soybean fields. The 24 remaining listed species that were not ruled out because the ir range contains areas that include treated fields were considered in more depth in EPA’s refined endangered species assessments. Species

- specific biological information along with dicamba (DGA) use patterns were also considered. After utilizing processes such as refined modeling incorporating species

specific information and migration habits, EPA made a determination that exposure occurring on the field would have “may affects” (either "unlikely to adversely affect" or “likely to adversely affect” on 2 sp ecies (the Spring Creek Bladderpod and the Audubon Crested Caracara) in 2 counties (Wilson county, TN and Palm Beach county, FL, respectively) within the States covered by this proposed decision. Furthermore, the Agency has concluded that the 2 species in question will not be of concern as the registrant has agreed to include on the final labeling a prohibition on application in both counties, thus mitigating any possible chance of exposure.

Additionally, the Agency considered the potential effects attribu ted to runoff. As refined modeling predictions indicate that expected exposures from runoff (sheet flow) are below the most sensitive toxicological endpoint thresholds, EPA’s analysis supports a “no effects” determination for runoff exposure for off

- field listed plants for the proposed lab eled use of
dicamba DGA. Additionally, EPA is proposing to require rainfast mitigation on the label (“Do not irrigate treated fields for at least 24 hours after application of this product . Do not make application of this product if rain is expected in the next 24 hours.”) to protect against the risk of exposure to listed species off the treated field.

V. Resistance Management

The emergence of herbicide resistant weeds is an increasing problem that has become a significan t issue to growers. This has led to a concern that the use of dicamba on genetically

modified crops may result in over

- reliance on dicamba and result in a larger number of resistant
weeds. Currently, in certain areas of the United States there are populat ions of Kochia and prickly lettuce known to be resistant to dicamba. Kochia infests millions of acres of soybean and cotton and, in addition, glyphosate

- resistant biotypes have been identified in Kansas and
Nebraska.

In an effort to address these issues, EPA is proposing, as a term of registration, that Monsanto develop an Herbicide Resistance Management (HRM) plan that will promote herbicide resistance management efforts by growers, the registrant, and others. The plan mandates that
Monsanto must investi gate any reports of lack of performance. Dicamba users who experience a25 lack of performance can communicate directly with Monsanto by a toll free telephone number that is identified on the label to get advice on how to resolve any uncontrolled weeds.

“Lac k of performance” refers to inadequate weed control with various possible causes, including, but not limited to: application rate, stage of weed growth, environmental conditions, herbicide resistance, plugged nozzle, boom shut off, tank dilution, post

- appl ication weed flush, unexpected rainfall event, weed misidentification, etc. It can be challenging to distinguish emerging weed
resistance from other causes at an early stage. Therefore, EPA has identified criteria that should
be used to evaluate instances of “lack of performance” to determine if they do in fact constitute “likely herbicide resistance.” These “likely herbicide resistance” criteria are: (1) failure to control a weed species normally controlled by the herbicide at the dose applied, especially if control is achieved on adjacent weeds; or (2) a spreading patch of uncontrolled plants of a particular weed species; or (3) surviving plants mixed with controlled individuals of the same

spec ies (Norsworthy, et al., 2012). The identification of any of these criteria in the field indicates that “likely herbicide resistance” is present. The responsibilities of the registrant if “likely
herbicide resistance” is found are discussed below.

Researchers, extension specialists, growers, USDA, and other leaders involved with pest management all acknowledge the importance of scouting (e.g., monitoring the fields) in herbicide resistance management. For the proposed uses, the labeling states that fields should be scouted before application of dicamba to identify t he weed species present as well as their stage of growth. Fields also should be scouted after each application to identify lack of performance that may be the early signs of resistance. Additionally, the labeling states that in the event that a

user encoun ters lack of performance they should report this to Monsanto or its representative using the toll

- free number identified on the label. The registrant must then evaluate the situation to determine if lack of performance is caused by resistance or likely res istance.

When a lack of performance is identified and reported to the registrant, Monsanto or its representative must investigate and conduct a site visit if needed to evaluate the lack of performance using decision criteria identified by leading weed scie nce experts in order to determine if “likely herbicide resistance” is present (also termed “possible resistance” by Norsworthy [i] , et al., 2012). A report of lack of herbicide performance to Monsanto will be the trigger to start this investigation.

When Monsanto or its representative applies the Norsworthy, et al., criteria cited above, and likely herbicide resistance is identified, Monsanto must proactively engage with the grower to control and contain likely resistant weeds in the infested area. T his may be accomplished by re

treating with an herbicide or using mechanical control meth ods. After implementing these measures, Monsanto must follow

- up with the growers, with the growers’ permission, to determine if the likely resistant weeds have been co ntrolled. Monsanto must also annually report to EPA findings of likely herbicide resist ance. In addition, prior to implementing control measures, Monsanto must make best efforts to obtain samples of the likely herbicide resistant weeds and/or seeds, and a s soon as practicable, laboratory or greenhouse testing must be initiated in order to confirm whether resistance is the reason for the lack of herbicide efficacy.

Beginning January 15 th , 2018, on or before January 15 th of each year, Monsanto must submit

an nual summary reports to EPA. These reports must include a summary of the number of instances of likely and confirmed resistance by weed species, crop, county and state. These reports will also summarize the status of laboratory or greenhouse testing for resistance. The26 annual reports will also address the disposition of incidents of likely or confirmed resistance reported in previous years.

Monsanto must report annually any inability to control likely resistant weeds to relevant stakeholders. To accompli sh this, Monsanto must establish a website to facilitate delivery of
resistance information to users.

Several best management practices that are designed to help users avoid initial occurrences of weed resistance appear on the proposed dicamba product labe l listed under the Herbicide
Resistance Ma nagement heading of the label. These practices are discussed in Section VIII.B.3
of this document.

Refer to Section VIII.C below for EPA’s terms of registration to address the issue of weed
resistance.

VI. Response to Comments

The Agency received 1 1 comments in response to the Notice of Receipt (Docket Number: EPA

HQ

- OPP

- 2010

- 0496) for the application to register the use of dicamba on genetically

- modified soybeans and no comments in response to the Notice of Receipt (Docket Number: EPA

- HQ

OPP

- 2012

- 08 41) for the application to register the use of dicamba on genetically

- modified

cotton. The majority of comments expressed concern (e.g., spray drift and volatilization) and requested that the Agency deny the proposed registration. The EPA welcomes input f rom the public during the decision process when registering pesticides, and is committed to thoroughly evaluating and mitigating any potential risks from registered pesticides, consistent with applicable statutory standards. EPA considered the public comm ents received in this regulatory
decision.

The commenters focused on spray drift and volatilization concerns affecting non

- target plants. The Agency has evaluated the risks regarding the potential drift of pesticides to sensitive crops and other non

- targe t plants that may be adjacent to treatment areas

. Specific label directions and restrictions have been proposed to protect from off

- target movement of this pesticide product. Specifically, the proposed registration decision requires a 110

- 220 foot buffer
b etween the treated area and edge o f the field in all directions. These buffers are expected to keep spray drift from moving beyond the edge of the crop field to be treated as well as reduc e the
concern for volatil i ty

. In addition, the label will specify a spray nozzle and pressure combination that is expected to reduce drift of the herbicide to d istances within these buffers. The proposed regulatory decision also specifies that this product cannot be applied when the wind speed is over 15 mph, and no ae rial application is permitted. Label language regarding spray volume, equipment ground speed, and spray boom height is intended to further protect against off

- target drift. More details on EPA’s and Monsanto’s efforts to minimize effects to non

- target plant

sp ecies can be found in Section VIII.B.4 of this document.

Commenters also expressed concerns that weeds resistant to dicamba will become more prevalent as a result of this proposed use. Weed resistance is an increasing problem that has become a significant economic issue to growers. In an effort to address this concern and to prevent new weed resistance from happening, while giving growers another essential tool in their integrated pest management programs, Monsanto must put into place a stewardship program to promote responsible use of the proposed product in order to minimize the potential for increased27 levels of weed resistance. This plan is discussed in detail in Section V and Section VIII.B.3 of
this document.

VII. Benefits

Growers throughout the United States have experienced yield and economic losses due to weeds developing resistance to the herbicide glyphosate and other heavily used herbicides. The need for additional tools to manage these resistant weeds has become impor tant as resistance to both glyphosate and other herbicides has become a significant financial, production and pest managment issue for many cotton and soybean growers. Weeds such as marestail, giant ragweed, common waterhemp, and Palmer amaranth can be dif ficult to control during the crop growing

season. urrent registered uses of dicamba only allow for pre

- plant application and post

- harvest application in cotton for conventional or conservation tillage systems. Similarly, the currently registered use of d icamba on soybeans only allows for preplant application along with a pre

harvest broadcast or spot treatment application. New postemergence uses of dicamba would expand weed management options on genetically

- modified cotton and soybeans by providing an
add itional mechanism of action during the growing season. Dicamba used during the season would target new flushes of weeds, thereby reducing populations of these weeds and particularly would help reduce seed banks. Postemergence use of dicamba will expand opt ions for weed control in cotton and soybeans and enable control of broadleaf weeds, including glyphosate

resistant biotypes.

VIII. Proposed Registration Decision

In accordance with FIFRA, EPA only registers a pesticide when it can ensure that it will not cause unreasonable adverse effects on man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of the pesticide. Under FIFRA, EPA is charged with balancing the uncertainties and risks posed by a pesticide agains t its
benefits. EPA must determine if the benefits in light of its use outweigh the risks in order for the Agency to register a pesticide.

In the case for the proposed use of dicamba on dicamba

- tolerant soybeans and cotton, and in
considera tion of all best available data and assessment methods, EPA believes this proposed decision to register these uses meets the requirements of FIFRA. The database submitted to support the assessment of human health risk is sufficient for a full hazard evaluation and is considered adequate to evaluate risks to infants and children. The Agency has not identified any risks of concern in regards to human health, including all population subgroups, or for occupational handlers.

In terms of ecological risk, some levels of concern were exceeded for certain birds and mammals that may be in th e fields that would be treated. The Agency notes that these are ver y conservative risk estimates using screening level (worst case) assumptions, and that they most likely do not apply to the majority of the birds and mammals that are outside of the treatment area. For example, it is assumed that animals would forage for f ood exclusively in the treated area consuming only the treated crop, neither of which is likely to be true

. Additionally, the protections afforded by the labeling, such as the requirement of infield buffers, would reduce the likelihood of spray drift and v olatilization that could affect organisms loc ated beyond the treated28 field. Because of these additional restrictions, EPA expects the proposed uses to have less environmental impact than other currently registered products that d o not require the same
buff ers. It is also noted that, if further refinements that included more realistic exposure scenarios were conducted, these risks would likely fall below the Agency’s level s of concern.

On the benefits side of the analysis, use of dicamba on dicamba

- tolerant soybeans and cotton is expected become an important part of a resistance management strategy for these crops. Soybeans and cotton are extremely important agricultural commodities in th e United States and
the world. According to the USDA’s National Agricul tural Statistics Service, soybeans are
grown on approximately 85 million acres and cotton is grown on approximately 9 million acres. USDA’s Economic Research Service describes soybeans as the world's largest source of animal protein feed and the second la rgest source of vegetable oil, and describes cotton as one of the most important textile fibers in the world, accounting for around 35 percent of total world fiber
use. The United States is the world’s leading soybean producer and exporter, and together with China and India provide two

- thirds of the world's cotton. USDA estimates the gross value of soybean production at approximately 48 billion dollars in the United States, and soybean is grown throughout the United States with more than 80 percent of U.S. soybean acreage

conc entrated in the upper Midwest. The g ross cotton production is estimated by USDA at over 6 billion dollars in the United States, and is gr own in 17 states stretching across the south ern half
of the United States. However, resistance to glyphosate, the current market leader in soybeans and cotton, is having severe economic consequences in soybean and cotton production. The
Weed Science Socie ty of America and other weed control experts warn that the problem of glyphosate resistance is increasing, and that significant economic consequences will continue to
increase without effective alternative s for weed control.

Consequentially , use of dicamba on dicamba

- tolerant soybeans and cotton would be beneficial as it provides an effective tool to treat especially noxious weeds such as marestail, giant ragweed, common waterhemp, and Palmer amaranth, including glyphosate

- resistant biotypes that threaten

s oybea n and cotton production today. By adding an effective tool to combat glyphosate

- resistant weeds, dicamba could help reduce this difficult weed pressure and aid significantly in production, reducing economic losses to soybean and cotton growers. In add ition, effective treatment of glyphosate

- resistant weeds can help control the spread of resi stance. And, as stated previously, using dicamba for these uses according to the proposed labeling restrictions will include protections such as in

- field buffers, b est practice requirements for drift management and application techniques, and active resistance management stewardship of weed populations.

After weighing all the risks of concern against the benefits of the proposed uses, EPA finds that when the proposed mitigation measures are applied, the risks that may remain are minimal, if they exist at all, while the b enefits are potentially great. Therefore, the benefits outweigh the risks and registering these uses will not generally cause unreasonable adverse eff ects on human health or the environment during the 5

- year time limited registration being proposed (a 5

- year registration is proposed so that any unexpected weed resistance issues that may result from the proposed uses can be addressed before grant ing an e xtension or EPA can allow the registration to terminate if necessary). EPA believes that the available data and scientific assessments as well as the overall considerations for benefits for weed management in these important crops support a
FIFRA Section 3 (c)(5) registration finding for the proposed uses.29 A. Data Requirements

There are no outstanding data requirements required to support t he registration of this action. However, data may be required in connection with registration review activities for dicamba. Those requirements would be generic to dicamba uses and products in general and would be handled in accordance with the registration review process.

B. Labeling Req uirements

The following labeling is included in the proposed supplemental labels unless otherwise noted
below.

1. Worker Protection (Although the following Worker Protection labeling applies to the proposed new uses, it is not included in the proposed supple mental labeling. This labeling can be found in the previously accepted master labeling that was accepted by the Agency on September 18, 2013 for this product.)

Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application. For any requirements specific to your state or tribe, consult the agency responsible for pesticide regulation.

Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 24 hours.

PPE required for mixers, loaders, applicators and other handlers is:

• Long

- sleeved shirt and long pants

• Chemical

- resistant gloves

• Shoes plus socks

PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, is:

• Coveralls worn over short sleeved shirt and short pants

• Chemical

- resistant footwear plus socks

• Chemical

- resistant gloves made of any waterproof material

• Chemical

- resistant headgear for overhead exposure

• Protective eyewear

2. Environmental Hazards (Although the following Environmental Hazards labeling applies to the proposed new uses, it is not included in the proposed supplemental labeling. This labeling can be found in the previously accepted master labeling that was accepted by the Agency on September 18, 2013 for this product.)30 Do not apply directly to wate r, to areas where surface water is present, or to intertidal areas
b elow the mean high water mark. Do not contaminate water when disposing of equipment
washwaters or rinsate. Apply this product only as directed on the label.

This chemical is known to leach through soil into ground water under certain conditions a s a result of agricultural use. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, may result in ground water contamination.

3. Resistance Mana gement

To aid in the prevention of developing weeds resistant to this product, the following steps
should be followed:

• Scout fields before application to ensure herbicides and rates will be appropriate for the weed species and weed sizes present.

• Apply f ull rates of M1691TM for the most difficult to control weed in the field at the specified time (correct weed size) to minimize weed escapes.

• Scout fields after application to detect weed escapes or shifts in weed species.

• Report any incidence of non

- perform ance of this product against a particular weed species to your Monsanto retailer, representative or call XXXXXXX.

• If resistance is suspected, treat weed escapes with an herbicide having a mode of action other than Group 4 and/or use non

- chemical methods to remove escapes, as practical, with the goal of preventing further seed production.

Additionally, users should follow as many of the following herbicide resistance management practices as practicable:

• Use a broad spectrum soil

- applied herbicide with othe r modes of action as a foundation in a weed control program.

• Utilize sequential applications of herbicides with alternative modes of action.

• Rotate the use of this product with non

- Group 4 herbicides.

• Incorporate non

- chemical weed control practices, such a s mechanical cultivation, crop rotation, cover crops and weed

- free crop seeds, as part of an integrated weed control

program.

• Thoroughly clean plant residues from equipment before leaving fields suspected to
contain resistant weeds.

• Avoid using more than two applications of dicamba and any other Group 4 herbicides within a single growing season unless in conjunction with another mode of action herbicide with overlapping spectrum.

• Manage weeds in and around fields, during and after harvest to reduce weed se ed production.31 4. Spray Drift Management

Nozzle type:

Use the Tee Jet® TTI11004 nozzle with a maximum operating pressure of 63 psi when applying M1691 Herbicide. Do not use any other nozzle and pressure combination not specifically allowed by this label.

Spray Volume:

Apply this product in a minimum of 10 gallons of spray solution per acre. Use a higher spray volume when treating dense vegetation.

Equipment Ground Speed:

Select a ground speed that will deliver the desired spray volume while ma intaining the desired spray pressure, but do not exceed a ground speed of 15 miles per hour. Slower speeds generally result in better spray coverage and deposition on the target area.

Spray boom Height:

Spray at the appropriate boom height based on nozzle selection and nozzle spacing, but do not exceed a boom height of 24 inches above target pest or crop canopy. Set boom to lowest effective height over the target pest or crop canopy based on equipment

man ufacturer’s directions. Automated boom height controllers are recommended with large booms to better maintain optimum nozzle to canopy height.

Temperature and Humidity:

When making applications in low relative humidity, set up equipment to produce larger droplets to compensate for evaporation. Larger droplets have a lower surface to volume ratio and are impacted less by temperature and humidity. Droplet evaporation is most severe when conditions are both hot and dry.

Temperature Inversions:

Applications should not occur during a local, low level temperature inversion be cause drift potential is high. Temperature inversions restrict vertical air mixing, which causes small suspended droplets to remain in a concentrated cloud. This cloud can move in unpredict able directions due to the light variable winds common during
inversions. Temperature inversions are characterized by increasing temperatures with altitude and are common on nights with limited cloud cover and light to no wind. They begin to form as the s un sets and of ten continue into the morning. Their presence can be indicated by ground fog; however, if fog is not present, inversions can also be identified by the movement of the smoke from a ground source generator. Smoke that layers and moves laterally in a concentrated cloud (under low wind conditions) indicates an inversion, while smoke that moves upward and rapidly dissipates indicates good vertical32 air mixing. The inversion will dissipate with increased winds (above 3 MPH) or at
sunrise when the sur face air begins to warm (generally 3°F from morning low).

Wind Speed:

Drift potential is lowest between wind speeds of 3 to 10 miles per hour. Do not apply at wind speeds greater than 15 mph. A chart is included in the product label that lists the appropri ate wind speeds and application conditions and restrictions.

5. Protection of Sensitive Areas:

a. Buffer

Maintain a 110

- foot buffer (when applying 16 fl oz of this product per acre), or a 220

- foot buffer (when applying 32 fl oz of this product per acre) between the treated area and the edge of the field in all directions.

b

. Susceptible Plants:

Do not apply under circumstances where spray drift may occur to food, forage, or other plantings that might be damaged or the crops thereof rendered unfit for sale, use or consumption. Do not allow contact of herbicide with foliage, green stems, exposed no n

woody roots of crops, and desirable plants, including beans, cotton, flowers, fruit trees, grapes, ornamentals, peas, potato, soybean, sunflower, tobacco, tomato, and other broadleaf plants, because severe injury or destruction may result, including plan ts in a greenhouse. Small amounts of spray drift that may not be visible may injure susceptible broadleaf plants.

Applicators are required to ensure that they are aware of the proximity to sensitive areas, and to avoid potential adverse effects from off

- target movement of M1691 Herbicide. Before making an application, the applicator must survey the application site for neighboring sensitive areas prior to application. The applicator should also consult sensitive crop registries for locating sensitive areas where available.

Failure to follow the requirements in this label could result in severe injury or destruction to desirable sensitive broadleaf crops and trees when contacting their roots, stems or foliage.

Specifically, commercially grown tomatoes and other fruiting vegetables (EPA crop group 8), cucurbits (EPA crop group 9), and grapes are sensitive to dicamba. In order to prevent unintended damage from any drift of this product, do not apply this product when the wind is blowing towards adjacent commercially grown sensitive crops.

6 . Application Restrictions:

• Do not apply this product aerially.

• Do not tank mix any other herbicides with M1691 Herbicide.

• Do not make an application of the product if rain is expected in the next 24 hours.33 • The maxi mum combined quantity of this product that may be applied for all preplant,

at

- planting, and preemergence applications is 32 fluid ounces (1.0 lb a.e. dicamba) per

acre per season for both cotton and soybeans

.

• The maximum application rate for a single, pr eplant, at

- planting, or preemergence application must not exceed 32 fluid ounces (1.0 lb a.e. dicamba) per acre for both cotton and soybeans

.

• The combined total application rate from crop emergence up to R1 must not exceed 32 fluid ounces (1.0 lb a.e. dicamba) per acre for soybeans.

• The combined total application rate from crop emergence up to 7 days pre

- harvest must not exceed 64 fluid ounce (2.0lb a.e dicamba) per acre for cotton.

• All applications for both cotton and soybeans must not exceed 64 fluid ounces (2.0 lb a.e dicamba) per acre.

C. Registration Terms

EPA has determined that certain registration terms are needed to ensure that likely weed resistance as discussed in section V will be adequately addressed. EPA believes that it is important to address likely weed resistance and not wait until confirmation that resistance has
been found. EPA is basing the proposed registration terms on a list of criteria, presented in the peer

- reviewed publication, Norsworthy, et al., “Reducing the Risks of Herbicide
Resistance: Best Management Practices and Recommendation s,” Weed Science 2012 Special
Issue: 31

– 62 (Norsworthy criteria).

1. Herbicide Resistance Management (HRM) Plan

Monsanto must have an Herbicide Resistance Management (HRM) Plan for M1691 Herbicide developed and approved by EPA before a final registration can be issued. The HRM Plan must focus on educating growers on the appropriate use of the M1691
Herbicide and the associated dicamba

- tolerant seeds. EPA is requiring that the HRM Plan include the following measures that will reduce the potential for the de velopment
of weed resistance.

a. Investigation

Monsanto or its representative must investigate reports of lack of herbicide efficacy as reported by users following “scouting.” When investigating any reports of lack of herbicide efficacy, Monsanto or its repr esentative must make an effort to evaluate the field for “likely resistance” by applying the “Norsworthy criteria.”

b. Remediation

If “likely resistance” is found, Monsanto must engage with the grower to control and prevent the spread of likely resistant weed s in the affected area. Additionally, Monsanto must collect material, if possible, for further testing. Monsanto must provide the grower with specific information and recommendations to control and contain likely resistant weeds, including retreatment and/ or other nonchemical controls, as appropriate, and if34 requested by the grower, Monsanto will assist the grower in implementing those
additional weed control measures.

c. Annual Reporting of Herbicide Resistance to EPA

Monsanto must submit annual summary repor ts to EPA that include a summary of the number of instances of likely and confirmed weed resistance by weed sp ecies, crop, county and state. The annual reports must include summaries of the status of laboratory

or gre enhouse testing for resistance. The ann ual reports will also address the disposition of incidents of likely or confirmed resistan ce reported in previous years. These reports will not replace or supplement adverse effects reporting required under FIFRA § 6(a)(2).

d. Reporting of Likely Resistance to other Interested Parties

Monsanto must inform growers and other stakeholders of cases of likely resistance that are not resolved by the application of additional weed control measures.

e. Education

Monsanto must develop an education program that will provide growers with the best available information on herbicide resistance management.

2 . EPA’s Continued Control over the Registration

Because the issue of weed resistance is an extremely important issue to keep under control and can be very fast moving, this registration will expire 5 years from the date of the registration issuance, unless this term is removed or modified by EPA. At the end of 5 years, EPA can work to address any unexpected weed resistance issues that may result from the proposed uses before granting an extension or allow the registration to terminate if necessary.

3 . Geographic Limitation on Use of Dicamba M1691 Herbicide

EPA is proposing to issu e this registration only to be sold and us ed in Alabama, Arizona, Arkansas, Colorado, Delaware, Florida, Georgia, Illinois, Iowa, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oh io, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia,
and Wisconsin.

[i] Norsworthy , J. K., Ward, S. M., Shaw, D. R., Llewellyn, R. S., Nichols, R. L., Webster, T. M., Bradley, K. W., Frisvold, G., Powles, S. B., Burgos, N. R., Witt, W. W., Barrett, M. 2012. Reducing the risks of herbicide resistance: Best Managment Practices and Recomme ndations. Weed Science Special Issue: 31

- 62. http://wssajournals.org/doi/pdf/10.1614/WS

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