Docket Number EPA-HQ-OPP-2010-0815 

www.regulations.gov

Carfentrazone-ethyl Final Work Plan 

Registration Review 

August 2011 
Carfentrazone-ethyl Final Work Plan

Registration Review

Case # 7422

Approved By:

G¥=tlYl .d--P ~~," Richard P. Keigwin, Jr.

Director

Pesticide Re-evaluation Division

Date

2
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Introduction

This is the Environmental Protection Agency’s (EPA’s) Final Work Plan for the registration 

review of carfentrazone-ethyl. This work plan includes the expected registration review timeline. 

The work plan also addresses public comments received concerning the Preliminary Work Plan 

in the Summary Document, which was posted in the carfentrazone-ethyl registration review 

docket (EPA-HQ-OPP-2010-0815), and any other comments concerning the initial docket 

postings. The Summary Document provided information on what EPA knows about the 

pesticide and what additional risk analyses and data or information the Agency believes are 

needed to make a registration review decision. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. Changes in science, public policy, and pesticide use practices will occur over time. 

The registration review program is intended to make sure that, as the ability to assess risk 

evolves and as policies and practices change, all registered pesticides continue to meet the 

statutory standard. The public phase of registration review begins when the initial docket is 

opened for each case. Information on this program is provided at: 

http://www.epa.gov/oppsrrd1/registration_review/. 

Carfentrazone-ethyl is a post-emergent herbicide registered for use to control broadleaf weeds. It 

is registered for use on a variety of agricultural crops, turf (including golf courses and residential 

lawns), aquatic areas (including water bodies and wetlands), and industrial and utility sites. 

Carfentrazone-ethyl is part of the class of herbicides referred to as Light Dependent Peroxidizing 

Herbicides (LDPH), which have enhanced toxicity in the presence of solar ultraviolet light. 

Carfentrazone-ethyl was first registered in the United States in 1998, and therefore it was not 

subject to the FIFRA reregistration program. 

Comments Received on Preliminary Work Plan

Comments were received during the 60-day public comment period on the planned ecological 

assessment discussed in the Preliminary Work Plan. However, these comments do not alter the 

Agency’s Preliminary Work Plan for the registration review of carfentrazone-ethyl. For further 

discussion on these comments, please see the Summary of Comments and Agency Responses 

section of this document. In the Preliminary Work Plan, EPA also solicited comments on three 

specific topics: environmental justice, water body impairment, and trade irritants. No information 

was received during the comment period concerning environmental justice, trade irritants, or 

water body impairment. 
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Anticipated Risk Assessment and Data Needs

The Agency anticipates requiring data considered necessary to conduct a comprehensive 

ecological risk assessment, including an endangered species risk assessment, and to update the 

human health risk assessment for all uses of carfentrazone-ethyl. Below is a summary of the 

issues relevant to the registration review of carfentrazone-ethyl and the data the Agency 

anticipates requiring. 

Ecological Risk:

• Since carfentrazone-ethyl products are registered for direct applications to water, the 

Agency anticipates requiring additional data to assess potential risk to aquatic organisms. 

The Agency anticipates requiring data on the degradate carfentrazone acid, which is 

expected to be dominant in water after application of carfentrazone-ethyl. 

• Given that carfentrazone-ethyl is an herbicide, and incident reports confirm adverse 

effects to non-target plants, the Agency anticipates requiring additional data to assess 

potential risk to terrestrial plants. Toxicity data using a typical end-use product is 

anticipated to be required to evaluate risk to plants. 

• Toxicity data are not available for passerine bird species that may, in some cases, be 

more sensitive than the waterfowl and upland game birds that were tested in previous 

carfentrazone-ethyl studies. The Agency anticipates requiring passerine data. 

• LDPH registrants are in the process of conducting a modified freshwater fish early life 

stage study to quantitatively determine the increase in toxicity of this class of herbicides 

in the presence of direct sunlight. The Agency expects to receive these data in the winter 

of 2011 in response to the Data Call-in (DCI) for this study. These data will be used in 

the registration review ecological risk assessment for carfentrazone-ethyl. 

• The Agency has not conducted an ecological risk assessment that supports a complete 

endangered species determination for carfentrazone-ethyl. The ecological risk 

assessment planned during registration review will allow the Agency to determine 

whether carfentrazone-ethyl’s use has “no effect” or “may affect” federally listed 

threatened or endangered species (listed species) or their designated critical habitats. 

When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife 

Service (FWS) and/or National Marine Fisheries Service (NMFS) (the Services), as 

appropriate. 

• The Agency anticipates requiring the following data in order to conduct a complete 

ecological risk assessment, including an endangered species assessment, for 

carfentrazone-ethyl:
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Environmental fate

o Guideline No. 835.2240 – Photodegradation in water (carfentrazone acid) 

o Guideline No. 835.4400 – Anaerobic aquatic metabolism 

o Guideline No. 835.6100 – Terrestrial field dissipation (only an independent 

laboratory validation (ILV) of the submitted analytical method would likely be 

required to satisfy this guideline) 

o Guideline No. 835.6200 – Aquatic) field dissipation (only frozen storage stability 

data would likely be required to satisfy this guideline) 

Ecological toxicity

o Guideline No. 850.1025 – Invertebrates acute toxicity – mollusk (saltwater) 

(carfentrazone acid) 

o Guideline No. 850.1075 – Fish acute toxicity (saltwater) (carfentrazone acid) 

o Guideline No. 850.1300 – Aquatic invertebrate life-cycle (freshwater) (carfentrazone 

acid) 

o Guideline No. 850.1350 – Aquatic invertebrate life-cycle (saltwater) (carfentrazone 

acid) 

o Guideline No. 850.1400 – Fish early life stage (saltwater) (carfentrazone acid) 

o Guideline No. 850.1500 – Fish life-cycle (freshwater) (carfentrazone acid) 

o Guideline No. 850.2100 – Avian acute oral toxicity (passerine species) 

o Guideline No. 850.4100 - Seeding Emergence (Tier II) 

o Guideline No. 850.4150 - Vegetative Vigor (Tier II) 

• Please refer to the March 8, 2011 “Registration Review: Preliminary Problem 

Formulation for Environmental Fate, Ecological Risk, Endangered Species, and 

Drinking Water Exposure Assessments for Carfentrazone-ethyl,” for a more detailed 

discussion of the anticipated ecological risk assessment and data needs.

Human Health Risk:

• The Agency anticipates conducting a drinking water assessment in registration review. 

Results of the updated drinking water assessment may necessitate a revised dietary 

exposure assessment. 

• The Agency anticipates conducting new occupational exposure assessments in 

registration review. Several occupational handler scenarios need to be assessed, which 

have not been assessed previously, or need to be reassessed based on higher application 

rates or area treated. 

• A revised residential exposure assessment may need to be performed to include 

residential handler scenarios and updated residential post-application scenarios (higher 

turf/home lawn application rate). This may necessitate a new aggregate exposure 

assessment. 
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• If new policies or procedures are put into place, the Agency may revisit the need for a 

quantitative post-application inhalation exposure assessment for carfentrazone-ethyl. 

• The analytical tolerance enforcement method for livestock, fish, and shellfish was 

considered acceptable pending validation from EPA’s Analytical Chemistry Laboratory. 

However, the validation procedure has changed, and now laboratory validation is not 

required. As part of registration review, the Agency may evaluate the suitability of the 

existing analytical tolerance enforcement method for livestock, fish, and shellfish 

according to new procedures. If the method is found to be unsuitable for tolerance 

enforcement, then the technical registrant would need to propose and validate a new 

method. 

• As part of registration review, the Agency anticipates making the following tolerance 

changes: 

o The banana tolerance may be lowered to 0.10 ppm. 

o The following currently-established tolerances may be deleted: cotton hulls, cotton 

meal, cotton oil, barley flour, barley bran, millet flour, oat flour, rye flour, rye bran, 

wheat bran, wheat flour, wheat middlings, wheat shorts, wheat germ, and caneberry 

subgroup 13A. 

o The cereal grain forage, hay, stover, and straw tolerances may be altered as there are 

conflicting commodity definitions and/or tolerance levels. 

o The tolerance expression may be updated as follows to conform to current standards: 

Tolerances are established for residues of carfentrazone-ethyl, including its 

metabolites and degradates, in or on the commodities listed below. Compliance with 

the following tolerance levels is to be determined by measuring carfentrazone-ethyl 

(ethyl alpha-2-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-

triazol-1-yl]-4-fluorobenzenepropanoate) and its metabolite carfentrazonechloropropionic acid (alpha, 2-dichloro-5-[4-difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic acid). 

• The Agency anticipates requiring the following data in order to conduct a complete 

human health risk assessment for carfentrazone-ethyl: 

• A 28-day inhalation toxicity study was previously waived for carfentrazone-ethyl. 

However, the Agency is re-evaluating its inhalation waiver criteria, so this study may be 

required for registration review. 

o Guideline No. 870.3465 – 901-day inhalation - rat 

o Guideline No. 870.7800 – Immunotoxicity 

1

 A 28-day study may be sufficient to satisfy guideline requirement. 
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• In addition, the Agency anticipates requiring the following residue chemistry data to 

complete the residue chemistry database for carfentrazone-ethyl. 

o Guideline No. 860.1500 Crop Field Trials – soybeans 

In lieu of conducting this study the registrant may revise label language to include a 

restriction prohibiting the feeding of soybean forage and hay to livestock. 

o Guideline No. 860.1500 Crop Field Trials - cranberry 

In lieu of conducting this study the registrant may remove instructions for application to 

cranberry from all labels. 

o Guideline No. 860.1500 Crop Field Trials – dry peas, vegetable legume (Group 6), 

and vegetable foliage of legume (group 7) 

In lieu of conducting these studies the registrant may revise label language to restrict 

harvest-aid application to only the following crops: cereal grains, soybean, cotton, 

peanut, sugarcane, and potato. 

o Guideline No. 860.1900 Field Rotational Crops 

 In lieu of conducting this study the registrant may revise label language that indicate the 

following rotational crop restrictions: seasonal application rate of <0.031 lb ai/acre - 

rotate to a registered crop at anytime and to all other crops 12 months after application; 

seasonal application rate of >0.031 lb ai/acre - rotate to only a registered crop. 

Provided these changes are made, the residue chemistry database will be adequate to 

support carfentrazone-ethyl registrations. 

• Please refer to the January 19, 2011 “Carfentrazone-ethyl. Human Health Assessment 

Scoping Document in Support of Registration Review,” available in the docket, for a 

detailed discussion of the anticipated human health risk assessment and data needs. 

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision, EPA reviewed these data and 

selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 
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hazard database. However, as required by FFDCA section 408(p), carfentrazone-ethyl is subject 

to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Carfentrazoneethyl is not among the group of 58 pesticide active ingredients on the initial list to be screened 

under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP 

orders/data call-ins, requiring the submission of EDSP screening assays for carfentrazone-ethyl. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website: http://www.epa.gov/endo/. 

Timeline

 

The Agency has created the following estimated timeline for the completion of the registration 

review for carfentrazone-ethyl. One year has been added to the projected timeline included the 

Preliminary Work Plan. In the Preliminary Work Plan, the time frame between issuing the 

DCI and data submission was projected to be two years. However, one of the anticipated data 

requirements, field accumulation study in rotational crops (Guideline No. 860.1900), is actually a 

three year study. However, in lieu of conducting this study the registrant may revise label 

language. If the registrant chooses that option, the time frame between issuing the DCI and data 

submission will be reduced to two years from the current three years. 

Registration Review for Carfentrazone-ethyl – Projected Registration Review Timeline

Activities Estimated Date 

Opening the docket 

Open Docket and Public Comment Period 2011 – March 

Close Public Comment 2011 – May 

Case Development 

Final Work Plan 2011 – August 
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Issue DCI 2012 – Apr. - June 

Data Submission 2015 – Apr. - June 

Open Public Comment Period for Preliminary Risk Assessments 2016 – Oct. - Dec. 

Close Public Comment Period 2017 – Jan. - March 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

2017 – Apr. - June 

Close Public Comment Period 2017 – July – Sept. 

Registration Review Decision and Begin Post-Decision Follow-up 2018 

Total (years) 7 

Summary of Comments and Agency Responses

The carfentrazone-ethyl registration review docket was open for a 60-day comment period 

beginning in March 2011. The comments received did not result in a change to the Agency’s 

Preliminary Work Plan for carfentrazone-ethyl. However, it did result in a change to the data 

requirements. 

For the sediment tests: The partitioning of carfentrazone-ethyl between soil and water is 

uncertain because acceptable batch equilibrium data have not been submitted. However, aquatic 

laboratory (MRID 44419016) and field studies (MRIDs 44654701, 46253901) indicate that less 

than 10% of applied carfentrazone-ethyl will partition to sediment. Due to the apparent lack of 

partitioning of carfentrazone-ethyl to sediment, the requested whole sediment data (OCSPP 

guidelines 850.1735 and 850.1740) will not be required for the Data Call-in for carfentrazoneethyl. 

FMC Corporation Agricultural Products Group (FMC) commented that it was a member of the 

FIFRA Endangered Species Task Force and cited information from studies already submitted 

along with a rationale explaining how these data might negate the need for some of the requested 

studies from the Registration Review Problem Formulation Data Call-In. FMC commented on 

the following list of data needs for environmental fate and ecological toxicity: 

(1) cited an ILV to support the 1994 soil dissipation study (RAN-0270, MRID 44165039 and 

RAN-0270M, MRID 44165040), also noting the 1995 soil dissipation study (MRID 44419018) 

and subsequent ILV (MRID 44165043; 

Agency Response: MRID 44419018 was not the analytical method used in the terrestrial 

field dissipation (TFD) study submitted under MRID 44165039. The Agency is 

requesting an independent laboratory validation (ILV) of MRID 44165040, which is the 

analytical method used in MRID 44165039. This method included a methylene chloride 

partition, did not include solid phase extraction, and did not analyze for 3-OH-F8426-

BAc. If an ILV is not submitted to support MRID 44165040 or if a submitted ILV 

indicates that the analytical method in MRID 44165040 is not quantitative, then the study 

classification for the TFD study it supports may be downgraded and additional terrestrial 
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field dissipation data may be requested. 

(2) that the required storage stability data for water, soil and sediment in two aquatic filed 

dissipation studies have already been reported in three separate reports; 

Agency Response: Frozen storage stability data are needed to support the aquatic field 

dissipation study, MRID 44654701, in which these data were not provided (MRIDs 

44419019 and 46253901 have additional deficiencies that are not upgradeable). The 

following are the available storage stability data on carfentrazone-ethyl and its 

transformation products: 

• MRID 44165049: This is a frozen storage stability study of transformation products 

of carfentrazone-ethyl stored for 15 months in soil. These data may not be relevant to 

the storage stability of these compounds in the sediment sampled in aquatic field 

dissipation studies. Carfentrazone-ethyl was not studied. 

• MRID 44419019: This is an unacceptable aquatic field dissipation study. A storage 

stability study was not conducted. However, field spikes were prepared in water and 

stored frozen with water samples for 105-110 days. The field spikes indicated that 

carfentrazone-ethyl was not stable in water in storage. Recoveries were 8±2% for 

Site 1 and 21±2% for Site 2. Field spikes were not prepared in soil or sediment. The 

study authors indicated that carfentrazone-ethyl has not been included in frozen soil 

stability studies because it is known to degrade rapidly in soil, even in frozen 

conditions (p. 13). 

• MRID 44654701: This is an upgradeable aquatic field dissipation study with no 

storage stability study. However, sediment that was spiked and stored frozen 

indicated that carfentrazone-ethyl degraded 67% over 9 months. It was not clear 

whether the sediment was spiked in the field and handled and processed similar to 

study samples or spiked in the laboratory. Field spikes were not prepared in soil or 

water. Study samples were stored frozen for 5 months (soil), 6 months (sediment), 

and 107 days (water). 

• MRID 46253901: This is a supplemental aquatic field dissipation study with no 

storage stability study. Field spikes were prepared in water and sediment. However, 

they were only stored frozen for 3-6 days; whereas, study samples were stored for up 

to 1 month. Additionally, recoveries in water after 3-6 days were poor. The study 

authors followed up with laboratory spikes and additional field spikes from another 

site. However, the following spikes were irrelevant because the original field spike 

results were not shown to be invalid. 

(3) some photodegradation studies in water (carfentrazone acid) and ecological toxicity are not 

needed because of rapid degradation and nearly complete conversion of carfentrazone-ethyl to 
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carfentrazone chloropropionic acid in aqueous environments. Thus, FMC requested that the 

following studies be waived: aqueous photodegradation using carfentrazone-ethyl, aquatic 

invertebrate life cycle studies for both fresh and saltwater, and fish early life-stage and fish full 

life cycle studies. 

Agency Response:

• Photodegradation Study: Carfentrazone acid was not detected in the submitted, 

acceptable aqueous photolysis study conducted with carfentrazone-ethyl (MRID 

44934201). Because carfentrazone-ethyl undergoes nearly complete conversion to 

carfentrazone acid in aqueous environments, the environmental fate of carfentrazone 

acid in water needs to be understood. Therefore, the Agency is requesting aqueous 

photolysis data on carfentrazone acid. 

• Aquatic Invertebrate and Fish Chronic Studies: Since carfentrazone-ethyl is 

applied directly to water, chronic data are required for aquatic invertebrates and fish. 

The rationale for asking for the acid, rather than the parent, is the rapid breakdown. 

For aquatic invertebrates, the daphnid study (MRID 44419006) was classified invalid 

and may not be used for risk assessment. The Agency needs acceptable chronic 

toxicity data using aquatic invertebrates to assess risk of carfentrazone acid to these 

taxa. 

For fish, MRID 44424201 is an acceptable rainbow trout early life-stage (ELS) flowthrough study for carfentrazone-ethyl, however, this study does not satisfactorily 

address the chronic toxicity of carfentrazone-ethyl acid. 

Two of the submitted fish ELS studies (MRIDs 44963201 and 46037001) are rainbow 

light-dependent peroxidizing herbicide (LDPH) studies conducted under enhanced 

lighting conditions to estimate the enhanced toxicity of carfentrazone-ethyl under 

strong light. However, these studies are based on parent light-enhanced toxicity and 

the concentration of carfentrazone-ethyl acid was not determined. LDPH toxicity will 

be evaluated in the risk assessment, but chronic toxicity data on the major degradate 

(carfentrazone-ethyl acid) is needed, as well. 

FMC commented that while EPA is re-evaluating its inhalation waiver criteria for the 28-day 

inhalation toxicity study, which was previously waived for carfentrazone-ethyl; the criteria basis 

for the inhalation waiver previously granted by the Agency has not changed. 

FMC also commented that while EPA’s Fact Sheet indicated “there are no recent or pending 

actions for carfentrazone-ethyl,” FMC notes that there are pending label amendment and PRIA 

actions to add new crop uses. 

Agency Response: When conducting the Preliminary Risk Assessment for 

carfentrazone-ethyl, any pending new uses will be taken into account, if they are approved. 
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Additional clarification to the Agency’s above responses to FMC comments are provided in the 

response to public comments document located in docket EPA-HQ-OPP-2010-0815. 

The Physicians Committee for Responsible Medicine commented on potential alternative 

methods for conducting some of the anticipated toxicity studies. 

Agency Response: The Agency responded that it is currently evaluating the results from 

studies utilizing the alternative guideline for consistency with the data requirements 

described in 40 CFR Part 158 and 40 CFR Part 161. Additionally, until validation has 

occurred for this guideline, as it relates to certain species studies, it is doubtful the 

Agency would have confidence in studies done under this alternative guideline. However, 

the Agency recognizes that specific situations might warrant additional examination. 

The FIFRA Endangered Species Task Force (FESTF) commented that it has submitted data to 

the Agency that fulfill the requirements of Pesticide Registration Notice 2000-2 and is the best 

available data necessary for the proximity analysis of Carfentrazone-ethyl use and listed species 

locations. FMC is a member of FESTF and is entitled to rely on FESTF data. For all other nonmember registrants, FESTF is making every effort to inform them of role of FESTF data. 

Agency Response: The Agency thanks FESTF for its comment and will consider this 

 information as it conducts the registration review and makes its registration review 

 decisions. 

The public comments and the Agency’s response, “Response to Public Comments on 

Registration Review Problem Formulation for Environmental Fate, Ecological Risk, Endangered 

Species, and Drinking Water Exposure Assessments for Carfentrazone-ethyl,” dated August 16, 

2011, are available in docket EPA-HQ-OPP-2010-0815. 

Next Steps

The Agency plans to issue a Data Call-in (DCI) for carfentrazone-ethyl in 2012. The information 

received in response to this DCI will be used to conduct the planned human health, ecological 

risk, and endangered species assessments for carfentrazone-ethyl. 

Summary of Data Needs for the Registration Review of Carfentrazone-ethyl

Guideline 

Number Data Requirement Test Substance 

Estimated 

Timeframe 

(months) 

835.2240 Aqueous Photolysis Carfentrazone acid 12 

835.4400 Anaerobic Aquatic Metabolism Carfentrazone-ethyl 24 

835.6100 (ILV) Independent Laboratory Validation Parent plus analyzed 

degradates 

24 

835.6200 (SS) Frozen Storage Stability 24 
13

850.1025 Oyster Acute Toxicity 

Carfentrazone acid 

12 

850.1075 Fish Acute Toxicity 24 

850.1300 Daphnid Chronic Toxicity 12 

850.1350 Mysid Chronic Toxicity 12 

850.1400 Fish Early Life Stage (ELS) Toxicity 12 

850.1500 Fish Life-Cycle Toxicity2 24 

850.2100 Avian Acute Oral Toxicity Carfentrazone-ethyl 12 

850.4100 Tier II Plant Toxicity – Seedling 

Emergence Typical End-Use 

Product 

12 

850.4150 Tier II Plant Toxicity – Vegetative Vigor 12 

860.1500 Crop Field Trials – Soybean3 24 

860.1500 Crop Field Trials – Cranberry4 24 

860.1500 

Crop Field Trials – Dry Peas, Vegetable 

Legume (Group 6), and Vegetable Foliage 

of Legume (Group 7)5

24 

860.1900 Field Rotational Crops6 36 

870.3465 90-day inhalation7 - Rat 24 

870.7800 Immunotoxicity 12 

 

2

 Data requirement may be satisfied by submission of an ELS study. However, results from an ELS study may 

trigger a life-cycle study. 

3

 In lieu of conducting the study, the registrant may revise label language to include a restriction prohibiting the 

feeding of soybean forage and hay to livestock. 

4

 In lieu of conducting the study, the registrant may remove instructions for application to cranberry from all labels. 

5

 In lieu of conducting the study, the registrant may revise label language to restrict harvest-aid application to only 

the following crops: cereal grains, soybean, cotton, peanut, sugarcane, and potato. 6

 In lieu of conducting the study, the registrant may revise label language that indicate rotational crop restrictions for 

seasonal application rates of <0.031 lb ai/acre – rotate to a registered crop at anytime and to all other crops 12 

months after application; seasonal application rate of >0.031 lb ai/acre – rotate to only a registered crop. 7

 A 28-day study may be sufficient to satisfy guideline requirement. A waiver was deemed acceptable for this 

guideline study in August 2002, however, the Agency is currently reevaluating the inhalation waiver criteria and 

based on this analysis, an inhalation study may be required in the future.