Document ID: EPA-HQ-OPP-2009-0841-0036
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-09-02T04:00Z

Fenbutatin-Oxide
                                       
                 Proposed Interim Registration Review Decision
                               Case Number 0245
                                       
                                       
                                   June 2020
                                       
                                       
                                       
			Approved by:          ___________
					   Elissa Reaves, Ph.D.
                                 Acting Director
                           Pesticide Re-evaluation Division

                  Date:	____      06-26-2020      ____________
                               Table of Contents

I.	INTRODUCTION	3
A.	Summary of Fenbutatin-Oxide Registration Review	4
B.	Summary of Public Comments on the Draft Risk Assessments and Agency Responses	5
II.	USE AND USAGE	7
III.	SCIENTIFIC ASSESSMENTS	8
A.	Human Health Risks	8
1.	Risk Summary and Characterization	9
2.	Human Incidents and Epidemiology	14
3.	Tolerances	15
4.	Human Health Data Needs	17
B.	Ecological Risks	17
1.	Risk Summary and Characterization	18
2.	Ecological Incidents	22
3.	Ecological and Environmental Fate Data Needs	23
C.	Benefits Assessment	23
IV.	PROPOSED INTERIM REGISTRATION REVIEW DECISION	24
A.	Proposed Risk Mitigation and Regulatory Rationale	24
1.	Proposed Changes to Application Methods	25
2.	Proposed Spray Drift Requirements and Drift Buffers for Ground Applications	26
3.	Proposed Increase Restricted Entry Intervals (REIs)	29
4.	Proposed Voluntary Cancellation of Use Sites	30
5.	Personal Protective Equipment (PPE)	31
6.	Additional Label Clarifications	31
B.	Tolerance Actions	31
C.	Proposed Interim Registration Review Decision	31
D.	Data Requirements	32
V.	NEXT STEPS AND TIMELINE	32
A.	Proposed Interim Registration Review Decision	32
B.	Implementation of Mitigation Measures	32
Appendix A:  Summary of Proposed Actions for Fenbutatin-Oxide	33
Appendix B:  Proposed Labeling Changes for Fenbutatin-Oxide Products	34
Appendix C:  Endangered Species Assessment	41
Appendix D:  Endocrine Disruptor Screening Program	43

 INTRODUCTION
	
This document is the Environmental Protection Agency's (the EPA or the agency) Proposed Interim Registration Review Decision (PID) for fenbutatin-oxide (PC Code 104601, case 0245), and is being issued pursuant to 40 CFR §§ 155.56 and 155.58. A registration review decision is the agency's determination whether a pesticide continues to meet, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The agency may issue, when it determines it to be appropriate, an interim registration review decision before completing a registration review. Among other things, the interim registration review decision may require new risk mitigation measures, impose interim risk mitigation measures, identify data or information required to complete the review, and include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. Additional information on fenbutatin-oxide, can be found in the EPA's public docket (EPA-HQ-OPP-2009-0841) at www.regulations.gov. 

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandates the continuous review of existing pesticides. All pesticides distributed or sold in the United States must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the agency periodically re-evaluates pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at http://www.epa.gov/pesticide-reevaluation. In 2006, the agency implemented the registration review program pursuant to FIFRA § 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.

The EPA is issuing a PID for fenbutatin-oxide so that it can (1) move forward with aspects of the registration review that are complete and (2) implement interim risk mitigation (see Appendices A and B). The agency is currently working with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (collectively referred to as, "the Services") to develop methodologies for conducting federally threatened and endangered (listed) species assessments for pesticides in accordance with the Endangered Species Act (ESA) § 7. Therefore, although the EPA has not yet fully evaluated risks to federally-listed species, the agency will complete its listed species assessment and any necessary consultation with the Services for fenbutatin-oxide prior to completing the fenbutatin-oxide registration review. Fenbutatin-oxide is on List 1 for endocrine screening and the EPA has received all of the required Tier 1 assay data. The data have been reviewed and the reviews are available in the docket (EPA-HQ-OPP-2009-0841-0017). Based on weight of evidence, there was no convincing evidence of potential interactions with E, A, or T signaling pathways and no Tier 2 tests were recommended. See Appendices C and D, respectively, for additional information on the listed species assessment and the endocrine screening for the fenbutatin-oxide registration review. 

Fenbutatin-oxide is a non-systemic, restricted use organotin miticide that inhibits adenosine triphosphate (ATP) synthase, resulting in disruption of cellular respiration. It was first registered in the United States in 1974. A Registration Standard was issued in 1987, and a Reregistration Eligibility Decision was completed in 1994. On January 7, 2015, the National Marine Fisheries Service issued its Endangered Species Act Section 7 Consultation Conference and Biological Opinion on the EPA's registration of pesticides containing fenbutatin-oxide. It is registered for use on a variety of crops including apple, almond, cherry (sweet and sour), citrus fruit, grape, eggplant, nectarine, papaya, peach, pear, pecan, pistachio, plum, prune, raspberry, strawberry, and walnut. Fenbutatin-oxide is also registered for use on Christmas trees and greenhouse, outdoor, and landscape ornamentals. There is one end-use product that contains fenbutatin-oxide, and while there are currently residential use sites on the label homeowners are not allowed to use the product because of the restricted use classification.

This document is organized in five sections: Introduction, which includes this summary and a summary of public comments and the EPA's responses; Use and Usage, which describes how and why fenbutatin-oxide is used and summarizes data on its use; Scientific Assessments, which summarizes the EPA's risk and benefits assessments, updates or revisions to previous risk assessments, and provides broader context with a discussion of risk characterization; Proposed Interim Registration Review Decision, which describes the mitigation measures proposed to address risks of concern and the regulatory rationale for the EPA's PID; and, lastly, Next Steps and Timeline for completion of this registration review.

 Summary of Fenbutatin-Oxide Registration Review

Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for fenbutatin-oxide with the opening of the registration review docket for the case. The following summary highlights the docket opening and other significant milestones that have occurred thus far during the registration review of fenbutatin-oxide.

 December 2009 - The Fenbutatin-Oxide Registration Review Summary Document: Initial Docket, Fenbutatin-Oxide (Vendex): Registration Review Scoping Document for Human Health Assessments, September 2009; and Registration Review: Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Assessments in Support of the Registration Review of Fenbutatin-oxide (Vendex), September 2009 were posted to the docket for a 60-day public comment period. 

 March 2010- The Fenbutatin-Oxide Final Work Plan (FWP) Registration Review was issued. One comment was received on the fenbutatin-oxide Preliminary Work Plan (PWP) during the 60-day public comment period, which began on December 16, 2009 and closed on February 16, 2010. This comment did not change the work plan or timeline established in the PWP. 

 April 2010 - A Generic Data Call-In (GDCI) for fenbutatin-oxide (GDCI-104601-834) was issued for data needed to conduct the registration review risk assessments. All data were submitted or waived, and the GDCI is satisfied.

 September and October 2019 - The agency announced the availability of the Fenbutatin-Oxide: Draft Ecological Risk Assessment for Registration Review and the Fenbutatin-Oxide: Draft Human Health Risk Assessment for Registration Review for a 60-day public comment period. Two comments were received during the comment period, one from U.S. Department of Agriculture (USDA) and one from the National Agricultural Aviation Association (NAAA). These comments and the agency's responses are summarized below. The comments did not change the risk assessments or registration review timeline for fenbutatin oxide.

 June 2020 - The agency is now announcing the availability of the PID in the docket for fenbutatin oxide, for a 60-day public comment period.  Along with the PID, the following documents are also posted to the fenbutatin-oxide docket:

 Biological and Economic Analysis Division, Fenbutatin Oxide (PC #104601): Usage and Benefits of Fenbutatin Oxide, and Impacts of Mitigation, June 2020 
            
 Fenbutatin-Oxide. Addendum to the Registration Review Human Health Risk Assessment to Support the Proposed Interim Decision, June 2020

 Response to Public Comments on the Fenbutatin-Oxide Draft Risk Assessment for Registration Review (Health Effects Division/HED), June 2020

 Response to Public Comment on the Draft Risk Ecological Risk Assessment of Fenbutatin-Oxide, January 2020

 Fenbutatin Oxide (104601) Screening Level Usage Analysis (SLUA), September 2018

Summary of Public Comments on the Draft Risk Assessments and Agency Responses 

During the 60-day public comment period for the fenbutatin-oxide Draft Risk Assessments, which opened on September 30, 2019 and closed on November 29, 2019, the agency received public comments from two sources. Comments were submitted by the United States Department of Agriculture (USDA) and the National Agricultural Aviation Association (NAAA).  These comments are summarized below. The agency thanks all commenters for their comments and has considered them in developing this PID.

Comments Submitted by USDA (Docket ID: EPA-HQ-OPP-2009-0841-0032)
Comment: USDA noted that while fenbutatin-oxide is no longer a primary mite control tool for most crops, significant usage is still reported on citrus. Additionally, USDA indicated that, based on the EPA's screening-level usage analysis (SLUA), strawberries and raspberries may also be important agricultural uses. Given the lack of available usage data, USDA is concerned about the potentially limited availability of miticide options for eggplants, papayas, Christmas trees, and ornamentals. USDA also stated that fenbutatin-oxide provides growers with an additional resistance management tool. With regard to risk mitigation, USDA requested that the EPA explore aerial application prohibitions as a mitigation option, consider potential efficacy implications in any potential droplet size or rate reduction proposals, extension of Pre-Harvest Intervals (PHIs) instead of Restricted-Entry Intervals (REIs), and, in general, focus on practical and feasible measures that minimize off-site movement of fenbutatin while retaining the efficacy and utility of this miticide for crops where usage remains important, particularly citrus and raspberries. 

With regard to the human health risk assessment, USDA agreed with the EPA's draft human health dietary risk assessment and noted that all dietary and aggregate risk estimates are below levels of concern (LOC). USDA indicated that aerial applications may be of limited value due to the need for thorough foliar coverage to achieve adequate mite efficacy. For backpack and mechanically pressurized handguns, USDA stated that the EPA's default assumption on volume of spray applied per workday may be over-estimates of exposure and suggested taking the recent survey from the Agricultural Handlers Exposure Task Force (AHETF) into consideration. Regarding post-application risks that are driven by hand harvesting, USDA suggested that the EPA consider that some revisions to pre-harvest intervals (PHIs) may be more workable for growers than proposing extended re-entry intervals for the hand-harvesting activities.  

Regarding the ecological risk assessment, USDA agreed with the EPA's conclusions on potential risks of concern for aquatic taxa and believes that the restricted use classification of the compound in combination with application buffers from water bodies have historically addressed such risks. For birds and mammals, USDA was concerned that default assumptions used in estimating terrestrial animal exposure may over-estimate the potential risk. With respect to terrestrial invertebrates, USDA recognized there are uncertainties in the risk profile based on lack of honey bee data but noted that, since fenbutatin-oxide is not systemic in plants, pollinator exposure is likely limited.

EPA Response: The EPA thanks USDA for its comments, its consideration of the risk characterization in the assessments, and its willingness to conduct additional grower outreach. The EPA incorporated some of USDA's observations on the pest management benefits of fenbutatin-oxide in its analysis of the usage, benefits, and impacts of the proposed risk mitigation.

Based on recent updates to the Occupational Pesticide Handler Unit Exposure Surrogate Reference Table  -  Revised in March 2020, the EPA completed a revised occupational handler assessment for fenbutatin-oxide for all registered uses.  See the Fenbutatin-Oxide.  Addendum to the Registration Review Human Health Risk Assessment to Support the Proposed Interim Decision (D457731) for the updated aggregate risk indices (ARIs).   

USDA suggested changes to the PHI to address potential post-application risks of concern. For fenbutatin-oxide specifically, multiple activities across use sites (not just hand-harvesting) were identified as having post-application risk well beyond the current label-specified REI of two days, which negates the utility of using the PHI to address worker risk from field re-entry. However, there are additional considerations of the potential post-application risks along with proposed mitigation to address these concerns in Section IV.A.3 of this document. 

EPA concurs with USDA that the restricted use classification of fenbutatin-oxide in combination with buffers to water bodies at all use sites will help to reduce ecological exposure; however, the aquatic exposure assessment, along with monitoring data provide evidence that even with such restrictions in place, the compound can move off-site and potentially pose risks of concern to aquatic communities.

Detailed responses to USDA's comments are found in the Response to Public Comments Draft Risk Assessment for Registration Review and the Response to Public Comment on The Draft Ecological Risk Assessment for Fenbutatin-Oxide in the public docket.

Comments Submitted by NAAA (Docket ID: EPA-HQ-OPP-2009-0841-0033)
Comment:  NAAA provided comments on the spray drift analyses conducted for the draft
risk assessments, particularly concerning the spray drift model, AgDrift, the inputs used in the model (e.g., drift fraction, application rates, droplet sizes), exposure assumptions, and the uses modeled. NAAA believes that the tier-1 component of the AgDrift model is inadequate because some of the assumptions it uses are unrealistic.  The organization recommends a refined assessment with a higher tiered model. Additionally, NAAA discussed the water-soluble packaging (WSP) that is used for fenbutatin-oxide applications. NAAA asked the EPA to clarify whether current best practices for handling WSPs were incorporated into the assumptions for the handler scenarios, as well as whether the EPA would consider Personal Protective Equipment (PPE) for the WSP scenarios. 

EPA Response:  The agency acknowledges and thanks NAAA for their comments. AgDrift is
the currently approved model for evaluating potential spray drift from a pesticide application.
The agency appreciates the additional information provided by NAAA about application practices and continues to work with industry to update and improve modeling methods to better reflect these practices. It is noted, however, that modeling for a national‐level assessment is first conducted using maximum application rates, limitations, and instructions listed on the fenbutatin-oxide labels. In the absence of specific use directions and application restrictions implemented across all product labels, default assumptions (based on empirical data) are used.

Regarding the WSP used for fenbutatin-oxide, the EPA strives to use the most current data to assess exposure and risk for occupational pesticide handlers. The WSP data set included in the fenbutatin-oxide addendum memo is the newest data set available to the agency, and the data does not include use inconsistent with best practices.  See the Fenbutatin-Oxide. Addendum to the Registration Review Human Health Risk Assessment to Support the Proposed Interim Decision (D457731) for the updated aggregate risk indices (ARIs).   

Detailed responses to USDA's comments are found in the Response to Public Comments Draft Risk Assessment for Registration Review and the Response to Public Comment on The Draft Ecological Risk Assessment for Fenbutatin-Oxide in the public docket.
 USE AND USAGE

Fenbutatin-oxide is a restricted-use organotin miticide with one end-use product (Vendex[(R)] 50 WP, EPA Registration Number 70506-211) registered for use on a variety of food crops, including some orchard crops, Christmas trees, ornamentals, and landscapes. Fenbutatin-oxide is non-systemic and inhibits adenosine triphosphate (ATP) synthase, resulting in disruption of cellular respiration. It is in the Insecticide Resistance Action Committee (IRAC) Mode of Action Group 12 B. The compound was initially registered in the United States in 1974 and appears to target spider mites, eriophyid (rust) mites, and some predatory mites (mites that feed on spider and rust mites). 

Fenbutatin-oxide is registered for use on apple, almond, cherry (sweet and sour), citrus fruit, grape, eggplant, nectarine, papaya, peach, pear, pecan, pistachio, plum, prune, raspberry (Washington and Oregon only), strawberry, and walnut. Fenbutatin-oxide is also registered for use on Christmas trees (Washington and Oregon only) and greenhouse, outdoor, and landscape ornamentals. It is formulated as a wettable powder in water soluble packaging, and is applied post-emergence via ground, aerial, or orchard air-blast application when mites first appear. Fenbutatin-oxide is registered for uses on ornamentals and landscapes but must be applied by a licensed applicator and is not for use by homeowners. Single application rates range from 0.5 to 2.0 lb a.i./acre. Fenbutatin-oxide can be applied up to four times per year, depending on the use site. 
  
EPA's Screening Level Usage Analysis (dated September 16, 2018; which can be found in the docket) estimated an average of approximately 43,000 lb of fenbutatin-oxide a.i./year used on surveyed agricultural crops annually. The grapefruit, strawberries, tangerines, and pears usage is estimated to be about 10,000 lbs a.i./year on 15% of acres grown per year, on average. For oranges usage is also estimated to be about 10,000 lbs a.i./year but on less than 2.5% of acres grown per year, on average. These data cover usage across the years 2008-2017.

An examination of usage reported by a proprietary farmer survey database for recent years only (2014-2018) indicates that treatments with fenbutatin-oxide have declined in almost all surveyed crops. Usage of fenbutatin oxide on agriculture in this time span averaged about 20,000 lbs to treat approximately 20,000 acres of cropland. Grapefruit and oranges together account for about 85% of the usage in total pounds applied and 80% in total acres treated. 
However, the average percent crop treated (PCT) with fenbutatin oxide was higher in grapefruit (20%) than oranges (1%). Other agricultural uses (average PCT)  -  albeit at very low levels- include caneberries (5%; in raspberry, as it is the only caneberry use site on the label), pears (3%), and peaches (2%). All other registered crops show a PCT of 1% or less.
SCIENTIFIC ASSESSMENTS

 Human Health Risks 

A summary of the agency's human health risk assessment is presented below. The agency used its most current science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of fenbutatin-oxide.  For additional details on the human health assessment for fenbutatin-oxide, see the Fenbutatin-Oxide: Draft Human Health Risk Assessment for Registration Review, and the Fenbutatin-Oxide. Addendum to the Registration Review Human Health Risk Assessment to Support the Proposed Interim Decision which are available in the public docket.

Risk Summary and Characterization

Dietary (Food + Water) Risks

Dietary risks of concern were not identified for fenbutatin-oxide uses.  The acute (food and water) risk estimates are below levels of concern for all population subgroups. At the 99.9[th] percentile of exposure, the estimated acute dietary exposure is 15% of the acute Population-Adjusted Dose (aPAD) for general U.S. population and 69% of the aPAD for children (1-2 years old), the most highly exposed population subgroup. The estimated chronic dietary exposure is 6.6% of the chronic Population-Adjusted Dose (cPAD) for the general U.S. population and 15% of the cPAD for children (1-2 years old), the most highly exposed population subgroup. The level of concern (LOC) for dietary exposure is 100% of the aPAD and cPAD. Fenbutatin-oxide is classified as Category E, "No evidence of carcinogenicity." Therefore, a cancer dietary exposure analysis was not conducted.

Residential Handler Risks
Products containing fenbutatin-oxide may only be used by certified applicators; therefore, a quantitative residential handler assessment was not conducted. 

Residential Post-Application Risks
There is potential for post-application exposure for individuals exposed as a result of being in a residential environment that has been previously treated with fenbutatin-oxide. The residential post-application risks are not of concern (margins of exposure [MOEs] >= 100) for adults and children from contact with residues in trees and retail plants treated with fenbutatin-oxide. However, there are potential residential post-application risks of concern (MOEs < LOC of 100) for adults (MOE = 14) and children (6 < 11 years old; MOE = 23) from contact with residues in gardens treated with fenbutatin-oxide. These scenarios were not included in the aggregate assessment since they resulted in risks of concern. 

Aggregate Risks
The FQPA requires the agency to consider and aggregate (add) pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. The acute and chronic aggregate risk assessments combine exposures to fenbutatin-oxide in food and drinking water only and are not of concern as discussed in the Dietary (Food + Water) Risks section above. 

Short-term aggregate risk assessments were also conducted for adults (females 13-48 years old) and children 6 <11 years old since there is potential for dermal post-application exposure from contact with residues on treated trees. The short-term aggregate MOE for adults and children (6 < 11 years old) are 140 and 210, respectively, and are not of concern for the scenarios assessed (LOC is an MOE of 100). However, there are potential residential post-application risks of concern for both adults and children contacting residues in gardens treated with fenbutatin-oxide. An intermediate-term aggregate risk assessment was not conducted as intermediate-term residential exposures are not anticipated. 

Bystander Risks

A quantitative non-occupational spray drift assessment was conducted for the registered uses of fenbutatin-oxide. Dermal risks were estimated for adults and children (1 < 2 years old) and incidental oral risk estimates were calculated for children 1 < 2 years old (LOC is an MOE of 100). For adults, most dermal MOEs were potentially of concern (i.e., the MOE is less than 100) at the edge of the field for aerial, groundboom, and airblast applications. For children 1 < 2 years old, most combined (dermal and incidental oral) MOEs were potentially of concern at the edge of the field for aerial, groundboom, and airblast applications. 

Distances from the edge of the field necessary to reach MOEs below the level of concern range from 0 feet to greater than 250 feet depending on the application equipment and equipment parameters. Assuming a fine to medium droplet size, the distance from the edge of the field to reach an MOE of 100 ranged from 0 to 250 feet for aerial applications. Assuming a low boom height and medium to coarse droplet size, no risks of concern were identified at the edge of the field for groundboom applications. For airblast applications to sparse canopies, the distance from the edge of the field to reach an MOE of 100 ranged from 10 to 50 feet. These three application scenarios are presented in Table 1.

Table 1. Summary of Spray Drift Distances to reach the LOC

                                     Crop
                               Application rate 
                            Adult Summary (Dermal)
          Children 1 < 2 years Summary (Dermal + Incidental Oral)
                                       
                                       
                              Distance to reach 
                               MOE of 100 (Feet)
                              Distance to reach 
                               MOE of 100 (Feet)
                                       
                                       
                                    Aerial
                               (fine to medium)
                                  Groundboom
                           (low boom medium/coarse)
                                   Airblast
                               (sparse canopies)
                                       
                                    Aerial
                               (fine to medium)
                                  Groundboom
                           (low boom medium/coarse)
                                   Airblast
                               (sparse canopies)
                          Orchard (Citrus, AZ and CA)
                                   2 lb ai/A
                                      100
                                    At Edge
                                      25
                                      250
                                    At Edge
                                      50
                      Orchard Citrus (TX and FL), Cherry
                                  1.5 lb ai/A
                                      100
                                    At Edge
                                      25
                                      200
                                    At Edge
                                      25
              Orchard (Grapes, Almonds, Pistachio, Pecan, Walnut)
                                 1.25 lb ai/A
                                      100
                                    At Edge
                                      10
                                      150
                                    At Edge
                                      50
   Orchard (Apple, Pear, Peach, Plum, Prune, Nectarine, Papaya, Raspberry) 
                                   1 lb ai/A
                                    At Edge
                                    At Edge
                                      10
                                      125
                                    At Edge
                                      25
                                Christmas Tree
                                   1 lb ai/A
                                    At Edge
                                    At Edge
                                Not Applicable
                                      125
                                    At Edge
                                Not Applicable
                             Strawberry, Eggplant
                                  1.5 lb ai/A
                                      100
                                    At Edge
                                Not Applicable
                                      200
                                    At Edge
                                Not Applicable
MOE=margin of exposure

Cumulative Risks
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fenbutatin-oxide and any other substances and fenbutatin-oxide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that fenbutatin-oxide has a common mechanism of toxicity with other substances.

Occupational Handler Risks 
Occupational handler dermal and inhalation exposure and risk estimates were calculated for the registered uses of fenbutatin-oxide. Since the toxicological effects are the same but the levels of concern are different (dermal LOC is an MOE of 100, inhalation LOC is an MOE of 30), the handler dermal and inhalation exposures are combined using the aggregate risk index (ARI) methodology. The LOC for an ARI is 1, and ARIs that are less than 1 are potential risk estimates of concern. 

In addition to being packaged in a water-soluble bag which is an engineering control, the fenbutatin-oxide label requires coveralls over a short-sleeved shirt and short pants, socks, chemical-resistant shoes, chemical-resistant gloves, protective eyewear (goggles, face shield, or safety glasses) chemical resistant headgear, National Institute for Occupational Safety and Health (NIOSH) approved respirator with any R, P, or HE cartridge, and chemical-resistant apron (for cleaning activities). The occupational handler exposure and risk estimates indicate that the ARIs are potentially of concern (i.e., ARIs are < 1) for twelve scenarios assuming the use of label-required Personal Protective Equipment (PPE) and use of the product's water-soluble packaging engineering controls. Additional mitigation not required on current labels (double layer clothing) was also assessed and still identified potential risks of concern. The twelve scenarios using label-required PPE and engineering controls are:

Occupational handlers mixing/loading using engineering controls (i.e., water-soluble packaging)
 Mixing/loading water soluble packet for aerial applications at application rates at or above 1 lb ai/A in orchard/vineyards (ARIs range from 0.16 up to 0.32),
 Mixing/loading water soluble packet for aerial applications at 1.5 ai/A on typical field crops (strawberry, eggplant) (ARI = 0.22), 
 Mixing/loading water soluble packet for groundboom applications at 1.5 ai/A on typical field crops (strawberry, eggplant) (ARI = 0.95).

Occupational handlers applying sprays
 Airblast applications at 1 lb ai/A to 2 lb ai/A on orchard/vineyards (ARI = 0.3). If engineering controls (enclosed cab) are used, the occupational handler ARIs are not of concern.

Occupational handler flagger
 Aerial applications at 1 lb ai/A to 2 lb ai/A on orchard/vineyards. With a double layer (coveralls), chemical resistant gloves, and PF10 respirators, the ARIs are still of concern (ARIs = 0.94 and 0.47).
 Aerial applications at 1.5 lb ai/A on typical field crops (strawberry, eggplant). With a double layer (coveralls), chemical resistant gloves, and PF10 respirators, the ARIs are still of concern (ARI = 0.63).

Occupational handler mixing/loading/applying water soluble packet
The following risk estimates reflect risks as updated in the addendum to reflect the most recent exposure data available. For the following scenarios the addition of double layer (coveralls over long-sleeved shirt and long pants), chemical-resistant gloves, and PF10 respirators (for applicators), the occupational handler ARIs are still potentially of concern:

 Backpack applications at 0.05 lb ai/gallon to Christmas trees (broadcast, foliar ARI = 0.1; ground/soil directed = 0.43), 
 Mechanically-pressurized handgun at 0.01 lbs ai/gallon (drench/soil/ground directed ARI = 0.26) to 
 Mechanically-pressurized handgun at 0.02 lb ai/gallon to orchard/vineyards (broadcast ARI =0.13),
 Mechanically-pressurized handgun at 0.05 lb ai/gallon to Christmas trees (ARI = 0.052),
 Mechanically-pressurized handgun at 0.005 lb ai/gallon to nursery ornamentals (broadcast, foliar ARI = 0.71; drench/soil/ground-directed ARI =0.71) and landscaping trees/shrubs/bushes (broadcast, foliar ARI = 0.52),
 Mechanically- pressurized handguns at 0.03 lb ai/gallon on typical field crops (strawberry, eggplant) (broadcast, foliar ARI = 0.087; drench/soil/ground-directed ARI = 0.087).

Occupational Post-Application Risks 

 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, including activities related to crop production. Post-application exposure levels vary over time and depend on things such as the type of activity, the nature of the crop treated or pest targeted, the type of pesticide application, and the chemical's degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly influence the potential for post-application exposure.
 
 The occupational post-application risk estimates indicate that the short- and intermediate-term MOEs are potentially of concern at the current labeled restricted-entry interval (REI) for the majority of the scenarios. Most of the occupational post-application MOEs are potentially of concern (i.e., MOEs < the LOC of 100) on day two. Currently, fenbutatin-oxide labels require a restricted-entry interval (REI) of 48 hours as required by the Worker Protection Standard based on the acute toxicity classification of the product (acute Toxicity Category III for dermal and IV for skin irritation potential).  
 
 For those crops that have potential post-application risks of concern on day 2, the days needed for the MOE to be greater than the LOC range from 3 days to more than 30 days. The occupational post-application scenarios that result in potential risks of concern on day 2, as well as the number of days needed for the MOE to reach the LOC are presented in Table 2.  
 
 Table 2: Occupational Post-Application Summary Table
                                       
                                       
                                     Crop
Maximum number of days across all activities assessed in the Human Health Risk Assessment [1, 3]
               Maximum number of days for MOE to reach LOC [2] 
                                       
Almond
                                 15 (scouting)
                                      N/A
Apple
                              30 (thinning fruit)
                             21 (hand harvesting)
Cherry
                             30+ (thinning fruit)
                             25 (hand harvesting)
Christmas tree
                           24 (irrigation, hand set)
                             21 (hand harvesting)
Eggplant
                           28 (irrigation, hand set)
                             16 (hand harvesting)
Grapes (wine, juice, and raisin)
              30 (hand harvesting, leaf pulling, tying/training)
                      30 (hand harvesting, leaf pulling)
Grapes (table)
     30 (girdling, turning, hand harvesting, leaf pulling, tying/training)
             30 (girdling, turning, hand harvesting, leaf pulling)
Grapefruit
                             28 (hand harvesting)
                             28 (hand harvesting)
Lemon
                             28 (hand harvesting)
                             28 (hand harvesting)
Nectarine
                              30 (thinning fruit)
                             21 (hand harvesting)
Nursery Crop (ornamentals, non-bearing plants)
                           17 (irrigation; hand set)
                           17 (irrigation; hand set)
Greenhouse Crop (ornamentals, non-bearing plants)
                                      N/A
                                      N/A
Orange
                             28 (hand harvesting)
                             28 (hand harvesting)
Papaya
                             21 (hand harvesting)
                             21 (hand harvesting)
Peach
                              30 (thinning fruit)
                              30 (thinning fruit)
Pear
                              30 (thinning fruit)
                              30 (thinning fruit)
Pecan
                          15 (hand pruning, scouting)
                               15 (hand pruning)
Pistachio
                             23 (hand harvesting)
                           4 (mechanical harvesting)
Plum, prune
                              30 (thinning fruit)
                              30 (thinning fruit)
Raspberry
                           24 (irrigation, hand set)
                             21 (hand harvesting)
Strawberry
                             23 (hand harvesting)
                             23 (hand harvesting)
Walnut, English
                                 15 (scouting)
                                      N/A
LOC=level of concern; MOE=margin of exposure; N/A not applicable.; WPS=Worker Protection Standard
[1] Including all activities not likely to occur in the field and WPS-exempted activities
2 For all activities that are expected to occur in the field that are not exempted by WPS
3 https://www.epa.gov/pesticide-worker-safety/protections-workers-who-must-enter-pesticide-treated-areas-early

Human Incidents and Epidemiology
The agency collects data from the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR). The agency's IDS records incidents in two modules: Main IDS and Aggregate IDS.  Main IDS contain incidents resulting in higher severity outcomes and provides more case-specific detail. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature of the incident. Main IDS incidents involving only one pesticide are considered to provide more certain information about the potential effects of exposure from the pesticide. Aggregate IDS contain incidents resulting in less severe human incidents (minor, unknown, or no effects outcomes).

Fenbutatin-oxide incidents were most recently reviewed in 2019. In the current five-year analysis from January 1, 2014 to January 28, 2019, there was one incident reported that involved the active ingredient fenbutatin-oxide.  This incident involved multiple active ingredients. For Aggregate IDS for the five years from January 1, 2014 to January 28, 2019, there were 31 incidents reported involving fenbutatin-oxide.  These incidents were classified as minor severity.  A query of SENSOR-Pesticides from 2011-2015 identified seven cases involving fenbutatin-oxide.  

Based on the continued low frequency of fenbutatin-oxide incidents reported to both IDS and SENSOR-Pesticides, there does not appear to be a concern at this time.  The agency will continue to monitor the incident information. Additional analyses will be conducted if ongoing human incident monitoring indicates a concern. For additional information on the information found in the databases, see memo "Fenbutatin-Oxide: Tier I Update Review of Human Incidents and Epidemiology for Draft Risk Assessment". 

Tolerances

Tolerances for fenbutatin-oxide are established in 40 CFR § 180.362, and no changes to the tolerance expression are needed at this time.

The U.S. plant residue definition is harmonized with Codex, and Canada. There are U.S. and Codex maximum residue limits (MRLs) established for residues of fenbutatin-oxide on animal commodities; however, there are no Canadian tolerances for residues in animal commodities. 

The U.S. and Codex tolerances are not harmonized for some commodities because the U.S. has established the tolerances based on different use patterns. The U.S. tolerances, except a few commodities (e.g., cherry), are either in harmony or higher than the Codex or the Canadian MRLs.  In general, EPA is not recommending to harmonize these tolerances because it may result in over-tolerance residues in the U.S. based on the U.S. use pattern.  

The agency anticipates some changes to the tolerances for fenbutatin-oxide, as shown in Table 3. The agency intends to undertake tolerance actions pursuant to its Federal Food, Drug, Cosmetic Act (FFDCA) authority in a process separate from this registration review. 

  Table 3: Summary of Anticipated Tolerance Actions
Fenbutatin-Oxide: Summary of Proposed Tolerance Actions 
             Correct Commodity Definition/ Current Commodity Name
                                  Established
                                Tolerance (ppm)
                           Proposed Tolerance (ppm)
                                   Comments
40 CFR 180.362 (a) General (1)
Almond Hulls 
                                     80.0
                                      80

1) Corrected value to be consistent with OECD rounding classes. 
2) Based on previous processing studies.[1] 
Apple
                                     15.0
                                      15

Apple, wet pomace 
                                     100.0
                                      100

Fruit, citrus, group 10-10, dried pulp 
                                      --
                                      100

1) Corrected value to be consistent with OECD rounding classes. 
2) Based on previous processing studies.[1]
3) Commodity definition revision.
          Citrus, dried pulp
                                     100.0
                                    Remove

Fruit, citrus, group 10-10, oil 
                                      --
                                      140

         Citrus, oil
                                     140.0
                                    Remove

Cucumber 
                                      4.0
                                    Remove
No information available for cucumbers on use pattern. 
Fruit, citrus group 10-10
                                      --
                                      20
1) Corrected value to be consistent with OECD rounding classes
2)  Crop group conversion 
     Fruit, citrus group 10
                                     20.0
                                    Remove

Grape, raisin
                                     20.0
                                      20
Corrected value to be consistent with OECD rounding classes.
Nut, tree, group 14-12
                                      --
                                      0.5

1) Commodity definition revision
2) Corrected value to be consistent with OECD Rounding Class Practice
3) Crop group conversion/
Revision.[2]

     Nut, tree, group 14
                                      0.5
                                    Remove

     Pistachio[2]
                                      0.5
                                    Remove

Peach 
                                     10.0
                                      10

Corrected value to be consistent with OECD rounding classes.
Pear 
                                     15.0
                                      15

Plum prune dried 
                                     20.0
                                      20

Strawberry 
                                     10.0
                                      10

1 The agency  previously reviewed the processing data for apple wet pomace and citrus oil and citrus dried pulp. Although there was a previous recommendation for updated tolerances, the 40 CFR was not revised (memo, S. piper, 08-NOV-2001, D272901). As a part of the registration review, the agency intends to update the tolerances in table 3.
[2]The individual tolerance for pistachio should be removed and a tolerance for residue in/on nut, tree, group 14-12 should be established at 0.5ppm.   

Fenbutatin-Oxide: Summary of Proposed Tolerance Actions 
                                   Commodity
                                  Established
                                Tolerance (ppm)
                          Recommended Tolerance (ppm)
Comments 
40 CFR 180.362 (b) General (1)
Egg
                                      0.1
                                    Remove
                                       
                                       
                                       
Classified under Category 3 of 40 CFR §180.6 (a)[3]
                                       
Hog, fat 
                                      0.5
                                    Remove

Hog, meat 
                                      0.5
                                    Remove

Hog meat, by-product
                                      0.5
                                    Remove

Poultry, fat 
                                     0.10
                                    Remove 

Poultry, meat byproduct
                                     0.10
                                    Remove

Poultry, meat 
                                     0.10
                                    Remove

[3] Category 3 of 40 CFR §180.6 (a) classification: That it is not possible to establish with certainty whether a finite residue will be incurred, but there is no reasonable expectation of finite residues.
Tolerances for eggs, swine and poultry should be removed per the recommendation in the last Residue chemistry chapter memo (S. Piper, 08-NOV-2001, D272901).

Fenbutatin-Oxide: Summary of Proposed Tolerance Actions 
                                   Commodity
                                  Established
                                Tolerance (ppm)
                          Recommended Tolerance (ppm)
Comments [Correct Commodity Definition]
40 CFR 180.362 (c)
                                  Raspberry 
                                     10.0
                                      10
Corrected value to be consistent with OECD rounding classes.
Tolerances with regional registration. 

Human Health Data Needs

The toxicology database for fenbutatin-oxide is complete; however, Fenbutatin-Oxide: Draft Human Health Risk Assessment for Registration Review, and the Fenbutatin-Oxide. Addendum to the Registration Review Human Health Risk Assessment to Support the Proposed Interim Decision identified the need for dislodgeable foliar residue (DFR) data.

Ecological Risks

A summary of the agency's ecological risk assessment is presented below. The agency used the most current science policies and risk assessment methodologies to prepare a risk assessment in support of the registration review of fenbutatin-oxide. For additional details on the ecological assessment for fenbutatin-oxide, see the Fenbutatin-Oxide: Draft Ecological Risk Assessment for Registration Review, which is available in the public docket.

On January 7, 2015, the National Marine Fisheries Service issued its Endangered Species Act Section 7 Consultation Conference and Biological Opinion on the EPA's registration of pesticides containing fenbutatin-oxide. The EPA is currently working with its federal partners and other stakeholders to implement an interim approach for assessing potential risk nationwide to federally listed species and their designated critical habitats. Once the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats are finalized, the agency plans to complete a nationwide endangered species assessment for fenbutatin-oxide. See Appendix C for more details. As such, potential risks for non-listed species only are described below. 

 Risk Summary and Characterization

Terrestrial Risks 

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals by examining the dietary exposure pathway, focusing on the result of foraging on or outside a field treated with fenbutatin-oxide. As a result of exposures from post-application foraging, potential risks for both birds and mammals were identified on a chronic exposure basis. An additional exposure pathway of concern is for birds and mammals that consume aquatic organisms, as fenbutatin-oxide has the potential to bioconcentrate and bioaccumulate in aquatic organisms. 

Mammals 

Fenbutatin-oxide is classified as practically non-toxic to mammals on acute oral exposure basis. Based on the highest exposure values (i.e., those modeled for strawberries) the highest dose-based Risk Quotient (RQ) was 0.08 (i.e., for small mammals foraging on short grass) and is below the acute risk LOC of 0.5; therefore, there are no acute risks of concern for mammals. 

Potential chronic risks of concern were, however, identified for mammals. In laboratory studies, chronic exposure resulted in decreased growth (19% reduction in F1 pup weight gain during lactation). Across all the use rates evaluated, dose-based RQ values (0.13 - 71.0) exceed the chronic risk LOC of 1.0 for all size classes of mammals on the majority of forage items except for granivores foraging on seeds. Dietary-based RQ values (0.2 - 11.2) also exceed the chronic risk LOC of 1.0 for mammals foraging on short and tall grasses, broadleaf plants and arthropods across the majority of uses evaluated. 

Dietary-based RQs above the LOC, in addition to the dose-based LOC exceedances, support the conclusion that chronic mammalian risks are potentially of concern. The highest estimated RQ values were for high application rates used on strawberries (i.e., 3 applications of 1.5 lbs a.i./A with 14-day retreatment interval) where RQs ranged as high as 71 for small (15 g) mammals feeding on short grasses. Even if the chronic RQ was based on the Lowest Observed Adverse Effect Level (LOAEL) of 16.6 mg a.i./kg bw (Lowest Observed Adverse Effect Concentration=250 mg/kg diet), chronic dose-based RQ values for small (15 g), medium (35 g) and large-sized (1,000 g) mammals foraging on short and tall grasses, broadleaf plants and arthropods would range from 3.93 to 21.9 and still exceed the chronic risk LOC.

Fenbutatin-oxide has the potential to bioaccumulate in aquatic food chains, which represents a route of exposure for mammals that consume aquatic prey. Acute RQ values for this exposure pathway were below the acute risk LOC; however, chronic dose-based RQ values exceed the chronic risk LOC of 1, ranging from 16 to 65 while dietary-based RQ values range between 2.8 and 8.1. Based on the agency's analysis, there are potential chronic risks of concern for mammals that consume aquatic prey which have bioaccumulated residues of fenbutatin-oxide.

Birds, Reptiles, and Terrestrial-Phase Amphibians 

Fenbutatin-oxide is classified as practically non-toxic to birds (which serve as a surrogate for reptiles and terrestrial-phase amphibians) on both an acute oral and subacute dietary exposure basis. In both cases, the toxicity estimates have non-definitive values; therefore, acute risk quotients (RQs) were not calculated and there are no acute risks of concern for birds, reptiles, and terrestrial-phase amphibians.

Chronic dietary-based RQs exceed the chronic risk LOC for birds, reptiles, and terrestrial-phase amphibians.  On a chronic exposure basis, the No Observed Adverse Effect Concentration (NOAEC) for birds is 150 mg a.i./kg diet, which was based on decreased reproduction (32% reduction in the total number of eggs laid and a 15% reduction in the number of eggs per hen) at the lowest observed adverse effect concentration (LOAEC) of 500 mg ai/kg diet. Chronic dietary-based RQ values ranged from 0.1 up to 5.60 and exceed the chronic risk LOC of 1.0 across all the evaluated uses. In order to get the dietary-based RQ below the chronic risk LOC, the maximum single application rate of fenbutatin-oxide would have to be reduced to 0.6 lbs ai/A. Based on exposure to birds from spray drift alone, adverse effects may extend to approximately 7 feet from the edge of the treated field for the eggplant use, which represents the maximum exposure scenario evaluated.

Fenbutatin-oxide has the potential to bioaccumulate in aquatic food chains, which represents a route of exposure for birds that consume aquatic prey which have bioaccumulated residues of fenbutatin oxide. For this exposure pathway, acute dose-based and dietary-based RQ values were below the acute risk LOC of 0.5; however, chronic dietary-based RQs range between 2.1 to 5.6 and exceed the chronic risk LOC of 1.0. Based on this analysis and the capacity of fenbutatin-oxide to accumulate in the tissues of aquatic organisms, estimated residues in aquatic prey can reach concentrations that may result in adverse chronic effects in birds. 

Terrestrial Invertebrates (honey bees) 

Although the agency has limited honey bee data for fenbutatin-oxide, it is classified as practically non-toxic to adult honey bees on an acute contact exposure basis. The highest acute contact RQ value for adult bees is 0.001, which is well below the acute risk LOC of 0.4, and therefore, not of concern. 

Oral toxicity data for honey bees were not available for fenbutatin-oxide. As a result, the agency was unable to assess the potential risk to individual adult or larval bees from either acute or chronic exposure to residues in pollen and/or nectar. 

Additional data may be necessary to fully evaluate risks to non-target terrestrial invertebrates, especially pollinators. Although the EPA identified the need for certain data to evaluate potential effects to pollinators when initially scoping the registration review for fenbutatin-oxide, the problem formulation and registration review DCI for fenbutatin-oxide, were both issued prior to the EPA's issuance of the June 2014 Guidance for Assessing Pesticide Risks to Bees. This 2014 guidance lists additional pollinator studies that were not included in the fenbutatin-oxide registration review DCI. Therefore, the EPA is currently determining whether additional pollinator data are needed for fenbutatin-oxide. If the agency determines that additional pollinator exposure and effects data are necessary for fenbutatin-oxide, then the EPA will issue a DCI to obtain these data. The pollinator studies that could be required are listed in Table 4.  

Table 4: Potential Pollinator Data Requirements
Guideline #
Study
                                    Tier 1
OCSPP 850.3020
Acute contact toxicity study with adult honey bees 
OCSPP 850.3030
Honey bee toxicity of residues on foliage 
Non-Guideline (OECD TG 213)
Honey bee adult acute oral toxicity 
Non-Guideline (OECD TG 237)
Honey bee larvae acute oral toxicity 
Non-Guideline (OECD TG 245)
Honey bee adult chronic oral toxicity 
Non-Guideline (OECD GD 239)
Honey bee larvae chronic oral toxicity 
                                  Tier 2[†]
Non-Guideline
Field trial of residues in pollen and nectar 
Non-Guideline (OECD GD 75)
Semi-field testing for pollinators  
                                  Tier 3[†]
OCSPP 850.3040
Full-Field testing for pollinators  
OECD=Organization for Economic Cooperation and Development; TG=Test Guideline; GD=Guidance Document
[†] The need for higher tier tests for pollinators will be determined based upon the results of lower tiered tests and/or other lines of evidence and the need for a refined pollinator risk assessment.  

Terrestrial Plants 
No risks of concern were identified for terrestrial plants. There were no adverse effects detected in the terrestrial plant studies conducted up to measured application rates of 2.03 lbs a.i./A, which is roughly equivalent to the maximum single application rate (2 lbs a.i./A) allowed for fenbutatin-oxide. Since no adverse effects were detected in terrestrial plant toxicity studies, RQ values for plants were not calculated as they would be below the LOC for risk to terrestrial plants.

Aquatic Risks

Freshwater Fish and Aquatic-Phase Amphibians 
Fenbutatin-oxide is classified as very highly toxic to freshwater fish on an acute exposure basis. For each of the uses evaluated, acute RQs for freshwater fish exceed the acute risk LOC of 0.5 (RQ range: 3.1 - 48.5), and the chronic RQ values exceed the chronic risk LOC of 1.0 for freshwater fish (RQ range: 7.6 -168).

The ecological risk assessment also evaluated the distance between the field edge and a water body that is needed to reduce aquatic RQs below levels of concern. Eggplant use represents the maximum exposure scenario, where adverse effects to freshwater fish from acute and chronic exposure via spray drift may occur up to approximately 26 feet and 85 feet, respectively, from the edge of the treated field when assuming a fine to medium droplet size.  These distances are reduced to 3 and 10 ft, respectively, when a medium to course droplet size is assumed. The rate scenario with the lowest rate (prune use) had potential adverse effects. Assuming fine to medium droplet sizes, distances from acute exposure via spray drift to freshwater fish may occur up to approximately 7 feet from the edge of the treated field, whereas potential chronic exposure from spray drift may happen up to10 feet from the edge of the treated field. Spray drift distances decreased to zero when medium to course droplet sizes are selected for the prune use.

Estuarine/Marine Fish 
Fenbutatin-oxide is classified as very highly toxic to estuarine/marine fish on an acute exposure basis. Estuarine/marine fish are less sensitive to fenbutatin-oxide on an acute exposure basis with RQ values ranging from 0.2 to 2.7. The RQ values for estuarine/marine fish exceed the acute risk LOC of 0.5 for the maximum use rate on all the uses evaluated except raspberry. On a chronic exposure basis, RQs range from 2.7 to 53 and exceed the chronic risk LOC of 1.0 for all evaluated uses.

The ecological risk assessment also evaluated the distance between the field edge and a water body that is needed to reduce RQs below levels of concern. Based on the eggplant use, adverse effects to estuarine/marine fish from chronic exposure via spray drift may occur up to approximately 7 feet beyond the edge of the treated field. When the minimum use exposure scenario (prunes) was used, spray drift distances decreased to zero when medium to course droplet sizes are selected.

Freshwater Invertebrates 
Fenbutatin-oxide is classified as very highly toxic to freshwater invertebrates on an acute exposure basis. Acute RQ values for freshwater invertebrates exceed the acute risk LOC of 0.5 at maximum application rates for most of the uses evaluated with RQ values ranging between 0.23 to 3.6. On a chronic exposure basis, RQ values range up to 3.3 for freshwater invertebrates and exceed the chronic risk LOC of 1.0 for all the uses evaluated except peaches and raspberry (RQ range: 0.15  -  3.28).  

Based on both the maximum and minimum (eggplant and prune, respectively) use scenarios, which considered fine to medium droplet size, adverse effects for freshwater invertebrates from exposure via spray drift are not expected to occur. 

Estuarine/Marine Invertebrates 
Fenbutatin-oxide is classified as very highly toxic to estuarine/marine invertebrates on an acute exposure basis. Estuarine/marine invertebrates are more sensitive to fenbutatin-oxide than freshwater invertebrates on an acute exposure basis, RQ values for estuarine/marine invertebrates range from 1.3 to 20.3 and exceed the acute risk LOC of 0.5 across all of the uses evaluated by factors ranging between 2.6 to 40.6. Of particular note, the acute toxicity estimate for marine mollusk (Eastern oyster LC50 = 0.37 ug ai/L), which was based on a 50% reduction in shell growth, is roughly 60 times more sensitive than the acute toxicity estimate for mysid shrimp. The RQ values for mollusks range from 9.9 to 153.

On a chronic exposure basis, the chronic risk LOC of 1.0 is exceeded at maximum application rates for all the evaluated uses, and RQ values ranged from 4.98 to 109
Examining the eggplant scenario which allows the highest application rate of fenbutatin oxide, and using fine to medium droplet size, acute and chronic adverse effects to estuarine/marine organisms via spray drift only, may occur up to approximately 3 feet to 36 feet from the edge of field, respectively. For the use on the plums/prunes scenario (which represents the lowest application rate of fenbutatin-oxide), adverse effects from spray drift alone are not expected to occur beyond the edge of the treated field. 

For benthic estuarine/marine invertebrates, chronic RQ values (range: 0.47 - 10.6) exceed the chronic risk LOC across the majority of uses evaluated. 

Aquatic Vascular and Non-Vascular Plants 
While risk estimates for aquatic vascular plants are below the LOC of 1.0, those for non-vascular plants (range 0.22  -  3.34) exceed the LOC for risk to plants. There is a potential for adverse effects to non-vascular plants from fenbutatin-oxide; however, the degree to which adverse effects may occur is formulation-dependent, as the formulation will influence the extent to which fenbutatin-oxide may be dissolved in water and available for uptake by plants.  

Ecological Incidents

The Incident Data System (IDS) was searched on November 13, 2018; the IDS provides information on the available ecological pesticide incidents, including those that have been aggregately reported to the EPA.

A total of two incidents, both involving plants, are reported in the IDS. In one incident in 2002 a grower in California reported spotting on oranges following ground foliar application of a tank mixture of Lorsban(TM) 4E (chlorpyrifos; PC Code 058101), Success(TM) (spinosad; PC Code 110003), Vendex[(TM)] at 2 lbs product/A, and Bayfolan[(TM)] . The incident was assigned a certainty index of "possible"; however, given the number of products associated with the incident, it is not possible to accurately attribute the reported effects to fenbutatin-oxide alone.

The second incident (IO009262-105) occurred in 1999 where a homeowner in Washington, DC applied Isotox[(TM)] Insect Killer (dual formulation of 0.5% fenbutatin-oxide and 8% acephate (PC Code 103301) to a dwarf Alberta pine and the tree subsequently died. The application rate used by the homeowner was not specified. The incident was assigned a certainty code of "probable"; however, as with many incidents, limited information is provided with which to assess a cause-effect relationship. 

No aggregate incidents are reported. EPA's changes in the registrant reporting requirements for incidents in 1998 may account for a reduced number of non-aggregated reported incidents. Registrants are now only required to submit detailed information on "major" fish, wildlife, and plant incidents. Minor fish, wildlife, and plant incidents, as well as all other non-target incidents, are generally reported aggregately.

The agency will continue to monitor ecological incident information as it is reported to the agency. Detailed analyses of these incidents are conducted if reported information indicates concerns for risk to non-target organisms.

Ecological and Environmental Fate Data Needs

The ecological effects database is largely complete for fenbutatin-oxide However, uncertainties remain with respect to the potential effects of fenbutatin-oxide on honey bees. Although fenbutatin-oxide is characterized as practically non-toxic to adult worker bees on an acute contact exposure data, there are no data currently available with which to assess potential risks to adult and/or larval bees following either acute (single dose) or chronic (repeat dose) oral exposure. No additional pollinator data are anticipated to be needed to be called-in for this registration review at this time. The EPA will consider requiring submission of pollinator data as a separate action.

The environmental fate data required by the registration review GDCI were submitted to the agency. However, the environmental chemistry method (ECM) and its corresponding independent laboratory validations (ILV) in soil and water are data needs that were identified in the risk assessment and remains a data gap.

Benefits Assessment
There are several pest management benefits of fenbutatin-oxide in agricultural use sites. Fenbutatin-oxide is the only IRAC Group 12B registered for use in the United States, providing a unique mode of action (MoA) in pest management programs. Spider mites are especially prone to insecticide resistance, and fenbutatin-oxide may play a role in resistance management. This active ingredient targets both adult and immature life stages of susceptible plant-feeding (phytophagous) mites. By contrast, many miticides labeled for use in agricultural and non-agricultural sites, such as Christmas trees, are mite growth regulators and thus are only effective against eggs or immature mite stages. When there are populations of both adult and immature mites, miticides such as fenbutatin-oxide that also have activity against adults are advantageous. 

Encouraging biological control of pests is often an important aspect of pest control in agriculture. Fenbutatin-oxide is regarded as having a relatively low impact on all natural pests in citrus and specifically a short or days long impact on predatory mites. Disruptions in biological control that last weeks are not only associated with outbreaks of the targeted pest but often with outbreaks of secondary pests because non-target natural enemies were killed. The unintended mortality of natural enemies has unforeseen consequences of additional pest control costs and possibly yield reduction or market value losses if pest injury is severe.

Finally, for grapefruit (site with highest usage) another benefit is that fenbutatin-oxide has good efficacy against both spider mites and rust mites. There are only three miticides recommended for control of both types of mites in the fall. The loss of fenbutatin-oxide, a novel MoA, from this list could result in increased insecticide resistance pressure on the remaining two miticides for growers who need simultaneous control of pests. If resistance does develop, the convenience of using a single a.i. to target multiple pests reduces grower time and effort to control multiple pests in grapefruit would be lost.

For more in-depth analysis of the usage, benefits and potential impacts of key risk mitigation measures being proposed, please refer to the Biological and Economic Analysis Division, Fenbutatin Oxide (PC #104601): Usage and Benefits of Fenbutatin Oxide and Impacts of Mitigation document located in the fenbutatin-oxide docket.

PROPOSED INTERIM REGISTRATION REVIEW DECISION

 Proposed Risk Mitigation and Regulatory Rationale

In developing the proposed risk management strategy for the fenbutatin-oxide registration review, the EPA considered the human health and ecological risks as well as the benefits associated with fenbutatin-oxide usage. At this time, the agency has identified potential human health risk of concern to residents coming into contact with residues after application to gardens, occupational handlers, workers re-entering fenbutatin-oxide treated fields, and bystanders exposed to spray drift. The agency also identified potential ecological risks of concern to mammals, birds (surrogate for terrestrial amphibians and reptiles), freshwater (surrogate for aquatic-phase amphibians) and estuarine/marine fish, freshwater and estuarine/marine invertebrates, and aquatic plants. To mitigate potential risks of concern, the agency is proposing a number of mitigation measures. Additionally, the EPA is also proposing label changes to address generic labeling requirements for all fenbutatin-oxide products and uses.

If the changes proposed are implemented, all potential human health risks of concern to bystanders, occupational handlers and workers re-entering fenbutatin-oxide-treated fields will be mitigated, and there will be no human health risks of concern. In evaluating the ecological risks of concern to wildlife from the use of fenbutatin-oxide, EPA considered and weighed the risks and benefits, and determined that if the proposed mitigation measures are implemented any remaining ecological risks are outweighed by the potential resistance management benefits associated with the use of fenbutatin-oxide.

There is one technical registrant for fenbutatin-oxide: UPL Limited. The following are proposed mitigation measures to which the registrant has agreed:
 prohibiting aerial, mechanically pressurized handgun, and backpack sprayer applications on the label;
 prohibiting use on eggplants, raspberries, ornamentals, greenhouse and outdoor ornamentals (including nursery stock, flowers, and plants grown for propagation purposes), and established landscape ornamentals (commercial application to established landscape ornamentals, including trees, shrubs, flowering ornamentals, bedding plants, annuals, and perennials;
 requiring enclosed cabs for airblast applications;
 requiring the use of medium or coarser droplet size for groundboom applications;
 requiring a release height of 2 feet or less above the ground or crop canopy for groundboom applications;
 requiring maximum windspeed restrictions of 10 mph for both groundboom and airblast applications; 
 establishing 50-foot drift buffers from residential and commercial areas for airblast applications; and
 establishing 25-foot drift buffers from water bodies at all use sites.

In addition to these proposed changes, EPA is also soliciting comments during this public comment period on the agency-proposal to extend REIs for all WPS use sites to which the registrants have not yet agreed. 

While it appears that the benefits of fenbutatin-oxide are low for many uses based upon the  low usage of the chemical and low percent crop treated for most crops, before EPA makes an interim decision as to the risk and benefits of fenbutatin-oxide, any comments that are submitted regarding the benefits and impacts of these proposed measures will be considered in the Interim Registration Review Decision. 

  Proposed Changes to Application Methods
EPA is proposing to prohibit aerial applications of fenbutatin-oxide for all use sites and has received agreement from the fenbutatin-oxide technical registrant on this proposal. This proposal was also suggested by USDA as a potential mitigation option. By prohibiting aerial applications of fenbutatin-oxide, the potential risks to occupational handlers, flaggers, and bystanders associated with aerial applications will be mitigated. Additionally, potential off-field risks to wildlife will be reduced by eliminating aerial application methods. The agency is proposing this restriction given the limited use and low benefit of aerial applications of fenbutatin-oxide, as well as the availability of alternative application methods (e.g., groundboom, airblast). 

The agency is also proposing to prohibit the use of mechanically pressurized handguns for all use sites and backpack sprayers for the Christmas trees use. The agency has determined that the potential risks of mechanically pressurized handguns for all use sites and backpack application methods for Christmas trees outweigh the benefits and has received agreement from the fenbutatin-oxide technical registrant on this proposal. By proposing to prohibit both mechanically pressurized handguns and backpack sprayers, potential risks to occupational handlers who mix, load, and apply fenbutatin oxide using these application methods are mitigated. The EPA does not know how many growers apply fenbutatin-oxide by mechanically pressurized handgun and backpack sprayers. However, as stated above, given the availability of alternative application methods (e.g., groundboom, airblast) and the likelihood that these methods are more widely used to apply fenbutatin-oxide the potential impacts from this proposed restriction is probably low. In addition, the agency has concluded that prohibiting mechanically pressurized handgun and backpack sprayer applications would have a low impact on Christmas tree growers based on information from extension service sources indicating that insecticides/miticide applications in Christmas trees can be done with airblast sprayers or groundboom equipment. 

Finally, the agency is proposing to require enclosed cabs for airblast applications, which would reduce the risk of exposure to fenbutatin-oxide by airblast applicators. The registrant has agreed to this proposed requirement. The agency does not know how many handlers currently apply fenbutatin-oxide by airblast use tractors with enclosed cabs. Those handlers not using tractors with enclosed cabs could retrofit an existing tractor or purchase a new tractor with an enclosed cab; however, given the cost of these options, growers may choose to use an alternative to fenbutatin-oxide, such as pyridaben. Grapefruit is the commodity with the highest proportion of treated acreage according to recent usage data. Compared to the other registered fenbutatin oxide uses, grapefruit accounts for the most total pounds applied and acres treated, meaning grapefruit growers may be most impacted if additional fenbutatin-oxide risk mitigation results in growers selecting another miticide. Grapefruit growers could face an increase in production costs using an alternative, such as pyridaben, in place of fenbutatin-oxide. In addition, because fenbutatin-oxide is one of only three miticides recommended for control of both spider mites and rust mites in the fall and is a novel MoA, the increased use of the other two miticides could result in increased insecticide resistance pressure for growers who need simultaneous control of pests. Please see the Biological and Economic Analysis Division, Fenbutatin Oxide: Usage and Benefits of Fenbutatin Oxide, and Impacts of Mitigation document, which is available in the fenbutatin-oxide public docket.

  Proposed Spray Drift Requirements and Drift Buffers for Ground Applications
The agency is proposing mandatory and advisory drift statements to reduce off-target spray drift of fenbutatin-oxide, and the registrant has agreed to this proposal. In combination with proposed drift buffers to residential and commercial areas, these drift reduction measures will fully mitigate potential bystander risks of concern. Reducing spray drift will also reduce the extent of environmental exposure and risk to non-target plants and animals. To further mitigate the potential risk to aquatic organisms and the terrestrial animals that feed on those organisms, the agency is also proposing 25-foot drift buffers from water bodies for all uses. Although the agency is not making a complete endangered species finding at this time, these label changes are expected to reduce the extent of exposure and may reduce risk to listed species whose range and/or critical habitat co-occur with the use of fenbutatin-oxide.  
The agency is proposing the following spray drift mitigation language to be included on the fenbutatin-oxide product label. The proposed spray drift language is intended to be mandatory, enforceable statements and supersede any existing language already on product labels (either advisory or mandatory) covering the same topics. The agency is also proposing advisory drift language that outlines best management practices to reduce drift. The registrant must ensure that any existing advisory language left on labels does not contradict or modify the new spray drift statements proposed in this PID, once effective.  The proposed mandatory drift requirements are outlined below, and the advisory drift language is found in the Appendix B.
 Applicators must not spray during temperature inversions.
 For groundboom applications, apply with the spray release height no more than 2 feet above the ground or crop canopy.
 Applicators must only spray when wind speed is 10 miles per hour (mph) or less at the application site.
 For groundboom applications, select nozzle and pressure that deliver medium or coarser droplets as indicated in nozzle manufacturers' catalogues and in accordance with American Society of Agricultural & Biological Engineers Standard 572.3 (ASABE S572.3).
 For air blast applications, nozzles directed out of the orchard must be turned off in the outer row.
 For air blast applications, applications must be directed into the canopy foliage. 

Temperature Inversion Restriction

The proposed requirement could result in delays to intended applications and, more generally, reduce the amount of time users have to apply fenbutatin-oxide. Potentially, growers could switch to a different active ingredient that does not have this restriction, but that could be costly and potentially difficult to obtain in a short period of time. 
Groundboom Spray Release Height
Groundboom restrictions should have little to no impact on grapefruit growers because they use airblast sprayers, not groundbooms, to apply miticides and insecticides to the foliage of trees.

Aside from strawberries, other crops that will continue to be a registered use site include either trellised vines (i.e., grapes) or evergreen (i.e., Christmas tree plantations) and deciduous fruit and nut trees. Applications of miticides and insecticides would not be made by groundboom for these crops. In trellised vines, applications of insecticides and miticides are made with air blast or tower sprayers and suggests that groundboom restrictions would have no impact on the use of fenbutatin-oxide for this use site.  Strawberry plants do not grow more than twelve inches off the ground. Insecticide applications are made by groundboom for strawberries; however, the EPA expects that the groundboom height restriction of two feet would not have an effect on the grower's ability to use fenbutatin oxide. 

Wind Speed Restrictions
Wind conditions vary across the U.S. and wind speed restrictions (that is, prohibitions against application when the wind speed is greater than 10 mph) could prevent timely applications of fenbutatin-oxide. Survey data indicate that most applicators consider wind speed when making applications and typically apply at wind speeds of 15 mph or lower. However, there are situations (e.g., when rain and other weather conditions are right for application, when pest pressure is high, etc.) when applicators will spray at wind speeds greater than 15 mph (less than 5 percent of survey respondents). Mandatory wind speed restrictions may complicate pest and crop management by reducing the available time to make applications and make it more likely that a grower may need to alter pest control plans. However, changing plans may be more costly given that a different, more expensive chemical may be used.  If applications were not made in a timely manner, pest control could decline, leading to additional applications, yield losses, and/or accelerate the development of resistance.
Windspeed restrictions would limit the number of hours in a day to apply fenbutatin oxide, but the relatively low usage of fenbutatin-oxide on most use sites suggests that growers have other effective miticides. Grapefruit grown in Florida has the most usage of fenbutatin oxide, but a 12-mph mandatory windspeed restriction is already in place.

Groundboom Droplet Size Restrictions
In addition to including the spray drift restrictions on fenbutatin-oxide labels, all references to volumetric mean diameter (VMD) information for spray droplets are proposed to be removed from all fenbutatin-oxide labels where such information currently appears. The proposed new language above, which cites ASABE S572.3, eliminates the need for VMD information.
The agency is proposing a restriction on droplet size, because coarser droplets have been demonstrated to decrease spray drift, and therefore, reduce potential risks to bystanders. Because chemical-specific data for the performance of droplet sizes is limited, the EPA was not able to evaluate the effects of medium or coarser droplet sizes (as defined by ASABE S572.3) specifically for fenbutatin-oxide. Therefore, the EPA does not know the effect this requirement will have on the performance of fenbutatin-oxide across various use patterns. In general, potential negative impacts to growers from requiring larger droplets could include reductions in efficacy, increased selection pressure for the evolution of miticide resistance due to a decrease in lethal dose delivered to target pests, increased application rates used by growers, increased costs associated with reduced yield, more miticide applications, purchase of alternative products, or an inability to use tank mix or premix products. However, the agency does not have enough information to allow an estimate of the likelihood or extent of such outcomes. The EPA encourages comments on any potential impacts to growers from specifying a mandatory minimum droplet size on product labels. Without a mandatory droplet size of medium or coarser, drift buffers to residential and commercial areas would need to be 10 to 75 feet for groundboom in order to address bystander risks.
Spray Drift Buffers to Bystanders
Because implementing the above spray drift mitigation would not fully mitigate bystander risks of concern, the agency is also proposing 50-foot spray drift buffers to residential/commercial areas for airblast applications. Additional buffers are not needed to address potential risks of concern to bystanders from groundboom applications.  

Spray Drift Buffers to Water Bodies

To mitigate potential risk to aquatic animals, as well as birds and mammals that feed on aquatic prey, the agency is proposing a 25-foot drift buffer to water bodies for all uses. The Vendex(TM) 50 WP label currently has 25-foot buffers to water bodies in Florida, which, with this proposal, would apply these buffers to all use sites in all states. Additionally, the previous Biological Opinion decision stated that mitigation measures should be taken to help protect Pacific salmon bearing waters from receiving drift from the use of fenbutatin-oxide. Implementing the proposed 25 feet buffer to all water bodies could may mitigate the potential risk to those areas.

While the registrant has agreed to these proposals for drift buffers that protect bystanders and wildlife. EPA has not assessed the impact of the buffer requirements.  Except for grapefruit grown in Florida, all use sites on the label have very little annual usage of fenbutatin oxide and mandating the use of buffers on these use sites will likely have little impact on most growers. In some situations, buffers may require growers to remove land from production thus decreasing revenue while imposing costs to maintain the buffers. The potential impact of the buffer requirement can be highly localized and critically depends on the size and shape of a field.  Some growers may choose to no longer use fenbutatin-oxide if these proposed requirements are implemented.  For grapefruit growers, effective alternatives to fenbutatin-oxide are available at an increase in cost and increased insecticide resistance pressure on the remaining miticides.

Proposed Increase Restricted Entry Intervals (REIs) 
To address potential risks to workers entering fenbutatin-oxide treated fields, the EPA is proposing to extend the current 48-hour (2-day) restricted-entry interval (REI) for the majority of registered use sites. These proposed REI changes are outlined below and will mitigate potential risks to post-occupational workers as specified in the Worker Protection Standard. The agency's proposed changes to the REIs are as follows:

 For pecan, extending the REI to 15 days
 For apple, Christmas tree plantations, nectarine, papaya, extending the REI to 21 days
 For pistachio and strawberry, extending the REI to 23 days
 For cherry, extending the REI to 25 days
 For grapefruit, lemon, and orange, extending the REI to 28 days
 For peach, pear, plum, and grape, extending the REI to 30 days

The agency is proposing these REIs for a number of reasons: the lower application rates needed to address the potential risk would likely not be efficacious, the low annual usage of fenbutatin oxide across most uses may indicate the benefits are generally low, and while the additional proposed restrictions may result in some growers switching to an alternative miticide it would remain available for growers as a tool to address miticide resistance as necessary. For most growers, the length of the proposed REI will make the use of fenbutatin-oxide infeasible. As discussed previously, fenbutatin-oxide is not used extensively on most crops and, as a result, this mitigation is not expected to have widespread impacts. Given the relatively low usage on fenbutatin-oxide, it is assumed that cost-effective alternatives to fenbutatin oxide are available. The agency evaluated the potential impact of an extended REI on grapefruit, which is the commodity with the highest proportion of treated acreage according to recent usage data. This analysis indicated that, as in many other crops, there are effective alternatives to fenbutatin-oxide, and that while the use of such alternatives could raise production costs, the estimated economic impact is relatively small. 

For more details on this assessment, please refer to the Biological and Economic Analysis Division, Fenbutatin Oxide (PC #104601): Usage and Benefits of Fenbutatin Oxide and Impacts of Mitigation document located in the fenbutatin-oxide docket. 

As mentioned earlier, to reduce post application risks to workers, the agency is considering an increase in the REI in citrus groves from 48 hours to 28 days. This REI is inclusive of all post-application worker activities that prompt the agency's risks of concern, and includes grove 
maintenance (i.e., activities such as propping), baiting or trapping, hand pruning, and hand harvesting. EPA's information about grapefruit production in Florida indicate that harvesting and pruning are always done via mechanical means. The EPA is seeking input from other regions of the country that also use fenbutatin-oxide on grapefruit crops to understand if mechanical pruning and harvesting are also typical in those areas. If additional information on the impact of these proposed REI extensions is submitted during the public comment period, the EPA will consider it as part of its Interim Registration Review Decision for the fenbutatin-oxide case.

For more information on worker re-entry, including exceptions to the Worker Protection Standard, visit https://www.epa.gov/pesticide-worker-safety/protections-workers-who-must-enter-pesticide-treated-areas-early .
 
Proposed Voluntary Cancellation of Use Sites

The fenbutatin-oxide registrant has agreed to voluntarily cancel the use of fenbutatin-oxide on raspberry, eggplant, greenhouse and outdoor ornamentals (including nursery stock, flowers, and plants grown for propagation purposes), and established landscape ornamentals (commercial application to established landscape ornamentals, including trees, shrubs, flowering ornamentals, bedding plants, annuals, and perennials). The available pesticide usage data suggests that fenbutatin-oxide is not widely used on these use sites and, as a result, the agency assumes that effective alternatives are available for the pests targeted by fenbutatin-oxide. Removing these use sites from fenbutatin-oxide labels will eliminate all potential human health and ecological risks resulting from fenbutatin-oxide application at these use sites, as well as any surrounding areas where potential risks could occur as a result of spray drift.  
 
If additional information on the benefits of these uses is submitted during the public comment period, EPA will consider it as part of its interim decision for the fenbutatin-oxide case. If additional information changes the benefits for some of these uses, additional restrictions not discussed in this PID may be needed, including, but not limited to, changes to REIs, application rates, and application methods.

Personal Protective Equipment (PPE)

Due to the toxicity category of "Danger" and the potential of dermal toxicity or skin irritation the clothing statement needs to be updated to require handlers to wear coveralls over long-sleeved shirt and long pants. Updates to respirator language are also needed on the label, and may be found in the Label Table in Appendix B.
 
Additional Label Clarifications

The agency is proposing to include the units (lb product/A) for the maximum annual application rates on the fenbutatin-oxide label, which are currently not specified. The units the agency is proposing are consistent with those established for single application rates for clarity of the user.

The agency is also proposing to change seasonal rates and number of applications to annual rates and number of applications. The seasonal application rates and numbers of applications imply more than one season for a crop in a year.

Additionally, the agency is proposing to establish a 21-day minimum retreatment interval for each use site that does not have a retreatment interval already specified on the label.

Finally, the agency is proposing to change label references to "Christmas Trees" to "Christmas Tree Plantations," which is consistent with the agency's proposal to delete all non-agricultural use sites. 

Tolerance Actions 

No changes to the tolerance expression for fenbutatin-oxide are needed.  The agency is anticipating changes to some of the tolerances as discussed in Section III.A.3 and will use its FFDCA rulemaking authority to make the needed changes to the tolerances.

Proposed Interim Registration Review Decision 

In accordance with 40 CFR §§ 155.56 and 155.58, the agency is issuing this PID. Except for the Endocrine Disruptor Screening Program (EDSP) and the Endangered Species Act (ESA) components of this case, the agency has made the following proposed interim decision: (1) data gaps identified at this time include a DFR study, ECM/ILV data, and pollinator data. and (2) changes to the affected registrations and their labeling are needed at this time, as described in Section IV. A and Appendices A and B.

In this PID, the agency is making no human health or environmental safety findings associated with the EDSP screening of fenbutatin-oxide, nor is it making a complete endangered species finding. Although the agency is not making a complete endangered species finding at this time, the proposed mitigation described in this document is expected to reduce the extent of environmental exposure and may reduce risk to listed species whose range and/or critical habitat co-occur with the use of fenbutatin-oxide. Additionally, the agency believes that these proposed mitigation measures, if implemented, are consistent with measures included in the National Marine Fisheries Service's 2015 Biological Opinion to reduce exposures to aquatic species, including those that are federally listed as threatened and endangered. The agency's final registration review decision for fenbutatin-oxide will be dependent upon the result of the agency's ESA assessment and any needed § 7 consultation with the Services and an EDSP FFDCA § 408(p) determination.

Data Requirements
The registrant has agreed to conduct a Dislodgeable Foliar Residue (DFR) study in an orchard setting that may refine post-application worker risk estimates. The registrant has indicated that this study is expected to take place in 2020, and the data scheduled to be submitted in early 2021. The ECM/ILV was not previously submitted and remains a data gap. No additional pollinator data are anticipated to be needed to be called-in for this registration review at this time. The EPA will consider requiring submission of pollinator data as a separate action.

NEXT STEPS AND TIMELINE 

 Proposed Interim Registration Review Decision

A Federal Register Notice will announce the availability of this PID for fenbutatin-oxide and will allow a 60-day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the agency to change its proposed interim decision, the EPA may issue an interim registration review decision for fenbutatin-oxide. However, a final decision for fenbutatin-oxide may be issued without the agency having previously issued an interim decision. A final decision on the fenbutatin-oxide registration review case will occur after: (1) an EDSP FFDCA § 408(p) determination, and (2) an endangered species determination under the ESA and any needed § 7 consultation with the Services.

Implementation of Mitigation Measures 

Once the Interim Registration Review Decision is issued, the fenbutatin-oxide registrant must submit amended labels that include the label changes described in Appendices A and B. The revised labels and requests for amendment of registrations must be submitted to the agency for review within 60 days following issuance of the Interim Registration Review Decision in the docket. 

  
 Appendix A:  Summary of Proposed Actions for Fenbutatin-Oxide
Registration Review Case#: 0045
PC Code: 104601
Chemical Type: miticide
Chemical Family: organotin 
Mode of Action: non-systemic ATP synthase inhibitor, and cellular respiration disruptor  
                            Affected Population(s)
                                       
                              Source of Exposure
                               Route of Exposure
                             Duration of Exposure
                         Potential Risk(s) of Concern
                               Proposed Actions
                                   Comment 
Residential Post-Application (outdoor)
Residues at/on site of treatment
Dermal
Acute
Acute toxicity
-Prohibit use on Greenhouse and Outdoor Ornamentals (including nursery stock, flowers, and plants grown for propagation purposes)

-Prohibit use on Established Landscape Ornamentals (Commercial application to established landscape ornamentals, including trees, shrubs, flowering ornamentals, bedding plants, annuals, and perennials.)

Prohibit these uses on the technical label
Occupational Handlers
Aerial and ground application
Dermal and Inhalation
Acute and Chronic
Acute toxicity and inhalation toxicity
-Prohibit aerial, pressurized handgun, and backpack sprayer applications on the label.
-Require enclosed cabs for airblast application
-Voluntary cancellation of eggplant and raspberry uses

Prohibit eggplant and raspberry uses on the technical label
Occupational Post-Application 
Residues at/on site of treatment
Dermal
Acute
Acute toxicity
Extend REIs 

Bystanders
Residues from spray drift
Dermal 
Acute
Inhalation toxicity and acute toxicity
-Prohibiting aerial applications
-Mandatory drift language
-Drift buffers to commercial and residential areas (50 ft)

-Birds
-Mammals
-Fish (freshwater and estuarine/marine) 
-Aquatic Invertebrates (freshwater and estuarine/marine)
Dietary
Ingestion
Acute and Chronic

-Prohibiting aerial applications
-Mandatory drift language
-25-foot buffer to all water bodies for all uses (for risks to aquatic invertebrates only)

 
 Appendix B:  Proposed Labeling Changes for Fenbutatin-Oxide Products

                                  Description
             Proposed Label Language for Fenbutatin-Oxide Products
                              Placement on Label

                              Technical Products

Cancelation of Use Sites

UPDATE "Directions for Use"

"It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Only for formulation into a miticide:
For the following uses: 
Terrestrial Food Crops  -  REMOVE Eggplant, Raspberry. 
Terrestrial Nonfood Crops  -  REMOVE Ornamental Plants UPDATE Christmas Tree Plantations
Greenhouse Nonfood Crops  -  REMOVE Ornamental Plants

Directions for Use

                               End Use Products 

Mode/Mechanism of Action Group Number
Note to registrant:
 --------------------------------------------------------------------------------
   Include the name of the ACTIVE INGREDIENT in the first column
 --------------------------------------------------------------------------------
   Include the word "GROUP" in the second column
 --------------------------------------------------------------------------------
   Include the MODE/MECHANISM/SITE OF ACTION CODE in the third column (for herbicides this is the Mechanism of Action, for fungicides this is the FRAC Code, and for insecticides this is the Primary Site of Action); for Herbicides this is SITE OF ACTION
 --------------------------------------------------------------------------------
   Include the type of pesticide (i.e., HERBICIDE or FUNGICIDE or INSECTICIDE) in the fourth column. 
                                       
--------------------------------------------------------------------------------
FENBUTATIN-OXIDE
--------------------------------------------------------------------------------
GROUP
--------------------------------------------------------------------------------
12B
--------------------------------------------------------------------------------
INSECTICIDE
                                       
Front Panel, upper right quadrant.
All text should be black, bold face and all caps on a white background, except the mode of action code, which should be white, bold face and all caps on a black background; all text and columns should be surrounded by a black rectangle.
Updated Clothing Statement
In the Personal Protective Equipment (PPE) within the Precautionary Statements:
 REMOVE "Coveralls over short sleeve shirt and short pants" and REPLACE with "Coveralls over long sleeve shirt and long pants"

In the Personal Protective Equipment (PPE) within the Precautionary Statements
Updated Respirator Language

 "Wear a minimum of a NIOSH-approved particulate filtering facepiece respirator with any N*, R or P filter; OR a NIOSH-approved elastomeric particulate respirator with any N*, R or P filter; OR a NIOSH-approved powered air purifying respirator with HE filters."
*Drop the "N" option if there is oil in the product's formulation and/or the product is labeled for mixing with oil-containing products.
In the Personal Protective Equipment (PPE) within the Precautionary Statements
Enclosed Cab Requirement for Airblast Applications
Registrants, add the following language:

"Airblast equipment applicators must use an enclosed cab that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(5)]"

Engineering Control Statements 
Change Seasonal Rates to Annual Rates, Annual maximum rates clarified, Number of applications per year specified.
Registrants, REPLACE all instances of
 "pounds per year" with "pounds of product per year"
 "per season" with "per year"
Directions for Use
Specify Minimum Retreatment Interval
Registrant, add the following language for each use site EXCEPT Grape, Citrus in California and Arizona, Citrus in Texas, Citrus in Florida, Papaya, and Christmas Tree Plantations in Washington and Oregon:
 "Do not spray in less than 21-day intervals."

Directions for Use Under the Appropriate Crop Specific Directions
Cancelation of Use Sites
Registrant, REMOVE the following use sites from the fenbutatin-oxide label: 
 Established landscape ornamentals (Commercial application to established landscape ornamentals, including trees, shrubs, flowering ornamentals, bedding plants, annuals and perennials
 Greenhouses and Outdoor Ornamentals (including nursery stock, flowers and plants grown for propagation purposes)
 Eggplant
 Raspberry
Directions for Use
Non-Agricultural Use Prohibition

[Note to registrant: DELETE the Non-Agricultural Use Requirements box. REVISE the label to specify that the product is only for agricultural use, per the following:]
"DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling.
*Only for Agricultural Use."

[Note to Registrant: in the Specific Use Rates table, change Christmas tree to Christmas Tree Plantations, as is consistent with agricultural use:]
"Christmas Tree Plantations in Washington and Oregon" 
Directions for Use
Prohibition of Application Methods
Registrants, add the following statements:
 "Do not apply product with aerial application equipment."
 "Do not apply product with mechanically pressurized handgun equipment. "
 "Do not apply product using backpack sprayers."
Directions for Use, under Restrictions Header
REI statement for the Agricultural Use Requirements Box when there are multiple crops with different REIs
Registrants, REPLACE "Do not enter or allow worker entry into treated areas during the restricted-entry interval of 48 hours" with the following:
 "Do not enter or allow workers to enter during the restricted-entry interval (REI). The REI is listed in the Directions for Use associated with the crop"
Within the Agricultural Use Requirements Box
Restricted Entry Intervals for almonds and walnuts 
Registrants, add the REIs for the uses permitted on the label.
 "Almonds: The REI is 2 days."
 "Walnuts: The REI is 2 days."
Directions for Use Under the Appropriate Crop Specific Directions
Restricted Entry Intervals for pecans
Registrants, add the REIs for the uses permitted on the label.
 "Pecans: The REI is 15 days."

Directions for Use Under the Appropriate Crop Specific Directions
Restricted Entry Intervals for apples, nectarines, papayas, Christmas tree plantations
Registrants, add the REIs for the uses permitted on the label.
 "Apples: The REI is 21 days."
 "Nectarines: The REI is 21 days."
 "Papayas: The REI is 21 days."
 "Christmas Tree Plantations: The REI is 21 days."
Directions for Use Under the Appropriate Crop Specific Directions
Restricted Entry Intervals for pistachios, strawberries
Registrants, add the REIs for the uses permitted on the label.
 "Pistachios: the REI is 23 days."
 "Strawberries: the REI is 23 days."
Directions for Use Under the Appropriate Crop Specific Directions
Restricted Entry Intervals for cherries
Registrants, add the REIs for the uses permitted on the label.
 "Cherries: the REI is 25 days"
Directions for Use Under the Appropriate Crop Specific Directions
Restricted Entry Intervals for grapefruits, lemons, oranges
Registrants, add the REIs for the uses permitted on the label.
 "Grapefruits: the REI is 28 days."
 "Lemons: The REI is 28 days."
 "Oranges: The REI is 28 days."
Directions for Use Under the Appropriate Crop Specific Directions
Restricted Entry Intervals for grapes, peaches, pears, plums/prunes
Registrants, add the REIs for the uses permitted on the label.
 "Grapes: The REI is 30 days."
 "Peaches: The REI is 30 days."
 "Pears: The REI is 30 days."
 "Plums/Prunes: The REI is 30 days."
Directions for Use Under the Appropriate Crop Specific Directions
Resistance-management labeling statements for insecticides and acaricides

Include resistance management label language for insecticides/acaricides from PRN 2017-1 (https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year)

Directions for Use, prior to directions for specific crops
Additional Required Labelling Action
Applies to all products delivered via liquid spray applications

Remove information about volumetric mean diameter from all labels where such information currently appears.
Directions for Use
Spray Drift Management Application Restrictions for products applied via liquid spray that allow groundboom application
"MANDATORY SPRAY DRIFT MANAGEMENT
Groundboom Applications: 
 --------------------------------------------------------------------------------
   User must only apply with the release height recommended by the manufacturer, but no more than 2 feet above the ground or crop canopy.
    Applicators are required to use a medium or coarser droplet size (ASABE S572.3).
 --------------------------------------------------------------------------------
   Do not apply when wind speeds exceed 10 mph at the application site. 
 --------------------------------------------------------------------------------
   Do not apply within 25 feet of water bodies
 --------------------------------------------------------------------------------
   Do not apply during temperature inversions."

Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Groundboom Applications"
Spray Drift Management Application Restrictions for products applied via liquid spray that allow airblast applications
"MANDATORY SPRAY DRIFT MANAGEMENT

Airblast applications:
 Sprays must be directed into the canopy.
 Do not apply when wind speeds exceed 10 miles per hour at the application site.
 --------------------------------------------------------------------------------
User must turn off outward pointing nozzles at row ends and when spraying outer row. 
 --------------------------------------------------------------------------------
Do not apply during temperature inversions."
Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Airblast Applications"
Advisory Spray Drift Management Language for all products delivered via liquid spray application
"SPRAY DRIFT ADVISORIES
THE APPLICATOR IS RESPONSIBLE FOR AVOIDING OFF-SITE SPRAY DRIFT.
BE AWARE OF NEARBY NON-TARGET SITES AND ENVIRONMENTAL CONDITIONS.

IMPORTANCE OF DROPLET SIZE
An effective way to reduce spray drift is to apply large droplets. Use the largest droplets that provide target pest control. While applying larger droplets will reduce spray drift, the potential for drift will be greater if applications are made improperly or under unfavorable environmental conditions.

Controlling Droplet Size  -  Groundboom (note to registrants: remove if groundboom is prohibited on product labels)
:: Volume - Increasing the spray volume so that larger droplets are produced will reduce spray drift. Use the highest practical spray volume for the application.  If a greater spray volume is needed, consider using a nozzle with a higher flow rate.
:: Pressure - Use the lowest spray pressure recommended for the nozzle to produce the target spray volume and droplet size.
:: Spray Nozzle - Use a spray nozzle that is designed for the intended application. Consider using nozzles designed to reduce drift.

Controlling Droplet Size  -  Aircraft (note to registrants: remove if aerial application is prohibited on product labels)
:: Adjust Nozzles - Follow nozzle manufacturers' recommendations for setting up nozzles.  Generally, to reduce fine droplets, nozzles should be oriented parallel with the airflow in flight.

BOOM HEIGHT  -  Groundboom (note to registrants: remove if groundboom is prohibited on product labels)
For ground equipment, the boom should remain level with the crop and have minimal bounce.

RELEASE HEIGHT - Aircraft (note to registrants: remove if aerial application is prohibited on product labels)
Higher release heights increase the potential for spray drift.  

SHIELDED SPRAYERS
Shielding the boom or individual nozzles can reduce spray drift.  Consider using shielded sprayers.  Verify that the shields are not interfering with the uniform deposition of the spray on the target area.

TEMPERATURE AND HUMIDITY
When making applications in hot and dry conditions, use larger droplets to reduce effects of evaporation.

TEMPERATURE INVERSIONS
Drift potential is high during a temperature inversion. Temperature inversions are characterized by increasing temperature with altitude and are common on nights with limited cloud cover and light to no wind. The presence of an inversion can be indicated by ground fog or by the movement of smoke from a ground source or an aircraft smoke 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 vertical air mixing. Avoid applications during temperature inversions. 

WIND
Drift potential generally increases with wind speed.  
Applicators need to be familiar with local wind patterns and terrain that could affect spray drift."
Directions for Use, just below the Spray Drift box, under the heading "Spray Drift Advisories

    
    Appendix C:  Endangered Species Assessment

This Appendix provides general background about the Agency's assessment of risks from pesticides to endangered and threatened (listed) species under the Endangered Species Act (ESA). Additional background specific to fenbutatin-oxide appears at the conclusion of this Appendix.

In 2013, the EPA, along with the Fish and Wildlife Service (FWS), the National Marine Fisheries Service (NMFS), and the United States Department of Agriculture (USDA) released a summary of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides.  These Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recommendations that discussed specific scientific and technical issues related to the development of pesticide risk assessments conducted on federally threatened and endangered species. 
      
Since that time, EPA has conducted biological evaluations (BEs) on three pilot chemicals representing the first nationwide pesticide consultations. These initial consultations were pilots and were envisioned to be the start of an iterative process.  The agencies are continuing to work to improve the consultation process.  For example, advancements to the initial pilot interim methods have been proposed based on experience conducting the first three pilot BEs.  Public input on those proposed revisions is currently being considered.  
      
Also, a provision in the December 2018 Farm Bill included the establishment of a FIFRA Interagency Working Group to provide recommendations for improving the consultation process required under section 7 of the Endangered Species Act for pesticide registration and Registration Review and to increase opportunities for stakeholder input.  This group includes representation from EPA, NMFS, FWS, USDA, and the Council on Environmental Quality (CEQ). Given this new law and that the first nationwide pesticide consultations were envisioned as pilots, the agencies are continuing to work collaboratively as consistent with the congressional intent of this new statutory provision. EPA has been tasked with a lead role on this group, and EPA hosted the first Principals Working Group meeting on June 6, 2019.  
      
Given that the agencies are continuing to develop and work toward implementation of approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this PID for fenbutatin-oxide does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although the EPA has not yet completed effects determinations for specific species or habitats, for this PID, the EPA's evaluation assumed, for all taxa of non-target wildlife and plants, that listed species and designated critical habitats may be present in the vicinity of the application of fenbutatin-oxide. This will allow the EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. Once that occurs, these methods will be applied to subsequent analyses for fenbutatin-oxide as part of completing this registration review.

Between 2008 and 2015, NMFS released seven Biological Opinions specific to listed Pacific salmon and steelhead species for various pesticides, including fenbutatin-oxide. EPA plans to address risks to listed species and critical habitats from use of fenbutatin-oxide and other pesticides assessed in prior NMFS Biological Opinions as part of the final registration review decisions for these pesticides, pending completion of the nationwide consultation process.

 Appendix D:  Endocrine Disruptor Screening Program

"As required by FIFRA and FFDCA, the EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, sub-chronic 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, the EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision for fenbutatin-oxide, the EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA § 408(p), fenbutatin-oxide is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

The 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 the 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 § 408(p), the agency must screen all pesticide chemicals. Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. The agency has reviewed all of the assay data received for the List 1 chemicals and the conclusions of those reviews are available in the chemical-specific public dockets. Fenbutatin-oxide is on List 1 and the review conclusions are available in the fenbutatin-oxide public docket (see EPA-HQ-OPP-2009-0841).A second list of chemicals identified for EDSP screening was published on June 14, 2013, and includes some pesticides scheduled for Registration Review and chemicals found in water.  Neither of these lists should be construed as a list of known or likely endocrine disruptors. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit the EPA website.  

In this PID, the EPA is making no human health or environmental safety findings associated with the EDSP screening of fenbutatin-oxide. Before completing this registration review, the agency will make an EDSP FFDCA § 408(p) determination."