   	


                                       
                                       
                                       
                                       
                                       
	
                                       
                                   Boscalid
                                       
                 Proposed Interim Registration Review Decision
                               Case Number 7039
                                       
                                       
                                  March 2020
                                       
                                       
                                       
			Approved by: ____________
					   Elissa Reaves, Ph.D.
                                 Acting Director
                           Pesticide Re-evaluation Division


                  Date:	March 30, 2020
                               Table of Contents
I.	INTRODUCTION	3
A.	Summary of Boscalid Registration Review	4
B.	Summary of Public Comments on the Draft Risk Assessments and Agency Responses	5
II.	USE AND USAGE	9
III.	SCIENTIFIC ASSESSMENTS	9
A.	Human Health Risks	9
1.	Risk Summary and Characterization	9
2.	Human Incidents and Epidemiology	12
3.	Tolerances	12
4.	Human Health Data Needs	15
B.	Ecological Risks	15
1.	Risk Summary and Characterization	16
2.	Ecological Incidents	19
3.	Ecological and Environmental Fate Data Needs	19
C.	Benefits Assessment	20
IV.	PROPOSED INTERIM REGISTRATION REVIEW DECISION	20
A.	Proposed Risk Mitigation and Regulatory Rationale	20
1.	Residential Handlers	21
2.	PPE for Occupational Handlers	21
3.	Re-entry Interval (REI or Restricted Entry Interval)	22
4.	Spray Drift Management	25
5.	Environmental Hazard Statements	26
6.	Pesticide Resistance Management	27
B.	Tolerance Actions	27
C.	Proposed Interim Registration Review Decision	27
D.	Data Requirements	28
V.	NEXT STEPS AND TIMELINE	28
A.	Proposed Interim Registration Review Decision	28
B.	Implementation of Mitigation Measures	28
Appendix A:  Summary of Proposed Actions for Boscalid	29
Appendix B:  Proposed Labeling Changes for Boscalid Products	30
Appendix C:  Endangered Species Assessment	35
Appendix D:  Endocrine Disruptor Screening Program	36


I.	INTRODUCTION
	
This document is the Environmental Protection Agency's (the EPA or the agency) Proposed Interim Registration Review Decision (PID) for boscalid (PC Code 128008, case 7039), 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 boscalid. can be found in the EPA's public docket (EPA-HQ-OPP-2014-0199) 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 boscalid 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 national 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 boscalid prior to completing the boscalid registration review. Likewise, the agency will complete endocrine screening for boscalid, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) § 408(p), before completing registration review. See Appendices C and D, respectively, for additional information on the listed species assessment and the endocrine screening for the boscalid registration review. 

Boscalid is classified as a pyridine-carboxamide fungicide in the Fungicide Resistance Action Committee (FRAC) Group 7. Boscalid targets cellular respiration in fungal pathogens. Products containing boscalid are registered for control of economically important fungal diseases in many agricultural crops, including almonds, grapes, potatoes, and strawberries. It is also registered for use as a seed treatment, and on golf course turf, gardens, residential fruit and nut trees, and ornamentals. A limited number of products containing boscalid are registered for use in residential settings. Boscalid may be formulated as a single active ingredient pesticide or co-formulated with the fungicides pyraclostrobin and chlorothalonil and with the insecticide lambda-cyhalothrin. Boscalid was first registered in 2003 and was not subject to reregistration. 
 
This document is organized in five sections: the Introduction, which includes this summary and a summary of public comments and the EPA's responses; Use and Usage, which describes how and why boscalid 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; the 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, the Next Steps and Timeline for completion of this registration review.

 Summary of Boscalid Registration Review

Pursuant to 40 CFR § 155.50, the EPA formally initiated registration review for boscalid 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 boscalid.

    December 2014 - The Boscalid Preliminary Work Plan (PWP), Boscalid. Human Health Assessment Scoping Document in Support of Registration Review, and Registration Review: Draft Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Boscalid were posted to the docket for a 60-day public comment period. The PWP included a number of data needs that were required for boscalid including soil and aquatic metabolism studies, sediment toxicity, aquatic invertebrate, fish early life, and fish life cycles; environmental chemistry, and 90-day inhalation studies. 

    June 2015 - The Boscalid Final Work Plan (FWP) was issued. The planned data needs did not differ from those in the PWP.

    January 2016 - A Generic Data Call-In for boscalid (GDCI-128008-1505) was issued for data needed to conduct the registration review risk assessments. All data requirements have been satisfied with the exception of the Tier 2 and 3 honeybee data (i.e., semi-field/field studies).  

    November 2019 - The agency announced the availability of Boscalid. Human Health Risk Assessment for Registration Review, and the Boscalid. Draft Ecological Risk Assessment for Registration Review for a 60-day public comment period, and eight comments were received. These comments and the agency's responses are summarized below. The comments resulted in minor changes the risk assessments but did not affect the registration review timeline for boscalid.

    March 2020 - The agency is now announcing the availability of the PID in the docket for boscalid for a 60-day public comment period. 

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

During the 60-day public comment period for the Boscalid Draft Risk Assessments, which opened on November 18, 2019 and closed on January 17, 2020, the agency received public comments from eight sources. Comments were submitted by the technical registrant, BASF; USDA; The IR-4 Project; the California Specialty Crops Council; the University of California, Riverside; the National Agricultural Aviation Association (NAAA); the Northwest Horticultural Council; and the Washington State Potato Commission. Substantive comments, comments of a broader regulatory nature, and the agency's responses to those comments are summarized below. The agency thanks all commenters for their comments and has considered them in developing this PID. 

Comments submitted by BASF (Document ID: EPA-HQ-OPP-2014-0199-0044)

Comment: BASF identified errors in the ecological risk assessment and sought clarification on several issues.

Response: The agency acknowledges several errors in the ecological risk assessment, as noted below, and is clarifying other statements that BASF referred to in its comments.

    The ecological risk assessment references the lack of an acute larval honeybee study, but BASF had previously submitted such a study (MRID 49361801). 
    For an acute toxicity study on Daphnia magna (MRID 50158201), the agency incorrectly identified the test material.  The correct test material is Bonide FT09. 
    The ecological risk assessment discusses adverse effects associated with the solvent control in a chronic larval honeybee toxicity study (MRID 50414301). BASF commented that the study met all validity criteria from the test guideline and was adequate to assess the effects of the treatment. The agency does not disagree, but believes the solvent issue is relevant to its characterization of the test results. 
    Risk estimates for fish are misstated in some parts of the assessment.  The agency acknowledges the error and notes that the correct values appear in Table 1-1 of the ecological risk assessment. 
    BASF referenced Table 10-1 in the ecological risk assessment, noting that tomatoes are not attractive to honeybees. The agency has reviewed the table and does not agree that it suggests tomatoes are pollinated by honeybees, but rather that they are pollinated by bumble bees.
    The registrant noted that the ecological risk assessment seems to indicate incorrectly that in the honeybee queen development studies on almond (MRID 49009304) and phacelia (MRID 49009303), applications of Pristine were not made while bees were actively foraging. The agency confirms that is true of MRID 49009304 only.
    The risk assessment inadvertently provides an incorrect citation for a study by "Johnson and Percel, 2012." The agency acknowledges that the study was actually published in 2013. BASF also pointed out that a solvent control was not used in either that study or DeGrandi-Hoffman et al., 2013. The agency wishes to clarify that a reference to a third study (chronic larval honeybee toxicity, MRID 50414301) was made because that study and the two 2013 studies together provide evidence that boscalid itself did not cause adverse effects to honeybees.  The reference to increased mortality in the solvent control only applies only to MRID 50414301.
    Also concerning the Johnson and Percel study, BASF commented that the Pristine formulation was not implicated in the observed, adverse effects on honeybee queen development and survival.  The agency concurs and relates the adverse effects observed in that study to the positive control (diflubenzuron).

Comment: For estuarine/marine taxa, EPA's exposure model may overestimate concentrations that result from movement off-field to estuarine/marine waters, based on standard the farm pond model, since most agricultural fields are not directly adjacent to marine habitat and pesticide residues would be subject to considerable downstream dilution.

Response: Concentrations may be lower from run-off into estuarine/marine environments relative to the farm pond, but it is well-documented that pesticides have the potential to reach estuarine/marine habitats from pesticide applications nearby or from water or particulates moving from inland areas (see references 1 through 3 below).  Estuarine/marine areas serve as nurseries and habitats for many taxa and the farm pond model is intended to be protective of these vulnerable habitats.  The pond model does not simulate flow-through or sediment burial/turnover and pesticide concentrations are likely to  be lower in many estuarine/marine environments, but the rate of mixing and tidal dilution is highly variable and will not necessarily result in rapid or extensive dilution of the pesticide compound in vulnerable estuaries (i.e., estuaries with low volume/high residence time) (see references 4 and 5 below). 
Smalling and Orlando (2011) collected water and sediment samples within three of the largest watersheds along California's Central Coast and analyzed for pesticides including boscalid. Boscalid was detected in 85% of samples, at concentrations up to 36 ug/L, in three different estuaries. The monitoring did not likely to capture peak concentrations; nevertheless the concentrations in those samples are just below the EECs (i.e., 51  -  237 ug/L) the agency used to calculate risk quotients (RQs) for estuarine/marine organisms and close to the levels where chronic effects have been reported in laboratory toxicity studies (the most sensitive endpoint, from estuarine/marine fish, is a NOAEC of 45.5 μg/L). These lines of evidence support potential for boscalid to occur in environmentally relevant concentrations in the estuarine/marine environment.  

Comment: BASF intends to propose the harmonization of tolerances for tree nuts with the Codex MRLs.  

Response: The agency acknowledges BASF's interest in doing so.

Comments submitted by the USDA (Document ID: EPA-HQ-OPP-2014-0199-0040)

Comment: USDA expressed concerns about the implications of the occupational post-application risk assessment for turning and girdling in grapes, noting that a 22-day REI would render boscalid essentially useless for grape production in the United States. USDA wrote that while girdling and turning are used less commonly than they may have been in the past, in table grapes girdling and turning still have some applicability. USDA provided information on grape production practices that reduce dependence on turning and girdling and offered to facilitate information exchange with table grape growers, extension personnel, and production experts on the practices and benefits of boscalid use on grapes. In addition, USDA provides a breakdown of average application rates for boscalid on grapes in several states.

Response: The agency is cognizant of the potential impacts of a long REI on grape production and is actively seeking information that it can use to better understand the prevalence of turning and girdling, application parameters for boscalid, and the potential impacts of its proposed risk management approach. In Section IV of this PID, the agency poses a number of questions for stakeholders on these and related topics, in the hopes of improving its understanding the scope of the potential risks and alternate approaches to reducing those risks. The agency is grateful for any additional assistance that USDA can provide.

Comment: EPA's exposure models may overestimate concentrations of boscalid in brackish and saltwater habitats, and hence, risks to estuarine/marine taxa, that result from off-field movement of the pesticide.  In addition, USDA indicates that chronic risks to marine/estuarine fish also may be overstated, since the endpoint is a marginal decrease in body weight.

Response: The agency acknowledges the conservative nature of its estuarine/marine risk estimates. Because the adverse effect in the chronic estuarine/marine fish study represents just a small difference between fish at the NOAEC and the untreated controls, the agency evaluated the potential risks associated with the LOAEC (which is > 2X the NOAEC), and found potential risks of concern were still associated with most uses.  The agency's overall risk concerns remain despite the conservative assumptions about estuarine/marine fish.  

Comment: USDA is concerned that if the agency implements overly stringent droplet size restrictions for boscalid, it could drive some fungicide users to increase application rates or use alternatives with broader risk profiles.

Response:  The agency's proposed droplet size requirements for boscalid are the same as what the registrant has said is common practice already, so impacts on users should be minimal.

Comment Submitted by NAAA (Document ID: EPA-HQ-OPP-2014-0199-0047)

Comment: NAAA provided comments on the spray drift analysis conducted for the
ecological risk assessment, 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.

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 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 boscalid labels. In the absence of specific use directions and application restrictions implemented across all product labels, default assumptions (based on empirical data) are used.

Comments Submitted by the Northwest Horticultural Council, IR-4, the Washington State Potato Commission, the California Specialty Crops Council, and the University of California at Riverside (Document IDs: EPA-HQ-OPP-2014-0199-0041, EPA-HQ-OPP-2014-0199-0042, EPA-HQ-OPP-2014-0199-0043, EPA-HQ-OPP-2014-0199-0045, EPA-HQ-OPP-2014-0199-0046)

Comment: These entities provided use and usage information for boscalid, and discussed the importance of boscalid in the production of various crops.

EPA Response: The EPA thanks the commenters for the information provided on the use of boscalid. The agency agrees that boscalid is a valuable fungicide that is useful in resistance management programs. The comments from these stakeholders have been considered in the development of this PID.

USE AND USAGE

Boscalid is a broad-spectrum fungicide with products registered for agricultural use on tree nuts, pome fruits, citrus fruits, stone fruits, berries, succulent and dry peas and beans, brassica vegetables, cucurbit vegetables, fruiting vegetables, bulb vegetables, grapes, lettuce, peanut, canola, carrot, celery, potato, mint, edible peas, and sunflowers. Boscalid's agricultural uses also include seed treatment for legumes, brassica vegetables, bulb vegetables, cucurbits, and cotton. Additionally, boscalid is registered for disease control in golf course turf.  

Products containing boscalid are formulated as water dispersible granules, dry flowables, aerosols, or flowable concentrates, and can be applied as ground, airblast, or aerial sprays; via chemigation and handheld equipment, or as seed treatments. There are ten registrations for end-use products containing boscalid and three Special Local Need registrations.

According to The AgroTrak Study by Kynetec USA Inc., an average of 600,000 pounds of boscalid was applied annually to 2.3 million acres from 2014-2018. Nearly two-thirds of boscalid applications, by acreage, were made to wine grapes (19%), dry beans and peas (18%), potatoes (13%), and almonds (12%). Among small-acreage crops, boscalid is often applied to a large percentage of crop acres, demonstrating its importance in production of those crops. Crops with a high percent of acres treated with boscalid include table grapes (63%), wine grapes (48%), strawberries (43%), cherries (39%), carrots (39%), and caneberries (38%). The Agency does not have current boscalid seed treatment usage data.  

Boscalid is registered for disease control in golf course turf.  About 21,000 pounds of boscalid were applied to golf courses in 2011 and about 178,000 pounds of boscalid were applied to golf courses in 2013. An additional 4,200 pounds of boscalid was applied in nurseries and greenhouses in 2011.[,]
	
SCIENTIFIC ASSESSMENTS

 Human Health Risks 

A summary of the agency's human health 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 boscalid.  For additional details on the human health assessment for boscalid, see Boscalid. Human Health Risk Assessment for Registration Review, which is available in the public docket.

Risk Summary and Characterization

Dietary (Food + Water) Risks

An endpoint for acute exposure has not been identified, so an acute dietary risk assessment was not conducted. Chronic dietary risk estimates are not of concern. A cancer dietary risk assessment was not conducted since boscalid was classified by the Cancer Assessment Review Committee as having "suggestive evidence of carcinogenicity," so that quantification of human cancer risk is not recommended.

Residential Handler Risks

Several boscalid products are labeled in a way that indicates they may be used on residential use sites. One product (EPA Reg #4-488, "Bonide RT09," formulated as both an emulsifiable concentrate and a ready-to-use spray) is labeled as "intended for residential use only," and marketing claims on the label are pertinent to residential handlers. This product has been assessed by EPA for use by residential handlers with risk estimates not being of concern, i.e., the margin of exposure (MOE) is greater than the level of concern (LOC) of 100. 

The label of another boscalid product (EPA Reg # 7969-353, "Homeowner Garden Spray Fungicide," formulated as a flowable concentrate) is ambiguous with respect to the intended user, and the agency is seeking clarification from the registrant. This product has been assessed by EPA for occupational exposures, and those exposures are considered protective of residential handler exposures, with risk estimates not being of concern (MOEs > the LOC of 100) for either residential or occupational handlers.  

In both instances, EPA is seeking input as to how the products are used and is considering the need for revised labeling to clarify the issue. 

Residential Post-Application Risks

There is the potential for post-application exposure for individuals exposed as a result of being in an environment that has previously been treated with boscalid. Outdoor post-application dermal exposure was assessed for applications to turf (golf course only) and residential gardens/trees. There are no residential post-application risks of concern for any life stage (adults and children).

Non-Occupational Spray Drift Assessment 

Spray drift is a potential source of exposure to individuals adjacent to applications of boscalid; therefore, a non-occupational spray drift assessment was conducted for the registered uses of boscalid. There are no risk estimates of concern for adults or children at the field edge as a result of spray drift from ground spray or airblast.

Aggregate Risks

There are no aggregate risks of concern for boscalid.

Cumulative Risks

The EPA has not made a common mechanism of toxicity to humans finding as to boscalid and any other substance and it does not appear to produce a toxic metabolite produced by other substances. Therefore, the EPA has not assumed that boscalid has a common mechanism of toxicity with other substances for this assessment.
 
Occupational Handler Risks 

Occupational handler exposure is expected from the current uses of boscalid. Dermal and inhalation risk estimates were combined for the assessment, since the endpoints for each exposure route are derived from the same toxicological effects. Risks were assessed separately for field applications of boscalid and seed treatments. Assuming baseline clothing (long-sleeved shirt and long pants, socks and shoes), the MOEs for combined dermal and inhalation exposure scenarios for occupational handlers ranged from 71 to 630,000 (LOC = 100; MOEs lower than the LOC represent potential risks of concern).  Potential risks of concern for occupational handlers are summarized in Table 1.

Table 1: Occupational Handler Risk Estimates for Boscalid 
                               Exposure Scenario
                             Crop/Target Category
                                  Dermal MOE 
                                  (LOC = 100)
                                Inhalation MOE
                                  (LOC = 100)
                                   Total MOE
                                  (LOC = 100)
Mixing/Loading Dry Flowable Formulations for Aerial Application
                           Field crop, high acreage
                                 Baseline: 89
                                      340
                                 Baseline: 71


                                SL*/Gloves: 390

                                SL/Gloves: 180
* SL  -  Single Layer attire represents long-sleeved shirt and long pants, socks and shoes.

As shown above, only one occupational handler scenario poses potential risks of concern at baseline (long-sleeved shirt, long pants, shoes, and socks).  The use of chemical-resistant gloves raises the MOEs above 100, where the risks are not of concern.  There are no risks of concern associated with handlers involved in any seed treatment activities, either for those treating the seed or those handling treated seed.

Occupational Post-Application Risks 

Occupational post-application exposure is expected from the current uses of boscalid. A 12-hour restricted entry level interval (REI) is required for most boscalid products registered for use on agricultural sites. One product (Reg # 7969-199, "Pristine Fungicide," that contains boscalid co-formulated with pyraclostrobin), requires an REI of 5 days for grapes when conducting cane tying, cane turning, or cane girdling activities. 

Most of the dermal post-application scenarios resulted in MOEs greater than the LOC (MOE >= 100) on the day of treatment (i.e., Day 0) and are not of concern. There is a potential risk of concern for turning and girdling following applications of boscalid to grapes. Based on the current exposure assessment, which relies on a chemical-specific Dermal Absorption Factor of 15% derived from an in vivo study in rats, short- and intermediate-term dermal post-application risk estimates were of potential concern for turning and girdling of table grapes up to 22 days after application. On the day of application, the MOE is 69; on Day 9, the MOE is 80; and on Day 22, the MOE is 100 (application rate 0.362 lb ai/A).  For context, the pyraclostrobin component of Pristine was assessed with an MOE of 100 at Day 18 for these same activities.

The EPA has received extensive feedback regarding updated grape crop management practices, particularly for turning and girdling of table grape vines. It appears that for numerous reasons, turning and girdling may be less common than in the past. The agency is soliciting information through this PID on the subject of turning and girdling, in an effort to understand field conditions and how they relate to the pesticide exposure of post-application workers. Specific kinds of information that could help the agency determine the best approach to managing the risks associated with turning and girdling in grapes (table, wine, juice, raisin) are detailed in Section IV of this PID, and the agency is hopeful that stakeholders will help fill in the gaps in our understanding.

Human Incidents and Epidemiology

The EPA completed a review of existing incident data for boscalid in the Incident Data System (IDS). From January 1, 2014 to July 10, 2019, no human incidents involving a single active ingredient and three boscalid incidents involving multiple active ingredients were reported to Main IDS; there were two boscalid incidents reported to Aggregate IDS. A query of the Sentinel Event Notification System for Occupational Risk (SENSOR)-Pesticides database for 2011-2015 identified 22 cases involving boscalid.

Based on the continued low frequency of boscalid incidents reported to both IDS and SENSOR-Pesticides, there does not appear to be a risk 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.

Tolerances

Tolerances for boscalid are established in 40 CFR § 180.589, and no changes to the tolerance expression are needed at this time. 

The agency anticipates some changes to the tolerances for boscalid, as shown in Table 2. 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 2: Summary of Anticipated Tolerance Actions
Correct Commodity Definition/ Current Commodity Name
                          Established Tolerance (ppm)
                           Proposed Tolerance (ppm)
                                   Comments 
                                       
40 CFR 180.589 (a) General (1)
             Tolerance Revisions for Various and Multiple Reasons
Almond, hulls
                                      17
                                      15
Harmonization with Codex
Avocado
                                      1.5
                                       2
Harmonization with Canada
Banana[1]
--
                                      0.6
Commodity definition correction/Harmonization with Codex
     Banana, import[1]
                                     0.40
                                      --

Coffee, green bean[1]
                                      --
                                     0.05
Commodity definition correction
     Coffee, green bean, import[1]
                                     0.05
                                      --

Endive, Belgian
                                      --
                                       6
Commodity definition correction/ Corrected value to be consistent with Organization for Economic Cooperation and Development (OECD) rounding class practice
     Endive, Belgium
                                      6.0
                                      --

Fennel, florence, fresh leaves and stalk
                                      --
                                      45
Commodity definition correction
     Fennel, Florence
                                      45
                                      --

Fruit, citrus, group 10-10, dried pulp
                                      --
                                      4.5

     Citrus, dried pulp
                                      4.5
                                      --

Fruit, citrus, group 10-10, oil
                                      --
                                      85
Commodity definition correction/ Corrected value to be consistent with OECD Rounding Class Practice
     Citrus, oil
                                     85.0
                                      --

Fruit, stone, group 12-12
                                      3.5
                                       5
Harmonization with Codex
Mango
                                      1.5
                                       2
Harmonization with Canada
Papaya
                                      1.5
                                       2

Peppermint, fresh leaves
                                      --
                                      30
Commodity definition correction/ Corrected value to be consistent with OECD Rounding Class Practice
     Peppermint, tops
                                     30.0
                                      --

Rapeseed subgroup 20A, oil
                                      --
                                       5

     Canola, refined oil
                                      5.0
                                      --

Spearmint, leaves
                                      --
                                      30

     Spearmint, tops
                                     30.0
                                      --

Vegetable, legume, dried shelled, except soybean, subgroup 6C
                                      --
                                       3
Commodity definition correction/Harmonization with Codex
    Pea and bean, dried shelled, except soybean, subgroup 6C
                                      2.5
                                      --

Vegetable, legume, edible podded, subgroup 6A
                                      --
                                       5
Commodity definition correction/Corrected value to be consistent with OECD Rounding Class Practice
     Vegetable, legume, edible podded subgroup 6A
                                      5.0
                                      --

Vegetable, legume, succulent shelled, subgroup 6B
                                      --
                                      0.6

     Pea and bean, succulent shelled, subgroup 6B
                                     0.60
                                      --

40 CFR 180.589 (a) General (2)
Hog, fat
                                     0.20
                                      0.3
Harmonization with Canada
Hog, meat 
                                     0.05
                                     0.01

Hog, meat byproducts
                                     0.10
                                     0.35

             Tolerance Revisions for Rounding Class Practice Only
40 CFR 180.589 (a) General (1)
Alfalfa, forage
                                     30.0
                                      30
Corrected value to be consistent with OECD Rounding Class Practice
Alfalfa, hay
                                     65.0
                                      65

Artichoke, globe
                                      6.0
                                       6

Bushberry subgroup 13-07B
                                     13.0
                                      13

Caneberry subgroup 13-07A
                                     10.0
                                      10

Cotton, gin byproducts
                                     55.0
                                      55

Fruit, citrus, group 10-10
                                      2.0
                                       2

Fruit, pome, group 11-10
                                      3.0
                                       3

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F
                                      5.0
                                       5

Grain, aspirated fractions
                                      3.0
                                       3

Kohlrabi
                                      6.0
                                       6

Nut, tree, group 14-12
                                     0.70
                                      0.7

Persimmon
                                      8.0
                                       8

Soybean, vegetable
                                      2.0
                                       2

Star apple
                                      8.0
                                       8

Vegetable, root, except sugar beet, subgroup 1B
                                      2.0
                                       2

40 CFR 180.589 (a) General (2)
Cattle, fat
                                     0.30
                                      0.3
Corrected value to be consistent with OECD Rounding Class Practice
Cattle, meat
                                     0.10
                                      0.1

Goat, fat
                                     0.30
                                      0.3

Goat, meat
                                     0.10
                                      0.1

Horse, fat
                                     0.30
                                      0.3

Horse, meat
                                     0.10
                                      0.1

Milk
                                     0.10
                                      0.1

Poultry, fat
                                     0.20
                                      0.2

Poultry, meat byproducts
                                     0.20
                                      0.2

Sheep, fat
                                     0.30
                                      0.3

Sheep, meat
                                     0.10
                                      0.1

4 0CFR 180.589 (d) (Indirect or Inadvertent Residues)
Animal feed, nongrass, group 18, forage, except alfalfa
                                      1.0
                                       1
Corrected value to be consistent with OECD Rounding Class Practice
Animal feed, nongrass, group 18, hay, except alfalfa
                                      2.0
                                       2

Grain, cereal, forage, fodder and straw, group 16, forage
                                      2.0
                                       2

Grain, cereal, forage, fodder and straw, group 16, straw
                                      3.0
                                       3

Grain, cereal, group 15
                                     0.20
                                      0.2

Grass, forage, fodder, and hay, group 17, forage
                                      2.0
                                       2

Grass, forage, fodder, and hay, group 17, hay
                                      8.0
                                       8

Grass, forage, fodder, and hay, group 17, seed screenings
                                     0.20
                                      0.2

Grass, forage, fodder, and hay, group 17, straw
                                     0.30
                                      0.3

Rice, hulls
                                     0.50
                                      0.5

Vegetable, foliage of legume, group 7, hay
                                      2.0
                                       2

Vegetable, leafy, except brassica, group 4, except celery, lettuce, and spinach
                                      1.0
                                    Remove
Commodities are covered by primary crop tolerances; rotational tolerance no longer necessary
[1] No US registration as of September 16, 2009

Human Health Data Needs

 The agency does not anticipate requiring any further human health data for boscalid at this time.

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 boscalid. For additional details on the ecological assessment for boscalid, see the Boscalid. Draft Ecological Risk Assessment for Registration Review, which is available in the public docket.

The EPA is currently working with its federal partners and other stakeholders to implement an interim approach for assessing potential risk to 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 will complete its endangered species assessment for boscalid. See Appendix C for more details. As such, potential risks for non-listed species only are described below. 

 Risk Summary and Characterization

Terrestrial Risks 

Mammals 

Based on a median lethal dose (LD50) greater than 5,000 mg/kg body weight, boscalid is classified as practically non-toxic to mammals on an acute oral exposure basis, so acute risk quotient (RQ) values were not calculated. Estimates of mammalian chronic risk are based on a no observed adverse effect level (NOAEL) of 11 mg a.i./kg-bw/day; there was a 7% reduction in body weight and reduced weight gain in second generation pups at the lowest observed adverse effect level (LOAEL) of 113 mg a.i./kg-bw/day. 

Mammalian dose-based RQs exceed the chronic risk LOC of 1.0 for animals feeding on short grasses, tall grasses, broadleaf plants/small insects, and arthropods (RQ range: 0.8 to 17) across all of the assessed uses. The RQ for small mammals feeding on fruits/pods/seeds (RQ = 1.09) slightly exceeds the chronic risk LOC for boscalid use on ornamentals. These chronic risk estimates are based on upper-bound exposure values. Had RQs been based on mean Kenaga exposure estimates rather than upper-bound Kenaga estimates, then the highest RQ (17) would be reduced to 6.2, and the RQ for small mammals feeding on fruits/pods/seeds would fall below the chronic risk LOC.

Dietary-based RQs range up to 4.4 with most use sites, mammal size ranges, and dietary items yielding RQs above the chronic risk LOC of 1.0. If these RQs were based on the LOAEC rather than the NOAEC, they would still exceed the chronic risk LOC for small- and medium-sized mammals feeding on short grass. 

For bulb vegetable and legume seed treatments, representing the highest and lowest seed treatment application rates for boscalid, respectively, dose-based RQs range up to 6.4. The number of seeds required to trigger a chronic risk concern was assessed for small, medium, and large-sized mammals and suggests that smaller mammals foraging in fields planted with treated legume seeds could ingest sufficient numbers of treated seeds to trigger the chronic risk LOC. The risk assessment also examined the impact of the foraging area needed to trigger the chronic risk concern and concluded that chronic risks of concern for mammals of all size ranges and both seed types could not be precluded. 

Boscalid product labels address actions the user can take to limit the development of resistance, including not making more than two sequential applications of boscalid-containing products before switching to a fungicide with a different mode of action. If RQs  were based on that recommendation (e.g., waiting 28 days after a second consecutive application of boscalid before applying boscalid again), rather than the shorter maximum re-treatment interval allowed in the directions for use on the product label, chronic RQs would decrease by approximately 21% for both dose-based and dietary-based estimates, but many of the RQs would still exceed the chronic risk LOC. 


Birds, Reptiles, and Terrestrial-Phase Amphibians 

For risk assessment purposes, birds are considered to be surrogates for reptiles and terrestrial-phase amphibians. Acute dose-based and sub-acute dietary-based RQ values were not calculated as boscalid is categorized as practically non-toxic to avian species on an acute oral and sub-acute dietary exposure basis. 

Chronic risk to birds was based on a NOAEC of 300 mg a.i./kg diet.  At the LOAEC (1,000 mg a.i./kg-diet), there were a treatment-related 37% reduction in 14-day old survivors, a 41% reduction in number of eggs laid per hen per week, and a 4-fold increase in the total number of embryonic deaths. Dietary RQs for birds feeding on short grasses exceed the chronic risk LOC slightly only for boscalid use on strawberries, based on upper-bound exposure estimates. A chronic RQ based on mean exposure estimates fall below the LOC.  When chronic RQs are calculated using the LOAEC rather than the NOAEC value, they fall below the LOC for all dietary items and all use sites.

For birds exposed via seed treatment uses, chronic RQs were 2.42 for bulb vegetables and 1.21 for legume vegetables, both exceeding the LOC of 1.0. The number of seeds required to trigger a chronic risk concern was assessed. For small, medium, and large-sized birds that number of legume vegetable seeds needed would be 17, 86, and 858 seeds, respectively. However, legume vegetable seeds are too large for small- and medium-sized birds to consume, so risks of concern for these birds through the consumption of legume vegetable seed is not expected. For bulb vegetable seeds, 1072, 5361, and 53607 seeds would be needed to trigger chronic risk concerns for small, medium, and large birds, respectively. 

The number of legume vegetable seeds that would exceed the chronic risk LOC for large birds, would be found within a foraging area of 1906 ft[2] (or 0.02% of estimated home range). Because the forage area of concern is substantially smaller than the home range for large birds, potential risk from consuming treated legume vegetable seeds is not precluded by this analysis.

Terrestrial Invertebrates (honeybees) 

Boscalid is categorized as practically non-toxic to adult honeybees (Apis mellifera) on an acute oral and acute contact exposure basis.  EPA did not identify either acute (LOC=0.4) or chronic risks (LOC=1) of concern for adult or larval honeybees.  

For reference when considering the ecological incident information discussed below, RQs for pyraclostrobin (which is co-formulated with boscalid in a product implicated in several reported bee incidents) may exceed the LOCs for honeybee adults (acute and chronic exposure) and larvae (chronic exposure) for a number of registered uses. 

The agency required Tier 1,2, and 3 for pollinators in its registration review DCI.  No additional Tier 1 data are needed at this time. The EPA is currently determining whether additional pollinator data are needed for boscalid, based on the results of the Tier 1 honeybee studies (i.e., laboratory studies) and other lines of evidence.

Terrestrial Plants 

There are no LOC exceedances identified for terrestrial plants for the highest exposure scenarios, for either monocots and dicots, or upland and semi-aquatic plants. 

Aquatic Risks

As discussed in the ecological risk assessment, monitoring data show that boscalid residues are present in surface water and groundwater, sometimes at concentrations close to those derived via agency modeling. The relevant surface water monitoring data come from studies that vary in their association with areas where fungicides in general are likely to be used, nevertheless detectable levels of boscalid were found in upwards of 70% of the water samples collected. In laboratory testing in freshwater fish, the NOAEC and LOAEC are within an order of magnitude of the maximum concentrations of boscalid observed in the monitoring data.   

The monitoring studies are not expected to have captured peak boscalid concentrations because sampling was infrequent and did not necessarily take place where boscalid was used. Despite the uncertainties, the monitoring data support the potential for boscalid to reach levels in surface water that could result in adverse chronic effects to aquatic invertebrates and fish. 

The risk assessment also concluded that, based on the farm pond model that is used for assessing aquatic exposure, boscalid residues can accumulate in waterbodies over time, resulting in potential risks of concern for aquatic taxa.

Freshwater Fish and Aquatic-Phase Amphibians 

Freshwater fish are considered to be surrogates for aquatic-phase amphibians. Boscalid is classified as moderately toxic to freshwater fish on an acute exposure basis. Based on standard surface water modeling, RQ values are below the acute risk LOC of (0.5) for all uses.  In a chronic study, survival was adversely affected (16% increase in mortality at the LOAEC). RQs based on that endpoint exceeded the chronic risk LOC of 1.0 for most uses (RQs ranging from 1.3 to 2.0), except turf, canola, almond, and onion (seed treatment). 

Estuarine/Marine Fish 

Boscalid is considered to be moderately toxic to estuarine/marine fish on an acute exposure basis, but acute RQs are below the LOC of 0.5 for all uses. In chronic testing, there was an 8.8% reduction in wet weight at the LOAEC. Chronic RQ values exceed the chronic risk LOC for all foliar uses, with RQs up to 5.2. 

Measured concentrations of boscalid from monitoring data approach the NOAEC for chronic effects in sheepshead minnow, indicating that the modeled EECs are environmentally relevant.




Freshwater Invertebrates 

Boscalid is classified as moderately toxic to freshwater invertebrates on an acute exposure basis.  Following chronic exposure, there was a 45% reduction in survival at the LOAEC.  However, there are no acute or chronic LOC exceedances for freshwater invertebrates based on exposure through either the water column or benthic sediments across any of the uses evaluated. 

Estuarine/Marine Invertebrates 

Boscalid is classified as moderately toxicity to estuarine/marine invertebrates on an acute exposure basis, but the RQs are below the LOC in the water column and the benthos for all uses evaluated.  Following chronic exposure to mysid shrimp, there was a 55% reduction in the number of offspring per surviving female at the LOAEC. Chronic RQs exceed the chronic risk LOC of 1.0 for foliar uses on ornamentals and strawberries only (both RQs = 1.1). 

Aquatic Vascular and Non-Vascular Plants 

There are no LOC exceedances identified for either vascular or non-vascular aquatic plants. 

Ecological Incidents

 A review of the Incident Data System (IDS) was conducted for the boscalid, covering reported incidents since the first product registration through 2017. A total of ten incidents were reported for boscalid; all of the incidents were reported by beekeepers and involved adverse effects to honeybees including honeybee mortality, adverse effects on honeybee brood (larvae and pupae), and queen development and occurred primarily around almond orchards. Of the ten incidents, the certainty codes for four were "possible" and one was "highly probable" 

The four incidents with certainty codes of possible and higher were associated with foliar application of Pristine (Reg # 7969-199, containing 25.2% boscalid and 12.8% pyraclostrobin), to almond trees (for a fifth incident, the use site was not specified). The "highly probable" incident was determined to be the result of legal use; the legality of use associated with the other incidents was not determined. Residue analysis confirmed the presence of boscalid and pyraclostrobin in hive wax samples. Residues of other pesticides also were detected. 

The agency will continue to monitor ecological incident information as it is reported. 

Ecological and Environmental Fate Data Needs

The agency does not anticipate any further ecological or environmental fate data needs for boscalid at this time. Boscalid is registered for several bee-attractive crops, as well as crops that require managed pollinators. The full suite of Tier 1 honeybee toxicity data are available, except an acute larval toxicity study. Since the 8-day LD50 from the chronic toxicity study was used as a surrogate for the acute larval toxicity endpoint, there are no gaps in the Tier I data set for boscalid. All risk quotients are less than their respective acute and chronic risk levels of concern. Some Tier II data are available, including residue studies and tunnel studies. Colony-level study (OECD GD 75) of formulated product (Pristine, containing both boscalid and pyraclostrobin) showed no adverse effect on queen performance or colony condition. While bee kill incident reports have been associated with the use of Pristine, the available Tier 1 laboratory-based studies and Tier 2 colony-level study do not support risk concerns for bee colonies from the use of boscalid.  Furthermore, subsequent research indicated that an alternate insecticide was more likely to be the causative agent in the bee kills associated with the use of Pristine. Therefore, higher-tier data with honeybees are not needed at this time.

Benefits Assessment

Boscalid is a fungicide belonging to FRAC code 7. It is a broad-spectrum fungicide that provides effective control of many fungal diseases on plants. Boscalid kills phytopathogenic fungi on contact and stops plant fungal disease development at different stages of plant growth. Boscalid has a unique mode of action that makes it a valuable tool in forestalling the development of resistance in fungal diseases of plants, although boscalid itself appears to pose a medium-to-high risk for the development of fungicide resistance. 

Boscalid is an important fungicide to manage multiple fungal diseases on many crops (such as grapes, dry beans and peas, potatoes, almonds, strawberries, cherries, carrots and caneberries). Based on pesticide market research data, the majority of boscalid used on grapes is applied to control powdery mildew and Botrytis gray mold disease. On dry beans and peas, it is used to control Aschochyta blight, Alternaria leaf spot, and gray mold disease. On potato it is used to control early blight, white mold, and gray mold diseases. It is used on turf to control dollar spot disease. Boscalid is also used as seed treatment for many crops for protection against soil-borne fungal pests (such as various species of Rhizoctonia, Penicillium, and Fusarium). It is an important fungicide to control fungal diseases on small-acreage crops, such as strawberry, cherries, carrots and caneberries.

Stakeholders who commented on the boscalid risk assessments identified several uses of boscalid that are particularly important to growers.  For example, comments from California indicate that boscalid is considered among the most efficacious of the conventionally applied fungicides for the control of Alternaria in carrots. Also, in California boscalid is used in pears to control pear scab and in peppers for mildew and Botrytis. Lettuce producers use boscalid to control Sclerotinia, and the boscalid/pyraclostrobin combination is important to growers of garlic, onions, and prunes.

The Northwest Horticultural Council reported that the formulated product Pristine (containing both boscalid and pyraclostrobin) is effective against certain pathogens with resistance to Group 11 fungicides by themselves, including pyraclostrobin, azoxystrobin, trifloxystrobin and kresoxim-methyl. The Washington State Potato Commission noted that boscalid is among the most important fungicides for the control of early blight, white mold, and brown spot in the state, and that it is the most efficacious as well as a relatively low-cost option.

PROPOSED INTERIM REGISTRATION REVIEW DECISION

 Proposed Risk Mitigation and Regulatory Rationale

The agency has reviewed the uses, risks, and benefits of boscalid. As discussed in Section III of this document, the EPA identified potential risks of concern for some occupational handlers at baseline and some occupational post-application scenarios. The agency is seeking clarification on the use of boscalid by residential handlers and proposing some changes to affected labels. As discussed below, the EPA is proposing label clean-up and risk mitigation measures based on conclusions from the occupational risk assessment. The agency is also soliciting the submission of data and information that could impact the interim registration review decision, particularly with regard to post-application practices in grapes and impacts associated with extending the re-entry interval for those practices. The agency has also identified potential risks of concern for wildlife and is proposing to address those concerns with proposals for managing spray drift and updating surface water and groundwater advisories. With the exception of an extended re-entry interval, the registrant of technical grade boscalid, BASF, has agreed to the mitigation proposed in this PID. BASF is cooperating with the Agency on the information gathering associated with potential post-application risks in grapes.

 Residential Handlers

For EPA Reg. # 7969-353, both the product name, "Homeowner Garden Spray Fungicide," and directions for use that advise the user not to "use kitchen utensils such as measuring cups and spoons for food purposes after they have been used with pesticides," suggest that the product may be intended for use by residential handlers.  On the other hand, the "intended user" statement is unclear and the label includes a requirement for the user to "[w]ear long-sleeved shirt and long pants, socks, shoes, and chemical-resistant gloves."  The agency generally will not include requirements for residential handlers to wear specific clothing or personal protective equipment (PPE) such as gloves, because such requirements are not enforceable and may be overlooked by the casual user. The agency evaluated this product for residential handlers and determined that use without the specified clothing and gloves would not result in risks of concern.  The agency is proposing that the product label clarify the intended user and that the clothing and PPE requirements be dropped.  If those requirements are necessitated by product-specific acute toxicity concerns or for some other reason, the product may not be suitable for use by residential handlers and the registrant should consult with the agency about appropriate labeling. 

These changes are relatively minor and the agency does not anticipate that the proposed labeling imposes an additional burden on users. 

 PPE for Occupational Handlers

The agency is proposing to address risks for mixer/loaders of dry flowable formulations of boscalid supporting aerial application to high-acreage field crops by requiring the use of chemical-resistant gloves. Most boscalid product labels already require the use of gloves, although the agency has begun implementing changes to standard language describing the type of gloves that are appropriate for individual products. The agency is proposing that the labeling for all boscalid products be updated to reflect these changes. 

In particular, all glove statements that refer to the chemical resistance category selection chart are proposed to be removed from boscalid labels, as they might cause confusion for users.  These statements are proposed to be replaced with specific chemical-resistant glove types, consistent with the Label Review Manual.  

The proposed new glove language does not fundamentally change the personal protective equipment that workers need to use, and therefore should impose no impacts on users.

 Re-entry Interval (REI or Restricted Entry Interval)

Occupational post-application risk estimates of concern were identified for the activities of turning and girdling vines in grapes. At this time, the agency is proposing a 22-day REI for the turning and girdling activities.

There are two end-use boscalid-containing products (Endura Fungicide, EPA Reg. # 7969-197 and Pristine Fungicide, EPA Reg. # 7969-199) that are currently registered for use on grapes via foliar application.  The current Endura label prescribes an REI of 12 hours for all post-application activities, while the current Pristine label prescribes an REI of 5-days for grapes when conducting girdling, turning, and cane tying activities. The agency's occupational risk assessment indicates that an MOE of 100 (equivalent to the LOC) is not achieved for exposures due to turning and girdling until 22 days after application of boscalid at the maximum application rate. 

The agency has reviewed available information to enhance its understanding of the scope of the potential worker risks posed by girdling and turning and the potential economic impacts of a longer REI than what is on labels now. Boscalid may be used several times a year in a vineyard, overlapping with the time when girdling and turning are necessary to achieve acceptable quality in some varieties of grapes. An REI for these activities greater than 5 to 7 days, such as the proposed 22-day REI, would effectively restrict boscalid applications to the period after fruit set. The long REI would render boscalid unusable for early-season disease management of powdery and downy mildew in table grape vineyards where turning and girdling take place and may also impact early applications of boscalid for management of Botrytis in these vineyards.  

If growers seek alternatives to boscalid, they may end up using either more expensive and/or less efficacious fungicides.  Based on available market research data, all boscalid applied in table grapes is applied as Pristine, a premix of boscalid and pyraclostrobin.  This premix has a broader disease control spectrum, higher efficacy, and reduced risk of resistance relative to the two fungicides alone and is similar in price to boscalid alone. Common drawbacks associated with alternatives to Pristine are reduced pest control spectra, resistance risks, and lowered efficacy.

The agency currently has information on several aspects of grape culture that are relevant to understanding potential post-application exposures. In summary, girdling and turning are used primarily in certain varieties of table grapes to increase size and sweetness. Turning and girdling are labor-intensive practices and growers are moving toward new varieties of grapes and new trellising systems that do not rely on girdling and turning. For example, BASF has indicated that Thompson seedless grapes require girdling and turning more so than other varieties grown for fresh consumption (red seedless, etc.) that can be grown with the newer trellising techniques (such as "Y-trellises").  Such trellises open up the canopy and help increase the size and sweetness of the grapes so that girdling and turning are not necessary to achieve adequate fruit quality.

According the BASF, Thompson seedless grapes can be used for raisins, wine, or table grape production depending on how the vines are managed, and they are now primarily relegated to raisin production. For raisins, there is little to no interaction with the vines by workers until harvest. 

For Thompson seedless table grape production on a single trellis line, BASF indicates that workers tie canes up and turn some of the canes depending on need for better coverage or to open the canopy more. For wine production, some opening of the canopy may occur, and depending on the production system, girdling may also occur. 

BASF notes that table grape production in general is moving toward Y-trellis systems with some mechanical pruning of canes that stretch beyond the trellis (between rows).  Girdling is still used on some table grape varieties to increase sugar accumulation, but workers involved in pruning and girdling can walk below the trellis without ever touching foliage. Cane turning is no longer a part of table grape production. BASF believes EPA is generally over-estimating worker contact with treated foliage.

BASF has also provided information on the timing and retreatment intervals for pesticides that target Botrytis and powdery mildew in raisin, wine, and table grapes. 

In order to understand the need for and the potential exposures associated with turning and girdling, and to get a better understanding of the impact of a longer REI on grape production, the agency is seeking additional information on these practices, including as it pertains to different varieties of grapes grown for the fresh market. For example:

    What techniques and equipment are used for girdling and turning? Are there new technologies or equipment that could reduce worker exposure during turning and girdling relative to older technologies and equipment? 
    How prevalent is the adoption and use of Y-trellises or other aspect of table grape production that reduce dependence on girdling and turning?
    What is the relative acreage of table grape varieties that depend on turning and girdling and varieties that do not?
    When are workers performing girdling and turning relative to when fungicides (in this case, boscalid) are applied?  
    What other important activities in vineyards would be impacted by a 22-day REI, or REIs of duration between five days and 22 days?
    Are there activities other than turning and girdling that have similar potential for worker contact with treated foliage? 
    How much time is spent performing girdling and turning during the course of the year (i.e., days per year) and are these activities that a worker would be likely to engage in for a full work day?
    Multiple fungicides may be applied to grapes to treat various diseases during the course of the year. To forestall fungicide resistance, growers are encouraged to use different chemistries in rotation. Is there a way to sequence the applications of the different fungicides so that the fungicide applied directly before girdling and turning take place is one for which the calculated REI would generally be shorter?  For example, the fungicides X, Y, and Z are used in rotation. The REIs are 22 days, 10 days, and 5 days, respectively. Is it feasible that the application sequence can be adjusted so that fungicide Z is the last fungicide that is applied prior to the time when girdling and turning are needed?

In addition, for boscalid specifically, additional information that could further our understanding of post-application worker risks (and potentially other risks) includes:

    The maximum single application rate to control most target diseases in grapes (e.g., powdery mildew) appears to be about (1/2) the rate for treating Botrytis gray mold. In addition, the average rate for a single application of boscalid on grapes overall, calculated from total pounds of boscalid applied to grapes/year divided by the total acres treated/year, also is about (1/2) the maximum label rate, suggesting that many applications are made at less than the maximum rate.  Information on the distribution of application rates for boscalid in grapes would be helpful. (BASF has indicated that the Pristine product is focused on treatment for Botrytis.)
    How does boscalid usage for treatment of Botrytis gray mold differ from boscalid usage for other diseases (does one predominate)?  Does it differ between varieties of table grapes or between table grapes and wine grapes?
    Does the rotation of fungicides for treating diseases in grapes effectively reduce the number of boscalid applications/year relative to the maximum numbers of applications of boscalid/year allowed by the label? (Note that number of applications per year is not directly a factor in estimating occupational risks).
    Are there existing data that could be used to refine the 15% Dermal Absorption Factor for boscalid? (See reference to the Dermal Absorption Factor in Section II above.)  

The answers to these questions may help refine the risk estimates for post-application exposure.  For example, based on preliminary information, the agency evaluated the risks associated with worker re-entry to perform girdling and turning in grapes for an application rate of (1/2) the labeled maximum.  In that case, the MOE at Day 0 after application of boscalid for girdling and turning exceeds the LOC of 100, representing a risk not of concern. 

The agency recognizes, as discussed here, that an REI of 22 days may be problematic for vineyard management and is willing to consider other risk management options. Other options could include reduced maximum application rates, regional restrictions, and restrictions based on grape use (e.g., wine grape, table grape) or cultural practices (e.g., trellising systems).  In addition, the Agency considers the benefits of the pesticide relative to the risks in developing its risk management decision and specific information on these benefits will aid in making an optimal decision

 Spray Drift Management

The agency is proposing label changes designed to reduce off-target spray drift and establish a baseline level of protection against spray drift that is consistent across all boscalid products. Reducing spray drift will reduce the extent of environmental exposure and risk to non-target plants and animals. 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 boscalid.  

In summary, the agency is proposing spray drift mitigation language to be included on all boscalid product labels for products applied by outdoor liquid spray application on non-residential sites. The proposed spray drift language is comprised of mandatory, enforceable statements that supersede any existing language on the same topics that is already on product labels and is supplemented by uniform advisory language that provides additional information to the user. Registrants must ensure that any existing spray drift language on their product labels does not contradict or modify any of the new spray drift statements proposed in this PID, once effective. Adoption of the proposed spray drift management language will allow boscalid registrants to standardize all affected boscalid product labels. The specific proposed elements of both the mandatory and advisory language are detailed in Appendix B of this document. Key elements of the mandatory language include: 

::	Applicators must not spray during temperature inversions.
::	For aerial applications, do not apply when wind speeds exceed 15 mph at the application site. If the wind speed is greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed wing aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom length must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of the rotor diameter for helicopters.
::	If the windspeed is 10 miles per hour or less, aerial applicators must use (1/2) swath displacement upwind at the downwind edge of the field.  When the windspeed is between 11-15 miles per hour, applicators must use (3/4) swath displacement upwind at the downwind edge of the field.
::	For aerial applications, the release height must be no higher than 10 feet from the top of the crop canopy or ground, unless a greater application height is required for pilot safety. 
::	For groundboom applications, do not apply when wind speeds exceed 15 mph.  Apply only with a release height no more than 4 feet above the ground or crop canopy.  
::	For ground and aerial 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 572.1 (ASABE S572.1).
::	For air blast applications, nozzles directed out of the orchard must be turned off in the outer row, and applications must be directed into the canopy foliage. 

The temperature inversion requirement could reduce the amount of time available for users to apply boscalid.  It could move users to switch to other products that do not have the same restriction.  It is worth noting that the temperature inversion prohibition is becoming common in other chemicals going through registration review, as the agency addresses potential risks from drift and works toward consistent labeling for pesticides with similar risks (for example, it is being proposed for pyraclostrobin).
 
Similarly, the proposed wind speed restrictions could hamper timely applications of boscalid. 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 when applicators will choose to spray at greater wind speeds (less than 10 percent of survey respondents). Once the window of application passes for the target pest, the pest population may be too large to be adequately controlled by boscalid, which could accelerate the development of resistance and could reduce yields and/or quality of the harvested good. The agency thinks growers will not be negatively impacted by the air blast requirements or spray release height requirements for aerial and ground application for boscalid.

The agency is proposing a restriction on droplet size because coarser droplets have been demonstrated to decrease spray drift and reduce potential risks to non-target species. Because chemical-specific data for the performance of droplet sizes is limited, EPA was not able to evaluate the effects of medium or coarser droplet sizes (as defined by ASABE S572.1) specifically for boscalid. Therefore, the EPA does not know the effect this requirement will have on the performance of boscalid 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 fungicide resistance due to a decrease in lethal dose delivered to target pests, increased application rates used by growers, increased production costs, more fungicide applications, purchase of alternative products, or an inability to use tank mix or premix products. The EPA encourages comments on any potential impacts to growers from specifying a mandatory minimum droplet size on product labels.  The technical registrant, BASF, has indicated that the proposed droplet size restriction is consistent with how boscalid is typically applied in the field, so that the effect on product efficacy and economic impacts of this proposal may be minimal.

In addition to including the indicated spray drift restrictions on boscalid labels, all references to volumetric mean diameter (VMD) information for spray droplets are proposed to be removed from those labels where such information currently appears. The proposed new language above, which cites ASABE S572.1, eliminates the need for VMD information.

 Environmental Hazard Statements

Residues of boscalid have been detected in ground- and surface water.  To address the potential for boscalid to contaminate surface water and groundwater through drift and run-off, the agency is proposing several advisory statements. These advisory statements are intended to inform the user of the potential for pesticide contamination of waterbodies and provide supplemental actions the user may take to reduce that potential.  The text of the statements proposed for boscalid labels can be found in Appendix B. The changes should not impose an additional burden on users.

 Pesticide Resistance Management

Pesticide resistance occurs when genetic or behavioral changes enable a portion of a pest population to tolerate or survive what would otherwise be lethal doses of a given pesticide. The development of such resistance is influenced by a number of factors. One important factor is the repeated use of pesticides with the same mode (or mechanism) of action. This practice kills sensitive pest individuals but allows less susceptible ones in the targeted population to survive and reproduce, thus increasing in numbers. These individuals will eventually be unaffected by the repeated pesticide applications and may become a substantial portion of the pest population. An alternative approach, recommended by resistance management experts as part of integrated pest management (IPM) programs, is to use pesticides with different chemical modes (or mechanisms) of action against the same target pest population.  This approach may delay and/or prevent the development of resistance to a particular mode (or mechanism) of action without resorting to increased rates and frequency of application, possibly prolonging the useful life of pesticides. 

The EPA is proposing fungicide resistance management labeling, as detailed in Appendix B, for products containing boscalid in order to provide pesticide users with easy access to important information to help maintain the effectiveness of useful pesticides. Additional information on the EPA's guidance for resistance management can be found at the following website: https://www.epa.gov/pesticide-registration/prn-2017-1-guidance-pesticide-registrants-pesticide-resistance-management.

While most boscalid product labels already address fungicide resistance, the language proposed herein will update and standardize the information provided to users.  

Tolerance Actions 

No changes to the tolerance expression for boscalid 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) no additional data are required at this time; 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 boscalid, 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 boscalid. The agency's final registration review decision for boscalid 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 agency does not anticipate calling-in additional data for registration review of boscalid at this time. All data requirements from the registration review DCI have been satisfied with the possible exception of the Tier 2 and 3 honeybee data (i.e., semi-field/field studies), but it has been determined that additional honeybee data is not needed.

NEXT STEPS AND TIMELINE 

 Proposed Interim Registration Review Decision

A Federal Register Notice will announce the availability of this PID for boscalid 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 boscalid. However, a final decision for boscalid may be issued without the agency having previously issued an interim decision. A final decision on the boscalid 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 boscalid registrants 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 Boscalid
Registration Review Case#: 7039
PC Code: 128008
Chemical Type: Fungicide
Chemical Family: Pyridine-carboxamide 
Mode of Action:  Cellular respiration in fungal pathogens
                            Affected Population(s)
                              Source of Exposure
                               Route of Exposure
                             Duration of Exposure
                          Potential Risks of Concern
                               Proposed Actions
                                    Comment
Mixer/loaders of dry flowable formulations of boscalid supporting aerial application to high-acreage field crops
Residues from contact with the product during mixing and loading
Dermal absorption 
Short- and intermediate term
Occupational
Require chemical-resistant gloves 
Most potentially affected labels already require the use of gloves 
Workers performing turning/girdling activities on grape vines

Residues on treated site
Dermal absorption
Short- and intermediate term
Occupational
Restrict entry for these activities for 22 days after application of boscalid
The current REI is 12 hours, with an exception on one label for turning, girdling, and cane tying in grapes with a 5-day REI  
Freshwater and marine/estuarine fish and invertebrates
Runoff (surface and ground water) and spray drift
Direct contact with water containing residues, ingestion
Chronic
Growth, weight, mortality
-Update surface water and groundwater advisories
-Require spray drift reduction language


 Appendix B:  Proposed Labeling Changes for Boscalid Products
                                  Description
                 Proposed Label Language for Boscalid Products
                              Placement on Label
                               End-Use Products
For products used outdoors on agricultural crops, as well as products labeled for greenhouse production and ornamental crops
   (Does NOT apply to products applied by homeowners to residential sites.)
Mode of Action Group Number 7

--------------------------------------------------------------------------------
 
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 OF ACTION CODE in the third column (for fungicides this is the FRAC Code) 
 --------------------------------------------------------------------------------
      Include the type of pesticide (i.e., FUNGICIDE) in the fourth column. 
                                       
--------------------------------------------------------------------------------
BOSCALID
--------------------------------------------------------------------------------
GROUP
--------------------------------------------------------------------------------
7
--------------------------------------------------------------------------------
FUNGICIDE
                                       
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.
Resistance management label language for fungicides from 
PRN 2017-1 (https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year)
Note to registrant:

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



Directions for Use, prior to directions for specific crops
           For products used by professional/commercial applicators
PPE -- glove requirements for dry flowable products registered for use on "field crops-high acreage"
"Mixer/loaders of dry flowable formulations of boscalid supporting aerial application to [insert specific high-acreage field crops] must wear chemical-resistant gloves."

Note to registrant:

Use the gloves statement consistent with Chapter 10 of the Label Review Manual.  In particular, list the appropriate chemical-resistant glove types to use. Also be sure to modify this gloves statement appropriately based on the crops listed on your label.
In "Personal Protective Equipment (PPE)" within the Precautionary Statements and Agricultural Use Requirements, if applicable
Updated Gloves Statement -- if gloves are required by the label 


Note to registrant:

Update the gloves statements to be consistent with Chapter 10 of the Label Review Manual.  In particular, remove reference to specific categories in EPA's chemical-resistance category selection chart and list the appropriate chemical-resistant glove types to use. 


In "Personal Protective Equipment (PPE)" within the Precautionary Statements and Agricultural Use Requirements, if applicable
REI for all products allowing use on grapes
"DO NOT enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 12 hours for all crops except for grapes that may be subject to cane turning or cane girdling. The REI is 22 days for treated grapes that may be subject to cane turning or girdling.

Note to stakeholders: This PID includes requests for information that could be used by the agency to revise the proposed REI for cane turning or cane girdling on grapes. Please refer to section IV.A. of this document for suggestions on the kind of information which could be helpful. 
Agricultural Use Requirements
  For products used in agriculture and on turf, and applied via liquid spray
Spray Drift Management Application Restrictions for all products that allow aerial application
"MANDATORY SPRAY DRIFT MANAGEMENT
Aerial Applications: 
 --------------------------------------------------------------------------------
   Do not release spray at a height greater than 10 ft above the ground or vegetative canopy, unless a greater application height is necessary for pilot safety.
    Applicators are required to use a medium or coarser droplet size (ASABE S572.1). 
    Do not apply when wind speeds exceed 15 mph at the application site. If the windspeed is greater than 10 mph, the boom length must be 65% or less of the wingspan for fixed wing aircraft and 75% or less of the rotor diameter for helicopters. Otherwise, the boom length must be 75% or less of the wingspan for fixed-wing aircraft and 90% or less of the rotor diameter for helicopters  
    If the windspeed is 10 miles per hour or less, applicators must use (1/2) swath displacement upwind at the downwind edge of the field.  When the windspeed is between 11-15 miles per hour, applicators must use (3/4) swath displacement upwind at the downwind edge of the field.
 --------------------------------------------------------------------------------
   Do not apply during temperature inversions."
Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Aerial Applications" 
Spray Drift Management Application Restrictions for all products that allow airblast application
"MANDATORY SPRAY DRIFT MANAGEMENT
Airblast applications:
    Sprays must be directed into the canopy.
    Do not apply when wind speeds exceed 15 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"
Spray Drift Management Application Restrictions for all products that allow groundboom application
"MANDATORY SPRAY DRIFT MANAGEMENT
Ground Boom Applications: 
::	User must only apply with the release height recommended by the manufacturer, but no more than 4 feet above the ground or crop canopy.
::	Applicators are required to use a medium or coarser droplet size (ASABE S572.1).
::	Do not apply when wind speeds exceed 15 miles per hour at the application site. 
::	Do not apply during temperature inversions."
Directions for Use, in a box titled "Mandatory Spray Drift Management" under the heading "Ground Boom Applications"
                   For all products applied via liquid spray
Advisory drift language for all products except those products exclusively applied via boom-less ground sprayers and/or handheld technology
"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  -  Ground Boom (note to registrants: remove if ground boom 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  -  Ground Boom (note to registrants: remove if ground boom 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.
AVOID APPLICATIONS DURING GUSTY WIND CONDITIONS.
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"
Advisory drift language for all products applied via boom-less ground sprayer 
"SPRAY DRIFT ADVISORIES
Boomless Ground Applications: 
Setting nozzles at the lowest effective height will help to reduce the potential for spray drift."
Directions for Use, just below the Spray Drift box, under the heading "Spray Drift Advisories"
Advisory drift language for all products applied via handheld equipment
"SPRAY DRIFT ADVISORIES
Handheld Technology Applications: 
 --------------------------------------------------------------------------------
   Take precautions to minimize spray drift."


Directions for Use, just below the Spray Drift box, under the heading "Spray Drift Advisories"
Additional Required Labelling Action--
for all products delivered via liquid spray applications
Remove information about volumetric mean diameter from all labels where such information currently appears.
Directions for Use
           For all products with outdoor uses, except seed treatment
Advisory for protecting surface water resources
"SURFACE WATER ADVISORY:

Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwater or rinsate." 
Under Environmental Hazards
                      For products with agricultural uses
Advisory for protecting surface water resources
"SURFACE WATER ADVISORY:

Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. A level, well-maintained vegetative buffer strip between areas to which this product is applied and surface water features such as ponds, streams, and springs will reduce the potential loading of boscalid from runoff water and sediment. Runoff of this product will be reduced by avoiding applications when rainfall or irrigation is expected to occur within 48 hours."
Under Environmental Hazards
                     For all residential consumer products
Advisory for protecting surface water 
"SURFACE WATER ADVISORY: 

To protect the environment, do not allow pesticide to enter or run off into storm drains, drainage ditches, gutters or surface waters. Applying this product in calm weather when rain is not predicted for the next 24 hours will help to ensure that wind or rain does not blow or wash pesticide off the treatment area. Rinsing application equipment over the treated area will help avoid run off to water bodies or drainage systems."
Under Environmental Hazards
           For all products with outdoor uses, except seed treatment
Advisory for protecting groundwater resources
"GROUNDWATER ADVISORY:

Boscalid is known to leach through soil into groundwater under certain conditions as a result of label use. This chemical may leach into groundwater if used in areas where soils are permeable, particularly where the water table is shallow."

                           Product-specific labeling
Revised labeling for EPA Reg # 7969-353
Remove the statement currently on labels, "Intended for use in disease control and plant health on homeowner ornamentals and landscape gardens.  The general use sites may be retained on the label as ornamentals and landscape gardens but the word "homeowner" should be deleted or changed to "residential." 

Under "Hazards to Humans and Domestic Animals," remove the following text, "Wear long-sleeved shirt and long
pants, socks, shoes, and chemical-resistant gloves."
Directions for Use

 Appendix C:  Endangered Species Assessment

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 boscalid 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 boscalid. 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 boscalid as part of completing this registration review.


 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 boscalid, 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), boscalid 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. 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. Boscalid is not on either list. 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 boscalid. Before completing this registration review, the agency will make an EDSP FFDCA § 408(p) determination.
