Document ID: EPA-HQ-OPP-2014-0199-0061
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-10-23T04:00Z

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

                  Date:	         09/29/2020_________
                               Table of Contents
I.	INTRODUCTION	3
A.	Updates Since the Proposed Interim Decision Was Issued	4
B.	Summary of Public Comments on the Draft Risk Assessments and Agency Responses	4
II.	USE AND USAGE	7
III.	SCIENTIFIC ASSESSMENTS	7
A.	Human Health Risks	7
B.	Ecological Risks	10
C.	Benefits Assessment	10
IV.	INTERIM REGISTRATION REVIEW DECISION	11
A.	Risk Mitigation and Regulatory Rationale	11
1.	Residential Handlers	12
2.	PPE for Occupational Handlers	12
3.	Restricted Entry Interval (REI)	12
4.	Spray Drift Management	14
5.	Environmental Hazard Statements	15
6.	Pesticide Resistance Management	15
B.	Tolerance Actions	15
C.	Interim Registration Review Decision	18
D.	Data Requirements	19
V.	NEXT STEPS AND TIMELINE	19
A.	Interim Registration Review Decision	19
B.	Implementation of Mitigation Measures	19
Appendix A:  Required Labeling Changes for Boscalid Products	21

I.	INTRODUCTION
	
This document is the Environmental Protection Agency's (EPA or the Agency) Registration Review Interim 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 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 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.

EPA is issuing an Interim Decision 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 Appendix A). 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 improve the consultation process for national threatened and endangered (listed) species for pesticides in accordance with the Endangered Species Act (ESA) § 7. Therefore, although 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. 

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 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 any updates since the PID was published, as well as a summary of public comments received and 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.
 
 Updates Since the Proposed Interim Decision Was Issued

In March 2020, EPA published the PID for boscalid. In this ID, there is one update to what was proposed in the PID. The Agency has reconsidered its proposal for a 22-day Restricted Entry Interval (REI) for workers conducting turning and girdling of grape vines, in light of information that enhances the Agency's understanding of the potential post-application worker risks and the potential economic impacts associated with a longer REI. This reconsideration resulted in a change relative to what was proposed for addressing those risks, as discussed below in Sections III and IV of this document. For the reasons explained in this document, the Agency is now establishing a 5-day REI for table grapes that are turned and girdled. There have not been any other updates to what was proposed in the PID, nor any updates to the draft risk assessments (DRAs), although this document discusses the risk characterization that contributed to the change in the REI. This ID thus finalizes the Agency's draft supporting documents Boscalid. Human Health Risk Assessment for Registration Review and Boscalid: Ecological Risk Assessment for Registration Review, which are available in the public docket.

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

During the 60-day public comment period for the boscalid PID, which opened on May 5, 2020 and closed on July 6, 2020, the Agency received eight public comments. All of the public comments are considered to be substantive and are summarized below, along with the Agency's responses to the comments. The Agency thanks all commenters and has considered the comments in developing this ID.

Comments Submitted by BASF, the California Association of Winegrowers, the Oregon IPM Center, the Western IPM Center, the Washington Winegrowers, and an anonymous commenter (Document ID's:   EPA-HQ-OPP-2014-0199-0052, EPA-HQ-OPP-2014-0051-0064, EPA-HQ-OPP-2014-0199-0057, EPA-HQ-OPP-2014-0051-0058, EPA-HQ-OPP-2014-0199-0055

Comment: These entities provided comments about growing practices and the importance of boscalid in the prevention of powdery mildew and botrytis in grape production. Boscalid is useful as part of resistance rotation, even though by itself it poses a potential high risk of resistance. (The potential for developing resistance is reduced when boscalid is used in rotation with other fungicides.) Oregon IPM noted that many growers have moved away from using Pristine (EPA Reg # 7969-199), the boscalid + pyraclostrobin product, due to resistance issues, but is hopeful that it can be preserved as a tool for future use.

There are mechanical options for many tasks involved in grape production, but in-field workers remain essential to many vineyard activities and it would be extremely difficult, if not entirely impractical, to accommodate EPA's proposed restricted entry interval for boscalid. The commenters asked EPA to reconsider the proposed REI of 22 days associated with table grapes that are turned and girdled. 

According to the commenters, the proposed 22-day REI would prevent canopy management that is vital for preventing disease and improving fungicide spray penetration, which would result in the products containing boscalid becoming unusable in vineyards. Eliminating boscalid from the list of products that can be used to combat botrytis may result in building disease resistance to the few fungicides that would remain in use.

EPA Response: EPA has reviewed these and related comments regarding the importance of boscalid and what a 22-day REI would mean for the grape industry. The Agency has re-evaluated the proposed REI in light of the potential impacts and an enhanced understanding of the scope and magnitude of the potential risks. Please see Sections III and IV for details.

Comments submitted by the United States Department of Agriculture (USDA) (Document ID: EPA-HQ-OPP-2014-0199-0053)

Comment: The USDA noted that it had reached out to grape growers and other stakeholders in order to obtain additional information on current practices used in the table grape industry. (USDA subsequently provided that information to EPA and it is discussed in Sections III and IV of this ID.) USDA indicated that many producers have transitioned away from turning vines by hand as modern trellising systems have been adopted. Similarly, variety selection and newer trellis systems have reduced the need for girdling in table grapes overall. Finally, USDA noted that preliminary input from the stakeholders indicated that the amount of time workers spend on girdling and worker contact with treated foliage may be overestimated in the Agency's risk assessment. 

EPA Response: The Agency has taken these comments and the subsequent submission from USDA on the use of boscalid into consideration in re-evaluating the REI. Please see Section III in particular for an explanation of the Agency's conclusions about the scope and magnitude of the risks associated with girdling and turning.

Comment: The USDA encourages EPA to evaluate the potential for Codex Maximum Residue Limit (MRL) harmonization to the greatest extent possible or provide detailed, risk-based explanations for not harmonizing when U.S. tolerances are lower than the Codex MRLs. In addition, USDA encourages EPA to consider a more comprehensive approach to MRL harmonization by evaluating not only existing U.S. tolerances, but also cases where Codex has established an MRL and EPA has no corresponding tolerance.

EPA Response:  The EPA thanks the USDA for its comments and will take them into consideration.  Regarding the potential for additional harmonization with Codex MRLs), EPA attempts to harmonize existing US tolerances with Codex MRLs where feasible.  However, harmonization is not always possible for several reasons, for example, due to differences in the tolerance expression (e.g., a difference in metabolites covered by the expression), differences in commodity definition (e.g., livestock meat versus livestock fat), or differences in use patterns (e.g., in-season versus post-harvest). Furthermore, EPA does not routinely harmonize US tolerances for pesticide residues in/on livestock feed commodities with Codex MRLs. Additionally, the Agency does not establish new tolerances in the registration review process other than those that might result from crop group updates. Any petition to establish a new tolerance should be sent to the Registration Division Product Manager for boscalid. Lastly, the Agency notes that any proposed changes to the tolerances for boscalid will be announced in the Federal Register and will be subject to public comment prior to the establishment of new or revised tolerances, according to established rule-making requirements. 

Comment submitted by National Agricultural Aviation Association (NAAA; Document ID: EPA-HQ-OPP-2014-0199-0056)

Comment: NAAA stated the overall importance of aerial applications and the advantages of aerial applications over other forms of application. While NAAA supports the proposed spray drift mitigation language for aerial applications, NAAA described the need for clear label language regarding the specific altitude above which temperature inversions are not of concern. NAAA states it is currently collaborating with the USDA-Agricultural Research Service (ARS) Aerial Application Technology Research Unit to conduct a literature review on the matter.    

EPA Response: EPA thanks NAAA for their work with USDA.  The Agency will review any additional information submitted regarding the altitude of temperature inversions as it relates to pesticide applications.  At this time EPA is not changing the temperature inversion label restriction proposed in the Boscalid 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. 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 and ornamentals.  

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 FIFRA Section 24c 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.  

In 2011, about 25,000 pounds of boscalid were applied to golf courses and about 4,200 pounds of boscalid were applied in nurseries and greenhouses.

SCIENTIFIC ASSESSMENTS

 Human Health Risks 

A summary of the Agency's human health risk assessment was presented in the boscalid PID. The Agency did not identify dietary, residential, bystander, or aggregate risks of concern. The Agency concluded that exposure to boscalid poses potential risks of concern for occupational post-application workers for some scenarios. 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. Additionally, boscalid is classified by the Cancer Assessment Review Committee as having "suggestive evidence of carcinogenicity", so a quantification of human cancer risk was not recommended and was not conducted.  

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 for boscalid. Since the PID was published, the Agency has updated some of the risk characterization, specifically as it relates to to workers who perform certain post-application activities in vineyards, i.e., turning and girdling in table grapes. The quantitative risk assessment of human health has not changed since it was issued. 

There are several factors impacting the Agency's understanding of post-application exposures to the workers performing turning and girdling in table grapes.  For boscalid, these practices are associated with the greatest potential occupational post-application exposures (the activities described in more detail below). The Agency enlisted the assistance of the USDA in gathering information about where and how grapes intended for fresh consumption (table grapes) are grown (the information was not submitted to the docket during the comment period on the PID). The Agency also solicited information of the same type in the boscalid PID. Information was submitted by the USDA, university experts, industry specialists, grower groups, and BASF, a registrant of technical-grade boscalid. This information led to a better understanding on the part of the Agency of the extent and magnitude of potential exposures to workers performing turning and girdling of table grapes. 

Cane turning is a part of grape canopy management in which canes are moved by hand from one side of the trellis to the other. Canes are the smaller branches of the grape vine that bear the grape clusters. Turning promotes grape productivity. Girdling, a highly specialized skill, involves scoring a cut into the vine bark approximately (1/4) inch deep around the entire circumference of the trunk, at 8 to 12 inches above the ground. This practice alters nutrient transport and can result in larger table grapes. The term canopy is used to describe the collective arrangement of the vine's canes, leaves, and fruit.  

Several sources have indicated that "turning" refers to a practice that is no longer common in table grapes, particularly with grapes grown on newer trellis systems (Y-trellises). On older trellis systems (T-trellises), canes that were dangling at the top of the trellis would be moved by hand to increase airflow, expose clusters of grapes for application, or shade clusters from the sun. Newer Y-trellis systems have increasingly replaced older T-trellis systems, and canes grown with Y-trellises do not need to be turned to manage canopies. Some respondents noted that "turning" was an unfamiliar term that is not in common use. Sun-Maid reported that cane turning was a costly, labor-intensive practice that has been replaced by tractor-mounted cane cutters. The Agency has concluded that few if any workers engage in cane turning for table grapes at this time. 

Y-trellis systems also promote the development of larger grapes and reduce the need for girdling relative to older T-trellis systems. Girdling is a labor-intensive practice that adds to production costs, and grower groups have noted that a key objective of table grape breeding programs is to develop varieties that do not need to be girdled because of their large natural berry size (Gabler, 2020 and Vasquez, 2020). 

Numerous sources indicate that a large majority of table grapes in the US are grown in California. The California Table Grape Commission reports that approximately 99% of commercial table grapes grown in the US are produced in California. A university specialist in California estimated that approximately 85% of table grapes are grown on Y-trellises, and thus would not be dependent on either turning or girdling. A specialist at Sun-Maid Growers of California estimated that 60 to 65% of table grapes are not girdled. 

In its comments on the Boscalid PID, BASF noted that the girdling process is used primarily on older varieties of table grapes such as Summer Royal, Flame varieties, Thompson, and Princess Sugarone (or Sugraone). BASF estimated that less than 50% of table grapes are varieties that require girdling, possibly more commonly grown by small growers. (BASF also stated that "there may be one or two small fields in the state of California that do not use the Y-shaped trellis.")

Based on the public comments received on the PID and information compiled by the USDA, girdling is likely performed on a subset of table grape acreage. Considering the movement toward Y-trellis systems and the work of table grape breeders, it seems likely that over time, fewer table grapes will require girdling.

Based on their timing, these studies were conducted on vines grown on the older T-trellises, so the resulting risk estimates are most applicable to the vineyard workers who perform turning and girdling activities on older table grape varieties and table grapes grown on the older T-trellis systems.

BASF has commented that workers involved in girdling can walk below Y-trellises without ever contacting the foliage. Photographs submitted by BASF with its comments on the PID and videos cited by USDA appear to show that Y-trellis systems, with their more open, raised canopies and less draping of foliage, may reduce the potential for worker contact with pesticide residues during girdling. (Links to these videos are found within the document titled, "EPA Inquiry: Grape Turning/Girdling Practices" and can be found on the boscalid docket.) USDA has expressed its views that girdling entails very little direct foliar contact and that "available information (including demonstrative videos) shows that [girdling] is more comparable to tasks such as pruning, tying, or hand-harvesting at worst." Therefore, while the high exposure potential represented by EPA's current girdling assessment still accurately represent the smaller fraction of growers still using older T-trellis systems, workers conducting girdling activities under the modern/Y-trellis systems are expected to have  lower exposure potential in line with that of pruning, tying/training, or hand harvesting activities.

As noted in the PID, the occupational risk assessment for boscalid on grapes is based on the maximum single application rate (0.363 lb ai/A), which is used especially when treating for Botrytis gray mold. BASF has indicated that the end-use product Pristine(TM) (containing both boscalid and pyraclostrobin) is often used to treat for Botrytis. The maximum single application rate to control other target diseases in grapes (e.g., powdery mildew) is 0.197 lb ai/A, about half the rate used to treat Botrytis. In addition, usage data from EPA Biological and Economic Analysis Division (BEAD) indicates the average application rate, calculated from total pounds of boscalid applied to grapes/year divided by the total acres treated/year, also is about half the maximum label rate, suggesting that many applications are made at less than the maximum rate. At the maximum application rate of 0.363 lb ai/A, the MOE at day zero is 69, and the post-application risks of concern do not reach the level of concern until day 22.  When the average application rate (0.197 lb ai/A) is used to assess exposure, the occupational worker post-application risk estimates for both turning and girdling at day zero do not represent a risk of concern (the MOE is 130).

Based on the factors discussed above, the Agency has concluded that cane turning in modern trellising systems for table grapes is not common and so few, if any, workers will be exposed via turning.  The Agency has also concluded that girdling has become less prevalent over time, and that worker exposure during girdling may be less than it was in the past when grapes were grown predominantly on the older trellis type. Furthermore, such exposures are reduced when the average application rate for boscalid on grapes is used. Overall, the Agency has concluded that worker exposure during turning and girdling is limited in modern table grape production.

Ecological Risks

A summary of the Agency's ecological risk assessment was presented in the PID. There were no identified risks to honey bees (Apis mellifera), which serve as surrogates for non-Apis bees, terrestrial plants, freshwater invertebrates, or vascular and non-vascular aquatic plants. The Agency did identify exceedances of the chronic risk level of concern (LOC) for mammals, birds, reptiles, terrestrial-phase amphibians, freshwater fish and aquatic-phase amphibians, estuarine/marine fish, and estuarine/marine invertebrates. Boscalid is one of the most commonly detected pesticides in surface water with a maximum detected concentration of 36 ug/L.

Since the PID, there have been no changes to the Agency's previous ecological risk conclusions. For additional details on the ecological assessment for boscalid, see the Boscalid: Ecological Draft Risk Assessment for Registration Review, which is available in the public docket.

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. 

Boscalid is an important fungicide to manage multiple fungal diseases on many crops (e.g., 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. In a comment on the boscalid risk assessments, 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.

Information about fungal resistance to boscalid alone or in co-formulated products is mixed. Boscalid itself appears to pose a medium-to-high risk for the development of fungicide resistance. The Northwest Horticultural Council reported that Pristine[(TM)] (EPA Reg. # 7969-199, containing boscalid and pyraclostrobin) is effective against certain pathogens with resistance to Group 11 fungicides by themselves, including pyraclostrobin, azoxystrobin, trifloxystrobin and kresoxim-methyl. According to the Oregon IPM Center, many grape growers have reduced or stopped using the combination product Pristine[(TM)] due to widespread resistance issues for the group 11 fungicides (of which pyraclostrobin is a member), so many grape growers have reduced or stopped using Pristine[(TM)]. The Western IPM Center related observations about fungicide resistance in Botrytis on grapes, and the Washington Winegrowers commented that both pyraclostrobin and boscalid have a potential high risk of resistance.

Based on available market research data, essentially all boscalid applied to table grapes is applied as Pristine[(TM)] (boscalid co-formulated with pyraclostrobin). Pristine[(TM)] has a broader disease control spectrum, higher efficacy, and reduced risk of resistance relative to boscalid or pyraclostrobin alone. Pristine[(TM)] is similar in price to boscalid alone.  

INTERIM REGISTRATION REVIEW DECISION

 Risk Mitigation and Regulatory Rationale

The Agency has reviewed the uses, risks, and benefits of boscalid. As discussed in Section II of this document, boscalid poses potential human health and ecological risks from its labeled uses.   EPA identified potential risks of concern for some occupational handlers and some occupational post-application scenarios. The Agency also identified potential risks of concern for wildlife. In addition, this ID addresses label changes specific to one end-use product that appears to be intended for use by residential handlers, consistent with the Agency's position on residential handler clothing requirements and personal protective equipment (PPE). 

 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 is 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 "wear 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 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 requiring that the product label clarify the intended user and that the clothing and PPE requirements be dropped if it is intended for use by homeowners.  If those PPE 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 required labeling imposes an additional burden on users. 

 PPE for Occupational Handlers

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

The Agency is requiring an update to glove statements to be consistent with Chapter 10 of the Label Review Manual. In particular, the Agency is requiring the removal of reference to specific categories in EPA's chemical-resistance category selection chart and requiring that labels specify the appropriate glove types to use. For example, the chemical-resistant glove statements in the label should remove "such as" language and not state the solvent category, but rather add all acceptable glove types that provide high-level chemical resistance for the solvent category as mentioned in Table 3 of Chapter 10 of the Label Review Manual. This minor clarification does not fundamentally change the personal protective equipment that workers are currently required to use.

 Restricted Entry Interval (REI)

Occupational post-application risk estimates of concern were identified for the activities of turning and girdling in table grapes. In the PID, the Agency proposed a 22-day REI for table grapes subject to turning and girdling. 

There are two end-use boscalid-containing products (Endura[(TM)] Fungicide, EPA Reg. # 7969-197 and Pristine[(TM)] Fungicide, EPA Reg. # 7969-199) that are currently registered for use on grapes via foliar application. The current Endura[(TM)] 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 original occupational risk assessment indicated 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 of 0.362 lb ai/A. 

EPA has received extensive feedback regarding crop management practices for grapes, which has increased the Agency's understanding of the magnitude and extent of risks associated with girdling and turning. The Agency's rationale for establishing an REI for post-application activities in table grapes and the economic impacts associated with a longer REI are addressed below.

According to the feedback received from various sources after publication of the PID (described in Section III of this document), many grape growers have adopted the newer Y-trellising systems and are planting table grape varieties that do not require girdling. Workers in vineyards where table grapes are grown on older T-trellis systems are potentially exposed to foliage with pesticide residues while performing girdling and turning tasks, as described in the original occupational risk assessment for boscalid. Workers in table grape vineyards where vines are grown on the newer Y-trellises are not performing girdling or turning to a great extent, if at all. Thus, the potential risks the Agency has estimated for worker post-application exposures during turning and girdling are applicable to some but not all workers in table grape vineyards. 

The Agency has considered the potential economic impacts of a 22-day REI in grapes subject to turning and girdling. Commenters on the PID have provided a general sense of vineyard activities that would be negatively affected by the proposed REI of 22 days and expressed concern about the feasibility of using boscalid on table grapes if the 22-day REI was required.  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. According to various stakeholders, including the technical registrant and groups representing grape growers, an REI greater than 5 to 7 days would be detrimental to table grape growers. According to stakeholder comments, the potential effects of a longer REI include:
 growers could choose other fungicides, which could compromise resistance management (BASF);
 shoot positioning could be delayed (Oregon IPM Center);
 important tasks such as leafing, pest and disease scouting, research, harvest estimates, water potential analysis, and leaf sampling for nutrient analysis would be impacted (Western IPM Center); and,
 canopy management vital for preventing disease and improving fungicide spray penetration could be prevented; boscalid would become unusable (Washington Winegrowers).

In the PID, the Agency acknowledged that a 22-day REI may effectively restrict boscalid applications to the period after fruit set. A 22-day REI may render boscalid unusable for early-season disease management of powdery and downy mildew in table grape vineyards where turning and girdling take place and could also impact early applications of boscalid for management of Botrytis in these vineyards.

Overall, risk estimates and any corresponding restricted entry intervals (REIs) or other risk management actions for turning and girdling grapes should be considered in light of the differing trellis systems. For older T-trellis systems, the cane turning and girdling activity transfer coefficient (TC) of 19,300 cm2/hr is relevant as currently established in the risk assessment. However, for the modern Y-trellis systems, turning activities are no longer considered a relevant activity for exposure assessment. Lastly, for modern Y-trellis system girdling activities, a reduced exposure potential is anticipated. While no new monitoring data are currently available, a transfer coefficient in line with that of pruning, tying/training, or hand harvesting activities with a TC of 5,500 cm2/hr may be more representative of actual exposures (MOE = 240 on day 0). The Agency will continue to monitor all available information sources to best assess and characterize the exposure potential for workers in grape agricultural settings.

The Agency recognizes that the REI of 22 days proposed in the PID (based on the maximum application rate for treating Botrytis gray mold) may adversely impact some aspects of vineyard management. Based on the risks to workers associated with the post-application tasks of turning and girdling in table grapes, aspects of vineyard management that play a role in post-application exposures, the benefits associated with the use of boscalid on grapes, and the projected impacts of a longer REI, the Agency is requiring an REI of 5 days in table grapes that are grown on older T-trellis systems. The default REI of 12 hours applies to grapes using the modern Y-trellis systems. 
  
The Agency further acknowledges that growers seeking alternatives to boscalid could end up using either more expensive and/or less efficacious fungicides.  Available market research data indicate that essentially all boscalid applied in table grapes is applied as Pristine[(TM)], a co-formulation 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.  

Pyraclostrobin, the other chemical in Pristine[TM], is also undergoing registration review.  As always, labels containing multiple active ingredients must add the most restrictive statements to the updated product labels.  While both boscalid and pyraclostrobin both identified potential post-application risks of concern for grape workers, based on chemical-specific and post-application activity differences, the REIs required for these two chemicals are different.  

 Spray Drift Management

While all current boscalid labels with spray applications include advisory spray drift language, EPA is requiring updated language 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 that are not exposed on the treated field. 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. For the advisory spray drift language required for boscalid labels, see Appendix A.

 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 requiring the addition of several standard advisory statements to the labels. These advisory statements (found in Chapter 8 of the Label Review Manual) 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 specific text required for boscalid labels can be found in Appendix A. 

 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. 

EPA is requiring fungicide resistance management labeling, as detailed in Appendix A, 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.

Tolerance Actions 

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

As outlined in the PID, the Agency anticipates some changes to the tolerances for boscalid, as shown in Table 1. These changes relate to opportunities for harmonization with Codex and Canadian MRLs, changes in commodity definitions, and rounding of residue concentration values. 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 1: 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

Interim Registration Review Decision 

In accordance with 40 CFR §§ 155.56 and 155.58, the Agency is issuing this Interim Registration Decision. Except for the Endocrine Disruptor Screening Program (EDSP) and the Endangered Species Act (ESA) components of this case, the Agency has made the following 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 III.A and Appendix A.

In this Interim Registration Decision, 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 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 designated 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

A Generic Data Call-In (GDCI) was issued for boscalid for data needed to conduct the registration review risk assessments. All data requirements have been satisfied.

NEXT STEPS AND TIMELINE 

 Interim Registration Review Decision

A Federal Register Notice will announce the availability of this Interim Registration Decision for boscalid. 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 Appendix A. 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. 

Registrants must submit a cover letter, a completed Application for Registration (EPA form 8570-1) and electronic copies of the amended product labels. Two copies for each label must be submitted, a clean copy and an annotated copy with changes. In order for the application to be processed, registrants must include the following statement on the Application for Registration (EPA form 8570-1):

"I certify that this amendment satisfies the requirements of the boscalid Interim Registration Review Decision and EPA regulations at 40 CFR Section 152.44, and no other changes have been made to the labeling of this product. I understand that it is a violation of 18 U.S.C. Section 1001 to willfully make any false statement to EPA. I further understand that if this amendment is found not to satisfy the requirements of the boscalid Interim Registration Review Decision and 40 CFR Section 152.44, this product may be in violation of FIFRA and may be subject to regulatory and/or enforcement action and penalties under FIFRA."

Within the required timeframe, registrants must submit the required documents to the Re-evaluation section of the EPA's Pesticide Submission Portal (PSP), which can be accessed through the EPA's Central Data Exchange (CDX) using the following link: https://cdx.epa.gov/. Registrants may instead send paper copies of their amended product labels, with an application for a fast-track, Agency-initiated non-PRIA label amendment to Lauren Weissenborn at one of the following addresses, so long as the labels and application are submitted within the required timeframe: 

      VIA US Mail
USEPA Office of Pesticide Programs 
Pesticide Re-evaluation Division  
Mail Code 7508P
1200 Pennsylvania Ave NW 
Washington, DC 20460-0001

      VIA Courier 
Pesticide Re-evaluation Division 
c/o Front End Processing
Room S-4910, One Potomac Yard 
2777 South Crystal Drive 
Arlington, VA 22202-4501

 Appendix A:  Required Labeling Changes for Boscalid Products
                                  Description
                 Required 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 
--------------------------------------------------------------------------------
 
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 already 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 table grapes that may be subject to cane turning or cane girdling. The REI is 5 days for treated table grapes grown on T-trellis systems."
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 nozzles and pressure that deliver 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 nozzles and pressure that deliver 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: 

This product may impact surface water quality due to runoff of rainwater. This is especially true for poorly draining soils and soils with shallow ground water. This product is classified as having a high potential for reaching aquatic sediment via runoff for several months or more after application.

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" must 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