Document ID: EPA-HQ-OPP-2016-0039-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2019-05-24T04:00Z

ALIPHATIC SOLVENTS
                                       
                 Proposed Interim Registration Review Decision
                               Case Number 3004
                                       
                                       
                                      MARCH 2019
                 Approved by: 
                                    Charles "Billy" Smith
                                       Acting Director
                               Pesticide Re-evaluation Division
                       Date:
                                       
                                       
                                       
                                       
                  
                               Table of Contents
I.	INTRODUCTION	3
A.	Summary of Aliphatic Solvents Registration Review	4
II.	USE AND USAGE	5
III.	SCIENTIFIC ASSESSMENTS	6
A.	Human Health Risks	6
1.	Risk Summary and Characterization	6
2.	Human Incidents and Epidemiology	6
3.	Tolerances	7
4.	Human Health Data Needs	7
B.	Ecological Risks	7
1.	Risk Summary and Characterization	7
2.	Ecological Incidents	10
3.	Ecological and Environmental Fate Data Needs	10
C.	Benefits Assessment	10
IV.	PROPOSED INTERIM REGISTRATION REVIEW DECISION	11
A.	Proposed Risk Mitigation and Regulatory Rationale	11
1.	Spray Drift Management	12
2.	Environmental Hazards Statements	12
3.	Insecticide and Fungicide Resistance Management	13
4.	Label changes specified in the aliphatic solvents RED and revised RED	13
B.	Tolerance Actions	14
C.	Proposed Interim Registration Review Decision	14
D.	Data Requirements	14
V.	NEXT STEPS AND TIMELINE	15
A.	Proposed Interim Registration Review Decision	15
B.	Implementation of Mitigation Measures	15
Appendix A:  Summary of Proposed Actions for Aliphatic Solvents	16
Appendix B:  Aliphatic Solvents:  Proposed Labeling Language	17
Appendix C:  Endangered Species Assessment	23
Appendix D:  Endocrine Disruptor Screening Program	24

 INTRODUCTION
	
This document is the Environmental Protection Agency's (EPA or the agency) Proposed Interim Registration Review Decision (PID) for Aliphatic Solvents (PC Codes 063502 and 063503, case 3004), and is being issued pursuant to 40 CFR §§ 155.56 and 155.58. Previously, active ingredients in this case included several with different PC codes, but all registrations in which they were contained as active ingredients have been cancelled since the Re-registration Eligibility Decision (RED) was issued.  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 is determined 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 aliphatic solvents, can be found in the EPA's public docket (EPA-HQ-OPP-2016-0039) 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.

EPA is issuing a PID for aliphatic solvents 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 (together, 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 listed species, the agency will complete its listed species assessment and any necessary consultation with the Services for aliphatic solvents prior to completing the aliphatic solvents registration review. Likewise, the agency will complete endocrine screening for aliphatic solvents, pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) §408(p), before completing registration review. Finally, the EPA will determine whether pollinator exposure and effects data are necessary to make a final registration review decision for aliphatic solvents and issue a data call-in (DCI) to obtain any such data prior to completing the aliphatic solvents registration review.  See Appendices C and D, respectively, for additional information on the endangered species assessment and the endocrine screening for the aliphatic solvents registration review.

Products containing aliphatic solvents are registered for use as insecticides and miticides, including for use as mosquito larvicides and pupacides.  They are applied to agricultural crops such as tree fruits and nuts, field crops, spices, and vegetables.  They are also applied as general insecticides to ornamentals, turf, and other non-crop sites such as nurseries; and to water for the mosquitocide use. Aliphatic solvents have a wide range of non-pesticidal uses, including uses as inerts in pesticide formulations, and in moisturizers and laxatives. The first pesticide products containing aliphatic solvents as an active ingredient were registered in the United States as far back as in the 1940's, predating the establishment of the EPA.  The aliphatic solvents were subject to reregistration, and a RED was issued in August 2006; a revised RED was issued in November 2007.  The technical registrants are Wilbur Ellis Company, LLC; Drexel Chemical; BV-Associates, Inc.; Petro-Canada Lubricants Inc.; Calumet Lubricants Co., LP; HollyFrontier Refining & Marketing; Planet Industries; and Chevron.  There are over 100 registered aliphatic solvents pesticide products.

This document is organized in five sections: the Introduction, which includes this summary; Use and Usage, which describes how and why aliphatic solvents 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 proposed interim registration review decision; and, lastly, the Next Steps and Timeline for completion of this registration review.

 Summary of Aliphatic Solvents Registration Review

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

 November 2016- The Aliphatic Solvents Preliminary Work Plan (PWP), Aliphatic Solvents: Human Health Assessment Scoping Document in Support of Registration Review, BEAD Chemical Profile (BCP) for Registration Review. Aliphatic Solvents (Case No. 3004), and Registration Review: A Joint Problem Formulation and Draft Risk Assessment of the Environmental Fate and Ecological Risk of Aliphatic Solvents were posted to the docket for a 60-day public comment period. 

 April 2017- The Final Work Plan (FWP) for Aliphatic Solvents was issued. The agency received one public comment on the PWP from SciReg, Inc. on behalf of the Horticultural Spray Oil Task Force. The comment did not result in changes to the risk assessment, data needs, or timeline presented in the FWP.

 February 2019- A Generic Data Call-In (GDCI) for aliphatic solvents (PC codes 065302 and 065303) was issued for data needed to conduct the registration review risk assessments.

 March 2019- The agency published the Aliphatic Solvents: Draft Human Health Risk Assessment in Support of Registration Review and for a 60-day public comment period.

 March 2019- The agency is now announcing the availability of the Proposed Interim Registration Review Decision (PID) in the docket for aliphatic solvents, for a 60-day public comment period.  The ecological risk assessment was completed in November 2016 and was published for a 60-day public comment period.  Because there are no potential human health risks of concern due to there being no endpoints identified for the human health risk assessment, EPA has decided to move forward with this PID.  EPA will consider all comments received on both the human health risk assessment and the PID before issuing the Interim Decision.  Along with the PID, the agency is posting the following support document to the docket: 
   
  Aliphatic Solvents-Tier I Update Review of Human Incidents and Epidemiology for Draft Risk Assessment. March 2019.
 Additional Benefits References for Aliphatic Solvents. March 2019  
         
 USE AND USAGE

The aliphatic solvents include mineral oil and other aliphatic petroleum hydrocarbons.  The aliphatic solvents are products of petroleum distillation processes and are complex mixtures of long chain aliphatic (paraffinic) compounds.  Products containing aliphatic solvents are registered to control insects and mites on fruits (including stone fruit, pome fruit, citrus, berries, and tropical fruit), vegetables (including fruiting vegetables, Cole crops, leafy vegetables, root and tuber crops, bulb vegetables, beans, peas, and cucurbits), tree nuts, peanuts, sorghum, corn, cotton, and tobacco.  Products also are registered for use as mosquito larvicide/pupacides.  As mosquitocides, aliphatic solvents are applied to aquatic areas which include intermittently flooded areas, swamps, marshes, catch basins, and sewage and drainage ditches. Aliphatic solvent products are also registered for use on ornamentals, turf, aquatic areas, and other non-crop areas.  Aliphatic solvents' mode of action is through the formation of air-impermeable films, either directly on target insects or the water in which they live, which kills pests by suffocating them. Aliphatic solvents also have a wide range of non-pesticidal uses, including as inert ingredients in other pesticide registrations.

Aliphatic solvents are formulated as oils.  Formulated products are applied via broadcast, chemigation, by air, and with handheld equipment.  Mosquito control products are mainly applied with ground equipment, although there is at least one label allowing aerial application.  The leading agricultural use by average annual amount of aliphatic solvents applied is oranges (approximately 30 million pounds; per data from 2009-2013).  In the same time period, approximately 68 million pounds of active ingredient were applied annually on all agricultural sites, on approximately 3.25 million acres.  Between 2006 and 2009, approximately 300,000 pounds of aliphatic solvents/year were applied to non-agricultural sites. The agency lacks information on the mosquito control uses, although this chemical is included in the mosquito control plans of several states and has been identified by the Centers for Disease Control as important for mosquito management. For additional information, please see the BEAD Chemical Profile (BCP) for registration Review:  Aliphatic Solvents (Case No.3004), which can be found in the EPA's public docket (EPA-HQ-OPP-2016-0039) at www.regulations.gov. 
      	
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 aliphatic solvents. The most recent human health risk assessment was conducted in December 2018.  For additional details on the human health assessment for aliphatic solvents, see Aliphatic solvents: Draft Human Health Risk Assessment in Support of Registration Review, which is available in the public docket.

Risk Summary and Characterization

No toxicological points of departure (PODs) have been established and aliphatic solvents are generally recognized as safe (GRAS) as food additives for human consumption.  Therefore, there are no potential dietary, residential or occupational risks of concern for aliphatic solvent uses.  EPA has not made a common mechanism of toxicity to humans finding as to aliphatic solvents and any other substance and it does not appear to produce a toxic metabolite produced by other substances. Therefore, EPA has not assumed that aliphatic solvents has a common mechanism of toxicity with other substances for this assessment.

Human Incidents and Epidemiology

Both OPP Incident Data System (IDS) and the National Institute for Occupational Safety and Health (NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR-Pesticides) databases were consulted for pesticide incident data on the active ingredient aliphatic solvents. In the Main Incident Data System (IDS, 2011-2018), there were three moderate severity incidents associated with the use of aliphatic solvents. In Aggregate IDS, for the same time, 17 incidents were reported. Aggregate IDS incidents are typically low in severity and include few details. SENSOR-Pesticides (1998-2018) recorded more than 600 incidents, all of which involved multiple active ingredients.  Most of the cases were low severity; 40 cases related to one spray drift incident.  Based on the relatively low frequency and severity of incidents associated with the use of aliphatic solvents, as well as the involvement of other active ingredients in most cases, the Agency has not concluded that there is a concern at this time.  The agency will continue to monitor the incident information.  Additional analyses will be conducted if ongoing incident monitoring indicates a concern.

Tolerances

Since no toxicological points of departure have been established and the compounds are classified as GRAS, an exemption from the requirement of a tolerance for the aliphatic solvents has been established (40 CFR §180.905, petroleum oil; 40 CFR §180.910, mineral oil; and 40 CFR §180.930, mineral oil).

Human Health Data Needs

Currently, the human health database for aliphatic solvents is complete.  No human health data were required by the February 2019 GDCI for registration review.

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 aliphatic solvents.  For additional details on the ecological assessment for aliphatic solvents, see the September 16, 2016 document, Registration Review:  A Joint Problem Formulation and Draft Risk Assessment of the Environmental Fate and Ecological Risk of Aliphatic Solvents, 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 aliphatic solvents.  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 and Birds 

The Agency has not identified potential acute risks for mammals and birds exposed to the aliphatic solvents. Applying oils as a coating to bird eggs is generally known to reduce their viability by causing suffocation of the developing chick (a use employed to reduce the proliferation of Canada geese, for example). There may be some limited potential for chronic risk to birds from the agricultural use of aliphatic solvents, but it is not certain that deposition associated with these uses would impact nearby eggs and there are no reproduction data for terrestrial vertebrates (either birds or mammals) with which to confirm or quantify chronic risks. The possibility of risk to terrestrial vertebrates that breed on or adjacent to treated fields has been documented (Hoffman 2004). Overall, there is potential for some risk, but the level of confidence for that finding is low due to the data gaps.
 
Terrestrial Invertebrates (honeybees) 

No potential risks of concern to adult bees from contact exposure were identified, although there are uncertainties for honey bee risk overall due to absence of most Tier 1 toxicity data.  No toxicity data are currently available to evaluate acute or chronic oral exposure for adult or larval bees.

The EPA identified the need for certain data to evaluate potential effects to pollinators when initially scoping the registration review for aliphatic solvents. These data needs were listed in the problem formulation and the FWP for aliphatics solvents; they represent a subset of the pollinator studies identified in EPA's June 2014 Guidance for Assessing Pesticide Risks to Bees. Data for the honey bee acute contact toxicity study (Guideline 850.3020) and honey bee toxicity of residues on foliage (850.3030) were not requested due to the information available at the time of the FWP.  This 2014 guidance includes a suite of pollinator studies that are typically anticipated to be needed to facilitate a pollinator risk assessment for registration review. The agency issued a DCI requiring the aliphatic solvents pollinator data from the problem formulation and FWP in February 2019.  The list of studies required by the February 2019 DCI is shown in Table 1 below.

Table 1: Potential Pollinator Data Requirements
Guideline #
Study
                                    Tier 1
Non-Guideline (OECD 213)
Honey bee adult acute oral toxicity 
Non-Guideline (OECD 237)
Honey bee larvae acute oral toxicity 
Non-Guideline
Honey bee adult chronic oral toxicity 
Non-Guideline
Honey bee larvae chronic oral toxicity 
                                  Tier 2[†]
Non-Guideline
Field trial of residues in pollen and nectar 
Non-Guideline (OECD 75)
Semi-field testing for pollinators  
                                  Tier 3[†]
850.3040
Full-Field testing for pollinators  
[†] The need for higher tier tests for pollinators will be determined based upon the results of lower tiered tests and/or other lines of evidence and the need for a refined pollinator risk assessment.  
   
Terrestrial Plants

Potential risk for terrestrial plants exposed to spray applications of aliphatic solvents has not been quantified, and empirical terrestrial plant toxicity data are not available with which to evaluate risk.  Several factors provide relevant information, although they are somewhat contradictory.  Some of these factors suggest the potential for risk to plants with some aliphatic solvents end-use products bear phytotoxicity warnings on their labels, and some terrestrial plant incidents have been recorded.  Other factors could support a different conclusion as aliphatic solvents applied as insecticides/larvicides are intentionally applied to many different plant types where target pests are present.  Plants may be exposed to aliphatic solvents not only as an active ingredient but as inerts in many other pesticidal products, yet the number of incidents reported is relatively small.  Additionally, the incident reports are associated primarily with exposures to multiple pesticides, and for the most part, the legal use of aliphatic solvent pesticide products as the causal agent is considered to "probable' for only one incident.  Overall, the agency believes that there is some potential for risk to terrestrial plants, but the level of confidence for that finding is low. 

Aquatic Risks

Freshwater fish and Estuarine/Marine Fish

No potential acute or chronic risks for freshwater fish and estuarine/marine fish exposed to aliphatic solvents by spray drift alone, run-off alone, or direct application to water have been identified.  There are no acute toxicity data available for estuarine/marine fish and no chronic data for either freshwater or estuarine/marine fish.  In acute testing of freshwater fish, the highest dose tested did not elicit adverse effects.  On that basis, in consideration of the widespread use of aliphatic solvents as a pesticide inert ingredient, the agency's concern for risks to fish is low. 

Freshwater Invertebrates

The agency has identified potential acute risks of concern for freshwater invertebrates exposed to aliphatic solvents and has calculated risk quotients (RQs) at the highest labeled rates for land and aquatic applications of 8.5 for drift exposure alone (210 lb ai/A), 7.5 for run-off alone (210 lb ai/A), and 105 for direct applications to water (37 lb ai/A), relative to an acute level of concern (LOC) of 0.5.  Chronic data with aquatic organisms are not available to evaluate risk.  Based on the data that are available, the agency has potential concerns about risks to freshwater invertebrates. 

Estuarine/Marine Invertebrates 

Acute RQs above the LOC of 0.5 for estuarine/marine invertebrates exposed to aliphatic solvents are associated with direct applications to water only with an RQ of 1.8.  Chronic risk for estuarine/marine invertebrates cannot be evaluated due to the lack of toxicity data. 

Aquatic Vascular and Non-Vascular Plants 

Toxicity data are not available for vascular and non-vascular aquatic plants to evaluate risk.  Based on the same factors as those for terrestrial plants, the agency believes that there is a potential of risk to aquatic plants, but the level of confidence for that finding is low.  

Ecological Incidents

The Ecological Incident Information System (EIIS) is an OPP database that houses reports of ecological incidents that have been reported to the agency.  From the time at which the agency began recording incident reports until August 2016, when a search was conducted, fifteen ecological incidents have been reported; all but one involves damage to terrestrial plants, although exposure was classified to be "probable" for only one incident involving two beech trees.  One incident was associated with adverse effects (unspecified) in 21 Canada geese, but was the result of misuse. Overall, only four of the incidents were associated with registered uses of aliphatic solvents. The aggregate incident database for aliphatic solvents contains 41 incidents in 59 species (2 `wildlife-minor,' 57 "plant damage-minor'), but no additional information is available for those incidents.

The agency will continue to monitor ecological incidents. A detailed analysis of these incidents will be conducted if reported information indicates concerns for risk to non-target organisms.

Ecological and Environmental Fate Data Needs

The agency issued a generic data call-in notice (GDCI) in February 2019, which required the submission of certain pollinator data.  These data will facilitate a complete pollinator risk assessment in the future. Aside from the potential need for additional pollinator studies, the ecological and environmental fate database for aliphatic solvents is adequate for registration review and no other data requirements are anticipated for registration review at this time. 
 
Benefits Assessment

In agriculture, aliphatic solvents are most often used in the form of horticultural oil or "dormant season" oils. Such oils are used to suffocate insects on plant surfaces by preventing air from reaching the trachea (windpipe). They are often used in tree crops during dormancy, in combination with other active ingredients, to kill insects before they lay eggs or feed on the crop. This use is important for pest management in a wide variety of tree fruits and nuts, as supported by usage data available to the agency. Aliphatic solvents are also recommended for control of some tree fruit pests in-season, either mixed with other insecticides or as a stand-alone option. When mixed with other insecticides, oils can increase translaminar movement of those pesticides inside the plant and help retain their effectiveness over a longer period. For some insecticides, university extension guidance for growers of tree fruit such as apples and cherries recommend the addition of oils containing aliphatic solvents to avoid the risk of residues exceeding pesticide tolerances on harvested fruit. 
   
While aliphatic solvents may be used as stand-alone pest control options by some growers, BEAD does not have usage data to characterize the extent of such use across all registered crops. Use may be higher in organic crop production since some horticultural oil is allowed in these production systems, according to the USDA (see https://www.ams.usda.gov/rules-regulations/organic/national-list). 
   
EPA does not have usage data to characterize the extent of the mosquito control use, but aliphatic solvents are mentioned in the descriptions of mosquito management control tactics in some states, and their importance for this use pattern was highlighted to EPA by the CDC in 2007. These chemicals have been recently mentioned (usually as "mineral oil") as low-environmental impact options for reducing mosquito larval populations by California sources (e.g., NCMAD, 2015 and references therein). Descriptions of killing mosquito larvae with aliphatic solvent oils are also available from Florida mosquito control authorities (Connelly and Carlson, 2009). It appears that the exact mechanism of toxicity is unknown, though it probably involves both the direct suffocation of larvae and pupae by preventing respiration and internal poisoning when oils are ingested through the insects' trachea. They can also kill newly emerged adults that rest on the water surface.  A list of source documents for information in this section, Additional Benefits References for Aliphatic Solvents. March 2019, is available on the public docket. 

PROPOSED INTERIM REGISTRATION REVIEW DECISION

 Proposed Risk Mitigation and Regulatory Rationale

At this time, the agency has determined that there are no human health risks of concern which require changes to aliphatic solvents product labels or registrations, based on the recent draft registration review risk assessment.  As discussed in Section III. B of this document, potential risks of varying degrees and of varying certainty have been identified for wildlife and non-target plants, but the most certain risks of concern are to freshwater invertebrates.  In addition, a recent review of aliphatic solvents pesticide labels has revealed that they have not been consistently amended to reflect the reregistration eligibility decision, which covered elements such as clothing and PPE requirements and general application requirements for products with WPS and non-WPS uses on the label. In addition, environmental hazard statements and drift management labeling are lacking or variable. The label review also found that on some labels, use site descriptions must be clarified.  

The benefits associated with the use of aliphatic solvents and their presence as inerts in other pesticides support the risk management proposals put forth in this document. The proposed elements are expected to have minimal economic impact on users while enhancing overall protections to humans and the environment.  To address potential risks to wildlife and non-target plants, particularly freshwater invertebrates, the agency is proposing the addition of uniform advisory spray drift management and environmental hazard statements on product labels.  EPA is also proposing label changes to address potential insecticide and fungicide resistance, implement the reregistration eligibility decision, and correct other labeling deficiencies that were identified through a recent review of current product labels. These proposed changes are detailed below and in Appendix B. 

 Spray Drift Management 

The EPA is proposing standardized advisory spray drift language to reduce off-target spray drift and establish a baseline level of protection against spray drift that is consistent across all aliphatic solvents pesticide products. Reducing spray drift will reduce the extent of environmental exposure and risk to freshwater invertebrates, as well as non-target plants and other 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 aliphatic solvents.  

Depending on the application method, the agency is proposing various advisory language that includes information on the importance of droplet size, and the effects of release height, temperature, and wind on drift.

 Environmental Hazards Statements

Aquatic Organism Advisory Statements:

The agency is proposing the addition of a consistent aquatic organism advisory statement for all aliphatic solvents end-use product labels except those intentionally applied to water for the control of mosquitos, as a means to address potential risks to aquatic animals and plants, particularly freshwater invertebrates. The proposed text is:  

   This product is toxic to aquatic invertebrates. Do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean highwater mark. Do not contaminate water when disposing of equipment wash water or rinsate. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.  Avoid drift or runoff into storm drains, drainage ditches, or surface waters.  Applying this product in calm weather when rain is not predicted for the next 24 hours will help to maximize the chances that wind, or rain will 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.

A similar statement is proposed for mosquitocide product labels: 

   This product is toxic to aquatic invertebrates. Do not contaminate water when disposing of equipment wash water or rinsate. Rinsing application equipment over the treated area will help avoid run off to water bodies or drainage systems.  Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.  Avoid drift or runoff into storm drains, drainage ditches, or surface waters.  

 Insecticide and Fungicide Resistance Management

Pesticide resistance may occur when genetic or behavioral changes enable a portion of a plant pest populations (such as bacteria, fungi, insects or other organisms) to tolerate or survive what would otherwise be lethal doses of a pesticide. The surviving pest populations increase with continued exposure to a no longer effective pesticide. Resistance to pesticides by plant pest appears to be increasing in the U.S. and worldwide. Managing the evolution of pesticide resistance in plant pests is an important part of sustainable pest management and an integral part of IPM programs, to assist crop producers to manage plant pests effectively.    

The development of pesticide resistance is influenced by several factors. One important factor that fosters pesticide resistance is the repeated use of pesticides with the same mode of action on the same pest population. Repeated use of a pesticide with a single mode of action kills sensitive pests but allows pests in the population that are tolerant of the pesticide to increase in numbers. These individuals will generally be unaffected by the repeated pesticide applications and may ultimately make-up a substantial portion of the pest population. Thus, an important proactive pesticide resistance-management strategy is to rotate pesticides with different modes of action to increase the likelihood of controlling of target pests in any given location or area. This approach may delay and/or prevent the development of resistance to a mode of action without resorting to increased rates and frequency of application and may prolong the useful life of pesticides. The EPA is proposing resistance-management labeling, as listed in Appendix B, for products containing the insecticide, aliphatic solvents, 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/pesticide-registration-notices-year.

 Label changes specified in the aliphatic solvents RED and revised RED

The label changes specified in the aliphatic solvents RED and revised RED that are proposed to be implemented on the labels include: 
 Active ingredient statements must be revised to include the active ingredient name "Mineral Oil".
 An environmental hazard statement for manufacturing-use products.
 Minimum clothing requirements for handlers.
 Early entry personal protective equipment for products with WPS uses on the label. 
 Entry restrictions for products with non-WPS uses on the label.
 Maximum application rates for citrus. 

 Application Site Definition for Small Gardens

References to "small garden use only" are imprecise.  The label must describe the use sites as "residential gardens" or with a similar term.

Tolerance Actions

No changes to the tolerance levels, crop listings, or the tolerance expression for aliphatic solvents are necessary at this time.  Refer to Section III.A.3 for details.

Proposed Interim Registration Review Decision 

In accordance with 40 CFR §§ 155.56 and 155.58, the agency is issuing this proposed interim registration review decision. Except for the Endocrine Disruptor Screening Program (EDSP), the Endangered Species Act (ESA), and pollinator components of this case, the agency has made the following proposed interim registration review decision: (1) except for the data recently required by the GDCI, 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 aliphatic solvents, nor is it making a complete endangered species finding or a complete assessment of effects to pollinators. 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 aliphatic solvents. The agency's final registration review decision for aliphatic solvents will be dependent upon the result of the agency's ESA assessment and any needed § 7 consultation with the Services, an EDSP FFDCA § 408(p) determination, and an assessment of non-target exposure to pollinators (bees).

Data Requirements

Beyond the requirements of the recently issued GDCI, no additional data are anticipated to be needed for this chemical at this time. 

NEXT STEPS AND TIMELINE 

 Proposed Interim Registration Review Decision

A Federal Register Notice will announce the availability of this proposed interim registration review decision for aliphatic solvents and will allow a 60-day comment period on the proposed interim decision. If there are no significant comments or additional information submitted to the docket during the comment period that leads the agency to change its PID, the EPA may issue an interim registration review decision for aliphatic solvents. However, a final decision for aliphatic solvents may be issued without the agency having previously issued an interim decision. A final decision on the aliphatic solvents registration review case will occur after: (1) an EDSP FFDCA § 408(p) determination, (2) an endangered species determination under the ESA and any needed § 7 consultation with the Services, and (3) an assessment of non-target exposure to pollinators.

Implementation of Mitigation Measures 

Once the Interim Registration Review Decision is issued, the aliphatic solvents registrants must submit amended labels that include the label changes described in Appendices A and B. The revised labels and registration amendments must be submitted to the agency for review within 60 days following issuance of the Interim Registration Review Decision.  

 
 
 
 
 Appendix A:  Summary of Proposed Actions for Aliphatic Solvents 
                            Affected Population(s)
                                       
                              Source of Exposure
                               Route of Exposure
                             Duration of Exposure
                         Potential Risk(s) of Concern
                               Proposed Actions
Aquatic invertebrates
and other non-target taxa
-Spray Drift

-Run-off

-Direct application to water
Aquatic exposure
Acute
Mortality
-Propose aquatic organism advisory statements

-Propose advisory spray drift reduction language

 

 Appendix B:  Aliphatic Solvents:  Proposed Labeling Language
                                  Description
            Proposed Label Language for Aliphatic Solvents Products
                              Placement on Label
                          Manufacturing-Use Products
Required on all MUP's 
"Only for formulation into the following use(s):
[Note to the registrant: list only with those uses that are being supported by registrants of manufacturing-use products]."
Directions for Use
One of these statements may be added to a label to allow reformulation of the product for a specific use or all additional uses supported by a formulator or user group.
"This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)." 

"This product may be used to formulate products for any additional use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards Statement

"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA."
Directions for Use
                                  Description
            Proposed Label Language for Aliphatic Solvents Products
                              Placement on Label
                             All End-Use Products
Resistance-management labeling for products containing directions for use as insecticides/acaricides
 Include resistance management label language for insecticides/acaricides from PRN 2017-1 (https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year)

Directions for Use
Resistance-management labeling for products containing directions for use as fungicides
 Include resistance management label language for fungicides from PRN 2017-1 (https://www.epa.gov/pesticide-registration/pesticide-registration-notices-year
Directions for Use
Name of Active Ingredient

Active Ingredient statements must be revised and may include only the following: 
"Mineral Oil".
 
Note:  Other names may be specified, providing there is adequate justification.
Ingredient Statement
Environmental Hazards Statement for end-use products other than those registered exclusively for mosquito control

"ENVIRONMENTAL HAZARDS"

"This product is toxic to aquatic invertebrates. Do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean highwater mark. Do not contaminate water when disposing of equipment wash water or rinsate. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.  Avoid drift or run off into storm drains, drainage ditches, or surface waters.  Applying this product in calm weather when rain is not predicted for the next 24 hours will help to maximize the chances that wind, or rain will 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."
Precautionary Statements under Environmental Hazards

Environmental Hazards Statement for end-use products registered for mosquito control

"ENVIRONMENTAL HAZARDS"
   
"This product is toxic to aquatic invertebrates. Do not contaminate water when disposing of equipment wash water or rinsate. Rinsing application equipment over the treated area will help avoid runoff to water bodies or drainage systems.  Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.  Avoid drift or runoff into storm drains, drainage ditches, or surface waters."
Precautionary Statements under Environmental Hazards
Application site definition for products registered for use on residential sites
References to "small garden use only" are imprecise.  Identify the use site as "residential gardens" or similar.
Directions for Use
       End-Use Products Intended for Occupational Use (WPS and non-WPS)
Handler PPE Requirements 
"Personal Protective Equipment (PPE)" 

"Handlers must wear: 
    :: long-sleeve shirt, long pants, and 
    :: shoes plus socks." 
Precautionary Statements: Hazards to Humans and Domestic Animals
User Safety Requirements

"Follow manufacturer's instructions for cleaning/maintaining PPE.  If no such instructions for washables exist, use detergent and hot water.  Keep and wash PPE separately from other laundry." 
"Discard clothing and other absorbent material that have been drenched or heavily contaminated with the product's concentrate.  Do not reuse them."   
Precautionary Statements: Hazards to Humans and Domestic Animals immediately following PPE requirements
User Safety Recommendations

"USER SAFETY RECOMMENDATIONS"
 
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet." 
"Users should remove clothing/PPE immediately if pesticide gets inside.  Then wash thoroughly and put on clean clothing." 

"Users should remove PPE immediately after handling this product.  Wash the outside of gloves before removing.  As soon as possible, wash thoroughly and change into clean clothing."

Precautionary Statements under: Hazards to Humans and Domestic Animals immediately following PPE requirements

(Must be placed in a box)
Restricted-Entry Interval for products with WPS uses

"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 12 hours." 

Note:  Product Registration Notice 95-3 declared aliphatic solvents to be eligible for a 4- hour restricted-entry interval.  A 4- hour REI is permitted, but only provided that the registrant certifies that the end-use product meets all the conditions established in PR Notice 95-3 for end-use products to be eligible for a 4- hour REI.
Directions for Use, Agricultural Use Requirements Box
Early Entry Personal Protective Equipment for products with WPS uses
"PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as soil or water, is: 

 coveralls, 
 shoes plus socks, and
 chemical-resistant gloves made of any waterproof material."
Directions for Use, Agricultural Use Requirements Box

Entry Restrictions for products registered for uses other than mosquito control with non-WPS uses on the label

"Do not enter or allow others to enter until sprays have dried."

If no WPS uses on the product label, place the appropriate statement in the Directions for Use Under General Precautions and Restrictions.  If the product also contains WPS uses, then create a Non-Agricultural Use Requirements box as directed in PR Notice 93-7 and place the appropriate statement inside that box.

General Application Restrictions for products with WPS uses on the label
"Do not apply this product in a way that will contact workers or other persons, either directly or through drift." 

"Only protected handlers may be in the area during application."
Directions for Use
General Application Restrictions for products with non-WPS uses on the label
"Do not apply this product in a way that will contact adults, children, or pets, either directly or through drift."
Directions for Use
Advisory Spray Drift Management Language for all products except those products exclusively applied with boom-less ground sprayers and/or handheld technology 
                                                 Advisory Spray Drift Language

"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.  When applying aerially to crops, do not release spray at a height greater than 10 ft above the crop canopy, unless a greater application height is necessary for pilot safety.
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, under the heading "Spray Drift Advisories"
Advisory Spray Drift Management Language for products that are applied as liquids and allow boom-less ground sprayer applications
"SPRAY DRIFT 
 -  -  -  -  -  -  - Boom-less Ground Applications:
 Setting nozzles at the lowest effective height will help to reduce the potential for spray drift."
Directions for Use, under the heading "Spray Drift Advisories"
Advisory Spray Drift Management Language
SPRAY DRIFT 
 -  -  -  -  -  -  - Handheld Technology Applications:
 Take precautions to minimize spray drift."
Directions for Use, under the heading "Spray Drift Advisories"
Maximum Application Rates for products with directions for use on citrus
The maximum application rate for citrus in Texas and Florida is 159 pounds active ingredient per acre (maximum 1500 gallons of spray mix per acre), and, in California,  212 pounds active ingredient per acre (maximum 2000 gallons of spray mix per acre). 
Directions for Use

 Appendix C:  Endangered Species Assessment

In November 2013, the EPA, along with the Services 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. The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences' (NAS) recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops  -- in April and October 2014, in April 2015, and in June 2016  --  allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper Interim Approaches for National-Level Pesticide Endangered Species Act (ESA) Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report, dated November 1, 2013.
 
Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, the ecological risk assessment supporting this proposed interim decision for aliphatic solvents does not contain a complete ESA analysis that includes effects determinations for specific listed species or designated critical habitat. Although EPA has not yet completed effects determinations for specific species or habitats, for this proposed interim decision EPA's evaluation assumed, for all taxa of non-target wildlife and plants, that listed species and designated critical habitats may be present near the application of aliphatic solvents. This assessment will allow 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 the agencies have fully developed and implemented the scientific methodology for evaluating risks for listed species and their designated critical habitats, these methods will be applied to subsequent analyses for aliphatic solvents 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 Aliphatic Solvents, 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), Aliphatic solvents 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. Aliphatic solvents are 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 proposed interim decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of aliphatic solvents. Before completing this registration review, the agency will make an EDSP FFDCA § 408(p) determination."