Document ID: EPA-HQ-OPP-2016-0039-0021
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2020-02-03T05:00Z

ALIPHATIC SOLVENTS
                                       
                     Interim Registration Review Decision
                               Case Number 3004
                                       
                                       
                                 October 2019
                                       
                                       
                                       
			Approved by: _
					   Elissa Reaves, Ph.D.
                                 Acting Director
                           Pesticide Re-evaluation Division

                  Date:	____10-4-2019_______
                               Table of Contents
I.	INTRODUCTION	3
A.	Updates Since the Proposed Interim Decision was Issued	4
B.	Summary of Aliphatic Solvents Registration Review	4
  C.	Summary of Public Comments on the Draft Human Health Risk Assessment and the Proposed Interim Decision, and Agency Responses	5
II.	USE AND USAGE	7
III.	SCIENTIFIC ASSESSMENTS	7
A.	Human Health Risks	7
1.	Risk Summary and Characterization	7
2.	Human Incidents and Epidemiology	8
3.	Tolerances	8
4.	Human Health Data Needs	8
B.	Ecological Risks	8
1.	Risk Summary and Characterization	9
2.	Ecological Incidents	11
3.	Ecological and Environmental Fate Data Needs	11
C.	Benefits Assessment	12
IV.	INTERIM REGISTRATION REVIEW DECISION	13
A.	Risk Mitigation and Regulatory Rationale	13
1.	Spray Drift Management	13
2.	Environmental Hazards Statements	14
3.	Label Clarity	14
B.	Tolerance Actions	14
C.	Interim Registration Review Decision	14
D.	Data Requirements	15
V.	NEXT STEPS AND TIMELINE	15
A.	Interim Registration Review Decision	15
B.	Implementation of Mitigation Measures	15
Appendix A:  Summary of Required Actions for Aliphatic Solvents	17
Appendix B:  Aliphatic Solvents:  Required Labeling Language	18
Appendix C:  Endangered Species Assessment	24
Appendix D:  Endocrine Disruptor Screening Program	25

INTRODUCTION 
	
This document is the Environmental Protection Agency's (EPA or the agency) Interim Registration Review Decision (ID) for the aliphatic solvents (PC Codes 063502 and 063503, case 3004), 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 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 an ID 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.  See Appendices C and D, respectively, for additional information on the endangered species assessment and the endocrine screening for the aliphatic solvent's 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 reregistration eligibility decision (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 a summary of public comments and EPA's responses; Use and Usage, which describes how and why aliphatic solvents is used; 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 Interim Registration Review Decision, which describes the mitigation measures required to address risks of concern and the regulatory rationale for the EPA's interim registration review decision; and, lastly, the Next Steps and Timeline for completion of this registration review.

Updates Since the Proposed Interim Decision was Issued

After the PID was published, the agency determined that the resistance management labeling proposed in the PID is not applicable to the aliphatic solvents, because the mode of action is not something to which pests can develop resistance.  The pesticides act to prevent oxygen exchange in the target organisms.  In addition, required labeling has been revised so that the requirement for using the nomenclature of "mineral oil" as the active ingredient in the ingredients statement applies to both manufacturing-use and end-use products. None of the other mitigation measures proposed in the PID have changed.  

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- Generic Data Call-In Notices (GDCIs) for the aliphatic solvents (PC codes 065302 and 065303) were issued for pollinator data needed to conduct the registration review risk assessments.  The data requirements for the two PC Codes were the same.  Data submissions are still pending.

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

 May 2019- The agency announced the availability of the Aliphatic Solvents Proposed Interim Registration Review Decision (PID) for a 60-day public comment.  

 October 2019- The agency is now announcing the availability of the Aliphatic Solvents Interim Registration Review Decision (ID). 

Summary of Public Comments on the Draft Human Health Risk Assessment and the Proposed Interim Decision, and Agency Responses

The agency published the aliphatic solvents human health draft risk assessment for public comment on April 8, 2019.  The comment period closed on June 7, 2019, and during that time, the agency received two public comments, from the United States Department of Agriculture's Office of Pest Management Policy (USDA OPMP) and SciReg, Inc. on behalf of the Horticultural Spray Oil Task Force (HSOTF). Prior to the closure of the comment period on the draft risk assessment, the agency published the proposed interim registration review decision for aliphatic solvents for public comment.  The comment period opened on May 23, 2019 and closed on July 24, 2019.  During that time, the agency received one public comment, from USDA OPMP.

The HSOTF did not submit comments on the PID. The agency contacted the HSOTF to find out if the organization intended to do so and was advised that they did not. 

The public comments, and EPA's responses, are summarized below.  Public comments in their entirety are located in the public docket.  The comments received did not change the agency's conclusions on the draft risk assessment or the PID. 

Comments submitted by USDA OPMP on the Registration Review Draft Human Health Risk Assessment for Aliphatic Solvents (Document ID: EPA-HQ-OPP-2016-0039-0017)

Comment:  USDA OPMP appreciated EPA's streamlined approach to risk assessment and understanding of the benefits of aliphatic solvents to IPM and for vector-control.  USDA cited supporting information from the American Mosquito Control Association and other sources.   

EPA Response:  The agency thanks USDA for its comments.  

Comments submitted by the HSOTF on the Registration Review Draft Human Health Risk Assessment for Aliphatic Solvents (Document ID: EPA-HQ-OPP-2016-0039-0018)

Comment:  HSOTF commented on inconsistencies in the lists of the CAS numbers identified by the agency as being associated with the aliphatic solvents registration review case. 
  
EPA Response:  The agency did not rely on CAS numbers to determine which aliphatic solvents compounds were subject to registration review, but rather used the agency's own coding system, in which active ingredients are identified by PC codes. The agency determined that the PC codes for active ingredients in this registration review case are 063502 and 063503. The agency recognizes that these two PC codes include a number of related compounds with different CAS numbers and similar names, and that there is some overlap in these compounds between the two PC codes. The use of the PC codes, rather than CAS numbers, to identify the registrations in the aliphatics solvents case, relies on information easily obtained from product labels, while CAS numbers may appear only on documentation that is not readily accessible to the public. Prior to initiation of registration review for the aliphatic solvents, the agency verified that all appropriate products were considered to be subject to the aliphatic solvents registration review.  The agency reconfirmed this determination after registration review began. 

Comments submitted by USDA OPMP on the Proposed Interim Registration Review Decision for Aliphatic Solvents (Document ID: EPA-HQ-OPP-2016-0039-0019) 

Comment: USDA OPMP relayed its support of the spray drift advisory language proposed in the aliphatic solvents PID, indicating that it would not be expected to negatively impact users of aliphatic solvents, and would provide both label clarity and flexibility for growers. USDA OPMP also approved of other measures proposed by the agency for label consistency and clarity.

EPA Response:  The agency thanks USDA OPMP for its comments.

USE AND USAGE

Products containing aliphatic solvents are registered to control insects and mites on fruits, vegetables, tree nuts, peanuts, sorghum, corn, cotton, and tobacco.  Products also are registered for use as mosquito larvicide/pupacides, and for use on ornamentals, turf, 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.

The leading agricultural use site is oranges (approximately 30 million pounds/year, 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.  After oranges, the leading agricultural use sites in that time period were almonds, apples, grapefruit, and pears.  Combined usage on these crops approaches the usage on oranges; other individual agricultural use sites account for less than 5% of total pounds applied. For some crops with lower average annual usage, most acreage is treated with aliphatic solvents, including pluots and artichokes at close to 100% crop treated in certain years. Between 2006 and 2009, approximately 300,000 pounds of aliphatic solvents/year were applied to non-agricultural sites.

Products are applied via broadcast, chemigation, by air, and with handheld equipment.  Mosquito control products are mainly applied with ground equipment.  

For additional information on use and usage, 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 conducted a qualitative risk assessment in support of the registration review of aliphatic solvents. For additional details, 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.  The agency has determined that there are no dietary, residential, aggregate, or occupational risks of concern for aliphatic solvent uses. The agency has not made a common mechanism of toxicity to humans finding as to aliphatic solvents and any other substance and aliphatic solvents do not appear to produce a toxic metabolite produced by other substances. Therefore, the agency has not assumed that aliphatic solvents have a common mechanism of toxicity with other substances for this assessment.

Human Incidents and Epidemiology

Both OPP's Incident Data System (IDS) and the National Institute for Occupational Safety and Health 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 GDCIs for the aliphatic solvents 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.

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).  While the potential exists for bird eggs in the field to be exposed to aliphatic solvents incidentally as a result of pesticide application, it is not clear that such exposures would have the same effect as intentional oiling, and there are no reproduction data for terrestrial vertebrates (either birds or mammals) with which to confirm or quantify any potential chronic risks. 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. 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. In February 2019, the agency issued a DCI requiring the submission of pollinator data for the aliphatic solvents as listed in Table 1 below.

Table 1: Aliphatic Solvents 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 (OECD 245)
Honey bee adult chronic oral toxicity 
Non-Guideline (OECD 239)
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 information relevant to understanding the potential risks to terrestrial plants posed by the use of aliphatic solvents pesticides, although they are somewhat contradictory.  On one hand, labels of some products include phytotoxicity warnings, suggesting that plant damage could occur when the products are used under drought conditions, when residues of certain other pesticides are present on leaves, or if sprays contact sensitive plants such as ferns or particular tree species. Additionally, as noted below, some terrestrial plant incidents have been recorded.  On the other hand, aliphatic solvents pesticides are labeled for use on and intentionally applied to many different plant types where target pests are present.  The incident reports for aliphatic solvents 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 be "probable' for only one incident. Plants can 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.  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 and Estuarine/Marine Fish

No potential acute or chronic risks of concern for freshwater or 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 associated with drift exposure alone (RQ = 8.5, at an application rate of 210 lb ai/A), run-off alone (RQ = 7.5, same rate), and for direct applications to water (RQ = 105, at an application rate of 37 lb ai/A), relative to an acute level of concern (LOC) of 0.5.  Chronic data for freshwater invertebrates are not available to evaluate risk.  Based on the data that are available, the agency has concerns about potential 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 application 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 will be conducted if additional information suggests the need.

Ecological and Environmental Fate Data Needs

The agency issued GDCIs in February 2019 that required the submission of certain pollinator data for the two PC codes associated with the aliphatics solvents case (see Table 1 above).  These data will facilitate a complete pollinator risk assessment in the future. Aside from the need for pollinator data, the ecological and environmental fate database for aliphatic solvents is adequate for registration review and no other data requirements are anticipated for this 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 or breathing apparatus. The aliphatic solvents are used in tree crops during dormancy or early in the growing season, sometimes in combination with other active ingredients, to kill insects before they lay eggs or feed on the crop. Aliphatics solvents are 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 Centers for Disease Control 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). The exact mechanism of toxicity is unknown but likely 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.  

Alternatives to aliphatic solvents include families of pesticides with much greater potential human health and/or ecological risks such as the organophosphates, pyrethroids, and neonicotinoids.

A list of source documents for information in this section, Additional Benefits References for Aliphatic Solvents, March 2019, is available on the public docket.

  
INTERIM REGISTRATION REVIEW DECISION

 Risk Mitigation and Regulatory Rationale

As indicated in Section III of this document, 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. Potential risks of varying degrees and of varying certainty have been identified for wildlife and non-target plants, and the available data suggest that there are particular risks of concern for freshwater invertebrates. 

A review of current aliphatic solvents pesticide labels revealed that they have not been consistently amended to reflect the RED, which included labeling elements such as handler requirements for Personal Protective Equipment (PPE). 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.

In evaluating the potential need for risk management and options for risk management for aliphatic solvents, the agency considered the risk, the use and usage, the benefits (including alternatives), and the potential impacts of the risk mitigation measures.  The benefits associated with the use of aliphatic solvents and their presence as inerts in other pesticides support the risk management decisions put forth in this document. The required risk mitigation measures are expected to have minimal economic impact on users while enhancing overall protections to humans and the environment.  

To mitigate potential risks to wildlife and non-target plants, particularly freshwater invertebrates, the agency is requiring the addition of uniform advisory spray drift management and environmental hazard statements on aliphatic solvents product labels. The agency is also requiring label changes to implement the reregistration eligibility decision and correct other labeling issues. These required changes are detailed below and in Appendix B. No comments opposing these measures were received from the registrants or any other stakeholder at the time they were proposed. 

 Spray Drift Management 

The agency is requiring advisory spray drift management 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 requiring various advisory language that includes information on the importance of droplet size, and the effects of release height, temperature, and wind on drift. The complete text is provided in Appendix B.

Environmental Hazards Statements 

The agency is requiring the addition of consistent aquatic organism hazard statement for all aliphatic solvents end-use product labels, as a means to address potential risks to aquatic animals and plants, particularly freshwater invertebrates. The statement to be included on labeling for products intentionally applied to water for the control of mosquitos is by necessity slightly different than the aquatic organism advisory statement for other aliphatic solvents products. The required text is provided in Appendix B.
 
Label Clarity 

The agency is requiring the following updates to the aliphatic solvents labels to ensure clarity and compliance with the RED conclusions, as detailed in Appendix B.  

 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

Aliphatic solvents are exempt from the requirement of a tolerance, and no changes to the exemption or the tolerance expression for aliphatic solvents are necessary at this time.  

Interim Registration Review Decision 

In accordance with 40 CFR §§ 155.56 and 155.58, the agency is issuing this interim registration review decision. Except for the Endocrine Disruptor Screening Program (EDSP), and the Endangered Species Act (ESA), the agency has made the following interim registration review decision: (1) except for the data recently required by the GDCIs, 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 interim registration review decision, 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. 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 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. 

Data Requirements

Beyond the requirements of the recently issued GDCIs, no additional data are anticipated to be needed for this registration review chemical at this time.  
NEXT STEPS AND TIMELINE 

 Interim Registration Review Decision

A Federal Register Notice will announce the availability of this interim registration review decision for aliphatic solvents. A final decision on the aliphatic solvents 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 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.  

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 of each label must be submitted, a clean copy and 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 Aliphatic Solvents 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 Aliphatic Solvents 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 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 Veronica Dutch 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:  Summary of Required Actions for Aliphatic Solvents 
                            Affected Population(s)
                                       
                              Source of Exposure
                               Route of Exposure
                             Duration of Exposure
                         Potential Risk(s) of Concern
                               Required Actions
Aquatic invertebrates
and other non-target taxa
-Spray Drift

-Run-off

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

-Require advisory spray drift reduction language

 Appendix B:  Aliphatic Solvents:  Required Labeling Language
                                  Description
            Required Label Language for Aliphatic Solvents Products
                              Placement on Label
                                 All Products
Name of Active Ingredient
The aliphatics solvents component of the ingredient statement must be revised to identify the active ingredient as "Mineral Oil."
 
Note:  Other ingredient names may be specified, if adequately justified and approved by the EPA.
                             Ingredient statement
                          Manufacturing-Use Products
Supported Uses 
"Only for formulation into products with the following use(s):
[Note to the registrant: list only those uses that are being supported by registrants of manufacturing-use products]."
Directions for Use
One of these statements may be added to allow formulation for additional uses
"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
                             All End-Use Products
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 there are no WPS uses on the label, place this statement in the Directions for Use under General Precautions and Restrictions.  If there are also WPS uses on the label, then create a Non-Agricultural Use Requirements box as directed in PR Notice 93-7 and place this 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
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"
For products that are applied as liquids and allow boom-less ground 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"
For products that are applied via handheld equipment
"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 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 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 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."