SOAP SALTS 

Interim Registration Review Decision 

Case Number 4083 

July 2015 

Approved by: ~~ p~~ )4' 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 

Date: ---~~~ a_o._f_~_ S ___ _ 
III. SCIENTIFIC ASSESSMENTS ..................................................................................... 5 

A. Human Health .......................................................................................................... 5 

1. Risk Conclusions ............................................................................................... 5 

2. Human Incidents ................................................................................................ 6 

3. Tolerances .......................................................................................................... 6 

B. Ecological ................................................................................................................ 6 

1. Risk Conclusions ............................................................................................... 7 

C. Endangered Species Assessment ............................................................................. 8 

D. Endocrine Disruptor Screening Program ................................................................. 9 

IV. INTERIM REGISTRATION REVIEW DECISION ..................................................... 9 

V. NEXT STEPS AND TIMELINE ................................................................................... 9 

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before completing a registration review. Among other things, the· Interim Registration Review 

Decision may: 1) require new risk mitigation measures; 2) impose interim risk mitigation 

measures; 3) identify data or information required to complete the review; and 4) include 

schedules for submitting the required data, conducting the new risk assessment and completing 

the registration review. For further information on soap salts, additional documents can be found 

in EPA's public docket (EPA-HQ-OPP-2008-0519) at www.regulations.gov. 

FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the 

continuous review of existing pesticides. All pesticides distribute~ or sold in the United States 

generally 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 as www.epa.gov/oru>srrdllregistration review/. 

In 2006, the Agency implemented the registration review program pursuant to FIFRA 

section 3(g) and will review each registered pesticide every 15 years to determine whether it 

continues to meet the FIFRA standard for registration. 

Products containing soap salts are registered for use as ac.¢cides, algaecides, herbicides, 

and insecticides on food and non-food crops in various settings, ehiefly residential and 

agricultural. Products containing ammonium and sodium soap salts are also registered for use as 

animal repellants. The Reregistration Eligibility Decision document (RED) for soap salts was 

completed in 1992. 

Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for soap 

salts (case 4083). The following highlights significant events that have occurred during the 

registration review of soap salts and can be found in EPA's public docket, EPA-HQ-OPP-2008-

0519, accessed at www.regulations.gov: 

• September 15,2008- Publication of Soap Salts Prelimin{;lry Work Plan (PWP) for a 60-

day public comment period. The Preliminary Work Plan (PWP) was accompanied by the 

scoping document and problem formulation. While the public comment period was 

underway, the Agency revised the list of data needs to more accurately represent the 

registered uses and chemical properties of the three soap salts and revised the Preliminary 

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received during the 60

day comment period for the soap salts PWP. While this comment 

did not affect the proposed data requirements, risk assessments, or timeline, the FWP did 

present a reduced list of data needs from the PWP based on the conclusions of the revised 

problem formulation. 

• February 25, 2010- Generic Data Call-In Notice (GDCI) for soap salts issued. 

• March 20,2013- The Agency published the Environmental and Ecological Risk 

Assessment for the Registration Review ofSoap Salts dated March 5, 2013 and the Soap 

Salts. Preliminary Risk Assessment to Support Registration Review dated August 29, 

2012 for a 60-day public· comment period. Two sets of comments were received. These 

comments were addressed in the Soap Salts Proposed Interim Registration Review 

Decision, dated March 11, 2015 and by the Revised Environmental and Ecological Risk 

Assessment for the Registration Review ofSoap Salts, dated March 3, 2015. The 

comments enabled refmements to the ecological risk assessment. 

• May 8-9, 2013- The Agency held focus meetings with the soap salts registrants. 

• March 26, 2015 - The Agency published the Soap Salts Proposed Interim Registration 

Review Decision, dated March 11,2015, in docket number EPA-HQ-OPP-2008-0519, for 

a 60-day public period. One comment was received which is discussed below. 

In addition to this document, the Agency published the following revised risk assessment, 

updated to incorporate additional information provided by soap salts registrants: 

o Revised Environmental and Ecological Risk Assessment for the Registration 

Review ofSoap Salts, dated March 3, 2015 

• September 2015- The Agency is now publishing the Soap Salts Interim Registration 

Review Decision. 

A. Public Comments 

Comments Received from the Center for Biological Diversity (EP A-HQ-OPP-2008-0519) 

Comment: The Center for Biological Diversity's (CBD) comments focus on the EPA's duty to 

consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the 

Services) on the registration review of soap salts in accordance with the Endangered Species Act 

(ESA). The CBD comments mention various aspects of the risk assessment process, including 

use of the best available data to· develop endangered species risk assessments, and evaluation of 

effects on endangered and threatened species (listed) and their designated critical habitat. CBD 

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its federal counterparts 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 speies and their designated critical habitats are 

finalized, the Agency will complete its endangered species assessment for soap salts and issue a 

final decision for registration review. See Section III. (C.) for a description of the Agency's plan 

to address risks to endangered species and critical habitat. 

II. USE AND USAGE 

The active ingredients comprising the soap salts case are ammonimum, potassium, and 

sodium salts of fatty acids. Products containing these salts are registered for use as acaricides, 

algaecides, herbicides, insecticides on food and non-food crops in various settings, chiefly 

residential and agricultural. Soap salts are registered for use on a wide range of food and nonfood crops as well as ornamental plants, shrubs, lawns, walks, driveways, dogs, and cats. 

Products containing ammonium and sodium soap salts are also registered for use as animal 

repellants. 

Soap salts products are formulated as aerosol sprays, solids, ready-to-use liquids, and 

liquid concentrations. Potassium salts of fatty acids disrupt the exoskeleton in insects, causing insects to die. They also kill plants by disrupting the photosynthetic process. Ammonium and 

sodium salts of fatty acids act as repellants, affecting the olfactory nerves of deer and rabbits, 

thus repelling the animals away from the target area 

III. SCIENTIFIC ASSESSMENTS 

A. Human Health 

A summary of the Agency's human health risk assessment is presented below. The 

Agency used the most updated Agency science policies and risk assessment methodologies to 

prepare a qualitative risk assessment in support of the registration review of soap salts. For a 

detailed discussion of the human health assessment for soap salts, see Soap Salts. Preliminary 

Risk Assessment to Support Registration Review, dated August 29, 2012 available in the public 

docket EPA-HQ-OPP-2008-0519, which can be accessed at http://www.regulations.gov/. 

1. Risk Conclusions 

The Agency conducted a qualitative human health risk assessment for the soap salts to 

evaluate potential occupational, residential, dietary, and aggregate risk from the soap salts' 

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2012. Based on the low frequency and severity of incident cases reported for soap salts, there 

does not appear to be a concern at this time that would warrant further investigation. The Agency 

will continue to monitor the incident information and if a concern is triggered, additional 

analysis will be conducted. 

3. Tolerances 

Potassium and ammonium salts are currently exempt from the requirement of a tolerance. 

An exemption for sodium salts is not needed, as there are no uses on/near food crops. 

B. Ecological 

A summary of the Agency's ecological risk assessment is presented below. The Agency 

used the most updated Agency science policies and risk assessment methodologies to prepare a 

quantitative risk assessment in support of the registration review of soap salts. For a detailed 

discussion of the ecological assessment for soap salts, see Revised Environmental and Ecological 

Risk Assessment for the Registration Review ofSoap Salts dated March 3, 2015 available in the 

public docket EPA-HQ-OPP-2008-0519, which can be accessed at http://www.regulations.gov/. 

When initially scoping the registration review for soap salts, EPA did not identify the 

need for any additional studies to evaluate potential effects on pollinators. However, since the 

issuance ofthe June 2014 Guidance for Assessing Pesticide Risks to Beesf11, EPA has begun to 

require these data where applicable. EPA is currently determining whether additional pollinator 

data are needed for active ingredients in registration review whose dockets opened prior to June 

2014. For those active ingredients where EPA determines that additional pollinator exposure and 

effects data are necessary to help make a final registration review decision, EPA intends to issue 

a DCI to obtain these data. In the near future, EPA will provide further information and 

guidance on this effort. The pollinator studies that could be required are included in Table 1 

below. The Agency will require data it believes are necessary to help inform the pollinator risk 

assessment. 

[IJ http://www2.epa.gov/sites/production/files/20 14-

06/documents/pollinator risk assessment guidance 06 19 14.pdf 

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(OECD 213) 

Non-Guideline* Honey bee larvae acute oral toxicity 

(OECD 237) 

Non-Guideline* Honey bee adult chronic oral toxicity Non-Guideline* Honey bee larvae chronic oral toxicity 

Non- Residues in pollen and nectar/field residue analysis Guideline** 

Non- Semi-field testing for pollinators (tunnel or colony feeding Guideline** 

(OECD 75) studies) 

*Tier I (Laboratory-based studies) 

**Tier 2 and 3 (Semi-field and full field colony-level studies) The need for a higher tier test for pollinators will be determined 

based upon lower-tiered tests and/or other lines of data and the need for a refined pollinator risk assessment. 

1. Acceptable data have already been submitted for soap salts or are waived based on available information. 

The Agency also completed a screening-level endangered and threatened (listed) species 

assessment for soap salts and identified potential risks to several taxa: freshwater invertebrates, 

estuarine/marine invertebrates, and terrestrial plants. In order to meet the requirements ofFIFRA 

and the ESA, this assessment follows EPA guidance on conducting ecological risk assessments and the Office ofPesticide Program's Overview Document, which contains guidance for 

assessing pesticide risks to non-target and listed species (USEPA, 2004). However, as described 

below, the Agency is currently working with its Federal counterparts 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 soap salts. 

1. Risk Conclusions 

Terrestrial Assessment 

The screening-level risk assessment identified the potential for minor risk to terrestrial 

plants from the use of potassium and ammonium salts. However, the Agency believes there is 

little actual risk to non-target plants exposed to soap salts due to the rapid degradation of soap 

salts in surface water runoff, which is not accounted for in the risk assessment model, and the 

inherent insolubility and low toxicity of soap salts. Additionally, to be effective, soap salts 

generally must be applied to thoroughly wet the target pest (insect or plant) since they have a 

physical, not toxic, mode of action. This limits the effect of soap salts to species within the 

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such as soap salts are not sufficiently soluble in ambient water to be toxic to aquatic organisms. 

Therefore, the Agency has no risk concerns from the aquatic assessment for non-listed species. 

C. Endangered Species Assessment 

Consistent with EPA's responsibility under the Endangered Species Act (ESA), the 

Agency will evaluate risks to federally listed threatened and endangered (listed) species from registered uses of pesticides in accordance with the Joint Interim Approaches developed to 

implement the recommendations of the April2013 National Academy of Sciences (NAS) report, 

Assessing Risks to Endangered and Threatened Species .from Pesticides. The NAS reportlll 

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. EPA will address concerns specific to soap salts in 

connection with the development of its final registration review decision for soap salts. 

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries 

Services (the Services), and the U.S. Department of Agriculture released a white paper 

containing a summary of their joint Interim Approaches for assessing risks to listed species from 

pesticides. These Interim Approaches were developed jointly by the agencies in response to the 

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. Details 

of the joint Interim Approaches are contained in the November 1, 2013 white paper, Interim 

Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the 

Recommendations ofthe National Academy ofSciences Apri/2013 Report. fll 

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 Registration 

Review Decision for soap salts does not contain a complete ESA analysis, including effects 

determinations for specific listed species or designated critical habitat. While the agencies continue to develop a common method for ESA analysis, the revised risk assessment for the 

registration review of soap salts describes the level of ESA analysis completed for this particular 

registration review case. 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 methods necessary to complete risk assessments for listed species and 

[II http://www.nap.edu/catalog.php?record id=18344 [21 http://www.epa.gov/espp/20 13/nas.html 

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such endocrine effects as the Administrator may designate." Under FFDCA section 408(p ), the 

Agency must screen all pesticide chemicals. Between October 2009 and November 2010, EPA 

issued test orders/data call-ins for the first group of 67 chemicals and published a second list of 

chemicals proposed for order issuance in the future. Soap salts are not among the group of 58 

pesticide active ingredients on the initial list nor are they proposed on the second list of 

chemicals to be screened under the EDSP. Accordingly, as part of registration review, EPA will 

issue future EDSP orders/data call-ins for registration review chemicals, including soap salts. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, future chemical lists proposed for screening, the test guidelines and the Tier 1 

screening battery, please visit our website: http://www.epa.gov/endo/. 

In this interim decision, EPA is making no human health or environmental safety findings 

associated with the EDSP screening of soap salts. Before completing this Registration Review, 

the Agency will make an EDSP FFDCA section 408(p) determination. 

IV. INTERIM REGISTRATION REVIEW DECISION 

In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this 

Interim Registration Review Decision document for soap salts. Except for the EDSP, ESA, and 

pollinator components of this case, EPA has made the following Interim Registration Review 

Decision determination for soap salts: 1) no additional data are required at this time; and 2) no 

changes to the affected registrations or their labeling are needed at this time. 

In this interim registration review decision, EPA is making no human health or 

environmental safety findings associated with the EDSP screening of soap salts, nor is it making 

a complete endangered species finding or a complete assessment of effects to pollinators. The 

Agency's final registration review decision for soap salts will depend upon the results of an ESA 

Section 7 consultation with the Services, an EDSP FFDCA section 408(p) determination, and an 

assessment of the non-target exposure to bees. 

V. NEXT STEPS AND TIMELINE 

Interim Registration Review Decision 

A final decision on the soap salts registration review case will occur after ESA and EDSP 

FFDCA section 408(p) determinations have been made, as well as completion of an assessment 

of the non-target exposure to bees. 

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