2 Table of Contents

I. Introduction ............................................................................................................... ................ 3

A. General Background ......................................................................................................... .. 4

II. Scientific Assessments .................................................................................................... ......... 4

B. Environmental Assessment ................................................................................................. 4 Threatened and Endangered Species ...................................................................................... 5

C. Human Health Assessment ................................................................................................. 5

D. Endocrine Disruptor Screening Program ............................................................................ 6

III. Proposed Registration Review Decision ............................................................................... 6

IV. Next Steps and Timeline ................................................................................................... ..... 63 I. Introduction

This document is the Environmental Pr otection Agency’s (EPA or the Agency) Proposed Registration Review Decision for Dioctyl Sodium Sulfosuccinate (DSS) which is being issued pursuant to 40 CFR Sections 155.57 and 155.58. DSS is co-formulated w ith undecylenic acid (UDA) for which a separate proposed registration review decision ha s been issued, located in the UDA Registration Review docket, EPA-HQ-OPP-2011-0910. A regist ration review decision is the Agency’s determination that a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, F ungicide, and Rodenticide Act (FIF RA). Among other things, the proposed registration review decision (1) states the Agency’s proposed findings with respect to the FIFRA standard for registration and descri bes the basis for such proposed findings; (2) identifies proposed risk mitigation measures or ot her remedies as needed and describes the basis for such proposed requirements; (3) states wh ether additional data are needed and, if so, describes what is needed; (4) specifies proposed labeling changes; and (5) identifie s deadlines for completing any required actions.

FIFRA, as amended by the Food Quality Pr otection Act (FQPA) of 1996, mandated the continuous review of existing pestic ides. All pesticides distributed or sold in the United States must generally be registered by EPA, based on sc ientific data showing that they will not cause

unreasonable risks to human health or the envi ronment when used as directed on product labeling. The registration review program is intende d to make sure that, as the ability to assess and reduce risk evolves and as polic ies and practices change, all regi stered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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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. Pursuant to 40 CFR § 155.50, the Agency formally initiated registration revi ew for DSS (Case 4029). The following timeline highlights significant events that have occurr ed during the registration review of DSS:

 December 22, 2010– Publication of the DSS Summary Document that included the Preliminary Work Plan, and was accompanied by the ecological Problem Formulation

and the human health Scoping Document in the docket (EPA-HQ-OPP-2010-1006) for a 60-day public comment period.

 May 3, 2011– Final Work Plan (FWP) for DSS is signed. No public comments were received during the 60-day comment period on the DSS S ummary Document . In the PWP, EPA specifically solicited comments on environmental justice, water quality concerns, and trade irritant s. The FWP notes that no a dditional ecological or human health data were needed for DSS registrati on review because sufficient information was available to conduct qualitativ e risk assessments to support a proposed registration review decision, pursuant to 40 CFR Section 155.53(b).4  March 7, 2013 – Publication of Dioctyl Sodium Sulfosuccinate Preliminary Human

Health Risk Assessment in Support of Registration Review 1 and Preliminary Environmental Fate and Ecological Risk A ssessment for the Registration of Dioctyl Sodium Sulfosuccinate (Case #4029) and Undecylenic Acid (Case #4095) 2 for a 60-day public comment period; no substantiv e public comments were received.

The documents cited above and additional information on DSS can be found in EPA’s public docket (EPA-HQ-OPP-2010-1006) at www.regulations.gov

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A. General Background

DSS is an insecticide and miticide in shampoos and spray products registered for indoor use on pets including dogs, cats, pup pies, kittens, and reptiles to kill mites and fleas on contact. The first pesticide product containing DSS was registered in 1995. These products may be applied to the pet’s coat or to bedding and te rrarium surfaces. DSS is co-formulated with the active ingredient undecylenic acid (UDA). As a pesticidal activ e ingredient, there are no food

uses and no tolerances established.

DSS is also an inert ingredient in seve ral end-use agricultura l and non-agricultural pesticide products, as well as in residential and comm ercial disinfectants and sanitizers. It is used as a wetting agent in industri al, pharmaceutical, cosmetic, and f ood products, as a disperser and solubilizing agent in foods, and as an adjuvant in tablet formation. Over the counter human drugs (stool softeners and laxati ves) that contain DSS have mu ch higher doses than would be associated with pesticide uses. As an inert ingr edient, there are exemptions from the requirement

of a tolerance establishe d under 40 CFR 180.910 and 180.930. DSS is used in pesticide formulations for pre- and post-harvest application to crops and for direct application to livestock as an inert ingredient. DSS is classified as “G enerally Recognized as Safe” (GRAS) by the Food and Drug Administration.

II. Scientific Assessments

B. Environmental Assessment

A summary of the Agency’s environmenta l risk assessment is presented below. For a detailed discussion, see the Preliminary Ecological Risk Asse ssment for the Registration of Dioctyl Sodium Sulfosuccinate (Case #4029) and Undecylenic Acid (Case #4095) noted above. The Agency’s risk assessment evaluated the ac tive ingredients from tw o different registration review cases, DSS and UDA, which are regi stered for use as co-formulated pet shampoo products. The findings of the assessment are appli cable to both registratio n review cases.

DSS is not expected to persist in the e nvironment. Ester hydrolysis of DSS produces octanol and sulfosuccinic acid, wh ich are both readily biodegradable and not expected to be of toxic concern. Terrestrial expos ure is not expected to resu lt from indoor usage and was not

1 http://www.regulations.gov/#!document Detail;D=EPA-HQ-OPP-2010-1006-0003

2 http://www.regulations.gov/#!document Detail;D=EPA-HQ-OPP-2010-1006-00095 assessed. DSS has the potential to enter wate rways through wastewater treatment plants (WWTPs) after use as a pet shampoo. Risks to aquatic taxa were assessed because DSS is slightly acutely toxic to fish, freshwater and estuarine invertebrates, and nonvascular aquatic plants.

EPA’s Office of Pollution Prevention and Toxics (OPPT) Down the Drain module EFast 3 was used to estimate DSS/UDA concentratio ns in receiving waters based on confidential production data and assumptions of 24% WWTP removal and no dilution. Toxicity endpoints came from open literature in the ECOTOX 4 database for DSS and chronic endpoints were estimated using Quantitative Structure Activity Relationship (QSAR) pred ictive modeling. Risk quotient (RQ) values are all below the Agency’s Level of Concern (LOC) for aquatic taxa. The

estimated environmental concentration of DSS is orders of magnitude below the concentration expected to cause adverse effect s in aquatic organisms.

Threatened and Endangered Species

There is no exposure to non-targ et terrestrial organisms, a nd the Agency has determined

that there is minimal risk of a dverse effects to non-target aquati c organisms. Therefore, EPA has made a “no effect” determination under the Endange red Species Act (ESA) for all listed species and designated critical habitat for such species, and has theref ore concluded that consultation

with the Fish and Wildlife Service and the Natio nal Marine Fisheries Service under ESA section 7(a)(2) is no t required.

C. Human Health Assessment

The Agency considered the HED scoping docum ent, its supporting documents, and the most updated Agency science polic ies and risk assessment methodologi es to prepare a qualitative risk assessment in support of th e registration review of DSS. Because of the low toxicity of DSS, its classification by the FDA as GRAS, a nd its use as a pharmaceutical drug in higher doses than would result from pesticide uses, th e Agency determined that a quantitative human

health risk assessment was not required under registration review . For a detailed discussion, see

the Dioctyl Sodium Sulfosuccinate Preliminary Human Health Ri sk Assessment in Support of Registration Review noted above. A summary of the Agency’s human health risk assessment is presented below.

There are no dietary, residentia l, occupational, or aggregate risks of concern for DSS. All toxicity data requirements were waived when DSS was registered, except for acute toxicity studies; therefore endpoints have no t been selected for DSS. DSS has no registered food uses as a pesticide and no residue chemistry data were required or submitted to support its use as an active ingredient or its inert uses in conventiona l and antimicrobial pesticide formulations. As an inert ingredient, DSS is exempted from the require ment for a tolerance. It is used in pesticide formulations intended for pre- and post- harvest applications to raw agricultural commodities and direct application to livestock. Because of th e low toxicity of DSS, quantitative residential handler, occupational, post-applic ation exposure and aggregate asse ssments were not required. It

3 http://www.epa.gov/oppt/exposure/index.htm

4 http://cfpub.epa.gov/ecotox/6 has not been determined that DSS shares a comm on mechanism of toxicity with other chemicals;

therefore a cumulative risk asse ssment was also not required.

D. Endocrine Disruptor Screening Program

Pursuant to FFDCA Section 408(p)(4), EPA ha s exempted DSS from the requirements of

the EDSP in an Administrative Order entitled Exemption of Dioctyl Sodium Sulfosuccinate (DSS) and Undecylenic Acid (UDA) from the Requireme nts of the Endocrine Disruptor Screening Program , dated April 11, 2014. The Order is available in the docket for this registration review at EPA-HQ-OPP-2010-1006. The Administrative Order de scribes the analysis and rationale that the Agency used to evaluate DSS in order to determine that it qualifies for the exemption.

III. Proposed Registration Review Decision

In accordance with 40 CFR Sections 155.57 and 155.58, the Agency is issuing this Proposed Registration Review Decision document. The Agency has made the following proposed decision: (1) no additiona l data are required at this time; and (2) no changes to the affected registrations or their la beling are needed at this time . In addition, EPA does not expect

DSS to have direct or indirect adverse effects to non-listed and listed species or to adversely modify any designated critical habitat for such species. EPA has made a “no effect” determination under the ESA for all listed speci es and designated critic al habitat for such species. Further, the Agency has also determined th at based on its structure, chemical nature, and history of uses for human consumption and pharm aceutical applications, D SS is exempt from the EDSP requirement. EPA’s proposed Registration Review Decision de termination for DSS is that the pesticide meets the standard for registration under FIFRA.

IV. Next Steps and Timeline

A Federal Register Notice will announce the av ailability of this Proposed Registration

Review Decision in the DSS and allow a 60-da y comment period. If th ere are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA will issue its registration re view decision for DSS (case 4029).