United States Chemical Safety September 2011 Environmental Protection and Pollution Prevention Agency (7510P)



# Tetrakis (Hydroxymethyl)Phosphonium Sulf ate (THPS) Registration Review : Final Work Plan September 2011Docket Number: EPA

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3 of 14 Tetrakis (Hydroxymethyl)Phosphonium Sulf ate (THPS) Registration Review Team

Human Health & Environmental Effects Nathan Mottl Najm Shamim

Risk Management Eliza Blair Lance Wormell

Office of General Counsel Philip Ross

________________________________________ S upporting documents for the Tetrakis (Hydroxymethyl)Phosphonium Sulf ate (THPS) Case may be found in the registration review docket EPA

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4 of 14 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of Tetrakis (hydroxymethyl)phosphonium sulf ate (THPS) (Case 5034 )

. The work plan includes the expected registration review timeline . The work plan also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted in the Tetrakis (hydroxymethyl)phosphonium sulf ate (THPS) registration review docket , and any other comments concerning the initial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Agency believes are ne eded to make a registration review decision.

The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science, public policy and pesticide use practices will occur over time. The registration review program is intended to make sure that, as the ability to assess risk

ev olves and as policies and practices change, all registered pesticides continue to meet that statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this program is provided at: http ://www.epa.gov/oppsrrd1/registration_review/.

The Tetrakis (Hydroxymethyl)Phosphonium Sulf ate (THPS) Preliminary Work Plan (PWP) (PC Code 129058 ) was published on March 30, 2011 and the 6 0

- day comment period ended on May 31, 2011 . The Preliminary Work Plan document is available on www.regulations.gov docket number EPA

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. The first product containing Tetrakis(hydroxymethyl)phosphonium sulfate (PC Code 129058 ) as an active ingredient was registered in the United States in 1995

. Currently, there are 15 products containing THPS registered with EPA. T he pesticide is currently used as a materials preservative in paperboard manufacturing, and emulsion and solution preservation in addition to fire
p rotection systems. The chemical also has industrial process and water systems uses in oil field and petrochemical areas . There are no inert use s associated with this chemical. There are no tolerances for this chemical.

Th e Agency believe s that THPS may release formaldehyde. According to a recent EPA review (more information in “Revised Summary of Human Health Effects Data for the THPS Registration Review Decision Document ”, dated 9/21/2011) , t he formula of this chemical is such that it is likely to release formaldehyde because it contains hydroxymethyl group, which is an essential component in the production of formaldehyde , and the degradation products in aquatic medium are t rihydroxymethyl phosphine (THP) molecules which are formed by releasing two formaldehyde (HCHO) molecules

. The Agency does not have emissions (e.g. air chamber) data to estimate potential concentrations of formaldehyde released into the air under various conditions. The Agency will likely need data
to determine the extent of the THPS degradation i n air to form formaldehyde and THP. If the Agency identifies that THPS is in fact a formaldehyde releaser, EPA may also need to developDocket Number: EPA

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5 of 14 additional inhalation risk assessments to assess the contribution of for maldehyde t o the overall aggregate risk from all sources.

Comments Received on the Preliminary Work Plan

The Agency r eceived comments from three sources during the public comment period on the initial docket, described below. In the PWP, the Agency solic ited comments on four specifi c topics: environmental justice, water body impairment

, trade irritants , and structure activity relationships

. The Agency received no comments during the public comment period concerning those four issues

. This document makes final the work plan for the Tetrakis(hydroxymethyl)phosphonium sulfate (THPS) registration review process.

Comment :

The FIFRA Endangered Species Task Force (FESTF) submitted a comment noting that it has data that will assist the Agency in conducting an endangered species risk assessment for THPS

, and requesting that any technic al registrant for THPS who is not a member of the FESTF (or a company having met its data compensation obligati ons) be asked to provide a formal offer

- to

pay to FESTF for reliance on their data

.
Response :

The Agency thanks FESTF for its comment and will consider this information as it conducts the registration review and makes its registration review decisions.

Comment:

There are several errors in the mentioned use patterns for THPS. THPS is an industrial antimicrobial targeted for use in various industrial process water use sites (oilfield production and stimulation, cooling towers, and paper mills, etc). THPS is not used as an in

- can preservative in any paint applications, nor was this use ever envisioned due to the ineffectiveness of THPS in these applications. However, we do concede that such a use may be construed from current label language, and Rhodia offe rs to include a new statement on our labels prohibiting such use, e.g. “not for use in paint”.

Elsewhere, THPS is mentioned as a leathe r preservative, but Rhodia believe s this also to be inappropriate. THPS is used as a leather tanning agent in some parts of the world (e.g. Asia, etc.), but this involves a chemical “tanning” reaction, not a biocidal application, and thus does not belong in this assessment.

Rhodia also has no customer uses for THPS as a wood preservative. Rhodia has not examined the use of T HPS as a wood preservative, and we do not believe it is ever u sed in this application area. Rhodia believe s reference to use of THPS in wood preservation is inappropriate.

Finally, Rhodia

- manufactured THPS is not marketed for use in surface disinfectants and there are no claims on our manufacturing

- or end

- use labels for such uses.Docket Number: EPA

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6 of 14 Response:

The human health assessment does not mention the use of THPS as a wood preservative or surface disinfectant. We have deleted an erroneous entries to leather uses found in the Appendix. Based on the manufacturing use as a preservative in water based coatings, pigments, and slurries, we construed the use to be paint. When the label is changed to reflect the "not for u se in paints" statement, EPA will revise the THPS human health assessment, removing paint data requirements and assessments

. Comments on Handler Data Requirements& Risk Assessments :
EPA lists the following studies as being data gaps based on the use of THPS in paints:

o 90

- day inhalation toxicity study (Series 870.3465)

o Dermal Exposure (outdoor and Indoor) (GDLN 875.1100 and 875.1200)

o Inhalation exposure (Outdoor and Indoor) (GDLN 875.1300 and 875.1400)

o Data Reporting and Calculations (GDLN 875.1600) )

o Pro duct Use Information (GDLN 875.1700) \

Most applications of THPS are expected to be made with automated dosing pumps, but some applications by open pour may occur. Rhodia is part of the Antimicrobial Exposure Assessment Task Force II ( AEATFII ) that is plan ning to conduct a monitoring study to look at open pour
expos ures (dermal and inhalation). Rhodia would be able to provide this data when the study is complete, if it is required by EPA.

Response :

Should the registrant(s) revise ( s ) the labels with the new label statement "not for use in paints",
t he Agency anticipates that only an occupational dermal risk assessment for the open pour/pump liquid applications for the uses in industrial processes and water systems uses and material preservative uses woul d be needed.

Thus, the Agency would expect that the anticipated 90

- day inhalation toxicity data (Series 870.3465) need based on the paint use would be eliminated in this case

. Likewise, should the paint use be deleted, the Agency would expect that the a nticipated inhalation exposure requirements (GDLN s 875.1300 and 875.1400) would also be eliminated in this case

. Comments on Postapplication Risk Assessments & Data Requirements:

THPS is not used in paints and Rhodia plans to add labeling to clarify “no t for use in paints”. Given this, exposure studies and a post

- application risk assessment for THPS linked to use in paint should not be necessary.

Response :
The registrant is correct in stating what a consequence would be once it revises its labels to incl ude a new label statement "not for use in paints" . Once that change is final and effective, the Agency would expect that the postapplication exposure data requirements and postapplicationDocket Number: EPA

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7 of 14 exposure assessments will longer be required for this case based on the other use patterns

. As

s uch, once the change to the lab e l is final and effective, the Agency would expect to no longer need the following data :

o (GDLN 875.2500) Inhalation exposure

o (GDLN 875.2700) Product Use Information and

o (GDLN 875.2900) Data reporting and calculations

Comments on Residential Risk Assessment :
A residential risk assessment should not be required for THPS as residential use is not anticipated. An occupational risk assessment for paint applicators should also not be necessary as THPS is to our knowledge not used in paint.

Response :
Once the registrant(s) revises the labels with the new label statement "not for use in paints", the Agency expects that residential risk assessments w ould no longer be required for THPS since paint application is the only use that would trigger a residential assessment. All of the paint

related occupational risk assessments w ould also no longer be expected to be required once the aforementioned label change is final and effective

.

Co mment :
It is stated in the workplan in several locations that no earlier risk assessments have been conducted. This appears to be an error, as the indirect food use of THPS as a slimicide in paper mills producing food contact paper and paperboard has been assessed by FDA (21CFR 176.300) and EPA (D257896 + MRID# 45542001). More recently an assessment has been completed by FDA (FCN 955) for use of THPS as a preservative in slurries that may be used in paper and paperboard coatings.

R esponse :

T he registrant is correct that in the human health assessment conducted for the preliminary work plan, we acknowledge that an earlier dietary risk assessment was conducted. The final work plan reflects this.

Note: Registrants citing an FDA dietary risk assessment for paper and paperboard are encouraged to submit the full reference to the Agency so that it can be located and incorporated into the THPS Registration Review risk assessment

.

Comment:

The registrant submitted ecological/environmental fate data over a d ecade ago that would satisfy some of the data requirements in this work plan.Docket Number: EPA

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8 of 14 Response:

If registrants believe they have submitted data that could satisfy the anticipated data requirement

, r egistrants are encouraged to cite MRIDs either prior or in response to the Data C all

- In expected to be issued for thi s case, and the Agency will review them for adequacy

.

Comment:

The biocide industry is concerned about the use of the term “ formaldehyde releaser ” with respect to THPS.

Response:

The Agency uses this term merely to n ote that the p otential exist s for the release of fo rmaldehyde from a particular biocide. It does not necessarily imply that in all cases the release of formaldehyde is a risk concern. I f data exist for a particular biocide which show s that the level of release of f ormaldehyde is low

, then in many cases the A gency will not have any concerns . The explanation and scientific information provided by t he registrants i ndicates that formaldehyde release from THPS will be low; however, the hydrolysis study the Age ncy anticipates requiring will characterize the amount

.

Comment:

The Agency has listed the s olubility of THPS in organic solvents as a data gap. However, as noted for aqueous solubility data, THPS is manufactured in situ as an aqueous solution. The material is therefore not isolated in a form suitable for solubility testing

. Response:

T he Agency accepts the rationale for not asking solubility in organic solvents, and will remove it from the data requirements list.

Additional Changes to the Final Work Plan and Associated Documents

The Preliminary Work Plan incorrectly stated that no prior dietary risk assessment had been performed. A dietary risk assessment was conducte d during registration to examine the indirect food use exposures for food contact paper and paper board. According to the dietary risk
assessment , the Agency concluded that dietary risks were acceptable. Although a dietary risk assessment has been done du ring registration, the Agency will likely reevaluate the indirect food uses (e.g. paper and paperboard, water based coatings, pigments, etc.) and exposures and toxicological endpoints and conduct a new acute and chronic dietary assessment during registrati on r eview

. Additionally, it was discovered that an end

- use registrant has a new registered use on its THPS labels

- sanitizers and disinfectants

- for which no additional data were requ ired at the time of registration. This use is not supported by the tech nical registrants of THPS; therefore, the end

use registrant, Kidde Fire Fighting, will need to submit the sanitizers and disinf ectants dataDocket Number: EPA

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9 of 14 listed below when required to do so by a data call

- in notice or amend their THPS labels to remove this use. A revised Human Health Scoping Document for THPS has also been posted incorporating the expanded anticipated risk assessment and data needs for this sanitizer/disinfectant use.

**•** (GDLN 875.2300) Ind oor Surface Residue Dissipation

**•** (GDLN 875.270 0) Product Use Information (for 875.2300)

**•** (GDLN 875.2900 Data Reporting and Calculations (for 875.2900)

Risk Assessments and Anticipated Data Needs

The Agency will conduct a comprehensive ecological risk assessment, including an endangered species risk assessmen t, for all uses of THPS. The Agency will conduct a human health risk
assessment. The Agency expects to require additional data for use in conducting the registration review for THPS.

Ecological Risk Assessment Status and Data Needs

**•** No ecological risk assessment has been performed for THPS

.

**•** The Agency anticipates the need to require the following additional ecological data for use in conducting the registration review of THPS.

GLN 850.1010

-- Aquatic invertebrate acute toxicity, freshwat er daphnids GLN 850.1300

-- Daphnid chronic toxicity test GLN 850.1350

-- Mysid chronic tox

- aquatic invertebrate life

- cycle (saltwater) GLN 850.4400

-- Aquatic plant toxicolog y test using Lemna spp., Tier I GLN 850.1400

-- Fish early

- life stage toxicity test (freshwat er) GLN 850.5400

-- Algal Toxicity Tier I and Tier II

**•** The Agency anticipates the need to require the following additional environmental fate data for use in conducting the registration review of THPS.

GLN 835.2240

-- Photodegradation in water GLN 835.1230

-- Sediment and soil adsorption/desorption GLN 835.1240

-- Leaching and adsorption/desorption GLN 835.4300

-- Aerobic aquatic metabolism GLN 835.4400

-- Anaerobic aquatic metabolism GLN 835.3110

-- Ready Biodegradability

**•** F or more information

, please refer to Scoping Document: Produc t Chemistry/Environmental Fate/Ecotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate , located in the docket

.
Human Health Risk Assessment Status and Data Needs

**•** No recent full human health risk assessment has been performed for THPS

. A dietary risk

a ssessment was perfor med at the time of registration in 1995

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10 of 14 Dietary Assessment

**•** THPS is used as a microbiocide/slimicide and is registered for use to control bacteria, fungi, and algae in the manufacture of paper and paperboard products and adhesives that do not contact food. S ome end use products are also registered for use in emulsions that are applied to food

- contact paper and paperboard. Ther efore, indirect dietary exposure to food could be expected based on the latter use. An FDA tolerance was not identified. D ietary exposures via drinking water may occur and assessments will be needed based on the use in recirculating cooling towers and po tential release of water containing THPS residues to surface water

. Upon receipt and review of the environmental fate data the Agency anticipates requiring, the Agency will determine the need for a down

- the

- drain drinking water assessment.

**•** A dietary risk assessment was conducted during registration to examine the indirect food use exposures f rom the food contact paper and paper board uses . According to the dietary risk assessment, EPA concluded that dietary r isks were acceptable. Although a dietary risk

a ssessment has been done during registration, EPA will likely reevaluate the indirect food uses (e.g. paper and paperboard, water based coatings, pigments, etc.) and exposures and toxicological endpoint and conduct a new acute and chronic dietary assessment during registration review.

Tolerances and International Harmonization

**•** There are no tolerances for this chemical. However, i t should be noted that a food contact substance notification (FCN No. 955) was submitted by the registrant to FDA on 6/17/2010 to allow THPS at levels not to exceed 400 ppm in water based coatings, starches, pigments, and filler substances. T HPS is also listed by FDA in 21 CFR §176.300 as a slimicide in paper/paperboard at a m aximum use level of 84 mg/kg in the pulp slurry. The additive may also be added to water, which when introduced into the pulp slurry, results in a concentration in the pulp slurry not to exceed 84 mg/kg. The EPA

- registered labels with paper and paperboard uses state that the concentrations of THPS in the re gistered p aper and paperboard products cannot exceed 84 ppm.
Occupational and Residential Assessment and Risk

**•** Based on the available use information, the Agency believes that there is potential exposure to occupational handlers from open pour/pump liquid applications for the uses in industrial processes and water systems uses and material preservative uses. In addition, since THPS is found as a material preservative in water based coatings, pigments and slurries, EPA assumes that THPS could also be used as an in

- can preservative in paints even though this application is not stated in the existing registered labels . Currently the l abel does not prohibit this use . If painting use is prohibited, the Agency anticipates that s ome data will not be needed.

**•** Unt il labels prohibit the paint use, the Agen cy will continue to assume THPS is used in paints. Therefore, both occupational and residential application techniques typically associated with painting exposures (pump/pour liquids, brush/roller, and airless spra yer) will be assessed using the labeled rates typically used for similar chemicals to preserve the waterDocket Number: EPA

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11 of 14 based coatings, pigments, and slurries. The Agency will assess residential handler exposure to paints assessing applications to brush/roller and airles s sprayer.

**•** Product use data provided by the registrant will be useful to clarify whether THPS added to water based coatings, pigments, and slurries are later formulated into paints. Based on product use data, the Agency may later decide to refine the risk assessment scenarios and to refine exposure assessment assumptions. If label prohibitions on paint use are put into effect then the Agency anticipates that painting exposure data will not be necessary.

**•** If THPS is used to manufacture paints , the Agency anticipates that i t may need to perform an inhalation occupational and residential post

- ap plication exposure as sessment for the degradate formaldehyde. Other inhalation post

- application exposures to THPS or from formaldehyde for uses such as oil drilli ng are expected to be minimal. Dermal post

application exposures for water

- treatment and other material preservation uses such paper manufacturing or oil drilling are likely to be minimal for THPS or formaldehyde.

**•** Residential Handlers *: Residential handler exposure (dermal and inhalation) can occur through the application of THPS

- p reserved coatings via paintbrush/roller or sprayer application for painting. The Agency expects to conduct residential handler risk assessments for these scenarios.

* Note that if the material preservatives used in coatings, pigments and slurries are prohibited for the use in paint products, the Agency anticipates that painting exposure data will not be
necessary.
Aggregate and Cumulative Exposure and Risk

**•** In examini ng aggregate exposure, EPA takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as

non

- occupational pesticide exposures. The Agency expects to conduct an aggregate risk

ass essment that will include residential, dietary and drinking water exposures.

**•** Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding

as to THPS and any other substances.

**•** The Agency believes that THPS may release formaldehyde. According to the human health scoping document which may be found in the docket for this Registration Review case

, (more information in “Revised Summary of Human Health Effects Data for the THPS Registration Review Decision Document ”, dated 9/21 /2011), t he formula of this chemical is such that it is likely to release formaldehyde because it contains hydroxymethyl group, which is an essential component in the production of formaldehyde , and the degradation products in aquatic medium are t rihydrox ymethyl phosphine (THP) molecules which are formed by releasing two formaldehyde (HCHO) molecules

.

**•** If the required hydrolysis study reveals that formaldehyde is being released in quantities of concern, the Agency will incorporate this into its cumulative assessment of formaldehydeDocket Number: EPA

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12 of 14 and THPS. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pe sticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/.

Human Health Data Needs

**•** The Agency anticipates the need to require the following additional human health data for use in conducting the registration review of THPS

.
GLN 870.3465

-- 90

- day inhalation toxicity (rat) GLN 87 5.1100

-- Dermal outdoor exposure GLN 875.1200

-- Dermal indoor exposure GLN 875.1300

-- Inhalation outdoor exposure GLN 875.1400

-- Inhalation indoor exposure GLN 875.1600

-- Application exposure data reporting and calculations (for 875.1100

- 1400) GLN 875.1700

-- Product use information (for 875.1100

- 1400)

**•** If sufficient quantities of THPS degradate s such as formaldehyde are identified in a hydrolysis study, the Agency may also need air monitoring data and , if so, would expect to

re quire the following data for use in examining THPS and formaldehyde inhalation exposure. The studies anticipated as needed would be:

GLN 875.2500

-- Inhalation exposure GLN 875.2700

-- Product use information GLN 875.2900

-- Data reporting and calculations

**•** Additionally, the end

- use registrant with the disinfecting foam use on their label (EPA Reg. # 82932

- 1) will need to submit the following studies in response to the data call

- in in order to retain this use:

GLN 875.2300

-- Indoor Surface Residue Dissip ation GLN 875.2700

-- Product Use Information GLN 875.2900

-- Data Reporting and Calculations

**•** For more information, please refer to the revised Summary of Human Health Effects Data for the THPS Registration Review Decision Document

, dated August 9, 2011, located in the docket

. Product Chemistry Data Needs

**•** The Agency does not anticipate the need to require additional product chemistry data for this registration review at this time.Docket Number: EPA

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13 of 14 **•** F or more information

, please refer to Scoping Document: Product Chemistry/E nvironmental Fate/Ecotoxicity of Tetrakis (hydroxymethyl) Phosphonium Sulfate

, located in the docket

.
Incidents:

Ecological:

**•** No THPS ecological incidents have been reported in the Agency' s Ecological Incident Information System (EIIS)

.
Human Health:

**•** There have been no human incidents in the OPP Incident Data System (IDS) that are associated with exposure to THPS

. Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species determination for THPS

. The ec ological risk assessment planned during registration review will allow the Agency to determine whether THPS ’s use has 'no effect' or 'may affect' federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

En docrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessme nts 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, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects i n different taxonomic groups. As part of its most recent registration decision for THPS , 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 section 408(p), THPS is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ing redients) 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 requi red 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 EPADocket Number: EPA

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14 of 14 will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identif y 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 section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and Feb ruary 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. THPS is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

- ins, requiring the submission of EDSP screening assays for THPS

. For further information on the status of the EDSP, the policies and procedures, the li st of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.
Timeline

EPA has created the following estimated timeline for the completion of the Tetrakis(hydroxymethyl)phosphonium sulfate (THPS) registration review:

Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket Completed Close Public Comment Period for Docket Completed Phase 2: Case Development Develop Final Work Plan (FWP) September 2011 Issue DCI September 2012 Data Submission September 2014 Open Public Comment Period for Preliminary Risk Assessments March 2016 Close Public Comment Period for Preliminary Risk Assessments April 2016 Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision September 2016 Close Public Comment Period for Proposed Reg. Review Decision November 2016 Final Decision and Begin Post

- Decision Follow

- up March 2017 Total (years) 6

Next Steps

A DCI will be developed regarding the anticipated data needs listed under the “Risk Assessments and Anticipated Data Needs” section of this document. The Agency expects to issue the DCI in September 2012 . Human health and environmental fate and ecological hazard assessments will be conducted for all uses.