### Docket Number EPA-HQ

-OPP-2015-0639 www.regulations.gov



# Aquashade Combined Work Plan, Preliminary Risk Assessment, and Proposed Interim Registration Review Decision Case Number 4010 September 2015

Approved by: 

### Director Pesticide Re-evaluation Division
Date:

### Table of Contents Contents 

### I. INTRODUCTION ............. . ................................................... .. ................ .4 

### II. STATUTORY AND REGULATORY AUTHO RITY... ....... . ......................... .. .... .4 III. AQUASHADE CHEMICAL FACTS . . . . ............ . ............................. . ................ 5 IV. RECENT ACTIONS .............................................................. ... .... . ..... ....... 6 V. SCIENTIFIC ASSESSMENTS . ... . ............ ... .............................................. .. .. 6 A. Human Health Assessment ..................... .. ......... .. . ..... ........ ... .. ............................................................... 6 1. Risk Conclu sions ............... ........... . ............................. ... .. ...... ....................................................... 6 2. Human Health Incidents .. . ... .. . .................................................. . ............. .................................... 7 3. Food Tolerances ................. . ................................... ..... .............. .................. ...... . ....... . ................ .. 7 B. Ecological Assessment ......... .... .. .. ...... ..... .. .. ........ .... ....................................................................... ......... 7 1. Risk Conclu sions ................. ... .. . ... ....... ....... .... . ..... ...... .............. .................................................... 8 2. Ecological Incidents ......... ........ ....... .... .. . . ..................................................... .. .... ... . ...................... 8 C. 

### Endangered Species Assessment .................... ......... ...... .......... ................... ....... ... .. ......... ...................... 8 D. E ndocrine Disruptor Screening Program ...... .. ............ ..... ........ ..................................... .. ...... ...... ........ 9 VI. PROPOSED INTRERIM REGISTRAT ION REVIEW DECISION ....... .............. ...................... .. ................. .. ............................ 10 VII. NEXT STEPS AND TIMELINE . . ......................................... . ........ .. . .. .... .. ... 11



### 2References: 

### This document summarizes the Enviro nmental Protection Agency's current position based on the following documents:

1. 

### Problem Formulation and Preliminary RiskAmssment for Support qfthe Registration Ret.Jiew forAquati c Dyes ContainingAa:d Blue 9 (PC Code 110301) andAcid Yellow 23 (PC Code 110302). Nicholas Mastrota and James K. 

### Wolf. August 27,2015. 2. 

### ./lquasbade Scoping Document and Preliminary Risk AJJessment for Regzstration Review. Uma Habiba, Ronnie Bever, and Katelynn King. July 13, 2015. 3. 

### AquaJhade, Acid Yellow 23, andAcid Blue 9, Diammoni11m Salt: Tier I (Scoping) Ret;iew 

## if Human Inc id

e nts. Elizabeth Evans and Shanna Recore. May 6, 2015. 4. 

### AquaJhade (110301

- 110302) Label Use Report Package in Support 

## if Registration Retiew. LaVerne Dobbins. November 6, 2014. These and other supporting documents for the Aquashade registration review case may be found in the docket EPr\ -HQ-OPP

-2015-0639 at http: l/www.regulations.gov.



### 3

## L INTRODU CTION The docket for aquashade is now open, initiating the public comment period for this registration review (docket number EPA-HQ
-OPP
-2015
-0639). The Environmental Protection Agency's (EPA or the Agency) is issuing a combined Work Plan, Preliminary Risk Assessment and Proposed Interim Registration Review Decision for Aquashade pursuant to 40 CFR Sections 155 .50, 155.53, 155.56, and 155.58, followed by a sixty (60) day public comment period. This document explains what EPA's Office of Pesticide Programs knows about aquashade, and the potential human health and ecological risks from aquashade, as well as its proposed interim registration review decision for this compound. This document and supporting documents are being made available for public comment for a sixty (60) day period and can found in the docket EPA
-HQ
-OPP
-2015-0639 at http: //www.regulations.gov. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it 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 comp leting the registration review. Aquashade is a dye that contains both erioglaucine ( Acid Blue 9, or FD&C Blue No. 1) and tartrazine ( Acid Yellow 23, or FD&C Yellow No.5). Aquashade is registered for use as an aquatic herbicide. The mode of action is by light filtration. It is primarily used in small water bodies 

### (e. g. , ornamental ponds, small lakes, or fountains) and other landscaping water features such as swimming holes, aquaculture ponds, and animal watering holes. Erioglaucine and tartrazine also have non pesticidal use as a food additive/food coloring (21 CFR 74.101 and 21 CFR 74 .705). The fust pesticide products containing aquashade were registered in the United States in 

### 1981, and a Reregistration Eligibility Decision (RED) for aquashade was issued on September 23, 2005 . For further information about Aquashade, additional documents can be found in EPA's public docket ( EPA
-HQ
-OPP
-2015
-0639) at www.regulations .gov. 

### II. STATUTORY AND REGULATORY AUTHORITY The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. r\ll pesticides distributed or sold in the U.S. generally must be registered by EPA, based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to 

### meet the statutory standard of no unreasonable 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 program, the Agency periodically re -evaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at www .epa.gov/ oppsrrdl / registration review /. The Agency is implementing the registration review program pursuant to Section 3(g ) of FIFRA, and will review each registered pesticide every 15 years to 

### determine whether it continues to meet the FIFR.r\ standard for registration. The regulations governing registration review begin at 40

### 4

### CFR 155.40. The Agency will consider benefits information and data as required by FIFRA.. The public phase of registration review begin s when the initial docket is opened for each case. The docket is the Agency's opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision. 

### III. AQUASHADE CHEMICAL FACTS Table 1: Chemical facts for Aquashade PC code 110301 (erioglaucine), 110302 (tartrazine), 110303 (aquashade) Case Number 4010 CAS Number 2650-18-2 (erioglaucine); 1934-21-0 (tartrazine) Year first registered 1981 Pesticide Type Aquatic Algaecide/Herbicide Reregistration Eligibility Completed September 23, 2005 Decision (RED) Tolerance Reassessment Since there are no food uses associated with the pesticidal uses of Eligibility Decision aquashade, a TRED was not issued. (TRED) Cumulative group Not applicable. T he Agency has not determined that aquashade shares a common mechanism of toxicity with other chemical substances. 40 CFR Citation An exemption for tolerances for erioglaucine when used as an aquatic plant growth agent, has been has been establis hed under 40 CFR 1 80.1074. A 

### tolerance exemption for tartrazinc has been established, when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest, under 40 CFR 180 .910. A tolerance exemption for tartrazine has been established, when used as an inert in antimicrobial formulations, under 40 CFR 180.940. Dual-use Conventional pesticidal uses only Non-pesticidal uses Food additive (coloring) Pesticide Re -evaluation Christina Motilall, motilall.christina@epa.gov, (703) 603 -0522 Division, Chemical Review Manager Registration Division, Kathryn Montague, Montague.Kathryn@epa .gov, (70 3) 305-1243 Product Manager



### Table 2: Aquashade Use and Usage Information Summary of Use For use in 

### natural and man-made contained lakes and ponds to suppress the rate and extent of underwater growth. Use Sites Aquashade is registered for use in natural and man-made ponds, lakes, fountains, golf courses, and swimming pools with little or no outflow of water. 

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### Formulation Type(s) Aquashade is formulated as a liquid concentrate. Application Method(s) Aquashade is generally applied to water bodies or to ice cover. Technical Registrant(s) BASF Corporation (EPA company number 67064) No. of Registrations There are four FIFRA Section 3

**r~strations** 

### Restricted Use No 

### IV. RE CENT ACTIONS There are no recent registration actions for aquashade. 

### V. SCI ENTIFIC ASSESSMENTS A. Human H ealth Assessm ent The Agency has determined that the human health exposure and toxicological database for aquashade is adequate and no additional data are needed to complete a human health assessment of aquashade. A summary of the human health risk assessment is presented below . For detailed discussions see: Aquas hade Scoping Document and Pr eliminary RiskAssessment for Registration Review, dated July 13,2015, in the public docket (EPA-HQ-OPP-2015-0639) which can be accessed at www.rcgulations.gov. 

### 1. Ris k Conclus io ns Dietary AJSeJSment Since aquashade is applied to contained water bodies, i.e ., those with little or no outflow, and because product labels preclude use in water bodies that serve as a source of drinking water, no drinking water exposure is expected. Although water treated with aquashadc may potentially be used for irrigation of food crops, livestock watering, or used in fish farms and hatcheries, a quantitative dietary assessment was not conducted for several reasons: (1) aquashade is primarily used in ornamental and/or recreational waterbodies and, therefore, very little treated water is expected to be used for agricultural purposes; (2) aquashade is a highly water soluble compound and, as such, not likely to accumulate in livestock, or fish tissues; and, (3) any residues of aquashade that may occur in foods from the use as an aquatic algaecide/herbicide would be negligible compared to residues in food from the use of these dyes as food coloring additives. R esidentialAsswment Aquashade is labeled for consumer use in ponds and lakes and therefore, residential exposure is expected. All residential handler scenarios assessed by EPA resulted in estimated risks that are not of concern, where the target margin of exposure (MOE) for residential scenarios is 

### > 100, and estimated combined MOEs (i.e., for both inhalation and dermal routes of exposure) range from 14,000
- 110,000. Post-application exposures are also anticipated for children and adults who may swim in water bodies that have been treated with aquashade. All residential post-application scenarios assessed also resulted in estimated risks that are not of concern, where combined MOEs ( i.e., for the dermal, ingestion, and inhalation routes of exposure) exceed 9 x lOr' .



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### Aggr egate A.r.r e nment The Agency considers aggregate pesticide exposures and risk from three major sources: food, drinking water and residential exposures. Since the Agency did not estimate dietary (food or drinking water) exposure from aquashade, aggregate risk is equal to only the residential exposures. Estimated risks from all residential exposure scenarios were not of concern and therefore, aggregate risks from aquashade, are also not of concern. 

### OccupationalA.r.r e .r.rment Based on the types of application equipment and techniques that can be used for aquashade, occupational exposure is expected to occur. I\ll occupational scenarios assessed resulted in estimated risks that are not of concern, where the target MOE for occupational scenarios is 

### > 100 and combined MOEs (i.e., for the dermal and inhalation routes of exposure) ranged from 1,500- 46,000 . 

### 2. H um an H ealth Incidents In May 2015, the Agency reviewed its Incident Data System (IDS) and the Centers for Disease Control and Prevention/ National Institute for Occupational Safety and Health (CDC/ IOSI-1 ) databases for the years 2010
-2015 and the Sentinel Event Notification System for Occupational Ri sk-Pesticides (SENSO R) database for the years 1998
-2011 for human health incidents associated with aquashade. Fifty three incidents involving aquashade were reported to IDS, classified as 'minor severity' and no incidents associated with aquashade were reported to SENSOR. Therefore, based upon the lack of severity of events associated with aquashade, the Agency does not have a concern, and at this time further investigation is not warranted. For additional information on human health incidents associated with erioglaucine and / or tartrazine, see the I\gency document, 

### Aqua.rbade, Acid Yell ow 23, andAcid Blue 9, Diammonium Sall: Tie r I (Scoping) Rmew of f--Tttman Inczdent.r, in the public docket (EPI\
-HQ-OPP
-2015
-0639) which can be accessed at www.regulations.goY. 

### 3. Food Toler ances As noted above, aquashade is comprised of erioglaucine and tartrazine . An exemption from tolerances for erioglaucine, when used as an aquatic plant growth agent, has been has been established under 40 CFR 180 . 1074. An exemption for tartrazine when used as an inert ingredient (dye) and when used as an inert in anti-microbial formulations, has been established under 40 CFR 180.910. The exemptions for tartrazine under 40 CFR 180.910 and 40 CFR 180.940, respectively, are not adequate for use of tartrazine as an aquatic plant growth agent, and the Agency proposes to initiate action to exempt tartrazine from tolerances when used as an aquatic plant growth agent.


### B . Ecological Assessm ent The I\gency has determined that the ecological fate and ecotoxicity database for aquashade is adequate and no additional data are needed to complete an ecological fate and risk assessment of aquashade. To conduct its ecological risk assessment, the Agency relied, in part, upon its previous ecological risk assessment, completed in 2005 . The Agency supplemented its ecological risk analysis 

### 7of aquashade with information from the open literature. In addition, as part of its ecological analysis, the Agency has also completed a screening-level endangered and threatened (listed) species assessment for aquashade. A summary of the Agency's preliminary ecological risk assessment is presented below. For detailed discussions see the 

### Problem }"""0rmulatlon and Preliminary fuJk 

### AJJ eJJment for Support 

## of the R egi.rtration Ret;iew forAquatic Dye.r ContainingAtid Blue 9 (PC Code 110301) andAdd Yellow 23 (PC Code 110302), dated August 27, 2015, in the public docket (EPA

-HQ

-OPP-2015

-0639) which can be accessed at www.rcgulations.gov. 

### 1. Risk Conclusions Aquatic Organi.rm.r Based on the use pattern of aquashade, exposure to non-target aquatic animals is expected to be limited to those living in and around the water bodies which are directly treated. Risk quotients (RQs) for aquatic animals (fish and aquatic invertebrates) were estimated and found to b e of no concern, where the target acute RQ is 

### < 0.1, and the target chronic RQ is 

### < 1 and estimated RQs were below 0.01. With respect to non-target aquatic plants, based upon the use pattern for aquashade, i.e., application to water bodies with little or no outflow, the Agency expects little exposure or effect to these organisms. 

### Terre.rtn.al OrganijmJ RQs for terrestrial animals (birds and mammals) were estimated to be below 0 .01 and therefore not of concern. Available ecotoxicity data, mode of action, and unlikely route of exposure suggests that the potential toxicity of aquashade to bees (surrogate for other terrestrial invertebrates) is also low. With respect to terrestrial plants, and again, based upon the use pattern of aquashade, exposure to terrestrial plants is not expected. 

### 2 . 

### E cological Incidents A review of all available incident information associated with either erioglaucine or tartrazine from the following databases was completed in March 2014: EPA's Ecological Incident Information System (EllS); EPA's Aggregate Incident Data System (IDS) database; and the American Bird Conservancy's Avian Monitoring Information System (AIMS). One ecological incident (20 10) was reported in EIIS that involved birds and fish. While the cause of this incident is unknown, the very low toxicity of aquashade to both birds and fish make it very unlikely that aquashade was the cause of the reported incident. This incident is therefore classified as "unlikely" for these two dyes. A single minor incident (2013) was identified in the IDS data base and no incidents involving aquashade were identified in the AIMS database. For additional discussion of the reported ecological incidents, see the 

### Problem Formulation and Pr eliminary fuJ-k /lJJe.r.rment for Support of the R egi.rtration Rezriew for Aquatic Dye.r Containzng/ldd Blue 9 (PC Code 110301) andAdd Ye!!ow 23 (PC Code 110302).



### 8

### C. Endangered Species Assessment Consistent with EP "\ 's responsibility under the Endangered Sp ecies 1 \ct (ES-'\ ), the -'\gency will evaluate risks to federally li sted threatened and endangered 0isted) specie s from registered uses of pe sticides in accordance with the Joint Interim . Approaches developed to implement the recommendations of the r \pril 

### :2013 National 1 \cademy of Sciences (NAS) report, .· 1JJf.IJing Ri.rkJ /o 

### nndrm,gm'a and 'f' hrea/wed Jpm·eJji·om P e.rticideJ . The NAS report 1 outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EP 1 \ and the Setvices must conduct in connection with their obligations under the ES 1 \ and ]<' TJ : R
. \. EP.\ will address concerns specific to aquashade in connection with the development of its final registration review decision for aquashade. In November 

### :2013, EP 1 \, the U.S. fish and Wildlife Service, National Marine l'isheries SetYices (collccti, ·cly, the Services), and the L'.S. Department of . Agriculture released a white paper containing a summary of their joint Interim 1 \pproaches for assessing risks to listed species from pesticides. These l nterim 1 \ pproaches were developed jointly by the Agencies in response to the N 1 \S recommendations, and reflect a common approac h to risk assessment shared by the agencies as a way of addressing scientific differences between the EP1 -\ and the Services. Details of the joint Interim 1 \pproaches are contained in the Ncwember 1, 2013 white paper, 

### Interim .·1pproad h :.1fi;r j \ '

ational- 1 .--<wl fli'Jiicide nndcm,gererl SpecieJ /Jd
.. ·1JJI'JJJl11'/7/J 

### Ba.rerl 017 the IZ et017/IIll'nrla!iom q/the 

### f\..T ationt!l /J.o-ademy

**rifS~7·ena•.r.** 

### '1 ptil 2013 

### Report. 2 Ci,·en that the . Agencies are continuing to de, ·elop and work toward implementation of the Interim .\pproaches to assess the potential risks of pesticides to listeJ species and their Jesignated critical habitat, the ecological risk assessment supporting this Proposed Interim Registration Review Decision for ac1uashade is screening-level and docs not contain a complete ES.1 \ analrsis, including effects determinations for specific listed species or designated critical habitat. While the agencies continue to develop a common method for ESr\ analysis, the preliminary risk assessment for the registration review of aqua shade describes the le\' el of 

### ES 1 \ analysis completed for this particular registration rc, ·iew 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

**han ~**  

### been 

### fully '\'ettcd. Once the agencies have 

### fully developed and implemented the scientific methods necessary to complete risk assessments for listed species anJ their de signated critical habitats, these methods will be applied to subsec1ucnt analyses of aquashadc as part of completing this registration review.


### D. Endocrine Disruptor Screening Program As required by FIFR!\ and FFDCt\, E PA reviews numerous studies to assess potential adverse o utc omes from exposure to chemicals. Collectivel y, these studies include acute, subchronic and chronic to xicity, including assessments of carcinogenicity, neurotoxicity, dev elopmental, reproductive, and general or sys temic to xicity . These studies include endpoints which may be susceptible to en docrine influence, including e ffects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, f ertility, pregnancy rates, reproductive loss, and sex ratios

1 http ://www.nap.edu/catalog.php?record

_ id = 18344 2 http ://www.epa.gov/espp/20 13/nas .html 

### 9in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxo nomic groups. As part of its most recent registration decision for aquashade, EPA reviewed these data and determined that a qualitative toxicity assessment is appropriate for aquashade. However, as required by FFDCA section 408(p), aquashade is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). EPA has developed the EDSP to detennine whether certain substances ( including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced b y 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 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 section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 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 . A second list of chemicals identified for EDSP screening was published on June 14, 2013 1 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. 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 our website. 4 In this proposed interim, EPA is making no human health or environmental safety findings associated with the EDSP screening of aquashade. Before completing this registration review, the Agency will make an EDSP FFDCA section 408(p) determination. 

### VI. PROPOSED INTERIM REGISTRATION REVIEW DECISION The Agency has completed a combined scoping and preliminary human health risk assessment for aquashade, as well as a combined problem formulation and preliminary ecological risk assessment for aquashade. The Agency has determined that no data (ecological fate, human exposure, ecotoxicity, or human health hazard) are needed for aquashade . Based upon a qualitative dietary (food and water), and a quantitative residential and occupational assessment, the Agency has determined that there are no human health risks of concern from the current registered uses of aquashade. Similarly, based upon both a quantitative and qualitative analysis, no ecological risks of concern are expected, outside of target aquatic plants ( i.e. algae and submerged macrophytes ), from the current registered uses of aquashade.
3 See http ://www.regulations.gov/# !documentDetaii;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of chemicals. 4 http ://www.epa.gov/endo/ 

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### PropoJed Interim R egiJtration Ret;iew Ded.rion In accordance with 40 CFR Sections 155.50, 155.53, 155.56, and 155 .58, the Agency is issuing this combined work plan, preliminary risk assessment and proposed interim registration review decision for aquashade. Except for the EDSP and ESA components of the aquashade registration review case, the Agency has made the following proposed interin1 decision: (1) no additional data, including pollinator data, are required at this time; (2) no changes to the affected aquashade registrations or their labeling are needed at this time; and (3) as part of the registration review for aquashade, the Agency proposes to exempt tartrazine from tolerances when used as an aquatic plant growth agent. In this proposed interim registration review decision, EPA is making no human health or environmental safety findings associated with the EDSP screening of aquashade, nor is it making a complete endangered species finding. The Agency's final registration review decision for aquashade will be issued once an ESA Section 7 consultation with the Services has taken place, and an EDSP FFDCA section 408(p) determination has been made. 

### VII. NEXT STEPS AND TIMELINE A Federal Register Notice will announce the availability of this combined work plan, preliminary risk assessment, and proposed interim registration review decision for aquashade and allow a 60-day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its proposed decision, EPA may issue an Interim Registration Review Decision for Aquashade (case 4010).



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