Docket Number EPA-HQ-OPP-2015-0639 

www.regulations.gov 

Aquas hade 

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 AUTHORITY ... ....... .......................... .. .... . 4 

III. AQUASHADE CHEMICAL FACTS ................ .............................. ................. 5 

IV. RECENT ACTIONS .............................................................. ... .... ...... ....... 6 

V. SCIENTIFIC ASSESSMENTS .... ............. ... .............................................. .. .. 6 

A. Human Health Assessment .................................. ................. .. ............................................................... 6 

1. Risk Conclusions ........................................................... .. ............................................................. 6 

2. Human Health Incidents ...... .. ..................................................................................................... 7 

3. Food Tolerances ........................................................................................................................... 7 

B. Ecological Assessment ............... .. ............. .. ............................................................................................ 7 

1. Risk Conclusions .......................... ................................................................................................ 8 

2. Ecological Incidents ............................ .. ......................................................... ....... ....................... 8 

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

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

VI. PROPOSED INTRERIM REGISTRATION REVIEW 

DECISION ....... .............. ...................... .. ................. .. ............................ 10 

VII. NEXT STEPS AND TIMELINE ........................................... ......... .. . .. .... .. ... 11 

2 
References: 

This document summarizes the Environmental Protection Agency's current position based on the 

following documents: 

1. Problem Formulation and Preliminary Risk Amssment for Support qfthe Registration Ret.Jiew for Aquatic 

Dyes ContainingAa:d Blue 9 (PC Code 110301) and Acid Yellow 23 (PC Code 110302). Nicholas 

Mastrota and James K. Wolf. August 27,2015. 

2. ./lquasbade S coping Document and Preliminary Risk AJJessment for Regzstration Review. Uma Habiba, 

Ronnie Bever, and Katelynn King. July 13, 2015. 

3. AquaJhade, Acid Yellow 23, and Acid Blue 9, Diammoni11m Salt: Tier I (Scoping) Ret;iew if Human 

Incidents. Elizabeth Evans and Shanna Recore. May 6, 2015. 

4. AquaJhade (110301 - 110302) Label Use Report Package in Support if Registration Retiew. La Verne 

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. 

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L INTRODUCTION 

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 completing 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 nonpesticidal 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 begins 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. The 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 established under 40 

CFR 180.1074. 

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, (703) 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. 

5 
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. RECENT ACTIONS 

There are no recent registration actions for aquashade. 

V. SCIENTIFIC ASSESSMENTS 

A. Human H ealth Assessment 

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 S coping Document and Preliminary Risk Assessment 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. Risk Conclusions 

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 water bodies 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. 

Residential Asswment 

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'. 

6 
Aggregate A.r.renment 

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. 

Occupational A.r.re.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 uman Health 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 

Risk-Pesticides (SENSOR) 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 

Y ellow 23, and Acid Blue 9, Diammonium S all: Tier I (Scoping) Rmew of f--Tttman I nczdent.r, in the public 

docket (EP I\ -HQ-OPP-2015-0639) which can be accessed at www.regulations.goY. 

3. Food Tolerances 

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 180.107 4. 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 Assessment 

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 

7 
of 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 AJJeJJment 

for Support of the Regi.rtration Ret;iew for Aquatic Dye.r ContainingAtid Blue 9 (PC Code 110301) and Add 

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 be 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. Ecological 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 (2010) 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 Preliminary fuJ-k /lJJe.r.rment for Support of the Regi.rtration Rezriew 

for Aquatic Dye.r Containzng/ldd Blue 9 (PC Code 110301) and Add Ye!!ow 23 (PC Code 110302). 

8 
C. Endangered Species Assessment 

Consistent with EP"\ 's responsibility under the Endangered Species 1\ct (ES-'\), the -'\gency 

will evaluate risks to federally listed threatened and endangered 0isted) species from registered uses 

of pesticides 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 Pe.rticideJ. The NAS report 1 outlines recommendations on 

specific scientific and technical issues related to the development of pesticide risk assessments that 

EP1\ and the Setvices must conduct in connection with their obligations under the ES1\ 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, EP1\, 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 

N1\S recommendations, and reflect a common approach to risk assessment shared by the agencies 

as a way of addressing scientific differences between the EP 1-\ and the Services. Details of the joint 

Interim 1\pproaches are contained in the Ncwember 1, 2013 white paper, Interim .·1pproadh:.1fi;r 

j\ 'ational-1.--<wl fli'Jiicide nndcm,gererl SpecieJ /Jd .. ·1JJI'JJJl11'/7/J Ba.rerl 017 the IZet017/IIll'nrla!iom q/the f\..Tationt!l 

/J.o-ademy rifS~7·ena•.r. '1ptil 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 ES1\ 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 designated 

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 outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic 

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 

1 http://www.nap.edu/catalog.php?record _ id= 18344 2 http://www.epa.gov/espp/20 13/nas.html 

9 
in offspring. For ecological hazard assessments, 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 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 

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 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, 20131 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/ 

10 
PropoJed Interim RegiJtration 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). 

11