Docket Number EP A-HQ-OPP-20 15-0639 

www.regulations.gov 

Aquashade 

Interim Registration Review Decision 

Case Number 4010 

March 2016 

/' Approved by: 1 <::: ______ _, 

Yu-Ti~ Guilaran 

Director 

Pesticide Re-evaluation Division 

Date: 3(iv; r~ ------------------------
Contents 

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

II. Use and Usage ................................. .................... .. ................................... ..................... .......... 4 

III. Scientific Assessments ......................................................................................................... 5 

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

I. Human Health Risk Summary ............................................................................................ 5 

Dietary Exposure Assessment ................................................................................................. 5 

Residential Exposure Assessment ........................................................................................... 5 

Occupational Exposure Assessment ....................................................................................... 5 

Aggregate Exposure Assessment ............................................................................................. 6 

2. Food Tolerance ................................................................................................................... 6 

3. Human Incidents ................................................................................................................. 6 

B. Ecological Environmental Assessment ............................... .............. ............................... ..... 6 

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

Aquatic Organisms .................................................................................................................. 7 

Terrestrial Organisms ............................................................................................................. 7 

2. Ecological Incidents ................................... .. ............ ............................. .................... ........ .. 7 

IV. Endangered Species Assessment ..................... ..................................... ............................... 7 

V. Endocrine Disruptor Screening Program ................................................................................ 8 

VI. Interim Registration Review Decision ...................... ....................................... ............ ........ 9 

VII. Next Steps and Timeline ......................................................... ................................ ........... 10 

I. Interim Registration Review Decision ............................................................................... 10 

2. Final Registration Review Decision ......................................................... ................. ... ..... I 0 

VIII. References .................................................................................... .................................. II 

2 
I. Introduction 

This document is the Environmental Protection Agency's (EPA or the Agency) Interim 

Registration Review Decision for aquashade (case 4010, PC code 11 0303) and is being issued 

pursuant to 40 CFR sections 155.56 and 155.58. 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: 1) 

require new risk mitigation measures; 2) impose interim risk mitigation measures; 3) identify 

data or information required to complete the review; and 4) include schedules for submitting the 

required data, conducting the new risk assessment and completing the registration review. For 

further information on aquashade, additional documents can be found in EPA's public docket 

(EPA-HQ-OPP-2015-0639) at http://www.regulations.gov. 

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

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

generally must be registered by the EPA based on scientific data showing that they will not cause 

unreasonable risks to human health or to the environment when used as directed on product 

labeling. 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. The registration review program is 

intended to make sure that, as the ability to assess and reduce risk evolves and as policies and 

practices change, all registered pesticides continue to meet the statutory standard of no 

unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically re-evaluates 

pesticides to make sure that as these changes occur, products in the marketplace can continue to 

be used safely. Information on this program is provided as 

W\\w.epa.gov/oppsrrd ]/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 plant control agent. 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 first pesticide products containing aquashade were registered in the United 

States in 1981 , and a Reregistration El'igibility 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) accessible at www.regulations.gov. 

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

aquashade (case 401 0) in September 2015 with the initial docket opening for this case. All 

relevant documents with regards to the registration review of aquashade can be found in the 

public docket at: EPA-HQ-OPP-2015-0639, accessible at ww\\.regulations.gov. The following 

highlights significant events that have occurred during the registration review of aquashade: 

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• September 15,2015 - Issuance of Aquashade Combined Work Plan, Preliminary Risk 

Assessment, and Proposed Interim Registration Review Decision for a 60-day public 

comment period. 

o The Combined Work Plan noted that no additional data were anticipated to be 

needed for the aquashade registration review because sufficient information was 

available to conduct preliminary risk assessments to support a registration review 

decision. 

o No comments were submitted to the Agency during the 60-day public comment 

period for the Aquashade Combined Work Plan, Preliminary Risk Assessment, 

and Proposed Interim Registration Review Decision. 

• March 2015 -The Agency is now publishing the Aquas hade Interim Registration Review 

Decision on www.regulations.gov under docket number EPA-HQ-OPP-20 15-0639. 

II. Use and Usage 

Aquashade is reported to be widely used by consumers as an aquatic plant control agent. 

Its mode of action is through the absorption of specific wavelengths of light to reduce 

photosynthesis. Aquashade is intended to be used in natural and man-made contained lakes, 

ponds, swimming pools with little to no outflow. 

Aquashade Use and Usaee Information 

Summary of Use Registered for use in natural or manmade contained lakes and 

ponds to suppress the rate and extent of underwater plant growth. 

Use Sites Aquashade is registered for use in natural or man-made ponds, 

lakes, fountains, golf courses, and swimming pools with little or 

no outflow of water. 

Formulation Type(s) Formulations include liquid concentration. 

Application Method(s) Aquashade is generally applied to water bodies or to ice cover. 

Technical Registrant(s) Aquashade (33068); BASF Corporation (67064) 

No. of Registrations Four- FIFRA Section 3 registrations 

Restricted Use No 

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III. Scientific Assessments 

A. Human Health Assessment 

The Agency has determined that the human health exposure and toxicological database 

for aquashade is adequate and no additional data were required to complete a human health 

assessment. A summary of the human health risk assessment is presented below. Overall, the 

Agency concluded dietary (food or drinking water) exposure from aquashade was neglible and 

therefore did not assess it. In addition, estimated risks from all residential and occupational 

exposure scenarios were not of concern. For detailed discussions see: Aquashade Scoping 

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.regulation.gov. 

1. Human Health Risk Summary 

Dietary Exposure Assessment 

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. Further, while water bodies treated with aquashade 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 in fish tissues; and 

(3) any residues of aquashade that may occur in foods from the use as an aquatic plant control 

agent would be negligible compared to residues in food from the use ofthese dyes as food 

coloring additives. 

Residential Exposure Assessment 

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 106

. 

Occupational Exposure Assessment 

Based on the types of application equipment and techniques that can be used for 

aquashade, occupational exposure is expected to occur. All occupational scenarios assessed 

resulted in estimated risks that are not of concern, where the target MOE for occupational 

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scenarios is > I 00 and combined MOEs (i.e., for both dermal and inhalation routes of exposure) 

ranged from I ,500 - 46,000. 

Aggregate Exposure Assessment 

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. 

2. Food Tolerance 

As noted above, aquashade is comprised of erioglaucine and tartrazine. An exemption 

from tolerances for erioglaucine, when used as an aquatic plant control agent, has been 

established under 40 CFR 180.I 074. The Agency will initiate action, under 40 CFR 180 Subpart 

D, to exempt tartrazine from tolerances when used as an aquatic plant control agent. 

3. Human Incidents 

In May 20 I5, the Agency reviewed its Incident Data System (IDS) and the Centers for 

Disease Control and Prevention/National Institute for Occupational Safety and Health 

(CDC/NIOSH) databases for the years 2010-2015, and the Sentinel Event Notification System 

for Occupational Risk-Pesticides (SENSOR) database for the years 1998-20 I1 for human health 

incidents associated with aquashade. IDS records incidents in one of two modules: main IDS and 

aggregate IDS. Aggregate IDS contains incidents resulting in less severe human incidents 

(minor, unknown, or no effects outcomes). These are reported by registrants only as counts in 

aggregate summaries. Fifty three incidents involving aquashade were reported to IDS, classified 

as 'minor severity', and no incidents were reported to SE SOR. 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 Agency document, Aquashade, Acid 

Yellow 23, and Acid Blue 9, Diammonium Salt: Tier I (Scoping) Review of Human Incidents, in 

the public docket (EPA-HQ-OPP-20I5-0639) which can be accessed at www.regulations.gov. 

B. Ecological Environmental Assessment 

The Agency has determined that the ecological fate and ecotoxicity database for 

aquashade is adequate, and no additional data were required to complete an ecological risk 

assessment for aquashade. To conduct its ecological risk assessment, the Agency relied, in part, 

upon its previous ecological risk assessment, completed in 2005 for the RED. The Agency 

supplemented its ecological risk analysis of aquashade with information from the open literature. 

In addition, as part of its ecological analysis, the Agency also completed a screening-level 

endangered and threatened (listed) species assessment for aquashade. Based on the current use 

pattern and target pest (i.e., certain aquatic plants), exposure to honey bees is not expected. 

Therefore, no additional data are being requested at this time. Overall, the Agency concluded 

effects to aquatic and terrestrial organisms are not of concern. For detailed discussions see the 

6 
Problem Formulation and Preliminary Risk Assessment for Support of the Registration Review 

for Aquatic Dyes Containing Acid Blue 9 (PC Code 110301) and Acid Yellow 23 (PC Code 

110302), dated August 27,2015, in the public docket (EPA-HQ-OPP-2015 -0639) which can be 

accessed at http://www.regulations.gov 

1. Risk Conclusions 

Aquatic Organisms 

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 non-target aquatic animals (fish and aquatic invertebrates) were estimated 

and found to be not of concern, where the target acute RQ is <0.1 , and the target chronic RQ is 

<1 and estimated RQs were <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. 

Terrestrial Organisms 

RQs for non-target terrestrial animals (birds and mammals) were estimated to be below 

0.01, and therefore not of concern. The available ecotoxicity data, mode of action, and unlikely 

route of exposure suggest that the potential risk of aquashade to bees (surrogate for other 

terrestrial invertebrates) is also low. With respect to non-target terrestrial plants, based upon the 

use pattern of aquashade, exposure to terrestrial plants is not expected. 

Pollinators 

EPA has begun to require pollinator studies as a result of the June 2014 Guidance for 

Assessing Pesticide Risk to Bees. However, EPA is not requiring pollinator data at this time for 

aquashade, since the use pattern for aquashade does not allow for a complete exposure pathway 

to pollinators. While some aquatic plants may be exposed to aquashade, the available toxicity 

data do not suggest a potential pathway for toxicity to bees. The Agency has determined that 

based on this use pattern, no pollinator data are required. 

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 (20 1 0) was reported in EllS that involved birds and fish. While the cause of 

this incident is unknown, the very low toxicity of aquashade to both birds and fish makes 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 database, and no incidents involving aquashade were identified in the AIMS database. For 

7 
additional discussion of the reported ecological incidents, see the Problem Formulation and 

Preliminary Risk Assessment for Support of the Registration Review for Aquatic Dyes 

Containing Acid Blue 9 (PC Code 110301) and Acid Yellow 23 (PC Code 110302). 

IV. Endangered Species Assessment 

In November 2013, the EPA, along with the Services and the USDA, released a summary 

of their joint Interim Approaches for assessing risks to endangered and threatened (listed) species 

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

the National Academy of Sciences' (NAS) recommendations and reflect a common approach to 

risk assessment shared by the agencies as a way of addressing scientific differences between the 

EPA and the Services. The NAS report outlines recommendations on specific scientific and 

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

Services must conduct in connection with their obligations under the ESA and FIFRA. 

The joint Interim Approaches were released prior to a stakeholder workshop held on 

November 15, 2013 . In addition, the EPA presented the joint Interim Approaches at the 

December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues 

Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder 

workshops - in April and October 2014, and in April 2015 - allowing additional opportunities for 

stakeholders to comment on the Interim Approaches. Additional workshops are planned to 

enhance stakeholder involvement. As part of a phased, iterative process for developing the 

Interim Approaches, the agencies will also consider public comments on the Interim Approaches 

in connection with the development of upcoming registration review decisions. However, no 

comments were received for aquashade. The details of the joint Interim Approaches are 

contained in the white paper Interim Approaches for National-Level Pesticide Endangered 

Species Act (ESA) Assessments Based on the Recommendations of the National Academy of 

Sciences April2013 Report, dated November 1, 2013. 

Given that the agencies are continuing to develop and work toward implementation of the 

Interim Approaches to assess the potential risks of pesticides to listed species and their 

designated critical habitat, the ecological risk assessment supporting this Interim Decision for 

aquashade does not contain a complete ESA analysis that includes effects determinations for 

specific listed species or designated critical habitat. Although EPA has not yet completed effects 

determinations for specific species or habitats, for this interim decision, EPA's evaluation 

assumed, for all taxa of non-target wildlife and plants, that listed species and designated critical 

habitats may be present in the vicinity of the application of aquashade. This assessment allows 

EPA to focus its future evaluations on the types of species where the potential for effects exists 

once the scientific methods being developed by the agencies have been fully vetted. When the 

Agencies have fully developed and implemented the scientific methodology for evaluating risks 

for listed species and their designated critical habitats, these methods will be applied to 

subsequent analyses for aquashade as part of completing the final registration review decision. 

V. Endocrine Disruptor Screening Program 

As required by FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA 

reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. 

8 
section 408(p ), aquashade is subject to the endocrine screening part of the Endocrine Disrupter 

Screening Program (EDSP). 

EPA has developed the EDSP to determine 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 

1) 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. Aquatic dyes containing 

acid blue 9 and acid yellow 23 were not included in the first or second group of chemicals issued 

an order to conduct Tier 1 EDSP testing. 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.

2 

In this interim decision, 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. Interim Registration Review Decision 

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

Interim Registration Review Decision. Based upon quantitative and qualitative analysis for 

human health and wildlife, the Agency has concluded that the use of products containing 

aquashade will not result in unreasonable adverse human health or ecological effects. The 

Agency's analysis also constitutes a screening-level endangered species analysis for aquashade. 

No additional data are being requested at this time. 

Therefore, except for the EDSP and ESA components of the aquashade registration 

review case, the Agency has made the following interim registration review decision: (1) no 

changes to the affected aquashade registrations or their labeling are required; (2) no additional 

1 See h.!JP.'- ''"" .rc_g!llat.ion~._g.Qv 11 1 document Dctl!_ilJ) l·. P A-l!Q:QJ>Pl2QQ.2-04]7-0Q7::!- for the final second list of 

chemicals. 

2 httj). '' W\\ .CJ2_a._gov end(!_ 

9 
data, including data on pollinators, are required; and, (3) the Agency will initiate action, under 40 

CFR 180 Subpart D, to exempt from a tolerance the use oftartrazine as an aquatic plant control 

agent. 

In this 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 

1. Interim Registration Review Decision 

Based upon the Agency's conclusions for aquashade under registration review, no 

actions, other than the Agency to initiate a tolerance exemption action, are required at this time 

for this interim registration review decision. 

2. Final Registration Review Decision 

A final decision on the aquashade registration review case will occur after an EDSP 

FFDCA section 408(p) determination has been made and after ESA Section 7 consultation with 

the Services has taken place. 

10 
VIII. References 

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

following documents: 

1. Aquashade Combined Work Plan, Preliminary Risk Assessment, and Proposed Interim 

Registration Review Decision. September 15, 2015. 

2. Problem Formulation and Preliminary Risk Assessment for Support of the Registration 

Review for Aquatic Dyes Containing Acid Blue 9 (PC Code 110301) and Acid Yellow 23 

(PC Code 110302). Nicholas Mastrota and James K. Wolf. August 27,2015. 

3. Aquas hade Scoping Document and Preliminary Risk Assessment for Registration Review. 

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

4. Aquashade, Acid Yellow 23, and Acid Blue 9, Diammonium Salt: Tier I (Scoping) Review 

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

5. Aquashade (II 0301 - II 0302) Label Use Report Package in Support of Registration 

Review. La Verne Dobbins. November 6, 2014. 

These and other supporting documents for the aquashade registration review case may be found 

in the docket EPA-HQ-OPP-2015-0639 at http://www.regulations.gov. 

11