### Docket Number EPA-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
............................ ............................. ................. ... ..... I0 VIII. References
.................................................................... .... ... ...... ... ............. ............ ......... II

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### 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 ofexisting 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 ofaction 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 ofaquashade 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 ofaquashade:

3• September 15,2015

- Issuance ofAquashade Combined Work Plan, Preliminar y Risk Assessment, andProposed 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 Aquashade 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 ofaction 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 ofUse Registered for use in natural or manmade contained lakes and ponds to suppress the rate and extent ofunderwater plant growth. Use Sites Aquashade is registered for use in natural or man-made ponds , lakes, fountains, golfcourses , and swimming pools with little or no outflow ofwater. 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. ofRegistrations 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 ofthe 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 ofconcern. 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 ofdrinking water, no drinking water exposure is expected. Further, while water bodies treated with aquashade may potentially be used for irrigation offood 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 ofaquashade 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 ofconcern, where the target margin ofexposure (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 ofapplication 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 ofconcern, where the target MOE for occupational
5scenarios is >I00 and combined MOEs (i.e. , for both dermal and inhalation routes ofexposure) 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 ofconcern and therefore, aggregate risks from aquashade are also not ofconcern. 2. Food Tolerance As noted above, aquashade is comprised oferioglaucine 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 1998-20I1 for human health incidents associated with aquashade. IDS records incidents in one oftwo 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 ofevents 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 ofHuman 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 ofconcern. For detailed discussions see the
6Problem Formulation and Preliminary Risk Assessment for Support ofthe 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 ofaquashade, 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 ofconcern, 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 ofconcern. The available ecotoxicity data, mode ofaction, and unlikely route ofexposure suggest that the potential risk ofaquashade to bees (surrogate for other terrestrial invertebrates) is also low. With respect to non-target terrestrial plants, based upon the use pattern ofaquashade, exposure to terrestrial plants is not expected. 

### Pollinators EPA has begun to require pollinator studies as a result ofthe 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 ofall 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 ofaquashade to both birds and fish makes it very unlikely that aquashade was the cause ofthe 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
7additional discussion ofthe reported ecological incidents, see the Problem Formulation and Preliminary Risk Assessment for Support ofthe 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 oftheirjoint Interim Approaches for assessing risks to endangered and threatened (listed) species from pesticides. The Interim Approaches were developedjointly 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 ofaddressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development ofpesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA
. Thejoint Interim Approaches were released prior to a stakeholder workshop held on November 15 , 2013
. In addition, the EPA presented thejoint 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 ofa phased, iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development ofupcoming registration review decisions. However, no comments were received for aquashade. The details ofthe joint Interim Approaches are contained in the white paper Interim Approaches for National-Level Pesticide Endangered Species Act (ESA) Assessments Based on the Recommendations ofthe National Academy of Sciences April2013 Report, dated November 1, 2013. Given that the agencies are continuing to develop and work toward implementation ofthe Interim Approaches to assess the potential risks ofpesticides 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 ofnon-target wildlife and plants, that listed species and designated critical habitats may be present in the vicinity ofthe application ofaquashade. 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 ofcompleting 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
. 8section 408(p), aquashade is subject to the endocrine screening part ofthe 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 ofa battery of 11 screening assays to identify the potential ofa 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 ofthe EDSP where EPA will determine which, ifany, ofthe 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 ofthese lists should be construed as a list ofknown or likely endocrine disruptors. Aquatic dyes containing acid blue 9 and acid yellow 23 were not included in the first or second group ofchemicals issued an order to conduct Tier 1 EDSP testing. For further information on the status ofthe EDSP, the policies and procedures, the lists ofchemicals, 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 ofproducts 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 ofthe 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·. PA-l!Q:QJ>Pl2QQ.2-04] 7-0Q7::!- for the final second list of chemicals.
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### 9data, 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 ofaquashade, 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
.

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### VIII. References This document summarizes the Environmental Protection Agency's current position based on the following documents:



### 1. Aquashade Combined Work Plan, Preliminary RiskAssessment, andProposed Interim Registration Review Decision. September 15, 2015. 2. 

### Problem Formulation andPreliminary RiskAssessment for Support of the Registration Review for Aquatic Dyes ContainingAcidBlue 9 (PC Code 110301) andAcid Yellow 23 (PC Code 110302). Nicholas Mastrota and James K. Wolf. August 27,2015. 3. 

### Aquas hade Scoping Document and Preliminary RiskAssessment for Registration Review. Uma Habiba, Ronnie Bever, and Katelynn King. July 13,2015. 4. 

### Aquashade, Acid Yellow 23, andAcidBlue 9 , Diammonium Salt: Tier I (Scoping) Review ofHuman Incidents. Elizabeth Evans and Shanna Recore. May 6, 2015. 5. 

### Aquashade (II0301

- II0302) 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
.

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