UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D.C. 20460
OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### MEMORANDUM Date: May 6, 2015 SUBJECT: Aquashade, Acid Yellow 23, and Acid Blue 9, Diammonium Salt: Tier I (Scoping) Review ofHuman Incidents
PC Code: II 030I, I I0302, I I0303 Decision No.: 500211 Petition No.: NA DP Barcode: 0427136 Registration No.: NA Regulatory Action: NA Case No.: NA Risk Assessment Type: NA TXRNo.: NA MRID No.: NA CAS No.: 2650-18-2, 1934-21-0, 92170-50-8 40CFR: NA


### FROM:

THROUGH:

TO: Sharma Recore, Industrial Hygienist Toxicology and Epidemiology Branch Health Effect Division (7509P) and Elizabeth Evans, Environmental Protection Specialist Toxicology and Epidemiology Branch Health Effects Division (7509P) 

# t) .· David Miller, Acting Branch Chief !/ 

# J 

# ;#!Itt Toxicology and Epidemiology Bra c 

### Health Effects Division (7509P) Uma Habiba, Risk Assessor Risk Assessment Branch VII Health Effects Division (7509P) and Carissa Cyran, Chemical Review Manager Risk Management & 

### Implementation Branch 1 Pesticide Re-evaluation Division (7508P) Summary and Conclusions Ver.Apr. 08



### Based on the low severity ofincidents involving aquashade (pc code 11 0303) , acid yellow 23 (pc code 11 0302) , and acid blue 9, diammonium salt (pc code 110301) reported to IDS and the fact that no incidents involving aquashade, acid yellow 23, and acid blue 9, diammonium salt were reported to SENSOR-Pesticides, there does not appear to be a concern at this time that would Page 1 of4warrant further investigation

. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be included in the risk assessment. Detailed Review I. ACTION REQUESTED This review is intended to fulfill our requirement to docket summaries ofincident data that were reported to the Agency, as well as to ensure human incident data and the Agricultural Health Study (AHS) are part ofthe problem formulation phase ofregistration review. Reports of adverse health effects allegedly due to a specific pesticide exposure (i.e. , an "incident") are largely self-reported and therefore, generally speaking, neither exposure to a pesticide or reported symptom (or the connection between the two) is validated or otherwise confirmed. Typically, causation cannot be determined based on incident data. However, incident information can be an important source offeedback to the Agency: incidents of severe outcome, or a suggested pattern or trend among less severe incidents, can signal the Agency to further investigate a particular chemical or product. Observational epidemiology studies relate the risk ofdisease, 

### e.g. , cancer, and exposure to an agent such as a pesticide product in the general population or specific sub-groups like pesticide applicators

. II. BACKGROUND The dyes erioglaucine (Acid Blue 9 or FD&C Blue No. 1) and tartrazine (Acid Yellow 23 or FD&C Yellow No. 5), when combined, act as an aquatic algaecide/herbicide

. This aquatic herbicide is commonly referred to by the trade name Aquashade

. The mixture oferioglaucine and tartrazine control the wavelength range ofthe sunlight spectrum required for photosynthesis, thereby inhibiting growth offilamentous algae and submerged aquatic vegetation. It can be used in natural or manmade ponds, lakes, fountains , fish farms , and fish hatcheries, and may be applied by both professional applicators and homeowners

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For this evaluation, both the OPP Incident Data System (IDS) and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for Occupational Risk-Pesticides (SENSOR) databases were consulted for pesticide incident data on the active ingredients aquashade, acid yellow 23 , and acid blue 9, diammonium salt (pc codes: 110301 , 110302, and 110303). The purpose ofthe database search is to identify potential patterns in the frequency and severity ofthe health effects attributed to aquashade exposure. Aquashade is not included in the AHS, and therefore this study does not provide information for this report. III. RESULTS/DISCUSSION

a. IDS (Incident Data System)

1 Reregistration Eligibility Decision For Erioglaucine and Tartrazine (Aquashade *) http://www.epa.gov/pesticides/reregistration/REDs/aquashade

_red

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### OPP's IDS includes reports ofalleged human health incidents from various sources, including mandatory Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Section 6(a)(2) reports from registrants, other federal and state health and environmental agencies, and individual consumers. Since 1992, OPP has compiled these reports in IDS. IDS contains reports from across the U.S. and most incidents have all relevant product information recorded. Reports submitted to the IDS represent anecdotal reports or allegations only, unless otherwise stated in the report. IDS records incidents in one oftwo modules: Main IDS and Aggregate IDS:

o Main IDS contains incidents resulting in higher severity outcomes and provides more detail with regard to case specifics. This system stores incident data for death, major and moderate incidents, and it includes information about the location, date and nature ofthe incident. Main IDS incidents involving only one active ingredient (as opposed to pesticide products with multiple active ingredients) are considered to provide more certain information about the potential effects ofexposure from the pesticide.

o 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 what are aggregate summaries. For the Main IDS, from January 1, 2010 to February 12, 2015, there were 0 incidents reported involving aquashade or acid blue 9, diammonium salt in the database. There were 4 incidents reported involving yellow acid 23. These incidents involved the product Lysol All Purpose Cleaner (Reg No. 777-89) and not aquashade2

. 

### The symptoms reported were dermal, respiratory and ocular. These incidents were classified as moderate severity. In Aggregate IDS, from January 1, 2010 to February 12,2015 , there were 53 incidents reported involving aquashade. These incidents were classified as minor severity

. There were 156 incidents involving acid yellow 23. These incidents all involved Lemon Breeze Scent Lysol Brand Disinfectant All Purpose Cleaner (Reg No. 777-89). These incidents were classified as minor severity. There were no incidents reported involving acid blue 9, diammonium salt. b. SENSOR-Pesticides The SENSOR-Pesticides database covers 12 states from 1998-2011 , although reporting varies from state to state. Cases ofpesticide-related illnesses are ascertained from a variety of sources, including: reports from local Poison Control Centers, state Department ofLabor workers' compensation claims when reported by physicians, reports from State Departments of Agriculture, and physician reports to state Departments ofHealth. Although both occupational and non-occupational incidents are included in the database, SENSOR-Pesticides focuses on occupational pesticide incidents, and is ofparticular value in providing that information. The state coordinator at each ofthe 12 respective state Departments ofHealth conducts case follow2 When Acid Blue 9 and Acid Yellow 23 are combined they act as an aquatic algaecide/herbicide. This aquatic herbicide is commonly referred to by the trade name Aquashade. These dyes are also present in other pesticide products which were included in this analysis. 

### Page 3 of4up activities such as obtaining medical records to verify symptoms and severity. Using standardized protocol and case definitions derived from poison center reporting, the state SENSOR-Pesticide coordinator enters the incident information into the state-based system which is sent to NIOSH annually to be aggregated. A review ofSENSOR-Pesticides 1998-2011 identifies no cases involving aquashade.

c. Agricultural Health Study (AHS) The AHS is a high quality, prospective epidemiology study evaluating the link between pesticide use and various health outcomes including cancer. The AHS includes private and commercial pesticide applicators and their spouses. Ifthere are AHS findings relevant to a particular pesticide going through registration review, the Agency will ensure they are considered in the problem formulation/scoping phase ofthe process and, ifappropriate, fully reviewed in the risk assessment phase ofthe process. The AHS includes information on use of 80 different pesticide active ingredients commonly used in agriculture. Aquashade is not included in the AHS , and therefore this study does not provide information for this report. IV. CONCLUSION Based on the low severity ofincidents involving aquashade (pc code 110303), acid yellow 23 (pc code 110302), and acid blue 9, diammonium salt (pc code 110301) reported to IDS and the fact that no incidents involving aquashade, acid yellow 23, or acid blue 9, diammonium salt were reported to SENSOR-Pesticides, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor the incident information and ifa concern is triggered, additional analysis will be included in the risk assessment.

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