**[UNITED STATES ENVIRONMENTAL PROTECTION
AGENCY]{.mark}**![](media/image2.png){width="0.9965277777777778in"
height="0.8097222222222222in"}

[WASHINGTON, D.C. 20460]{.mark}

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[]{.mark}

[OFFICE OF]{.mark}

[PREVENTION, PESTICIDES]{.mark}

[AND TOXIC SUBSTANCES]{.mark}

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[]{.mark}

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[]{.mark}

[Date: 09/27/2005]{.mark}

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[]{.mark}

**[[MEMORANDUM]{.underline}]{.mark}**

[]{.mark}

[]{.mark}

[SUBJECT: Aquashade: Revised HED Chapter of the Reregistration
Eligibility Decision Document (RED). PC Code: 110301, DP Barcode:
321912]{.mark}

[]{.mark}

[Regulatory Action: *Phase 1 Reregistration Action*]{.mark}

[]{.mark}

[FROM: Wade Britton, MPH, Industrial Hygienist and Risk Assessor]{.mark}

[Reregistration Branch 3]{.mark}

[Health Effects Division (7509C)]{.mark}

[]{.mark}

[AND]{.mark}

[]{.mark}

> [Kim Morgan, PhD, Toxicologist]{.mark}
>
> [Reregistration Branch 3]{.mark}

[Health Effects Division (7509C)]{.mark}

[]{.mark}

[THROUGH: Catherine Eiden, Branch Chief]{.mark}

[Reregistration Branch 3]{.mark}

[Health Effects Division (7509C)]{.mark}

[]{.mark}

[TO: Kendra Tyler, CRM]{.mark}

[Reregistration Branch 1]{.mark}

[SRRD (7508C)]{.mark}

[]{.mark}

[]{.mark}

The HED Chapter has been revised to reflect a correction made in Section
6.3.2, Recreational Uses. In the original document, the dose and MOE
reported for adult and child recreational swimmers were reversed.

**[Table of Contents]{.mark}**

[]{.mark}

[]{.mark}

[1.0 Executive Summary 4](#__RefHeading___Toc113170842)

[[2.0]{.mark} [Ingredient Profile]{.mark}
8](#__RefHeading___Toc113170843)

[2.1 [Summary of Registered/Proposed Uses]{.mark}
9](#__RefHeading___Toc113170844)

[[2.2]{.mark} Structure and Nomenclature
10](#__RefHeading___Toc113170845)

[2.3 Physical and Chemical Properties 10](#__RefHeading___Toc113170846)

[[3.0]{.mark} [Metabolism Assessment]{.mark}
11](#__RefHeading___Toc113170847)

[[3.1]{.mark} [Comparative Metabolic Profile]{.mark}
11](#__RefHeading___Toc113170848)

[[4.0 Hazard Characterization/Assessment]{.mark}
11](#__RefHeading___Toc113170849)

[4.1 Hazard Characterization 11](#__RefHeading___Toc113170850)

[4.1.5. Acute Toxicity 12](#__RefHeading___Toc113170851)

[4.2 FQPA Hazard Considerations 15](#__RefHeading___Toc113170852)

[4.2.1 Adequacy of the Toxicity Data Base
15](#__RefHeading___Toc113170853)

[4.2.2 Evidence of Neurotoxicity 15](#__RefHeading___Toc113170854)

[4.2.3 Developmental Toxicity Studies 15](#__RefHeading___Toc113170855)

[4.2.4 Reproductive Toxicity Study 16](#__RefHeading___Toc113170856)

[4.2.5 Additional Information from Literature Sources .
17](#__RefHeading___Toc113170857)

[4.2.6 Pre-and/or Post-natal Toxicity 17](#__RefHeading___Toc113170858)

[4.3 Recommendation for a Developmental Neurotoxicity Study
18](#__RefHeading___Toc113170859)

[4.3.1 Evidence that supports requiring a Developmental Neurotoxicity
Study 18](#__RefHeading___Toc113170860)

[4.3.2 Evidence that supports not requiring Developmental Neurotoxicity
Study 18](#refheading___toc113170861)

[4.4 Hazard Identification and Toxicity Endpoint Selection
18](#__RefHeading___Toc113170863)

[4.4.1 Acute Reference Dose (aRfD) - Females age 13-49
18](#__RefHeading___Toc113170864)

[4.4.2 Acute Reference Dose (aRfD) - General Population
18](#__RefHeading___Toc113170865)

[4.4.3 Chronic Reference Dose (cRfD) 18](#__RefHeading___Toc113170866)

[4.4.4 Incidental Oral Exposure (Short- and Intermediate-Term)
20](#__RefHeading___Toc113170867)

[4.4.5 Dermal Absorption 20](#__RefHeading___Toc113170868)

[4.4.6 Dermal Exposure (Short, Intermediate -Term)
20](#__RefHeading___Toc113170869)

[4.4.7 Inhalation Exposure (Short, Intermediate- Term)
21](#__RefHeading___Toc113170870)

[4.4.8 Margins of Exposure 21](#__RefHeading___Toc113170871)

[4.4.9 Recommendation for Aggregate Exposure Risk Assessments
22](#__RefHeading___Toc113170872)

[4.4.10 Classification of Carcinogenic Potential
22](#__RefHeading___Toc113170873)

[4.5 Special FQPA Safety Factor 25](#__RefHeading___Toc113170874)

[5.0 Public Health Data 25](#__RefHeading___Toc113170875)

[5.1 Incident Reports 25](#__RefHeading___Toc113170876)

[6.0 Exposure Characterization/Assessment
26](#__RefHeading___Toc113170877)

[6.1 Dietary Exposure/Risk Pathway 26](#__RefHeading___Toc113170878)

[6.2 Water Exposure/Risk Pathway 27](#__RefHeading___Toc113170879)

[6.3 Residential (Non-Occupational) Exposure/Risk Pathway
27](#__RefHeading___Toc113170880)

[6.3.1 Home Uses 28](#__RefHeading___Toc113170881)

[6.3.2 Recreational Uses 30](#__RefHeading___Toc113170883)

[6.3.3 Residential Aggregated Exposure and Risk Estimates
30](#__RefHeading___Toc113170884)

[6.3.4 Other (Spray Drift, etc.) 31](#__RefHeading___Toc113170885)

[7.0 Aggregate Risk Assessments and Risk Characterization
31](#__RefHeading___Toc113170886)

[7.1 Acute Aggregate Risk 31](#__RefHeading___Toc113170887)

[7.2 Short-Term Aggregate Risk 32](#__RefHeading___Toc113170888)

[7.4 Long-Term Aggregate Risk 32](#__RefHeading___Toc113170889)

[7.5 Cancer Risk 32](#__RefHeading___Toc113170890)

[8.0 Cumulative Risk Characterization/Assessment
32](#__RefHeading___Toc113170891)

[9.0 Occupational Exposure/Risk Pathway
33](#__RefHeading___Toc113170892)

[9.1 Short/Intermediate/Long-Term Handler Risk
33](#__RefHeading___Toc113170893)

[9.2 Short/Intermediate/Long-Term Postapplication Risk
36](#__RefHeading___Toc113170894)

[10.0 Data Needs and Label Requirements
37](#__RefHeading___Toc113170895)

[10.1 Toxicology 37](#__RefHeading___Toc113170896)

[10.2 Occupational and Residential Exposure
37](#__RefHeading___Toc113170897)

[1.0 TOXICOLOGY DATA REQUIREMENTS 39](#__RefHeading___Toc113170898)

[2.0 NON-CRITICAL TOXICOLOGY STUDIES 40](#__RefHeading___Toc113170899)

[3.0 TOLERANCE REASSESSMENT 42](#__RefHeading___Toc113170900)

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[]{.mark}

[]{#__RefHeading___Toc113170842 .anchor}**1.0 Executive Summary**

The Health Effects Division (HED) of EPA\'s Office of Pesticide Programs
has evaluated the toxicity and exposure data bases for the aquatic
algaecide/herbicide Aquashade, containing the dyes erioglaucine (Acid
Blue 9 or FD&C Blue No. 1) and tartrazine (Acid Yellow 23 or FD&C Yellow
No. 5); and has conducted a human health risk assessment in support of
the Reregistration Eligibility Decision (RED) for these active
ingredients.

Erioglaucine and tartrazine have many non-pesticidal uses, including
their use as inert ingredients (dyes) in other pesticide formulations
and as approved food coloring additives in a variety of applications.
These substances are each Generally Recognized As Safe (GRAS) for
general use as food, drug, and cosmetic color additives by the Food and
Drug Administration (FDA).

This risk assessment considers only the use of erioglaucine and
tartrazine as active ingredients in Aquashade and similar products.
Human health risks associated with their use as inert ingredients were
recently assessed by the Office of Pesticide Programs\' Registration
Division (RD) \[*Reassessment of the Requirement of a Tolerance for the
FDA-Certified Color Additives FD&C Blue No. 1, FD&C Red No. 40, and FD&C
Yellow No. 5 (Tartrazine)*, K. Liefer, December 21, 2004). HED relied
heavily on the information presented in RD's inert ingredient risk
assessment in this assessment of the human health risks from the
pesticidal uses of Aquashade.

*Use Information*

Aquashade is registered for use as an aquatic algaecide/herbicide. The
two dyes erioglaucine and tartrazine work by blocking penetration of the
portion of the light spectrum required for photosynthesis, thereby
limiting the growth of filamentous algae and submerged aquatic
vegetation. Application is recommended early in the growing season while
growth is on the bottom of the water body or later in the season after
the killing and/or removal of any existent growth. Repeated applications
are allowed to maintain an effective concentration of product in the
water body. Aquashade may be used in natural or manmade ponds, lakes,
fountains, fish farms and fish hatcheries; and may be applied by both
professional applicators and homeowners (Admiral Liquid; EPA Reg. No.
67064-2 -- approved 3/24/05). Water bodies treated with Aquashade may
not be used for human consumption. However, treated water may be used
for irrigation of crops, livestock watering and fishing.

*Toxicology*

The available toxicity data on the two main ingredients of Aquashade,
erioglaucine and tartrazine, are adequate to assess the chemical's
hazard potential. A product containing 68% erioglaucine and 4.5%
tartrazine was used in the acute studies. It has a low acute toxicity
with no deaths occurring near the limit dose in oral studies (Category
IV). It has a moderate acute toxicity in dermal studies (Category III).
Based on the uses, the requirement for the acute inhalation study has
been historically waived. There were no clinical signs of systemic
toxicity in the acute oral and dermal studies. No significant
differences exist between males and females. The tested product caused
slight eye irritation (Category III). It was negative for dermal
irritation (Category IV); however, it is a dermal sensitizer.

Tartrazine and erioglaucine each have very low toxicity potentials. A
definitive target organ has not been identified and clinical signs were
not observed in any study performed using these dyes. Systemic toxicity
was observed in one study in the toxicity database and was limited to a
decrease in mean body weight following long-term dietary exposure to
high doses in rats. There were no adverse effects observed in mice or
dogs. All NOAELs were reported to be 500 mg/kg/day with the exception of
a non-guideline 21-day dermal study in rats. The NOAEL for this study
was 5 mg/kg/day; however, this was the highest dose tested.

In both the prenatal developmental toxicity study in rats and the
3-generation reproduction study in rats with tartrazine, adverse effects
were not observed at any levels below the limit dose. Given the similar
toxicity profiles of the two dyes, erioglaucine is expected to
demonstrate a similar developmental and reproductive toxicity profile.
No adverse effects have been associated with exposure resulting from the
FDA-approved uses of either tartrazine or erioglaucine. Based on the
lack of evidence of pre- and/or post-natal susceptibility following
exposure to tartrazine or erioglaucine, and considering the lack of
residual uncertainties for pre- and/or post-natal toxicity, no special
FQPA safety factor is needed (1X).

There was no evidence of neurotoxicity reported in any study.

No evidence of carcinogenicity was observed in carcinogenicity studies
in mice and rats with erioglaucine, (Borzelleca and Hallagan, 1988a,
1988b) and tartrazine (Borzelleca et al, 1990). These substances are not
mutagenic in the standard Ames assay with or without metabolic
activation (Brown et al, 1978).

Erioglaucine and tartrazine are rapidly metabolized, and excreted in
rats, rabbits, and dogs. Erioglaucine is poorly absorbed; however, this
is not the case for tartrazine. The presence of the dyes was found in
the bile. The parent compounds are excreted unchanged mainly in the
feces with a small amount excreted by the urine.

*Residue Chemistry*

Water bodies treated with Aquashade may not be used for human
consumption. However, treated water may be used for irrigation of crops,
livestock watering and fishing, which could theoretically result in
residues of erioglaucine and/or tartrazine in human foods. In addition,
Aquashade may be used in fish farms/hatcheries. In 1982, based on
Aquashade\'s low toxicity profile, EPA waived residue chemistry data
requirements and established an exemption from the requirement of a
tolerance for erioglaucine when used as an aquatic plant control agent
under 40 CFR 180.1074. Tartrazine, when used as a dye, had previously
been exempted from the requirement of a tolerance as an inert (or
occasionally as an active) ingredient in pesticide formulations applied
to growing crops or to raw agricultural commodities after harvest under
40 CFR 180.1001(c) (currently 40 CFR 180.910). HED has determined that
the existing exemption for tartrazine as an inert ingredient is not
sufficient to satisfy reregistration requirements for the active
ingredient when used as an aquatic plant control agent. Therefore, we
are recommending that the exemption for erioglaucine at 40 CFR 180.1074
be revised to include both erioglaucine and tartrazine.

*Environmental Fate*

The color additives erioglaucine and tartrazine are water soluble, are
fully dissociated in the environmentally significant pH range of 5 to 9,
and are stable towards abiotic hydrolysis. Indirect photolysis in water
is a major route of transformation for these and other structurally
related dyes. The two dyes are not readily biodegradable under aerobic
conditions, but biodegrade under anaerobic conditions. They do not
adsorb strongly to soils/sediments and are predominantly found in the
water column. Volatilization from soils and water is not likely to be a
transport process in the environment. Both dyes are highly hydrophilic
and are not likely to bioaccumulate in fish.

Products containing erioglaucine and tartrazine are applied to contained
water bodies with little or no outflow, and none of the water bodies
treated with the products serves as a source of drinking water.
Therefore, no drinking water assessment is needed for these chemicals
when used as algaecides/ herbicides according to product labeling.

*Residential Exposure*

Aquashade is labeled for consumer use to control aquatic algae and weeds
in ponds and lakes. The anticipated use patterns and current labeling
indicate several residential handler scenarios based on the types of
equipment and techniques that can potentially be used to make Aquashade
applications. Residents or consumers applying Aquashade products to
ponds or lakes may be exposed for short-term (1 to 30 days) duration
through skin contact or by inhalation. All residential handler scenarios
assessed (dermal and inhalation) resulted in estimated MOEs greater than
100 and, therefore, are not of concern. Residential short-term dermal
MOEs range from 1,930 (Liquids for Pouring Applications) to 16,000
(Liquids for LCO Handgun), and short-term inhalation MOEs range from
550,000 (Liquids for Garden Hose End Sprayer) to 6,600,000 (Liquids for
Pouring Applications).

Postapplication exposures to children and adults that contact
Aquashade-treated swimming ponds are anticipated. To address the risk of
such exposures, a screening tool called the Swimmer Exposure Assessment
Model (SWIMODEL) was applied. The SWIMODEL uses well-accepted screening
exposure assessment equations to calculate the total worst-case exposure
for swimmers expressed as a mass-based intake value (mg/ event).
Postapplication residential exposure durations are expected to be short-
and intermediate-term (1 to 6 months) in duration. All residential
postapplication scenarios assessed (dermal, ingestion, aural, buccal/
sublingual, and nasal/ orbital routes of exposure) resulted in estimated
combined MOEs well above 100 and, therefore, are not of concern.

To better quantify residential Aquashade hazard, results from
residential handler and residential postapplication (i.e., swimmer) risk
assessments were aggregated. Aggregate calculations of residential
exposure were performed using worst-case MOEs resulting from each
assessment.

The residential aggregated exposure resulted in an estimated MOE of 1700
and, therefore, is not a risk of concern.

*Aggregate Risk*

In accordance with the FQPA, HED must consider and aggregate pesticide
exposures and risks from three major sources: drinking water, food and
residential exposures. Since Aquashade is applied to contained water
bodies with little or no outflow, and none of the treated water bodies
serves as a source of drinking water, no drinking water exposure is
expected. Although water treated with Aquashade may potentially be used
for irrigation of food crops and livestock watering, and Aquashade is
registered for use in fish farms and hatcheries, HED has not
quantitatively assessed exposures and risks from food sources for
several reasons: (1) Aquashade is used primarily in ornamental and/or
recreational lakes and ponds with very little treated water expected to
be used for agricultural purposes. (2) Erioglaucine and tartrazine are
highly water soluble compounds and, as such, not likely to accumulate in
livestock or fish tissues. The results of the rat metabolism study with
erioglaucine support this determination, since nearly the entire
administered dose was excreted unchanged in the feces in less than 2
days. (3) Any residues of erioglaucine or tartrazine occurring in foods
from the use of Aquashade as an aquatic algaecide/herbicide would be
negligible compared to residues in food from the common use of these
dyes as food coloring additives. (4) The most significant route of
exposure to erioglaucine and tartrazine from the use of Aquashade is
residential exposure, including residential handler and postapplication
(swimming) exposure. HED believes that the conservative residential
exposure and risk estimates discussed above are more than adequate to
cover any food exposures that could potentially occur from the use of
Aquashade as an aquatic algaecide/herbicide.

*Occupational Exposure*

Exposure of pesticide handlers is likely during the occupational use of
Aquashade in a variety of occupational environments. Since no
chemical-specific handler exposure data are available for Aquashade,
short- and intermediate-term dermal and inhalation exposures were
assessed using data from the Pesticide Handlers Exposure Database (PHED)
Version 1.1 and from the Outdoor Residential Exposure Task Force
(ORETF). PHED and ORETF data were used with other HED standard values
for areas treated per day, body weight and the level of personal
protective equipment (PPE) and engineering controls to assess handler
exposures to Aquashade. Using these assumptions, the calculated
occupational handler exposures for all scenarios resulted in estimated
MOEs greater than 100 and, therefore, are not of concern. Short- and
intermediate-term dermal MOEs range from 410 (Liquids for Pouring
Applications) to 4,300 (Liquids for Garden Hose-End Sprayer), and short-
and intermediate-term inhalation MOEs range from 120,000 (Liquids for
Garden Hose End Sprayer) to 1,600,000 (Liquids for Pouring
Applications).

Since Aquashade is an algaecide/ herbicide, HED is not aware of any
postapplication activities which may result in exposure. No harvesting
is required, and while scouting may include identifying any algae or
aquatic weed regrowth, these activities should not require contact with
the treated water body. For these reasons, occupational postapplication
exposure of workers to previously treated water bodies is expected to be
negligible and was not assessed. Furthermore, any postapplication
activities that could potentially occur would not be expected to exceed
those assessed from residential exposures to Aquashade which are not of
concern.

*Conclusions*

Aquashade is a low toxicity algaecide/ herbicide whose potential
non-occupational routes of exposure include residential handler and
postapplication (swimming) exposures. None of the water bodies treated
serves as a source of drinking water; and, while treated water may be
used to irrigate food crops or for livestock watering, resulting food
residues are expected to be negligible. Under the conditions of its
current use, human health risks to workers handling the pesticide or to
the general population are below HED's level of concern. Aggregate risk
estimates from residential handler and postapplication residential
exposures are well below HED's level of concern.

[]{.mark}

[]{#__RefHeading___Toc113170843 .anchor}**[2.0 Ingredient
Profile]{.mark}**

[]{.mark}

[Aquashade is an aquatic algaecide/ herbicide which is composed]{.mark}
of a combination of the dyes erioglaucine and tartrazine. Application is
recommended early in the growing season while growth is on the bottom of
the water body or later in the season after the killing and/ or removal
of any existent growth. Repeated applications are allowed to maintain an
effective concentration of product in the water body. Aquashade works by
controlling the portion of the light spectrum required for
photosynthesis, thereby inhibiting growth of filamentous algae and
submerged aquatic vegetation.

Aquashade is formulated for use in occupational settings as either a
liquid or water soluble packet (WSP) product, and can be applied by
pouring or dropping the WSP in water body from the shoreline, or
possibly by boat for larger water bodies. It is formulated for
residential use as a liquid product only (67064-2). While not specified
on product labeling, applications could be made by LCO handgun or garden
hose end sprayer. The combination of erioglaucine and tartrazine are the
active ingredients for 5 registered products. Each product has a
different ratio of the dyes, but in all of the product formulations the
percent of Acid Blue 9 is higher than that of Acid Yellow 23. Aquashade
is applied at a rate of 0.22 to 1.1 pounds of active ingredient per
acre-foot.

[]{#__RefHeading___Toc113170844 .anchor}**2.1** **[Summary of
Registered/Proposed Uses]{.mark}**

[]{.mark}

+----------+----------------+---------+--------------+---------------+
| **Table  |                |         |              |               |
| 2.1      |                |         |              |               |
| Summary  |                |         |              |               |
| of       |                |         |              |               |
| Re       |                |         |              |               |
| gistered |                |         |              |               |
| A        |                |         |              |               |
| quashade |                |         |              |               |
| Co       |                |         |              |               |
| mmercial |                |         |              |               |
| Uses**   |                |         |              |               |
+----------+----------------+---------+--------------+---------------+
| **Liquid |                |         |              |               |
| Formu    |                |         |              |               |
| lation** |                |         |              |               |
+----------+----------------+---------+--------------+---------------+
| **P      | **Crop**       | **Max   | **Amount of  | **Application |
| roduct** |                | App     | Product for  | Methods**     |
|          |                | Rate    | Area To Be   |               |
|          |                | (lb ai/ | Treated**    |               |
|          |                | acre-   |              |               |
|          |                | foot)** |              |               |
+----------+----------------+---------+--------------+---------------+
| A        | Ornamental and | 1.1     | 0.5 gallon/  | Pouring       |
| quashade | Recreational   |         | acre-foot    |               |
|          | Lakes and      |         |              |               |
| (        | Ponds, Fish    |         | (2 ppm)      |               |
| 33068-1) | Rearing and    |         |              |               |
|          | Fish Farming   |         |              |               |
|          | Ponds, Golf    |         |              |               |
|          | Course Ponds   |         |              |               |
+----------+----------------+---------+--------------+---------------+
| Admiral  | Fountains,     | 0.73    | 0.5 gallon/  | Pouring       |
| Liquid   | Fish Farms,    |         | acre-foot    |               |
|          | Fish           |         |              |               |
| (        | Hatcheries,    |         | (2ppm)       |               |
| 67064-2) | Golf Courses,  |         |              |               |
|          | Lakes, Manmade |         |              |               |
|          | Ponds,         |         |              |               |
|          | Swimming Ponds |         |              |               |
+----------+----------------+---------+--------------+---------------+
|          |                |         |              |               |
+----------+----------------+---------+--------------+---------------+
| Algae    | Garden Ponds,  | 0.22    | 120 ml /     | Pouring       |
| Blocker  | Goldfish       |         | 1500 gallons |               |
|          | Ponds, Koi     |         |              |               |
| (8709-6) | Ponds,         |         |              |               |
|          | Ornamental     |         |              |               |
|          | Ponds          |         |              |               |
+----------+----------------+---------+--------------+---------------+
| A        | Aquariums,     | 0.22    | 1 ounce/     | Pouring       |
| quashade | Fountains,     |         | 1000 gallons |               |
| OA       | Ornamental     |         |              |               |
|          | Ponds,         |         |              |               |
| (        | Recirculated   |         |              |               |
| 33068-2) | or Artificial  |         |              |               |
|          | Waterscapes    |         |              |               |
+----------+----------------+---------+--------------+---------------+
| **Water  |                |         |              |               |
| Soluble  |                |         |              |               |
| Packets  |                |         |              |               |
| (WSP)**  |                |         |              |               |
+----------+----------------+---------+--------------+---------------+
| Admiral  | Fish Farms,    | 0.73    | 2 WSPs/      | WSP           |
| WSP      | Fish           |         | acre-foot    |               |
|          | Hatcheries,    |         |              |               |
| (        | Fountains,     |         | (11 ounces)  |               |
| 67064-1) | Golf Courses,  |         |              |               |
|          | Manmade Ponds, |         |              |               |
|          | Swimming Ponds |         |              |               |
+----------+----------------+---------+--------------+---------------+

[]{.mark}

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[[]{#__RefHeading___Toc113170845 .anchor}**2.2 **]{.mark}**Structure and
Nomenclature**

[]{.mark}

+---------+------------------------------+-----------------------------+
| *       |                              |                             |
| *[Table |                              |                             |
| 2.2     |                              |                             |
| Aq      |                              |                             |
| uashade |                              |                             |
| N       |                              |                             |
| omencla |                              |                             |
| ture]{. |                              |                             |
| mark}** |                              |                             |
+---------+------------------------------+-----------------------------+
| [C      | ![](media/i                  | ![](media/image4.png){w     |
| hemical | mage3.png){width="2.28125in" | idth="2.3881944444444443in" |
| Str     | he                           | hei                         |
| ucture] | ight="1.3215277777777779in"} | ght="0.8895833333333333in"} |
| {.mark} |                              |                             |
|         |                              | []{.mark}                   |
+---------+------------------------------+-----------------------------+
| [Em     | C~37~H~34~N~2~Na~2~ O~9~     | C~16~H~9~N~4~O~9~S~2~Na~3~  |
| pirical | S~3~                         |                             |
| F       |                              |                             |
| ormula] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [Common | [Erioglaucine, Acid Blue     | [Tartrazine, Acid Yellow    |
| Name]   | 9]{.mark}                    | 23]{.mark}                  |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [CAS    | disodium                     | 4,5                         |
| Name]   | bis\[4-(N-ethy               | -dihydro-5-oxo-1-(4-sulophe |
| {.mark} | l-N-3-sulfonatophenylmethyl) | nyl)-4-\[(4-sulfophenyl)azo |
|         | aminophenyl\]phenylmethylium | \]-1H-pyrazole-3-carboxylic |
|         |                              | acid trisodium salt         |
+---------+------------------------------+-----------------------------+
| [CAS    | 2650-18-2                    | 1934-21-0                   |
| R       |                              |                             |
| egistry |                              |                             |
| Number] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [End    |                              |                             |
| Use     |                              |                             |
| Pr      |                              |                             |
| oducts/ |                              |                             |
| EPs]    |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [3      | [23.63%]{.mark}              | [2.39%]{.mark}              |
| 3068-1] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [3      | [2.36%]{.mark}               | [0.24%]{.mark}              |
| 3068-2] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [6      | [49.72%]{.mark}              | [3.27%]{.mark}              |
| 7064-1] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [6      | [15.31%]{.mark}              | [1.00%]{.mark}              |
| 7064-2] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+
| [       | [2.36%]{.mark}               | [0.24%]{.mark}              |
| 8709-6] |                              |                             |
| {.mark} |                              |                             |
+---------+------------------------------+-----------------------------+

[]{.mark}

[]{.mark}

3.  []{#__RefHeading___Toc113170846 .anchor}**Physical and Chemical
    Properties**

[]{.mark}

  --------------------------------------------------------------------------
  **Table 2.3                                                
  Physicochemical                                            
  Properties of                                              
  Aquashade**                                                
  ----------------- ------------------- -------------------- ---------------
  **Parameter**     **Value**                                **Reference**

                    **Acid Blue 9**     **Acid Yellow 23**   

  Molecular Weight  792.86              534.37               SRC, 2004

  Melting point     \> 250 °C           \> 300 °C            SRC, 2004

  Water solubility  at 25 °C            160 g/L at 25 °C     EPI Suite, 2004

  Vapor pressure    2.97 x 10^-42^ mmHg 7.43 x 10^-22^ mmHg  EPI Suite, 2004
                    at 25°C             at 25 °C             

  Octanol/water     K~ow~ = 0.032       K~ow~ = 6.3 x        SRC, 2004
  partition                             10^-11^              
  coefficient                                                
  (K~ow~)                                                    
  --------------------------------------------------------------------------

[]{.mark}

[]{.mark}

[]{#__RefHeading___Toc113170847 .anchor}**[3.0 Metabolism
Assessment]{.mark}**

[]{.mark}

1.  []{#__RefHeading___Toc113170848 .anchor}**[Comparative Metabolic
    Profile]{.mark}**

Erioglaucine was administered orally to rats as a 2% aqueous solution at
a level of 200 mg/rat. Almost the entire amount was excreted unchanged
in the feces within 40 h after administration. In a later investigation,
the presence of the color in the bile was observed in rats, rabbits and
dogs after oral administration. In the case of the dog, the amount did
not exceed 5% of the dose administered (Hess & Fitzhugh, 1953; 1954;
1955). Administration of an aqueous solution of the color by stomach
tube resulted in 89 % excretion in the feces; none was found in the
urine. After subcutaneous injection of 80-100 mg some 79% was excreted;
77% appeared in the feces and 2.5% in the urine (Imperial Chemical
Industries, 1958).

Metabolism studies for plants and livestock are not available for
comparison and have not been required.

[]{.mark}

[]{#__RefHeading___Toc113170849 .anchor}**[4.0 Hazard
Characterization/Assessment]{.mark}**

[]{.mark}

[[]{#__RefHeading___Toc113170850 .anchor}]{.mark}**4.1 Hazard
Characterization**

A combination of erioglaucine (Acid Blue 9 or FD&C Blue No. 1) and
tartrazine (Acid Yellow 23 or FD&C Yellow No. 5) is commonly referred to
as Aquashade. Five currently registered pesticide products, which are
used as aquatic algaecides/ herbicides, contain a combination of
erioglaucine and tartrazine. These substances are each Generally
Recognized As Safe (GRAS) for general use as food, drug, and cosmetic
color additives by the Food and Drug Administration (FDA).

The end-use products each have a different ratio of the dyes. A product
containing 68% erioglaucine and 4.5% tartrazine was used in the acute
studies. It has a low acute toxicity with no deaths occurring near the
limit dose in oral studies (Category IV). It has a moderate acute
toxicity in dermal studies (Category III). Based on the uses, the
requirement for the acute inhalation study has been historically waived.
There were no clinical signs of systemic toxicity in the acute oral and
dermal studies. No significant differences exist between males and
females. The tested product caused slight eye irritation (Category III).
It was negative for dermal irritation (Category IV); however, it is a
dermal sensitizer.

Tartrazine and erioglaucine each have very low toxicity potentials. A
definitive target organ has not been identified and clinical signs were
not observed in any study preformed using these dyes. Systemic toxicity
was observed in one study in the toxicity database and was limited to a
decrease in mean body weight following long-term dietary exposure to
high doses in rats. There were no adverse effects observed in mice or
dogs. All NOAELs were reported to be 500 mg/kg/day with the exception of
a non-guideline 21-day dermal study in rats. The NOAEL for this study
was 5 mg/kg/day; however, this was the highest dose tested.

In both the prenatal developmental toxicity study in rats and the
3-generation reproduction study in rats with tartrazine, adverse effects
were not observed at any levels below the limit dose. Given the similar
toxicity profiles of the two dyes, erioglaucine is unlikely to
demonstrate quantitative or qualitative susceptibility. No adverse
effects have been associated with exposure resulting from the
FDA-approved uses of either tartrazine or erioglaucine.

Based on the lack of evidence of pre- and/or post-natal susceptibility
following exposure to tartrazine or erioglaucine, and considering the
lack of residual uncertainties for pre- and/or post-natal toxicity, no
special FQPA safety factor is needed (1X).

There was no evidence of neurotoxicity reported in any study.

No evidence of carcinogenicity was observed in carcinogenicity studies
in mice and rats with erioglaucine, (Borzelleca and Hallagan, 1988a,
1988b) and tartrazine (Borzelleca et al, 1990). These substances are not
mutagenic in the standard Ames assay with or without metabolic
activation (Brown et al, 1978).

Erioglaucine and tartrazine are rapidly metabolized, and excreted in
rats, rabbits, and dogs. Erioglaucine is poorly absorbed; however, this
is not the case for tartrazine. The presence of the dyes was found in
the bile. The parent compounds are excreted unchanged mainly in the
feces with a small amount excreted by the urine.

[]{#__RefHeading___Toc113170851 .anchor}**4.1.5. Acute Toxicity**

+-------------+--------------+--------------+--------------+-----------+
| **Table     |              |              |              |           |
| 4.1a Acute  |              |              |              |           |
| Toxicity    |              |              |              |           |
| Profile -   |              |              |              |           |
| Admiral WSP |              |              |              |           |
| (E          |              |              |              |           |
| rioglaucine |              |              |              |           |
| 68.13%;     |              |              |              |           |
| T           |              |              |              |           |
| artrazine** |              |              |              |           |
|             |              |              |              |           |
| **4.51%)**  |              |              |              |           |
+-------------+--------------+--------------+--------------+-----------+
| **Guideline | **Study      | **MRIDs**    | **Results**  | *         |
| No.**       | Type**       |              |              | *Toxicity |
|             |              |              |              | C         |
|             |              |              |              | ategory** |
+-------------+--------------+--------------+--------------+-----------+
| 870.1100    | Acute oral   | 45281101     | LD~50~ \>    | IV        |
|             | \[rats\]     |              | 5000 mg/kg   |           |
+-------------+--------------+--------------+--------------+-----------+
| 870.1200    | Acute dermal | 45144401     | LD~50~       | III       |
|             | \[rabbit\]   |              | \>2000 mg/kg |           |
+-------------+--------------+--------------+--------------+-----------+
| 870.1300    | Acute        | NA           | data         |           |
|             | inhalation   |              | requirement  |           |
|             |              |              | waived       |           |
+-------------+--------------+--------------+--------------+-----------+
| 870.2400    | Acute eye    | 44902902     | No eye       | III       |
|             | irritation   |              | irritation   |           |
|             | \[rabbit\]   |              |              |           |
+-------------+--------------+--------------+--------------+-----------+
| 870.2500    | Acute dermal | 45086102     | negative     | IV        |
|             | irritation   |              |              |           |
|             | \[rabbit\]   |              |              |           |
+-------------+--------------+--------------+--------------+-----------+
| 870.2600    | Skin         | 44902904     | positive     |           |
|             | s            |              |              |           |
|             | ensitization |              |              |           |
|             | \[guinea     |              |              |           |
|             | pig\]        |              |              |           |
+-------------+--------------+--------------+--------------+-----------+

+-----------------------+------------------------+---------------------+
| **Table 4.1b          |                        |                     |
| Subchronic, Chronic   |                        |                     |
| and Other Toxicity    |                        |                     |
| Profile**             |                        |                     |
+=======================+========================+=====================+
| **Guideline No./      | **MRID No. (year)/     | **Results**         |
| Study Type**          | Classification         |                     |
|                       | /Doses**               |                     |
+-----------------------+------------------------+---------------------+
| 870.3200              | 43410101               | **Systemic**        |
|                       |                        |                     |
| 21/28-Day dermal      | Ac                     | NOAEL ≥ 5.0         |
| toxicity (species)    | ceptable/Non-Guideline | mg/kg/day (HDT)     |
|                       |                        |                     |
|                       | 0, 0.5, 5 mg/kg/day    | LOAEL = not         |
|                       |                        | identified          |
+-----------------------+------------------------+---------------------+
| 870.3700a             | 434081011              | **Maternal** NOAEL  |
|                       |                        | = 1000 mg/kg/day    |
| Prenatal              | Acceptable/Guideline   | (HDT)               |
| developmental (rats)  |                        |                     |
|                       | 0, 100, 300, 1000      | LOAEL = not         |
| Tartrazine            | mg/kg/day              | identified          |
|                       |                        |                     |
|                       |                        | **Developmental**   |
|                       |                        | NOAEL = 1000        |
|                       |                        | mg/kg/day (HDT)     |
|                       |                        |                     |
|                       |                        | LOAEL = not         |
|                       |                        | identified          |
+-----------------------+------------------------+---------------------+
| 870.3700b             | No MRID                | **Materna**l NOAEL  |
|                       |                        | = 1000 mg/kg/day    |
| Prenatal              | Collins et al 1990     | (HDT)               |
| developmental (rats)  |                        |                     |
|                       | 0, 60, 100, 200, 400,  | LOAEL = not         |
| Tartrazine            | 600 or 1000 mg/kg/day  | identified          |
|                       |                        |                     |
|                       |                        | **Developmenta**l   |
|                       |                        | NOAEL = 1000        |
|                       |                        | mg/kg/day (HDT)     |
|                       |                        |                     |
|                       |                        | LOAEL = not         |
|                       |                        | identified          |
+-----------------------+------------------------+---------------------+
| 870.3800              | 43410901               | **                  |
|                       |                        | Parental/Systemic** |
| Reproduction and      | Acceptable/Guideline   | NOAEL = 750         |
| fertility effects     |                        | mg/kg/day (HDT)     |
|                       | 0, 7.5, 75, 225 or 750 |                     |
| (rats)                | mg/kg/day              | LOAEL = not         |
|                       |                        | identified          |
| Tartrazine            |                        |                     |
|                       |                        | **Reproductive**    |
|                       |                        | NOAEL = 750         |
|                       |                        | mg/kg/day (HDT)     |
|                       |                        |                     |
|                       |                        | LOAEL = not         |
|                       |                        | identified          |
|                       |                        |                     |
|                       |                        | **Offspring** NOAEL |
|                       |                        | = NOAEL = 750       |
|                       |                        | mg/kg/day (HDT)     |
|                       |                        |                     |
|                       |                        | LOAEL = not         |
|                       |                        | identified          |
+-----------------------+------------------------+---------------------+
| 870.4100              | No MRID                | NOAEL = 500         |
|                       |                        | mg/kg/day           |
| Chronic toxicity      | FDA, 1985              |                     |
| (dog)                 |                        | LOAEL = not         |
|                       |                        | identified          |
| Tartrazine            |                        |                     |
+-----------------------+------------------------+---------------------+
| 870.4200              |                        | Satisfied by        |
|                       |                        | 870.4300a-          |
| Carcinogencity        |                        |                     |
+-----------------------+------------------------+---------------------+
| 870.4300a             | No MRID                | NOAEL = 631         |
|                       |                        | mg/kg/day           |
| Combined chronic      | Borzelleca et al, 1990 |                     |
| toxicity/             |                        | LOAEL = 1262        |
|                       | F: 0, 63, 631, 1262    | mg/kg/day based on  |
| Carcinogenicity       | mg/kg/day              | decreased body      |
|                       |                        | weight in females.  |
| (rat)                 | M: 0, 54, 536, 1072    |                     |
|                       | mg/kg/day              | **No evidence of    |
| Erioglaucine          |                        | carcinogenicity**   |
+-----------------------+------------------------+---------------------+
| 870.4300b             | No MRID                | NOAEL = 2641        |
|                       |                        | mg/kg/day (HDT)     |
| Combined chronic      | Borzelleca et al,      |                     |
| toxicity/             | 1988a                  | LOAEL = not         |
|                       |                        | identified          |
| Carcinogenicity       | F: 0, 53, 1056, 2641   |                     |
|                       | mg/kg/day              | **No evidence of    |
| (rat)                 |                        | carcinogenicity**   |
|                       | M:0, 67, 1339, 3348    |                     |
| Tartrazine            | mg/kg/day              |                     |
+-----------------------+------------------------+---------------------+
| 870.4300c             | No MRID                | NOAEL = 1200        |
|                       |                        | mg/kg/day (HDT)     |
| Combined chronic      | FDA, 1982              |                     |
| toxicity/             |                        | LOAEL = not         |
| Carcinogenicity       |                        | identified          |
| (mice)                |                        |                     |
|                       |                        | **No evidence of    |
| Erioglaucine          |                        | carcinogenicity**   |
+-----------------------+------------------------+---------------------+
| 870.4300d             | No MRID                | NOAEL = 7354        |
|                       |                        | mg/kg/day (HDT)     |
| Combined chronic      | Borzelleca et al, 1990 |                     |
| toxicity/             |                        | LOAEL = not         |
| Carcinogenicity       | F: 0, 897, 2690, 8966  | identified          |
| (mice)                | mg/kg/day              |                     |
|                       |                        | **No evidence of    |
| Erioglaucine          | M: 0, 735, 2206, 7354  | carcinogenicity**   |
|                       | mg/kg/day              |                     |
+-----------------------+------------------------+---------------------+
| 870.4300e             | No MRID                | NOAEL = 8103        |
|                       |                        | mg/kg/day (HDT)     |
| Combined chronic      | Borzelleca et al,      |                     |
| toxicity/             | 1988b                  | LOAEL = not         |
| Carcinogenicity       |                        | identified          |
| (mice)                | F: 0, 974, 2912, 9735  |                     |
|                       | mg/kg/day              | **No evidence of    |
| Tartrazine            |                        | carcinogenicity**   |
|                       | M: 0, 41, 2431, 8103   |                     |
|                       | mg/kg/day              |                     |
+-----------------------+------------------------+---------------------+
| 870.5100              | No MRID                | Negative.           |
|                       |                        |                     |
| Bacterial reverse     | Hansen et al, 1964 as  |                     |
| mutation test         | cited in JEFCA, 1969   |                     |
|                       |                        |                     |
| Tartrazine            |                        |                     |
+-----------------------+------------------------+---------------------+
| 870.6200b             | N/A                    |                     |
|                       |                        |                     |
| Subchronic            |                        |                     |
| neurotoxicity         |                        |                     |
| screening battery     |                        |                     |
+-----------------------+------------------------+---------------------+
| 870.6300              | N/A                    |                     |
|                       |                        |                     |
| Developmental         |                        |                     |
| neurotoxicity         |                        |                     |
+-----------------------+------------------------+---------------------+
| 870.7485              | No MRID                | Erioglaucine was    |
|                       |                        | administered orally |
| Metabolism and        | Imperial Chemical      | to rats as a 2%     |
| pharmacokinetics      | Industries, 1958       | aqueous solution at |
|                       |                        | a level of 200      |
| (species)             |                        | mg/rat. Almost the  |
|                       |                        | entire amount was   |
|                       |                        | excreted unchanged  |
|                       |                        | in the feces within |
|                       |                        | 40 h after          |
|                       |                        | administration.     |
+-----------------------+------------------------+---------------------+
| 870.7600              | N/A                    |                     |
|                       |                        |                     |
| Dermal penetration    |                        |                     |
|                       |                        |                     |
| (species)             |                        |                     |
+-----------------------+------------------------+---------------------+
| Special studies       | N/A                    |                     |
+-----------------------+------------------------+---------------------+

[]{#__RefHeading___Toc113170852 .anchor}**4.2 FQPA Hazard
Considerations**

[]{#__RefHeading___Toc113170853 .anchor}**4.2.1 Adequacy of the Toxicity
Data Base**

This risk assessment takes a weight of the evidence approach,
considering the available data from a variety of sources, including
studies submitted and reviewed by the agency, the Food and Drug
Administration (FDA) and the Joint Expert Committee on Food Additives of
the Food and Agriculture Organization/World Health Organization (JECFA).
This information is sufficient to evaluate the toxicity of Aquashade and
related compounds. Based on the information available from these
sources, the database is complete and there are no data gaps.

[]{#__RefHeading___Toc113170854 .anchor}**4.2.2 Evidence of
Neurotoxicity**

Neurotoxicity studies have not been conducted on either erioglaucine or
tartrazine. However, no evidence of neurotoxicity was observed in any
study. No clinical signs indicative of neurotoxicity were noted in
subchronic and chronic studies in dogs or rats.

[]{#__RefHeading___Toc113170855 .anchor}**4.2.3 Developmental Toxicity
Studies**

In a developmental toxicity study (MRID 43408101), groups of 22-23
Long-Evans female rats were administered tartrazine (92%, Lot No.
CCIC-7) at dose levels of 0, 100, 300, or 1000 mg/kg/day. Included were
3 control groups containing 22 female rats per group and one positive
control group in which trypan blue was administered to 22 female rats at
30 mg/kg/day from day 7 through day 9 of gestation by subcutaneous
injection. All dams were sacrificed on day 20 of gestation.

No clinical signs of toxicity and no mortality were observed. There were
no treatment related effects on maternal body weight gain, pregnancy
rate, early deliveries, fetal resorption, viability, fetal weight or sex
ratio. The NOAEL for maternal toxicity was 1000 mg/kg/day (HDT). The
LOAEL could not be determined. The NOAEL for developmental toxicity was
1000 mg/kg/day (HDT) and the LOAEL could not be determined.

The study is acceptable/guideline. It satisfies the requirement for a
guideline series 83-3(a) developmental toxicity study in rats. Although
the dose levels chosen for this study were insufficient to produce
systemic or developmental toxicity, the limit dose was reached and the
intent of the guideline requirement was met. The high dose of 1000
mg/kg/day is consistent with no effects in rats and is considered to
adequately address the issue as to whether or not FD&C Yellow No. 5
causes prenatal developmental toxicity.

In a second cited prenatal developmental study, tartrazine was given to
Osborne-Mendel rats by gavage at dose levels of 0, 60, 100, 200, 400,
600 or 1000 mg/kg/day on days 0-19 of gestation. No maternal or
developmental toxicity was observed when the rats were killed on day 20.
The mean daily food consumption for the entire period of gestation was
significantly greater in the females given 1000 mg/kg body weight/day
than in the controls, but maternal body-weight gain was not affected. No
dose-related effects were observed in implantations, fetal viability or
external fetal development. Fetal skeletal and visceral development was
similar among fetuses from all groups. At the doses given, tartrazine
was neither toxic nor teratogenic (Collins et al, 1990).

[]{#__RefHeading___Toc113170856 .anchor}**4.2.4 Reproductive Toxicity
Study**

In a 3-generation reproduction study (MRID 43410901), groups of 10 male
and 20 female Long-Evans rats were administered tartrazine (92% ai, Lot
No. CC1C-7) at dose levels of 0, 7.5, 75, 225, or 750 mg/kg/day in the
diet. First generation rats produced 2 litters; second generation rats
produced 3 litters (one of which was sacrificed on Day 19 G.D. for
embryologic examination), and the third generation produced 2 litters.

There were no adverse treatment related effects on parental survival,
body weight, body weight gain, food consumption, efficiency of food
utilization, mating, pregnancy or fertility rates, gestation length,
offspring viability, weight and sex, Day 19 sacrifice data or necropsy
findings. The NOAEL for reproductive/systemic effects is 750 mg/kg/day
(HDT). The LOAEL was not determined.

This study is acceptable and satisfies the guideline requirement for a
2-generation reproductive study (OPPTS 870.3800); OECD 416 in rat.
Although the dose levels chosen for this study were insufficient to
produce systemic or reproductive toxicity, the intent of the guideline
requirement was met as described in §81 through §86 of subdivision F of
the *Pesticide Assessment Guidelines*. The high dose of 750 mg/kg/day is
consistent with no effects in rats and is considered to adequately
address the issue as to whether or not FD& C Yellow No. 5 causes
reproductive toxicity.

[]{#__RefHeading___Toc113170857 .anchor}**4.2.5 Additional Information
from Literature Sources**

It should be noted that the toxicological database for erioglaucine and
tartrazine, including all subchronic and chronic studies, was evaluated
by the FDA and an international peer review committee, JEFCA
(**<http://www.fao.org/ag/AGP/AGPP/Pesticid/Default.html>[.]{.underline}**)
The FDA and JECFA evaluations of erioglaucine and tartrazine include
reviews of numerous animal toxicity studies involving dogs, hamsters,
guinea pigs, rabbits, rats, and mice as part of their toxicity endpoint
selection process. In permanently listing erioglaucine and tartrazine as
color additives for use in foods, drugs and cosmetics, FDA concluded
that these colorants were safe and determined a maximum acceptable daily
intake for erioglaucine and tartrazine (FDA 1982, 1985). Similarly,
JECFA has evaluated these compounds for the purpose of establishing
estimates of acceptable daily intakes (ADIs) (JECFA 1964, 1969, 1980).
Table 3 lists the respective FDA and JECFA ADIs for these substances.

  ----------------------- ----------------------- -----------------------
  **Table 3. FDA and                              
  JECFA Acceptable Daily                          
  Intake (ADI) Values (in                         
  mg/kg- bw/day)**                                

  **Color Additive**      **FDA ADI**             **JECFA ADI**

  Erioglaucine            12.0                    0 -12.5

  Tartrazine              5.0                     0 -7.5
  ----------------------- ----------------------- -----------------------

[]{#__RefHeading___Toc113170858 .anchor}**4.2.6 Pre-and/or Post-natal
Toxicity**

**4.2.6.1 Determination of Susceptibility**

No quantitative or qualitative evidence supports increased
susceptibility of rat or fetuses from *in utero* exposure to tartrazine
in the developmental toxicity studies. There was not a prenatal
developmental study in rabbits available in the database. In both the
prenatal developmental toxicity study in rats and the 3-generation
reproduction study in rats with tartrazine, adverse effects were not
observed at any levels below the limit dose. Given the similar toxicity
profiles of the two dyes, erioglaucine is unlikely to demonstrate
quantitative or qualitative susceptibility. No adverse effects have been
associated with exposure resulting from the FDA-approved uses of either
tartrazine or erioglaucine.

**4.2.6.2 Degree of Concern Analysis and Residual Uncertainties for Pre-
and/or Post-natal Susceptibility**

There is no degree of concern and there are no residual uncertainties.
No quantitative or qualitative sensitivity was observed in the rat and
rabbit developmental studies or in the 3-generation reproduction study
in the rat when tested with tartrazine. Given the similar toxicity
profiles of the two dyes, erioglaucine is unlikely to demonstrate
quantitative or qualitative susceptibility. Based on the lack of
evidence of pre- and/or post-natal susceptibility following exposure to
tartrazine or erioglaucine, and considering the lack of residual
uncertainties for pre- and/or post-natal toxicity, no special FQPA
safety factor is needed (1X). There is no concern for developmental
neurotoxicity resulting from exposure to erioglaucine and tartrazine.

[]{#__RefHeading___Toc113170859 .anchor}**4.3 Recommendation for a
Developmental Neurotoxicity Study**

[]{#__RefHeading___Toc113170860 .anchor}**4.3.1 Evidence that supports
requiring a Developmental Neurotoxicity Study**

There is no evidence that supports requiring a developmental
neurotoxicity study.

2.  **Evidence that supports not requiring Developmental Neurotoxicity
    Study**

    The available data on the toxicity of Erioglaucine and tartrazine do
    not support the

    recommendation for a developmental neurotoxicity study. No evidence
    of neurotoxicity was

    []{#refheading___toc113170861 .anchor}observed in any study.

    []{#__RefHeading___Toc113170863 .anchor}**4.4 Hazard Identification
    and Toxicity Endpoint Selection**

    []{#__RefHeading___Toc113170864 .anchor}**4.4.1 Acute Reference Dose
    (aRfD) - Females age 13-49**

There is no appropriate endpoint for females age 13-49 attributable to a
single exposure available from oral studies including the developmental
toxicity studies.

[]{#__RefHeading___Toc113170865 .anchor}**4.4.2 Acute Reference Dose
(aRfD) - General Population**

There is no appropriate endpoint for the general population to a single
exposure available from oral studies including the developmental
toxicity studies.

3.  []{#__RefHeading___Toc113170866 .anchor}**Chronic Reference Dose
    (cRfD)**

[Studies Selected:]{.underline} Chronic oral toxicity study in dogs
(tartrazine) and chronic oral toxicity/ carcinogenicity study in rats
(erioglaucine; co-critical).

[MRID No.:]{.underline} No MRID; listed as reviewed by the FDA

[Executive Summary:]{.underline} Chronic oral toxicity study in dogs
(tartrazine).

The chronic study in dogs was submitted to the FDA and was used to
establish their ADI. In Federal Register Vol. 50. No 171, the FDA
reported that there were a "large number of animals of both sexes".
Furthermore, "pilot studies to determine maximum tolerated dosages and
two control groups increased the power of these tests for detecting
dose-related effects." These studies were designed and conducted in full
compliance with good laboratory practice regulations and were subject to
FDA inspection while they were being conducted. The study in dogs showed
no adverse effects at any level. The NOAEL was 500 mg/kg/day and a LOAEL
was not established.

[Co-Critical Study]{.underline}

[MRID No.:]{.underline} No MRID; listed as cited by Borzelleca et al,
1990

[Executive Summary:]{.underline} Combined chronic
toxicity/carcinogenicity study in rats

FD & C Blue No. 1 (erioglaucine) was fed to Charles River CD rats as a
dietary mixture in lifetime toxicity/carcinogenicity studies. The rat
study was conducted with an in utero phase in which the compound was
administered to the F~0~ generation rats (60/sex/group) at dietary
concentrations of 0.0%, 0.1%, 1.0% or 2.0% equaling approximately 0, 63,
631 and 1262 mg/kg/day and 0, 54, 536, and 1072 mg/kg/day in females
males, respectively. After randomly selecting the F~1~ animals, the
lifetime phase was initiated at the same levels with 70 rats/sex/group,
including two control groups. The maximum exposure times were 116 and
111 weeks for males and females, respectively. The
no-observed-adverse-effect levels are dietary concentrations of 2.0% for
males (1072 mg/kg body weight/day), and 1.0% for females (631 mg/kg/day)
based on a 15.0% decrease in terminal body weight and decreased survival
in the high-dose (1262 mg/kg/day) females compared with the combined
control groups (Borzelleca et al, 1990 ).

[Dose and Endpoint:]{.underline} The NOAEL of 500 mg/kg/day (HDT) in the
chronic oral toxicity study in dogs with tartrazine. This is supported
by a combined chronic toxicity/ carcinogenicity study in rats with
erioglaucine, which reported a NOAEL of 631 mg/kg/day based on decreased
body weight at 1262 mg/kg/day in females (LOAEL).

[Uncertainty Factor (UF):]{.underline} 100; includes 10x for
interspecies extrapolation and 10x for intraspecies variations.

[Comments About Study/ Endpoint/ UF]{.underline}: In 1985, the FDA used
the chronic study in dogs to derive the ADI for tartrazine. The risk
assessment team also used this study (OPPTS number 870.4100a) for the
selection of the chronic endpoint. The rat combined chronic toxicity/
carcinogenicity study (OPPTS number 870.4300a) using erioglaucine is
considered supportive of the oral dog study using tartrazine. The NOAEL
of 500 mg/kg/day demonstrated in the chronic dog study with tartrazine
is the most conservative endpoint in the database. Although this study
is from the FDA's register, it is fully supported by rat combined
chronic toxicity/ carcinogenicity study (NOAEL = 631 mg/kg/day) with
erioglaucine and by other chronic studies in the tartrazine/erioglaucine
database which all demonstrate extremely high NOAELs (\>1000 mg/kg/day).
Since the formulated products used are often a combination of tartrazine
and erioglaucine, the selection of an endpoint using these two studies
allowed the team to make the most conservative and protective estimation
of the chronic reference dose.

+-----------------------------------------------------------------------+
| **Chronic RfD = [500 mg/kg/day]{.underline} = 5 mg/kg/day             |
| (tartrazine)**                                                        |
|                                                                       |
| **100**                                                               |
+=======================================================================+
+-----------------------------------------------------------------------+

[]{#__RefHeading___Toc113170867 .anchor}**4.4.4 Incidental Oral Exposure
(Short- and Intermediate-Term)**

[Studies Selected:]{.underline} Chronic oral toxicity study in dogs
(tartrazine) and chronic oral toxicity/ carcinogenicity study in rats
(erioglaucine; co-critical).

[MRID No.:]{.underline} No MRIDs; listed as reviewed by the FDA

[Executive Summary:]{.underline} see section 4.4.3

[Dose and Endpoint:]{.underline} The NOAEL of 500 mg/kg/day (HDT) in the
chronic oral toxicity study in dogs with tartrazine. This is supported
by a combined chronic toxicity/ carcinogenicity study in rats with
erioglaucine, which reported a NOAEL of 631 mg/kg/day based on decreased
body weight at 1262 mg/kg/day in females (LOAEL).

[Uncertainty Factor (UF):]{.underline} 100; includes 10x for
interspecies extrapolation and 10x for intraspecies variations.

[Comments About Study/ Endpoint/ UF]{.underline}: Prenatal developmental
studies using tartrazine in rats are available; however, the NOAELs are
1000 mg/kg/day. For this reason, the team selected the aforementioned
chronic studies and acknowledges that these endpoints are conservative
and should be protective for any potential adverse effects. Therefore,
the duration and dosing and the endpoint are appropriate for this
scenario.

[]{#__RefHeading___Toc113170868 .anchor}**4.4.5 Dermal Absorption**

No dermal absorption study was available. Therefore, the default dermal
absorption factor of 100% was used. It should be noted that use of the
default dermal absorption factor resulted in a highly conservative
estimation of risk through this route of exposure.

[]{#__RefHeading___Toc113170869 .anchor}**4.4.6 Dermal Exposure (Short,
Intermediate -Term)**

[Studies Selected:]{.underline} Chronic oral toxicity study in dogs
(tartrazine) and chronic oral toxicity/ carcinogenicity study in rats
(erioglaucine; co-critical).

[MRID No.:]{.underline} 43410101

[Executive Summary**:**]{.underline} See section 4.4.3

[Dose and Endpoint:]{.underline} The NOAEL of 500 mg/kg/day (HDT) in the
chronic oral toxicity study in dogs with tartrazine. This is supported
by a combined chronic toxicity/ carcinogenicity study in rats with
erioglaucine, which reported a NOAEL of 631 mg/kg/day based on decreased
body weight at 1262 mg/kg/day in females (LOAEL).

[Uncertainty Factor (UF):]{.underline} 100; includes 10x for
interspecies extrapolation and 10x for intraspecies variations.

[Comments about Study/Endpoint/UF:]{.underline} An appropriate dermal
toxicity study was not available for any exposure scenario. There was a
non-guideline 21-day dermal study in rabbits in the database with a
NOAEL of 5 mg/kg/day (HDT). However, given that all other guideline
studies had NOAELs ≥ 500 mg/kg/day and that 5 mg/kg/day was the highest
dose tested in the dermal study, selection of an endpoint based on this
study is likely to give an extremely conservative endpoint and is
unlikely to be near the threshold dose. Therefore, we selected the
chronic oral toxicity study in dogs, assuming 100% dermal absorption.
This selection is supported by the dietary combined chronic
toxicity/carcinogenicity study in rats using erioglaucine which had a
NOAEL of 631mg/kg/day (compared with 500 mg/kg/day with tartrazine). The
magnitude of the effect over this interval is considered appropriate for
short- and intermediate-term exposures. Since the end-use products are
composed of mainly erioglaucine, this endpoint should be conservative
and protective for any potential adverse effects via the dermal route of
exposure.

[]{#__RefHeading___Toc113170870 .anchor}**4.4.7 Inhalation Exposure
(Short, Intermediate- Term)**

[Studies Selected:]{.underline} Chronic oral toxicity study in dogs
(tartrazine) and chronic oral toxicity/ carcinogenicity study in rats
(erioglaucine; co-critical).

[MRID No.:]{.underline} 43410101

[Executive Summary**:**]{.underline} See Section 4.4.3

[Dose and Endpoint:]{.underline} The NOAEL of 500 mg/kg/day (HDT) in the
chronic oral toxicity study in dogs with tartrazine. This is supported
by a combined chronic toxicity/ carcinogenicity study in rats with
erioglaucine, which reported a NOAEL of 631 mg/kg/day based on decreased
body weight at 1262 mg/kg/day in females (LOAEL).

[Uncertainty Factor (UF):]{.underline} 100; includes 10x for
interspecies extrapolation and 10x for intraspecies variations.

[Comments about Study/Endpoint/UF:]{.underline} Appropriate inhalation
toxicity studies were not available for any exposure scenario. The
magnitude of the effect over this interval is considered appropriate for
short- and intermediate-term exposures. 100% inhalation absorption is
assumed.

[]{#__RefHeading___Toc113170871 .anchor}**4.4.8 Margins of Exposure**

The Margins of Exposure (MOEs) of concern for occupational exposure risk
assessments are as follows:

+-----------------+-----------------+-----------------+-----------------+
| **Route of      | **Duration of   |                 |                 |
| Exposure**      | Exposure**      |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
|                 | **Short-Term    | **In            | **Long-Term (\> |
|                 | (1-30**         | termediate-Term | 6 Months)**     |
|                 |                 | (1-6 Months)**  |                 |
|                 | **Days)**       |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| Occupational    |                 |                 |                 |
| (Worker)        |                 |                 |                 |
| Exposure        |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| Dermal          | 100             | 100             | NA              |
+-----------------+-----------------+-----------------+-----------------+
| Inhalation      | 100             | 100             | NA              |
+-----------------+-----------------+-----------------+-----------------+
| Residential     |                 |                 |                 |
| (Non-Dietary)   |                 |                 |                 |
| Exposure        |                 |                 |                 |
+-----------------+-----------------+-----------------+-----------------+
| Oral            | 100             | 100             | NA              |
+-----------------+-----------------+-----------------+-----------------+
| Dermal          | 100             | 100             | NA              |
+-----------------+-----------------+-----------------+-----------------+
| Inhalation      | 100             | 100             | NA              |
+-----------------+-----------------+-----------------+-----------------+

N/A = Not applicable

For occupational short- and intermediate-term dermal and inhalation
exposure risk assessments, a MOE of 100 is required. In addition, an MOE
of 100 is required for residential short- and intermediate-term oral,
dermal and inhalation exposure risk assessments. All MOEs are based on
the conventional uncertainty factor of 100X (10X for intraspecies
variation and 10X for interspecies extrapolation).

[]{#__RefHeading___Toc113170872 .anchor}**4.4.9 Recommendation for
Aggregate Exposure Risk Assessments**

As per 1996 FQPA, when there are potential residential exposures to the
pesticide, aggregate risk assessment must consider exposures from three
major sources: oral, dermal and inhalation exposures. All routes of
exposure for all durations of exposure can be aggregated. A cancer
aggregate risk assessment is not required because there is no evidence
of carcinogenicity (see cancer weight of evidence below).

[]{#__RefHeading___Toc113170873 .anchor}**4.4.10 Classification of
Carcinogenic Potential**

No evidence for carcinogenicity was seen in rats. Administration of
tartrazine or erioglaucine to rats for two years did not result in an
increase in overall tumor incidence or increase the incidence of any
specific type of tumor at doses approaching the limit dose. The chemical
was negative for gene mutation in *Salmonella typhimurium.*

+-------------+-------------+---------------+-------------------------+
| **Table     |             |               |                         |
| 4.4.        |             |               |                         |
| Summary of  |             |               |                         |
| To          |             |               |                         |
| xicological |             |               |                         |
| Doses and   |             |               |                         |
| Endpoints   |             |               |                         |
| for         |             |               |                         |
| Chemical    |             |               |                         |
| for Use in  |             |               |                         |
| Human Risk  |             |               |                         |
| As          |             |               |                         |
| sessments** |             |               |                         |
+=============+=============+===============+=========================+
| **Exposure  | **Dose Used | **Special     | **Study and             |
| Scenario**  | in Risk     | FQPA SF\* and | Toxicological Effects** |
|             | Assessment, | Level of      |                         |
|             | UF**        | Concern for   |                         |
|             |             | Risk          |                         |
|             |             | Assessment**  |                         |
+-------------+-------------+---------------+-------------------------+
| Acute       | NA          |               | No appropriate endpoint |
| Dietary     |             |               | for females age 13-49   |
|             |             |               | attributable to a       |
| (females    |             |               | single exposure.        |
| 13-49)      |             |               |                         |
+-------------+-------------+---------------+-------------------------+
| Acute       | NA          |               | No appropriate endpoint |
| Dietary     |             |               | for the general         |
| (general    |             |               | population attributable |
| population) |             |               | to a single exposure.   |
+-------------+-------------+---------------+-------------------------+
| Chronic     | NOAEL = 500 | FQPA SF = 1X  | Chronic oral toxicity   |
| Dietary     | mg/kg/day   |               | in dogs                 |
|             | (HDT)       | cPAD =        |                         |
| (all        | (           | [chronic      | LOAEL = not identified  |
| p           | Tartrazine) | RfD           | (Tartrazine)            |
| opulations) |             | ]{.underline} |                         |
|             | C           |               | Co-critical:            |
|             | o-critical: | FQPA SF       |                         |
|             | NOAEL = 631 |               | Combined chronic        |
|             | mg/kg/day   | = 5 mg/kg/day | t                       |
|             | (Er         |               | oxicity/carcinogenicity |
|             | ioglaucine) |               | study in rats           |
|             |             |               | (Erioglaucine)          |
|             | UF = 100X   |               |                         |
|             |             |               | LOAEL = 1262 mg/kg/day  |
|             | Chronic RfD |               | based on decreased body |
|             | = 5         |               | weight in females.      |
|             | mg/kg/day   |               |                         |
+-------------+-------------+---------------+-------------------------+
| Incidental  | NOAEL = 500 | Residential   | Chronic oral toxicity   |
| Oral        | mg/kg/day   | MOE = 100     | in dogs                 |
|             | (HDT)       |               |                         |
| Short- (1 - | (           | Occupational  | LOAEL = not identified  |
| 30 days)    | Tartrazine) | MOE=NA        | (Tartrazine)            |
| and         |             |               |                         |
| Interm      | C           |               | Co-critical:            |
| ediate-Term | o-critical: |               |                         |
| (1 -- 6     | NOAEL = 631 |               | Combined chronic        |
| months)     | mg/kg/day   |               | t                       |
|             | (Er         |               | oxicity/carcinogenicity |
|             | ioglaucine) |               | study in rats           |
|             |             |               | (Erioglaucine)          |
|             |             |               |                         |
|             |             |               | LOAEL = 1262 mg/kg/day  |
|             |             |               | based on decreased body |
|             |             |               | weight in females.      |
+-------------+-------------+---------------+-------------------------+
| Dermal      | NOAEL = 500 | Residential   | Chronic oral toxicity   |
|             | mg/kg/day   | MOE = 100     | in dogs                 |
| Short-(1-30 | (HDT)       |               |                         |
| days) and   | (           | Occupational  | LOAEL = not identified  |
| Interm      | Tartrazine) | MOE = 100     | (Tartrazine)            |
| ediate-Term |             |               |                         |
| (1 -- 6     | C           |               | Co-critical             |
| months)     | o-critical: |               |                         |
|             | NOAEL =     |               | Combined chronic        |
|             | 6           |               | t                       |
|             | 31mg/kg/day |               | oxicity/carcinogenicity |
|             | (Er         |               | study in rats           |
|             | ioglaucine) |               | (Erioglaucine)          |
|             |             |               |                         |
|             | UF = 100X   |               | LOAEL = 1262 mg/kg/day  |
|             |             |               | based on decreased body |
|             | (dermal     |               | weight in females.      |
|             | absorption  |               |                         |
|             | rate =      |               |                         |
|             | 100%)       |               |                         |
+-------------+-------------+---------------+-------------------------+
| Dermal      | NA          |               | NA                      |
|             |             |               |                         |
| Long-Term   |             |               |                         |
|             |             |               |                         |
| (\> 6       |             |               |                         |
| months)     |             |               |                         |
+-------------+-------------+---------------+-------------------------+
| Inhalation  | NOAEL = 500 | Residential   | Chronic oral toxicity   |
| Short- (1 - | mg/kg/day   | MOE = 100     | in dogs                 |
| 30 days)    | (HDT)       |               |                         |
| and         | (           | Occupational  | LOAEL = not identified  |
| Interm      | Tartrazine) | MOE = 100     | (Tartrazine)            |
| ediate-Term |             |               |                         |
| (1 -- 6     | C           |               | Co-critical             |
| months)     | o-critical: |               |                         |
|             | NOAEL = 631 |               | Combined chronic        |
|             | mg/kg/day   |               | t                       |
|             | (Er         |               | oxicity/carcinogenicity |
|             | ioglaucine) |               | study in rats           |
|             |             |               | (Erioglaucine)          |
|             | UF = 100X   |               |                         |
|             |             |               | LOAEL = 1262 mg/kg/day  |
|             | (inhalation |               | based on decreased body |
|             | absorption  |               | weight in females.      |
|             | rate =      |               |                         |
|             | 100%)       |               |                         |
+-------------+-------------+---------------+-------------------------+
| Inhalation  | NA          |               | NA                      |
|             |             |               |                         |
| Long-Term   |             |               |                         |
|             |             |               |                         |
| (\> 6       |             |               |                         |
| months)     |             |               |                         |
+-------------+-------------+---------------+-------------------------+
| Cancer      | **Classi    |               |                         |
| (oral,      | fication:** |               |                         |
| dermal,     | No evidence |               |                         |
| inhalation) | or          |               |                         |
|             | carc        |               |                         |
|             | inogenicity |               |                         |
+-------------+-------------+---------------+-------------------------+

4.  []{#__RefHeading___Toc113170874 .anchor}**Special FQPA Safety
    Factor**

    Based on the hazard data, the risk assessment team recommended the
    special FQPA SF be reduced to 1x because there are no concerns and
    no residual uncertainties with regard to pre- and/or post-natal
    toxicity. The erioglaucine and tartrazine risk assessment team
    evaluated the quality of the exposure data; and, based on these
    data, recommended that the special FQPA SF be reduced to 1x. The
    recommendation is based on the following:

-   No dietary food exposure assessment required.

-   The dietary drinking water assessment is not required.

-   The SWIMODEL, an assessment tool employed to address the potential
    for postapplication residential exposures/ risks (i.e., swimming
    ponds), uses screening exposure assessment equations to calculate
    the total worst-case exposure for swimmers. The SWIMODEL was
    developed based upon reliable data and is unlikely to underestimate
    exposure/ risk.

    **4.6 Endocrine disruption**

    EPA is required under the FFDCA, as amended by FQPA, to develop a
    screening program to determine whether certain substances (including
    all pesticide active and other ingredients) "may have an effect in
    humans that is similar to an effect produced by a naturally
    occurring estrogen, or other such endocrine effects as the
    Administrator may designate." Following recommendations of its
    Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA
    determined that there was a scientific basis for including, as part
    of the program, the androgen and thyroid hormone systems, in
    addition to the estrogen hormone system. EPA also adopted EDSTAC's
    recommendation that the Program include evaluations of potential
    effects in wildlife. For pesticide chemicals, EPA will use FIFRA
    and, to the extent that effects in wildlife may help determine
    whether a substance may have an effect in humans, FFDCA authority to
    require the wildlife evaluations. As the science develops and
    resources allow, screening of additional hormone systems may be
    added to the Endocrine Disruptor Screening Program (EDSP). In the
    available toxicity studies on erioglaucine and tartrazine, there was
    no estrogen, androgen, and/or thyroid mediated toxicity.

    When additional appropriate screening and/or testing protocols being
    considered under the Agency's EDSP have been developed, erioglaucine
    and tartrazine may be subjected to further screening and/or testing
    to better characterize effects related to endocrine disruption.

    []{#__RefHeading___Toc113170875 .anchor}**5.0 Public Health Data**

    []{#__RefHeading___Toc113170876 .anchor}**5.1 Incident Reports**

Reference: *Review of Aquashade Incident Reports, Chemicals #110303,
#110301, and #110302*, DP Barcode: D302184, Jerome Blondell, 08/22/05.

There were almost no reports of ill effects from exposure to Aquashade
in the available data bases. The lack of incidents further supports
HED's characterization of Aquashade as a low toxicity pesticide with
little potential for acute effects.

One report was found in the OPP Incident Data System (IDS) in which blue
water was observed in a government office building in Ohio in 1989. An
investigation found that Acid Blue 9 (a component of Aquashade) had
backflowed into the building's potable water system apparently causing
12 illnesses. Ultimately, it was determined that this incident is too
poorly documented and not a basis for conclusions about the human
toxicity of the product in question.

Reports from scientific literature suggest that there was concern that
Aquashade could cloud water to the point of reducing visibility and
disorient divers into lakes treated with Aquashade and possibly lead to
drowning. However, further studies were conducted and it was concluded
that "The results of this study suggest that the drownings reported in
North Carolina could not have been solely or primarily due to the
addition of Aquashade to the lake water. It appears more likely that a
high volume of plant material may have remained in the lake and may have
been more responsible for the disorientation of swimmers and divers who
drowned. Under the conditions of this experiment, Aquashade does not
appear to reduce the visibility of water significantly in a manner that
would create unsafe swimming hazards."

There are no incidents reported by the Poison Control Center (PCC), the
California Department of Pesticide Regulation (CDPR), the National
Pesticide Information Center (NPIC), or the National Institute of
Occupational Safety and Health's Sentinel Event Notification System for
Occupational Risks (NIOSH SENSOR).

[]{#__RefHeading___Toc113170877 .anchor}**6.0 Exposure
Characterization/Assessment**

[]{#__RefHeading___Toc113170878 .anchor}**6.1 Dietary Exposure/Risk
Pathway**

Since Aquashade is applied to contained water bodies with little or no
outflow, and none of the treated water bodies serves as a source of
drinking water, no drinking water exposure is expected. Although water
treated with Aquashade may potentially be used for irrigation of food
crops and livestock watering, and Aquashade is registered for use in
fish farms and hatcheries, HED has not quantitatively assessed exposures
and risks from food sources for several reasons: (1) Aquashade is used
primarily in ornamental and/or recreational lakes and ponds with very
little treated water expected to be used for agricultural purposes. (2)
Erioglaucine and tartrazine are highly water soluble compounds and, as
such, not likely to accumulate in livestock or fish tissues. The results
of the rat metabolism study with erioglaucine support this
determination, since nearly the entire administered dose was excreted
unchanged in the feces in less than 2 days. (3) Any residues of
erioglaucine or tartrazine occurring in foods from the use of Aquashade
as an aquatic algaecide/herbicide would be negligible compared to
residues in food from the common use of these dyes as food coloring
additives.

[]{#__RefHeading___Toc113170879 .anchor}**6.2 Water Exposure/Risk
Pathway**

Reference: *Ecological Risk Assessment for the Re-registration of
Tartrazine ("Acid Yellow 23\") and Erioglaucine ("Acid Blue 9\") Dyes in
the End-use Products Aquashade, Admiral, and Algae Blocker*, James
Goodyear and Silvia Termes, 09/XX/05.

The color additives erioglaucine and tartrazine are water soluble, are
fully dissociated in the environmentally significant pH range of 5 to 9,
and are stable towards abiotic hydrolysis. Indirect photolysis in water
is a major route of transformation for these and other structurally
related dyes. The two dyes are not readily biodegradable under aerobic
conditions, but biodegrade under anaerobic conditions. They do not
adsorb strongly to soils/sediments and are predominantly found in the
water column. Volatilization from soils and water is not likely to be a
transport process in the environment. Both dyes are highly hydrophilic
and are not likely to bioaccumulate in fish.

Products containing erioglaucine and tartrazine are applied to contained
water bodies with little or no outflow, and none of the water bodies
treated with the products serves as a source of drinking water.
Therefore, no drinking water assessment is needed for these chemicals
when used as algaecides/ herbicides according to product labeling.

3.  []{#__RefHeading___Toc113170880 .anchor}**Residential
    (Non-Occupational) Exposure/Risk Pathway**

    References: *Aquashade: Occupational and Residential Exposure
    Assessment and Recommendations for the Reregistration Eligibility
    Decision Document;* DP Barcode: D302180; W. Britton; 09/13/05.

    *Aquashade: Revised Occupational and Residential Exposure Assessment
    and Recommendations for the Reregistration Eligibility Decision
    Document;* DP Barcode: D321915; W. Britton; 09/27/05.

Aquashade is labeled for consumer use to control aquatic algae and weeds
in ponds and lakes. The anticipated use patterns and current labeling
indicate several residential handler scenarios based on the types of
equipment and techniques that can potentially be used to make Aquashade
applications. Residents or consumers applying Aquashade products to
ponds or lakes may be exposed for short-term (1 to 30 days) duration
through skin contact or by inhalation. While the potential for
inhalation exposure exists, risks are assumed to be negligible based
upon very low vapor pressure values corresponding to the dyes
erioglaucine and tartrazine; 2.97 x 10^-42^ mmHg and 7.43 x 10^-22^ mmHg
at 25 °C, respectively.

Postapplication exposures to children and adults that contact
Aquashade-treated swimming ponds are anticipated. To address the risk of
such exposures, a screening tool called the Swimmer Exposure Assessment
Model (SWIMODEL) was applied. The SWIMODEL uses well-accepted screening
exposure assessment equations to calculate the total worst-case exposure
for swimmers expressed as a mass-based intake value (mg/ event).
Postapplication residential exposure durations are expected to be short-
and intermediate-term (1 to 6 months) in duration.

To better quantify residential Aquashade hazard, results from
residential handler and residential postapplication risk assessments
were aggregated. Aggregate calculations of residential exposure were
performed using worst-case MOEs resulting from each assessment.

[]{#__RefHeading___Toc113170881 .anchor}**6.3.1 Home Uses**

**Aquashade Residential Handler Exposure Scenarios**: Aquashade is
labeled for consumer use to control aquatic algae and weeds in ponds and
lakes; therefore, pesticide handler exposure to Aquashade is likely to
occur during its use. The anticipated use patterns and current labeling
indicate several residential handler exposure scenarios based on the
types of equipment and techniques that can be potentially used for
consumer Aquashade applications. The quantitative exposure/risk
assessment developed for residential handlers is based on the following
scenarios.

*Mixer/ Loader/ Applicators:*

\(1\) Liquids for Pouring Applications (using PHED mixer/ loader data)

\(2\) Liquids for Garden Hose-End Sprayer (ORETF)

\(3\) Liquids for LCO Handgun (ORETF)

**Data and Assumptions for Handler Exposure Scenarios**: A series of
assumptions served as the basis for completing the residential handler
risk assessments. Each assumption and factor is detailed below. In
addition to these factors, unit exposure values were used to calculate
risk estimates. Mostly, these unit exposure values were taken from the
Pesticide Handlers Exposure Database (PHED) and the Outdoor Residential
Exposure Task Force (ORETF) studies. Both PHED and the individual
studies are presented below. \[Note: Several of the assumptions and
factors used for the assessment are similar to those used in the
occupational assessment presented in Section 9.1. As such, only factors
that are unique to the residential scenarios are presented below.\]

-   HED has developed standard unit exposure values for many
    occupational scenarios to ensure consistency in exposure
    assessments. These standard values were used to calculate handler
    exposures for the associated scenarios. For those scenarios where
    standard values have not been developed, surrogate values based on a
    similar scenario were used.

-   HED always considers the maximum application rates allowed by labels
    in its risk assessments. If additional information such as average
    or typical rates are available, these values also may be used to
    allow risk managers to make a more informed risk management
    decision.

    **Risk Summary**: A summary of the short-term risks (dermal and
    inhalation) for each exposure scenario is presented below in Table
    6.3.1. All residential handler scenarios assessed resulted in
    estimated MOEs greater than 100 and, therefore, are not of concern.
    Short-and intermediate-term MOEs do not differ because they share
    the same toxicological endpoint. Residential short-term dermal MOEs
    range from 1,930 (Liquids for Pouring Applications) to 16,000
    (Liquids for LCO Handgun), and short-term inhalation MOEs range from
    550,000 (Liquids for Garden Hose End Sprayer) to 6,600,000 (Liquids
    for Pouring Applications).

<table style="width:100%;">
<colgroup>
<col style="width: 9%" />
<col style="width: 16%" />
<col style="width: 8%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 9%" />
<col style="width: 6%" />
<col style="width: 7%" />
<col style="width: 10%" />
<col style="width: 11%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="10"><strong>Table 6.3.1 Short-term Exposures and Risks for
Residential Handlers of Aquashade</strong></td>
</tr>
<tr class="even">
<td><strong>Exposure Scenario (Scenario #)</strong></td>
<td><strong>Crop<sup>1</sup></strong></td>
<td><p><strong>Dermal Unit Exposure</strong></p>
<p><strong>(mg/lb ai) <sup>2</sup></strong></p></td>
<td><strong>Inhalation Unit Exposure (Ug/lb ai)
<sup>3</sup></strong></td>
<td><p><strong>Application Rate<sup>3</sup></strong></p>
<p><strong>(lb ai / acre foot) <sup>4</sup></strong></p></td>
<td><strong>Area Treated Daily (acre-feet) <sup>5</sup></strong></td>
<td><strong>Surface Area (acres)</strong></td>
<td><p><strong>Depth of</strong></p>
<p><strong>Water Body (feet)</strong></p></td>
<td><p><strong>Baseline</strong></p>
<p><strong>Dermal</strong></p>
<p><strong>MOE <sup>6</sup></strong></p></td>
<td><p><strong>Baseline</strong></p>
<p><strong>Inhalation MOE<sup>7</sup></strong></p></td>
</tr>
<tr class="odd">
<td colspan="10"><strong>Mixer/ Loader/ Applicator</strong></td>
</tr>
<tr class="even">
<td>Liquids for Pouring Applications (1)</td>
<td>Fountains, Fish Farms, Fish Hatcheries, Golf Courses, Lakes, Manmade
Ponds, Swimming Ponds</td>
<td>3.1</td>
<td>1.2</td>
<td>0.73</td>
<td>8</td>
<td>8</td>
<td>1</td>
<td>1930</td>
<td>5000000</td>
</tr>
<tr class="odd">
<td>Liquids for Pouring Applications (1)</td>
<td>Ornamental and Recreational Lakes and Ponds</td>
<td>3.1</td>
<td>1.2</td>
<td>1.1</td>
<td>4</td>
<td>1</td>
<td>4</td>
<td>2600</td>
<td>6600000</td>
</tr>
<tr class="even">
<td>Liquids for Garden Hose End Sprayer (ORETF) (2)</td>
<td>Fountains, Fish Farms, Fish Hatcheries, Golf Courses, Lakes, Manmade
Ponds, Swimming Ponds</td>
<td>2.6</td>
<td>11</td>
<td>0.73</td>
<td>8</td>
<td>8</td>
<td>1</td>
<td>2300</td>
<td>550000</td>
</tr>
<tr class="odd">
<td>Liquids for Garden Hose End Sprayer (ORETF) (2)</td>
<td>Ornamental and Recreational Lakes and Ponds</td>
<td>2.6</td>
<td>11</td>
<td>1.1</td>
<td>4</td>
<td>1</td>
<td>4</td>
<td>3100</td>
<td>720000</td>
</tr>
<tr class="even">
<td>Liquids for LCO Handgun (ORETF) (3)</td>
<td>Fountains, Fish Farms, Fish Hatcheries, Golf Courses, Lakes, Manmade
Ponds, Swimming Ponds</td>
<td>0.50</td>
<td>1.9</td>
<td>0.73</td>
<td>8</td>
<td>8</td>
<td>1</td>
<td>12000</td>
<td>3100000</td>
</tr>
<tr class="odd">
<td>Liquids for LCO Handgun (ORETF) (3)</td>
<td>Ornamental and Recreational Lakes and Ponds</td>
<td>0.50</td>
<td>1.9</td>
<td>1.1</td>
<td>4</td>
<td>1</td>
<td>4</td>
<td>16000</td>
<td>4200000</td>
</tr>
</tbody>
</table>

^1^Crops and use patterns are from product labeling.

^2^Baseline dermal unit exposures represent short pants and short
sleeved shirt. Values are reported in the PHED Surrogate Exposure Guide
dated August 1998 or are from data submitted by the Outdoor Residential
Exposure Task Force dated May 2000.

^3^Baseline inhalation unit exposures represent no respirator. Values
are reported in the PHED Surrogate Exposure Guide dated August 1998 or
are from data submitted by the Outdoor Residential Exposure Task Force
dated May 2000.

^4^Application rates are based on maximum values found in various
sources including LUIS and various labels. In most scenarios, a range of
maximum application rates is used to represent the range of rates for
different crops/sites/uses. Most application rates upon which the
analysis is based are presented as lb ai/acre-foot.

^5^Amount treated is based on the area or gallons that can be reasonably
applied in a single day for each exposure scenario of concern based on
the application method and formulation/packaging type. (Standard
EPA/OPP/HED values).

^6^ Dermal MOE = NOAEL (500 mg/ kg/ day) / Daily dermal dose (mg/ kg/
day). MOEs are reported to 2 significant figures.

^7^Inhalation MOE = NOAEL (500 mg/ kg/ day) / Daily inhalation dose (mg/
kg/ day). MOEs are reported to 2 significant figures.

[]{#__RefHeading___Toc113170883 .anchor}**6.3.2 Recreational Uses**

Aquashade can be used in areas that can be frequented by the general
population including residential areas (i.e., swimming ponds). There is
potential for dermal, ingestion, aural, buccal/ sublingual, and nasal/
orbital routes of exposure to adults and children following its
residential application. The potential for incidental exposures of
short-term duration exist from the day of application to the water body.
Intermediate-term exposures could also occur and were considered as
well.

Risks were calculated for residential handler and postapplication
exposures using the Margin of Exposure (MOE) approach; the MOE is a
ratio of the body burden to the toxicological endpoint of concern. All
short- and intermediate-term residential postapplication scenarios
assessed (dermal, ingestion, aural, buccal/ sublingual, and nasal/
orbital routes of exposure) resulted in estimated combined MOEs greater
than 100 and, therefore, are not of concern. A summary of these MOEs is
presented in Table 6.3.2.

+----------+----------+-----------+----------+----------+----------+
| **Table  |          |           |          |          |          |
| 6.3.2    |          |           |          |          |          |
| Recr     |          |           |          |          |          |
| eational |          |           |          |          |          |
| Swimmer  |          |           |          |          |          |
| A        |          |           |          |          |          |
| quashade |          |           |          |          |          |
| MOEs**   |          |           |          |          |          |
+----------+----------+-----------+----------+----------+----------+
| *        | **       | **Water   | **Dose** | *        | **MOE**  |
| *Exposed | Exposure | Conc      |          | *NOAEL** |          |
| Person** | Du       | entration | **(mg/k  |          |          |
|          | ration** | (µg/ L)** | g/day)** | **(mg/k  |          |
|          |          |           |          | g/day)** |          |
+----------+----------+-----------+----------+----------+----------+
| Child -- | Short-/  | 2000      | 0.10     | 500      | 4900     |
| 22 kg    | I        |           |          |          |          |
|          | ntermedi |           |          |          |          |
|          | ate-term |           |          |          |          |
+----------+----------+-----------+----------+----------+----------+
| Adult -- |          | 2000      | 0.032    | 500      | 15600    |
| 70 kg    |          |           |          |          |          |
+----------+----------+-----------+----------+----------+----------+

[]{#__RefHeading___Toc113170884 .anchor}**6.3.3** **Residential
Aggregated Exposure and Risk Estimates**

To better quantify residential Aquashade hazard, results from
residential handler and residential postapplication risk assessments
were aggregated. Aggregate calculations of residential exposure were
performed using worst-case MOEs resulting from each assessment.

The residential aggregated exposure resulted in an estimated MOE of 1700
and, therefore, is not a risk of concern.

4.  []{#__RefHeading___Toc113170885 .anchor}**Other (Spray Drift,
    etc.)**

    Spray drift is always a potential source of exposure of residents
    nearby to spraying operations. This is particularly the case with
    aerial application, but, to a lesser extent, could also be a
    potential source of exposure from the ground application methods
    employed for Aquashade. The Agency has been working with the Spray
    Drift Task Force, EPA Regional Offices and State Lead Agencies for
    pesticide regulation and other parties to develop the best spray
    drift management practices. On a chemical by chemical basis, the
    Agency is now requiring interim mitigation measures for aerial
    applications that must be placed on product labels/labeling. The
    Agency has completed its evaluation of the new data base submitted
    by the Spray Drift Task Force, a membership of U.S. pesticide
    registrants, and is developing a policy on how to appropriately
    apply the data and the AgDRIFT computer model to its risk
    assessments for pesticides applied by air, orchard airblast and
    ground hydraulic methods. After the policy is in place, the Agency
    may impose further refinements in spray drift management practices
    to reduce off target drift with specific products with significant
    risks associated with drift.

    []{#__RefHeading___Toc113170886 .anchor}**7.0 Aggregate Risk
    Assessments and Risk Characterization**

In accordance with the FQPA, HED must consider and aggregate pesticide
exposures and risks from three major sources: drinking water, food and
residential exposures. Since Aquashade is applied to contained water
bodies with little or no outflow, and none of the treated water bodies
serves as a source of drinking water, no drinking water exposure is
expected. Although water treated with Aquashade may potentially be used
for irrigation of food crops and livestock watering, and Aquashade is
registered for use in fish farms and hatcheries, HED has not
quantitatively assessed exposures and risks from food sources for
several reasons: (1) Aquashade is used primarily in ornamental and/or
recreational lakes and ponds with very little treated water expected to
be used for agricultural purposes. (2) Erioglaucine and tartrazine are
highly water soluble compounds and, as such, not likely to accumulate in
livestock or fish tissues. The results of the rat metabolism study with
erioglaucine support this determination, since nearly the entire
administered dose was excreted unchanged in the feces in less than 2
days. (3) Any residues of erioglaucine or tartrazine occurring in foods
from the use of Aquashade as an aquatic algaecide/herbicide would be
negligible compared to residues in food from the common use of these
dyes as food coloring additives. (4) The most significant route of
exposure to erioglaucine and tartrazine from the use of Aquashade is
residential exposure, including residential handler and postapplication
(swimming) exposure. HED believes that the conservative residential
exposure and risk estimates discussed above are more than adequate to
cover any food exposures that could potentially occur from the use of
Aquashade as an aquatic algaecide/herbicide.

1.  []{#__RefHeading___Toc113170887 .anchor}**Acute Aggregate Risk**

    A toxicological endpoint of concern attributable to a single dose
    has not been identified for

    Aquashade. Therefore, an acute aggregate risk assessment has not
    been conducted.

    []{#__RefHeading___Toc113170888 .anchor}**7.2 Short-Term Aggregate
    Risk**

    The short-term aggregate risk assessment considered residential
    handler and postapplication (swimming) exposures to Aquashade only,
    as there are no sources of drinking water treated with Aquashade and
    food exposures are expected to be negligible. Short-term residential
    handler exposure may result when Aquashade is used to control
    aquatic algae and weeds in ponds and lakes. Short-term residential
    postapplication exposures may result when children and adults
    contact Aquashade-treated swimming ponds. Short-term risks were
    calculated for residential handler and postapplication exposures
    using the Margin of Exposure (MOE) approach; the MOE is a ratio of
    the body burden to the toxicological endpoint of concern.

To better quantify residential Aquashade hazard, results from
residential handler and postapplication risk assessments were
aggregated. Calculations of aggregate residential exposures were
performed using worst-case MOEs from each assessment.

The estimated aggregate residential exposure resulted in an MOE of 1700
and, therefore, is not of concern.

**7.3 Intermediate-Term Aggregate Risk**

The use of Aquashade as an algaecide/herbicide is not expected to result
in dietary exposure to erioglaucine or tartrazine, either from drinking
water or food; and residential handler exposures are expected to be
short-term only. Therefore, only intermediate-term postapplication
(swimming) exposures are expected and an intermediate-term aggregate
risk assessment is not necessary.

4.  []{#__RefHeading___Toc113170889 .anchor}**Long-Term Aggregate Risk**

    Long-term exposures are not expected based on current uses;
    therefore, a long-term aggregate assessment was not conducted.

    []{#__RefHeading___Toc113170890 .anchor}**7.5 Cancer Risk**

    A cancer aggregate risk assessment is not required, since there was
    no evidence of carcinogenicity in the toxicology studies submitted
    for Aquashade.

    []{#__RefHeading___Toc113170891 .anchor}**8.0 Cumulative Risk
    Characterization/Assessment**

    Unlike other pesticides for which EPA has followed a cumulative risk
    approach based on a common mechanism of toxicity, EPA has not made a
    common mechanism of toxicity finding as to erioglaucine and
    tartrazine and any other substances and Aquashade does not appear to
    produce a toxic metabolite produced by other substances. For the
    purposes of this tolerance action, therefore, EPA has not assumed
    that Aquashade has a common mechanism of toxicity with other
    substances. For information regarding EPA's efforts to determine
    which chemicals have a common mechanism of toxicity and to evaluate
    the cumulative effects of such chemicals, see the policy statements
    released by EPA's Office of Pesticide Programs concerning common
    mechanism determinations and procedures for cumulating effects from
    substances found to have a common mechanism on EPA's website at
    http://www.epa.gov/pesticides/cumulative/.

    []{#__RefHeading___Toc113170892 .anchor}**9.0 Occupational
    Exposure/Risk Pathway**

    Reference: *Aquashade: Occupational and Residential Exposure
    Assessment and Recommendations for the Reregistration Eligibility
    Decision Document;* DP Barcode: D302180; W. Britton; 09/13/05.

HED determined that the potential for occupational exposure to Aquashade
exists in a variety of occupational environments. The anticipated use
patterns and current labeling indicate several occupational exposure
scenarios based on the types of equipment and techniques that can
potentially be used for Aquashade applications. These include the
handling of Aquashade during mixing, loading, and applying processes
(i.e. mixer/ loaders, and mixer/ loader/ applicators). As a result, a
risk assessment has been completed for the occupational handler
scenario. Short-term (1 to 30 days) and intermediate-term dermal and
inhalation exposures (1 to 6 months) may occur; however, long-term
exposures (greater than 6 months) are not expected.

[]{#__RefHeading___Toc113170893 .anchor}**9.1
Short/Intermediate/Long-Term Handler Risk**

**Aquashade Handler Exposure Scenarios**: The anticipated use patterns
and current labeling indicate several occupational exposure scenarios
based on the types of equipment and techniques that can be potentially
used for Aquashade applications. The quantitative exposure/risk
assessment developed for occupational handlers is based on the following
scenarios.

*Mixer/ Loaders:*

\(1\) Liquids for Pouring Applications

*Mixer/ Loader/ Applicators:*

\(2\) Liquids for Garden Hose-End Sprayer (ORETF)

\(3\) Liquids for LCO Handgun (ORETF)

**Data and Assumptions for Handler Exposure Scenarios**: A series of
assumptions served as the basis for the occupational handler risk
assessments. The assumptions used in the risk assessment calculations
are detailed below:

-   Occupational handler exposure estimates were based on surrogate data
    from the Pesticide Handlers Exposure Database (PHED) and the Outdoor
    Residential Exposure Task Force (ORETF).

-   HED has developed standard unit exposure values for many
    occupational scenarios to ensure consistency in exposure
    assessments. These standard values were used to calculate handler
    exposures for the associated scenarios. For those scenarios where
    standard values have not been developed, surrogate values based on a
    similar scenario were used.

-   The adverse effects for the short- and intermediate-term dermal and
    inhalation endpoints are based on studies where the effects were
    observed in males and females, therefore, the body weight of an
    average adult (i.e. 70 kg) was used to estimate exposure.

For non-cancer assessments, HED assumes the maximum application rates
allowed by labels in its risk assessments.

The average occupational workday is assumed to be 8 hours.

The daily areas treated were defined for each handler scenario (in
appropriate units) by determining the amount that can be reasonably
treated in a single day (e.g., acres, square feet, cubic feet, or
gallons per day). When possible, the assumptions for daily areas treated
are taken from the Health Effects Division Science Advisory Committee on
Exposure SOP #9: Standard Values for Daily Acres Treated in Agriculture,
which was completed on July 5, 2000. Since Aquashade is not used in
agriculture the above source is not applicable. Therefore, the daily
area treated with Aquashade was investigated and was assumed to be 25
acre-feet per day \[*Personal Communication per Email from Dr. Kurt
Getsinger (USACE) to J. Carter (OPP, BEAD), 8/22/05\].* This high-end
estimate is recognized to be conservative; however, the value is assumed
to result in risks that represent reasonable worst-case estimates of
exposure to occupational handlers of Aquashade.

**Risk Summary**: A summary of the short- and intermediate-term risks
(dermal and inhalation) for each exposure scenario is presented below in
Table 9.1. The calculated occupational handler exposures for all
scenarios resulted in estimated MOEs greater than 100 and, therefore,
are not of concern. Short-and intermediate-term MOEs do not differ
because they share the same toxicological endpoint. Short- and
intermediate-term dermal MOEs range from 410 (Liquids for Pouring
Applications) to 4,300 (Liquids for Garden Hose-End Sprayer), and short-
and intermediate-term inhalation MOEs range from 120,000 (Liquids for
Garden Hose End Sprayer) to 1,600,000 (Liquids for Pouring
Applications).

+-------+---------+-------+-------+-------+-----+---------+---------+
| **    |         |       |       |       |     |         |         |
| Table |         |       |       |       |     |         |         |
| 9.1   |         |       |       |       |     |         |         |
| S     |         |       |       |       |     |         |         |
| hort- |         |       |       |       |     |         |         |
| and   |         |       |       |       |     |         |         |
| In    |         |       |       |       |     |         |         |
| terme |         |       |       |       |     |         |         |
| diate |         |       |       |       |     |         |         |
| -term |         |       |       |       |     |         |         |
| Bas   |         |       |       |       |     |         |         |
| eline |         |       |       |       |     |         |         |
| Expo  |         |       |       |       |     |         |         |
| sures |         |       |       |       |     |         |         |
| and   |         |       |       |       |     |         |         |
| Risks |         |       |       |       |     |         |         |
| for   |         |       |       |       |     |         |         |
| Oc    |         |       |       |       |     |         |         |
| cupat |         |       |       |       |     |         |         |
| ional |         |       |       |       |     |         |         |
| Handl |         |       |       |       |     |         |         |
| ers** |         |       |       |       |     |         |         |
|       |         |       |       |       |     |         |         |
| **of  |         |       |       |       |     |         |         |
| A     |         |       |       |       |     |         |         |
| quash |         |       |       |       |     |         |         |
| ade** |         |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| **Exp | **Cr    | **D   | **    | **A   | **A | **Bas   | **Bas   |
| osure | op^1^** | ermal | Inhal | pplic | rea | eline** | eline** |
| Sce   |         | Unit  | ation | ation | T   |         |         |
| nario |         | Expos | Unit  | R     | rea | **D     | **Inh   |
| (Sce  |         | ure** | Exp   | ate** | ted | ermal** | alation |
| nario |         |       | osure |       | Da  |         | M       |
| #)**  |         | **(   | (     | **(lb | ily | **MOE   | OE^7^** |
|       |         | mg/lb | Ug/lb | ai /  | (a  | ^6^**   |         |
|       |         | ai)   | ai)   | acre  | cre |         |         |
|       |         | ^2^** | ^3^** | foot) | -fe |         |         |
|       |         |       |       | ^4^** | et) |         |         |
|       |         |       |       |       | ^5  |         |         |
|       |         |       |       |       | ^** |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| **M   |         |       |       |       |     |         |         |
| ixer/ |         |       |       |       |     |         |         |
| Loa   |         |       |       |       |     |         |         |
| der** |         |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| Li    | Orn     | 3.1   | 1.2   | 1.1   | 25  | 410     | 1100000 |
| quids | amental |       |       |       |     |         |         |
| for   | and     |       |       |       |     |         |         |
| Po    | Recre   |       |       |       |     |         |         |
| uring | ational |       |       |       |     |         |         |
| Ap    | Lakes   |       |       |       |     |         |         |
| plica | and     |       |       |       |     |         |         |
| tions | Ponds   |       |       |       |     |         |         |
| (1)   |         |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| Li    | Fou     | 3.1   | 1.2   | 0.73  | 25  | 620     | 1600000 |
| quids | ntains, |       |       |       |     |         |         |
| for   | Fish    |       |       |       |     |         |         |
| Po    | Farms,  |       |       |       |     |         |         |
| uring | Fish    |       |       |       |     |         |         |
| Ap    | Hatc    |       |       |       |     |         |         |
| plica | heries, |       |       |       |     |         |         |
| tions | Golf    |       |       |       |     |         |         |
| (1)   | C       |       |       |       |     |         |         |
|       | ourses, |       |       |       |     |         |         |
|       | Lakes,  |       |       |       |     |         |         |
|       | Manmade |       |       |       |     |         |         |
|       | Ponds,  |       |       |       |     |         |         |
|       | S       |       |       |       |     |         |         |
|       | wimming |       |       |       |     |         |         |
|       | Ponds   |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| **M   |         |       |       |       |     |         |         |
| ixer/ |         |       |       |       |     |         |         |
| Lo    |         |       |       |       |     |         |         |
| ader/ |         |       |       |       |     |         |         |
| Ap    |         |       |       |       |     |         |         |
| plica |         |       |       |       |     |         |         |
| tor** |         |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| Li    | Orn     | 0.45  | 11    | 1.1   | 25  | 2800    | 120000  |
| quids | amental |       |       |       |     |         |         |
| for   | and     |       |       |       |     |         |         |
| G     | Recre   |       |       |       |     |         |         |
| arden | ational |       |       |       |     |         |         |
| Hose  | Lakes   |       |       |       |     |         |         |
| End   | and     |       |       |       |     |         |         |
| Sp    | Ponds   |       |       |       |     |         |         |
| rayer |         |       |       |       |     |         |         |
| (2)   |         |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| Li    | Fou     | 0.45  | 11    | 0.73  | 25  | 4300    | 170000  |
| quids | ntains, |       |       |       |     |         |         |
| for   | Fish    |       |       |       |     |         |         |
| G     | Farms,  |       |       |       |     |         |         |
| arden | Fish    |       |       |       |     |         |         |
| Hose  | Hatc    |       |       |       |     |         |         |
| End   | heries, |       |       |       |     |         |         |
| Sp    | Golf    |       |       |       |     |         |         |
| rayer | C       |       |       |       |     |         |         |
| (2)   | ourses, |       |       |       |     |         |         |
|       | Lakes,  |       |       |       |     |         |         |
|       | Manmade |       |       |       |     |         |         |
|       | Ponds,  |       |       |       |     |         |         |
|       | S       |       |       |       |     |         |         |
|       | wimming |       |       |       |     |         |         |
|       | Ponds   |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| Li    | Orn     | 0.50  | 1.9   | 1.1   | 25  | 2500    | 670000  |
| quids | amental |       |       |       |     |         |         |
| for   | and     |       |       |       |     |         |         |
| LCO   | Recre   |       |       |       |     |         |         |
| Ha    | ational |       |       |       |     |         |         |
| ndgun | Lakes   |       |       |       |     |         |         |
| (O    | and     |       |       |       |     |         |         |
| RETF) | Ponds   |       |       |       |     |         |         |
| (3)   |         |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+
| Li    | Fou     | 0.50  | 1.9   | 0.73  | 25  | 3800    | 100000  |
| quids | ntains, |       |       |       |     |         |         |
| for   | Fish    |       |       |       |     |         |         |
| LCO   | Farms,  |       |       |       |     |         |         |
| Ha    | Fish    |       |       |       |     |         |         |
| ndgun | Hatc    |       |       |       |     |         |         |
| (O    | heries, |       |       |       |     |         |         |
| RETF) | Golf    |       |       |       |     |         |         |
| (3    | C       |       |       |       |     |         |         |
|       | ourses, |       |       |       |     |         |         |
|       | Lakes,  |       |       |       |     |         |         |
|       | Manmade |       |       |       |     |         |         |
|       | Ponds,  |       |       |       |     |         |         |
|       | S       |       |       |       |     |         |         |
|       | wimming |       |       |       |     |         |         |
|       | Ponds   |       |       |       |     |         |         |
+-------+---------+-------+-------+-------+-----+---------+---------+

^1^Crops and use patterns are from product labeling.

^2^Baseline dermal unit exposures represent long pants, long sleeved
shirts, shoes, and socks. Values are reported in the PHED Surrogate
Exposure Guide dated August 1998 or are from data submitted by the
Outdoor Residential Exposure Task Force dated May 2000.

^3^Baseline inhalation unit exposures represent no respirator. Values
are reported in the PHED Surrogate Exposure Guide dated August 1998 or
are from data submitted by the Outdoor Residential Exposure Task Force
dated May 2000.

^4^Application rates are based on maximum values found in various
sources including LUIS and various labels. In most scenarios, a range of
maximum application rates is used to represent the range of rates for
different crops/sites/uses. Most application rates upon which the
analysis is based are presented as lb ai/acre-foot.

^5^Amount treated is based on the area or gallons that can be reasonably
applied in a single day for each exposure scenario of concern based on
the application method and formulation/packaging type. (Standard
EPA/OPP/HED values).

^6^ Dermal MOE = NOAEL (500 mg/ kg/ day) / Daily dermal dose (mg/ kg/
day). MOEs are reported to 2 significant figures.

^7^Inhalation MOE = NOAEL (500 mg/ kg/ day) / Daily inhalation dose (mg/
kg/ day). MOEs are reported to 2 significant figures.

HED believes that the risk estimates presented in this occupational
assessment represent the best quality results that could be produced
given the exposure, use, and toxicology data that are available. HED
also believes that the risks represent reasonable worst-case estimates
of exposure, because maximum application rates are coupled with medium-
to high-end estimates of area treated daily to define risk estimates
that likely fall in the upper percentiles of the actual exposure
distributions. Using these worst-case assumptions, estimated
occupational handler MOEs for all exposure scenarios are greater than
100 and are, therefore, not of concern.

[]{#__RefHeading___Toc113170894 .anchor}**9.2
Short/Intermediate/Long-Term Postapplication Risk**

HED uses the term Apostapplication@ to describe exposures that occur
when individuals are present in an environment that has been previously
treated with a pesticide (also referred to as re-entry exposure). Such
exposures may occur when workers enter previously treated areas to
perform job functions, including activities related to crop production,
such as scouting for pests or harvesting. Postapplication exposure
levels vary over time and depend on such things as the type of activity
(scouting, harvesting, etc.), the nature of the crop or target that was
treated, the type of pesticide application (foliar, soil-incorporated,
banded, etc.) and the chemical=s degradation properties. In addition,
the timing of pesticide applications, relative to harvest activities,
can greatly reduce the potential for postapplication exposure.

Aquashade is generally applied prior to or early in the growing season
when growth is on the bottom of the water body. Applications can also be
made later in the growing season when growth is closer to the surface
after the killing and/ or removal of any existent growth. Since
Aquashade is an algaecide/ herbicide, HED is not aware of any
postapplication activities which may result in exposure. No harvesting
is required, and while scouting may include identifying any algae or
aquatic weed regrowth, these activities should not require contact with
the treated water body. For these reasons, occupational postapplication
exposure of workers to previously treated water bodies is expected to be
negligible and was not assessed. Furthermore, any postapplication
activities that could potentially occur would not be expected to exceed
those assessed from residential exposures to Aquashade which are not of
concern.

[]{.mark}

In accordance with the Worker Protection Standard (WPS), a
restricted-entry interval (REI) is established to mitigate contact with
a pesticide in treated agricultural areas. However, since Aquashade has
no agricultural applications an REI was not required.

[]{#__RefHeading___Toc113170895 .anchor}**10.0 Data Needs and Label
Requirements**

[]{#__RefHeading___Toc113170896 .anchor}**10.1 Toxicology** -- none
required

[]{#__RefHeading___Toc113170897 .anchor}**10.2 Occupational and
Residential Exposure** - none

**References:**

*Review of Aquashade Incident Reports, Chemicals #110303, #110301, and
#110302*, DP Barcode: D302184, Jerome Blondell, 08/22/05.

*Aquashade: Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document;*
DP Barcode: 302180, Wade Britton, 09/13/05.

*Aquashade: Revised Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document;*
DP Barcode: D321915; W. Britton; 09/27/05.

**Toxicity References:**

BIBRA. 1999. BIBRA International Ltd. Toxicity profile: Brilliant Blue
FCF, 3^rd^ ed. Carshalton, Surrey: BIBRA International Ltd., 11 pp.

Borzelleca, J.F. and J.B. Hallagan. 1988a. Chronic
toxicity/carcinogenicity studies of FD&C Yellow No. 5 (tartrazine) in
rats. Fd. Chem. Toxicol. 26(3):179-187.

Borzelleca, J.F. and J.B. Hallagan. 1988b. A chronic
toxicity/carcinogenicity study of FD&C Yellow No. 5 (tartrazine) in
mice. Fd. Chem. Toxicol. 26(3):189-194.

Borzelleca, J.F., K. Depukat, and J.B. Hallagan. 1990. Lifetime
toxicity/carcinogenicity studies of FD&C Blue No. 1 (Brilliant Blue FCF)
in rats and mice. Fd. Chem. Toxicol. 28:221-234.

Brown, J.P., G.W. Roehm, and R.J. Brown. 1978. Mutagenicity testing of
certified food colors and related azo, xanthene and triphenylmethane
dyes with the Salmonella/microsome system. Mutat. Res. 56:249-271.

Collins, T.F.X., T.N. Black, L.H. Brown, et al. 1990. Study of the
teratogenic potential of FD&C Yellow No. 5 when given by gavage to rats.
Fd. Chem. Toxic. 28(12):821-827.

Collins, T.F.X., T.N. Black, M.W. O\'Connell, Jr., et al. 1992. Study of
the teratogenic potential of FD&C Yellow No. 5 when given in drinking
water. Fd. Chem. Toxic. 30(4):263-268.

FDA. 1982. FD&C Blue No. 1.; Final Rule. 47 FR 42563; September 28, 1982

FDA. 1985. FD&C Yellow No. 5.; Final Rule; Removal of Stay. 40 FR 35774;

September 4, 1985.

IACM. 2004. International Association of Color Manufacturers. Test Plan
and Robust Summaries for C.I. Acid Yellow 23 (FD&C Yellow 5).
<http://www.epa.gov/chemrtk/ciacdylo/c15133tp.pdf>

JECFA. 1964. Joint FAO/WHO Expert Committee on Food Additives.
Tartrazine. WHO Food Additive Series. 66.25/NMRS 38B-JECFA 8/88.
<http://www.inchem.org/documents/jecfa/jeceval/jec_1936.htm>

JECFA. 1969. Joint FAO/WHO Expert Committee on Food Additives.
Toxicological Evaluation of Some Food Colours, Emulsifiers, Stabilizers,
Anti-caking Agents and Certain Other Substances. FAO Nutrition Meetings
Report Series No. 46A . World Health Organization, Geneva.
<http://www.inchem.org/documents/jecfa/jecmono/v46aje08.htm>

Leifer, Kerry. 2004. United States Environmental Protection Agency.
Reassessment of Exemptions from the requirement of a tolerance for the
FDA-certified color additives FD&C Blue No. 1, FD&C Red No. 40, and FD&C
Yellow No. 5.

Sasaki, Y.F., S. Kawaguchi, A. Kamaya, et al. 2002. The comet assay with
8 mouse organs: results with 39 currently used food additives. Mutat.
Res. 519:103-119.

SRC. 2004. Syracuse Research Corporation. Interactive Physical
Properties (PHYSPROP) Database Demo. Search terms: FD&C Blue. No. 1,
FD&C Red No. 40, FD&C Yellow No. 5. (November 28, 2004)
<http://www.syrres.com/esc/physdemo.htm>

**Appendices**

[]{#__RefHeading___Toc113170898 .anchor}**1.0 TOXICOLOGY DATA
REQUIREMENTS**

The requirements (40 CFR 158.340) for food use for erioglaucine and
tartrazine are in Table 1. Use of the new guideline numbers does not
imply that the new (1998) guideline protocols were used.

+-----------------------------------------+-------------+-------------+
| **Test**                                | **          |             |
|                                         | Technical** |             |
+=========================================+=============+=============+
|                                         | *           | **          |
|                                         | *Required** | Satisfied** |
+-----------------------------------------+-------------+-------------+
| 870.1100 Acute Oral Toxicity            | yes         | yes         |
|                                         |             |             |
| 870.1200 Acute Dermal Toxicity          | yes         | yes         |
|                                         |             |             |
| 870.1300 Acute Inhalation Toxicity      | no          | \-          |
|                                         |             |             |
| 870.2400 Primary Eye Irritation         | yes         | yes         |
|                                         |             |             |
| 870.2500 Primary Dermal Irritation      | yes         | yes         |
|                                         |             |             |
| 870.2600 Dermal Sensitization           | yes         | yes         |
+-----------------------------------------+-------------+-------------+
| 870.3100 Oral Subchronic (rodent)       | yes         | yes\*       |
|                                         |             |             |
| 870.3150 Oral Subchronic (nonrodent)    | yes         | yes\*       |
|                                         |             |             |
| 870.3200 21-Day Dermal                  | yes         | yes         |
|                                         |             |             |
| 870.3250 90-Day Dermal                  | no          | \-          |
|                                         |             |             |
| 870.3465 90-Day Inhalation              | no          | \-          |
+-----------------------------------------+-------------+-------------+
| 870.3700a Developmental Toxicity        | yes         | yes         |
| (rodent)                                |             |             |
|                                         | yes         | yes         |
| 870.3700b Developmental Toxicity        |             |             |
| (nonrodent)                             | yes         | yes         |
|                                         |             |             |
| 870.3800 Reproduction                   |             |             |
+-----------------------------------------+-------------+-------------+
| 870.4100a Chronic Toxicity (rodent)     | yes         | yes         |
|                                         |             |             |
| 870.4100b Chronic Toxicity (nonrodent)  | yes         | yes         |
|                                         |             |             |
| 870.4200a Oncogenicity (rat)            | yes         | yes\*\*     |
|                                         |             |             |
| 870.4200b Oncogenicity (mouse)          | yes         | yes\*\*     |
|                                         |             |             |
| 870.4300 Chronic/Oncogenicity           | yes         | yes         |
+-----------------------------------------+-------------+-------------+
| 870.5100 Mutagenicity---Gene Mutation - | yes         | yes         |
| bacterial                               |             |             |
|                                         | no          | \-          |
| 870.5300 Mutagenicity---Gene Mutation - |             |             |
| mammalian                               | no          | \-          |
|                                         |             |             |
| 870.5375 Mutagenicity---Structural      | no          | \-          |
| Chromosomal Aberrations                 |             |             |
|                                         |             |             |
| 870.5385 Mutagenicity---Other Genotoxic |             |             |
| Effects                                 |             |             |
+-----------------------------------------+-------------+-------------+
| 870.6100a Acute Delayed Neurotox. (hen) | no          | \-          |
|                                         |             |             |
| 870.6100b 90-Day Neurotoxicity (hen)    | no          | \-          |
|                                         |             |             |
| 870.6200a Acute Neurotox. Screening     | no          | \-          |
| Battery (rat)                           |             |             |
|                                         | no          | \-          |
| 870.6200b 90 Day Neuro. Screening       |             |             |
| Battery (rat)                           | no          | \-          |
|                                         |             |             |
| 870.6300 Develop. Neuro                 |             |             |
+-----------------------------------------+-------------+-------------+
| 870.7485 General Metabolism             | yes         | yes         |
|                                         |             |             |
| 870.7600 Dermal Penetration             | no          | \-          |
+-----------------------------------------+-------------+-------------+
| Special Studies for Ocular Effects      | no          | \-          |
|                                         |             |             |
| > Acute Oral (rat)                      | no          | \-          |
| >                                       |             |             |
| > Subchronic Oral (rat)                 | no          | \-          |
| >                                       |             |             |
| > Six-month Oral (dog)                  |             |             |
+-----------------------------------------+-------------+-------------+

\*Satisfied by the chronic (rodent) toxicity study-guideline 870.4100a

\*\*Satisfied by the chronic (nonrodent) toxicity study-guideline
870.4100b

\*\*Satisfied by the chronic/oncogenicity study-guideline 870.4300

2.  []{#__RefHeading___Toc113170899 .anchor}**NON-CRITICAL TOXICOLOGY
    STUDIES**

*Chronic toxicity/carcinogenicity studies of FD & C Yellow No. 5
(tartrazine) in rats (870.4300b)*

FD & C Yellow No. 5 was fed to Charles River CD rats as a dietary
mixture in two long-term toxicity/carcinogenicity studies. The studies
were conducted with an in utero phase in which the compound was
administered to the F~0~ generation rats (60/sex/group) at levels of
0.0, 0.1, 1.0 or 2.0% (\'original study\') equal to 0, 53, 1056, 2641
mg/kg/day and 0, 67, 670, 1339, 3348 mg/kg/day, in males and females,
respectively. A second study ('high-dose study') was conducted with 0.0
or 5.0% tartrazine equal to 2641 or 3348 in males and females,
respectively. The concurrent control groups received the basal diet.
After random selection of the F1 animals, the long-term phase was
initiated using the same dietary levels with 70 rats of each sex/group,
including the three control groups. The maximum exposure to the coloring
was 113 and 114 wk for males and females, respectively, in the
\'original\' study and 122 and 125 wk for males and females,
respectively, in the \'high-dose\' study. No compound-related effects
were noted. The no-adverse-effect level found in this study was 5.0% in
the diet providing an average intake of 2641 and 3348 mg/kg/day for male
and female rats, respectively (Borzelleca et al, 1988b).

*Chronic toxicity/carcinogenicity studies of FD & C Blue No. 1
(erioglaucine) in mice (870.4300d)*

Charles River CD-1 mice (60/sex/group) were fed FD & C Blue No. 1 as a
dietary admixture at levels of 0.0%, 0.5%, 1.5% or 5.0% in a lifetime
toxicity/carcinogenicity study. The maximum exposure time was 104 wk for
both males and females. No consistent, significant compound-related
adverse effects were noted. The no-observed-adverse-effect level
established in this study is a dietary concentration of 5.0% (7354
mg/kg/day and 8966 mg/kg/day for male and female mice, respectively
(Borzelleca et al, 1990)

*Chronic toxicity/carcinogenicity study of FD & C Yellow No. 5
(tartrazine) in mice (870.4300e)*

Charles River CD-1 mice were fed FD & C Yellow No. 5 in the diet at
levels of 0.0, 0.5, 1.5 or 5.0% in a long-term toxicity/carcinogenicity
study. Each group consisted of 60 males and 60 females. Maximum exposure
was 104 wk for both males and females. No consistent, significant
compound-related adverse effects were noted. The no-observed-adverse
effect level established in this study was 5.0% (8103 mg/kg/day and 9735
mg/kg/day for male and female mice, respectively (Borzelleca et al,
1988b).

[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term=%22Borzelleca+JF%22%5BAuthor%5D](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Search&term="Borzelleca+JF"%5BAuthor%5D)

*21-Day Dermal (rabbits)*

In a subchronic dermal toxic: (MRID 43410101), 54 female albino rabbits
were divided into 6 treatment groups of 9 animals each. Three animals
with intact skin and 3 animals with abraded skin per group were given 20
treatments over 2 days. An additional 3 animals with intact skin per
group received 65 doses over 28-days. An additional 3 animals with
intact skin per group received 65 doses over a 91 day period. Treatments
were composed of the following: 1) water, 2) USP White Ointment, 3) 0.1%
a.i. (Acid Blue 9) in water, 4) 1.0% a.i. in water, 5) 0.1% a.i. in USP
ointment and 6) 1.0% a.i. in USP White Ointment. Treatments were applied
at a rate of 0.5 g or 0.5 ml per kg. of body weight (representing
approximately 0.5 and 5.0 mg/kg/day).

There were no treatment related effects on survival, clinical signs,
body weight, hematology, urinalysis, organ weight or pathology. The
NOAEL is \>5.0 mg/kg/day females (HDT). The LOAEL was not determined.

The study is acceptable/non-guideline. It satisfies the requirement for
a guideline series 82-2 subchronic dermal toxicity study in rabbits.

*Bacterial reverse mutation test (Ames Test)*

Thirty-seven azo, xanthene and triphenylmethane dyes including FD& C
colors currently approved for use in the U.S.A. and a number of
de-listed food colors were tested in the Salmonella/microsome system. In
addition to direct plate tests with five tester strains (TA1535, TA100,
TA1537, TA1538, TA98), the azo dyes were also assayed after chemical
reduction to their component amines. Also, a selected group of azo dyes
was subjected to liquid tests (both aerobic with microsomes and
anaerobic) and to plate tests involving initial 16 h anaerobic
incubations to facilitate microbial reduction of the azo bond. None of
the presently listed FD and C colors was mutagenic in any of the test
modifications. Among formerly listed colors only Butter Yellow
(p-dimethylaminoazobenzene), a recognized animal carcinogen, was
mutagenic in the aerobic liquid test. Several other azo dyes were either
directly mutagenic, viz. Acid Alizarin Yellow R and Alizarin Yellow GG;
required microsomal activation, viz. Acid Alizarin Red B and Methyl Red;
or required chemical reduction and microsomal activation, viz. Acid
Alizarin Violet N and Sudan IV. Of the non-azo dyes tested only two
xanthene dyes appeared to be mutagenic, viz.
9-(2-sulfophenyl)-6-hydroxy-3-isoxanthenone and its 2,4,5,7-tetrabromo

derivative (Brown et al, 1978).

*Metabolism*

Erioglaucine was administered orally to rats as a 2% aqueous solution at
a level of 200 mg/rat. Almost the entire amount was excreted unchanged
in the feces within 40 h after administration. In a later investigation,
the presence of the color in the bile was observed in rats, rabbits and
dogs after oral administration. In the case of the dog, the amount did
not exceed 5% of the dose administered (Hess & Fitzhugh, 1953; 1954;
1955). Administration of an aqueous solution of the color by stomach
tube resulted in 89 % excretion in the feces; none was found in the
urine. After subcutaneous injection of 80-100 mg some 79% was excreted;
77% appeared in the feces and 2.5% in the urine (Imperial Chemical
Industries, 1958).

3.  []{#__RefHeading___Toc113170900 .anchor}**TOLERANCE REASSESSMENT**

+-------------+-----------+----------+--------------------------------+
| > **Active  | >         | > **T    | **Comment**                    |
| > i         | **Current | olerance |                                |
| ngredient** | > To      | > Reasse |                                |
|             | lerance** | ssment** |                                |
+-------------+-----------+----------+--------------------------------+
| **Tolerance |           |          |                                |
| Exemption   |           |          |                                |
| Listed      |           |          |                                |
| Under 40    |           |          |                                |
| CFR         |           |          |                                |
| §           |           |          |                                |
| 180.1074:** |           |          |                                |
+-------------+-----------+----------+--------------------------------+
| > F.D.&C.   | >         | >        | In 1982, based on Aquashade\'s |
| > Blue No.  |  Exempted | Exempted | low toxicity profile, EPA      |
| > 1         | > from    | > from   | waived residue chemistry data  |
|             | > the     | > the    | requirements and established   |
|             | > re      | > req    | an exemption from the          |
|             | quirement | uirement | requirement of a tolerance for |
|             | > of a    | > of a   | erioglaucine (F.D&C. Blue      |
|             | >         | > t      | No. 1) when used as an aquatic |
|             | tolerance | olerance | plant control agent.           |
|             | > when    | > when   | Tartrazine, when used as a     |
|             | > used as | > used   | dye, had previously been       |
|             | > an      | > as an  | exempted from the requirement  |
|             | > aquatic | >        | of a tolerance as an inert (or |
|             | > plant   |  aquatic | occasionally as an active)     |
|             | > control | > plant  | ingredient in pesticide        |
|             | > agent.  | >        | formulations applied to        |
|             |           |  control | growing crops or to raw        |
|             |           | > agent. | agricultural commodities after |
|             |           |          | harvest under 40 CFR           |
|             |           |          | 180.1001(c) (currently 40 CFR  |
|             |           |          | 180.910). HED has determined   |
|             |           |          | that the existing exemption    |
|             |           |          | for tartrazine as an inert     |
|             |           |          | ingredient is not sufficient   |
|             |           |          | to satisfy reregistration      |
|             |           |          | requirements for the active    |
|             |           |          | ingredient when used as an     |
|             |           |          | aquatic plant control agent.   |
|             |           |          |                                |
|             |           |          | Therefore, HED recommends that |
|             |           |          | the exemption for erioglaucine |
|             |           |          | at 40 CFR 180.1074 be revised  |
|             |           |          | to include both erioglaucine   |
|             |           |          | (F.D.&C. Blue No. 1) and       |
|             |           |          | tartrazine (F.D.&C. Yellow No. |
|             |           |          | 5).                            |
+-------------+-----------+----------+--------------------------------+