Office of Water

Office Science and

Technology EPA 820-D- 14

- 09 2

May 2014



# Draft Update of Human Health

Ambient Water Quality Criteria:

4,4'- DDD

72

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May 2014



# Update of Human Health

Ambient Water Quality Criteria:

4,4'- DDD

72

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Draft

Office of Science and Technology

Office of Water

U.S. Environmental Protection Agency

Washington, DC 204604΂4͛ -DDD 72

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Table o f Contents

I ntroduction: Plan and Scope of Update

Problem Formulation

Criteria Formulas- Analysis Plan

Exposure Factors

Body Weight

Drinking Water Intake

Fish Consumption Rate

Bioaccumulation Factor

Hazard Identification and Dose Response: Cancer Slope Factor

Criteria Derivation- Analysis

Criteria Characterization

Chemical Name / Synonyms

References

Introduction: Plan and Scope of Update

Human health ambient water quality criteria (AWQC) are numeric values for pollutant

concentrations in ambient waters that the U.S. Environmental Protection Agency (EPA)

consider s to be protective of human health. EPA periodically revises water quality criteria to

ensure that they reflect the latest scientific knowledge. The current revisions of the criteria for

4΂4͛ -DDD * , contained in this document, incorporate updated information regarding body

weight, drinking water intake, fish consumption rate, and bioaccumulation. Updated body

weight and drinking water intake data a ι͋ Ί͇͋ΣχΊ͕Ί͇͋ ΊΣ E ́!͛ν ·EϳζΪνϢι͋ F̯̽χΪιν H̯Σ͇̼ΪΪΙ ́ 2011

E͇ΊχΊΪΣ͛ (Ε΋E ́!΂ 2011). The bioaccumulation factor ͇̯χ̯ Ίν Ϣζ͇̯χ͇͋ ϢνΊΣͽ E ́!͛ν Estimation

Program Interface (EPI) Suite modeling program (USEPA, 2012a). The overall fish consumption

rate and trophic level breakdowns are updated using E ́!͛ν ·EνχΊ΢̯χ͇͋ FΊν· ΪΣνϢ΢ζχΊΪΣ ·̯χ͋ν

for the U.S. Population and Selected Subpopulations (NHANES 2003- 2010)͛ (Ε΋E ́!΂ 2014)

. Unless otherwise specified, all sources of information used in this update are from peer

reviewed sources.

Note that the term "water quality criteria" can carry one of two possible meanings,

depending on the section of the Clean Water Act (CWA) associated with the particular criteria

̯χ ΊννϢ͋ ̈́ ͞Ρ̯χ͋ι θϢ̯ΜΊχΘ ̽ιΊχ͋ιΊ̯͟ ΢̯Θ ι͕͋͋ι χΪ Σ̯χΊΪΣ̯Μ Ϯ̯χ͋ι θϢ̯ΜΊχΘ ̽ιΊχ͋ιΊ̯ ι͋̽Ϊ΢΢͋Σ͇̯χΊΪΣν

issued under CWA § 304 ̈́ ͞Ρ̯χ͋ι θϢ̯ΜΊχΘ ̽ιΊχ͋ιΊ̯͟ ΢̯Θ ̯ΜνΪ ι͕͋͋ι χΪ Ϯ̯χ͋ι θϢ̯ΜΊχΘ ̽ιΊχ͋ιΊ̯

components of water quality standards adopted by states, territories, or authorized tribes

under CWA § 303.

National ambient water quality criteria recommendations for human health are issued

by the EPA under CWA § 304. They are based on the latest scientific information on the

relationship between the effects of a constituent concentration and human health. Protective

* This compound is not currently registered as a pesticide by EPA.

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assumptions are made regarding the potential human exposure intakes. These criteria do not

reflect consideration of non-human health endpoints or economic impacts. Nor do they reflect

the technological feasibility of meeting the chemical concentrations in ambient water. National

ambient water quality criteria recommendations for human health are not automatically

incorporated into water quality standards adopted by states, territories, or authorized tribes.

Rather, they provide scientific information to states, territories and authorized tribes to assist

them in adopting ambient water quality criteria for human health in water quality standards

that meet CWA requirements. National ambient water quality criteria recommendations for

human health are not regulations themselves and they do not impose legally binding

requirements on EPA, states, territories, authorized tribes, or the public. States, territories, and

authorized tribes have the discretion to adopt, where appropriate, other scientifically

͇͕͋͋ΣνΊ̼Μ͋ Ϯ̯χ͋ι θϢ̯ΜΊχΘ ̽ιΊχ͋ιΊ̯ χ·̯χ ͇Ί͕͕͋ι ͕ιΪ΢ E ́!͛ν Σ̯χΊΪΣ̯Μ ̯΢̼Ί͋Σχ ι͋̽Ϊ΢΢͋Σ͇͇͋ ̽ιΊχ͋ιΊ̯

for human health.

Ambient water quality criteria components of water quality standards are generally

adopted by the states, territories, and authorized tribes themselves, under § 303(c)(2). (In

certain circumstances EPA also may promulgate this type of criterion itself, pursuant to

§303(c)(4)). State ambient water quality criteria for human health represent a quality of water

that sufficiently protects human health to support a designated use of the state, territory, or

authorized tribe. Such criteria may be expressed in terms of constituent concentrations, levels,

or narrative statements. Once ambient water quality criteria for human health are adopted by a

state, territory, or authorized tribe into their water quality standards, they provide a basis for

controlling discharges or releases of pollutants, for developing permit limits, assessing waters,

and developing total maximum daily loads (TMDLs) for waters that do not meet the water

quality standard. Ambient water quality criteria for human health have a regulatory impact

once they have been adopted into water quality standards by the state, territory, or authorized

tribe under § 303(c)(2) (or alternatively issued by EPA pursuant to § 303(c)(4)).

The water quality criteria at issue in this document are national ambient water quality

criteria recommendations for human health issued under CWA § 304. Unless expressly

ΊΣ͇Ί̯̽χ͇͋ Ϊχ·͋ιϮΊν͋΂ ̯ΜΜ ι͕͋͋ι͋Σ̽͋ν χΪ ̽͞ιΊχ͋ιΊ̯΂͟ ͞Ϯ̯χ͋ι θϢ̯ΜΊχΘ ̽ιΊχ͋ιΊ̯΂͟ ̯͞΢̼Ί͋Σχ Ϯ̯χ͋ι θϢ̯ΜΊχΘ

̽ιΊχ͋ιΊ̯ (!ΡΆ) ι͋̽Ϊ΢΢͋Σ͇̯χΊΪΣν΂͟ Ϊι νΊ΢ΊΜ̯ι ϭ̯ιΊ̯Σχν χ·͋ι͋Ϊ͕΂ ̯ι͋ ι͕͋͋ι͋Σ̽͋ν χΪ Σ̯χΊΪΣ̯Μ

ambient water quality criteria recommendations for human health.

Problem Fo rmulation

Problem formulation provides a strategic framework for water quality criteria

development by focusing on the most relevant endpoints and increasing the transparency of

the effects assessment process. The structure of this criteria document is consistent with U.S.

E ́!͛ν · Framework for Human Health Risk Assessment to Inform Decision Making ͛ (USEPA,

2012 b ).

In the development of AWQC, EPA currently follows the deterministic assessment

methodology outlined in E ́!͛ν · Methodology for Deriving Ambient Water Quality Criteria for

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the Protection of Human Health (2000) ͛ (USEPA, 2000), hereafter known as the 2000

Methodology. For the development of criteria for carcinogens that express a non-threshold,

linear dose response, the 2000 Methodology takes into consideration exposure factors (body

weight, drinking water intake, fish consumption, and bioaccumulation), the increased cancer

risk due to exposure to the pollutant, and a 10 -6 (or 1 in 1,000,000) risk level for the general

population. The 10 -6 risk level utilized in the derivation of the AWQC represents the water

̽ΪΣ̽͋Σχι̯χΊΪΣ χ·̯χ ϮΪϢΜ͇ ̼͋ ͋ϳζ͋̽χ͇͋ χΪ ΊΣ̽ι̯͋ν͋ ̯Σ ΊΣ͇ΊϭΊ͇Ϣ̯Μ͛ν ΜΊ͕͋χΊ΢͋ cancer risk from

exposure to the particular pollutant by no more than one chance in one million, regardless of

the additional lifetime cancer risk due to exposure, if any, to that particular substance from

other sources. States and authorized tribes may consider adjusting exposure assumptions and

related model inputs according to guidance in the 2000 Methodology, to assure that

subpopulations are adequately protected if data are available.

Criteria Fo rmulas- Analysis Plan

The following formulas are used to develop E ́!͛ν Ρ! ΋͋̽χΊ on 304(a) human health

ambient water quality criteria. EPA develops criteria for ambient waters typically considering

two routes of exposure. The first formula can be used to derive a human health criterion that

assumes exposure through both the consumption of water and the consumption of aquatic

organisms. The second formula can be used to derive a criterion that assumes exposure

through the consumption of aquatic organisms, but not water. The use of one criterion over the

other depends on the designated use of the water bodies in question (i.e. drinking water source

and/or fishable waters).

EPA recommends inclusion of the drinking water exposure pathway for ambient surface

waters where drinking water is a designated use for the following reasons: (1) Drinking water is

a designated use for surface waters under the CWA, and therefore, criteria are needed to

assure that this designated use can be protected and maintained. (2) Although rare, there are

some public water supplies that provide drinking water from surface water sources without

treatment. (3) Even among the majority of water supplies that do treat surface waters, existing

treatments may not necessarily be effective for reducing levels of particular contaminants. (4)

͜Σ ̽ΪΣνΊ͇͋ι̯χΊΪΣ Ϊ͕ χ·͋ !ͽ͋Σ̽Θ͛ν goals of pollution prevention, ambient waters should not be

contaminated to a level where the burden of achieving health objectives is shifted away from

those responsible for pollutant discharges and placed on downstream users to bear the costs of

upgraded or supplemental water treatment (USEPA, 2000).

EPA recommends the organism only criterion in those cases where the designated uses

of a water body include only supporting fishable uses under Section 101(a) of the CWA, and

thus, fish or shellfish for human consumption, but not as a drinking water supply source (e.g.,

non-potable estuarine waters) (USEPA, 2000).

3Where:

AWQC = ambient water quality criteria (at the 10 -6 risk level)

CSF = cancer slope factor

BW = body weight

DI = drinking water intake

∑ 4 νϢ΢΢̯χΊΪΣ Ϊ͕ ϭ̯ΜϢ͋ν ͕Ϊι ̯θϢ̯χΊ̽ χιΪζ·Ί̽ Μ͋ϭ͋Μν (Αͫ) Ϯ·͋ι͋ χ·͋ Μ͋χχ͋ι ͞Ί͟ νχ̯Σ͇ν ͕Ϊι χ·͋

i=2 trophic levels to be considered, starting with TL 2 and proceeding to TL 4

FCR i = fish consumption rate for aquatic trophic levels 2, 3, and 4

BAF i = bioaccumulation factor for aquatic trophic levels 2, 3, and 4

† 10 -6 or 1 in 1,000,000 risk level for the general population

‡ 1000 μg/mg is used to convert the units of mass into micrograms from milligrams. 4΂4͛ -DDD 72

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The formulas for deriving the criteria values are as follows (USEPA, 2000):

For consumption of water and organisms:

(Eq. 1) AWQC (μg/L) = [10 -6 † / CSF (kg·d/mg)] × BW (kg) × 1000 (μg/mg) ‡

4 DI (L/d) + ∑ (F· Ί (Ιͽ ͇) ∓ !F Ί (ͫ Ιͽ))

Ί 2

For consumption of organisms only:

(Eq. 2) AWQC (μg/L) = [10 -6 † / CSF (kg·d/mg)] × BW (kg) × 1000 (μg/mg) ‡

4 ∑ (F· Ί (Ιͽ ͇) ∓ !F Ί (ͫ Ιͽ))

Ί 2

The following sections identify each of the components of the formulas for the human

health ambient water quality criteria and provide reference sources, previously used values

when available, and the values to be used in the updated criteria.

Exposure Factors:

Body Weight

The updated recommended body weight (BW) is 80 kg which represents the mean

weight for adults 21 years of age and older. Α·Ίν ι͋̽Ϊ΢΢͋Σ͇̯χΊΪΣ Ίν ͕ΪϢΣ͇ ΊΣ E ́!͛ν · Exposure

F̯̽χΪιν H̯Σ͇̼ΪΪΙ ́ 2011 E͇ΊχΊΪΣ͛ in Chapter 8. It was based on data derived from the National

Health and Nutrition Examination Survey (NHANES) 1999

− 2006 (USEPA, 2011). This body

weight replac es the recommended standard weight for adults of 70 kg that was described in

the 2000 Methodology which was approximated from the mean body weight of adults from the

National Health and Nutrition Examination Survey (NHANES) III database (1988-1994) and a

1989 study by the National Cancer Institute (USEPA, 2000).

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Drinking Water Intake

T he updated drinking water intake (DI) is 3 L/day, rounded from 3.091 L/day for

consumer-only estimates of direct and indirect water ingestion based on NHANES 2003-2006

data for all sources of water at the 90 th ζ͋ι̽͋ΣχΊΜ͋ ͕Ϊι ̯͇ϢΜχν (≥21 Θ̯͋ιν of age) (USEPA, 2011).

Direct water is defined as water ingested directly as a beverage (from all sources); indirect

water is defined as water added in the preparation of food or beverages, not including indirect

consumption of bottled water. This recommended value Ίν ͕ΪϢΣ͇ ΊΣ E ́!͛ν · Exposure Factors

H̯Σ͇̼ΪΪΙ ́ 2011 E͇ΊχΊΪΣ͛ in Table 3- 36. It replac es the drinking water intake standard of 2 L/day

described in the 2000 Methodology which represented the 86 th percentile for adults 20 years

̯Σ͇ ΪΜ͇͋ι ΊΣ χ·͋ Ε΋ D͋ζ̯ιχ΢͋Σχ Ϊ͕ !ͽιΊ̽ϢΜχϢι͋͛ν 1994 -96 Continuing Survey of Food Intake by

Individuals (CSFII) analysis or the 88 th percentile of adults in the National Cancer Institute study

of the 1977-78 Nationwide Food Consumption Survey (USEPA, 2000).

Fish Consumption Rate

The updated fish consumption rate (FCR) for the general adult population is 22

grams/day (0.022 kg/day) (USEPA, 2014: see Table 9a ). It represents the 90 th percentile per

capita consumption rate of freshwater and estuarine fish for the U.S. adult population 21 years

of age and older based on the Centers for Disease Control and Prevention (CDC) National

Health and Nutrition Examination Surveys (NHANES) conducted from 2003-2010. It replaces the

FCR default of 17.5 grams/day, which represented an estimate of the 90th percentile per capita

consumption rate of freshwater and estuarine fish for the U.S. adult population based on the

Ε ̈́΋ ̈́ D͋ζ̯ιχ΢͋Σχ Ϊ͕ !ͽιΊ̽ϢΜχϢι͋͛ν (Ε΋D!͛ν) ΪΣχΊΣϢΊΣͽ ΋Ϣιϭ͋Θ Ϊ͕ FΪΪ͇ ͜Σχ̯Ι͋ by Individuals

(CSFII) 1994-96 data (USEPA, 2002a).

As recommended in the 2000 Methodology, this update to the criteria distinguishes a

trophic level (TL) breakdown of the fish consumption rate to provide a better representation of

͇Ί͋χ̯ιΘ ͋ϳζΪνϢι͋ χΪ ͕Ίν· ̯χ ΢ϢΜχΊζΜ͋ χιΪζ·Ί̽ Μ͋ϭ͋Μν ̈́ !Σ Ϊιͽ̯ΣΊν΢͛ν χιΪζ·Ί̽ ζ osition in the aquatic

food web can have an important effect on the magnitude of bioaccumulation of certain

chemicals. The trophic levels are numbered 2, 3, and 4 and account for different categories of

fish and shellfish species based on their position in the aquatic food web. TL2 accounts for

benthic filter feeders, TL3 accounts for forage fish, and TL4 accounts for predatory fish.

In order to derive the trophic level breakdown of the 22 grams/day freshwater and

estuarine FCR, the trophic level specific freshwater and estuarine FCR data sets for adults 21

years of age and older were identified (USEPA, 2014: see Tables 16a, 17a, and 18a ). In each

χιΪζ·Ί̽ Μ͋ϭ͋Μ νζ͋̽Ί͕Ί̽ ͇̯χ̯ ν͋χ΂ χ·͋ ι̯χΊΪ Ϊ͕ χ·̯χ χιΪζ·Ί̽ Μ͋ϭ͋Μ͛ν 90 th percentile FCR compared to

the summation of all three trophic level specific 90 th percentile FCRs was applied to the 22

grams/day FCR used in this update. The trophic level ratios were calculated as follows: TL ratio

= 90 th percentile FCR for the TL divided by the sum of the 90 th percentile FCRs for all TLs. TL2 =

7.6/21.3 = 0.3568 (35.68%), TL3 = 8.6/21.3 = 0.4038 (40.38%), and TL4 = 5.1/21.3 = 0.2394

(23.94%). Applying these ratios to the updated FCR of 22 grams/day result in trophic level

breakdowns of TL2 = 8 grams/day (0.008 kg/day); TL3 = 9 grams/day (0.009 kg/day); and TL4 = 5

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grams/day (0.005 kg/day). These resulting trophic level FCRs are well within the confidence

ΊΣχ͋ιϭ̯Μν ͕Ϊι ̯͋̽· Ϊ͕ χ·͋ χιΪζ·Ί̽ Μ͋ϭ͋Μ νζ͋̽Ί͕Ί̽ ͇ΊνχιΊ̼ϢχΊΪΣν͛ 90 th percentiles and add to the total

of 22 grams/day (USEPA, 2014).

Bioaccumulation Factor

Several attributes of the bioaccumulation process are important to understand when

deriving national BAFs for use in setting national 304(a) criteria. First, the term

̼͞ΊΪ̯̽̽Ϣ΢ϢΜ̯χΊΪΣ͟ ι͕͋͋ιν χΪ χ·͋ Ϣζχ̯Ι͋ ̯Σ͇ ι͋χ͋ΣχΊΪΣ of a chemical by an aquatic organism

from ̯ΜΜ νϢιιΪϢΣ͇ΊΣͽ ΢͇͋Ί̯ (͋ ̈́ͽ ̈́΂ Ϯ̯χ͋ι΂ ͕ΪΪ͇΂ ν͇͋Ί΢͋Σχ) ̈́ Α·͋ χ͋ι΢ ̼͞ΊΪ̽ΪΣ̽͋Σχι̯χΊΪΣ͟ ι͕͋͋ιν χΪ

the uptake and retention of a chemical by an aquatic organism from water only. For some

chemicals (particularly those that are highly persistent and hydrophobic), the magnitude of

bioaccumulation by aquatic organisms can be substantially greater than the magnitude of

bioconcentration. Thus, an assessment of bioconcentration alone may underestimate the

extent of accumulation in ̯θϢ̯χΊ̽ ̼ΊΪχ̯ ͕Ϊι χ·͋ν͋ ̽·͋΢Ί̯̽Μν ̈́ !̽̽Ϊι͇ΊΣͽΜΘ΂ E ́!͛ν ͽϢΊ͇͋ΜΊΣ͋ν

presented in the 2000 Methodology emphasize the measurement or estimation of chemical

bioaccumulation by aquatic organisms (USEPA, 2000).

The bioaccumulation factors (BAF) have been estimat ed ϢνΊΣͽ E ́!͛ν EνχΊ΢̯χΊΪΣ  ́ιΪͽι̯΢

Interface (EPI) Suite (USEPA, 2012a). Α·͋ F!FTM ζιΪͽι̯΢ ϮΊχ·ΊΣ E ́͜ ΋ϢΊχ͋ estimates fish

bioaccumulation factors using octanol-water partition coefficients (K OW ) and biotransformation

data from a model designed by Arnot and Gobas (2003). The model includes mechanistic

processes for bioaccumulation such as chemical uptake from the water at the gill surface and

from the diet, chemical elimination at the gill surface, fecal egestion, growth dilution and

metabolic biotransformation. Other processes included in the calculations are bioavailability in

the water column (only the freely dissolved fraction can bioconcentrate) and absorption

efficiencies at the gill and in the gastrointestinal tract. The model requires the octanol-water

partition coefficient (K OW ) of the chemical and the normalized whole-body metabolic

biotransformation rate constant as input parameters to predict BAF values. Model predictions

may be highly uncertain for chemicals that have estimated log K OW values > 9. The model is not

recommended at this time for chemicals that appreciably ionize, for pigments and dyes, or for

perfluorinated substances (USEPA, 2012a).

For 4΂4͛ -DDD

, BAFs have been estimated using the EPI Suite model (USEPA, 2012a) as

described above for trophic levels 2, 3, and 4. The estimated lower (TL2), mid (TL3), and upper

(TL4) trophic level BAFs for 4΂4͛ -DDD (log K OW = 6.02 ) are 370,200 L/kg, 678,800 L/kg, and

1,636,000 L/kg wet-weight, respectively. These estimated BAFs replace the bioconcentration

factor (BCF) of 53,600 L/kg used in the 2002 criteria derivations, which was based on a BCF for

DDT calculated from measured steady-state bioconcentration studies, and represented all

trophic levels (USEPA, 19 80)

.

64΂4͛ -DDD 72

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Hazard Identification and Dose R esponse: Cancer Slope Facto r

4΂4 ͛ -DDD is characterized as a class B2 probable human carcinogen following the 1986

EPA Guidelines for Carcinogen Risk Assessment (USEPA, 1986; USEPA, 1991).

The cancer slope factor (CSF) is an upper bound, approximating a 95% confidence limit,

on the increased cancer risk from a lifetime oral exposure to an agent. Α·͋ ΋F ͕Ϊι 4΂4͛ -DDD is

2.4 × 10 – 1 per mg/kg·day (0.24 per mg/kg·day) (USEPA, 1988).

The principle study by Tomatis et al. (1974) chosen to calculate the cancer slope factor

for 4΂4͛ -DDD was based on development of liver tumors in mice orally exposed to 4΂4͛ -DDD

(USEPA, 1988).

Criteria Derivation- Analysis

Table 1 summarizes model inputs used to derive the 2014 updated human health

ambient water quality criteria for 4΂4͛ -DDD. Criteria calculations are presented below. These

updated 4΂4͛ -DDD criteria recommendations are based on the 2000 Methodology and updated

exposure assumptions as described above (Exposure Factors).

Table 1. Summary of input parameters for 2014 human health ambient water quality criteria

for 4΂4͛ -DDD

Component Value Source Input Characterization

CSF 0. 24 per mg/ kg·day USEPA,

1988 an upper bound, approximating a 95%

confidence limit, on the increased cancer risk

from a lifetime exposure to an agent by

ingestion

BW 80 kg USEPA,

2011 mean weight for adults (≥21 Θ̯͋ιν Ϊ͕ ̯ͽ͋)

DI 3 L/day USEPA,

2011 90 th ζ͋ι̽͋ΣχΊΜ͋ ͕Ϊι ̯͇ϢΜχν (≥21 Θ̯͋ιν of age)

FCR TL2 0.00 8 kg/day

USEPA

,

2014 90 th percentile consumption rate for the U.S.

̯͇ϢΜχ ζΪζϢΜ̯χΊΪΣ (≥21 Θ̯͋ιν Ϊ͕ ̯ͽ͋) TL3 0.00 9 kg/day

TL4 0.00 5 kg/day

BAF TL2 370,200 L/kg

USEPA,

2012 a EPI Suite K OW model estimated steady

- state BAF

values for non

- ionic organic chemicals in 3

general trophic levels of fish in temperate

environments (10°C) TL3 678,800 L/kg

TL4 1,636,000 L/kg

For consumption of water and organisms:

7 AWQC (μg/L) = [10 -6 / CSF (kg·d/mg)] × BW (kg) × 1000 (μg/mg)

4 DI (L/d) + ∑ (F·

Ί (Ιͽ ͇) ∓ !F

Ί (ͫ Ιͽ))

Ί 2= 10 -6 / 0. 24 kg·d/mg × 80 kg × 1000 μg/mg

3 L/d + ((0.008 kg/d × 370,200 L/kg) + (0.009 kg/d × 678,800 L/kg) + (0.005 kg/d × 1,636,000 L/kg))

= 0.00001 93 μg /L (rounded to 0.0000 19 μg/L because of significant figures, see 2000 Methodology) 4΂4͛ -DDD 72

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For consumption of organisms only:

AWQC (μg/L) = [10 -6 / CSF (kg·d/mg)] × BW (kg) × 1000 (μg/mg)

4 ∑ (F·

Ί (Ιͽ ͇) ∓ !F

Ί (ͫ Ιͽ) )

Ί 2

= 10 -6 / 0. 24 kg·d/mg × 80 kg × 1000 μg/mg

(0.008 kg/d × 370,200 L/kg) + (0.009 kg/d × 678,800 L/kg) + (0.005 kg/d × 1,636,000 L/kg)

= 0.00001 93 μg /L (rounded to 0.0000 19 μg/L because of significant figures, see 2000 Methodology)

The updated magnitude of the human health ambient water quality criteria for 4΂4͛ -DDD

at the 10 -6 risk level are 0.0000 19 μg/L (water and organism) and 0.0000 19 μg/L (organism

only) (Table 2). These updated criteria replace the previously published values (USEPA, 2002b).

Table 2. ΋Ϣ΢΢̯ιΘ Ϊ͕ E ́!͛ν ζι͋̽ΊΪϢνΜΘ ι͋̽Ϊ΢΢͋Σ͇͇͋ (2002) ̯Σ͇ updated ( 2014 ) human health

ambient water quality criteria for 4΂4͛ -DDD

2002 Human Health AWQC 2014 Human Health AWQC

Water and Organism 0.00031 μg/L 0.0000 19 μg/L ( 1.9 ×10 - 5 μg/L)

Organism Only 0.00031 μg/L 0.0000 19 μg/L ( 1.9 ×10 - 5 μg/L)

These AWQC are meant to be protective of human health for the general adult

population from an increased cancer risk due to exposure to 4΂4͛ -DDD at a 10 -6 or 1 in

1,000,000 risk level. The 10 -6 risk level associated with the AWQC represents the concentration

χ·̯χ ϮΪϢΜ͇ ̼͋ ͋ϳζ͋̽χ͇͋ χΪ ΊΣ̽ι̯͋ν͋ ̯Σ ΊΣ͇ΊϭΊ͇Ϣ̯Μ͛ν ΜΊ͕͋χΊ΢͋ cancer risk from exposure to the

particular pollutant by no more than one chance in one million, regardless of the additional

lifetime cancer risk due to exposure, if any, to that particular substance from other sources.

Criteria Characterization

The updated 2014 human health AWQC for 4΂4͛

- DDD take into account current data on

health effects and exposure input parameters, consistent with the 2000 Methodology. The

updated 2014 human health AWQC for 4΂4͛ -DDD are about an order of magnitude lower than

E ́!͛ν ζι͋ϭΊΪϢνΜΘ ι͋̽Ϊ΢΢͋Σ͇͇͋ 2002 ̽ιΊχ͋ιΊ̯ ; i.e. the water-and-organism criterion decreased

from 0.00031 to 0.0000 19 μg/L and the organism-only criterion decreased from 0.00031 to

0.0000 19 μg/L (Table 2). The following paragraphs describe the individual influence of each of

the revised model inputs and exposure assumptions on the overall change in value

.

84΂4͛ -DDD 72

- 54 -8

Body Weight

E ́ !͛ν Ϣζ͇̯χ͇͋ !ΡΆ ̯ννϢ΢͋ ̯ ·Ίͽ·͋ι body weight compared to the previously

recommended 2002 criteria, reflecting a recent rise in average adult body weight among the

U.S. population. The updated body weight assumption of 80 kg based on recent survey data

from the 1999

− 2006 NHANES data is 10 kg greater than the previous recommendation of 70 kg.

Assuming all other input parameters remain constant, a higher average body weight in the

AWQC calculations (Eq. 1 and 2 above) results in higher AWQC. That is, as body weight

increases, the level of a contaminant in water at or below which negative health effects are not

anticipated from a lifetime of exposure also increases.

Drinking Water Intake

The updated drinking water intake assumption is 3 L/day, which is higher than the

previously recommended rate of 2 L/day. Assuming all other input parameters remain constant,

a higher drinking water intake assumption in the AWQC calculations (Eq. 1 and 2 above) results

in lower AWQC. That is, as drinking water intake increases, and thus overall exposure increases,

the level of a contaminant in water at or below which negative health effects are not

anticipated from a lifetime of exposure decreases

.

Fish Consumption Rate

The updated fish consumption rate is 22 g/day, divided into trophic level rates of 8

g/day, 9 g/day, and 5 g/day for trophic levels 2, 3, and 4, respectively, which is higher than the

previously recommended rate of 17.5 g/day. Assuming all other input parameters remain

constant, a higher fish consumption rate assumption in the AWQC calculations (Eq. 1 and 2

above) results in lower AWQC. That is, as fish consumption increase, and thus overall exposure

increases, the level of a contaminant in water at or below which negative health effects are not

anticipated from a lifetime of exposure decreases.

Bioaccumulation Factor

The updated AWQC rely on EPI Suite model-estimated BAFs rather than the previously

recommended BCF of 53,600 L/kg. The lower (TL2), mid (TL3), and upper (TL4) trophic level

BAFs assumed in the updated criteria equations (Eq. 1 and 2 above) are 370,200, 678,800, and

1,636,000 L/kg wet-weight, respectively. Assuming all other input parameters remain constant,

the higher ratios of fish tissue concentrations to water concentrations of 4΂4͛ -DDD by aquatic

organisms result in lower AWQC. That is, as bioaccumulation or bioconcentration of a

contaminant in fish and shellfish increases, and thus overall exposure increases, the level of a

contaminant in water at or below which negative health effects are not anticipated from a

lifetime of exposure decreases. The utilization of a bioaccumulation factor rather than a

bioconcentration factor better represents the amount of a contaminant accumulating in an

Ϊιͽ̯ΣΊν΢ ̼̯͋̽Ϣν͋ Ίχ ̯̽̽ΪϢΣχν ΣΪχ ΪΣΜΘ ͕Ϊι χ·͋ Ϊιͽ̯ΣΊν΢͛ν ͋ϳζΪνϢι͋ χΪ χ·͋ ζΪΜΜϢχ̯Σχ ΊΣ χ·͋ Ϯ̯χ͋ι

column, but also from the food chain and surrounding environment as well as

94΂4͛ -DDD 72

- 54 -8

biotransformation of the pollutant in the organism due to metabolic processes. The utilization

of the three trophic levels of fish and shellfish consumed, as opposed to representing all trophic

levels of fish and shellfish consumed by a single value, allows for better exposure

representation, especially when pollutants bioaccumulate in significantly different amounts for

organisms in different trophic levels at different positions in the food chain.

Additional routes of exposure to a particular pollutant besides exposure from water

intake and fish consumption are possible and may be considered when setting criteria for a

state or tribe. Possible additional routes include, but are not limited to, dermal exposure,

inhalation exposure, marine fish and shellfish consumption (when not included in the fish

consumption rate), and non-fish dietary exposures (fruits, vegetables, grains, meats or poultry).

If scientific evidence exists which indicate that one or more of these routes pose a significant

risk of exposure, states and authorized tribes are encouraged to ensure that subpopulations are

adequately protected.

States, territories, and authorized tribes have the flexibility to develop criteria, on a sitespecific basis, that provide additional protection appropriate for highly exposed populations.

EPA is aware that exposure patterns in general, and fish consumption in particular, vary

substantially. EPA understands that highly exposed populations may be widely distributed

geographically throughout a given state, territory, or authorized tribal area. EPA recommends

that priority be given to identifying and adequately protecting the most highly exposed

populations. Thus, if a state, territory, or authorized tribe determines that a highly exposed

population is at greater risk and would not be adequately protected by criteria based on the

general population, and by the national 304(a) criteria in particular, the state, territory, or

authorized tribe may adopt more stringent criteria using alternative exposure assumptions

(USEPA, 2000). Subpopulations that may be considered include, but are not limited to,

recreational fishers, subsistence fishers, women of childbearing age, and children. When

scientific data exist showing one of these subpopulations is at risk of greater exposure to the

pollutant or are biologically more sensitive, then the relevant inputs should be considered in

setting criteria. This could entail raising the fish consumption rate to a level more reflective of

the subpopulation based on collected data or adjusting the body weight and drinking water

intake.

Chemical Name / Synonyms

 4΂4͛ -DDD (CAS Number 72

- 54 -8)

 1,1-bis(4-chlorophenyl)-2,2-dichloroethane

 1,1-bis(p-chlorophenyl)-2,2-dichloroethane

 2,2-bis(p-chlorophenyl)-1,1-dichloroethane

 DDD

 p,p'-DDD

 1,1-dichloro-2,2-bis(p-chlorophenyl)ethane

 Dichlorodiphenyl dichloroethane

104΂4͛ -DDD 72

- 54 -8

 Dichlorodiphenyl dichloroethane, p,p'-

 D ilene

 Rothane

 TDE

 p,p'-TDE

References

To matis, L., V. Turusov, R.T. Charles and M. Boicchi. 1974. Effect of long- term exposure to 1,1­

dichloro-2,2-bis(p-chlorophenyl)ethylene, to 1,1- dichloro-2,2-bis(p-chlorophenyl)­

ethane, and to the two chemicals combined on CF-1 mice. J. Natl. Cancer Inst. 52(3):

883

- 891.

USEPA (U.S. Environmental Protection Agency). 1980. Ambient Water Quality Criteria for DDT

. Office of Water. Washington, DC. EPA-440-5-80-0 38

. http://water.epa.gov/scitech/swguidance/standards/upload/2001_10_12_criteria_ambi

entwqc_ddt80.pdf

.

USEPA (U.S. Environmental Protection Agency). 1986. Guidelines for Carcinogen Risk

Assessment. Risk Assessment Forum. Washington, DC. EPA- 630 -R- 00 -004.

http://www.epa.gov/raf/publications/pdfs/CA%20GUIDELINES_1986.PDF

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USEPA (U.S. Environmental Protection Agency). 1988. p,p'-Dichlorodiphenyl dichloroethane

(DDD) (CASRN 72- 54 -8). Integrated Risk Information System . Retrieved 11 July 2013.

http://www.epa.gov/iris/subst/0347.htm

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USEPA (U.S. Environmental Protection Agency). 2000. Methodology for Deriving Ambient Water

Quality Criteria for the Protection of Human Health. Office of Water. Washington, DC.

EPA-822-B- 00

- 004.

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anhealth_method_complete.pdf

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USEPA (U.S. Environmental Protection Agency). 2002a. Estimated Per Capita Fish Consumption

in the United States. Washington, DC. EPA-821-C- 02 -003.

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on_report.pdf

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USEPA (U.S. Environmental Protection Agency). 2002b. National Recommended Water Quality

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- 047.

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.

114΂4͛ -DDD 72

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USEPA (U.S. Environmental Protection Agency). 2011 . Exposure Factors Handbook: 2011

Edition. Office of Research and Development. Washington, DC. EPA-600-R- 09 -052F.

http://www.epa.gov/ncea/efh/pdfs/efh-complete.pdf

. USEPA (U.S. Environmental Protection Agency). 2012̯ ̈́ EνχΊ΢̯χΊΪΣ  ́ιΪͽι̯΢ν ͜Σχ͋ι͕̯̽͋ ΋ϢΊχ͋TM

for Microsoft® Windows, v 4.10. United States Environmental Protection Agency,

Washington, DC, USA. http://www.epa.gov/oppt/exposure/pubs/episuite.htm

.

USEPA (U.S. Environmental Protection Agency). 201 2b

. Framework for Human Health Risk

Assessment to Inform Decision Making

. Office of the Science Advisor. Washington, DC.

EPA-601-D- 12

- 001. http://www.epa.gov/raf/files/framework-document-7- 13 -12.pdf

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USEPA (U.S. Environmental Protection Agency). 2014. Estimated Fish Consumption Rates for

the U.S. Population and Selected Subpopulations (NHANES 2003-2010). Office of Water.

Washington, DC. EPA-820-R- 14 -002.

12